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After announcing its quarterly earnings and a 24 percent increase in 2011 profits, AstraZeneca (AZ) today made public its decision to eliminate another 7,300 jobs. Earlier this week there was speculation that job cuts were likely but the exact numbers were not disclosed. 

The reasons given for the layoffs despite increased annual profits? Government spending cuts for healthcare and stiff generic competition for several of its blockbuster drugs including Seroquel XR (depression), Atacand (hypertension) Crestor (cholesterol-lowering) and Symbicort (asthma); all of which have lost or will be losing patent protection in the near future. According to a company press release generic competition cut revenues by $2.0 billion in 2011 whereas government price interventions cost the company another $1.0 billion. The announced job cuts are expected to save AZ $1.6 billion by 2014—great news for shareholders but not so much for the employees who are losing their jobs!

Most of the cuts will take place in R&D. To that end, the company will close its facility in Montreal and layoff staff at its Soedertaelje site in Sweden. Interestingly, the company plans on focusing more on neuroscience and intends to hire 40 to 50 scientists in its new Innovative Medicine unit which is partly based in Boston, MA and Cambridge in England.

While layoffs at AZ were expected, the size of the current layoff does not bode well for other pharmaceutical employees. It is becoming increasingly clear that big pharma companies are getting out of R&D and focusing their efforts on M&A and licensing deals to fill their thinning pipelines. Also, while shedding R&D and sales jobs in developed markets, big pharma companies are investing heavily in building facilities and hiring thousands of R&D and sales personnel in emerging markets. From my perspective, it appears that big pharma has consciously decided to abandon developed Western markets where sales growth is in the single digits in favor of emerging ones where double digit growth is expected for the next decade.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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Thing have been quiet in the pharma layoff space during 2012. I guess that is not so surprising since we are only one month into 2012. However, there was a post on yesterday’s Pharmalot blog which indicates pharma layoffs may resume in earnest over the next few weeks. 

According to the post, AstraZeneca (AZ) is poised to shed thousands of more jobs after the company announces it earnings later this week. As you may recall, AZ recently announced that it would lay off 400 employees at its US headquarters and eliminate another 1,150 jobs from its US sales force. Like other pharmaceutical companies, things have been tough for AZ as three of its blockbuster products Crestor (cholesterol lowering), Nexium (acid reflux) and Seroquel (antipsychotic) lose patent protection and face stiff generic competition.

The Pharmalot post also reported that:

“Between 2007 and 2009, AstraZeneca eliminated 12,600 positions, a move that saved $1.6 billion annually, although that figure rose to $2.4 billion by 2010. The cuts announced that year were designed to save $1.9 billion annually by 2014 It is not clear how much the drug maker hopes to save with still more cuts, but some $3 billion may be spent on a stock buyback to bolster shareholder confidence.”

It is important to note that the massive downsizing that has taken place in the pharma industry over the past decade has little to do with the recession and everything to do with the loss of blockbuster revenues due to generic encroachment. Put simply, most pharma companies grew too large too quickly and subsequently realized that could not sustain their vast infrastructures if the loss of blockbuster sales revenues could not be replaced by new products. To wit, if you look at the P&L statements of many pharmaceutical companies, most have $5 billon to $30 billion of readily-available cash reserves on hand to “play” with. Sadly, the downsizing that has taken place had little to do with the present and everything to do about the future profitability of big pharma companies.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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Chicago-based Abbott Laboratories today announced that it would lay off 700 employees from its medical devices and diagnostics division as part of an ongoing restructuring effort. 

Most of the layoffs will take place in the Chicago area and affect employees that manufacture the company’s cardiovascular stents and diagnostic tests. According to a company spokesperson approximately 500 persons who work in stent manufacturing and 200 who work in diagnostics will lose their jobs.

The restructuring of Abbott’s manufacturing operations began several years ago and about this time last year the company layed off about 1,900 employees in Lake County, Illinois.

In October, Abbott surprised investors and analysts with the announcement that it would spin off its branded drug business, including Humira (psoriasis and rheumatoid arthritis) it’s largest selling branded pharmaceutical product. Company executives argued that the split would allow stakeholders and investors to separately and more accurately value Abbott’s other less risky businesses which include nutritional (baby) formula, generic drugs and medical devices and diagnostics.

Despite signs of economic recovery, it appears that layoffs are still occurring at a pretty good clip at many pharma and biotech companies. It now appears that medical devices and diagnostic company employees, who were once immune to downsizing and reorganization, are now fair game.

Until next time...

Good Luck and Good Job Hunting!!!!

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Ed Silverman, the intrepid author of the Pharmalot Blog, reported today that the average price of prescription drugs through last month rose 7.2 per cent; which tops the annual price rate increases over the past decade. The cost analysis was done on 130 prescription drugs.

The biggest winners were: Suboxone, marketed by Reckitt Benckiser to treat opioid addiction which rose 21 percent. Cephalon raised the price of its Provigil narcolepsy pill by 15 percent and Sunovion Pharma hiked the prices of its Xopenex asthma and COPD med by 9.8 percent. Other drugmakers on the list included Genentech, Merck and Abbott Laboratories.

Ed cautioned that “the price changes are based on WAC, or wholesale acquisition cost, for more than 90 percent of the drugs, which means that less than 10 percent of increases are based on direct price or suggested wholesale price” Nevertheless, any wholesale price increases are always passed on to the end users aka patients!

It is troubling that in these tough economic times that drug prices continue to rise at unprecedented rates. And access to reasonably priced medicines continues to diminish.  Not surprisingly, prices continue to rise in advance of healthcare reform legislation that doesn’t kick in entirely until 2014.

Until next time

Good Luck and Good Job Hunting!!!!!!!

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Over the past week or so there have been daily snippets on various media platforms about business deals and opportunities in the Indian and Chinese life sciences market. While it is not news that many life sciences companies are expanding operations into these markets, the growing frequency of news items about the “goings on” in both markets are noteworthy.

The first bit of news that started the Indian and Chinese life sciences news avalanche, was a note on May 29 that appeared on The Economic Times’ website that reported that New Delhi-based JB Chemical and Pharmaceuticals planned to double the size of its medical sales reps to 1,500 over the next two years to increase its penetration into rural Indian markets. The company had previously divested it over-the-counter consumer business in Russia and other Commonwealth Independent States (CIS; composed of countries from the former Soviet Union) to start up new divisions in gynecology and dental products.

The same day, another New Delhi-based drugmaker called Lupin that specializes in generic drugs, announced that it plans to launch 50 new products by FY12; twelve of which will be generic drugs launched in the US. Both bits of information suggest that new previously untapped commercial opportunities are rapidly beginning to emerge in India and that Indian drug makers are looking to compete in the US and Western European markets that were previously dominated by American, Western European and Japanese companies.

In other India-related pharmaceutical news, an article appeared on June 2 at the Online Pharma Times website that reported that Shlomo Yanai, CEO of the Israeli generic pharmaceutical giant Teva, had flown to India to discuss potential collaborations with pharmaceutical companies there. While most analysts do not think that an acquisition is likely—Teva agreed to buy US-based Cephalon in May for $6.8 billion and also paid $460 million to acquire a controlling stake in Japanese generics group Taiyo Pharmaceuticals—it signals a growing interest by foreign companies to do deals in India to establish a presence it that market.

Like the Indian market, the Chinese market is beginning to heat up. An article at Bloomberg.com published on June 1 reported that Novo Nordisk will boosts its investment in China to preserve its dominance in the diabetes market after rival Sanofi announced a new foray into the Chinese market.

According to a report issued last fall by the International Market Analysis Research and Consulting Group, the Chinese diabetes market is expected to grow from $642 million in 2009 to more that $2.8 billion in 2015. The reason for the increase is attributed to the trend of more people moving from rural areas to cities and changes in eating habits and lifestyles that are contributing to a growing Chinese obesity problem. At present the US Centers for Disease Control in Atlanta estimates that roughly 8.3 percent of the U.S. population and 6.6 percent of the global population has diabetes

Novo first entered the Chinese market about 15 years ago and in 2002 created a diabetes research center and in 2007, in association with the Chinese Academy of Sciences established a foundation to fight diabetes. This year, the company plans on expanding its insulin packaging plant in China becoming the world’s largest insulin packaging facility.

Likewise, in 2005 Sanofi created a diabetes clinic. Three years later is expanded the clinics operations, established a clinical trial center and entered into a partnership with the Shanghai Institutes for Biological Sciences to develop treatments for diabetes, cancer and neurological diseases.

On Jun 3, Pfizer, the world’s largest drugmaker (for now) announced that it plans to partner in a joint venture with China’s Zhejian Hisun Pharmaceutical Company to produce generic drugs for the emerging Chinese market. According to the post on Bloomberg.com

“Pfizer is looking for new sources of revenue before it loses U.S. patent protection in November for Lipitor, the cholesterol medication that was the world’s best-selling drug last year with $10.7 billion in sales. Off-patent medicines, including branded generics, are one of the fastest growing segments in the global pharmaceutical market, Pfizer and Hisun said in a joint press release.”

At present, Pfizer is the top drug company in China (by sales) followed by AstraZeneca and Sanofi according to information supplied by the prescription drug intelligence firm IMS. The size of the Chinese drug market is project to grow by 25 percent this year and rough 60% of the existing market is dominated by generic drugs.

Finally, Chinese pharmaceutical companies are also beginning to invest in the US market. Late last week, the Tianjin Tasly Pharmaceutical Group signed an agreement with the State of Maryland to invest $40 million to build a tradition Chinese medicine (TCM) facility to provide TCM training and information. According to a press release:

“Tasly Pharmaceutical is currently preparing materials for approval by America’s Food and Drug Administration and plans to sell compound danshen drip pills in US and European markets. The medicine’s primary ingredient is obtained from the salvia miltiorrhiza species and is used to treat cardiovascular and cerebrovascular diseases. Danshen is also known colloquially as red sage or Chinese sage.”

I think it is time to pay more attentions to the ebb and flow of the Indian and Chinese markets!

Until next time,

Good Luck and Good Job Hunting (try India and China)!!!!!!

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The loss of patent protection and a decline in revenues for a number of blockbuster brand name antibiotics has caused many big pharmaceutical companies to exit the antibacterial drug discovery market. The three remaining big pharma companies still actively engaged in antibacterial research are GlaxoSmithKline, AstraZeneca and Novartis (all European owned companies).

A new report by UK-based Datamonitor entitled “Forecast Insight: Antibacterials” predicts that antibiotic sales revenues will decline from $19.6 billion in 2009 to about $16.4 billion in 2019. Not surprisingly, the report blames the projected decline on generic competition and the lack of new antibiotic launches over the past 10 years.

At present, the top seven antibiotic markets in the world include the US, Japan, France, Germany, Italy, Spain and the UK. According to Datamonitor’s analyses, total sales in these markets have fallen by about 1.6 percent annually since 2005 and will continue to decline by almost 2.0 percent a year through 2019. In 2009, three antibiotics had sales of about or more than $1.0 billion; Johnson & Johnson’s Levaquin (market leader), and Pfizer’s Zosyn, and Zyvox. Interestingly, Pfizer recently decided to shut down its US-based antibacterial drug discovery program and move it to China and Johnson & Johnson recently announced that it was getting out of the antibiotic discovery business. 

Big pharma’s decision to abandon antibiotic research could not have come at a worse time. The incidence of antibiotic resistance among both Gram positive and Gram negative bacteria is rising at unprecedented rates. And while safe and effective treatments for Gram positive infections including MRSA (methicillin-resistant Staphylococcus aureus) still exist, the number of treatment options to treat Gram negative infections caused by Acinetobacter spp, Pseudomonas aeruginosa and enteric bacteria is severely limited. The recent description and rapid spread of a beta-lactamase enzyme called NDM-1 that inactivates the antibiotic carbapenem—the last safe and effective antibiotic to universally treat infections caused by Gram negative bacteria —is extremely troubling and worrisome.

While much of the focus over the last decade was on MRSA, infections caused by untreatable, multiple drug resistant Gram negative bacteria will pose the greatest public health threat over the next 10 years. Unfortunately, it is much harder to develop new antibiotic treatments for Gram negative infections as compared with ones caused by Gram positive bacteria. Further, at present, most of the companies that remain in the antibiotic space continue to focus on new treatment for MRSA and related bacteria. Consequently, new treatments for Gram negative infections may be more than a decade away!

Finally, like MRSA, most infections caused by multiple drug resistant Gram negative bacteria are nosocomial in nature (although the incidence of community acquired infections is also on the rise). This means that the most likely place to become infected with these bacteria is institutionalized healthcare settings including hospitals and nursing homes.

In the past, we have relied on pharmaceutical and biotechnology companies to discover new antibiotic treatments. The decision of many of these companies to leave the antibacterial space for purely financial reasons is unfortunate and regrettable. However, the growing incidence of antibiotic resistance among both Gram positive and Gram negative bacteria suggests that new antibiotics are necessary and that alternate approaches to new antibiotic drug discovery must be implemented. Whether this is through public/private partnerships or strictly through government programs is irrelevant. The bottom line is that we need new antibiotics; and if they are not discovered soon, many patients will die from previously treatable bacterial infections!

Until next time...

Good Luck and Good Job Hunting (start an antibiotic drug discovery company)

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Takeda Pharmaceutical Company, Japan’s largest pharmaceutical company, yesterday announced its intention to purchase the Swiss drug maker Nycomed for 8 to 10 billion euros ($11.4-14 billion). While the deal is not certain to close, it signals Takeda’s intention to purchase its way into the US and European markets.

Takeda acquired Cambridge, MA-based Millennium Pharmaceuticals in 2008 for $8.8 billion, the largest foreign acquisition ever by a Japanese company. The Millennium acquisition was intended to bolster Takeda’s competencies in genomics and oncology drug discovery. If Takeda is successful in its bid, Nycomed would enhance the company’s standing in treatments for gastric, respiratory and inflammatory disorders. Nycomed has operations in roughly 70 countries, with Europe representing 50 percent of the company’s sale and emerging markets 38 percent.

Takeda’s chief executive officer Yasuchika Hasegawa has pursued an aggressive M&A strategy since assuming control of the company in 2003. Historically, Japanese drugmakers intentionally remained small and were content doing business in local and other Asian markets. However, Hasegawa has changed the “game” and has forced some of Takeda’s rivals to emulate his global strategy. To that end, in recent years Daiichi Sankyo Company has purchased Plexxikon and Ranbaxy and Astellas acquired OSI pharmaceuticals as part of a westward expansion.

While Takeda remains Japan’s largest pharmaceutical company, net profit slumped 17 percent last year and the company is losing patent protection for its largest selling drugs, Prevacid (ulcers) and Actos (diabetes). Like Takeda, Nycomed sales are being hit by the loss of patent protection for its largest selling drug Protonix (antacid). Worldwide sales of the drug plummeted by almost 28 percent. Therefore, it would appear that Takeda’s pursuit of Nycomed is based more on its pipeline rather than currently marketed products.

Stay tuned for late-breaking news on the deal!

Until next time,

Good Luck and Good Job Hunting!!!!!

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Layoffs at big pharma companies have become commonplace but downsizing at generic manufacturers? Aren’t generic drugs sales exploding through the roof? And, aren’t all major pharmaceutical companies facing patent cliffs responsible for the massive downsizing that has taken place over the past four years? Teva executives apparently didn’t get that memo and announced today that the company will lay off 200 employees at its Irvine, CA manufacturing facility. Of the 200, 195 will lose their jobs by February 6, 2011.

This is the second round of layoffs at the manufacturing facility that Teva acquired after purchasing biosimilar manufacturer Sicor Inc., in 2003 for $3.4 billion. Last July, 70 jobs were eliminated at the plant which previously manufactured Propofol, the powerful sedative implicated in Michael Jackson’s death. Teva has since discontinued production of the drug because of the drug because it was hard to manufacture and that the company got little or no profit from it.

The company had to halted production and recalled some Propofol in 2009 after 41 patients were sickened with flu-like symptoms. The problem resulted from elevated endotoxin levels found in some vials of the sedative. Several lawsuits also were filed over the drug.

Until next time...

Good Luck and Good Job Hunting!!!!

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Most major pharmaceutical companies left Brazil about 30 years ago. However, much has changed in the country over the past 30 years and most western pharmaceutical companies are rushing back into Brazil to expand their operations and make acquisitions. At the same time, many Brazilian drug makers are beginning to consolidate and spread abroad.

The exodus of multinational drug companies in the 1980s was prompted by high inflation, tough government-mandated price controls and the lack of strong intellectual property and patent laws. Over the past 20 years Brazil has become a leader in agricultural technologies and made substantial investments into biotechnology. Along with these gains, patent rules and regulatory rules for pharmaceuticals and generics have become much stricter; making Brazil much more attractive to most major pharmaceutical manufacturers as growth of established markets continues to slow and need to increase sales in developing markets is critical. At present, Brazil is the eight largest eighth-largest drug markets in the world by sales. Much of this growth has been spurred by the rapid growth of the middle class (remarkably without reimbursement from state or private health insurance).

Some of the drug makers that have already invested in Brazil include Novo Nordisk, Sanofi-Aventis, Pfizer and Astra Zeneca. Novo Nordisk was an early entrant with its purchase in 2001 of Biobrás, a large insulin production plant outside São Paulo. Last year, Sanofi-Aventis acquired Medley, growing its portfolio of over-the-counter and branded products to complement its own offerings. Last month, Pfizer bought 40 per cent of Teuto, another generics business; other US, European and Japanese companies are continuing to study the Brazilian market closely.

While many western companies have gained a foothold in Brazil through M &A activity, others are attempting to develop their own internal presence.  Astra Zeneca, for example, is preparing for a launch of a series of both branded and generic products in the country.

In addition to the growing interest of multinational companies, some of Brazil’s domestic drug makers have been active. For example, Aché, a family-owned group and one of Brazil’s largest branded generics producers, has made smaller domestic acquisitions, and was considering buying Medley. The company has also begun forging alliances across Latin America, while its rival Eurofarma earlier this year bought Laboratorios Gautier in Uruguay, as the groups seek economies of scale in manufacturing and sales across the region. Even Farmaguinhos, the state-owned Brazilian drug company, has been collaborating with the African nation Mozambique.

Although the Brazilian government has made sizeable investments into research units such as the Butantan Institute in São Paulo and Oswaldo Cruz in Rio de Janeiro, the Brazilian drug industry is still in its infancy. The question is whether or not domestic drug makers will be able to meet demand before they are acquired by foreign companies interested in making inroads into Brazil’s burgeon drug market.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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Despite assertions by its CEO that there isn’t enough scientific talent in the US, Eli Lilly announced that it will lay off a couple of thousand employees within the next 90 days. Most of the cuts will take place in Indianapolis at four different sites where the company currently employees about 13,000 workers. According to an article in today’s Indianapolis Star

“The struggling Indianapolis company, which has been cutting thousands of jobs in recent months, told the state on Monday that its downsizing is not temporary, but for the long haul.

The reductions in force at the Indianapolis sites of employment are expected to be permanent," wrote Kay Jackson, Lilly's senior director of human resources, in a letter to the Indiana Department of Workforce Development. She added that the cuts, when added up, are not expected to be more than 33 percent of the head count at any one site, or more than 500 workers at any site."

Like most of its rival big pharma companies, Lilly has cut the number of full-time equivalent workers by about 2,100 worldwide since last September. That's when it announced it would cut a total of 5,500 workers worldwide by 2011 to save $1 billion in annual costs. The reason for the cuts; an expected steep falloff in revenues over the next few years when the patents on Lilly's blockbuster drugs begin to expire and face low-priced generic competition  

John C. Lechleiter, Ph.D, Lilly’s CEO, contends that the lack of innovation and new product development at most American pharmaceutical companies can be explained by a dearth of qualified and adequately trained American scientists. Maybe this is why most pharma R&D job are currently being outsourced to China, India, Brazil and Eastern Europe? Alternatively, it may be cheaper to employ US-trained foreign nationals in these places rather than high priced American scientists who perform similar jobs in the US.  

Until next time...

Good Luck and Good Job Hunting (forget Indiana-not there is anything wrong with it)

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The once venerable drugmarker Eli Lilly & Co yesterday announced that it would co-brand its Humulin insulin product with Walmart one of the world’s largest retailers starting in mid September. According to a Lilly spokesperson the product will be sold in U.S. Wal-Mart pharmacies.

Humulin, with $1 billion in worldwide sales for Lilly last year, will be Lilly’s first co-branded product with a retail pharmacy and will replace Wal-Mart’s current Relion insulin brand. The Lilly-Walmart deal is indicative of the massive changes that are taking place in the pharmaceutical industry as generic products begin to encroach on blockbuster brand name product franchises. 

The move will undoubtedly expand the product lifecycle of Lilly’s Humulin brand given Walmart’s vast distribution channels and its gargantuan customer base.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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It is no secret that growth of the pharmaceutical industry has slowed to single digits in the past five years or more. In fact, many experts don’t expect there to be double digit growth in this sector for a long time. Instead, future robust growth of the pharmaceutical industry is expected to take place in emerging markets including India, China, Brazil, South Africa and others. This is because the economies of these countries are booming and the middle class in these nations continues to rapidly grow. 

While branded prescriptions drugs once dominated Western markets, it is likely that generics or branded generic products will be the major players in emerging markets. Because of this, big pharma companies such as GlaxoSmithKline, Daiichi Sankyo and most recently Abbott Laboratories have either purchased or crafted large marketing deals with smaller regional drug manufacturers.

Daiichi Sankyo paid $4.0 billion in 2008 for a major share of India’s Ranbaxy Laboratories and GlaxoSmithKline earlier this year acquired exclusive rights to over 100 products produced by Dr. Reddy’s Laboratories, another Indian drug maker with a broad reach in emerging markets.

Today, Abbott Laboratories announced that it would purchase the healthcare business of Piramal Healthcare Ltd, one of India’s largest purveyors of branded generics for $3.72 billion. When the deal closes, Abbott will inherit the rights to about 350 brands and trademarks and a manufacturing plant in northern India. Also, Piramal agreed to a six year non-compete agreement for branded generics. The remaining parts of Piramal include a custom manufacturing business, over-the-counter products, vitamins, diagnostic devices and Piramal Life Sciences a drug discovery company.

The company, which has India’s largest sales force, would become a subsidiary of Abbott Laboratories and employ about 7,500 workers. Last week, Abbott said it would license at least 24 products from Zydus Cadila to sell in emerging markets. Analysts estimate that emerging markets account for 20 percent of Abbott’s business. The Piramal and Zydus Cadila deals suggest that Abbott maybe the company to reckon with in emerging markets in India and elsewhere.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Those of us a certain age have all heard of the so-called new math—which by all accounts wasn’t much different than old math—that was suppose to revolutionize the way math was taught at the primary and secondary education levels. While new math may not have not have much different or better than old math from an academic perspective, pharmaceutical companies will have to reckon with the new math associated with the pricing of brand name prescription drugs if they want to remain competitive in the future.

According to statistics offered in a recent New York Times article on Teva Pharmaceuticals, the world’s largest generic drug manufacturer, generics now account for 75 per cent of the prescriptions filled in the United States. This figure is up 47 percent from a decade ago. Further, a recent study from IMS, the research firm that tracks prescription drug use, generic drugs saved the American healthcare system $734 billion between 1999 and 2008. These numbers, coupled with a paltry 25 per cent market share, suggest that brand name pharmaceutical companies must rethink the low volume, large margin pricing strategy that has guided big pharma for the past 50 years. 

As one Teva executive candidly put it, “If you are used to the fat margins of big pharma, it is hard to compete in the rough and tumble of price-cutting generics.” 

The push for wider adoption and use of generic pharmaceuticals and biologics (as compared with brand name drugs) suggests that there will likely be more belt-tightening at big pharma companies in the not-so-distant future.

Until next time..

Good Luck and Good Job Hunting!!!!!!

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After months of speculation and a nine month-long bidding war, Teva not Pfizer has emerged as the winner to purchase Ratiopharm; the financially-troubled, German generics manufacturer. Ratiopharm was Germany’s second largest generics manufacturer.

Teva Pharmaceutical Industries Ltd announced today that it has entered into a definitive agreement to acquire Ratiopharm, Germany's second largest generics producer (Novartis AG’s Hexal unit is first and Stada Arzneimittel AG is third) and the sixth largest generic drug company worldwide, for €3.625 billion ($ 5.0 billion). Teva expects to complete the transaction by year-end 2010.

The acquisition will position Teva as the leading generic pharmaceutical company in Europe. Ratiopharm's extensive product portfolio includes 500 molecules in over 10,000 presentation forms covering all major therapeutic areas marketed in 26 countries. Also, Ratiopharm has valuable know-how in biosimilars (a market that Teva has entered and is extremely bullish on) which consists number of products in advanced stages of development and a well-established sales and marketing team. The combined company will have 40,000 employees worldwide, of which 18,000 will be based in Europe. The purchase will bolster Teva’s visibility and standing in European markets.

Late last month, Ratiopharm board members implored Pfizer to enter a new bid, after it had rejected an earlier offer by the company. Apparently, the new bid was not sufficient to prevent Teva from acquiring the highly sought after generics manufacturer. Iceland-based generics manufacturer Actavis also put in a failed bid to acquire Ratiopharm.

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Astra Zeneca announced today that it has agreed to market 18 of Torrent Pharmaceuticals Ltd.’s branded generic drugs in 9 emerging markets, marking the U.K. drugmaker’s first generic-drug partnership.

Unlike some its competitors, Astra Zeneca is very vulnerable to generic competition as many of its best selling products such as Nexium for ulcers, the antipsychotic Seroquel and Crestor for cholesterol. are near patent expiry. Industry analysts expect the company to lose as much as 25% of its sales revenue to generic encroachment by 2014.

The company joins a growing list of big pharma companies including Pfizer, Sanofi-Aventis and GlaxoSmithKline that view generics as a viable replacement for revenues lost to generic competition for it top selling brands.

Last year, GlaxoSmithKline entered into joint ventures with the generic manufacturers Dr. Reddy’s Laboratories (India) and Aspen Pharmacare Ltd (South Africa). Also, the company paid $246.5 million for Bristol-Myers Squibb’s Pakistan and Egypt drug units and acquired UCB’s drug portfolio in Africa, the Middle East, Asia Pacific and Latin America for $702 million; clearing signaling its intention to more aggressively pursue emerging global markets.

Likewise, Sanofi-Aventis bought Zentiva NV of the Czech Republic, Helvepharm AG of Switzerland, Medley SA of Brazil and Laboratorios Kendrick SA of Mexico to bolster its branded generics portfolio. The company also took control of the Indian vaccine and biologics manufacturer Shantha Biotechnics which suggest that Sanofi may be looking to biotech in the future.

Finally, Pfizer continues its pursuit of the financially-troubled German, generics giant Ratiopharm. Actavis of Iceland and the Israeli generics manufacturer Teva have also put in bids to purchase Ratiopharm. However, there are signs that Ratiopharm's board would prefer to be purchased by Pfizer rather than Teva or Actavis.

Look for other big pharma companies to enter into deals with or purchase branded or conventional generics manufacturers.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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Earlier this week, an article appeared in the NY Times Business section heralding the entry of several large pharmaceutical companies into the branded generics industry. For those of you who may not know, generic drugs are lower cost versions of brand name prescription drugs that have lost patent protection. Generic prescription drugs are usually much cheaper than their brand name counterparts but generally deliver the same therapeutic effects as the branded product. In most cases, so-called “commodity generic drugs” are not branded and sold to consumers by their chemical names. A good example of a commodity generic drug is the anti-depressant sertraline HCl; which Pfizer sells under the brand name Zoloft. Pfizer still manufactures and sells Zoloft but Zoloft lost patent protection several years ago and a generic version of the active ingredient, sertraline HCl, is now available to consumers. Because sertraline HCl is much cheaper than Zoloft, pharmacists almost always substitute prescriptions for Zoloft with sertraline HCl. This is perfectly acceptable because sertraline HCl was approved by the US Food and Drug administration with an AB rating which means that sertraline HCl is biologically equivalent to Zoloft.

Unlike commoditized (no-name) generics, branded generics are off-patent prescription drugs that are sold to consumers—as the name implies—under a brand name. Typically, because these products are “branded” and actively marketed by manufacturers they are sold at higher prices than equivalent no-name generics. This is because consumers are generally willing to pay more for drugs that are manufactured by well known and trusted companies as compared with no-name generics which are usually produced by lesser known or unidentified manufacturers.

Branded generics are not a new or novel concept. They were previously championed by a number of generics manufacturers, most notably Barr Laboratories, which was recently purchased by the Israeli generics giant TEVA. In the past, when pharma embraced the blockbuster drug business model, drug manufacturers built in revenues— that eventually would be lost through patent expiry—into the price of their top selling drugs. This allows drug companies to maximize ROI early in a drug’s life cycle years before patent expiry Studies have shown that branded prescription drugs can lose as much as 90% of their original value two years after the introduction of generic equivalents. Consequently, because of drastically diminishing financial returns after patent expiry, it didn’t make economic sense to continue to promote and support a brand that was facing generic competition. Put simply, the company made its money on the drug and it is time to move on. 

However, the emergence in recent years of an affluent middle class in developing markets like China, India, Brazil, Eastern Europe and elsewhere is causing branded pharmaceutical companies to reconsider their generics strategy. In these markets, many people frequently pay out of pocket for their medicines but cannot afford to pay for the expensive brand name drugs. Also, in some emerging markets, where the threat of low quality or counterfeit prescription drugs may be high, consumers who can afford to purchase medicines are willing to pay more for drugs manufactured by well known and respected companies. Finally, IMS Health estimates that close to $89 billion in US drug sales alone will be lost to generic competition over the next five years or so.

In the absence of any new blockbuster drugs on the horizon, many big pharma companies have been scrambling to acquire or enter into relationship with established regional generic manufacturers. For example, GlaxoSmithKline recently bought a stake in Aspen a South African generics manufacturer and entered into an agreement with India-based Dr. Reddy’s laboratory to sell generic products in Asia and other emerging markets. Likewise, in the last year, Pfizer created an off-patent generics division (products are sold under Greenstone label which is a wholly owned subsidiary of Pfizer) and signed agreements with three Indian companies to sell their products in the US and other markets. These deals added about 200 products to Pfizer’s new generics portfolio. Further, Pfizer recently announced that the Greenstone brand has become the world’s seventh largest generics seller. In addition, Pfizer is expected to make a formal bid to purchase the financially-troubled German generics manufacturer Ratiopharm; one of Germany’s largest purveyor of generic drugs.

Not to be outdone by the competition, the French drug maker Sanofi-Aventis recently purchased Brazil-based Medley, a dominant player in the South American branded generics industry and Laboratorios Kendrik, a Mexican generics producer. Last year, the company also purchased Zentiva, a leading Czech generic manufacturer signally the company’s intention to move into financially-lucrative Eastern European markets.

Watson, one of the largest American generics manufacturers (which primarily operates in the US) recently purchased Arrow, a generic producer that operates in 20 different countries. Finally, Novartis, recognizing a business opportunity before most of its competitors, entered the generic market in 2003 following creation of Sandoz, a division of Novartis that manufactures and sells small molecule generic drugs and branded biosimilar products. Recently, Novartis purchased the German branded generics manufacturer Hexal, making it the world’s second largest generic drug manufacturer after Teva.

The entry of pharmaceutical companies into the generics business is allowing these companies to pursue a two-tiered business strategy in certain markets which is designed to preserve the long term value of their branded franchises. For example, companies can continue to sell their expensive name-brand drugs to the wealthy (or those that can afford them) and concurrently sell the more moderately priced branded generics which includes and over the counter products to the broader market. 

While some may lament the end of the blockbuster drug era, rising healthcare costs and generic competition is forcing big pharma to continue to explore novel and innovative strategies to reinvent itself.

Until next time...

Good Luck and Good Job Hunting (try the generic industry; business is booming)

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The loss of over 200,000 pharmaceutical jobs over the past three years has been mainly driven by the anticipated loss of revenue from blockbuster drugs that will lose patent protection by 2013. While drug makers frequently cite blockbuster patent expiry as the reason for the need to downsize, they rarely provide the business and economic metrics, numbers and statistics that have influenced their decisions. 

Patricia Van Arnum, Senior Editor of Pharmaceutical Technology wrote a fascinating article in this month’s issue of Pharmaceutical Technology Europe that skillfully outlined the economic forces that are driving branded pharmaceutical companies to downsize and reorganize. According to the article, in October 2009 the pharmaceutical intelligence firm IMS estimated that the global pharmaceutical market is expected to growth 4-6% in 2010 and reach $825 billion. Market growth at an annual rate of 4-7% is expected to continue through 2013 and the size of global pharmaceutical market is projected to exceed $975 billion. The US pharmaceutical market, the largest in the world, is expected to drive much of this growth. However, the growth of the American market is only expected to be 3.5% in 2010. In market contrast, China’s pharmaceutical market is expected to increase by a staggering 20% per year and contribute 21% to the overall growth of the global pharmaceutical market by 2013. 

While prospects for the US market are better than originally anticipated, the loss of nearly $137 billion in revenues in 2013— because of patent expiry of blockbuster products—coupled with fewer new drug approvals are the factors that will limit the growth of the global pharmaceutical market to single digits through 2013 and likely beyond. Some of the drugs slated to lose patent protection by 2013 include Lipitor (atorvastatin) by Pfizer, Plavix (clopidogrel) by Sanofi-Aventis and Bristol-Myers Squibb and Seretide/Advair (salmeterol and fluticasone) by GlaxoSmithKline. Lipitor, Plavix and Seretide were the number one-, two- and foruth best-selling drugs in 2008 with global sales of $13.7 billion, $8.6 billion and $7.7 billion respectively.

The increasing growth of the generic pharmaceutical industry is best reflected in the concomitant growth of merchant active pharmaceutical ingredient (API) manufacturing industry. In the API world, there are two types of manufacturers; the so-called captive API producers or companies that exclusively manufacture APIs for finished, branded products and merchant manufacturers which are third party providers of APIs. Over the past four years or so, the growth of the merchant API market for generic products has substantially outpaced the growth of the API for innovator products. For example, from 2004-2008 the merchant market for generics grew at an average annual rate of 9.1% from $12 billion in 2004 to $17 billion in 2008 according to a recent report by the Chemical Pharmaceutical Association (CPA). In contrast, the CPA determined that the merchant market for innovator/branded APIs only increased at an average annual rate of 4.4% from $16 billion in 2004 to $19 billion in 2008. Looking ahead, the worldwide market for merchant APIs is projected to grow at an average annual growth rate of 6.8% through 2013 to about $50 billion. During this period, growth of innovator APIs is expected to be about 1.8% whereas the growth of generic API is expected to be a robust 11.4%.

The US is currently the largest market for generic APIs and consumed roughly 22.9% of the total global demand for generic APIs in 2008. China, which is the second largest consumer of generic APIs, consumed 19.2%. While the US is expected to remain the largest consumer of both innovator and generic APIs, China is projected to become the largest consumer of generic APIs in 2013 capturing a 26% share of the total generic API market (the US will be number 2 with 20.5% market share).

According to industry analysts, China, India, Latin America and Central and Eastern Europe (most notably Russia), represent attractive growth opportunities for generic APIs. India and China now account for roughly 25% of the global generic market and demand in these countries is expected to remain strong for the foreseeable future as the middle class continues to emerge. To that end, China is projected to have the highest average annual growth rate at 18.4% and India’s market will grow by 14% through 2013. Similar growth is expected for the Eastern European, Russian and Brazilian generic API markets.

While the economic size of emerging generic markets is still small compared with those of the US, Western Europe and Japan, it signals that generic drugs will likely drive the future growth of the pharmaceutical industry. The lack of innovation and rising costs of branded, prescription drugs in developed nations is the main driving force behind the rapid emergence of the generic drug industry. That said, is it any wonder why Pfizer is thinking about entering the generic pharmaceutical business and that Western drug companies are shedding scientists and sales people in the US and Europe and growing the sizes of their R&D and sales force staffs in Asia, Eastern Europe and Latin America? Honestly, if I had any money left to invest, I would seriously be considering traded generic pharmaceutical manufacturers—their future success is almost guaranteed!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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GlaxoSmithKline (GSK) Britain’s largest pharmaceutical company today announced it plans on slashing 4,000 jobs over the coming months. The bulk of the cuts will be in America and Europe, and are part of the company’s efforts to shift resources away from low-growth territories into parts of the world with greater scope to expand sales, most notably Asia. GSK’s currently employs 99,000 workers worldwide. The reduction in headcount will be combined with a drive to make the company’s research and development more cost-efficient. 

While the job losses will not be as severe as those announced last week by its rival Astra Zeneca, they will provide further depressing news for a sector that is fighting to contain costs as it reduces its reliance on big-selling blockbuster drugs, many of whose patents will expire in the next two to three years.

The pipeline of new drugs at GSK is much deeper than at many of its rivals, say industry analysts. The company’s roster of planned launches includes Menhibrix, a vaccine to combat meningitis, and Benlysta (belimumab), a novel, monoclonal antibody treatment for systemic lupus erythematosus that it is co-developing with Maryland-based, Human Genome Sciences. In total, the group has more than 30 products in the advanced stages of development and testing.

While GSK continues to develop new drugs, it has increasingly been turning to emerging markets to find and sustain corporate growth. This has meant that thousands of jobs have already been sacrificed in the West, although the company is adding staff elsewhere. For example, it recently cut 2,000 sales jobs in America but added 1,500 staff in China. Also, GSK’s vaccine division has suffered a few regulatory setbacks with its pneumococcal vaccine Synflorix and its cervical cancer vaccine Cervarix. The loss of market share in these areas has put additional financial pressure on the company.

Like many of its competitors, GSK is looking to other divisions of the company to cover projected losses in the pharmaceutical sector. Recently, GSK has shifted a lot of its attention to its consumer products division, which owns brands such as Lucozade and Ribena soft drinks, Aquafresh and Sensodyne toothpaste, and over-the-counter medicines such as Panadol painkillers and Alli, a weight-loss pill. Analysts predict the division will have raised its annual sales 18% to £4.7 billion. A deal signed last year to increase sales of Lucozade in China has provided the blueprint for how the company would like to develop the consumer healthcare side of its business.

Similarly, last week, Sanofi-Aventis, a French rival, announced a joint venture with Minsheng Pharmaceutical Group, a Chinese company, to sell vitamin pills and nutritional supplements. Also, Pfizer recently announced it would bid for the possibility of purchasing the financially-troubled German generics manufacturer Ratiopharm; signaling the possibility that the world's largest branded pharmaceutical manager may be toying with the idea of getting into the generics business.

Late last year I predicted that more pharmaceutical company employees would loss their jobs. Sadly, this prediction has come true. That said, I am surprised at the scope and size of the layoffs that have already taken place in 2010. I suspect that more layoffs are likely in the near future if the economy doesn’t turn around anytime soon.

Hat tip to Ed at the Pharmalot blog!

Until next time...

Good Luck and Good Job Hunting (try medical devices or biotech)!!!!!!!!

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Pfizer is one of three companies vying for the opportunity to . Teva Pharmaceutical Industries Ltd, the Swedish private equity fund EQT and Pfizer are the three finalists to purchase Ratiopharm GmbH which is valued at about €2.8-3 billion. The finalists will make their bids in early February. France’s Sanofi-Aventis SA Euronext and China’s Sinopharm Group Co. Ltd. withdrew from the tender in December

Ratiopharm is a private company owned by the Merckle family. Ludwig Merckle put the company up for sale last year, after his late father Adolf Merckle committed suicide in early 2009 after losing control over his business empire to lenders. If Teva acquires Ratiopharm, it will win a major foothold in the German healthcare market, considered a large and growing market. Teva, the world’s largest generic drug company, is currently not a big player in the German market.

 The rising development and retail costs of name brand prescription drugs and the future possibility of price controls in the US is forcing pharmaceutical companies to reconsider the value of generic drugs. Currently, generic prescriptions are rapidly outpacing those for branded products and the size of the US and international markets for both small and large molecule drugs (biosimilars) growing daily. Previously, most innovator companies didn’t think the profit margins nor returns on investment were sufficient to add generic molecules to their product portfolios. However, a few large pharmaceutical companies have already entered the generics fracas; most notably Sandoz (a division of Novartis) which manufactures both generic small molecule and biosimilar biotechnology products and more recently established Merck BioVentures which aims to compete in the follow-on biologics market. 

Many experts believe that it is only a mater of time before most big pharma companies like Pfizer realize that they have to be in both the branded and generic sides of the business. Don’t be surprised over the coming months if other pharma companies consider doing deals to acquire generic drug manufacturers. Diversification will be the mantra of the next decade or so!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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Novartis AG today announced it plans to take over Alcon Inc. by paying $38.5 billion for the 77 percent stake it does not already own in a deal that would make it one of the biggest players in the global market for eye-care products.

The Swiss pharmaceutical and generics giant had already purchased 25 percent of Alcon from Nestle in April 2008 for $11 billion, with the option of buying the food and drinks company's remaining stake at a later date. With the acquisition of Alcon, Novartis will control about 70% of the world’s vision market (it already owns the Ciba Vision brand). Alcon is based in Huenenberg, Switzerland, and has its U.S. headquarters in Fort Worth, Texas. The company employs some 15,000 people worldwide and specializes in surgical equipment and devices, contacts lens solutions and other consumer eye-care products.

Daniel Vasella, MD, Novartis’ Chairman and CEO, said "This is the right time to simplify Alcon's ownership to eliminate uncertainties for employees and shareholders." He added "It will also allow us to strengthen innovation power by combining R&D efforts and grow our global market presence thanks to our complementary product portfolios."

If I were a betting man, I would say that Novartis is the pharmaceutical company to watch over the next decade. Like Johnson and Johnson, the company has diversified its business to include consumer goods, vaccines and perhaps most importantly generic pharmaceuticals via its Sandoz division. One area that Novartis hasn’t fully embraced to date is devices. However, as we enter the age of personalized medicine, don’t be surprised if the company acquires or invests in a variety of medical devices and diagnostic companies!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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The generic drug industry didn’t exist until the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This piece of legislation, better known in the pharmaceutical industry as the Hatch-Waxman Act, was proposed and adopted by the US Congress because of the escalating costs of brand name drugs manufactured by large pharmaceutical companies (sound familiar?). The act provided the US Food and Drug Administration (FDA) with a regulatory pathway to approve and bring to market “generic” versions of branded drugs that lost patent protection. During the debate over the amendment, and for many years thereafter, branded pharmaceutical manufacturers tried to stifle the growth of the generic drug industry by suggesting that generic versions of their branded medications were unreliable and unsafe. This tactic was partly responsible for the stinted growth of the generic pharmaceutical industry until the mid 1990s when the price of branded pharmaceutical drugs began to skyrocket and insurance companies began to realize that something had to be done to manage rising drug reimbursement costs. To that end, insurers and third party payors began requiring patients to use generics (when available) instead of branded products to cap rising prescription drug costs. Because of this, the generic industry has grown by leaps and bound over the past decade and now threatens the stability of the branded pharmaceutical industry! 

Unfortunately, while increased generic drug use may be good for generic drug manufacturers and insurance companies, it isn’t always in the best interests of patients who use prescription medications. For example, there are a growing number of stories and complaints from patients who were forced to switch from a brand name drug to a generic one and had side effects, or found that their symptoms returned or may have been worse than before. In fact, this happened to my mother who was switched from a brand name pain reliever that worked to a generic version that no longer controlled her symptoms and induced some untoward side effects. Scientifically, there ought to be little difference in the efficacy, safety or tolerability profiles of a branded drug and its generic equivalent. This is because both medications contain the same active pharmaceutical ingredient. However, differences in the formulation of the branded and generic versions of the drugs may be responsible for reduced efficacy or safety and tolerability issues.

While clinical studies conducted by the insurance industry suggest there are no safety or tolerability differences between brand name and generic drugs and the American Medical Association’s assertion that, as a whole, generic drugs do work as well as branded drug, there is some evidence to suggest that some generic drugs may not be interchangeable or substitutable for certain branded medications. This appears to be the case for certain drugs that are used to treat neurological conditions and mental health diseases like seizures, depression and bipolar disease. Lesley Alderman, in an article she wrote in today’s New York Time business sections provides excellent examples of this.   

The problems with some generic drugs may arise as a result of the approval process for this class of drugs. According to provisions outlined in the Hatch Waxman Act which stipulate that a generic version must have the same active ingredient, strength and dosage form as the brand name drug or reference product. The generic version must also be demonstrated to be “bioequivalent” to the brand name drug. This means that the generic product must be shown to reach blood levels (drug concentration) that are very similar to the brand name product. This is usually determined by administering the generic and brand name drugs to a relatively small number (24 to 36) of healthy human volunteers. Generally speaking, once bioequivalence is established it paves the way for regulatory approval of the product. Typically, once approved, many generics receive what is known as an AB rating. Generics that are AB-rated can freely be substituted (by a licensed pharmacist) for a brand name product even though the physician may have written the prescription for the branded product.

In the past, patients were usually given a choice between a generic and a brand name drug —a decision that was largely based on the percentage of the cost of drug that would be covered by insurance. These days, patients no longer have a choice and are generally forced to use generic drugs rather than brand name products based on formulary lists compiled by insurance companies. While I am not practically or philosophically opposed to using generic drugs, there is a growing body of evidence which suggests that not all patients respond the same way to branded and for that matter generic drugs. Therefore, I contend that allowances ought to be made for these differences and patients who don’t respond to (or experience side effects) after taking generics shouldn't’t be denied access to the branded product that, in most cases, was originally prescribed by that patient’s physician. It is one thing to cut costs; it is another to increase a patients suffering or anxiety. If you are concerned about switching from a branded medication to a generic, please read this for some helpful tips and guidance.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Sanofi Aventis asked it entire sales force to remain at home the Monday after Thanksgiving to wait for a phone call to see whether or not they still had jobs. Nice way for the affected employees to spend Thanksgiving, eh?

Sanofi-Aventis is laying off an unspecified number of US sales reps, as the firm restructures because of generic exposure on some of its lead products including its blockbuster anti-clotting drug Plavix. The layoffs are part of a transformation that began last year, shortly after new CEO Chris Viehbacher took charge at the company. At the time, Sanofi-Aventis announced plans to cut 10% or less of its 6,500 US reps. According to a post at BNET, the company currently employs about 5,600 reps. Those laid off will get three weeks’ base pay per year of service, up to a maximum of 78 weeks’ base pay.

A company spokesperson said “Sanofi-Aventis U.S. is continuing to evolve in order to deliver greater value to our customers in a rapidly changing business climate. This includes changes to our sales force to better correspond with market dynamics and customer needs. As a part of our continuing transformation, we have identified areas where we will prioritize sales support and others where reductions are necessary.”

Sanofi joins a growing number of pharmaceutical companies that made it something of a tradition to layoff employees immediately before or during the holiday season. I guess company executives believe that the blow may be less devastating if the ex-employees get to spend more time with their families during the holidays. Unlike most corporate executives who are paid millions when they are fired, many laid off pharmaceutical companies will have a tough time finding new employment opportunities in the rapidly shrinking US pharmaceutical job market. At last count, about 59,000 pharmaceutical employees lost their jobs in 2009. Don’t be surprised if more pharmaceutical layoffs are announced in the coming weeks.

Until next time...

Good Luck and Good Job Hunting??????

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I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.

First, I heard a story on NPR this morning (while driving my daughter to middle school) about FDA’s initiative to require that oysters harvested from the Gulf of Mexico be pretreated before they can be served in restaurants and eaten raw. The reason for this initiative is that a majority of live oysters harvested from the Gulf of Mexico are usually contaminated with the opportunistic bacterial pathogen Vibrio vulnificus and other Vibrio species. Approximately, 15 or more immunocompromised patents die each year and many more get ill after ingesting raw Louisiana oysters infected with V. vulnificus. FDA, (which for those of you who don’t know also regulates the food and cosmetic industries in addition to the drug and devices industries), spent the past few years crafting regulatory guidelines that called for mandatory  treatment (irradiation or pasteurization) of oysters from the Gulf of Mexico before they are served “raw” at restaurants and other commercial food operations. The regulations were to be implemented sometime in 2011. While many of the larger commercial Louisiana-based raw oyster producers already pre-treat their oysters before they are sold to restaurants, the pretreatment requirement would be economically onerous and challenging to “mom and pop” oyster business throughout Louisiana. Not surprisingly, given the economic devastation caused by hurricane Katrina several years ago, FDA was assaulted by oyster manufacturing trade groups and Louisiana politicians and lobbyists asking the agency to delay implementation of the new rules. Unfortunately, FDA officials caved and yielded to the onslaught and agreed to conduct a pilot study designed to assess the effectiveness of the program before forcing the new rules on the Gulf Coast oyster industry.  For the record, I love eating raw oysters and the thought of eating a so-called “raw oysters” that have previously been pasteurized or irradiated seems unseemly and unappealing to me. However, FDA’s mission is to provide Americans with a safe food supply and to minimize the incidence of any public health risks associated with or caused by it. The fact that FDA was cajoled and yielded to calls that that the agency placed economic concerns ahead of known public health risks is lamentable and truly regrettable. Rather than spending excessive amounts of money on lobbying efforts to delay appropriate public health initiatives, the Gulf Coast oyster industry and its trade groups and lobbyist ought to consider investing in efforts to combat global warming and Gulf of Mexico water pollution, which in turn, would reduce the bacterial load of live oysters harvested from the Gulf of Mexico and serve to raw oyster enthusiasts. 

On a more upbeat note about infectious diseases (sort of), there was an article in today’s Science Times which reported the results of a study that linked exposure to five so-called common pathogens, Chalmydia pneumoniae, Helicobacter pylori, cytomegalovirus and Herpes simplex types 1 and 2 to increased risk of stroke. According to the article, each of these pathogens may persist after acute infections and contribute to an ongoing chronic low level infection. These low level infections coupled with chronic inflammation of blood vessels induced by the infections may contribute to the increased likelihood of stroke. While intriguing, authors of the study warn that their results don’t establish a cause-and-effect relationship between these infections and stroke. More research will be required to determine whether or not there is a definitive link between these infections and the incidence of stroke..

Speaking of stroke and heart attacks, I want to turn my attention to the clinical trial results reported yesterday by Merck & Co about its cholesterol-lowering drugs Zetia and Vytorin. As you may recall, a brouhaha erupted about a year ago about whether or not the cholesterol-lowering effects of  Merck’s  blockbuster drugs Zetia and Vytorin (which is a combination of Zetia and the statin Zocor) actually protected patients from increased risk of heart attack and stroke. The results of the long awaited study which were presented at an American Heart Association meeting on Monday support previous findings of two earlier clinical studies which showed that despite lowering LDL cholesterol levels, Zetia and Vytorin don’t reduce the risk of heart attack or stroke in at-risk patients. 

In the study patients who were at risk for cardiovascular disease were treated with statins in combination with either Zetia or Niaspan (a prescription, controlled-release formulation of over-the-counter niacin supplements that exhibits cholesterol-lowering properties). Patients who received statins plus Niaspan had decreased thickening of the walls (caused by atherosclerosis) of the carotid artery whereas those treated with Zetia failed to inhibit arterial plaque buildup. In other words, Zetia (and Vytorin) which are expensive prescription drugs don’t provide any health benefits beyond those offered by statins, many of which (including Merck’s Zocor) are available as low-cost generics.

Despite the lack of any clear medical or health benefits, sales of Zetia and Vytorin generated about $4.8 billion in sales last year. You would think that Merck and its stakeholders would be devastated by the results of the new study. However, they were actually happy about the news—they were fearful (based on data from the earlier studies) that Zetia may actually increase the risk of heart attack and stroke! What is particularly revealing (and disturbing) about the whole Zetia/Vytorin story is that Merck is relieved that an expensive drug that it heavily promoted as being beneficial and safe is in reality not beneficial. When did it become acceptable that the only requirement for FDA approval of prescription drugs is safety? Doesn’t a drug have to also show a positive therapeutic and clinical effect (over previously approved drugs for the same indication) before it wins regulatory approval? The fact that physicians continue to prescribe ineffective, multi-billion dollar drugs like Zetia instead of cheaper and effective generic versions of cholesterol-lowering drugs another troubling sign of  our current economic situation and the need for healthcare reform in the US.

Finally, for you patent aficionados, there was an illuminating and incisive op-ed piece in today’s NY Times that shed light on the problems with the current US patent approval process. While I have substantial experience in this area, I learned more from reading this article than I did from the many years that I worked closely with patent and intellectual property attorneys. This article is a must read for those persons considering careers in intellectual property and patent law and entrepreneurial individuals who are interested in starting up life sciences companies.

Until next time...

Good Luck and Live and Learn!!!!

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The Pharmalot Blog reported today that AstraZeneca offered all of it sales representatives—numbering 5,000-6,000—a buyout option. However, AstraZeneca prefers to avoid the term buyout and instead instructed its reps to ’self identify’ whether or not they want a package to leave the company. According to the post, an AstraZeneca spokesman declined to discuss how many reps it would like to shed, but did provide this statement:

“AstraZeneca is making changes to our sales force, which will be managed first by looking at vacancies and offering field sales employees the opportunity to self-identify whether they are interested in leaving the company. We will know the full scope of the changes in the coming weeks.”

Like many other pharma companies, AstraZeneca will lose $11.1 billion in patented-protected revenue by the end of 2012 and face stiff generic competition.

Pharma sales reps, like R&D scientists, have been facing tough times over the past three years or so. In the late 1990s, pharma companies hired massive numbers of reps, only to realize several years later, that increasing the number of reps didn’t necessarily translate into increase drug sales. The economic downturn, coupled with projected loss of revenues due to patent expiry of blockbuster drugs over the next few years, provided pharma with an opportunity to downsize. Finally, the growing use of web-based strategies to educate physicians, contract sales forces and a diminishing number of products led to the demise of the pharma rep as we know it.

My recommendation to downsized reps is to get some biotechnology training or device/diagnostic training and to try and leverage previous experience into sales jobs at biotechnology and devices companies. Both industries have enormous growth potential and the transition from pharma to them shouldn’t be all that onerous.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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Mark Sendak, author of the incisive EyeonFDA blog and social media enthusiast, has been keeping a watchful eye (pun intended) on the growing number of pharmaceutical companies that are adding channels and videos to YouTube. 

On his blog today, Mark reviews several new channels developed by Novartis, Johnson and Johnson, Teva, Boehringer Ingelheim and AstraZeneca. While a growing number of pharmaceutical companies continue to add new channels on YouTube, Mark contends that the “success of these channels has varied greatly and several companies have obviously developed the channels without any idea of what they would like to do with them and some of the channels show obvious signs of neglect.”

To learn more about pharma’s incursion on YouTube, read Mark’s post!

Until next time...

Good Luck and Good Video Watching

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As the Congressional debate over follow-on biologics slogs on, the Obama Administration has finally weighed in and backs 7 years of data exclusivity for follow-on biologics. As you may recall, innovator companies want a 12-14 year data exclusivity period whereas follow-on biologics manufacturers are seeking a 5-year period (which is identical to the data exclusivity period for small molecules generic drugs outlined in the Hatch Waxman Act). What this means—based on the Obama Administration's proposal—is that a follow-on biologic manufacturer must wait seven years from the date of approval for the innovator (branded) drug before the US Food and Drug Administration could consider approval of a follow-on version of the molecule.

It is not surprising that the Obama Administration supports a 7 data exclusivity period--it is, after all, a compromise between the 5 year period sought by the follow-on manufacturers and the 12-14 years that the innovator companies are seeking. And, Mr Obama has repeatedly shown a willingness to compromise when it comes to getting important legislation passed. Hopefully, Congress will take the Obama Administration's compromise to heart and pass follow-on biologics legislation as quickly as possible.

 Until next time...

 Good Luck and Good Job Hunting!

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From time to time, I come across some interesting facts and statistics that are worth noting. This month’s issue of Pharmaceutical Technology Europe offered several things that were blog-worthy. Here they are: 

• IMS Health has readjusted the growth of the pharmaceutical industry in 2009 from 4.5-5.5% to 2.5-3.6% with sales expected to exceed $820 billion
• The size of the US pharmaceutical market is expected to contract by 1-2% in 2009
• Emerging markets like China, India and Brazil are expected to contribute to more than half of the global market growth in 2009 and sustain an average growth rate of 40% by 2013
• The size of the Middle East pharmaceutical market is predicted to exceed $18 billion by 2014

As one industry analyst put it “This high level of growth in emerging markets, combined with the contraction of the US market and ongoing low single-digit growth in other developed markets, is driving the pharmaceutical market to a new world order.” If I had money, I would be investing in generic pharmaceutical companies and follow-on biologic manufacturers!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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GlaxoSmithKline (GSK) inked a deal yesterday with the Indian generics manufacturer Dr. Reddy’s Laboratories giving it access to over 100 future generic drugs and a gateway to Asia’s emerging pharmaceutical markets. The therapeutic areas covered under the agreement include diabetes, cardiovascular, pain management, gastroenterology and oncology. Dr Reddy’s Laboratories is one of India’s largest generic drug manufacturers. Like many of its competitors, Dr. Reddy’s Laboratories also have active development programs for new biotechnology drugs and biosimilar products.

UK-based, GSK joins a growing number of pharmaceutical companies including Pfizer, Merck and others that have entered into deals with major generic drug manufacturers—or purchased smaller generics companies—to gain access to generics pipelines and an ability to compete in emerging  non-branded pharmaceutical markets. Impending US healthcare reform and downward pricing pressures (resulting from increased global competition) have forced drug makers to reevaluate the role that generic drugs will likely play in future pharmaceutical revenue streams.

While generic drug makers have outstanding manufacturing capabilities, they generally lack the marketing, sales and distribution channels necessary to penetrate foreign markets and quickly ramp up drug sales. I suspect that the number of deals between pharmaceutical companies and generic manufacturers will continue to increase as many of the patents for multibillion, blockbuster drugs continue to expire in the next few years.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

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Let me begin with the good news. The Indianapolis Business journal reported today that Schwarz Pharma Manufacturing, Inc is planning a $12 million expansion of its Seymour, Indiana manufacturing plant and distribution center. When completed the expansion is expected to increase the company's employment in the southern Indiana city from 366 to 516 by 2011. The drug maker-a unit of Schwarz Pharma AG of Monheim, Germany-said it plans to begin hiring managers, business associates and production staff later this month.

And now, the bad news. The Pharmalot Blog reported today that the New Jersey-based generic manufacturer Par Pharmaceuticals is eliminating 26 percent of its workforce expected to save from $45 million to $55 million a year. Jobs will be lost in manufacturing, research and development, and other departments. How much more downsizing and job elimination can New Jersey take before it goes bankrupt? Maybe Icelanders can shed some light on that?

Until next time….

Good Luck and Good Job Hunting

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A post today on the Pharmalot blog suggests that Israeli generic manufacturer Teva is in talks to acquire US-based Barr Pharmaceuticals for  $7.0 -7.5$ billion. Barr’s present market cap is approximately $5.0 billion.

The acquisition would make sense for Teva to broaden its reach into the generic and branded generic markets in the US. Also, Barr recently acquired PLIVA which has active research programs on biosimilars and is currently selling its version of EPO in Croatia and other parts of Eastern Europe.

Teva has been trying to get into the biosimilar/follow-on biologics market for the past eight years or so. The company previously bought several early stage biogenerics manufacturers but have yet to advance their plans to formally enter the biosimilar/follow-on biologics market. This may be the opportunity that Teva has been looking for!

Check back for updates.

Until next time…

Good Luck and Good Job Hunting!!!!!!

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Rumor has it that Pfizer may offer a counteroffer to acquire India-based generics manufacturer Ranbaxy. As you may recall, Japan’s Daiichi Sankyo agreed earlier in the week to pay about $4.6 billion for a controlling interest in Ranbaxy. According to reports many analysts expect Pfizer to attempt to queer to the Daiichi-Ranbaxy deal because “it is battling Ranbaxy in about 18 countries on patent rights of Lipitor, the largest selling cholesterol drug in the world. Lipitor has annual sales of $13 billion. In most countries the patent on the drug will expire starting 2011.”  Ranbaxy has won favorable court decisions on Lipitor in many countries including in the US, the largest drug market in the world, which accounts for 28 per cent of the global generic market estimated at $72 billion.

I tend to agree with the pundits. Pfizer has a lousy pipeline and its recent clinical trial record is horrendous. Consequently, the company must hang on (as long as possible and at any cost) to its blockbuster brands to avoid financial ruin.

Stay tuned for late-breaking news and updates!

Until next time…

Good Luck and Good Job Hunting!!!!!

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It’s summertime during a recession. What better time is there to give employees an extended vacation by announcing job cuts at the start of summer?  

Generic manufacturer Mylan announced that it is cutting jobs at a pharmaceutical manufacturing plant in central Puerto Rico. According to a company spokesperson, 100 jobs will be eliminated in coming weeks. Mylan had announced in February that it would be eliminating jobs at five locations as part of a companywide restructuring. The Pittsburg, PA-based company is the latest pharmaceutical company to announce cuts in Puerto Rico. The industry has eliminated more than 3,000 jobs here since mid-2006.

In other news, Palo Alto, CA-based Jazz Pharmaceuticals Inc. said Wednesday it plans to cut 8 percent of its work force -- or 33 employees -- primarily in research and development and administrative areas, and delay development of two drugs.

Finally, according to Ed Silverman over at Pharmalot, New Jersey-based Schering Plough has begun the massive layoffs it announced last April. As you may recall, CEO Fred Hassan still reeling from the Vytorin and Zetia flap, assured analysts and shareholders that he can right the ship by laying off about 5,500 employees or 10% of Schering’s workforce. He vowed to “consolidate management; use more shared staff support and services; reduce travel; cut sales and marketing; slash R&D; consolidate product lines, particularly in the animal health unit; and close some of the 60 manufacturing plants.” The previously announced job cuts are in addition to the 400 jobs that were eliminated after Schering Plough acquired Organon Biosciences.

Unfortunately, I guess it is going to be a long, hot, summer for the folks who lost their jobs.

Until next time….

Good Luck and Try to Hold On To Your Job (if you have one)

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Daiichi Sankyo will buy a controlling interest (50.1%) of Ranbaxy, India’s third largest generic manufacturer.  Daiichi will pay as much as $4.6 billion for the opportunity.

The deal will put Daiichi Sankyo into ninth place in the $120 billion generic-drug market behind leaders Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit. According to the report “Daiichi Sankyo is mimicking strategies pursued by Novartis and Johnson & Johnson to weather turbulence in the branded-drug industry by diversifying into other markets. The acquisition also gives the Japanese company more reach in emerging regions including India, China and Eastern Europe. “

I think after this deal, that other pharmaceutical companies may consider buying profitable generics businesses. I am not sure why it has taken innovator companies so long to realize that it is much easier to join (buy??) rather than compete with generic manufacturers. It just seems so obvious to me—and I don’t even have an MBA!  Maybe there is some truth to the age-old aphorism “missing the forest for the trees.”

Until next time…

Good Luck and Good Job Hunting!!!!!

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The first biosimilar version of granulocyte colony stimulating factor (G-CSF) received a positive opinion from EMEA last month.  The European commission is expected to grant marketing approval for the product in the EU. The product, developed by Israel-based Teva, a global generics manufacturer, will be sold under the brand name TevaGrastim. The company is seeking EU approval for TevaGrastim a as treatment of chemotherapy-induced neutropenia.  

Amgen’s Neupogen, the innovator product, yields annual revenues of approximately $300 million in the EU. Teva hopes to cash in on a piece of that action. It appears that biosimilars are alive, well and making money in Europe!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Over the past few days, many drug companies have been reporting their earnings for the first quarter of 2008.  Few, if any, (except for Biogen/IDEC),  met the numbers that Wall Street analysts had expected and most reported that profits were "way down." Unfortunately, this means that more layoffs at drug manufacturers can likely  be expected in the coming months and that drug prices may rise.

Of course, the poor performances of these companies had little bearing on the compensation packages that many of the CEOs of these companies received in 2007.  It never ceases to amaze me that companies can lay off thousands of workers to cut cost s and then turn around and give CEOs who performed horribly (which led to the layoffs) tens of millions or more in compensation.  Just think how many workers could have kept their jobs and been able to feed their familiies if mediocre CEOs, who didn't do their jobs were paid what they are worth!

Ain't capitalism great?

Until next time....

Good Luck and Good Job Hunting!!!!!

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About five years ago, a friend of mine and I had an idea to form a non-profit dedicated to providing consumers with information regarding the safety of marketed pharmaceutical and biotechnology medicines.  At the time, we observed that consumers were repeatedly being misinformed about the safety and efficacy of many products, most notably follow-on biologics aka biogenerics. Unfortunately, we could not garner enough interest or financial support to get the organization off the ground. I guess that  we had a good idea, but, as usual, were a little ahead of our time. A new organization called The Coalition for a Competitive Pharmaceutical Market has recently set up shop with the same concept in mind.

Members of the coalition include insurance companies (Aetna, Humana, United Health Care and Blue Cross Blue Shield), pharmacies and drug distributors (CVS, Medco, Express Scripts, Rite Aid and Wallgreens), generic manufacturers (Barr Laboratories, Hospira, Teva, Mylan Laboratories and Watson Pharmaceuticals) and a large roster of Fortune 500 companies including General Motors, Ford, Caterpillar, Chrysler, Dow and Eastman Kodak. Think of the lobbying power–how cool is that?

I guess the time has come for rational drug pricing for the US. Big pharma and biotech beware–a nationalized healthcare system may not be far behind!

Until next time….

Good Luck and Good Job Hunting!!!!

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Amgen announced yesterday that its osteoporosis drug, denosumab, was safe and outperformed Merck’s Fosamax to improve bone density in a small Phase III clinical trial that included almost 1,200 patients. Unlike Fosamax which is taken orally once a month, denosumab (a fully humanized monoclonal antibody) only needs to be injected twice a year. As mentioned in a previous post, Fosamax will be losing patent protection and Merck recently announced that it will sell an authorized generic version of the drug. Fosamax and its generic equivalent represent the stiffest competition for denosumab if it receives regulatory approval.

Despite being the largest biotechnology company in the world, Amgen has struggled for the past year due to declining sales from its EPO franchise. Amgen’s pipeline is thin and company executives have bet the future on denosumab becoming a top seller. That said, the key measure for any osteoporosis drug is whether it can reduce or prevent bone fractures. Results from a pivotal Phase III clinical trial with over 8,000 patients comparing denosumab to placebo in fracture prevention are expected later in 2008.

I bet  a lot of employees in a Thousand Oaks have their fingers crossed!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

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As many of you know, the pharmaceutical industry has been trending downward for the past year or so. Weak pipelines, uncontrolled corporate expansion and soaring drug prices have been offered to explain the recent down turn. However, the real back story to the downturn is the loss of  future revenues that is expected to occur starting in 2010 when many current blockbuster pharmaceutical products, e.g., Lipitor (Pfizer), Plavix (Sanofi Aventis), Avandia (GlaxoSmithKline), Zyprexa (Lilly), and others lose patent protection.

The loss of patent protection of branded blockbuster products is almost always accompanied by the development and subsequent, regulatory approval of lower cost, generic versions of the drugs. The Hatch Waxman Act permits generic manufacturers to begin to develop generic versions of branded products five years prior to patent expiry. This allows generic manufacturers to develop and gain regulatory approval of their products well in advance of a patent expiry date. Further, generic manufacturers usually launch their products (and flood the market) with generic versions of a branded product on the same day that its patent lapses. To induce and hasten generic development, Hatch Waxman grants market exclusivity for 180-days (6 month) to the first company that gains US regulatory approval for a generic version of a branded product that has lost patent protection.

Revenue generation and a company’s market share of branded drug products generally fall precipitously following introduction of less costly, generic versions of the drugs. From a financial standpoint, this is not surprising—why would anybody chose to pay more for a branded product when there is a cheaper and therapeutically efficacious generic alternative available?  In the past, most pharmaceutical companies chose to neglect (and ultimately abandon) blockbuster products after generic versions were introduced.  Many companies chose this strategy because, in the past, there was always another blockbuster in the pipeline that would replace the lost revenues caused by generic competition.

Unfortunately, as we all know, the days of the billon-dollar-a year blockbuster drug are long gone! This realization has caused many pharmaceutical companies to rethink their business strategies when a blockbuster drugs lose patent expiry. Many pharmaceutical companies are experimenting with a relatively new kind of product called an authorized generic–a copycat version of a company’s branded drug that is sold through a licensing agreement between the innovator company and a generic-drug manufacturer. This type of arrangement allows the innovator company to hold on to a larger share of a revenue stream from the drug once it loses patent protection and it falls prey to generic manufacturers.

Authorized generics have always made sense to me–who knows how to manufacture, market and distribute a drug better than the company that originally created it? Further, why would a company choose to give up on a revenue stream simply because a product can no longer generate billions each year due to generic encroachment– wouldn’t hundreds or even tens of millions suffice? Much to my surprise, late last week, Merck & Co announced that it had inked a deal for an authorized generic form of its blockbuster osteoporosis drug  Fosamax after the US patent expires on February 6. Merck did not disclose the terms of the deal or the identity of it generic manufacturing partner.

Industry analysts have suggested that cheaper generics will not only batter sales of Merck’s Fosomax but could also hurt rival Actonel (Proctor & Gamble Co/Sanofi-Aventis) and Boniva (Roche/GalxoSmithKline). Generic manufacturers.  Barr Laboratories and TEVA are expected to launch their own generic versions on February 6 and share the 180-day market exclusivity for their respective products.

Merck, once a champion of the old pharma blockbuster model, is slowing emerging as an industry innovator. The company’s recent decision to authorize a generic version of one of its former blockbuster drugs may be a harbinger of things to come in the pharmaceutical industry. That said, I don’t understand why big biotechnology companies like Amgen, Biogen/IDEC and Genentech are unwilling to consider the authorized generic model to stave off generic competition for blockbuster biotechnology products like EPO, Avonex and Rituxan. Whether these companies like it or not, I believe that biogenerics aka follow-on biologics will be a reality in the US in the next five years. Maybe Amgen can bolster is rapidly falling stock price by inking an authorized generic deal for EPO—rather than spending hundreds of millions on patent litigation—“whadda ya think?”

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

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