Mass high tech

Biomed Rounds: Alkermes’
week a roller coaster of
good and bad
Alkermes Inc. recently came through a good news-bad news week. But it should be months before executives learn which scenario will emerge as The positive tidings were that an Alkermes drug to treat schizophrenia was approved by the Food and Drug Administration. But shortly thereafter, the Cambridge company received the unwelcome news that it was being hit with several class-action lawsuits filed on behalf of stockholders.
Alkermes, headed by CEO Richard Pops, has been one of the most visible biotech companies in the region. It has forged high-level collaborations with the biggest pharmas in the land, and it has worked to develop its own At one point Alkermes was a glamorous high-flyer. In February 2000 its stock price was close to $100 per share.
But the company was slow to gain FDA approval for drugs in its own pipeline, including products to treat schizophrenia and alcoholism.
So imagine the good news for Alkermes when the FDA approved its file:///C|/Documents%20and%20Settings/jane/Desktop/Mass%20High%20Tech.htm (1 of 3) [11/11/2003 1:20:26 PM] Risperdal Consta as a drug treatment for schizophrenia. Company officials say Risperdal Consta is the first long-acting, newer- generation (atypical) anti-psychotic to be approved by the FDA.
A key benefit of the drug is that it allows a patient to take the medication once every two weeks rather than every day. “Patients don’t have to remember to take a pill every single day, which is difficult for anyone with a chronic disease,” said John Kane, professor of psychiatry at the Albert Einstein College of Medicine in New York, in a Alkermes developed the drug with Johnson & Johnson Pharmaceutical Research & Development LLC. The product will be marketed by Janssen Alkermes announced the FDA approval on Oct. 29. In the following days at least three class-action suits were filed against it, mostly in U.S. District One of litigants’ key claims is that Alkermes did not disclose problems with the drug between April 22, 1999 and July 1, 2002. During this period the FDA found problems with Alkermes’ data, and progress to win approval was minimal.
By the time the news that the FDA had reservations about the project became public on July 1, 2002, the stock had fallen from $98 per share to about $4 per share, one lawsuit claims. (Last week it was trading for about Lawyers for the litigants say that Alkermes executives withheld negative news in that period, causing major stockholder loss.
Stockholder suits against tech companies are common. Indeed, the filings by out-of-town law firms sound very much like the John Grisham novel In that text, avaricious law firms regularly sued drug companies in the Alkermes has had little to say about the litigation. But it must have spoiled Chris Anderson, president of the Massachusetts High Technology Council, recently floated a trial balloon during a discussion of how to deal with high He suggested that the state consider price supports for people who need file:///C|/Documents%20and%20Settings/jane/Desktop/Mass%20High%20Tech.htm (2 of 3) [11/11/2003 1:20:26 PM] “In this state we have programs for people who can’t afford heating oil,” Anderson said at a press conference. “Perhaps we should consider a program like this to help people in real need.” Biotech professionals of all stripes have been meeting in recent weeks to develop strategies to diffuse the drive of New Englanders to seek cheaper Drugs bought in other countries mean smaller profits for U.S. pharma corporation. Industry spokesmen say smaller profits mean smaller R&D Users are concerned that drug prices in the U.S. are higher than most Western countries. They say that the retirement security of senior citizens without coverage is threatened by the rising prices.
Dyke Hendrickson reports on biotechnology and medical devices. He can be reached at [email protected] All Rights Reserved. Mass High Tech 2000 file:///C|/Documents%20and%20Settings/jane/Desktop/Mass%20High%20Tech.htm (3 of 3) [11/11/2003 1:20:26 PM]

Source: http://www.mhtc.org/downloads/archives/111003_biomed_rounds.pdf

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