Tue Apr 16, 1:10 PM ET
By: Beth M. Mantz, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- In the fourth quarter, Schering AG (SHR) and its Berlex Laboratories unit will begin the largest trial of multiple sclerosis patients ever, further testing the theory that higher doses of medicine delivered more often translates to greater benefits.
Should results from the two-year trial prove that a higher dose of Betaseron serves multiple sclerosis sufferers with relapsing-remitting forms of the disease, Schering and its marketing partner Chiron Corp. (NasdaqNM: CHIR - news) (CHIR) may have a scientific advantage to attract market share away from market leader Biogen Inc.'s (BGEN) Avonex, up-and-coming U.S. rival Serono SA's (SRA) Rebif, and competitor Teva Pharmaceutical Industries Ltd.'s (TEVA) Copaxone.
In an international study called Betaseron Efficacy Yielding Outcomes of a New Dose, or BEYOND, the German drug maker will compare two doses of its popular multiple sclerosis treatment, an interferon beta drug called Betaseron, in more than 2000 patients with relapsing-remitting forms of the neurological disease to see if fewer relapses occur and brain lesions develop over two years.
Half of the study participants will be administered the currently-approved 250 microgram-dose of Betaseron every other day and the other half will be injected with a Betaseron dose twice that amount also every other day.
Schering plans to enroll its first patient in the middle of the fourth quarter and complete enrollment 15 months thereafter. The trial would complete in early 2006, and depending on the results, the German drug maker would submit an amendment to Betaseron's marketing application. It plans to conduct an interim trial analysis, but has not decided definitively whether researchers would open up the study after one year and take a peak at the data.
The 250 microgram-Betaseron injection has yielded multiple sclerosis patients significant benefits. Studies show relapses have fallen by a third and the number of brain lesions identified by magnetic resonance imaging declined by 80% in patients treated with Betaseron. Additionally, patients are able to tolerate the drug without suffering severe side effects; effects seen are those common to the class of interferon beta medicines: flu-like symptoms and injection site reactions.
The effectiveness and safety benefits have helped Betaseron to become the world's second-largest selling multiple sclerosis drug with $607 million in sales last year. Avonex reigns over the market with sales of $972 million in 2001.
"The scientific question is can we improve (the benefits)," said Ludger Heeck, Berlex vice president of strategic marketing, in a Dow Jones Newswires interview.
However, Schering believes and attempts to prove that a higher dose of Betaseron - already the highest interferon beta medicine on the market - will exceed these measures.
The drug maker expects multiple sclerosis patients treated with the higher dose will experience a "relative improvement of 20% to 25%" over patients taking the current dose of Betaseron, said Heeck and Ayad Abdulahad, Berlex vice president of clinical development in the central nervous system.
They "conservatively" expect the higher-dose patients will suffer fewer relapses by an additional 6%, bringing the total decline in relapses to 42%, at two years on treatment. But, the longer patients continue with the higher dose, the bigger the differential could be between the 250 microgram and the 500 microgram, said Heeck.
Schering decided to pursue this question because more data has emerged over the past year and a half suggesting higher doses and greater frequency deliver higher efficacy, and the multiple sclerosis community of patients, physicians, and advocates have urged the examination of higher doses, said Abdulahad.
If the trial proves Betaseron ought to be offered at the 500 microgram-dose, Schering would not remove its 250 microgram injection from the market so patients have various treatment alternatives. Heeck said the drug maker has not made any pricing decisions with regard to a higher dose.
American depository shares of Schering recently traded at $57.52, off 52 cents, or 0.9%, on composite volume of 33,400 shares, compared with average daily volume of 16,740 shares.
-Beth M. Mantz; Dow Jones Newswires; 201-938-5287
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