Cambridge, Massachusetts-based biotechnology company, Momenta Pharmaceuticals, Inc., has just announced the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted the company’s Clinical Trial Application (CTA) for a study of M923, a biologic similar to TNF inhibiting anti-inflammatory drug Humira® (adalimumab) by AbbVie, Inc., for the management of inflammatory processes associated with autoimmune diseases such as Crohn’s disease. The clinical trial for M923 will be in collaboration with Baxter International‘s pharmaceutical branch, which entitles Momenta to an aggregate payment worth $12 million within December 2014. The partnership aims to leverage Momenta’s novel technologies in developing biosimilar and potentially interchangeable biologics on a worldwide scale.
Crohn’s disease is a type of inflammatory bowel disease that can affect any part of the gastrointestinal tract, between the mouth and the anus. Patients experience a number of uncomfortable, life-altering chronic symptoms such as fatigue, abdominal pain, diarrhea, bleeding, fever, weight loss, and malnutrition. There is still no known cure, therefore available treatment focuses on relieving these symptoms, and inducing and maintaining remission. Crohn’s disease is estimated to affect about 3.2 per 1,000 people in Europe and North America.
Humira® (adalimumab) is the world’s leading treatment for autoimmune/inflammatory diseases, and named “world’s best selling drug” by the IMS Health. A year’s worth of continuous treatment with the standard dosage of 40mg every other week costs $13,000 to $14,000. Momenta and Baxter are working on commercializing M923 as a potentially interchangeable biologic for Humira that can offer a more cost-friendly treatment option.
“The European CTA acceptance for M923, our biosimilar version of Humira, represents a significant achievement by Momenta and Baxter in using the biosimilar regulatory pathway in an effort to expand patient choice,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We look forward to the initiation of the clinical study in first quarter of 2015.”
Biologics and biosimilars are emerging, yet highly promising treatment alternatives to today’s established, branded therapeutics, especially in the management of autoimmune diseases. Compared to corticosteroid use, biologics can be designed to target only specific receptors in the body, thereby minimizing systemic immunosuppression. A report entitled, “Crohn’s Disease and Ulcerative Colitis: U.S. Physician and Payer Perspectives on Established and Recently Launched Biologics, Emerging Novel Agents and Biosimilars,” surveyed gastroenterologists and payers about the current use of biologics and their opinion on the use of biosimilar versions in patients’ treatments.
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