When completed, the 16-Year LTF study will provide assessment of the patients who have been identified from the original 372 patients who enrolled in the Betaseron pivotal trial between 1988 and 1990. All 11 original trial sites are participating in the study. Patients in the pivotal trial were placed in one of three study arms, Betaseron 50 mcg*, Betaseron 250 mcg (currently approved dose) or placebo. After the pivotal study was completed, Betaseron was made available to all patients in the study. All three treatments groups are being followed in the 16-Year LTF study.
The updated data show that:
- 331 of the 372 original patients (89 percent) involved in the pivotal trial have been identified to date.
- 51 percent of the MS-patients originally assigned to the Betaseron 250 mcg group who have been identified reported being able to walk with or without assistance, compared with 45 percent originally assigned to the placebo group.
- 95 percent of the patients originally assigned to the Betaseron 250 mcg group who have been identified are still alive, as compared with 83 percent identified as originally assigned to the placebo group.
Additionally, the company has started an initial review of 210 patient case report forms received to date. A preliminary assessment of the forms shows that:
- Half of these 210 patients have been on Betaseron 250 mcg for 10 years or longer.
- The median duration on therapy is nearly 14 years for those patients who were in the original Betaseron 250 mcg treatment arm.
- 86 of the 210 patients (41 percent) have been taking Betaseron 250 mcg for more than 80 percent of the time span between the end of the pivotal trial and today.
"I am impressed by the fact that even after 16 years, the investigators in this study were able to identify nearly 90 percent of the patients from the original trial in a short period of time," said Professor George Ebers, lead investigator of the 16-Year LTF Study and Action Research Professor, University Department of Clinical Neurology, Oxford, UK. "This is important because results from follow-up studies with retention rates higher than 80 percent can be viewed with greater confidence."
Review of the patient data from the study is ongoing and the final results are expected to be announced during 2006.
"We look forward to the completion of the Betaseron 16-Year Long-Term Follow-up Study. MS is a chronic condition that requires long-term treatment, so it is important that patients and physicians have long-term information available to them to help them feel confident in their choice of treatment," said Ralph Makar, Vice President and General Manager, Therapeutics Business Unit, Berlex Laboratories. "The results of this study will provide valuable information regarding the potential impact of early treatment initiation and the long-term safety, efficacy and tolerability of Betaseron."
Sixteen Years of Betaseron Trials in Patients with MS
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 placed in one of three study arms, Betaseron 50mcg, Betaseron 250mcg or placebo, with a median duration of 45 months. Analysis after two years, demonstrated that significantly more patients receiving Betaseron were relapse-free, that those relapses that occurred were less severe and that hospitalizations for MS were cut nearly in half compared to placebo. These results were confirmed at five years.
The 16-Year Long-term Follow-up study is a multicenter, open, observational study of the patients who participated in the pivotal study. It is 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.
ABOUT BETASERON
Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS, the most common form of the disease. Tens of thousands of patients worldwide have used Betaseron in controlled research studies and in clinical practice, providing the broadest experience of any MS therapy. More than a decade after its introduction, Betaseron continues to be a first-line agent for relapsing forms of MS.
Chiron Corporation and Berlex, Inc. jointly developed Betaseron. It is manufactured by Chiron and sold in the United States by Berlex.
Betaseron is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. Relapses are repeat attacks during which new symptoms appear or existing symptoms worsen, followed by periods of recovery. Relapsing forms of MS include relapsing-remitting, the most common form, and secondary progressive MS with relapses.
In January 2002, the FDA approved a room-temperature-stable formulation of Betaseron. Betaseron is the first and only interferon beta therapy available in the United States that is stable at room temperature (25°C/77°F) for more than 30 days, providing a convenient option for MS patients. Injections for this formulation should be administered immediately after preparation. If the injection is delayed, the solution should be refrigerated and injected within a three-hour time period.
The recommended dose of Betaseron (interferon beta-1b) is 250 mcg injected subcutaneously every other day, which delivers an average total of 875 mcg per week.
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 cautioned about the potential risk of pregnancy. Cases of anaphylaxis have been reported rarely. (See "Warnings,” "Precautions,” and "Adverse Reactions” sections of Prescribing Information).
For full prescribing information, please visit www.betaseron.com.
ABOUT BERLEX
Berlex, a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), 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.
CONTACTS
Media Relations: Marcy Funk, T: +1-973-487 2095, marcy_funk@berlex.com
Investor Relations: Joanne Marion, T: +1-973-487 2164, joanne_marion@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.
* The Betaseron 50mcg dose was a study dose only. The dosage approved by the FDA and marketed by Berlex is the Betaseron 250mcg dose. Patients who continued on Betaseron after the trial was completed were moved to the approved dose.