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It seems like hostile takeover bids in the life sciences industry may be de rigueur (how can anyone forget the Sanofi-Aventis/Genzyme hostile takeover saga that dragged on for almost a year). Interestingly, there have been 219 acquisitions of U.S. pharmaceutical companies in the past 12 months, with an average disclosed price of $153.7 million and an average premium of 44 percent!

Late yesterday, Valeant Pharmaceuticals announced plans for a hostile takeover bid for Cephalon, a 24 year old Pennsylvania-based biopharmaceutical company with eight products on the US market and more than 100 products worldwide. The takeover bid became “hostile” after Cephalon’s management team rejected earlier proposals.

Cephalon’s main focus is on nervous system disorders, pain and cancers. It is one of the world’s top 10 and most profitable biopharmaceutical companies. The company had revenues of $2.81 billion last year from sales of its narcolepsy treatment Provigil ($1.2 billion) and its leukemia treatment Treanda ($393 million). Also, according to the Cephalon website, there are several oncology products (lung, melanoma and solid tumors) in its development pipeline. In 2010 Cephalon announced seven acquisitions many of which were intended to bolster its oncology expertise.

Valeant Pharmaceuticals International, long a struggling speciality pharma company, merged with Biovail Corporation late last year and re-emerged as a re-invented company with substantial financial resources at its disposal. Prior to the Biovail merger, Valeant had a long history of acquiring smaller companies to bolster its R&D capability and its flagging drug development pipeline. The new company specializes in neurology and dermatology and has a diverse product portfolio that consists of branded pharmaceuticals, branded generics and over-the-counter medicines. In 2009, its revenues were $1.65 billion and 2010 revenues (to be released) are likely to exceed $2.0 billion. 

According to Bloomberg News, Valeant has offered to buy Cephalon for $5.7 billion in cash. Under terms of the offer, Valeant would pay $73 a share in cash; a 24 percent premium on Cephalon’s Tuesday closing stock price or a 29 percent premium to company’s 30 day trading average. Not surprisingly Cephalon executives summarily rejected the offer as “too low.” Several financial analysts concur with Cephalon and contend that the $73 per share cash offer undervalues the company’s true worth. Valeant and Cephalon are main competitors in the oncology and neurology markets.

Unlike the Sanofi/Genzyme bid, where it was clear at the outset to most observers that Sanofi would ultimately prevail, it isn’t clear whether or not Valeant will be successful in its attempt for Cephalon. While Cephalon has had its share of trouble with FDA over the past few years (for a variety of infractions including off-label marketing of Provigil), the company is in much better shape than Genzyme and the current management team has more resources at its disposable to ward off Valeant’s hostile takeover bid.

The downside of a Valeant-Cephalon merger would be job loss for many current Cephalon employees. This is because Valeant’s bid for Cephalon appears to be a “pipeline grab” rather than an R&D play. Typically, these types of acquisitions result in reorganization and downsizing of personnel because of duplication of effort. Only time will tell if Valeant will prevail.

Stay tuned for more late breaking news!

Until next time...

Good Luck and Good Job Hunting!!!

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After seven months of public bickering over an appropriate sale price, the NY Time reports today that Sanofi Aventis may have hammered out a deal that would enable the French drug maker to acquire the world’s largest orphan drug manufacturer Genzyme for $19 billion. According to the report, Sanofi will acquire Genzyme for a $74 per share which is up from it previous offer of $69 per share.

Most analysts and the Genzyme management team felt that the previous $69 per share offer was too low and that the tipping price would be in the mid 70s. This made sense even to outsiders like me because Eli Lilly purchased ImClone, a company with only one approved product on the market, for $70 per share several years ago. Genzyme has multiple FDA-approved products with a strong late stage drug development pipeline. Not surprisingly, Sanofi tendered a low initial stock price purchase offer to give itself flexibility when it decided to enter into serious negotiations.

Despite the long drawn out and tiresome melodrama, the deal is a good one for Sanofi, a company that desperately needs to bolster its biotechnology pipeline and also for Genzyme which has been rocked by biomanufacturing and quality problems for the past couple of years.

Now that this deal is imminent, does anyone have an idea about which biotechnology company may be the next takeover target?

Until next time..

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

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Yesterday, Genzyme announced it would cut about 1,000 jobs worldwide as part of a restructuring plan. In addition, company spokespersons indicated that the company may outsource some of the eliminated permanent position and impose a hiring freeze. As part of its restructuring plan, the company plans on eliminating about 10 percent of its 12,800-employee workforce by 2012. It is unclear how many of the 4,500 US employees will lose their jobs.

In addition to the job cuts, the company announced that it had agreed to sell its diagnostic testing unit (reproductive and genetic testing) to Laboratory Corp of America for $925 million in cash. Henri Termeer, Genzyme’s beleaguered CEO also announced that the company’s other two units, molecular diagnostics and pharmaceutical ingredient manufacturing on also on the block and will be sold.

While Termeer insists that the job cuts and sale of non-core business units has nothing to do with Sanofi-Aventis’ attempt to purchase the company, many analysts believe that these measures are being taken to induce Sanofi to sweeten its $69 per share takeover bid. The additional monies garnered from the layoffs and division sales, will allow Genzyme to strengthen its stock position and bolster its cash reserves to defend against a possible hostile takeover attempt by Sanofi. 

The demise of Genzyme, once one of the most highly regarded and ethical biotechnology company in the world is directly linked to manufacturing problems at its Boston-based facility. The ongoing and protracted quality problems at the plant resulted in a consent decree by the US FDA and penalties totaling about $175 million. As most quality experts will tell you, systemic quality control and assurance issues generally stem from a lack of commitment to quality by senior management; in this case Termeer! 

Despite repeated request for his resignation, Termeer, who has run Genzyme for the past 25 years or so, has steadfastly refused to relinquish his post. Instead of stepping down to save the company, Termeer has chosen to “take the ship” down with him; the sure sign of an out-of-touch CEO who apparently was willing to sacrifice the reputation and worth of a company for entirely self-serving reasons.

Until next time...

Good Luck and Good Job Hunting

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Can things get any worse at Genzyme? First there were the manufacturing problems that result in plummeting stock share prices and a proxy battle by Carl Icahn and company. Next up was a $175 million consent decree judgment levied by the US Food and Drug Administration for the manufacturing problems. Then came the $18 billion takeover bid from Sanofi Aventis. Now, patients affected by shortages of the drugs Fabrazyme three patients have petitioned the US Department of Health and Human Services (HHS) to disregard Genzyme’s patent for the medicine to overcome the drug shortages.

Because of the manufacturing problems, Genzyme rationed its supplies of Fabrazyme to one-third of the normal dose for Fabry disease patients. Some of these patients reported increased pain and no newly diagnosed patients could receive the drug. Meanwhile, Shire Pharmaceuticals has been trying to obtain FDA approval of its Fabry disease treatment, Replagal which is approved in Europe.

The patients who petitioned HHS contend that HHS can override the patents because the National Institutes of Health paid for research at the Mount Sinai School of Medicine, which exclusively licensed Fabrazyme to Genzyme. The goal of the action is to induce another company to produce the drug in case Genzyme is unable to deliver adequate quantities to new and existing patients. Provisions in the Bayh-Dole Act suggest that this action may not be unreasonable if ‘a licensee cannot reasonably meet the public health and safety needs of the American public.’

Stay tuned for the next installment of the continuing Genzyme saga!

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The New York Times reported today that French drug maker Sanofi Aventis has made a bid to purchase beleaguered orphan drug manufacturer Genzyme. According to the report, Sanofi approached Genzyme about two weeks ago about a possible sale. Sanofi is currently waiting for a response from Genzyme. If Genzyme rebuffs the takeover bid, persons close to the deal said that Sanofi may possibly try to acquire Genzyme via a hostile takeover bid.

Sanofi is facing revenue losses because many of its blockbuster products including the anti-clotting agents Plavix and Lovenox will or have lost patent protection. Plavix's patent expiry will occur in 2001 whereas Lovenox has already lost patent protection ( yesterday the FDA approved a generic version of the drug). Further, Sanofi, unlike most major pharmaceutical companies, is glaringly deficient in biotechnology products and has long been known to be seeking a quick entry into the biotech market. To that end, the Genzyme bid makes complete strategic sense to bolster sales and secure Sanofi's future.

Genzyme is the fifth largest biotechnology company in the world. Sales of it orphan drugs to treat Gaucher’s, Fabry and Pompe disease annually exceed $3.0 billion in sales even though they are used to treat small numbers of patients (<20,000).

Genzyme’s value has plummeted in the past year because of manufacturing problems and is currently operating under a US Food and Drug Administration consent decree after being fined $175 million by the agency. Many shareholders have called for the dismissal of Henri Termeer, Genzyme’s CEO for the past 25 years. To date, Termeer has refused to step down even though Genzyme’s stock continues to under perform. News of a possible takeover caused Genzyme’s stock price to soar; gaining more than 15 per cent on Friday to $62.50.

I believe that Sanofi is approaching Genzyme at the right time. Recently, Genzyme reached an agreement with Carl Icahn, who owns a substantially amount of stock, to prevent a proxy battle to reshape Genzyme’s board and oust Termeer. Also, another major shareholder, Ralph Whitworth, is unhappy with recent events at the company. Sanofi’s acquisition of Genzyme would provide a quick entry into the biotechnology and orphan drug markets and also appease shareholders like Icahn and Whitworth if the deal is rich enough. Also, Sanofi’s manufacturing experience would help Genzyme overcome its problems in that area.

Stay tuned for updates.

Until next time...

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

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Carl Ichan, the billionaire, activist investor notified Genzyme that he will seek shareholder approval to seat four handpicked directors including himself to be appointed to the company’s board of directors in an attempt to remove embattled Chairman and CEO Henri Termeer who has led the company for the past 25 years.

The move was widely anticipated by industry analysts because Icahn own one percent of outstanding shares of Genzyme’s stock.  Icahn and other large shareholders believe the company would be better off under new leadership. Termeer has publicly stated that he has no intention of resigning.

Until recently, Genzyme’s standing and reputation in the biopharmaceutical and orphan drug industry was second-to-none. However, the company’s inability to quickly correct ongoing manufacturing problems at its biomanufacturing facilities for the past year has been extremely embarrassing and costly. Sloppy manufacturing and quality control problems this past year led to major shortages of two main products, Cerezyme and Fabrazyme. Consequently, in 2009 sales revenues dropped and company earnings were almost flat. Further, Genzyme shares lost 26% of their value in 2009, sinking to a five-year low.

Icahn is no stranger to hostile corporate takeovers and company sales. In spring of 2008, he unsuccessfully tried to gain control of the Biogen/Idec board to force the sale of the company (Ichan owns 5.6% of Biogen/Idec’s outstanding shares). Later that year, Icahn engineered the sale of ImClone to Eli Lilly for $7.0 billion; after getting into a very public and often acrimonious fight with Bristol-Myers Squibb CEO Jim Cornelius who tendered a “low-ball offer” (according to Icahn) to purchase ImClone.

According to my calculations, Icahn is batting .500 for his recent corporate takeover attempts. Do you think he will be able to go 2-for-3? I bet Henri Termeer is hoping that he can’t!

Until next time...

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

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While Genzyme has begun to address its manufacturing woes and its CEO and top leadership have managed to keep their jobs, the specter of a possible forced sale of the company has emerged. This is because Carl Icahn, the billionaire, activist investor with a history of forcing the sale of financially-challenged and underperforming public biopharmaceutical companies like ImClone and MedImmune, owns 1 percent of the outstanding shares of Genzyme.

Speculation is rife that Icahn and Ralph Whitworth, a founder of Relational Investors which owns 4 percent of Genzyme’s stock, may force the company to put itself up for sale. While many experts contend that this may not be in the best financial interests of Icahn and Whitworth (or other institutional investors), the threat may allow both men to get themselves or their representatives on Genzyme’s board. This would allow them to control the direction of the company and better position the company (the fifth largest biotechnology company in the world) for future sale. Henri Termeer, Genzyme’s embattle CEO, said he has had no contact with Icahn.

Investors have not been pleased with Genzyme’s current management team’s decision to plow profits from its orphan disease business into R&D activities that have been unsuccessful. According to a recent Citigroup financial report, the company may have squandered over $1.0 billion (throughout its history) by investing into unprofitable, non-core research areas including kidney disease diagnostics and surgical products. Conventional wisdom suggests that if Icahn and Whitworth gain control of the Genzyme board that they could sell off Genzyme’s unprofitable kidney disease and surgical lines which would allow management to focus on orphan diseases drug development and allow the company to fix its recent highly publicized manufacturing problems.  Relational’s Whitworth hinted that this is one scenario that he may be interested in pursuing. To date, Icahn has been uncharacteristically mute on a possible takeover attempt.

Stayed tuned for more details.

Until next time....

Good Luck and Good Job Hunting!!!!!! (try Genzyme, they are probably looking for a few good biomanufacturing executives and managers)  

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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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Carl Icahn, former corporate raider, hedge fund owner and activist investor, is still trying to exert his influence at Biogen/IDEC a biotechnology company in which he owns 5.6 percent of its outstanding shares of stock.  As you may recall, last year, Mr. Icahn tried to wrest control of the Biogen/IDEC board to force the company to put itself up for sale. That attempt failed but yesterday Mr. Icahn was managed to get two of his allies appointed to the Biogen/IDEC board of directors at the company's annual shareholder meeting.

Mr Icahn has long contended that Biogen/IDEC's management team is inhibiting growth and squandering shareholder value. Wall Street analysts predict that Carl will push hard to split the company into two separate entities: one focused on neurobiology (Biogen/IDEC is a market leader for drugs designed to treat Multiple Sclerosis) and the other on cancer.  Another scenario suggests that he will leave the company intact and find a buyer for it--similar to the plan that he attempted to implement last year.

The Biogen/IDEC news follows quickly on the heels of a management coup that he orchestrated at Amylin Pharmaceuticals earlier in the week. On Tuesday, Mr Icahn, along with the hedge fund Eastbourne Capital management, were successful in ousting Amylin's Chairman Joseph C. Cook, Jr. and director James N. Wilson. Mr. Icahn exerted his influence at Amylin because he felt that sales of its key diabetes drug Byetta were too low.  Others believe that he is preparing the company for sale to Eli Lilly which co-markets Byetta with Amylin.

Mr Icahn is certainly no stranger when it comes to maximizing shareholder value at biotechnology companies where he holds substantial stock positions.  Last year, he orchestrated the sale of ImClone to Eli Lilly after getting into a protracted bidding war with Bristol Myers Squibb (BMS) over the cancer drug Erbitux.  At that time, BMS had an exclusive marketing agreement with Imclone for US sales of Erbitux.

Whether or not you like Carl, he is very good at what he does. And, in the end, he has a gift for maximixing shareholder value of companies that he and others have invested in!

Until next time...

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

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The New York Times reported today that Genentech’s blockbuster cancer treatment, Avastin, failed to show a significant effect on preventing the recurrence of colon cancer, limiting its utility as an adjunct treatment to treat primary colorectal cancer. While Avastin is already a best-selling cancer treatment, success in this closely watched and highly visible clinical trial could have paved the way to a new uses of the drug, potentially increasing sales by billions of dollars a year.

Avastin had sales of $2.7 billion in the United States alone last year. But it is currently approved only for late-stage colon, breast and lung cancers. For those indications, patient’s lives have been prolonged for up to a few months. The new trial was designed to determine whether or not Avastin could be used earlier in the course of the disease, right after surgery to remove the tumor. The hope of such so-called adjuvant therapy is to prevent the cancer from coming back at all, effectively curing the patient.

While the Avastin failure will have little or no effect on Genentech’s financial outlook, it does call into question whether or not Roche paid too much last month to buy the 44 percent of Genentech it did not already own. Roche has long insisted that its desire to own all of Genentech did not hinge on the results of this trial. And yet, the trial appeared to play a major role in Roche’s months-long negotiations with Genentech.  It appeared that Roche, which had started those discussions last summer, wanted to complete the deal before results of the Avastin trial were announced — on the assumption that a successful trial would have sent Genentech’s stock soaring, possibly putting the takeover price it offered out of reach.  A failed trial, on the other hand, could have pushed down the value of Genentech’s stock. So it now looks as if Roche could have paid less had the results of the Avastin trial come out before it completed the deal.

Art Levinson, Genentech’s former CEO who played hardball with Roche over the course of negotiations, needs to be recognized for his outstanding business acumen. He and other Genentech executives convinced Roche that Avastin sales could quadruple, to $10 billion, by 2015 if the drug could be used for early-stage colon, lung and breast cancers. This possibility induced Roche to raise its bid for Genentech’s outstanding shares from $86.50 to $95 per share. Although Dr. Levinson wasn’t able to fend off Roche’s takeover and is no longer Genetech's CEO, he is likely “laughing all the way to the bank” as the expression goes. And, who said that PhDs aren’t any good at business?

Roche shares were down more than 10 percent on Wednesday, closing at $29.54.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Late last week, Roche raised the price of its hostile offer to buy out Genentech to $93 a share, from $86.50. While the Genentech board advised its shareholders that the company is worth $112 per share, many financial analysts believe that the $93 per share offer may entice institutional investors to “pull the trigger” on the deal. Roche also extended its offer to shareholders by a week, until March 20. Roche already owns over 65 percent of Genentech’s outstanding shares.

Roche has indicated that if fewer than half the minority shares were tendered, it would not buy any of the shares tendered by Genentech shareholders. The new offer is likely to bring in more than half the minority shares, which would raise Roche’s ownership to at least 78 percent. About 71 percent of 131 Genentech stockholders who responded to a survey by Deutsche Bank on Friday said they would tender at least some of their shares at $93, and of those, half said they would tender virtually all. It is not clear what will happen if Roche is unable to purchase 100% of Genentech's shares.

Roche is motivated to close the deal as quickly as possible before results are released next month from a clinical trial of Avastin, one of Genentech’s top-selling cancer drugs. That trial, testing Avastin as a treatment for colon cancer after surgical removal of the tumore, could open a huge new market for the drug, which is now approved to treat cancer only at a later stage. Positive results from the trial may push Genentech’s stock price to over $100 per share—something that Roche desperately doesn’t want to happen.

If Roche is successful in its takeover bid, it  will likely to result in massive layoffs at Roche’s Nutley, NJ headquarters. Previously, Roche announced that it would move its US headquarters from Nutley to the Bay area if it acquires Genentech. Not good news for the state of New Jersey which is still reeling from the Pfizer-Wyeth takeover announced six weeks ago and the Merck-Schering Plough merger mentioned earlier today.

Until next time...

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

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As reported yesterday by the Pharmalot Blog and verified by the New York Times today, the undisclosed “white knight” drug maker that may help ImClone ward off a hostile takeover bid by Bristol-Myers Squibb (BMS) will make a decision by Wednesday about whether or not it wants to make an offer for the biotech company. 

As you may recall, Carl Icahn, ImClone’s Chairman, announced about a month ago that an unnamed drug company may be willing to offer $70 per share for ImClone stock. BMS responded to the announcement by raising its initial offer from $60 to $62.50 per share for outstanding shares of ImClone’s stock. This feeble counteroffer did nothing but increase the hostilities between ImClone and BMS. BMS currently markets Erbitux ImClone’s blockbuster colon cancer treatment. Based on the tenor of this deal, it is becoming increasingly apparent that ImClone and BMS are not “close” even though they are business partners.

Mr. Icahn, in a brilliant display of his business acumen, has been able to prevent industry insiders from divining the identity of the mysterious suitor (if there is one at all). Conventional wisdom suggests that it is likely to be one of the larger drug companies that would like increase its market share in the biotechnology sector.  The good news is that we may only have to wait another 24 hours before this “cliffhanger” of a deal is resolved (ho-hum). Don’t be surprised that, in the end, BMS may wind up paying more than $70 per share to purchase ImClone.

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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Chalk up one for the good guys (good is a relative term). Carl Icahn has given up on his quest to gain control of the Cambridge-based biotechnology giant, Biogen/IDEC. Actually, he was forced to give up because the slate of board members that he hoped would be elected to the Biogen/IDEC board failed to gain shareholder support and lost its bid for the board at a recent shareholder meeting.

Icahn, who owns about 4% of outstanding shares of the company, wanted to gain control of the Biogen/IDEC board so that he could force the company to try once again to sell itself to a large pharmaceutical company (rather than remain independent). As you may recall, the company tried to sell itself late last year but failed to find any buyers. Icahn accused the company of not trying hard enough! Give it a break Carl…its not always about you!

Despite the fact that Carl has his name on a molecular biology building at Princeton University (he is an alumnus), he knows very little about the biotechnology business. My advice to him is to raid companies that make commodities that he knows something about—widgets, plastics, automobiles — maybe even oil.

Until next time….

Good Luck and Good Job Hunting (try Biogen/IDEC)!!!!!!!!

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I have been following the pharmaceutical business for the past 20 years or so and without fail; Bristol-Myers Squibb has been rumored to be a takeover target. Well, here we go again!

 that floated the possibility that BMS is a prime takeover target again. Like many other financial pundits, Zachs believes that a takeover by Sanofi-Aventis makes the most sense. As many of you may know, BMS and Sanofi-Aventis co-own the multibillion dollar Plavix franchise (which will lose patent protection in 2011).

Rumors of a BMS takeover started in 1988 and they have always proved to be false. In my opinion, BMS has one of the stronger biologics pipeline in the pharmaceutical industry. Further, BMS is spending an enormous amount of time and resources to vigorously reinvent itself as a “next generation biopharma” company (whatever that means). The impending loss of Plavix revenues does put some pressure on the company’s ability to remain independent, but BMS has weathered many storms in the past (and lived to talk about them). That said, it is anybody’s guess whether the current rumors are real or imagined.

Until next time…

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

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