Amalyte and Meiji Enter Into a License, Development and Commercialization Agreement on AM3301 and a Novel Class of Anti-Inflammatory Compounds

Amalyte and Meiji Enter Into a License, Development and Commercialization Agreement on AM3301 and a Novel Class of Anti-Inflammatory Compounds

Amalyte Pharmaceuticals LLC (Amalyte), a member of the Kemin group of companies, has announced today it has entered into a worldwide strategic alliance with Meiji Seika Kaisha Ltd. (Meiji) to discover, develop and commercialize a lead compound, ME3301 (now AM3301), and novel class of dual-acting anti-inflammatory compounds for a variety of human health applications.

Under the terms of the agreement, Amalyte will have exclusive rights to develop and commercialize collaboration products worldwide, except in Japan and several Asian countries where Meiji has a development and commercialization option for all products arising from the collaboration. The companies will co-market collaboration products in Spain and Portugal. Meiji will receive up-front and milestone payments as well as royalties upon commercialization.

“We are pleased to be in a position to collaborate with Meiji on this exciting class of anti-inflammatory compounds,” said Dr. Keith Bostian, CEO of Amalyte. “We have been working closely with Meiji for the past several months on the collaboration and are now well positioned to rapidly enter into a Phase IIa clinical trial for induction of remission in ulcerative colitis.”

Amalyte intends to develop AM3301 for multiple clinical indications in gastrointestinal (GI) inflammatory (IBD and IBS) and in allergic (rhinitis and asthma) diseases. Clinical activity has already been demonstrated for allergic rhinitis, along with an impressive array of biochemical, cellular and animal pharmacology studies. Animal studies have also shown AM3301 to be as effective as prednisolone in TNBS-induced and DSS-induced colitis in rats.

AM3301 is a novel anti-inflammatory small molecule NCE with steroid-like activity, but it interacts through a different mechanism (since it is not structurally related to steroids and does not bind steroid receptors). The pharmacological profile is unique in inhibiting both early-phase IgE-mediator release from mast cells as well as late-phase cytokine production from immune cells and other inflammatory cells. The compound has an additional advantage of a rapid onset-of-action.

“Meiji is pleased to have brought the ME3301 compound to this critical stage of the discovery and development pipeline. The Amalyte team brings the necessary expertise in clinical development and commercialization of products for immune and inflammatory disease treatment,” said Masahiko Matsuo, President of Meiji Pharmaceutical Company. “We look forward to achieving commercial success with Amalyte.”

Inflammatory bowel diseases (IBD) are autoimmune disorders involving an immune reaction to the body’s own intestinal tract. The two major IBDs are ulcerative colitis (UC) and Crohn’s disease (CD). Over 1 million people in the United States suffer from these two conditions, and an estimated 4 million people worldwide are affected. Patients with IBD are typically diagnosed by the age of 30 and symptoms are highly variable in frequency and intensity.

There is no known cure for Crohn’s Disease or Ulcerative Colitis, so the goal of treatment is to suppress the inflammatory response. The treatment pathway for both diseases is similar. The major classes of medications used to treat IBD include aminosalicylates (5-ASA’s), corticosteroids, immune modifiers, and antibiotics. Surgery is considered a last resort for both indications. Both Crohn’s Disease and UC currently have significant unmet needs that may benefit from novel therapies.

About Meiji Seika Kaisha Ltd.

Meiji Seika Kaisha Ltd. is located in Tokyo, Japan and is operating its business in the fields of confectionaries and pharmaceuticals. In the pharmaceutical division, Meiji Seika is dedicated to the discovery, development and commercialization of a wide variety of pharmaceutical products throughout Japan and some countries outside of Japan, as well. The main areas of its interest are infectious disease and central nervous system disorders. For more information on Meiji Seika, please visit the company’s website at www.meiji.co.jp .

About Amalyte Pharmaceuticals LLC

Amalyte Pharmaceuticals LLC (www.amalyte.com ), a member of the Kemin group of Companies, is a clinical stage biopharmaceutical company focused on identifying and developing novel therapies for the treatment of immune and inflammatory diseases. Amalyte is committed to addressing indications with significant unmet medical needs in large, multi-billion dollar markets. The Company’s strategy is to use licensing and capital efficient and highly capable clinical partners to accelerate its platform and shareholder value.

Founded in 1961, the Kemin group of companies (www.kemin.com ) provide health and nutritional solutions to the agrifoods, food ingredients, pet food, human health and pharmaceutical industries. Kemin operates in more than 60 countries, with manufacturing facilities in Belgium, Brazil, China, India, Singapore, South Africa, Thailand and the United States.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact:

Amalyte Pharmaceuticals LLC
Kerty Levy, 515-559-5100 (Media Inquiries)
klevy@amalyte.com