MONTVILLE, N.J., Feb. 23 /PRNewswire/ -- Berlex, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of a supplemental biologics license application (sBLA) requesting an expanded label for its multiple sclerosis (MS) therapy, Betaseron(R) (interferon beta-1b).
The submission seeks approval for the use of Betaseron to delay a second exacerbation in patients who have experienced a first clinical demyelinating event -- either monofocal (i.e., clinical evidence of a single lesion) or multifocal (i.e., clinical evidence of more than one lesion). Currently, Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. The company anticipates a response by Q4 2006.
Berlex, Inc. is supporting its application for this expanded indication based on data from its randomized study, BENEFIT*, the largest study of patients with the first clinical signs of MS. The BENEFIT trial showed that Betaseron treatment reduced the risk of developing clinically definite MS (CDMS) by 50 percent compared with placebo. Furthermore, patients in the Betaseron group were two times better protected against developing MS as defined by the McDonald diagnostic criteria. Results of the BENEFIT study were presented at the joint ECTRIMS/ACTRIMS Congress on September 30, 2005, in Thessaloniki, Greece.
“The acceptance of the filing is an important step towards a new and effective treatment option for patients with early MS,” said Dr. Ludger Heeck, Vice President and General Manager of Specialized Therapeutics at Berlex.
* Betaferon(R)/Betaseron(R) in Newly Emerging MS For Initial Treatment Additional Information About Betaseron
Betaseron(R) is approved 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 http://www.berlex.com.
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.
Berlex, Inc.
CONTACT: Media Relations, Kim Schillace Wix, +1-973-305-5258,kimberly_schillace@berlex.com; or Investor Relations, Joanne Marion,+1-973-487-2164, joanne_marion@berlex.com
Web site: http://www.berlex.com/
