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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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