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Sam Waksal, the former Founder and CEO of ImClone Systems who was convicted in 2003 of insider stock trading and spent about five years in prison is trying to make a comeback as a biotechnology entrepreneur.

Shortly after his release from prison, Sam started a new, privately-held, biotechnology company called Kadmon (a moniker taken from the Kabbalah). He reportedly was able to raise over $50 million in venture capital (much of it allegedly coming from Carl Icahn a long time investor, business partner and friend.*

Kadmon which has been operating in stealth mode for the past two years today announced that it had acquired Three Rivers Pharmaceuticals, a privately held company in Warrendale, PA that develops and sells drugs to treat hepatitis C infection. Three Rivers was acquired to provide Kadmon with an ongoing source of revenue to help develop other drugs. It sells versions of the drugs alpha interferon and ribavirin, mainstays of hepatitis C treatment.

According to a company spokesperson, Kadmon acquired Three Rivers for over $100 million. Previously, Kadmon quietly acquired PhytoCeutica a company developing a cancer drug derived from traditional Chinese medicine and Flux Therapeutics a company co-found by Thomas E. Shenk, PhD a Princeton University virologist. Coincidentally, Dr. Shenk works in the Carl Icahn Laboratories at Princeton University.

Despite his conviction for insider trading, Sam is a seasoned and successful biotechnology entrepreneur who almost single handedly brought the blockbuster anti-cancer drug Erbitux to market. Sam who has a PhD degree in Immunology from Ohio State University and  has a "leg-up" on many biotechnology entrepreneurs because he understand both science and business.  As you may recall, ImClone System (the company that he founded in the 1980s) was sold two years ago to Eli Lilly for $6.5 billion—a deal brokered by ImClone’s Chairman, Carl Icahn. 

Interestingly, Sam is prohibited by a settlement he made with the Securities and Exchange Commission from serving as a director or executive of a publicly traded company. It will be interesting to see whether or not Kadmon decides to remain private. I suspect that won’t be the case if the IPO window opens up a bit more over the next few years. Once biotechnology companies go public, there is no longer a need for entrepreneurial founders like Sam to stick around!

Until next time...

Good Luck and Good Job Hunting (try Kadmon, they have lots of cash)

 * An NY Times article published on Nov 1, 2010 contends that Carl Icahn had initially considered investing $30 million in Kadmon but ultimately decided to pass.

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Late last Friday, Sanofi-Aventis announced that it was restructuring it US pharmaceutical business to meet the demands of a more challenging American healthcare market. The company said that it will streamline U.S. Pharmaceutical Operations and reduce its workforce by an estimated 25 percent. This translates into eliminating approximately 1,700 positions. Decisions about the breadth and scope of the cuts will be finalized by mid-December.

Of the 13,000 US employees, 6,900 work in the Pharmaceutical Operations division. Other Sanofi-Aventis affiliates in the United States include its R&D group, Sanofi Pasteur Vaccines, BiPar and Chattem: its consumer healthcare business.

According to Gregory Irace, President of Sanofi-Aventis and CEO of Sanofi-Aventis US/.Canada Pharmaceutical Operations,

“Given the serious challenges facing our organization and the healthcare industry, it is important to act decisively now so that our organization has greater stability moving forward and that our resources are allocated to our strategic growth priorities. These changes will foster a renewed focus on the strong growth and pipeline opportunities that will drive our vision of being a diversified healthcare leader.” Sanofi faces a serious “patent cliff” in the very near future; mainly because its top selling anti-clotting drug Plavix is slated to lose patent protection in 2011. Also, the company lacks expertise in biotechnology: the discipline that most big pharma companies is going to drive future growth in the industry."

The lack of biotechnology prowess is largely responsible for Sanofi’s attempt to purchase Genzyme, one of the largest and profitable biotechnology companies in the world.

Last week, Sanofi confirmed that its bid for Genzyme had become hostile because its management team and board of directors failed to seriously consider a bid tendered at $69 per share or $18.5 billion. Genzyme’s management team and board of directors immediately rejected the hostile bid (as it did in the past when the offer was “friendly”). The hostile bid allows Sanofi-Aventis to bypass Genzyme’s Board and appeal directly to its shareholders to consider the offer.

Restructuring of its US pharmaceutical operations, may be a sign that Sanofi-Aventis is attempting to cut costs to finance the all cash deal.

I suspect that Sanofi-Aventis will prevail in its bid for Genzyme; but it will have to sweeten the offer to appease activist investor Carl Icahn who is likely seeking an offer in excess of $75 per share.

If I were a betting man, I would put my money on Icahn—a brilliant financial strategist who frequently gets what he wants

Stay tuned for more late-breaking Sanofi-Aventis/Genzyme news!

Until next time...

Good Luck and Good Job Hunting

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The Boston Globe reported today that this morning Henri Termeer, the embattled CEO of Cambridge, MA based Genzyme acknowledged for the first time that company was indeed up for sale. However, he was quick to point out that the $69 per share or $18.8 billion takeover bid from Sanofi Aventis was insufficient.

Over the past few days, Sanofi Aventis’ CEO Christopher A. Viehbacher turned up the heat on Termeer; forcing him to possibly take Sanofi’s latest offer directly to Genzyme shareholders. While Termeer acknowledged that the company was for sale, he hinted that other companies may join the bidding war to get the $75 per share price that the Genzyme board is seeking. 

The Sanofi Aventis-Genzyme situation is beginning to resemble the Bristol Myers Squibb (BMS)-ImClone standoff of two years ago. As you may recall, Jim Cornelius—BMS CEO at the time—publicly and repeatedly offered a “low-ball” price ($62 per share) to purchase ImClone despite admonishments from Carl Icahn, ImClone’s Chairman. As negotiations stalled, Icahn told Cornelius that there were other suitors who were willing to pay a higher price to acquire ImClone. Surprisingly, rather than continuing to negotiate in good faith, Cornelius decided to call Icahn’s “bluff.” In less than a week, Eli Lilly purchased ImClone for $70 per share ($6.5 billion); the price that Ichan had previously and publicly asked for to purchase the company.

Many of you already know that Icahn holds a substantial minority Genzyme stock position and is represented by two current Genzyme board members. That said, if I were Sanofi’s Viehbacher, I would proceed with extreme caution in future negotiations. Like him or not, Icahn is a financial genius and second-to-none negotiating M&A deals. 

Maybe Viehbacher ought to contact Cornelius for advice? Oh yeah...Cornelius retired as CEO earlier this year but he is still Chairman of the BMS Board of Directors. Maybe it is worth a call?

Stay tuned for new developments as the saga continues.

Until next time...

Good Luck and Good Job Hunting!!!!!

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As predicted by many industry insiders and Wall Street analysts, the Genzyme board may be  holding out for at least a $75 per share offer from Sanofi-Aventis.  Previously, Sanofi-Aventis offered Genzyme $69 per share despite clear signals from Genzyme's board and its shareholder that the proffered offer was inadequate.

The Genzyme board is likely under extreme pressure to hold out for the $75 per share price because that is the price being sought by its powerful and influential minority shareholders Carl Icahn and Ralph Whitworth.

Carl Icahn, no stranger to corporate buyouts, is a master at getting the price that he wants for the companies that he sells. He previously sold ImClone to Eli Lilly for $70 per share after Jim Cornelius, Bristol-Myers Squibb’s former CEO, refused to offer more than $64 per share of ImClone stock.

Conventional wisdom suggests that Sanofi will likely buy Genzyme for at least $75 per share if not more!

Stay tuned for updates!

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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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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Genzyme announced yesterday that it expects to be fined roughly $175 million in fines and penalties related to the manufacturing troubles at its Allston Landing, MA manufacturing plant that resulted in severe shortages of two of its best selling products, Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) 

The fines and penalties are part of a consent decree that the US Food and Drug Administration (FDA) intends to levy against the company for the manufacturing infractions. A substantial portion of the penalties included a disgorgement settlement, a process that allows FDA to collect a certain percentage of the sales of products made at the troubled Genzyme production facility.

According to an article in today’s New York Times business section, Genzyme representatives said that patients using Cerezyme would continue getting half a dose for two or three more months. It previously said full supplies would be restored May.

Patients who use Fabrazyme would continue to be allocated a third of their usual dose at least through the third quarter. The company had previously hoped to resolve the Fabrazyme shortage in the third quarter.

The highly publicized manufacturing problems at Genzyme, has shaken both physician and patient confidence in the company’s ability to safely manufacture and supply sufficient quantities of Cerezyme and Fabrazyme; two orphan drugs designed to treat patients with debilitating genetically-inherited diseases. 

Several physicians and patients who were previously loyal and ardent supporters of Genzyme, have indicated that they may switch to recently approved and new treatments being developed by Genzyme’s competitors that include Shire.

The lack of commitment to quality manufacturing by Genzyme executives has seriously tarnished the image of a once highly respected and reputable orphan drug developer.

Until next time…

Good Luck and Good Job Hunting!!!!!

Until next time…

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

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The recent manufacturing woes of orphan drug manufacturer Genzyme have been well documented and widely publicized. These problems resulted in massive shortages of some of its top selling drugs Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) causing many of the patients who depend on these drugs to maintain their quality of life to go without reduced or no treatments for months. 

Because both drugs were approved by the US Food and Drug Administration (FDA) as orphan drugs they enjoy seven years of market exclusivity from the date of regulatory approval which prohibits other companies from seeking approval and selling similar drugs in the US. Consequently, Genzyme is the only commercially-available source for the drugs. Genzyme’s ongoing biomanufacturing created massive shortages of both drugs last summer. Because of this, FDA allowed two other companies, Shire and Protolix Biotherapeutics (both have treatments for Gaucher (Protalix) and Fabry (Shire) disease in late stage clinical development), to make their drugs available (at no charge) to patients prior to regulatory approval. This was a relatively rare and bold move by the agency. But, to be fair, they had little choice because so many patients were suffering.  

In case you may be wondering there are approximately 1500 Cerezyme users and fewer than 1000 Fabrazyme users in the US. Despite the small numbers of patients, the cost of the treatments are extraordinarily high; costing patients as much as $200,000 per year for treatment.

According to an article in today’s NY Times as many a 15 percent of American Cerezyme users have switched to a different drug. Fewer patients with Fabry disease have switched mostly because Shire’s drug for Fabry disease Replagal was less widely available. The almost year-long shortages of both drugs have seriously tarnished Genzyme’s reputation. And previously loyal patients are questioning their almost decade long allegiance to the company. This, coupled with a 26 per cent decline in Genzyme’s stock price last year suggest that Genzyme’s standing as one of the top five biotechnology companies in the world may be in serious jeopardy. 

Despite calls for his resignation (and an attempt by Carl Icahn to wrest control of the company), CEO Henri A. Termeer, who has led Genzyme for over 20 years has vowed not to resign. While manufacturing problems are not uncommon in the biotechnology industry, the severity and ongoing nature of the manufacturing problems at Genzyme’s Allston Landing, MA production facility are unacceptable; especially for a company that specializes and prides itself in developing treatment for orphan disease indications. The FDA recently announced that it would fine Genzyme and place its manufacturing operations under a consent degree for an indefinite period of time.

Genzyme representatives now contend full supplies of Cerezyme will be available after May 1 and those for Fabrazyme possible in the third quarter of this year.

While so-called “copycat” or “me too” drugs developed by pharmaceutical companies tend to be vilified by consumers and patient advocacy groups, the agency prefers to approve more than one treatment option for a given disease indication in case one medication doesn’t deliver the intended therapeutic benefits or induces untoward adverse events. Unfortunately, the seven years of market exclusivity awarded to orphan drugs manufacturers that garner regulatory approval for their products prohibits this. The biomanufacturing fiasco at Genzyme suggests that it may be time to reexamine the Orphan Drug Act and modify some of the financial and regulatory terms that were included to induce drug companies to develop new treatments for orphan disease indications.

Until next time…

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

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Biogen Idec today announced that Dr. Eric K. Rowinsky and Dr. Stephen A. Sherwin have been appointed to its Board of Directors pursuant to an agreement with Icahn Partners. Dr. Rowinsky was proposed as a nominee to the Board by Icahn Partners and Dr. Sherwin was selected by the Company as part of its process to identify new directors.

"Under the terms of the agreement, Icahn Partners has agreed to vote its shares at the 2010 Annual Meeting for Biogen Idec's nominees, who will include current directors Nancy L. Leaming and Brian S. Posner as well as Drs. Rowinsky and Sherwin. In addition, under the terms of the agreement, Icahn Partners will withdraw its notice of nomination of persons for election as directors and its proposal to amend Biogen Idec's Bylaws to limit the size of the Board."

As you may recall, Icahn tried to wrest control of the company from its current management team in an attempt to force the company to sell itself because Icahn believed that its stock price was undervalued. Since that time, it appears that Biogen Idec executives are seeking to appease Icahn rather than publicly fight with him over the value of the company. Don’t be surprised if Biogen Idec is sold to a large pharmaceutical company by the end of this year.

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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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!!!!!!!

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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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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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After months of melodrama and acrimonious exchanges between Jim Cornelius and Carl Icahn, Eli Lilly, not Bristol-Myers Squibb, will acquire ImClone and gain access to the multibillion Erbitux franchise. In the end, Carl Icahn, ImClone’s Chairman, got the $70 per share that he wanted for ImClone stock.

BMS’s reluctance to purchase ImClone at the $70 per share price is puzzling. The Pharmalot blog reported that Jim Cornelius, BMS’s CEO, released the following statement after the ImClone/Lilly deal was finalized “We are pleased to have initiated a process that has resulted in the substantial increase of ImClone’s value for all of its stockholders. Perhaps Bristol-Myers has made a comfortable bid for ImClone which would be, in our view, very attractive to the company. If however, it did not succeed then it can liquidate its stake at a premium.” This makes about as much sense as Sarah Palin’s explanation of the factors responsible for global warming—the amount of money that BMS would garner if it liquidates its 16% stake in ImClone would pale in comparison to revenues that would annually accrue from Erbitux sales. Apparently I am not alone in my thinking. According to a financial analyst “the stake’s value independent of full ownership of IMCL is NOT strategic, and gets BMY nothing,”

In my opinion, Jim Cornelius’s failure to acquire ImClone (at any cost) has jeopardized BMS’s future. He had the opportunity to right the wrongheaded licensing deal that his predecessor Peter Dolan entered into with ImClone. The inability of BMS to retain at least partial ownership of its flagship biotechnology product doesn’t bode well for a company that is trying to reinvent itself as a “next generation biopharma company”—if there is a next generation at BMS.

 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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 Previously, on the Bristol-Myers Squibb/ImClone Let’s Make a Deal Show. BMS offered $60 per share for the outstanding shares of ImClone that it doesn’t already own. As expected, Carl Icahn, ImClones’s Chairman and former corporate raider, summarily rejected BMS’ offer as insulting and an attempt by BMS to undervalue ImClone’s stock. Then, after a month of silence between the two parties, Mr Icahn announced that an undisclosed pharmaceutical suitor had made a better offer to buy ImClone. Today, about three weeks after Mr Icahn disclosed the information about his mysterious stranger, BMS (as expected) grudgingly raised its offer from $60 to $62 per share. The mysterious stranger seems to be out of the mix now.

Conventional wisdom (and word on the street) suggests that ImClone’s stock is worth about $70-$75 per share and that Carl (and the ImClone board of directors) will not sell the company for anything less. Today’s exchange between BMS and ImClone prompted a Wall Street analyst who has been closely following the twists and turns of the deal to write “we view Bristol’s increased bid and attempt to remove the company’s board as futile. The premium over the prior $60 offer is insufficient, in our view, to woo the larger ImClone stock holders to join it in revolt against Mr. Icahn and his allies on the board. The net result of Bristol’s efforts will amount to little more than yet another exchange of testy letters between the two parties.” And, in fact, Jim Cornelius, BMS’s CEO took the opportunity to do just 

It seems to me that whether or not a deal is reached depends more on who wins the pissing match between Mr Cornelius and Mr. Icahn rather than what is in the best interest of the shareholders of both companies. C’mon guys, we are currently in the midst of the worst economic meltdown in the history of the US —do the right thing and consummate the deal already!

Tune in next time for latest installment of the BMS/ImClone Let’s Make a Deal Show.

Until next time….

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

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According to a post at the Pharmalot blog, Carl Icahn, Chairman of ImClone, thinks that BMS’ offer last week of $4.5 billion to purchase ImClone is way too low. Icahn feels that the bid was motivated, in part, because ImClone is developing a drug that may compete with Erbitux, and BMS may not have rights to the new drug. Bristol (like it has for Erbitux). I suspect that he is correct but as I mentioned last week, BMS is committed to becoming a next generation biopharma company and the acquisition of ImClone make perfect strategic and financial sense to me. Personally, I think that Carl is posturing (like any good businessman) because he knows that the BMS offer will not be the final offer tendered for ImClone.

As I have stated many times in the past on this blog, Carl seems to know a lot about biotechnology despite no formal training and no hands-on experience in the biz. Maybe he ought to start his own biotechnology company and own 100 percent of its stock. That way he will not have to raid other companies to gain control of their boards to purchase more stock or simply sell the companies? Life would certainly be easier for those biotechnology CEOs and their boards who have  work long and hard to create profitable businesses.

Don’t be surprised if BMS raises its purchase offer for ImClone. BMS finalized is flush with cash after it finalized the sale late last week of its former subsidiary ConvaTec for $6.6 billion.

Until next time…

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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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It looks as though Enzon Pharmaceuticals, the first company to successfully commercialize protein PEGylation, finally buckled under the pressure exerted by Carl Icahn, one of its major shareholders.  As I mentioned in a previous post, Carl recently started buying large blocks of Enzon stock to gain a controlling interest in the company to maximize shareholder value. To accommodate Icahn’s "vision" and demands, Jeff Buchalter, Enzon’s Chairman and CEO has decided to spin out a new biotechnology company.  According to an Enzon press release, the new company (to be named later) will get Enzon’s core technology (PEGylation) and its entire preclinical pipeline (i.e.; their RNA antagonist oncology portfolio). Enzon will also invest $150m in the new venture.

So, what does Enzon get out of the deal? It retains ownership of a small, aging manufacturing facility and a portfolio of nominally-performing specialty pharma drugs. I think comments made by Eben Tessari, a financial analyst who follows Enzon, sums up of the essence of the proposed spin out.  He writes: “Maybe I’m way off here but it seems to me in analyzing this deal that the new company gets all the goodies while Enzon is left with a manufacturing plant and a stable of marginal drugs (zero out of four therapies have over $50m a year in revenue). Now, I don’t mean to imply that I think Enzon is a bad company - hell, they’ve managed to make more profit this quarter than any pharma company I’ve ever worked for - I’m just saying they are selling their future based on the advice of a man notorious for breaking up companies and wringing every last dime out of a shakeup.”

Not surprisingly, Jeff Buchalter, the brains behind the deal, thinks it will provide Enzon shareholders with the value that they demand. “By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure. Operating separately will allow each company to benefit from greater strategic and managerial focus and appeal to their own unique shareholders. The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements. We look forward to creating this opportunity for the shareholders,” said Buchalter.

Jeff, who learned how to turn around failing companies from his former boss Fred Hassan (turn around specialist and current CEO of Schering Plough) ought to know a little something about value. According to SEC filings, last year Jeff made $773,558 (base salary) with $1,162,500 in bonuses for a total cash compensation of about $2 million. In addition, Jeff received just over $3.1 million in equity bringing his total 2007 compensation package to approximately $5.2 million —almost 3 times the amount received by any other Enzon executive.  Not that there is anything wrong with that!!!!!!!!!!!!

Until next time….

Good Luck and Good Job Hunting (try Enzon’s spin out, they are flush with cash)!!!!!!

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I have been following the trials and tribulations of New Jersey-based Enzon Pharmaceuticals for the past decade. My interest in Enzon was kindled because of a friendship with Abe Abuchowski, Enzon’s former Chairman, CEO and Founder.  For those of you who may not know, Abe is sometimes called the “father of protein PEGylation” because he was first to harness the commercial power of the technology (he played a pivotal role in creating the technology as a graduate student in Frank Davis’ lab at Rutgers University).

Abe left Enzon in the early 1990s (after shepherding the US regulatory approval for Adagen®, Oncospar®, and PEG-Intron®) and in 2004, he (along with my help) founded Prolong Pharmaceuticals, a biopharmaceutical company that specializes in PEGylation of biogenerics. Prolong is also using protein PEGylation to create new antimicrobial and blood replacement products.

Over the years, Enzon has had its share of “ups” and “downs.” Although profitable through much of the 1990s, Enzon is now a company riddled with huge debt– mostly because of bad decisions made company executives in the post-Abuchowski era.  Since 2004, Enzon’s Chairman and CEO, Jeffrey Buchalter, has worked diligently to “right” the company. He realigned and focused the company’s strategic objectives and, through some creative financing, reduced some of Enzon/s more onerous debt obligations. To that end, he was able to restore shareholder confidence and stabilize Enzon’s stock price. Unfortunately, Jeff’s efforts may not be enough to save the company from acquisition or merger.

Many industry insiders believe that Buchalter was hired four years ago to prepare the company for sale. Yesterday, Enzon disclosed in a SEC filing, that the self-proclaimed biotech maven, Carl C. Icahn, increased his Enzon stock position from 1,760,001 to 3,072,103 shares. After the purchase, Icahn owns about 6.93% of the company’s outstanding shares and is one of its largest, single shareholders. Not surprisingly, Icahn now wants the company to consider putting itself up for sale. Maybe the insiders were correct in their thinking?

Stay tuned for more details.

Until next time….

Good Luck and Good Job Hunting (forget New Jersey)!!!!!!!

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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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