for what it's worth, here's an "update" on Serono (read: Rebif) and their impending trial with Avonex.
and i thought switzerland was neutral? those jokesters.
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October 7, 1999 10:40 AM
Serono Seeks to Replace Biogen Drug in Multiple Sclerosis Treatment
Dow Jones Business News
WASHINGTON -(Dow Jones)- Pharmaceutical company Serono Laboratories Inc. thinks direct comparison might be to its advantage, so it is pitting its multiple sclerosis drug Rebif in a head-to-head trial against Biogen Inc.'s Avonex.
Last year, Avonex had U.S. sales of $300 million. In the other 59 countries the drug is sold, the Cambridge, Mass.-based biotechnology concern recorded $92 million in Avonex sales.
Rebif isn't sold in the U.S., and Serono estimates this year that the drug's sales will be $100 million in 49 countries.
But while Rebif isn't approved for sale in the U.S., the largest market, Serono is trying to get the drug approved under a rarely used exception to federal law. Biogen (BGEN) considers this head-to-head trial a Serono public-relations ploy.
Biogen and some analysts who follow it say Serono's one-year, 600-patient study is too short and too small to detect any real difference between the products.
Serono says the trial will prove Rebif both cuts the number of relapses in patients and decreases the number of brain lesions better than Avonex.
Serono also hopes this trial will convince the Food and Drug Administration to approve the Rebif application the company submitted in February 1998. In March the agency said it needs additional data on Rebif.
The problem is that Rebif is basically the same as Avonex, which was approved under the Orphan Drug Act. That law gives companies incentives to make drugs that treat rare diseases and therefore won't be blockbusters.
Drugs approved under the act don't have to worry about competing with similar drugs for seven years. Biogen's market exclusivity for Avonex expires in 2003.
A spokesman in the FDA's Office of Orphan Product Development said a company trying to circumvent the law and enter the market would either have to show their drug works better, that it has fewer side effects or that the product offers a major improvement to patient care.
To prove the drug in question is more effective, a head-to-head trial is needed to demonstrate the drug cures more patients or cures them faster, the spokesman said.
Ironically, Avonex was approved under such an exception. Biogen proved its formulation caused fewer side effects than Schering AG's Betaseron, which the FDA approved in 1993.
The trial Serono is planning will "shed some light" on Rebif's role in treating multiple sclerosis, said Dr. Hisham Samra, head of clinical development and regulatory affairs at Serono's Swiss parent, Ares-Serono International SA. "We are attempting to show clinical superiority, not only for the Orphan Drug Act, but to show patients and doctors and establish Rebif in this country and around the world as the drug of choice," Samra said.
The trial, which started enrolling patients at the beginning of the month, will be conducted at about 50 centers world-wide.
The study primarily will seek to establish which drug did the most to reduce the number of patient relapses and the number of brain lesions as detected by MRI. Samra said earlier Rebif studies support Serono's contention that their version of the product, which is injected just below the skin three times weekly, helps patients more than Avonex, which is given as an injection in the muscle once a week.
Kathryn Bloom, director of communications for Biogen, said the company is "pretty leery of this trial."
"It sounds like a marketing trial and not something to establish science," Bloom said.
Rather than looking at brain lesions and relapses, Bloom said standard multiple sclerosis studies look at whether a drug slows the progression of disability. Also, Bloom said trials of beta interferon products, a category into which Avonex and Rebif fall, typically run for at least two years.
Meirav Chovav, biotechnology analyst at Salomon Smith Barney, agreed that the trial seems too short. To show superiority in patients with multiple sclerosis, "you need a very long, very large trial."
Chovav said the market for multiple sclerosis products is more than $1 billion.
John Sonnier, vice president and biotechnology analyst at Prudential Vector Healthcare, said results of this comparison study won't be cut and dried.
Because the products are similar, higher doses of Avonex could have the same effect if Rebif appears to perform better in one study, Sonnier said.
There are three drugs currently approved to treat multiple sclerosis - Avonex, Betaseron and Copaxone, which is made by a partnership between Teva Pharmaceutical Industries (TEVIY) and Hoechst Marion Roussel, a Hoechst AG (HOE) unit. Sonnier said Avonex claims 60% of the U.S. market, which is expanding.
Sonnier said about 300,000 people in the U.S. have the disease, which usually starts with limb numbness and can lead to paralysis or blindness.
Now, doctors are treating multiple sclerosis earlier, and because more medicines are available, more people are seeking treatment, Sonnier said. |
