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HomePage >> Analysis
Savient to face generic competitor
URL/Mutual Pharmaceutical Company will probably begin marketing generic Oxandrin in 2004.
Avishay Ovadia 21 Jul 03 17:41
Savient Pharmaceuticals (Nasdaq:SVNT) (formerly Bio-Technology General) is about to face generic competition for Oxandrin. United Research Laboratories (URL)/Mutual Pharmaceutical Company is expected to begin marketing of generic Oxandrin in 2004. Sales of Oxandrin, a weight-loss preventative for cancer and AIDS patients, amounted to $11.9 million in the first quarter of 2003, 40% of Savient’s total sales.
Savient has had exclusive marketing rights to Oxandrin since 1993, when its acquired the drug’s developer Gynex Pharmaceuticals. Although Oxandrin’s patent expired eight years ago, Savient has never faced generic competition to the ethical drug.
This exclusivity is about to end. The US Food and Drug Administration (FDA) approved a Drug Master File application by Cedarburg Pharmaceuticals LLC to produce the active pharmaceutical ingredients (API) for oxandrolone, the raw material for Savient’s Oxandrin. Cedarburg can make oxandrolone for either Savient or URL/Mutual Pharmaceutical, or for any new generic competitor.
“The approval to manufacture the APIs was granted in May,” says Ilanot Batucha analyst Sophie Galper. “We’ve known that Oxandrin was exposed to competition. The question is who is behind the APIs and who are the recipients? In any event, I’m not overly worried. Competition will hurt Savient’s sales and profits, but I doubt the fall in profits will be dramatic.
“A second question is who enters the field. If it’s a major company, Savient could suffer a severe blow, but a small generic company will have a hard time against Savient, which has invested heavily in developing and marketing Oxandrin. Savient currently has a patent-protected 100-mg Oxandrin tablet.
“Savient also recently announced that it was adapting Oxandrin for cancer patients, but other Oxandrin makers will be able to enter this market as well. There is no need for additional clinical trials to enter this field.”
Galper does not think that Cedarburg will manufacture APIs for Savient. “If they were to make APIs for Savient, they wouldn’t have needed FDA approval,” she claims. “They must be manufacturing them for somebody else.”
Savient recently announced that it was expanding the uses for Oxandrin. Until now, Oxandrin was used to treat weight-loss in AIDS patients and chronic illnesses sufferers. Oxandrin will now be used by cancer patients, too.
“The expanded uses for Oxandrin are highly significant,” says Savient SVP, CTO and Bio-Technology General (Israel) general manager Dov Kanner. “Since launching Oxandrin, we focused on AIDS patients. In collaboration with the Ross Products Division of Abbott Laboratories (NYSE:ABT), we’ve begun marketing to old age homes and hospices that treat chronic illnesses, Ross’s specialization. Oxandrin has many other uses, such as treating burns, pulmonary diseases, etc. However, most of our sales are to AIDS patients.
“The cancer market, which hasn’t been a focus of ours to date, is one of the largest markets. We tested Oxandrin on cancer patients with encouraging results that led to our decision to market the drug to cancer patients, too.”
Kanner declined to provide numbers about the expanded use of Oxandrin, saying only, “There will be a substantial addition to revenue.”
Published by Globes [online] - www.globes.co.il - on July 21, 2003
HomePage >> Analysis
Savient to face generic competitor
URL/Mutual Pharmaceutical Company will probably begin marketing generic Oxandrin in 2004.
Avishay Ovadia 21 Jul 03 17:41
Savient Pharmaceuticals (Nasdaq:SVNT) (formerly Bio-Technology General) is about to face generic competition for Oxandrin. United Research Laboratories (URL)/Mutual Pharmaceutical Company is expected to begin marketing of generic Oxandrin in 2004. Sales of Oxandrin, a weight-loss preventative for cancer and AIDS patients, amounted to $11.9 million in the first quarter of 2003, 40% of Savient’s total sales.
Savient has had exclusive marketing rights to Oxandrin since 1993, when its acquired the drug’s developer Gynex Pharmaceuticals. Although Oxandrin’s patent expired eight years ago, Savient has never faced generic competition to the ethical drug.
This exclusivity is about to end. The US Food and Drug Administration (FDA) approved a Drug Master File application by Cedarburg Pharmaceuticals LLC to produce the active pharmaceutical ingredients (API) for oxandrolone, the raw material for Savient’s Oxandrin. Cedarburg can make oxandrolone for either Savient or URL/Mutual Pharmaceutical, or for any new generic competitor.
“The approval to manufacture the APIs was granted in May,” says Ilanot Batucha analyst Sophie Galper. “We’ve known that Oxandrin was exposed to competition. The question is who is behind the APIs and who are the recipients? In any event, I’m not overly worried. Competition will hurt Savient’s sales and profits, but I doubt the fall in profits will be dramatic.
“A second question is who enters the field. If it’s a major company, Savient could suffer a severe blow, but a small generic company will have a hard time against Savient, which has invested heavily in developing and marketing Oxandrin. Savient currently has a patent-protected 100-mg Oxandrin tablet.
“Savient also recently announced that it was adapting Oxandrin for cancer patients, but other Oxandrin makers will be able to enter this market as well. There is no need for additional clinical trials to enter this field.”
Galper does not think that Cedarburg will manufacture APIs for Savient. “If they were to make APIs for Savient, they wouldn’t have needed FDA approval,” she claims. “They must be manufacturing them for somebody else.”
Savient recently announced that it was expanding the uses for Oxandrin. Until now, Oxandrin was used to treat weight-loss in AIDS patients and chronic illnesses sufferers. Oxandrin will now be used by cancer patients, too.
“The expanded uses for Oxandrin are highly significant,” says Savient SVP, CTO and Bio-Technology General (Israel) general manager Dov Kanner. “Since launching Oxandrin, we focused on AIDS patients. In collaboration with the Ross Products Division of Abbott Laboratories (NYSE:ABT), we’ve begun marketing to old age homes and hospices that treat chronic illnesses, Ross’s specialization. Oxandrin has many other uses, such as treating burns, pulmonary diseases, etc. However, most of our sales are to AIDS patients.
“The cancer market, which hasn’t been a focus of ours to date, is one of the largest markets. We tested Oxandrin on cancer patients with encouraging results that led to our decision to market the drug to cancer patients, too.”
Kanner declined to provide numbers about the expanded use of Oxandrin, saying only, “There will be a substantial addition to revenue.”
Published by Globes [online] - www.globes.co.il - on July 21, 2003
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