Would add to companyís injectable drug for disease
October 31, 2002
By Julie Jette
The Patriot Ledger
Serono, a Swiss drug company whose U.S. headquarters are in Rockland, will develop what could be first pill to treat multiple sclerosis, it said yesterday.
The company has entered into a licensing agreement with IVAX, the Miami-based manufacturer of the drug cladribine. Financial terms of the deal were not disclosed.
"We think itís a real, tangible opportunity for us to have the first oral formulation for MS on the market," said Deborah Brown, Seronoís executive vice president for neurology.
Cladribine has been in use since 1993 as an injectable chemotherapy drug under the brand name Leustatin, and analysts were guarded about its prospects as a multiple sclerosis remedy.
"Itís an older chemotherapeutic drug, and itís not necessarily a sexy approach," said Eric Schmidt, a biotech analyst for S.G. Cowen, a brokerage and investment banking firm.
Sam Isaly, partner with OrbiMed Advisors, an investment firm that holds about $100 million worth of Seronoís stock, said, "It doesnít look like a major scientific advance."
"Serono can possibly do some business with this, but we doubt it will be a large product," he added.
Several trials have indicated cladribine may slow the progression of multiple sclerosis, which effects the nervous system. About 2 million people have the disease and Serono estimates the domestic market for multiple sclerosis drugs at about $1.5 billion.
Cladribine for cancer treatment is marketed by a subsidiary of Johnson & Johnson. Brown said Johnson & Johnson sold the right to develop it as a multiple sclerosis drug to IVAX.
While Johnson & Johnson declined to develop the drug for multiple sclerosis, Brown said it makes sense for Serono because it already has a major multiple sclerosis drug, Rebif, on the market.
Rebif sales have increased since it was launched in the United States earlier this year. Through Sept. 30, worldwide sales of Rebif reached $337.3 million, up 40 percent compared to the first nine months of 2001.
Rebif is a protein that Serono has not manufactured in pill form because it would breakdown in the stomach. All drugs to treat multiple sclerosis are injected, and Brown said the company would determine whether cladribine should be used in addition to, or instead of, Rebif.
Rebif has been eating into the market share of Avonex, a multiple sclerosis drug manufactured by Cambridge-based Biogen.
But Biogen is also working on a new drug, Antegren, that could treat both Crohnís disease and multiple sclerosis.
Rebif and Avonex are similar in their chemical makeup, while Antegren is part of a new class of drugs that would fight the disease differently.
Schmidt said one of his reservations about cladribine is that it is not a targeted drug; it essentially would knock out white blood cells that are part of multiple sclerosisís attack on the nervous system.
"From that standpoint, itís a much less elegant mechanism than some of the other therapies," he said.
Serono expects to begin tests to gain Food and Drug Administration approval
for cladribine in 2004 and hopes to begin marketing it by 2007.
© Copyright 2002 The Patriot Ledger