This today from the NY Times on IMCL. Note the quote from Avalon, who seem to be hanging in there with their short:
February 28, 2002
MARKET PLACE
Cancer Drug From ImClone May Receive New Review
By ANDREW POLLACK
mClone Systems Inc. (news/quote) said yesterday that federal regulators might consider approving its cancer drug without requiring new clinical trials beyond one already under way in Europe. The announcement sent shares of the embattled company up 32 percent on hopes that the drug might reach the market sooner than some analysts had expected.
The company's statement followed a meeting it had Tuesday with the Food and Drug Administration, which in December had refused to accept ImClone's application to market the drug, known as Erbitux. ImClone said the agency seemed open to the idea that it could file a new application if it submitted more complete data from the trial it had already completed as well as data from a trial being conducted by Merck (news/quote) of Germany, its European marketing partner.
If the F.D.A. were to accept the new data, Erbitux could reach the market from the middle of 2003 to early 2004, analysts said. While that would be a year to 18 months later than ImClone's initial expectations, it is a year or more earlier than if new trials had been required, as some analysts had expected.
"This is a very good outcome, and I suspect this is the turning point for the drug and for the company," said Dr. Douglas Lind, a former analyst at Morgan Stanley who is starting his own biotechnology investment fund.
Shares of ImClone rose $5.01, to $20.53, and shares of Bristol-Myers Squibb (news/quote), its American marketing partner, rose 4 percent, or $1.98, to $47.49.
ImClone still faces challenges. A person close to the situation said that Bristol- Myers, while it does not want to end its relationship with ImClone, still wants to reduce the amount of money it must pay under that agreement.
Nor was the news from the F.D.A. meeting all positive. ImClone, a New York biotechnology company, had hoped the F.D.A. would allow it merely to supply the missing data from its own clinical trial, without waiting for the results from Merck's European trial. Moreover, ImClone may not be able to find the needed data from its already completed trial, and the European trial may not have positive results.
Most important, ImClone, Bristol- Myers and Merck, which all had executives at the F.D.A. meeting, did not say that the F.D.A. actually agreed to approve the drug on the basis of the European trial.
"The meeting yesterday was a good sign for cancer patients and for the three companies involved because they didn't tell us to go away and never come back," said Phyllis Carter, a spokeswoman for Merck, which is based in Darmstadt, Germany. "But that doesn't mean they said yes to anything."
Samuel D. Waksal, ImClone's chief executive, said in a statement that the meeting "provides us with direction on an approach and a process" for resubmitting the application to sell Erbitux. But ImClone said it needed to have further discussions with the F.D.A. about the design of the European trial.
That left some analysts skeptical that the path ahead was really that clear. "The reality of ImClone's press release is not bullish," said David Hines, director of research at the Avalon Research Group in Boca Raton, Fla., who had predicted last April that the drug would not be approved. "Clearly the F.D.A. wants additional trials and ImClone is trying to convince the F.D.A. that data from Merck K.G.a.A. is going to be sufficient to satisfy that."
The F.D.A. did not comment yesterday on the ImClone meeting.
ImClone's statement was carefully worded. The company has been accused in the past of making statements that were overly positive about the drug's standing with the F.D.A. The company is being sued by shareholders for misleading investors and is being investigated by Congress and regulators.
But privately, a person close to ImClone seemed more positive than the cautious statement, saying the need for new trials was never discussed in the meeting, which lasted two hours.
Robert L. Erwin, an advocate for cancer patients who attended the meeting, said the atmosphere was positive. "The most encouraging thing to me is I don't think the F.D.A. is actively opposing anything and I don't think that ImClone is obstinately refusing to listen to anything," said Mr. Erwin, who heads the Marti Nelson Cancer Foundation in Vacaville, Calif.
"ImClone has a lot of work to do," added Mr. Erwin, who is also the head of a biotechnology company, Large Scale Biology (news/quote). "But I do think they are on track to enable this drug to be approved sooner than I thought a week ago."
Bristol-Myers said in a statement that the F.D.A. "provided clarity that the addition of the ongoing Merck K.G.a.A. colorectal trial data will be required to bolster the existing ImClone database." It added, "we are actively evaluating our options in view of yesterday's meeting with the F.D.A."
That last sentence hints at another looming problem for ImClone. Although Bristol-Myers seems to be pulling back its threat to terminate the agreement, it still wants a bigger role in having the drug approved.
Bristol-Myers agreed in September to pay $2 billion for rights to Erbitux and a 20 percent stake in ImClone. Earlier this month, Bristol publicly demanded that its payments be lowered, that it be given a greater role in the process of having the drug approved and that Dr. Waksal and his brother Harlan, the chief operating officer, step aside until the drug won approval. ImClone refused all the demands, and Bristol-Myers then said it would wait until the F.D.A. meeting to consider its options.
Analysts said that with the F.D.A. meeting having gone better than expected, Bristol may have less leverage than a few weeks ago.
Even if the deal with Bristol-Myers remains intact, however, the Waksal brothers and ImClone still face the government investigations. Last week, the House Energy and Commerce Committee asked for records from seven pharmaceutical companies that had discussed a deal for Erbitux with ImClone but then did not complete one. Those records are due today.
Many doctors who have worked with Erbitux said the drug had shown great promise in treating some advanced cancer patients who had little hope otherwise, and the F.D.A. has been under pressure from patient advocates to move the drug along.
ImClone tested its drug on 120 patients with colorectal cancer who were not responding to irinotecan, an existing drug. The company reported tumor shrinkage in 22.5 percent of the patients, who were given both Erbitux and irinotecan.
And in the FWIW category, this Yahoo post giving an anti-FDA perspective:
messages.yahoo.com
Whether or not the FDA actually changed their tune along the way should emerge at the Congressional hearings.
In the long term (as I think Rick has said) I think this whole IMCL fiasco will be good for biotech investors. Companies will be less cavalier in relaying (and spinning) the FDA position and I suspect the FDA might be a little more careful about their communications with companies and about changing their mind on stuff they already agreed to (if that's actually what happened here).
Note there is a separate issue that companies frequently bitch about. That is when the FDA agrees to something but then the Advisory Committee doesn't agree with what the FDA had committed to in terms of trial design etc. I don't think that issue will ever be resolved - by nature, AC's are independent-minded beasts and are likely to stay so. They also have the benefit of hindsight in terms of how the trial actually turned out and what problems were encountered.
Peter |
