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

To: Russian Bear who wrote (21693)	6/2/1998 1:01:00 PM
From: tommysdad	Read Replies (1) \| Respond to of 32384

SRGN went to 0.80 before dropping to 0.76, so someone knows the outcome already.

To: Russian Bear who wrote (21693)	6/2/1998 1:02:00 PM
From: Dan O.	Read Replies (1) \| Respond to of 32384

RB, Ligand said they were 90% certain, and I think the other 10% was simply the fact that they are dealing with the FDA (with it's bureaucracy and rules). If they don't get it today they will soon. The weak hands were not weak enough though. I only got a partial fill of lgndw at 7 1/8. If the approval is delayed I'll take another shot at it <g>. Dan Ogens

To: Russian Bear who wrote (21693)	6/2/1998 1:57:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Here's what Bloomberg had to say: ÿ\|ÿnewsÿ\|ÿchartÿ\|ÿcompare to competitors Seragen Wins FDA Panel Backing for Ontak Cancer Drug (Update1) Bloomberg News June 2, 1998, 9:32 a.m. PT Seragen Wins FDA Panel Backing for Ontak Cancer Drug (Update1) (Adds panel action) Gaithersburg, Maryland, June 2 (Bloomberg) -- Seragen Inc.'s Ontak drug won the backing of an expert government panel for fighting a rare cancer in patients who otherwise would have few options for battling the disease. In two unanimous votes, the U.S. Food and Drug Administration advisory panel decided the drug is safe and effective and should be cleared for sale to treat patients with an unusual cancer known as cutaneous T-cell lymphoma. The drug is ''truly a miracle,'' said William Smith, a patient from Hingham, Massachusetts. Hopkinton, Massachusetts-based Seragen originally developed the drug with Eli Lilly & Co. Last month, however, Ligand Pharmaceuticals Inc. said it planned to buy Seragen and to acquire Lilly's rights to Ontak. Seragen shares were unchanged at 54 cents in recent trading, while shares of San Diego-based Ligand fell 7/16 to 13 5/16. The panel is still deciding what further studies will be needed to determine how the drug best can be used and at what dosages. Cutaneous T-cell lymphoma is a very rare and ultimately fatal condition. Still, it's slow growing, and most patients live at least 10 years after diagnosis. Cancer experts today presented studies that showed about 30 percent of the 71 patients who got the drug had at least a partial response in which the disease and symptoms improved. All evidence of the disease disappeared in 10 percent of the patients, the studies showed. Side Effects Most patients had side effects ranging from infection to fever and chills. A significant number of patients also had cardiovascular problems after getting the drug. The company said it was difficult to assess which of the side effects were solely due to the drug, and not from the disease itself. In addition to improving a patient's health, the drug improved symptoms of the disease, very important in this particular cancer, experts said today. ''All except a few relapsing patients showed improvement (and) had a significant improvement in their quality of life,'' after being treated with the drug, said Madeleine Duvic, a cancer doctor from the M.D. Anderson Cancer Center, who participated in the company's study and presented data on the drug's effectiveness. The T-cell lymphomas begin as small plaques of tough, scaly patches and gradually spread over the skin. The brownish-black plaques -- which can grow to cover the majority of a patient's face and body -- are disfiguring, itch and are prone to infection. If left untreated, the topical cancer will develop into tumors, and finally seep into the organ systems and spread throughout the body. Experts today showed slides of patients whose faces and bodies had been obscured by the disease and told of one woman who said her daughter had been afraid of her until the drug shrank and healed the facial plaques. While the disease is slow moving, it accelerates in advanced forms and those who are diagnosed after the lymphoma has reached their organs generally live less than two years. The company is asking for clearance to sell the drug to treat patients who have more advanced disease and who have already failed other treatments. Currently, some patients have their bodies coated with toxic mustard treatments, have either their skin or their blood radiated, or undergo harsh chemotherapy regimens. These treatments are time consuming, and are extremely toxic to the skin, leading to lesions, further scarring and even other forms of skin cancers. Ontak is a form of a natural immune system compound called Interleukin-2 which is merged with the toxin from diphtheria. It is produced by genetically engineered e.coli bacteria. The company said it is still in studies to determine just what doses work best in patients. Later this morning the panel will hear the FDA's interpretation of the data, and then make a recommendation. This afternoon, the cancer advisory committee with consider whether to recommend SmithKline-Beecham's Hycamtin drug for patients with lung cancer. --Kristin Reed in Gaithersburg, Maryland with reporting from More News:ÿLGND

To: Russian Bear who wrote (21693)	6/2/1998 2:46:00 PM
From: Henry Niman	Respond to of 32384

Here's the earlier Bloomberg report: Seragen Tells FDA Panel Its Ontak Drug Can Fight Rare Cancer Bloomberg News June 2, 1998, 8:17 a.m. PT Seragen Tells FDA Panel Its Ontak Drug Can Fight Rare Cancer Gaithersburg, Maryland, June 2 (Bloomberg) -- Seragen Inc.'s Ontak cancer drug helps fight a rare cancer in patients who otherwise would have few options for battling the disease, an expert government panel heard. The advisory committee for the U.S. Food and Drug Administration heard the results of studies of the drug this morning, and will decide later today whether it will recommend the full agency clear the drug for sale to treat patients with an unusual cancer known as cutaneous T-cell lymphoma. The drug is ''truly a miracle,'' said William Smith, a patient from Hingham, Massachusetts. ''During my entire treatment period, I experienced no side effects from the therapy.'' Hopkinton, Massachusetts-based Seragen originally developed the drug with Eli Lilly & Co. Last month, however, Ligand Pharmaceuticals Inc. said it planned to buy Seragen and to acquire Lilly's rights to Ontak. Seragen shares fell 2 cents to 52 cents in recent trading, while shares of San Diego-based Ligand fell 5/8 to 13 1/8. Cutaneous T-cell lymphoma is a very rare and ultimately fatal condition. Still, it's slow growing, and most patients live at least 10 years after diagnosis. Cancer experts today presented studies that showed about 30 percent of the 71 patients who got the drug had at least a partial response in which the disease and symptoms improved. All evidence of the disease disappeared in 10 percent of the patients, the studies showed. Side Effects Most patients had side effects ranging from infection to fever and chills. A significant number of patients also had cardiovascular problems after getting the drug. The company said it was difficult to assess which of the side effects were solely due to the drug, and not from the disease itself. In addition to improving a patient's health, the drug improved symptoms of the disease, very important in this particular cancer, experts said today. ''All except a few relapsing patients showed improvement (and) had a significant improvement in their quality of life,'' after being treated with the drug, said Madeleine Duvic, a cancer doctor from the M.D. Anderson Cancer Center, who participated in the company's study and presented data on the drug's effectiveness. The T-cell lymphomas begin as small plaques of tough, scaly patches and gradually spread over the skin. The brownish-black plaques -- which can grow to cover the majority of a patient's face and body -- are disfiguring, itch and are prone to infection. If left untreated, the topical cancer will develop into tumors, and finally seep into the organ systems and spread throughout the body. Experts today showed slides of patients whose faces and bodies had been obscured by the disease and told of one woman who said her daughter had been afraid of her until the drug shrank and healed the facial plaques. While the disease is slow moving, it accelerates in advanced forms and those who are diagnosed after the lymphoma has reached their organs generally live less than two years. The company is asking for clearance to sell the drug to treat patients who have more advanced disease and who have already failed other treatments. Currently, some patients have their bodies coated with toxic mustard treatments, have either their skin or their blood radiated, or undergo harsh chemotherapy regimens. These treatments are time consuming, and are extremely toxic to the skin, leading to lesions, further scarring and even other forms of skin cancers. Ontak is a form of a natural immune system compound called Interleukin-2 which is merged with the toxin from diphtheria. It is produced by genetically engineered e.coli bacteria. The company said it is still in studies to determine just what doses work best in patients. Later this morning the panel will hear the FDA's interpretation of the data, and then make a recommendation. This afternoon, the cancer advisory committee with consider whether to recommend SmithKline-Beecham's Hycamtin drug for patients with lung cancer. --Kristin Reed in Gaithersburg, Maryland with reporting from More News:ÿLGND Seragen Tells FDA Panel Its Ontak Drug Can Fight Rare Cancer Bloomberg News June 2, 1998, 8:17 a.m. PT Seragen Tells FDA Panel Its Ontak Drug Can Fight Rare Cancer Gaithersburg, Maryland, June 2 (Bloomberg) -- Seragen Inc.'s Ontak cancer drug helps fight a rare cancer in patients who otherwise would have few options for battling the disease, an expert government panel heard. The advisory committee for the U.S. Food and Drug Administration heard the results of studies of the drug this morning, and will decide later today whether it will recommend the full agency clear the drug for sale to treat patients with an unusual cancer known as cutaneous T-cell lymphoma. The drug is ''truly a miracle,'' said William Smith, a patient from Hingham, Massachusetts. ''During my entire treatment period, I experienced no side effects from the therapy.'' Hopkinton, Massachusetts-based Seragen originally developed the drug with Eli Lilly & Co. Last month, however, Ligand Pharmaceuticals Inc. said it planned to buy Seragen and to acquire Lilly's rights to Ontak. Seragen shares fell 2 cents to 52 cents in recent trading, while shares of San Diego-based Ligand fell 5/8 to 13 1/8. Cutaneous T-cell lymphoma is a very rare and ultimately fatal condition. Still, it's slow growing, and most patients live at least 10 years after diagnosis. Cancer experts today presented studies that showed about 30 percent of the 71 patients who got the drug had at least a partial response in which the disease and symptoms improved. All evidence of the disease disappeared in 10 percent of the patients, the studies showed. Side Effects Most patients had side effects ranging from infection to fever and chills. A significant number of patients also had cardiovascular problems after getting the drug. The company said it was difficult to assess which of the side effects were solely due to the drug, and not from the disease itself. In addition to improving a patient's health, the drug improved symptoms of the disease, very important in this particular cancer, experts said today. ''All except a few relapsing patients showed improvement (and) had a significant improvement in their quality of life,'' after being treated with the drug, said Madeleine Duvic, a cancer doctor from the M.D. Anderson Cancer Center, who participated in the company's study and presented data on the drug's effectiveness. The T-cell lymphomas begin as small plaques of tough, scaly patches and gradually spread over the skin. The brownish-black plaques -- which can grow to cover the majority of a patient's face and body -- are disfiguring, itch and are prone to infection. If left untreated, the topical cancer will develop into tumors, and finally seep into the organ systems and spread throughout the body. Experts today showed slides of patients whose faces and bodies had been obscured by the disease and told of one woman who said her daughter had been afraid of her until the drug shrank and healed the facial plaques. While the disease is slow moving, it accelerates in advanced forms and those who are diagnosed after the lymphoma has reached their organs generally live less than two years. The company is asking for clearance to sell the drug to treat patients who have more advanced disease and who have already failed other treatments. Currently, some patients have their bodies coated with toxic mustard treatments, have either their skin or their blood radiated, or undergo harsh chemotherapy regimens. These treatments are time consuming, and are extremely toxic to the skin, leading to lesions, further scarring and even other forms of skin cancers. Ontak is a form of a natural immune system compound called Interleukin-2 which is merged with the toxin from diphtheria. It is produced by genetically engineered e.coli bacteria. The company said it is still in studies to determine just what doses work best in patients. Later this morning the panel will hear the FDA's interpretation of the data, and then make a recommendation. This afternoon, the cancer advisory committee with consider whether to recommend SmithKline-Beecham's Hycamtin drug for patients with lung cancer. --Kristin Reed in Gaithersburg, Maryland with reporting from More News:ÿLGND

To: Russian Bear who wrote (21693)	6/2/1998 2:51:00 PM
From: Henry Niman	Respond to of 32384

Here's a later Bloomberg report: Seragen Wins FDA Panel Backing for Ontak Cancer Drug (Update2) Bloomberg News June 2, 1998, 10:13 a.m. PT Seragen Wins FDA Panel Backing for Ontak Cancer Drug (Update2) (Adds additional panel comments, background.) Gaithersburg, Maryland, June 2 (Bloomberg) -- Seragen Inc.'s Ontak drug won the backing of an expert government panel for fighting a rare cancer in patients who otherwise would have few options for battling the disease. In two unanimous votes, the U.S. Food and Drug Administration advisory panel decided the drug is safe and effective and should be cleared for sale to treat patients with an unusual cancer known as cutaneous T-cell lymphoma. Panel members said they were impressed with the drug's ability to ease symptoms in the cancer, which was described as ''Biblical'' in the suffering and disfigurement it causes. ''This is truly a miserable disease,'' said Julie Vose, a professor at the University of Nebraska Medical Center and a voting consultant to the panel. ''Any drug that can help us get some symptomatic benefit . . . would be a very useful agent.'' Hopkinton, Massachusetts-based Seragen originally developed the drug with Eli Lilly & Co. Last month, however, Ligand Pharmaceuticals Inc. said it planned to buy Seragen and to acquire Lilly's rights to Ontak. Seragen shares rose 14 cents to 68 cents in recent trading, while shares of San Diego-based Ligand rose 1/8 to 13 7/8. The panel voted to back the drug under an FDA program known as accelerated approval, where less evidence from fewer patients is required at first because the drug shows promise in treating a grave condition. Companies with accelerated approvals must continue to show the FDA data and studies confirming a drug's benefits. The panel today voted to recommend that those studies look at how long the drug should be used and in what dosages. Cutaneous T-cell lymphoma is a very rare and ultimately fatal condition. Still, it's slow growing, and most patients live at least 10 years after diagnosis. Cancer experts today presented studies that showed about 30 percent of the 71 patients who got the drug had at least a partial response in which the disease and symptoms improved. All evidence of the disease disappeared in 10 percent of the patients, the studies showed. Side Effects Most patients had side effects ranging from infection to fever and chills, and more than a third of patients in one study dropped out because of the side effects. A significant number of patients also had cardiovascular problems after getting the drug. Still, the company and the FDA said it was difficult to assess which of the side effects were solely due to the drug, and not from the disease itself. In addition to improving a patient's health, the drug improved symptoms of the disease, very important in this particular cancer, experts said today. ''All except a few relapsing patients showed improvement (and) had a significant improvement in their quality of life,'' after being treated with the drug, said Madeleine Duvic, a cancer doctor from the M.D. Anderson Cancer Center, who participated in the company's study and presented data on the drug's effectiveness. The T-cell lymphomas begin as small plaques of tough, scaly patches and gradually spread over the skin. The brownish-black plaques -- which can grow to cover the majority of a patient's face and body -- are disfiguring, itch and are prone to infection. If left untreated, the topical cancer will develop into tumors, and finally seep into the organ systems and spread throughout the body. Currently, some patients have their bodies coated with toxic mustard treatments, have either their skin or their blood radiated, or undergo harsh chemotherapy regimens. These treatments are time-consuming, and are extremely toxic to the skin, leading to lesions, further scarring and even other forms of skin cancers. Ontak is a form of a natural immune system compound called Interleukin-2, which is merged with the toxin from diphtheria. It is produced by genetically engineered e.coli bacteria. The company said it is still in studies to determine just what doses work best in patients. This afternoon, the cancer advisory committee will consider whether to recommend SmithKline-Beecham's Hycamtin drug for patients with lung cancer. --Kristin Reed in Gaithersburg, Maryland

To: Russian Bear who wrote (21693)	6/2/1998 2:54:00 PM
From: Henry Niman	Read Replies (2) \| Respond to of 32384

Here's what Dow Jones had to say: Dow Jones Newswires -- June 2, 1998 FDA Panel Backs Seragen's Ontak For Lymphoma By Otesa Middleton WASHINGTON (Dow Jones)--Seragen Inc. (SRGN) received an endorsement from a federal advisory panel for its drug Ontak, which could be the first drug approved for treating cutaneous T-cell lymphoma. The final decision rests with the U.S. Food and Drug Administration, which usually clears products recommended by its expert panels. Cutaneous T-cell lymphoma is a rare disease, which afflicts 5,000 to 10,000 Americans. It is a non-Hodgkin's lymphoma that usually causes frequent skin infections, disfigurement, severe itching, pain and ultimately death. Treatment for the disease includes topical therapies, radiation, interferon-alpha and chemotherapy. Hopkinton, Mass.-based Seragen studied the drug in 456 patients. To show the drug's effectiveness, Seragen looked at 143 patients. The company said 30% of patients showed a partial response, which is at least a 50% reduction in tumor size, and 10% had a complete response. Most patients reported adverse reactions ranging from nausea to mental problems to cardiac events when taking Ontak, with seven deaths occurring during the trial. FDA reviewer Dr. Bernard Parker said it's hard to determine whether Ontak contributed to any of the deaths. The company applied to the FDA last December, and the agency agreed to accelerate its review to make a decision within six months of Seragen's filing. FDA has also designated Ontak an "orphan drug," which gives companies incentives to encourage the development of drugs to treat rare diseases. -Otesa Middleton: 202-862-6654 The committee said the drug should be approved for patients with advanced disease who have relapsed or patients in the early stages of the disease who have failed after using other therapies. The panel also urged the company to continue the trials. "We need another drug for this disease," said Dr. Wilma Bergfeld, a dermatologist and consultant to the FDA committee. Panelist Dr. Edward A. Sausville, a director at the National Cancer Institute, said no one can deny Ontak is active against the disease but said the benefits don't last as long as some other agents. "This disease is almost biblical in its symptoms and disfigurement." Ira Loss, an analyst who follows the pharmaceuticals industry for HSBC Washington Analysis, said the panel's recommendation "seals the deal" for Ligand Pharmaceuticals Inc. (LGND) to purchase Seragen. "If the committee didn't recommend the drug for approval, (Ligand) shareholders might have objected to the purchase." As reported May 11, Ligand Chairman David Robinson said the company signed a definitive agreement to acquire Seragen for $67 million in cash and stock, of which $37 million is contingent upon final regulatory approval of Ontak.