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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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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!!!!!!

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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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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!!!!!!!

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Monoclonal antibodies (MAbs) directed against vascular endothelial growth factor (VEGF) receptors on cancer cells, have been found to slow the growth of a variety of cancers including colorectal, breast and lung.  While a number of blockbuster biotechnology products( based on these MAbs (Avastin by Genentech/Roche and Eribitux by Bristol-Myers Squibb/ImClone/Merck KGA) have been approved to treat a variety of different cancers their effectiveness as cancer treatments has been the subject of intense debate since their approvals.

Although numerous human clinical trials have shown that VEGF inhibitors slow the growth and development of tumors, they, as a class, don’t seem to significantly increase the survival time for most cancer patients. Further, Avastin and Erbitux are generally not used as stand alone treatments but are used in combination with more tradition anti-cancer chemotherapies. The high costs of these drugs, (Avastin’s worldwide sales hit $ 3.5 billion last year) and their variable effectiveness have caused many to question the usefulness of this class of drugs to treat cancer patients.

The well-publicized use of these drugs as cancer treatments coupled with anecdotal evidence about their effectiveness has put practicing oncologists between a rock and a hard place when it comes to treating patietns with cancer. In an article in Sunday’s New York Times one prominent oncologist said that depsite the controversy,  “I still use Avastin routinely. It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.” Others are more sanguine about VEGF inhibitors as cancer treatments “Even when these drugs ‘work,’ what kind of impact are you talking about?” said Fran Visco, president of the National Breast Cancer Coalition. But we market them and give them to everybody.”  

Nevertheless, most oncologists find it difficult to withhold Avastin or Erbitux from cancer patients seeking hope. As one oncologist put it “ When I am not sitting in front of a patient, I think about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit — even if only a little — from Avastin, I think about the patient’s needs.” 

Regardless of their therapeutic value, the main issue with this class of anti-cancer drugs is cost. Avastin treatment costs patients about $4000-$9000 per month— Eribitux treatment is even more costly! While Medicare and most private insurers cover 80% of the cost, patients can be responsible for 20% or more of treatmetn costs.  As posited in the Times article “If Avastin were inexpensive or if it cured cancer or even held it at bay, as the drug Gleevec does for blood cancer, few might care.”

Are anti-VEGF drugs real cancer treatments or expensive red herrings? Clearly, the jury is still out on that one. That said, I think that only cancer patients can truly provide an accurate response to that question!

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

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