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Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time...

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

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Earlier this week, I suggested in a post that pharma layoffs were beginning to decline whereas biotech layoffs were rising. And wouldn’t you know it, just when big pharma employees thought that their jobs were safe, the Swiss pharmaceutical giant Novartis today announced that it was laying off 2,000 US employees. According to a post on the Pharmalot blog, 1,630 sales reps and an additional 300 positions will be eliminated at Novartis’ Hanover, NJ US headquarters. Last fall, Novartis eliminated 1,100 jobs in Switzerland, 900 R&D and 1,400 sales reps in The US and another 550 jobs at a manufacturing site in the UK 

While the announced layoffs may be part of a global downsizing effort that began last year, many analysts believe Novartis decided to reorganize because its new hypertension drug, Tekturna, performed poorly in clinical trials (increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension) to garner approval of the drug to treat patients with Type II diabetes who are a greater risk of cardiovascular and renal events. The company’s best-selling hypertension medicine Diovan lost patent protection in Europe earlier this year and it due to expire in the US next September.

Company executives were betting on Tekturna to replace hypertension sales lost to generic competition for Diovan. Tekturna, approved in Europe as Rasilez, generated sales of $449 million during the first nine months of the past fiscal year but the poor clinical trials results suggest that it may be difficult for the drug to generate the $1.4 billion in annual sales (by 2016) forecasted by many financial analysts.

Stay tuned for more big pharma layoff updates!

Until next time...

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

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Despite a stalling economy, there are signs that some American companies are hiring and helping to improve local economies. A good of example of this is Alcon Laboratories located in Fort Worth, Texas. The company, which specializes in vision products, today announced that it leased 87,000 sq. feet of office space to house 400 new employees that it is moving into the Fort Worth area.

The company immediately needed the space to accommodate employees relocating from Atlanta and to house new hires as the company plans to expand existing facilities in south Fort Worth. Alcon was acquired this past April by Novartis, which operate the Atlanta-based CIBA Vision and Novartis Ophthalmic Units which are being consolidated into Alcon’s existing Forth Worth operations. While some of Novartis’ Atlanta employees lost their jobs as a result of the Alcon acquisition, many of them are relocating to new jobs at the Forth Worth facility.

Alcon notified Fort Worth city officials that it plans on expanding its current workforce of 3,200 to about 4,000 and spends millions of dollars to expand existing facilities over the next few years. Ironically, while most big US pharmaceutical companies are slashing domestic jobs and investing in emerging markets like China and India, Novartis, a Swiss company, is investing in America! Go figure!!!!!!!

Until next time...

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

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A study conducted in November 2011 by Cegedim Strategic Data, a market research and promotional audit firm analyzed the world’s top 100 pharmaceutical companies expenditure on traditional promotional (marketing spends) and then compared that spending with their presence on Facebook and Twitter.

Not surprisingly, Pfizer, Novartis and Merck (the world’s largest big pharma companies) finished in the top three for traditional promotional spending. However, their use of social media i.e. Twitter and Facebook varied widely. For example, Pfizer—the top promotional spender—was first in its number of Twitter followers and third in the number of likes on Facebook. On the other hand, second ranked Novartis was fifth in the number of Twitter followers and in seventeenth position for likes on Facebook. Finally, third ranked Merck was fifteenth in the number of Twitter followers (third for the number of tweets) and in the tenth position for the number of likes on Facebook (but has more pages than any of its Facebook competitors).

Other notable companies included:

• Johnson &Johnson, eleventh in promotional spending and number two on the number of Facebook likes
• Roche, number fifteen on the promotional spending list was ranked number two for the number of Twitter followers
• Proctor and Gamble which ranked a distant 54^th in promotional spending was number four on the Twitter follower list

What does this all mean? A whole lot of nothing because nobody can determine what effects the use of social media has on the bottom line for most pharmaceutical companies. Unlike other industries, where social media can be used to sell products, it cannot be used for direct promotional purposes in the life sciences industry. While most people will tell you this is because of the lack of guidance by FDA on the use of social media, the bottom line is that social media will never be allowed for direct-to-consumer advertising in the pharmaceutical industry. That said, pharma and biotech will have to find other uses for social media including clinical trial recruitment and retention, adverse event reporting, employee recruitment and retention and education and outreach.

Until next time...

Good Luck and Good Tweeting (and Liking)

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Angry with recent job cuts announced by the Swiss pharmaceutical giant Novartis, protesters, this past Saturday, gathered in Basel and beside the villa of its former CEO and Chairman Daniel Vasella to express their displeasure with the company’s decision to layoff workers.

In Basel, about 1,000 people gathered and demanded that Novartis reverse its decision to layoff 1,100 people who work at the company. Meanwhile, about 20 protestors gathered in a field opposite Vasella’s walled lakeside Mansion. Two of the protestors handed Vasella a “fake pink slip” and according to witnesses he laughed and took the gesture in stride.

Vasella, who is not a stranger to protests, is one of Switzerland's highest-paid executives and in 2009 animal rights activists set fire to his Tirolean hunting lodge to protest Novartis’ use of animals to test pharmaceuticals and consumer products. 

Currently, the Occupy Wall Street movement in the US has primarily targeted banks and financial institutions. However, two weeks ago, a group of protestors in Croton, CT, staged a demonstration at Pfizer headquarters to express their anger a recent layoffs announced by the company.

Until next time...

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

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It seems that big pharma always waits for early Fall to announce pending job cuts. Novartis, Europe’s second largest pharmaceutical company, announced two days ago that it would eliminate 2,000 jobs mainly in the US and Switzerland but add new employees to operations in emerging markets like India and China. Novartis is just another addition to a growing list of big pharma companies that are slashing jobs in the US and Europe and hiring new employees in lower cost markets.

The announce cuts represent a 1 percent reduction in Novartis’ global workforce. The cuts will be implemented over the next three years and are predicted to save the company in excess of $200 million annually. 

According to a company spokesperson, Novartis will eliminate 1,100 jobs in Switzerland, with the balance in the U.S., Jimenez said. Some research will be moved to the U.S. from Switzerland, and reductions will be made in technical research and development, data management, clinical trial monitoring, drug safety and regulatory affairs. Novartis will add 700 positions in China and India in data management and trial monitoring.

As part of the reorganization and job cuts the company will close an over-the-counter drug manufacturing plant in Nyon, Switzerland and chemical production facilities in Basel and Torre, Italy.

The current cuts come after Novartis announced last November that it would eliminate 1400 U.S. sales jobs and more recently in March that it would reduce operations in the UK.

Although life science pundits recently suggested that job cuts in the pharmaceutical industry are slowing and may have hit rock bottom, it appears that the carnage is still taking place and will likely continue well into the future as more resources and monies are invested in emerging markets.

Until next time...

Good Luck and Good Job Hunting

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After a relatively quiet summer, big pharma companies are beginning to ramp up layoffs once again. Novartis recently announced that more job cuts were likely and last week I got wind of Merck’s impending reorganization and layoffs from a colleague whose partner works for the company. Today, Merck formally announced that it had sent e-mails to employees about the new round of layoffs. Last July, Merck said that it planned to cut 12 percent to 13 percent of its workforce of about 100,000 by 2015 as it adjusts to market conditions and its 2009 acquisition of Schering Plough.

The layoffs will be part of the company’s restructuring of “select HQ functions and field groups within the U.S. Market: Marketing & Customer Solutions; Managed Markets & Policy; Strategy & Commercial Model Innovation; and the Neuropsychiatric and Women's Healthcare specialty sales teams,"

While it is not clear how many workers will be layed off during the next round of downsizing, industry insiders are speculating that about 5,200 of the total cuts could be U.S. jobs, with from 3,000 to 4,000 in New Jersey and Pennsylvania. A Merck spokesman would not comment on the state-by-state plans. The cuts through October won't be the end of the process, though.

In August, the company offered buyout packages to some employees, but it is unlikely that buyouts and voluntary retirements alone would meet the numbers that Merck executive expect to make. Interestingly, Merck spokespersons said that the company will continue to add new employees but cut jobs elsewhere. I suspect that most of the cuts will come in R&D and sales as they have in the past.

Until next time...

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

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For the past several days, the rumor mill has been rampant with suggestions that UK-based Shire may acquire Cubist, a publicly traded Massachusetts-based biotechnology company that sells Cubicin, an antibiotic indicated for the treatment of certain infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Rumor has it that Shire approached Cubist about a month ago with a $44.5-a-share proposal ($2.0 billion) and the pair have been in talks about a deal ever since. Last week, Shire announced that it had entered into a deal to acquire private-held Advanced BioHealing for $750 million. Connecticut-based Advanced BioHealing markets and develops products to enhance wound healing and treat diabetic foot infections in patients with diabetes. Shire’s acquisition of both companies would provide it with a substantial US presence in the antibacterial treatment and diabetes markets.

While Cubist may be a good “fit” for Shire, it is not clear whether or not the company will prevail in its takeover bid. Last month, Cubist settled a patent dispute Teva Pharmaceuticals over Cubicin, which lessened the threat of generic competition by the Israeli drug maker. This sparked speculation among a number of Wall Street analysts that other pharmaceutical companies including AstraZeneca and Johnson & Johnson who are themselves facing generic competition, may consider acquiring Cubist in an attempt to add new antibiotics to their antibacterial portfolios. 

This is not the first time that analysts have speculated that Cubicin may be ripe for acquisition. Almost two years ago, word-on-the-street had it that Novartis may acquire the company. Nevertheless, Cubist is one of the few remaining publicly-traded biotechnology companies that specialize in new antibacterial drug discovery. Its potential acquisition by a big pharma company may signal the end of innovative drug discovery in the antibiotics discovery space. Here’s hoping that Cubist remains independent!

Until next time...

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

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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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Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.

To that end, an article that appeared in FiercePharma last October noted that eleven big pharma companies had paid a total of over $6.0 billion in fines to the US government over the last two years or so. The biggest losers include Eli Lilly paid over $1.4 billion in fines because of alleged illegal marketing of its anti-psychotic drug Zyprexa and Pfizer which paid $2.3 billion for marketing missteps with three drugs including Bextra (pain), Geodon (schizophrenia) , Lyrica (neuropathic pain) and Zyvox (antibiotic). 

More recently, GlaxoSmithKline agreed to pay $750 million fine in a whistle blower lawsuit that alleged that the company had sold "adulterated products" manufactured in a Cidra Puerto Rico production facility. Also, the company announced last February that it intends to pay $3.4 billion to settle lawsuits alleging the improper promotion and sale of several of its products including the blockbuster diabetes drug Avandia and Paxil (depression).

The article also included a timeline of some of the other major settlements that have recently taken place (seen below)

Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Infraction: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Infraction: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Infractions: Allergan's $600 million Department of Justice settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Infraction: The Irish drugmakers received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Infraction: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Infraction: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.

Despite concerted efforts by the US Food and Drug Agency to limit off-label promotion of prescription drugs, most pharma companies continue to see how far they can push the envelope before the agency catches up with them. Given the current budget woes facing FDA, don’t be surprised if the frequency of off label promotion and misrepresentation of prescriptions drugs continue to rise.

Until next time...

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

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Swiss pharmaceutical giant Novartis late yesterday announced that it would cut 550 jobs at it Horsham site West Sussex, England. At present, there are 950 workers at the Horsham site. The job cuts, 330 dedicated to respiratory research, will be made over the next two years.

This is more bad news for the UK pharma R&D workforce. In February, Pfizer said it would shut its Sandwich in Kent facility which employs 2,400 people. More job cuts are likely to take place in the US, UK and Europe as the pharmaceutical industry continues to scale back investment in R&D. 

Until next time..

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

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Despite signs earlier this summer that job cuts at pharmaceutical companies were beginning to slow, it appears that the number of jobs lost in 2010 may come close to the roughly 61,000 pharmaceutical jobs that were eliminated in 2009. This is based on quarterly Job-Cut Announcement Report published by the outplacement firm Challenger, Gray and Christmas. 

In past month or so, two big pharma companies, Roche and Novartis, announced that there will be major corporate reorganizations and deep job cuts to reduce spending, increase profits and bolster flagging stock prices. 

While things appear to be improving in other parts of the economy, the life sciences industry has been devastated by massive job layoffs in the past three years. Although pharma executives publicly blame the downsizing on the recession, massive R&D units, thinning pipelines and a failure to obtain a sufficient ROI on the huge sums of money poured into new drug development over the past decade are the real reason for the blood letting. Unfortunately, the US job market for life scientists won’t be improving anytime soon; mainly because it is more cost effective for companies to perform R&D and clinical testing in the emerging markets of China, India, Brazil and Russia (BRIC).

The ability of life sciences companies to successfully perform these activities outside of the US is in large part due to the lack of interest by American students in science careers and misguided immigration policies that prevented talented US-trained foreign nationals from remaining in the US after completing their training. This allowed many foreign countries to achieve a critical mass of US-trained life scientists and provide Western life sciences companies with a highly trained and well equipped scientific workforce.

With the holidays approaching, now may be a good time for those of you who work or considering careers in the life sciences industry to re-evaluate or consider alternate career options for life scientists.

Until next time...

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

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Despite public assertions made by Novartis a mere eight days ago that it would not be eliminating thousands of jobs, the company today announced that it was eliminating 1,400 sales reps. Roughly 1,150 jobs will be cut from its primary care division—which is being consolidated into three units from four in the US—and another 250 from psychiatric and neuroscience. No jobs will be eliminated from Novartis’ headquarters in Hanover, NJ. While the job cuts announced today were not in the thousands (almost) it isn’t clear whether or not more are to come.

According to a post on today’s Pharmalot blog:

"Novartis had attempted to dampen speculation that a huge bloodletting was imminent after Roche disclosed plans to axe 4,800 jobs worldwide (back story) and, in fact, Joe Jiminez, the CEO, had written on his internal blog that news reports about big layoffs were inaccurate. Technically, the Novartis reduction is not in the thousands, but the number is still large and, essentially, confirms concerns that have been expressed over the past month at CafePharma, the online forum where reps dish the dirt (look here)."

Don’t you just love the holidays?

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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Yesterday, Novartis, one of the world’s largest pharmaceutical company announced that it would double the size of a planned expansion of its R&D headquarters in Cambridge MA and add 200 to 300 new employees.

Not to be outdone, Teva, the world’s largest generic drug manufacturer, today announced that it would create 200 jobs at a distribution facility it plans to open in Northeast Philadelphia.

According to a press release, the $295 million project will create more than 200 jobs within three years and retain more than 200 existing positions. It would appear that cash-rich pharmaceutical and generic drug manufacturers are beginning to realize that investments in infrastructure are likely to be important as the pharmaceutical sector continues to undergo a transformation. Also, it is likely that they are running out of acquisition targets and have to spend some of their excess cash for tax purposes (I know pretty cynical but what can I say) In any event, this is good news for unemployed former pharmaceutical employee and also for the American economy!

Until next time...

Good Luck and Good Job Hunting

(Check out Philly; it's not as nice as Cambridge but a job is a job!)

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Unlike most of its competitors, which are downsizing operations, the Swiss drug maker Novartis yesterday announced plans to double the size of a planned office and laboratory complex in Cambridge, MA. A company spokesperson said that the expansion which will cost $600 million was part of a plan to bolster Novartis’ research operations and strengthen partnerships with local universities and biotechnology start ups. 

Novartis, Cambridge, MA largest corporate employer, expects to hire an additional 200 to 300 employs over the next five years increasing the size of its workforce in the city to 2,300.

Cambridge has become a something of a Mecca to pharmaceutical companies looking to tap into scientific information and intellectual property at Harvard and MIT and forging alliances or partnerships with early-stage biotechnology companies. In addition to the Novartis Research Institute, other companies in and around Cambridge include Sanofi-Aventis—which, last summer, unveiled a $65 million expansion in Cambridgeport that will house a new cancer research division and create 300 new jobs—AstraZeneca, GlaxoSmithKline, Shire and Pfizer.

In addition to its plan to expand operations and R&D capability in Cambridge, Novartis has agreed to build a $1.0 billion complex of offices and laboratories in Shanghai, China. Novartis like most other big pharma companies is trying to leverage scientific information and talent anywhere in the world to bolster their rapidly dwindling drug pipelines. 

The upside of Novartis’ Cambridge project is that it will help to create new construction, support and additional pharmaceutical jobs and help the city weather ongoing recessionary times. Who knows; maybe this is a sign that the US economy is growing and good times may be just around the corner!

Until next time...

Good Luck and Good Job Hunting (I highly recommend Cambridge MA)

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The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency. 

Despite the fact that off label marketing is illegal, many big pharma companies knowingly and willfully engaged in the practice. Luckily, the Obama administration has reinvigorated and restored the regulatory powers at the agency and FDA is now aggressively investigating and punishing companies that had promoted off-label use of their products over the last decade.

The New York Times today reported that Novartis joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the last few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million; and Forest Laboratories, $313 million. Pfizer, Lilly, Allergan and Forest pleaded guilty to crimes in the cases. The company was fined $422 million settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs. 

According to the article, the five other drugs involved in the civil settlement are Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.

It is important to make a distinction between the practices of off-label drug use and off label marketing. As many of you may know, licensed US physicians are allowed to prescribe any FDA-approved drugs if they believe that their use will benefit patients. This is off-label drug use. However, in contrast, it is illegal for companies to actively promote or market approved drugs for therapeutic indications for which they have not received regulatory approval. This is off-label marketing and a strategy that has been used by companies to increase sales of approved products without having to spend money on expensive clinical trials that are required to prove safety and efficacy for a new drug to gain regulatory approval. While this may be a backdoor strategy for companies to boost product sales, it clearly puts patients at risk because the actual safety and efficacy for the indications has not been adequately tested and proven.

Many drug makers have been critical of FDA’s increase scrutiny of drug safety and have argued that it has negatively impacted the regulatory approval rates of new experimental medicines. While this may be troubling to many pharmaceutical executives, the FDA was created to insure that all approved drugs are safe and effective and the risk to Americans who use them is minimal. In other words, the agency is simply doing its job—something it was prevented from doing for the past eight years!

Until next time,

Good Luck and Good Job Hunting!!!!

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The US Food and Drug Administration (FDA) sent a warning letter on July 29 to Novartis admonishing the company for placing a Facebook Share widget on a website promoting the use of Tasigna a treatment for chronic myeloid leukemia. An excerpt from the warning letter is as follows:

"This website contains a “Facebook Share” social media widget1 that generates Novartis-created information for Tasigna that can be shared with Facebook users (i.e., “shared content”). The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products".

Further according to the agency

“Facebook Share is a way for users of Facebook to share articles, pages, video, or flash content of a site with other Facebook users. Over two billion pieces of content are shared each week through Facebook. With two clicks, visitors to a website can share any page of that website through Facebook by generating a link to the page, along with a thumbnail image and a brief description (i.e., “shared content”) that will appear on the users’ profiles and, depending on privacy settings, in the home page stream of all of the users’ friends. Each time a link is shared by one user, potentially hundreds of new people may see and/or click through on the link.”

Novartis removed the widget as instructed in the letter by the agency. However, millions of people likely clicked the widget and received inappropriate information about Tasigna. The placement of a share widget on the Tasigna website is shocking because Novartis is not a newcomer to social media and the agency is in the process of formulating guidelines for the use of social media for promotional purposes. The recent Novartis brouhaha suggests that once again a big  pharma company is playing the tried and tested cat and mouse game with the agency to see how far they can push the limits before getting “spanked.” 

Perhaps big pharma companies that are interested in using social media for promotional purposes ought to study Novo Nordisk’s Race for the Cure Twitter campaign that is being used  to promote its insulin products. Unlike Novartis, Novo was very careful to work within established regulatory guidelines that guide print and broadcast media to create the Twitter campaign. To date, FDA has not sent Novo any warning letters about the campaign which appears to be wildly successful.

Hat tip to Ed at the Pharmalot Blog

Until next time…

Good Luck and Good Tweeting!!!!!

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The Advanced Learning Institute will be hosting a conference entitle Social Media for Pharma on May 24 & 25, 2010 at the Hyatt Hotel in Princeton, NJ. Presenters include representatives from AstraZeneca, Johnson & Johnson, Novartis, Sanofi-Aventis, NovoNordisk, Daiichi Sankyo, Lundbeck, Porter Novelli, the National Organization for Rare Diseases and many others. 

Topics to be covered include:

• Developing a social media strategy that works for your organization
• Update on regulatory guidance for social media
• Managing on going regulatory challenges for social media
• Building a business case and demonstrating ROI for social media platforms
• Creating a stronger sense of community and brand recognition using social media
• Monitoring customer feedback and satisfaction
• Determine the right mix of social media for your organization
• Latest innovations in social media
• Using twitter to turn your employees into stakeholders into brand ambassadors

and much more!

An agenda for the meeting can be found here. Mention BioJobBlog or BioCrowd and get $200 off the registration fee. For more information please contact melissa@aliconferences.com

I hope to see you at the meeting…it ought to be a good one!!!!!!!!!!

Until next time..

Good Luck and Good Tweeting, Blogging, Podcasting etc etc!!!!!

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Earlier this year, Dan Vasella, the longtime CEO of the Swiss drug maker Novartis, announced that he was resigning his CEO position to assume a full time role as the Chairman of the company’s board of directors. Joe Jimenez, an American, was appointed as the new CEO.

Today, Novartis announced the departure of Ludwig Hanston, the CEO of the US pharma business unit for the past two years. In addition to his departure, four new business units will be formed and 250 employees will lose their jobs effective May 1, 2010.

The four new business units are being formed to more accurately reflect the needs of patient populations. The new business units include 1) Primary Care, 2) Multiple Sclerosis, 3) Psychiatry/Neuroscience and 4) Respiratory/Transplant/Infectious Disease.

For a more detailed explanation of the changes taking place at Novartis please read the post on today’s Pharmalot blog.

Hat tip to Ed.

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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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 Pharmalot blog authored by the intrepid Ed Silverman today reported that Dan Vasella is out as CEO at Novartis and there has been an executive shake up at the company. According to the post, Vasella is reliquishing his post a CEO but retaining his chairman title For a complete run down and a glimpse at the new Novartis org chart read Ed's post

Vasella has come under fire (literally and figuratively) over the past year or so.  Industry insiders and Novartis shareholders contended that he couldn't manage the day-to-day operations of companies and succeed as Chairman. Also, Vasella was the victim of  unwarranted, vicious attacks by animal rights activists who publicly denounced him and set his home on fire!

Vasella, one of the few physicians to head a pharmaceutical company, held the top position since 1996 following the merger of Sandoz and Ciba-Geigy to form Novartis. The company has expanded in to new therapeutic areas and markets and performed well under Vasella's stewardship. However, many industry experts contend that ten years is the optimum tenure for most life sciences CEOs. What's four years in the scheme of things?

Until next time....

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

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Pfizer today announced that it’s looking to increase its sales force in China to 3,200 by the end of next year, up from about 2,300. The company expects to have sales representatives in about 250 Chinese cities by the end of 2011. It presently has a sales presence in about 185 cities. Previously, Pfizer it will cut nearly 20,000 jobs as part of the Wyeth merger. Over the pass several years more than 50,000 US pharma sales reps have lost their jobs.

Eli Lilly said last fall that it would continue to hire in China, even as it cuts jobs in the U.S. and other developed markets. Novartis is also making a big push into China, hiring hundreds of workers and spending $1 billion to expand a research center in Shanghai.

With business tough in developed markets, drug makers are counting on the developing world for growth and are expanding into biotechnology and generic drug manufacturing.

Like it or not, the emerging markets in China, India, Brazil and elsewhere represent a substantial upside whereas markets in the developing world are becoming less profitable. Drug companies, like most other large multinational companies, always will follow the profit stream not matter where it takes them or at what cost to the folks at home.

Until next time...

 Good Luck and Good Job Hunting (Try China, I hear they are looking for sales reps)

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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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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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Twitter, which is currently de rigueur in social media circles, is emerging as one of the most powerful branding and marketing social media tool that has been developed to date.   While other industries are already exploiting Twitter’s powerful marketing reach (to hawk their wares), drug makers have been reluctant to adopt Twitter and most other forms of social media. Industry analysts and company insiders contend that pharma’s reluctance to adopt social media can be attributed to the US Food and Drug Administration’s (FDA) lack of guidance on its use for promotional purposes. At present, it is anybody’s guess when this guidance may be issued, if ever.

Nevertheless, as always, there are a few daring companies willing to “boldly go where no pharma company has gone before”—in this case—Twitter! These companies include Boehringer Ingelheim (BI), Astra Zeneca, Novartis and Pfizer. According to a post on the Advance Market WoRx blog, BI is leading the way among pharma company Twitterers, with 679 following, 745 followers and 47 tweets. AstraZenecaUS has 136 following, 440 followers and 22 tweets. Pfizer has 351 following, 462 followers and 48 tweets.  Novartis has 0 following, 681 followers and 40 tweets (I guess Novartis has a thing” against following people).

Unlike its fellow pharma Twitters, BI—which began using Twitter in November 2008—actually uses it as an interactive and conversational microblogging platform (as it was intended). The other pharma company Twitters use it almost exclusively “as a one-way PR feed” says Ellen Hoenig Carlson at Advance Market WoRx. According to a post on the Pharmafocus website, "Boehringer has incorporated Twitter into its wider communications strategy and is using the site regularly to engage its stakeholders. In addition to posting press releases, BI uses Twitter to recommend web-based information about therapeutic areas and articles that its followers might find interesting or useful. To keep its finger on the pulse of the Twitterverse, BI uses media scanning programs to help monitor online conversations and responds quickly to join in or start up Twitter conversations.”

Kudos to Boehringer for recognizing Twitter’s potential to communicate with patients, physicians and other interested parties. I hope that more pharmaceutical companies begin to use Twitter and other forms of social media to engage and improve communications with their stakeholders.

Until next time...

Good Luck and Good Twittering (or should it be Tweeting?) 

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Today's New York Times reported that the US Food and Drug Administration (FDA) issued warning letters and ordered 14 pharmaceutical and biotechnology companies to stop running what it calls misleading ads on internet search pages displayed by search engines like Google. The agency faulted the companies for failing to identify product names (brand) and not listing potential side effects (only benefits) for the drugs. In other words, the ads lacked “fair balance” something that FDA stresses and that all drug makers are very familiar with. 

Drug makers and other interest groups pay search engines like Google to place ads on search result pages after someone types in a related search word. The sidebar ads typically contain a eye-catching headline about a relevant medical condition or product and links to websites promoting certain products. The companies receiving warning letters included: Bayer, Biogen Idec, Boehringer Ingelheim, Cephalon, Eli Lilly, Forrest Laboratories, Genentech, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, Roche, and Sanofi-Aventis. Not surprisingly, most of the world’s largest and most profitable were guilty of running misleading Internet search engine ads.

Historically, drug companies and FDA have engaged in a cat and mouse approach when it comes to advertising and marketing drug and medical devices and diagnostics. This is because FDA’s existing regulations that guide marketing and advertising practices are relatively lax and it provides drug makers with the opportunity to see how far they can push the agency before “they get caught.” While this practice may have been acceptable for print and television advertising, it may no longer be appropriate for Internet advertising— which potentially has a much broader and larger reach than traditional media because there are not national borders on the Web. Unfortunately, FDA has been slow (reluctant?) to react to digital media and is even more perplexed about social media and the drug industry. Rather than continue to play cat and mouse, I think it would be in the best interest of consumers if FDA and drug makers would sit down and craft new guidance on regulating Internet advertising and marketing practices. It is becoming increasingly apparent that the old rules are no longer sufficient as digital and social media continue to evolve.

Until next time....

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

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Rumors are rife that Novartis is going to purchase Lexington, MA-based Cubist for $1.6 billion. Wall Street analysts are speculating that Novartis may announce the deal as early as Monday.

Cubist manufactures Cubicin (daptomycin), one of only a handful of new antibiotics brought to market in the past 20 years that is effective against many infections caused by Gram-positive bacteria, most notably methicillin-resistant Staphylococcus aureus (MRSA). The company is developing new lipopeptide antibiotics similar to Cubicin and also has an active anti-viral drug discovery program.

Over the past 10 years, big pharma companies largely abandoned antibiotic research and placed all discovery efforts in the hands of only a few smaller public companies and startups. Cubist is the only independent biopharmaceutical company that successfully brought a new antibiotic to market. 

Novartis’ possible acquisition of Cubist signals, that at least one major pharmaceutical company sees opportunities and upside in the antibiotic drug discovery market. Several years ago, Pfizer acquired another antibiotic discovery company, Vicuron (formerly Versicor) but to date the acquisition has not yielded any new antibiotics. While Novartis’ acquisition of Cubist is yet another sign of consolidation that is taking place in the life sciences sector, it may bolster new efforts in the antibacterial drug discovery area. Unlike Cubist, Novartis has enough money and marketing muscle to increase Cubin sales and develop some of the exciting new molecular entities in Cubist’s drug development pipeline.

Until next time…..

Good Luck and Good Job Hunting!!!!

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The old baseball adage which says that  “you can’t tell the players apart without a program” is particularly apt when it comes to tracing the M &A activity that led to the creation of some today's largest pharmaceutical companies.

I used to be able to keep track of all of the moving parts  of most of these mergers but advancing age and unprecedented M&A activity in the pharma industry prevents me from successfully doing this any longer. To that end, about a week ago, the New York Times published a pretty cool and informative chart that historically traces the corporate mergers that lead to creation of Pfizer, Novartis, GlaxoSmithKline, Sanofi-Aventis and others.

Check it out!!!!!

Until next time...

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

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Twitter, the microblogging platform, is the current rage in social media. According to @Shwen, who writes the Med 2.0 Blog, it grew by 752% in 2008. Shwen is a social media enthusiast who is trying to convince the life sciences industry that Twitter and other social networks can be leveraged to improve drug development and deliver healthcare.

According to a recent post on Med. 2.0, there are currently three pharmaceutical companies that are actively using Twitter: Novartis (@novartis), Boehringer Ingelheim (@Boehringer) and Astra Zeneca (AstraZenecaUS). Also, it appears that Johnson and Johnson (@JNJcomm) launched an account last week. Tweets from @novartis and @Boehringer occur fairly regularly whereas AstraZenecaUS tweets are rare. Unlike YouTube, where pharmaceutical sponsors who create channels can regulate and control content, it is much more difficult to manage Twitter because tweets are in real time, uncensored (for the most part) and can be globally disseminated within seconds.

Despite these issues, Med 2.0’s Shwen muses “I can only imagine that more pharma companies are going to be jumping on board the Twitter-train sooner rather than later. How they use it to engage, on the other hand, is going to vary greatly from company to company. At the very least, I see companies setting up accounts as “listening posts”, but others may choose to engage, like @boehringer does in an informal manner. Whatever the case, Twitter is fast becoming the new dominant space for listening and/or engaging the life sciences community.”

Like Shwen, I believe that it a matter of time before pharma and biotech realize that they must embrace social media (in all of its various forms) to remain competitive in today’s increasingly interconnected marketplace.

For those of you who may be interested, you can follow BioJobBlog (@Biojobblog) and Biocrowd (@Biocrowd) on Twitter too!

Until next time…

Good Luck and Good Twittering

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The Pharmalot blog reported today that Bristol-Myers Squibb will be laying off 5% of its workforce (~ 34 employees) by year’s end at its manufacturing facility near Syracuse, NY. And, Sanofi-Aventis announced that it will be giving pink slips to about 10% of its sales force —about 650 reps—before the end of the year.

To make matters worse, Merck released its annual revenue projections for 2009 today which suggest that its earnings and revenue will not meet Wall Street expectations. Merck recently “cleaned house” and eliminated thousands of scientific and mid-management jobs. The list of pharmaceutical companies that have downsized in 2008 includes Merck, BMS, GlaxoSmithKline, Novartis, Schering Plough, Boehringer Ingelheim, Wyeth and Sanofi-Aventis. I probably missed a few but who is counting?

Until next time….

Good Luck and Hold On to Your Job (if you can)

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Novartis announced today that it will open a new research facility and hire an additional 150 people by the end of 2009 for a Research Center of Excellence in Virology in Cambridge, MA. That will increase the number of people employed by the company in Cambridge to more than 1,800 workers. Researchers at the new center will study vaccines for HIV/AIDS influenza, cytomegalovirus (CMV) and respiratory syncitial virus (RSV). 

The vaccine business once avoided like the plague by most pharma companies, has been growing by leaps and bound over the past five years and is sizzling hot these days. According to analysts, vaccines generated about $16 billion dollars last year. For example, Merck’s anti-human papilloma virus vaccine Gardasil generated $1.5 billion in sales in 2007.

Novartis clearly sees an upside in the vaccine business and is willing to make a wise investment for the future.

Until next time….

Good Luck and Good Job Hunting!!!!!

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First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its Fluflix campaign) asking people to submit videos about what it's like to have the flu. Earlier this year, Insmed upped the ante by posting a video lobbying for new legislation for the approval of follow-on biologics in the US. However, these pharma assaults on YouTube pale in comparison to the launch of Johnson & Johnson’s health channel on YouTube earlier this week.

The channel currently showcases a small selection of health information videos created by NBC News chief medical editor Nancy Snyderman while she worked J&J. Video sites, like YouTube and Vimeo, offer pharma companies a place to feature expensive off media advertising assets (that are currently collecting dust) and to post ads for new drugs and products that are ready for launch.  J &J is the first pharma company to recognize that it can leverage the current social media craze to increase its visibility, sell more drugs and bolster its stock price!

While companies could host videos on their own websites,YouTube’s massive traffic of more than 80 million users offers companies a much larger and diverse audience. And unlike blogs or forums, pharma companies have complete control over the content of the videos that they post on video websites. Moreover, they don't have to worry about negative comments being left after a post (YouTube comments can be turned off), and they can brand and edit video content to target a particular demographic or audience. Finally, videos can be changed or removed by companies as needed.

The bad news is, that like all other forms of media on the Internet, there are currently no regulations for videos posted by pharma companies on video websites sites like YouTube. In other words, pharma companies can do or say whatever they want in the videos that they post—never a good thing! I suspect that at some point FDA will draft a guidance document or two on the topic. But pharma companies need not worry, it will likely be many years before the agency divines regulations guiding the messaging and content of online pharmaceutical videos.

The appearance of pharma videos on YouTube, and the growing number of pharma profiles on social networking sites indicates that pharma is ready to embrace social media as the next best thing since DTC advertising. I was wondering what took them so long?

I hope that J&J doesn’t start following me on Twitter!

Hat tip to Eye on FDA for the story!

Until next time,

Good Luck and Good Job Hunting!!!

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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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Novartis announced today that it intends to purchase Malvern, PA-based Protez Pharmaceuticals for $400 million. Protez is developing a novel spectrum carbapenem antibiotic that is active against variety drug-resistant Gram positive (most notably MRSA )and Gram negative bacterial pathogens. Its lead compound, PZ-601, is in Phase II human clinical testing. Protez acquired PZ-601 (formerly SMP-216601) in 2005 from Dainippon Sumitomo Pharmaceuticals.   

Novartis is buying Protez to sure up its antibacterial drug pipeline. Novartis already sells Cubicin, (manufactured by Massachusetts-based Cubist Pharmaceuticals Inc.,) in Europe and is developing other antimicrobials including Aurograb and Tifacogin to treat infections.

Like many of the newly marketed antibiotics, PZ-601 is injected and not orally bioavailable. Nevertheless, it is likely that PZ-601 will provide much needed help against the ever increasing number of drug resistant bacterial isolates. Swiss companies Basilea Pharmaceutica AG and Arpida Ltd. are also working on experimental medicines to treat MRSA.

It is not clear how the acquisition will affect Protez employees.  I suspect that most of the employees will keep their jobs except for Company officers.

Until next time…

Good Luck and Good Job Hunting!!!!!

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Takeda Pharmaceutical Co., Japan’s largest pharmaceutical manufacturer, announced that it has agreed to buy Cambridge MA-based Millennium Pharmaceuticals for $8.8 billion. Millennium, founded in 1993 by high profile MIT researchers and once heralded as one the most innovative American biotechnology companies, never lived up to analyst’s expectations. That said, the company did develop and win regulatory approval for an anti-cancer drug, Velcade, which is expected to garner additional approval for wider use in oncology later this year.

Velcade, which is used to treat relapsed multiple myeloma after other drugs fail generated more than $800 million last year. Millennium anticipates U.S. approval by June to promote Velcade as an initial therapy to treat these disorders. Millennium markets Velcade in the US and shares revenue with Johnson & Johnson which markets Velcade in 85 other countries. Analysts predict that the Takeda acquisition will help to propel Velcade to blockbuster status.

The Takeda-Millennium deal follows Eisai Co.’s (another Japanese company) agreement in December to buy the U.S.'s MGI Pharma Inc. for $3.9 billion as Japanese companies, aided by a weak dollar against the yen, seek growth abroad. Japanese companies have been hampered by government-ordered price cuts, weak pipelines and a lack of new products  As one financial analyst put it ``There's no doubt the weak dollar against the yen is making U.S. biotech very attractive right now to potential Japanese buyers,''

Takeda’s best seller is the diabetes drug Actos which is slated to lose patent protection in the near future. Acquisition of Millennium provides Takeda with an entrée into the oncology and cardiovascular markets both of which are poised for expansive growth in the next five years. Analysts also believe that the Millennium acquisition will boost Takeda’s drug discovery and development flow. Millennium is conducting human trials with experimental drugs for cancer, heart disease, gastrointestinal disorders and rheumatoid arthritis.

The ongoing acquisition of American biotechnology companies by Japanese pharmaceutical companies reminds me of  the Japanese foray into the US real estate market in the early 1990s. Only time will tell whether the Japanese will be able to hang on to their acquisitions this go around (they weren’t the last time).  Earlier this week, Switzerland's Novartis AG agreed to buy 77 percent of eye-care company Alcon Inc. in a two-step transaction totaling $39 billion. Does anybody else see a troubling trend developing here as a result of the recession that we are in or heading into?

Don’t be surprised to see some “asset reallocation” and downsizing at Millennium. The Japanese are well recognized for increasing efficiency and work output with smaller numbers of employees.

Until next time….

Good Luck and Good Job Hunting (not in Cambridge MA)!!!!!!!!

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Is it luck or good planning that has prompted many pharmaceutical and biotechnology companies to set up manufacturing and research operations in Ireland? In my opinion, the recent Irish pharma and biotech explosion has little to do with luck and everything to do with strategic vision, excellent planning and a well trained, inexpensive workforce.

Currently, 28 out of the 50 top pharmaceutical/biotechnology companies in the world have facilities in Ireland. Some of these companies are Merck, Wyeth, Genzyme, GlaxoSmithKline, Pfizer, Johnson and Johnson, Schering-Plough and Bristol-Myers Squibb. Seven out of 10 of the world’s top selling blockbuster drugs are now manufactured in Irish production facilities. 

Pharmaceutical companies were the first to set up shop in Ireland. However, biotechnology is growing rapidly and biomanufacturing is starting to over shadow traditional small molecule production. Companies including Wyeth, Centocor, Bristol-Myers Squibb, Organon Biosciences (now part of Schering Plough) and Allergan manufacture biologics and biotechnology products in Ireland. In fact, Ireland is home to the world’s largest biomanufacturing facility, Wyeth’s € 1.3 billion Grange Castle near Dublin.

So why pharma and biotech are companies flocking to Ireland? First, the Irish labor force is well trained, everyone speaks English (albeit with an Irish lilt) and wages are still low. Second, Ireland has the lowest corporate taxes in the entire European Union. Further, there are R&D tax credits and financial support for start ups.  For example, there is financial support to purchase consultancy and innovation vouchers worth €10,000, a substantial amount of money for any startup! Finally, and perhaps most importantly, the Irish government had the foresight to create a public/private enterprise known as the National Development Plan (2000-2006) that invested € 2.5 billion to create an Irish R&D infrastructure.

The Irish strategy–“built it and they will come”– has certainly paid off handsomely for Ireland. Another country that has embraced a similar strategy is Singapore–which through a public/private initiative has been building a vibrant life sciences and biotechnology industry since 1999. Both countries now compete for pharma and biotech business. For example, in late 2007, Merck decided to build a € 200 million vaccine facility at Carlow Town in Southeast Ireland. Novartis, on the other hand, opted for Singapore to build a new $180 million pharmaceutical tabletting facility along side of its API production plant.

Unlike Ireland, the American pharmaceutical and biopharmaceutical industries are in trouble and losing their competitive edge. Perhaps the US can learn a thing or two from the Irish to give its bioscience industry a much needed shot-in-the arm.

Until next year….

Good Luck and Good Job Hunting (try Ireland)!!!!!!!!!!

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Novartis announced late last year that it intends to invest about $700 million to build a new biomanufacturing facility in Singapore. Construction will begin in early in 2008 and the plant is expected to be fully-operational by 2012. The new cell culture production facility will employ approximately 300 people and support manufacturing of both clinical and commercially-available products, mostly monoclonal antibodies.

At present, biologics and protein-based biotechnology products represent about 25% of Novartis’ drug pipeline. Most of these products are owned and manufactured by Novartis’ wholly owned subsidiary .

You gotta tip your hat to Singapore—their government-sanctioned plan to invest billions of dollars into biomedical research seems to be paying off!

Until next time

Good Luck and Good Job Hunting (try Singapore)!!!!!!

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As the debate continues to rage in the US about how to regulate biogeneric drugs, the European Medicines Agency (EMEA) has given the go-ahead to Hospira and Stada to sell their copycat version of Johnson & Johnson's anemia drug Procrit.

The European Commission approved Retacrit (epoetin zeta), a biosimilar version of erythropoietin (EPO), to treat anemia associated with chronic renal failure and chemotherapy. EMEA regulators determined that the drug was comparable in efficacy and safety to Procrit.

The EPO market is a large one and more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, Procrit (JNJ; US), Eprex (JNJ; Europe) and Epogen (Amgen; US). Worldwide annual sales of EPO drugs are estimated at more than $7 billion, $600 million of which comes from Europe.

The approval for Retacrit comes some three months after Novartis’ generics unit Sandoz got the first go-ahead in Europe to develop its version of epoetin alfa. Sales of Retracrit will begin in Germany in early 2008.

When are American pharmaceutical and biotechnology executives going to wake up and realize that they will lose millions in revenue to biosimilar competition?  I think the old adage; “If you can’t beat ‘em, join ‘em” is apt when talking about the biogenerics industry.

Until next time…

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

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Ed Silverman at Pharmalot alerted me to this tidbit. Daniel Vasella, CEO of the Swiss drug maker Novartis AG, mentioned in an interview with The Wall Street Journal that he is planning a companywide restructuring aimed at reducing “layers of management and bureaucracy—following through on reorganization comments he made several months ago.

Novartis, plans to disclose more about its restructuring plans by mid-month and elaborate further in February, adding that the restructuring will involve some job cuts, but Vasella declined to say how many. In an October briefing for analysts, Novartis executives said there would be 240 jobs cut in US headquarter functions Hanover, NJ) and 510 sales reps and 510 contracted rep positions eliminated, for savings of $230 million.

Novartis is one of several big drugmakers to cutback - AstraZeneca, Pfizer, Bristol-Myers Squibb, Glaxo and Johnson & Johnson have all announced layoffs in the past year. And Merck and Wyeth continue to trim selectively as part of ongoing savings programs.

According to the Journal, the changes at Novartis will follow recent management changes and comes after a tough year for Novartis. The drugmaker, faced generic competition on some of its

biggest drugs and failed to gain FDA approval for two new products–including the anti-diabetes drug Galvus (vildagliptin) which was predicted to be a blockbuster. Earlier this year, it also was forced to withdraw from the US and Swiss markets its drug for irritable-bowel syndrome, Zelnorm, after safety concerns.

One new rule Vasella has set: There should be no more than six layers of employees in any Novartis division, from the lowest-ranking person up to the division head. Novartis has four divisions: pharmaceuticals, generics (Sandoz), vaccines and diagnostics, and consumer health, which includes over-the-counter medicines.

Vasella says he realized the pharma division, in particular, was bogged down with bureaucracy after he had recent lunch with a group of its employees. The reorganization will also cut costs from Novartis’s procurement activities. One area that will come under particular scrutiny: the use of third-party CROs to oversee Novartis’s clinical trials which has been extremely costly for the Company.

Until next time....

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

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Ed Silverman who runs the  Pharmalot blog reported that Novartis is slated to cut about 1,200 jobs to save the company about $230 million a year.  According to the post at Pharmalot, Novartis will let 240 employees go at its US- based headquartersin Hanover, New Jersey and eliminate over 1,000 full time and contract sales representatives from its workforce.  Also reported was that Novartis is planning to create a biologics division within the company.  I find this extremely interesting because Novartis already has a strong footprint in the biologics biz  via its wholly-owned subsidiary Sandoz, which is one of the market leaders in the follow-on biologics aka biosimilar sector.

I guess having a biologics division is de rigueur these days if you are a big pharma company.  I am still wondering why it took so long for all of these high paid pharmaceutical executives to figure out that biotechnology was the next  big thing?  You would think that after 30 years, they would get the hint.  But then gain these are some of the same people who brought us Vioxx, Avandia, Exubera and ...go ahead ....pick your favorite.

Until next time....

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

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