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

To: Cacaito who wrote (11109)	11/15/1997 3:50:00 AM
From: Andrew H	Respond to of 32384

>>Will Ligand get any royalties from Eli Lilly osteoporosis drug? FDA approval is coming in next two three months.<< Cacaito, while LGND has a small piece of Pfizer's droloxifene, it has none of LLY's Evista.

To: Cacaito who wrote (11109)	11/15/1997 10:31:00 AM
From: Henry Niman	Respond to of 32384

Cacaito, LGND's deal with LLY includes development of a rexinoid that will compliment (synergize with) Raloxifene (Evista). The rexinoids have several molecular partners and I expect them to have many applications (some of which will provide LGND with royalties and some will be developed in-house). LGND is heavily involved in the anti-estrogen area which has many applications. The most advanced in the clinic are osteoporosis and breast cancer, but applications for Alzheimer's, memory, wrinkles, baldness are being explored. These markets will be fueled by aging baby boomers and LGND probably has the broadest program in the world. Two compounds have entered the clinic through the PFE alliance. Droloxifene is finishing up breast cancer trials and PFE has predicted an NDA filing next year for breast cancer. It is also getting ready to finish up phase II for osteoporosis and move into Phase III trials for that indication. LGND's second choice, CP-366,156 has aleady entered the clinic for treating osteoporosis. In addition to the two PFE compounds that are already in the clinic, LGND has a huge program with AHP, the makers of the most widely prescribed drug in the US, Premarin (estrogens isolated from mare's urine). AHP has announced that they will be filing a IND for TSE424 next quarter, which was developed under their LGND alliance. In addition to TSE424, AHP has folded their lead estrogen compounds into LGND's estrogen program. As you noted, LGND is also persuing an anti-estrogen program with LLY. Their compound, Evista, is the most advanced, and they will appear before an FDA panel next week. As Randall Tobias noted on CNBC last week, Evista has the potential of becoming a $1/2 Billion drug in its first year on the market. Osteoporosis of course is a rapidly expanding market for women and men. The LLY program really focuses on the role of Rexinoids which partner with many transcription factors including PPAR alpha and gamma. PPAR alpha appears to be involved in energy metabolism, while PPAR gamma is involved in insulin resistance. LGND has its own PPAR program (as do others such as WLA, SBH, and Takeda), but its RXR program is really the most advanced. An NDA for Targretin should be filed next year and the drug began tests in diabetics last spring. Once it is approved (for CTCL) it can be prescribed off-label for uses such as diabetes, obesity, other cancers, and possibly osteoporosis). LGND's chief competition in the area of rexinoids is AGN, but LGND gets royalties for the compounds that they develop also.

To: Cacaito who wrote (11109)	11/15/1997 10:54:00 AM
From: Henry Niman	Respond to of 32384

Speaking of anti-estrogens, LGND also has an extensive in-house anti-androgen program. Here's the latest on MRK's anti-androgen's application for baldness: By Lauran Neergaard The Associated Press B E T H E S D A, Md., Nov. 13 - The first pill to fight baldness is a step closer to the market, after scientific advisers told the Food and Drug Administration that Propecia appears to help some men grow new hair. But the FDA panel stopped short of give a total endorsement of Merck & Co.'s new pill-raising questions over whether men who took the pill for years would suffer fertility problems and other unforeseen side effects. The panel, without a vote, concluded that the pill was effective and left the safety question to the government. Now it is up to the FDA to decide whether to require Merck to extend the study of the drug or allow its sale and keep tabs on what happens to balding men over time. Despite the lingering questions, "I've been very impressed" by the effectiveness studies on Propecia, said panelist Dr. James Kilpatrick Jr. of the Medical College of Virginia. Balding men-the United States has 40 million of them-now have only one way to try to grow new hair: slathering nonprescription Rogaine on their scalps. It helps about 25 percent of users grow varying amounts of hair, but the hair falls out if they stop using it. Thousands spend $15 to $30 every month hoping for help from the drug. Merck wants to sell Propecia-by prescription only-as the first pill for male pattern baldness, the most common type. It is not a miracle pill-nobody grew a full head of hair in the tests and not everybody was helped. But before-and-after photographs showed Propecia shrinking bald spots, some only slightly but a few by enough that just a quarter-sized spot of scalp still showed. Dermatologists concluded that 30 percent of these men grew slight amounts of hair in a year, and another 18 percent grew moderate to heavy amounts. When Merck actually counted hairs, Propecia patients averaged a net of 106 more new hairs within a one-inch circle on top of the head than did patients who used a dummy cream. For receding hairlines, the improvement was a more modest 60 hairs. Propecia did not help every man. But Merck argued that many who did not grow new hair at least stopped losing what they had. The FDA's advisers were not sure that was proved, but Merck did note that when men stopped taking Propecia, their new hair fell out. Propecia is not for women, Merck stressed, because it can cause birth defects. Dr. Michael Weintraub, FDA dermatologic drug chief, was asked if younger men who take a pill that affects hormones for years will suffer long-term side effects. He suggested that male fertility was a concern, because of some evidence that users' ejaculate fluid was diminished. Some FDA advisers worried that Propecia might hide early signals of prostate cancer. Propecia blocks an enzyme that converts testosterone into the related hormone dihydrotestosterone, or DHT, that shrinks hair follicles. Merck argued that patients who took a dummy pill experienced fluctuating ejaculate levels, too, and that animal studies suggest no fertility problems. Merck's Dr. Keith Kaufman added that any serious side effects already would have emerged in men who take doses five times as high-under the brand name Proscar-to shrink enlarged prostates. Merck says the 1-milligram Propecia dose is safe for the merely hair-impaired. The main side effect, experienced by just 2 percent of men, are decreased libido and impotence. In addition, Kaufman said studies of men born with a rare disease that naturally depletes their DHT shows they not only never go bald, they also do not get enlarged prostates or prostate cancer, suggesting a possible protective effect.