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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: dwc who wrote (16351)	3/3/1998 3:56:00 PM
From: Henry Niman	Read Replies (2) \| Respond to of 32384

Here's more on Leptin: Tuesday March 3 1:25 PM EST Leptin May Help Trigger Puberty NEW YORK (Reuters) -- In mice, mutations in the leptin gene lead to severe obesity and infertility. Now, scientists have discovered that in humans, mutations of this gene may lead to low levels of leptin -- and individuals with two copies of the mutant gene have very low leptin levels associated with reproductive abnormalities, including a failure to enter puberty. The scientists, led by Professor A. Donny Strosberg of Universite de Paris, France, report their discovery in Nature Genetics. In a previous study, the only two obese patients with confirmed mutations in the leptin gene were children, so it was not possible to determine the effects of the genetic mutation on their reproductive function. Strosberg and his team found a Turkish family in which two obese adults had mutations in both copies of the leptin gene. One of these individuals, a woman, had primary amenorrhea -- she had never menstruated. The second was a male who "...had never entered into puberty and had clinical features of hypogonadism: no beard, scanty pubic and axillary (underarm) hair, bilateral gynecomastia (enlarged breasts), and small penis and testes," write the researchers. Strosberg's team reports family members who were not affected by the mutation "...had normal body weight." The male also had low levels of testosterone, but levels of the hormone rose when he was given a hormone that stimulated testosterone production. "These results... establish that leptin indeed plays an important role in human reproductive function," conclude the researchers. The researchers believe their findings suggest "...that leptin not only controls body mass but may also be a necessary signal for the initiation of human puberty." SOURCE Nature Genetics (1998;18:213-215)

To: dwc who wrote (16351)	3/3/1998 4:05:00 PM
From: Henry Niman	Read Replies (3) \| Respond to of 32384

Actually, The report wasn't all that unexpected. Most of the events were anticipated. However, a forth NDA filing this year should really catch the street's attention. If LGND could pull off 2 Phase IIs substituting for one Phase III, it would demonstrate that the FDA is serious about getting "slam dunks" onto pharmacy shelves, especially when the disease is life threatening. It would also give the FDA a chance to show that the "fast track" works for the little guys also. Since LGND's profile will be relatively high (three major conferences in 4 months including several presentations by the AIDS Consortium as well as LGND), the FDA may decide to tell LGND to "go for it". Not too many Biotechs (or Pharmas) in a position to file 4 NDAs in one year. With Biotechs continuing to disappoint, LGND has to start standing out.