Matthew Perrone
May 30, 2008 - 3:06 p.m.
WASHINGTON (AP) - Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective on account of short-term exercise, notwithstanding reservations by FDA scientists.
A panel of 16 outside advisers voted unanimously in favor of Promacta at a meeting held in Chicago, before-mentioned FDA spokeswoman Karen Riley. The drug is designed to deal with an immune system disorder that causes the body to destroy its own platelets, which can cause excessive bleeding.
The firmness sent shares of San Diego-based Ligand soaring more than $1, or 45 percent, to $3.41 on heavy volume. Shares of GlaxoSmithKline PLC rose 52 cents, or 1.2 percent, to $44.50.
Panel members noted that the companies have not provided long-term data on the drug, but said results from two, six-week studies appeared to show significant benefit. Long-term studies should be available by means of the expiration of the year, according to the companies.
British drugmaker Glaxo and partner Ligand want Promacta approved to treat patients' with chronic idiopathic thrombocytopenic purpura, which causes excessive bruising and blood-letting. About 60,000 people in the U.S. have the disease, according to Glaxo.
The FDA has to the time when June 19 to make a final decision without ceasing the mix with drugs. It is not required to follow the advice of its superficies panel, though it often does.
The panel's opinion came as a surprise to Wall Street, since the FDA on Wednesday released its own negative review of the drug. That news walloped Ligand's shares, sending them to their lowest point in at least 10 years, $2.16, only to recover by day's end at $2.30, still etc. 36 percent. The company has been a Glaxo partner since 1997.
Agency reviewers said that the drug did not significantly lower blood-letting compared with a placebo in two studies submitted by the companies.
FDA scientists too raised concerns about liver toxicity and the drug's safety in long-term use. Although the companies are seeking approval for short-term use, the FDA cautioned that doctors could continue prescribing the drug for extended periods of time.
Susquehanna Financial Group analyst Derek Jellinek faulted GlaxoSmithKline's clinical testing strategy in opposition to the critical FDA documents. While the company applied with a view to short-term use for Promacta, GlaxoSmithKline instead well-considered patients with the chronic condition who need long-term management, he said in a note to investors Thursday.
That choice of chronic patients could complicate the company's dealings with the FDA, he said, "because the agency believes that short-term data may not this moment translate into long-term results."
Jellinek reaffirmed a "Positive" rating but lowered his price target to $7 from $8.