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

To: squetch who wrote (20573)	5/12/1998 8:08:00 AM
From: Henry Niman	Respond to of 32384

Here's more on the FDA approval process: Can Those New Cancer Drugs Win FDA Approval? By JEFF NESMITH c.1998 Cox News Service WASHINGTON -- Cancer patients and investors who developed a sudden and urgent interest last Monday in a little-known Maryland biotech company because of a newspaper article about the company's potentially life-saving drugs might consider this: The two chemicals are at a stage of development that gives them at best a one-in-five chance of ever being licensed by the U.S. Food and Drug Administration (FDA). The odds were developed by the Center for the Study of Drug Development at Tufts University in Boston. ''The new drug development process is lengthy, risky and costly,'' said Joseph A. DiMasi, director of economic analysis at the center. Interest in the two drugs, angiostatin and endostatin, was driven to a near-stampede last week by an article in Sunday editions of The New York Times. The 52-employee company that has the license to develop the patented chemicals, Entremed Inc., of Rockville, Md., said its telephones were flooded with calls from cancer patients who hoped to get into clinical trials of the drugs. The American Cancer Society and individual physicians also reported receiving calls. And stock in Entremed, which was trading at around $12 a share, jumped to over $80 Monday before settling to $54 at the end of the day. It continued to decline during the week. The two substances belong to a relatively new class of drugs, known as antiangiogenics, which turn off chemical processes involved in the body's construction of new blood vessels. Tumors have a voracious need for blood and must force the victim's body to construct special blood vessels to supply it. Even when a tumor consists of little more than a microscopic clump of cells, it is releasing chemicals that induce the nearest blood vessel to start growing branches in its direction. As the tumor grows, the branches grow with it and new ones are also grown. If antiangiogenic compounds can turn off the chemical signal mechanism and stop the vital blood supply, they could become a fourth route for cancer therapy, joining chemotherapy, radiation and surgery. Patent Office records show that more than 33 substances with potential antiangiogenic properties have been patented, and some have already been given to human volunteers in preliminary tests. Although angiostatin and endostatin have been used only on laboratory animals, the Times's article said that ''if all goes well'' the first human clinical trials could be begin within a year. But all does not always go well in the clinical obstacle course a potential new drug has to run between ''looks good'' and ''works well.'' That course typically involves five separate stages of review: - Early research and pre-clinical testing: laboratory studies, usually with animals, that attempt to measure a substance's toxicity and determine if it demonstrates chemical properties that might be useful as a drug. If a chemical passes this step, the drug company files an ''investigational new drug application'' with the FDA for permission to begin human experiments. If the FDA does not disapprove it within 30 days, the tests can begin. - Phase I clinical trials: tests on 20 to 80 healthy human volunteers to further assess the substance's safety. - Phase II clinical trials: tests on a larger group, usually between 100 and 300 patient volunteers, to evaluate the drug's effectiveness and look for side effects. - Phase III clinical trials: tests on a still-larger group of patients, from 1,000 to 3,000 volunteers, to confirm effectiveness and monitor reactions to long-term use. If all goes well in Phase III trials - and the company must produce at least two trials showing both safety and efficacy - the company files a ''new drug application'' for permission to market the drug. DiMasi reported last year that for every 5,000 compounds that are evaluated in early research phase, only five move to clinical trials. And of those five, he said, only one is eventually licensed by the FDA. The process takes an average of 15 years, he said. The money spent on drug research and development by biotech firms and pharmaceutical manufacturers works out to an average of $312 million for every drug that is eventually licensed, the Tufts center reported. But a single new drug can boost a company's sales by that much or more every year, and drug companies continue to lay out the investment. ----- (The Cox web site is at coxnews.com )

To: squetch who wrote (20573)	5/12/1998 9:02:00 AM
From: Henry Niman	Respond to of 32384

Stan, Thanks for the psoriasis update. I went over to the FDA site at fda.gov to get the upcoming review schedule. I couldn't find ONTAK listed (most of the detail is for meetings this month) , but I did get the upcoming oncology schedule: Oncologic Drugs Advisory Committee 6/1-2/98 9/1-2/98 12/14-15/98 3/22-23/99 6/7-8/99 Looks like June 2 date is correct for ONTAK review. I suspect that topical Panretin review would be in September if NDA is filed this month and it gets priority review (and I expect both to happen).

To: squetch who wrote (20573)	5/12/1998 9:14:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Legg Mason came out with a LGND update this morning (on SRGN buyout). They indicate that ONTAK could be commercially available in 4Q of this year. LGND bid raised to 14 1/8.

To: squetch who wrote (20573)	5/12/1998 9:37:00 AM
From: Henry Niman	Respond to of 32384

Here's what Legg Mason said this morning: Seragen (SRGN) is a biopharmaceutical company specializing in the development of macromolecular drugs. The company's most advanced product, ONTAK, is scheduled to be reviewed by an FDA advisory committee June 1-2 for the treatment of Cutaneous T-cell lymphoma (CTCL). ú Ligand has acquired Lilly's rights to Seragen's ONTAK as part of last year's Ligand-Lilly collaborative agreement, and the acquisition of Seragen consolidates all rights to the drug. ú Ligand will pay Lilly up to $10 million if ONTAK is approved, and up to an addition $10 million in milestone payments once the drug is on the market. ú Ligand will pay $26 million in stock and $4 million in cash to Seragen, and an additional $37 million if ONTAK receives FDA approval. ú Ligand will also acquire the assets of Marathon Biopharmaceuticals, a contract manufacturing organization, for $5 million up-front and $3 million upon ONTAK approval. Marathon will produce ONTAK for Ligand, and continue to operate as a CMO. ú ONTAK could be commercially available in 4Q98 if it receives FDA approval, and Ligand's existing sales and marketing infrastructure will be used to market the drug. ú If ONTAK and the Targretin products are approved by the FDA, Ligand will own all drugs specifically approved for the CTCL indication.