Second Acts: ImClone Founder Sam Waksal is Seeking Investors for a New Biotechnology Company

As many of you may recall, in 2001, Sam Waksal, founder and former CEO of the biotechnology company ImClone was convicted (along with his good friend Martha Stewart) for fraud and insider trading of ImClone stock. Waksal, who was released from prison in late 2008 and lived in a half way house for several months had kept a relatively low profile until earlier this month. Rumor has it that Sam along with Richard Mulligan, PhD a Harvard professor and former ImClone director and Dr. Larry Witte, a current executive vice president in the ImClone division of Eli Lilly are attempting raise about $50 million for the privately-held new venture called Kadmon. Other reports indicate that Waksal and other members of the Kadmon team are putting up $50 million as well. 

According to insider reports the company will ostensibly focus on cancer and infectious disease targets and—taking a page out of the Cubist, Celgene and Sepracor play books—re-purpose once promising drug candidates discarded by other companies. To that end, according an article in TheStreet, the company's drug research programs include a "statin inhibitor for influenza" from a "leading Ivy League university" along with a variety of monoclonal antibodies for use as targeted cancer treatments, similar to Erbitux. Kadmon is also eyeing several existing cancer-focused drug companies, one of which already has a marketed product, as acquisition targets, according to the prospectus. For those of you who may be wondering about whether or not Waksal can legally start another biotechnology company, an agreement with the Securities and Exchange Commission bars Waksal from serving as an officer in a publicly traded company, but as previously mentioned, Kadmon is a private venture.

Whether you like Waksal or not, his track record in the biotechnology industry speaks for itself. Unlike the vast majority of his rivals, Waksal shepherded a molecule from discovery through commercialization. That molecule, a monoclonal antibody called Erbitux, became a multibillion dollar a year treatment for certain forms of colorectal cancer. More importantly, Waksal was one of the first to recognize that humanized monoclonal antibodies directed against certain cellular receptors could be used to treat a variety of oncology indications—a concept that is driving a large portion of discovery and product development in the oncology space. For those of you who may not know, Eli Lilly purchased ImClone two years ago for $7.0 billion dollars after a very public and acrimonious fight over the sale price of ImClone erupted between Carl Icahn, ImClone’s Chairman, and Jim Cornelius, CEO of Bristol-Myers Squibb (BMS). ImClone and BMS co-marketed Eribitux prior to the sale.

Waksal has been in and around the biotechnology industry for over 30 years and many consider him to be one of the early industry pioneers. Unfortunately, despite his dubious past, Waksal represents a dying breed of visionaries whose entrepreneurial spirit and unorthodox approach to new drug development is largely responsible the biotechnology industry’s current largess. Like other ex-felons Waksal did his time and like all Americans he is entitled to a second chance.

Let’s hope that Sam learned a few things during his incarceration and is smarter and wiser for his second and possibly final act. I wish Waksal success in his new venture and I hope that he and his team still possess the insight, creativity and tenacity required to discover and develop innovative oncology and infectious diseases drugs.

Until next time....

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

 

Former ImClone CEO Sam Waksal Is Released from Prison

Rumor has it that Sam Waksal was released from prison and is now living in a halfway house in the Bronx, NY. Waksal has a year remaining on his 2001 conviction for insider trading and fraud.

Now that Sam is out of jail, he can watch BMS takeover the company that he created way back in the early 80s. I suspect that he feels vindicated in some ways because BMS is willing to pay over $4.5 billion for ImClone. On the other hand, think of how much money he would have made if he didn’t get greedy.  As a stock broker friend of mine likes to say, “Bulls make money but pigs get slaughtered.”

The one thing that I know for sure is that Sam will not be calling his broker about ImClone shares this time!  

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 Can't Shake Sam Waksal's Legacy

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!

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!!!!!!!!!!!!

What a Difference a Few Years Can Make!!!

The Motley Fool published a synopsis today on the surprising strength of ImClone’s anti-cancer pipeline. According to the article, the company is conducting Phase 2 clinical trials on two new cancer treatments; an anti-insulin-like growth factor-1 receptor monoclonal antibody as a treatment for late stage metastatic prostate cancer and vascular endothelial growth factor receptor (VEGFR) inhibitor as a treatment for metastatic kidney cancer in patients who have failed with other VEGF inhibitors. Both drug candidates are highly touted and stock analysts are anxiously awaiting the results of these trials. Speaking of stocks, ImClone is trading around $35 per share, a stock price that is higher than Pfizer or Schering Plough.

For those of you who don’t remember the ImClone scandal, it resulted in Sam Waksal (ImClone’s CEO and founder) and Martha Stewart (Sam’s friend) going to prison and is partly responsible for the resignation of Bristol Myers Squibb’s previous CEO. Despite all of ImClone’s critics, Erbitux® has turned out to be a pretty good treatment for advanced colon cancer and the company is making money as a result. This has provided ImClone with the largesse to build a new manufacturing facility and add jobs in New Jersey (as I reported in a previous post).

Everyone (Stan Yakatan and I) thought that ImClone was finished a mere five years ago.  What a difference a few years can make in this business!

Until next time…..

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