Healthcare Industry News:  Betaseron 

Biopharmaceuticals Neurology

 News Release - April 4, 2006

Sixteen-Year Follow-up Study Reinforces Betaseron(R) Long-Term Efficacy, Safety and Tolerability in Multiple Sclerosis

Efficacy in relapse rate reduction beyond five years shown for the first time

SAN DIEGO, April 4 (HSMN NewsFeed) -- Berlex announced today that Betaseron® (interferon beta 1b) remained consistently safe, effective and well tolerated over the long term, according to results of the Betaseron 16-Year Long-Term Follow-up (16-Year LTF) Study presented at the 58th Annual Meeting of the American Academy of Neurology. This is the longest follow-up study for any disease modifying therapy in multiple sclerosis (MS).

Patients with relapsing forms of MS taking Betaseron (known as Betaferon® outside the US) had a sustained reduction in the annual rate of relapses of up to 40 percent over 16 years.

The data also showed that patients remaining on long-term Betaseron treatment had a slower disease progression compared to patients who did not. Among the patients who reached EDSS(1) level 6.0 (e.g., needing a cane for walking), those on long-term Betaseron treatment reached EDSS 6.0 after a median time of 13 years compared to seven years for patients on short-term treatment. Long-term treatment was defined as use of Betaseron for more than 80 percent of the time since the start of the pivotal trial (approx. 12 years or longer), while short-term treatment was defined as use for less than 10 percent of the time (approx. 1.6 years or less). The impact of long-term treatment on disease progression is being studied further using historical control groups.

"This study has comprehensively re-evaluated patients after 16 years," said Professor George Ebers, lead investigator of the study, Department of Clinical Neurology, Radcliffe Infirmary, University of Oxford. "The evidence for relapse rate reduction, combined with further support for long-term safety of Betaseron, is convincing. More studies are being done to further analyze the impact of treatment on disease progression."

The long-term use of Betaseron over 16 years revealed no new or unexpected adverse events. Betaseron was well accepted by patients in this long-term study. The median treatment duration with Betaseron of the analyzed trial participants was almost 10 years, while the longest duration on therapy is 17.1 years.

"The 16-year LTF is ground-breaking in that it is the longest follow-up study of patients on disease modifying MS therapy," said Richard Neiman, MD, Vice President, Head of Medical Affairs at Berlex. "These results show that first-line and long-term use of Betaseron for relapsing MS patients is safe, effective and well-tolerated. These data are very reassuring given the chronic nature of relapsing forms of MS, and the need for long-term therapy."

Sixteen Years of Betaseron Use in Patients with MS

The 16-Year LTF Study provides clinical assessment of patients who first enrolled in the Betaseron pivotal trial between 1988 and 1990. Of the original 372 patients involved in the pivotal trial, 328 (88.2 percent) have been identified. It is a multicenter, open-label, observational study designed to evaluate the impact of Betaseron treatment on long-term outcomes in patients with relapsing forms of MS. The study constitutes the longest follow up for any disease-modifying therapy in MS.

The results support a previously reported trend, in that there was a lower number of deaths in patients that were initially treated with Betaseron 250 mcg during the pivotal trial. This trend needs to be further evaluated.

The Betaseron pivotal trial was the first large, randomized, placebo- controlled study of any therapy in MS. This groundbreaking study was conducted in North America and led to the approval of Betaseron, the first disease-modifying agent for MS, in 1993. Patients were randomly assigned to one of three study arms, Betaseron® 50 mcg(2), Betaseron 250 mcg or placebo, with a median duration of observation of 45 months. Analysis after two years demonstrated that significantly more patients receiving Betaseron were relapse-free, that those relapses that occurred were less frequent and that hospitalizations for MS were cut nearly in half. These results were confirmed at five years.

About Betaseron

Betaseron® is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. The most commonly reported adverse reactions are lymphopenia, injection site reaction, asthenia, flu-like symptom complex, headache and pain. Betaseron should be used with caution in patients with depression. Injection site necrosis has been reported in 5 percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. Please see full Prescribing Information for more information.

About Berlex

Berlex is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health, diagnostics and neurology. Berlex also markets diagnostic imaging agents, innovative treatments in the areas of female health care and oncology, as well as specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system. Berlex has business operations in New Jersey, California and Washington. For more information, please visit

Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Berlex's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Berlex, Inc. undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

(1) EDSS or Expanded Disability Status Scale is a standard method of evaluating a person's level of impairment due to MS. EDSS level of 6.0 is defined as being able to walk, but needing a cane, crutch or brace for assistance.

(2) The Betaseron 50 mcg dose was a study dose only. The FDA approved and marketed dose is Betaseron 250 mcg.

Source: Berlex

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