PipelineReview.com - Biotech News & Online Store - Two-year Phase IIIb data show that the new formulation of Rebif® offers a near three-fold improvement in injection tolerability and reduced immunogenicity

Two-year Phase IIIb data show that the new formulation of Rebif® offers a near three-fold improvement in injection tolerability and reduced immunogenicity

12 Oct 2007

Merck Serono announced today the results of a two-year Phase IIIb, multicenter, single-arm, open-label study evaluating the safety and immunogenicity of the new formulation of Rebif® (interferon beta-1a) 44 micrograms (mcg) subcutaneously (sc) three times weekly (tiw) in 260 patients with relapsing forms of multiple sclerosis (MS)

GENEVA, Switzerland | October 11, 2007 | Merck Serono, a division of Merck KGaA, announced today the results of a two-year (96 weeks), Phase

IIIb, multicenter, single-arm, open-label study evaluating the safety and immunogenicity of the new formulation of Rebif® (interferon beta-1a) 44 micrograms (mcg) subcutaneously (sc) three times weekly (tiw) in 260 patients with relapsing forms of multiple sclerosis (MS). The data show that the new formulation of Rebif® offers a near three-fold improvement in injection tolerability and reduced immunogenicity compared with historical data for the previous formulation of Rebif®, as measured in the EVIDENCE1 study. These study results will be presented today at a satellite symposium and tomorrow at a poster session at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

“The new formulation of Rebif® offers the treatment benefits of a high-dose high-frequency interferon beta-1a coupled with improvements in the overall safety and immunogenicity profiles when compared with historical data for the previous formulation,” said Professor Per Soelberg Sørensen, Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital. “The favorable benefit-to-risk profile of Rebif® is thus expected to be improved with this new formulation.”

The incidence of injection site reactions with the new formulation of Rebif® at 96 weeks was nearly three-fold less than in the EVIDENCE study (30.8% versus 85.8%).

The primary endpoint of the study was the proportion of patients who are neutralizing antibody-positive at week 96 or last assessment. The primary analysis showed that 17.4% of patients were neutralizing antibody-positive. This is an approximately 20% relative improvement compared with the EVIDENCE study where 21.4% of patients were neutralizing antibody-positive with the previous formulation of Rebif®. Further sensitivity analyses confirmed the magnitude of improvement.

The study also indicated consistent efficacy of the new formulation of Rebif® with the previous Rebif® experience. At 96 weeks, 53.3% of patients remained relapse-free and overall the expanded disability status scale (EDSS) score remained stable throughout the study.

No unexpected adverse events were reported with the new formulation of Rebif®. The majority of adverse events were mild or moderate in severity. The most frequent side effect was flu-like symptoms (71.5%), which is typical of interferon therapy; most were mild in severity. Flu-like symptoms are transient and can be managed with prophylactic treatment.

The new formulation of Rebif® was recently approved in the European Union and Canada, with launches starting in September 2007. The new formulation of Rebif® is available in the same strengths and pharmaceutical forms as the previously registered formulation, i.e. 8.8, 22 and 44 mcg, as a solution for injection in pre-filled syringes. The new formulation of Rebif® is under review by the FDA in the US.

Rebif®, which was originally approved in Europe in 1998, has been proven effective on the following three key measures of treatment effectiveness: disability progression, relapse rates and MRI lesion area and activity2. The safety and efficacy of Rebif® are supported by a robust long-term clinical development program including comparative studies and 13 years of patient experience from around the world.

1 EVIDENCE: EVidence of Interferon Dose-response: European North American Comparative Efficacy

2 The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body’s immune system, fight disease and reduce inflammation.
Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area2. Rebif® is not approved for treatment of chronic progressive MS. Rebif® is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration pack (8.8 mcg).
Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.
About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif®, the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone® (mitoxantrone for injection concentrate) for worsening forms of MS. Full prescribing information for these products can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.
About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
About Merck Serono

Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), metabolic and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®). With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.
About Merck

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

SOURCE: Merck Serono

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