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After weeks of bad press regarding manufacturing problems and a narrowly-averted proxy contest, Genzyme today announced that its experimental drug for multiple sclerosis, alemtuzumab, received fast track approval status from the US Food and Drug Administration (FDA).

Alemtuzumab (marketed as Campath, MabCampath or Campath-1H) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived.

For those of you who may not know, FDA grants fast track status to experimental drug candidates that are designed to treat serious diseases, and may be superior to current treatments. Fast track status includes an expedited review and additional collaboration between Genzyme and the and the agency and allows Genzyme to submit portions of the alemtuzumab BLA as they are completed, rather than waiting to submit the completed application when testing is finished.

Until next time..

Good Luck and Good Job Hunting!!!

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Genzyme announced yesterday that it had reached an agreement with Carl Icahn to settle their very public and bitter proxy battle. As you may recall, Icahn, who controls approximately 4.9% of shares in Genzyme, sought to replace Henri A. Termeer, Genzyme’s embattled long-time CEO and three other company directors.

Under the terms of the agreement, Icahn will withdraw his slate of four nominees for the Genzyme board of directors and vote his shares in favor of two company nominees. Also, the Genzyme board will appoint two Icahn nominees Steven Burakoff, MD and Eric Ende, MD to serve as directors immediately following the company June 16, 2010 annual shareholders meeting. Dr. Burakoff is Professor of Medicine, Hematology and Medical Oncology at the Mount Sinai School of Medicine and Director of the Tisch Cancer Institute at the Mount Sinai Medical Center. Dr. Ende, a participant in the Icahn funds’ proxy solicitation, is a former biotechnology analyst with Merrill Lynch & Co. Inc.

This isn’t the first time that Icahn has threatened a proxy fight to get his nominees elected to the board of directors at companies where he controls a small but significant amount of outstanding shares of stock.  Previously, he attempted to wrest control of the Biogen and ImClone and Enzon Pharmaceuticals board of directors. While his attempt to commandeer the Biogen board failed, he was successful at ImClone, the maker of the anti-colon cancer drug Erbitux that he sold to Eli Lilly in 2008 for ca. $6.1 billion. In Enzon’s case, the CEO resigned about six months after accommodating Icahn’s demands.

It is patently obvious that biotechnology company executives don’t want Icahn to gain control of their companies. This is because once Icahn gains control of the companies he sells them to the highest bidder. While this may make sense to a financial guy like Carl, it doesn’t sit well with company executives who understand that they will likely lose their jobs once a company is sold! 

Although Carl’s public proxy contest strategy usually gets him most of what he wants, I am not sure that it is in the best interests of company stock price and shareholder. Publicly airing a company’s dirty laundry tends to reduce shareholder confidence and may push its stock price lower than necessary. I think that it may be in a company’s best interest to quietly negotiate with Icahn behind the scenes rather than take the fight to the public. In the end, Icahn invariably wins and the management team that is under fire may look less competent or weaker than it actually is. Biogen ultimately won but Enzon and Genzyme lost the public opinion battle.

Until next time...

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

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Beleaguered orphan drug manufacturer Genzyme responded to Carl Icahn’s attempt to remove current board members through a proxy fight by issuing a statement announcing a $2.0 billion stock buyback program. Also, the company announced that it would sell or spin off its underperforming genetic testing, diagnostics and pharmaceutical ingredient manufacturing divisions. Both initiatives were announced in an attempt to fend off Icahn’s current assault on the company.

Genzyme spokespersons stated that the company will repurchase $1.0 billion worth of stock in the near term and finance it with debt. An addition $1.0 billion of stock will be purchased over the next year, Genzyme said. While financial analyst believe that the announcement will please shareholders, it is unlikely to ward off the Icahn plan to wrest control of the company away from embattled CEO Henri Termeer.

Until next time..

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

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Carl Icahn, who controls about 4.9% of the outstanding shares of Genzyme’s stock, is trying to get himself and three persons loyal to him elected to the Genzyme board of directors via a proxy fight. 

Icahn has publicly stated that embattled Genzyme CEO, Henri Termeer must go after running the company for the past 25 years. Icahn contends that Termeer has made many bad decisions during his tenure and the recent highly publicized manufacturing problems at the company are causing Genzyme’s stock to plummet.

Icahn’s slate of proposed board members include himself, Dr. Richard C. Mulligan, a molecular biologist at Harvard Medical School, Dr. Alexander J. Denner an Icahn confidant and Dr. Stephen J. Burakoff, Director of the Tish Cancer Center at Mount Sinai School of Medicine in New York. If elected the Icahn slate will replace Mr. Termeer, are Connie Mack III, a former United States senator; Richard F. Syron, the former chief executive of Freddie Mac and of Thermo Electron, a scientific instrument company; and Charles L. Cooney, a professor of chemical and biochemical engineering at the Massachusetts Institute of Technology.

As many of you may know, Icahn, who is always referred to as an “activist investor” is no stranger to proxy fights or controversy. Previously, he attempted to oust members of the Biogen-IDEC board of directors—an underperforming company according to Icahn—and more recently, publicly out-maneuvered and humiliated Bristol-Myers Squibb (BMS) CEO Jim Cornelius by selling ImClone—a long-time BMS co-marketing partner of the blockbuster colorectal cancer drug Erbitux— to Eli Lilly.

Over the years, I have been a staunch critic of Icahn. However, I am beginning to realize that there is a “method to his madness” and surprisingly, things always seem to change for the better at companies that are on his radar screen. Like him or not, Icahn demands performance from the companies that he invests in and will relentlessly work on behalf of himself and other shareholders to get the ROI that he expects.

Until next time,

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

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Despite putting itself up for sale and finding no buyers, Carl Icahn still believes that Biogen is an attractive buyout opportunity for some unsuspecting pharma company. In fact, it was Carl who forced Biogen to put itself up for sale last fall (to avert a nasty proxy fight that he threatened). Carl, who owns 4.2 % of the company, believed that Biogen was underperforming and its stock price was too low.

To make his ongoing dream a reality, Mr. Icahn moved today to appoint three members (loyal to him) to the Biogen board. In an SEC filing, Mr. Ichan said that at Biogen's upcoming shareholder meeting he will nominate three people to Biogen's board (which elects four directors each year), and seek to cap the board's size at 12. If successful, Mr. Icahn would then be “within striking distance” to control a majority of Biogen's board by next year.

The three people that Icahn nominated were Alexander Denner, managing director of the Icahn investment vehicle Icahn Partners; Richard Mulligan, professor of genetics at Harvard Medical School and Dr. Anne Young, head of the neurology at Massachusetts General Hospital. Interestingly, Dr. Mulligan and Mr. Denner also serve on the board of ImClone Systems, which elected Icahn chairman last year, after a bitter battle during which Icahn accused the ImClone management of improperly developing its cancer drug Erbitux.

Carl has taken a fancy to biotech in recent years and now considers himself to be somewhat of maven.  Although there a molecular biology building at Princeton University which bears his name (he is an alumnus), he is still a corporate raider at heart. After moving into MedImmune stock in early 2007, Icahn threatened a proxy contest at the annual meeting if it did not find a buyer. Several days later, AstraZeneca said it would buy MedImmune for a whopping $15.6 billion. Carl usually gets what he sets out to do.

It appears that Biogen has not heard the last from Mr. Icahn. I suspect that things will continue to get ugly in Cambridge. Stayed tuned for updates!

Until next time…

Good Luck and Good Job Hunting (not at Biogen)!!!!!

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