Peter Rost for New FDA Commish?

Sometimes reality is stranger then fiction. The Pharmalot blog reported today that US Senator Sherrod Brown, an Ohio Democrat, is nominating several candidates for the post and one of them is Peter Rost, MD!

For those of you who may not know Dr. Rost, he is a former Pfizer marketing executive who blew the whistle on some alleged marketing and sales violations at the drug maker. His court case is working its way up the judicial ladder and Dr. Rost apparently has the upper hand so far.

Pfizer fired Dr. Rost “for cause” after a raucous, public skirmish that went on for almost 2 years. After he left Pfizer, he wrote a book, worked for the Huffington Post and started his own blog, which currently has a post about his candidacy for the FDA Commissioner job. 

I first met Peter when he was still at Pfizer and I was organizing a meeting on drug reimportation (he is an ardent supporter). He agreed to talk at the meeting but unfortunately the conference was canceled for one reason or another. I have no doubt that he has the medical credentials and business acumen to handle the job. The one thing that worries me is his penchant for self promotion—something that is not a desirable trait in  an FDA Commissioner.

Time will tell. Personally, I would like to see Dr David Kessler come back and run the agency—another whistleblower (at UCSF) who ran the agency from 1990-1997 and did an outstanding job. The way things are going at FDA these days maybe being a whistleblower ought to be one of the requirement for the job!

Until next time…

Good Luck and Good Job Hunting

Bristol-Myers Squibb Tenders an Offer to Buy ImClone

Bristol-Myers Squibb announced earlier today that its Board of Directors approved a deal to purchase ImClone for $4.5 billion. BMS already owns about 17% of ImClone’s shares and is ImClone’s US marketing partner for Erbitux, a monoclonal antibody treatment for colorectal and head and neck cancers. BMS bought Kosan Biosciences earlier this year for $195 million.

The ImClone offer comes after an announcement late last week from CEO Jim Cornelius who said that there will likely be more job cuts at BMS to keep pace with the company “productivity transformation initiative.”  Earlier this year, BMS sold ConvaTec, its wound care and medical device subsidiary for $6.5 billion which will likely provide BMS with the monies necessary to complete the ImClone purchase.

The acquisition makes sense for BMS because of its campaign to re-invent itself as a “next generation biopharma company.” Currently, BMS’s biotechnology roster consists of only two drugs: Erbitux (which was developed by ImClone and licensed by BMS) and Orencia a treatment for rheumatoid arthritis. That said, BMS has several monoclonal antibodies and other biotechnology drugs in its pipeline. I think that the purchase of ImClone makes BMS more attractive as a takeover target for Sanofi-Aventis or another major pharmaceutical company itching to get into the biotechnology frenzy.

BMS’s purchase of ImClone closes the book on a steamy and oft times nefarious drug development saga that I assume both companies would like to forget. As you may recall, in 2001, Peter Dolan, then CEO of BMS, cut a questionable licensing deal (and made a $2.0 billion investment in ImClone) for marketing rights to Erbitux. At that time, Sam Waksal, one of ImClone’s founders, was CEO of the company.  Shortly after the deal, BMS researchers discovered that the clinical trials data that were used to convince BMS that Erbitux was a treatment for colorectal cancer were flawed.  Because of this, BMS was forced to invest hundreds of millions of dollar and spend several more years before it would ultimately win regulatory approval for Erbitux.  Meanwhile, before the deal was finalized, Waksal, seeing a huge financial upside, engaged in insider trading of ImClone’s stock. Later, he disclosed that he needed the money to cover the enormous debt that he incurred because of his high profile NYC lifestyle. Ultimately, Waksal and his close friend Martha Stewart plead guilty to insider trading of ImClone stock and spent several years in prison.

Ironically, the acquisition of ImClone by BMS is something of a vindication for former CEO Peter Dolan. At the time that Dolan cut the deal with ImClone, many Wall Street analysts and industry insider thought that Dolan paid an excessive amount for Erbitux which was clinically unproven. Ultimately, Dolan was ousted as CEO after it was learned that he cut an illegal deal with Apotex, a Canadian generics manufacturer, to delay release of generic versions of its anti-clotting drug Plavix (co-marketed with Sanofi-Aventis) after expiry of Plavix patents in 2010.

The BMS-ImClone deal is one of several big M &A deals that have recently taken place as a result of financially-troubling times. Don’t expect consolidation in the pharma and biotechnology industries to subside any time soon!

Until next time….

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

ImClone: The Phoenix Rises

Remember the Sam Waksal-Martha Stewart insider trading scandal that rocked the financial world in the late 90s and early 2000s? What about Peter Dolan, the former BMS CEO, who plunked down $2.0 billion for an unproven colon cancer fighting drug Erbitux being developed by ImClone, a dubious biotechnology company?

Well, guess what? . At years end, ImClone’s stock price had spiked 65 percent! This is because Wall Street remained bullish on the company’s only product Erbitux, which has been approved to treat colon and some head and neck cancers. ImClone’s gains are in marked contrast with Amgen and Genentech losses, two of the world’s largest biotechnology companies, whose share prices declined 31 and 17 percent respectively in 2007.

Big biotech companies like Amgen and Genentech better watch their backs— much smaller and nimble companies like Gilead Sciences and OSI Pharmaceuticals also posted large gains in 2007.

As always, good science begets large profits. Despite BMS’s recent troubles, it executives certainly know how to recognize good science to create products that fulfill unmet medical needs!

Until next time….

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