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I just returned from the American Association of Pharmaceutical Scientists (AAPS) meeting in Washington DC where I gave three talks about biocareer development strategies. One of the talks, "Emerging Job Opportunities in the Life Sciences Industry" was reported on (see below) by a writer from Fierce Pharma.  While I don't usually "too my own horn." about my achievements, I thought a Number 2 ranking in the publications daily top 10 list was certainly worth a mention.  

 
New job opportunities emerging in Big Pharma
October 26, 2011 — 7:24am ET | By Maureen Martino

Since 2001, 300,000 pharma employees have lost their jobs, primarily in R&D and sales. That's according to Clifford Mintz, the founder of BioInsights, which develops and offers bioscience education and training. Mintz spoke at a session on new job opportunities in biotech and pharma at the annual AAPS meeting in Washington, D.C. While the losses have been steep, they're balanced by emerging, in-demand careers in the industry.

The industry's struggles are well-known: Many companies are facing loss of exclusivity on their biggest sellers but have little in the pipeline to pick up the slack. Productivity is dropping as the cost of bringing a new drug to market soars. Government and payors want more effective drugs for less money. The list goes on.

Developers are looking to new markets and new technologies to address these issues. But how do these trends play out for the pharma job seeker? Many people, particularly Ph.D.s, may have to consider getting additional training if they want to land their dream job. "Companies used to be willing to just hire smart people. But with the economic downturn and global competition, companies can no longer afford to invest in people who have promise. They need to see proven skills," Mintz explained. With the right blend of skills and experience, however, there still some pharma jobs that are in demand.

Clinical Research and Regulatory Affairs

"Clinical research is the lifeblood of the industry," Mintz said. As developers expand in emerging markets, there's a particular demand for people to manage and organize overseas clinical trials. "There's a huge need for clinical research professionals worldwide," he said, noting that most Phase I and II trials are conducted outside of the U.S.

Another one of the industry's perennial needs is regulatory affairs professionals. "Regulatory affairs experience is a skill that all companies large and small would die to get their hands on," explained Mintz. The increasingly complex and uncertain world of FDA regulation--particularly when it comes to new technology and science--means that companies are always on the prowl for individuals with solid regulatory knowledge and ability to interact with the FDA. You can read more about the demand for clinical research and regulatory affairs jobs here.

Biomanufacturing

The pharma industry's interest in biologics remains strong--just look at Sanofi's buyout of Genzyme, or Roche's purchase of Genentech. They're lured by disease-altering biologics that are less likely to face generic competition than traditional drugs. As a result, there's been increased demand for professionals who can navigate the complex world of biomanufacturing. Those with a background in upstream and downstream processes, large-scale protein purification, fermentation technology and bioengineering can make the transition to biomanufacturing.

Healthcare Information Technology

The rise of bioinformatics and genomics coupled with the push for electronic medical records has created jobs in healthcare information technology. Health informatics--the intersection of healthcare and IT--is ideal for people with expertise in genomics, bioinformatics or software that understand how to work with and manipulate large data sets and databases. The Obama administration has made EHRs a priority, and there's a need for software engineers and biologists who are comfortable working with medical information.

Medical Devices

"The medical devices industry has been experiencing explosive growth for the past decade," Mintz said. Regulatory hurdles in the medical device industry are much lower than they are for biologics or small molecules, making the industry a more stable alternative to biotech and pharma. The demand for devices, which address problems that can't be treated with medicine, will continue to grow as the population ages. Job seekers with strong backgrounds in bioinformatics, genomics, engineering and translational medicine are best suited to this field.

Medical Communications

Medical communications--which includes medical writing, editing, graphic design and science journalism--continues to boom. The demand for these jobs has risen because companies need a slew of communication materials to send to patients, physicians, researchers, investigators and the general public about their products and business.

Patent Law and Technology Transfer

Recent changes to U.S. patent laws have increased the demand for patent agents and patent attorneys in the life sciences field. Pharma's growing reliance on basic research from learning institutions means that there's a need for technology transfer experts. These experts manage the patent estate and intellectual property of universities and colleges that may engage in licensing deals with the industry. A law degree is a must to compete in this field.

Until next time...

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

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Times are tough for many in the legal profession these days. However, the demand for patent experts including attorneys and patent agents is skyrocketing. According to an article in today’s NY Times, openings for patent attorneys account for more than 15 percent of law firm job openings while only 3 percent of lawyers in the US specialize in this area. The bottom line: it is a great time to be a patent attorney or agent in today’s tough economy.

Not surprisingly, many patent attorneys (and agents) usually have a background in science or engineering. And, because of the scarcity of qualified applicants many law firms are doubling their recruiting spending to meet the growing demand for specialists in intellectual property (IP) and patents.

One of the reasons for the growing demand is passage of the America Invents Act, the largest overhaul in the US patent system in the past 60 years. The legislation which changes how patents are reviewed and process is spurring competition between firms to higher IP specialist to ease the transition pain. At present, there are over 230 IP openings among more than 1400 lawyer positions nationwide. Many of the openings have been unfilled for over 90 days and more are added daily.

Currently, there are about 40,000 patent attorneys and agents registered with the US Patent and Trademark Office (USPTO). In order to register with the USPTO agents and lawyers are required to pass the patent bar examination. While registered patent agents have taken and passed the exam, they are not lawyers who are required to pass state bar examinations to become licensed attorneys. For those of you who may not know, you don’t have to go to law school to take the patent bar exam nor is a law degree required to take individual state bar exams (however, person who are not law school graduate are likely not to pass the state tests). Patent agents can prepare patents and prosecute cases with the USPTO but cannot litigate in court or draw up contracts. There are roughly 1.2 million licensed patent attorneys in the US according to the American bar association.

The greatest demand for IP attorneys and agents is in information and computing technology and the life sciences. Persons with PhD degrees in the life sciences can sometimes find work at IP and patent law firms. Also, you may be able to find work at a patent examiner with the USPTO! PhD degree holders who have passed the patent bar are even more desirable. However a law degree plus a PhD degree will almost certainly guarantee you employment at most IP firms. That said, before you decide to go to law school, I high recommend that you talk with IP professionals or read a few dozen patent applications (they can all be found at www.uspto.org) in your spare time. If you find the reading interesting or manage to stay awake after reading the fifth application than patent law may be a good choice for you. If not, I suggest that you consider other alternate career options.

Until next time...

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

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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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According to a "mention" today on the Pharmalot blog, a French newspaper reportedly learned that Sanofi-Aventis may be spending up to $1 billion this year to acquire up to four ophthalmology companies. Although the companies were not identified, three of the companies that Sanofi is eying (pun intended) are located in the US and the fourth is reportedly in Israel.

An aging global population coupled with the diabetes epidemic plaguing the US and several other Western countries suggest that ophthalmology drugs may be a good bet for the future. This, coupled with the impending acquisition of Genzyme suggests that Sanofi-Aventis is trying to create somewhat of a soft landing for the company after patent expiry in early 2012 of Plavix, its major money maker.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Many industry insiders and financial analysts were pleased when former Pfizer CEO Jeffrey Kindler abruptly departed the company last December. Most felt that the company had grown too large after three mega-mergers and acquisitions (Warner Lambert, Pharmacia and most recently Wyeth) in the past decade or so. Pfizer bought Wyeth in late 2009 for $67 billion with the hope that it bolster the company’s drug development pipeline and replace vanishing Lipitor revenue (the move has not paid off which may explain Kindler unexpected departure).

Further, Pfizer’s best selling (and world leading) cholesterol-lowering drug Lipitor is due to lose patent protection in 2012. Lipitor had $10.7 billion in sales last year. This, along with the loss of patent protection for Viagra and a few other Pfizer prescription drugs, presumably left new CEO Ian Read, little choice but to slash R&D spending by close to $2 billion. Consequently, the company today announced it would close its research facility in Sandwich, England (which developed Viagra) and eliminate most of its 2,400 employees. An additional 1,000 employees at its research center in Groton, CT will either be offered transfers to its Cambridge, MA facility or layed off.

The elimination of 3500 Pfizer R&D employees begs the question “who will do the research to discover new drugs?” Not surprisingly, Pfizer’s answer is to outsource the work to Contract Research Organizations like Covance, Charles Rivers Laboratories and Parexel International Corp. Interestingly, much of this work is conducted by scientists who work outside of the US. And, if this down sizing trend continues how will the US ever get its unemployment rate below 10 percent?

Pfizer, like most other major US pharmaceutical companies, is no stranger to massive downsizing. The company alone has layed off over 19,000 employees over the past three years. And, unlike contractions in the life sciences industry in the past, I highly doubt that many of these R&D positions will be reinstated in the future. With this in mind, I highly recommend that those of you who were considering industrial R&D careers have a plan B or possibly a plan C to fall back on.

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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The expanding European financial crisis is forcing drug makers to continue to explore ways in which to cut costs. Faced with budget deficits amid a global economic crisis, European countries such as Germany, France and Greece have cut or plan to cut their health-care spending. Greece last month ordered drugmakers, including France’s largest drug maker Sanofi-Aventis, to cut prices by 3 percent to 27 percent to help rescue its economy. 

Not surprisingly, Sanofi Aventis responded by announcing new job cuts and more stringent cost control measures. Yesterday, Sanofi’s Chief Financial Officer announced at an analyst meeting in Los Angeles that “We are restructuring. We are changing our marketing model. We are merging sales forces, we are reducing sales forces, having a multiproduct sales force. We will continue to do that.” Most of the job cuts and cost saving measures will come at the expense of sales and marketing personnel. The size of pharmaceutical R&D and sales and marketing workforces have been devastated over the past three years with over 200,000 employees losing their jobs.

Sanofi-Aventis Chief Executive Officer Chris Viehbacher, who joined the company in 2008, shut or sold plants and canceled the least promising research projects in a bid to trim 2 billion euros ($2.46 billion) in costs. These actions, coupled with the most recent restructuring efforts were enacted to ensure 2013 earnings are at least equal to 2008 profit. Like most other big pharma companies, Sanofi has been looking to emerging markets and consumer products for new income as competition from generic drugs hurts sales. The anti-clotting drug Plavix which is Sanofi’s largest selling drug generating over $4.0 billion annually will lose patent protection in 2011-2012. Bristol Myers Squibb, Sanofi’s marketing partner for Plavix in the US, also exceeded $4.0 billion in sales last year.

Sanofi also announced today that it acquired the assets of Montreal-based Canderm Pharma, Inc a consumer products company for $1.9 billion signaling its intention to aggressively enter the North American consumer healthcare products markets.

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 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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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

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

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According to a post over at Pharmalot, BMS may be positioning itself for sale or readying itself as a potential M&A target.   

Although BMS has been rumored for years to be a takeover target, the impending loss of revenues generated by its anticlotting drug Plavix (co-marketed with Sanofi-Aventis) due to patent expiry in 2011 is wreaking havoc at the company.  As much as 50% of BMS’s revenue is generated by the Plavix franchise. The impending loss of Plavix suggests that thing must drastically change at the company in order for it to remain independent.

Time will sell….I mean tell....!!!!!

Until next time….

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

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As many of you may know, Ranbaxy was involved in a bitter patent dispute with Pfizer over Lipitor, Pfizer’s blockbuster multibillion, dollar anti LDL-cholesterol drug. Ranbaxy was challenging the validity of Pfizer’s intellectual property estate for Lipitor which would have extended patent protection for the drug until 2013 or longer. The patent dispute began after Ranbaxy filled an ANDA with the US Food and Drug Administration to sell generic Lipitor after uncontested Lipitor patents expire in early 2010.

Conventional wisdom suggested that Pfizer would ultimately lose the patent dispute and that Ranbaxy would be able to immediately flood the market with a much cheaper generic version of Lipitor. This would have an enormous negative impact on Pfizer’s financial stability and its future (Lipitor had $12.8 billion in sales in 2007). Nevertheless, untilDaiicho-Sankyo announced its intention to acquire Ranbaxy last week, Pfizer was willing to gamble and run the risk of losing the lawsuit. Apparently, Ranbaxy impending sale was enough of an impetus for Pfizer to settle the patent dispute which has grown increasingly acrimonious over the past year or so.

According to agreement (which needs to be approved by the US Federal Trade Commission), Pfizer was able to get Ranbaxy  to agree to delay the release of generic Lipitor until November 2011 — up to 20 months later than many analysts had been expecting (some insiders believed that generic Lipitor could reach the market as early as March 2010). Further, as part of the agreement, Pfizer will allow Ranbaxy to sell its version of Lipitor in Australia, Canada, Belgium, Germany, Italy, the Netherlands and Sweden two to four months before Liptor’s patents expire. This is likely the sweet part of the deal for Ranbaxy because all of the above mentioned markets are top sellers for anti-cholesterol drugs. Finally, because Ranbaxy was the first to file an ANDA for generic Lipitor with the FDA, it will get 6 months of market exclusivity guaranteed (in the Hatch Waxman Act) to a generic manufacturer that is first to file for generic production of a brand name drug nearing patent expiry.   However, after quickly perusing the terms of the deal, I think that it more closely resembles an authorized generics deal rather than a “true” competitive generics launch.

Currently, Lipitor costs about $2.50 to $3 a day. Analysts predict that Ranbaxy can sell its generic Lipitor for about 75 cents to $1 a day, or as low as 10 cents a day at some discount pharmacies. The potential drastic price reduction coupled with Daiichi-Sankyo’s intention to purchase Ranbaxy (which would have provided Ranbaxy with more money underwrite and press on with IP lawsuit, it what I believe forced Pfizer’s hand to act as quickly as it did to settle the suit. The deal, if approved, allows Pfizer to dodge a near fatal financial bullet and will provide it with a potentially lucrative revenue stream from it authorized generics deal that it struck with Ranbaxy. 

Nevertheless, given the financial stakes associated with the Lipitor franchise, it may make more sense for Pfizer to purchase Ranbaxy rather than enter into the pending deal. Also, a Ranbaxy purchase would allow Pfizer to enter the biologics and biotechnology fields—something that Pfizer executives have been talking about publicly to insure the company’s future. Like most other pharmaceutical generics manufacturers, Ranbaxy has active research programs on biosimilar and other biotechnology products. If I was driving the boat at Pfizer I would offer Ranbaxy a lucrative counteroffer to block its sale to Daiichi-Sankyo. I don’t know—the deal just makes sense to me. That said, not many recruiters have been calling me about CEO jobs lately!!!!!!

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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Wyeth announced yesterday that it is introducing a generic version of its blockbuster heartburn medication Protonix. The company is embroiled in nasty patent litigation with Israel-based Teva, one of the world’s largest generic drug manufacturers. The lawsuit, filed by Wyeth, claims that TEVA violated a violation of Protonix's patent which is set to expire in 2010. Teva introduced a generic version of the drug in December, which caused Protonix's sales to plummet, but then agreed to temporarily halt selling its rival product, known as pantoprazole, as the two companies engaged in settlement talks.

Protonix, one of Wyeth's top sellers, posted $1.45 billion of sales in the first nine months of 2007. Wyeth yesterday said its generic version would be distributed by Prasco Laboratories, a closely held Cincinnati company. A Teva spokeswoman declined to comment on what Wyeth's generic version means for settlement talks or whether Teva will resume sales of its own generic.

A steep drop in Protonix sales, which would be expected in the face of generic competition, would deliver yet another blow to Wyeth, which has tried and failed to win approval for some of its new medications including Pristiq for menopause symptoms and bazedoxifene for osteoporosis. Wyeth’s unprecedented move of a introducing a generic version of Protonix before patent expiry indicates how reliant the company is on sales of its blockbuster product.

If a court finds that Teva violated the Wyeth patent, Teva may have to pay triple damages awarded to the patent holder.

Until next time…

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

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Despite the Martha Stewart-Sam Waksal insider trading scandal in 2001, ImClone, the company founded by Waksal in 1984, is doing well and managed to sell $1.1 billion of its anti-cancer drug Erbitux in 2006. Erbitux is a monoclonal antibody that is approved to treat colorectal cancer and certain head and neck cancers. ImClone co-markets Erbitux, its only product, with Bristol Myers Squibb (US) and Merck KGA (Europe).

In September, ImClone agreed to pay over $65 million in cash to Waltham, Mass.-based Repligen - a portion of that was designated to the Massachusetts Institute of Technology - to get royalty-free rights to U.S. Patent No. 4,663,281 and U.S. Patent No. 5,665,578. Repligen had contended that ImClone infringed both patents when developing and manufacturing Erbitux for commercial purposes.

Now, here is where it gets interesting. Repligen gained the rights to Patent No. 5,665,578 from Abbott Laboratories via a sublicensing agreement. Although Repligen settled with ImClone over the disputed patent, Abbot has not. 

Late last week, Abbot filed papers in federal court requesting a face-to-face interview with Waksal who is currently serving a seven-year term in the Otisville Correctional Facility in New York. Abbot contends that Sam “played a central role in numerous issues significant to this [patent] litigation.” ImClone is not opposing the request. I guess ImClone knows a lot more about Sam than we do!

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The Wall Street Journal Online published an insightful article today on the future of the pharmaceutical industry.  The article did not contain anything that we didn’t already know–pharma is in deep doo-doo. Starting in 2010, the pharmaceutical industry faces one of the biggest waves of patent expirations ever, affecting dozens of top-selling drugs.

The WSJ was kind enough to put together a great table showing the drugs that will be losing patent protection in the near future, their manufacturers, the clinical indications for which the drugs were approved and the size of the current market for each product.

Don’t you just love the resources that high impact newspapers have at their disposal? Check it out…..

Until next time….

Good Luck and Good Job Hunting (if you can find one)!!!!!!

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