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More MS news articles for April 2003

Betaseron(R) Reduces Disease Activity in Early-Stage Relapsing-Remitting Multiple Sclerosis Patients

Friday April 4, 8:31 am ET
Source: Berlex Laboratories, Inc.
Montville, N.J.

At the American Academy of Neurology Annual Meeting in Honolulu, Hawaii, Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, announced results from a study that showed its multiple sclerosis (MS) treatment Betaseron® (interferon beta-1b) for SC Injection significantly reduced relapse rate and MRI disease activity in early-stage and relapsing-remitting MS patients with low levels of disability.

"Early treatment with Betaseron, even in patients with low levels of disease activity, can potentially slow the path toward disability," said lead investigator Barry Arnason, MD, Professor of Neurology, University of Chicago MS Center. "These findings demonstrate that frequent and high doses of Betaseron, given early in the course of the disease, can reduce repeat attacks and brain lesions, helping to impact disease progression."

The study was derived from a post-hoc subgroup analysis of the Betaseron pivotal two-year study. Data were evaluated in two subgroups: patients with low levels of disability (Expanded Disability Status Scale [EDSS] score of less than or equal to 2) and patients with early-stage disease (duration of less than or equal 2 years).

In the first group, 41 relapsing-remitting MS patients with low levels of disability were treated with Betaseron 250 mcg every other day, while 49 were given a lower dose of Betaseron (50 mcg), and 43 received a placebo. Results showed that Betaseron 250 mcg significantly reduced the mean relapse rate compared to placebo (1.0 versus 1.5, p=0.013), and significantly decreased MRI disease activity as measured by the mean percentage change in lesion area at two years (a reduction of 4.0%, compared to an increase of 31.2% with placebo, p=0.0001).

In the group with early relapsing-remitting MS, 38 patients were given Betaseron 250 mcg every other day, 48 received Betaseron 50 mcg, and 48 received a placebo. The results showed that treatment with Betaseron 250 mcg significantly reduced MRI disease activity, as assessed by mean change in lesion area, compared to placebo (a reduction of 8.3% versus an increase of 31.8%, p=0.0001).

About MS

MS is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect more than 350,000 people in the United States, and is the major acquired neurologic disease in young adults. People who develop MS may not immediately recognize their condition, because the symptoms of MS are nonspecific and may be similar to those of other diseases.

Common signs and symptoms of MS include fatigue, psychological and cognitive changes, weakness or paralysis of limbs, numbness, vision problems, speech difficulties, problems with walking or motor skills, bladder problems, and sexual dysfunction.

Relapsing-remitting forms of MS are characterized by periods of attacks, interspersed with stable periods. Most symptomatic patients are classified at onset with the relapsing-remitting form of the disease. About 50 percent of patients with relapsing-remitting disease advance into the secondary progressive form within 10 years. At this stage, after periods of intermittent attacks and remissions, the disease begins a course of steady progression.

About Betaseron

Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. In January 2002, the FDA approved a new room-temperature formulation of Betaseron. Betaseron is the first and only interferon therapy available as a room-temperature formulation (25 degrees C/77 degrees F) for MS, providing a convenient option for MS patients in the United States.

The recommended dose of Betaseron (interferon beta-1b) is 250 mcg (8 MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per week.

Serious side effects include depression, suicide, suicidal ideation, and injection site necrosis (skin breakdown, drainage of fluid and tissue destruction), which have been reported in 5 percent of patients in a controlled MS trial. The necrotic lesions are typically 3 cm or less in diameter, but larger areas have been reported, and they may occur at single or multiple sites.

Common side effects of Betaseron therapy include flu-like symptoms, shortness of breath, menstrual disorders, and injection site reactions (redness, pain, swelling, and blue-black discoloration have been reported). The exact relationship between MRI findings and the clinical status of people with MS is unknown.

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About Berlex Laboratories

Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc. develops and markets ethical pharmaceuticals in the areas of Female Healthcare, Diagnostic Imaging, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases. Berlex Laboratories, Inc. has business operations in Montville and Wayne, New Jersey, Richmond and San Diego, California as well as Bothell and Seattle, Washington. For more information about Berlex and its products, you may visit our website at

In order to utilize the "Safe Harbor" provision of the U.S. Private Securities Litigation Reform Act of 1995, the Company is providing the following cautionary statement. 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 Company plans and objectives to differ materially from those expressed or implied in the forward-looking statements (or from the past results). Although not exhaustive, the following factors could cause such differences: action by the Company's competitors or the failure or demand for the Company's products to develop as anticipated; legislative and regulatory changes and general changes in public health and approaches to health care and the treatment of ideas; unanticipated difficulties in the design or implementation of clinical trials, studies and investigations, or results that are inconsistent with previous results and the Company's expectations; the failure to obtain and maintain required authorizations from governmental authorities or the loss of or inability to patent or trademark protection for products; the risk of substantial product liability claims; unexpected costs or difficulties in production or distribution or in integrating the business and operations of the Company. These factors and other factors that could effect these forward-looking statements are described in our Form 20-F and our Form 6-K reports filed with the US Securities and Exchange Commission. The Company disclaims any obligation to publicly update or revise these forward-looking statements, whether to reflect new information or future events or circumstance or otherwise.

Source: Berlex Laboratories, Inc.

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