Bayer's Betaferon® approved in China for Treatment of Multiple Sclerosis
Launch planned by mid 2010
Berlin, December 1, 2009 - Bayer Schering Pharma AG announced today that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon® (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS). Bayer plans to launch Betaferon in China by mid 2010. Betaferon is available in more than 100 countries around the world.
"This approval is good news for MS patients in China, allowing them access to Betaferon, that has been demonstrated to modify the course of MS," said Habib Dable, Global Head, Neurology/Ophthalmology of Bayer Schering Pharma AG. "The approval of Betaferon in China underscores Bayer's ongoing commitment to address the unmet medical needs of people around the world. With the foundation of a research and development center in Beijing in February 2009, Bayer has strengthened its engagement in the Region. In the upcoming five years, a total of 100 million Euro is planned to be invested in a center for clinical research in Beijing.
The approval is based on established efficacy and safety data from pivotal Betaferon clinical trials, along with findings from a single-arm study designed to demonstrate the efficacy and safety of Betaferon among Chinese patients with relapsing-remitting MS. During the multi-center six-month study, Betaferon significantly decreased the number of newly active lesions on MRI in Chinese patients. The data in MS patients from China is comparable with data from Betaferon studies in different patient populations and with Bayer's post-marketing experience.
Betaferon, which is marketed in the U.S. and Canada under the trademark Betaseron, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. In the U.S., Europe and Japan, Betaferon has been approved for all relapsing forms of MS. Sixteen years' follow-up of people treated with Betaferon has shown that it is well tolerated when applied as directed.
About the Betaferon study in China
In the multicenter single-arm open label study, 39 patients were enrolled into a three-month pre-treatment phase followed by a six-month treatment phase. The primary efficacy endpoint was the number of newly active lesions during six months on therapy.
Newly active lesions were defined as new T1 Gd-enhancing lesions and non-enhancing T1 lesions appearing new (or enlarged) on T2-weighted scans at months three and six (cumulative six-month number divided by two), compared to the number of newly active lesions during a three-month pre-treatment period. In the treatment period, significant decreases were observed for the primary endpoint. The mean number of newly active lesions in the pretreatment group was 4.77, vs. the 1.55 in the treatment group (p<0.0001).
Adverse events (AEs) were usually self-limiting and mild or moderate. The most frequent AEs were flu-like-symptoms, injection site reactions and hepatic function abnormality. None of the patients discontinued treatment because of AEs or laboratory toxicity.
About Multiple Sclerosis
MS is a chronic, progressive disease of the central nervous system and the likelihood of disability increases the longer someone has MS. Symptoms of MS vary from person to person and can be unpredictable. They may include: Fatigue or tiredness, dimness of vision in one or both eyes, weakness in one or more extremities, numbness and tingling in the face, arms, legs and trunk of the body, spasticity (muscle stiffness), dizziness, double vision, slurred speech and loss of bladder control.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
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