Natrogen, Takeda announce license agreement

OSAKA, Japan—Takeda Pharmaceutical Company Limited and Natrogen Therapeutics International, Inc. have announced a new agreement under which Takeda will gain an exclusive license to develop Natrogen’s Natura-alpha compound, a synthetic small-molecule oral compound thought to be capable of inhibiting pro-inflammatory cytokine expression. Takeda will also gain an option to acquire Natrogen, a New York-based, mid-stage biotech specializing in therapeutics for immuno-inflammatory diseases, dermatological conditions and cancer.

Per the terms of the agreement, Takeda will receive an exclusive license for the worldwide development of Natura-alpha in all indications, as well as an option to acquire Natrogen. Takeda will pay an undisclosed amount up front, with the potential for future payments should it choose to exercise its option to acquire Natrogen. Those payments will include a payment upon the closing of the acquisition of Natrogen and potentially contingent payments if certain regulatory and sales milestones are met. In addition, Takeda will be responsible for funding and conducting all additional clinical development for Natura-alpha. No specific financial terms were disclosed.

“Natrogen’s strategy has been to demonstrate the drug’s efficacy and safety in clinical trials and then identify a major pharmaceutical company that has the expertise, commitment and financial resources to complete the regulatory process and bring the drug to market. We found the perfect partner, Takeda, a major research-based company that has a global presence in the area of gastrointestinal disease,” Louis Wang, M.D, president and chief scientist at Natrogen, said in a press release regarding the deal.

Natura-alpha is thought to inhibit a trio of cytokines—Interleukin-1, Interleukin-6 and tumor necrosis factor—known to exacerbate inflammation and certain diseases. It is believed that the compound blocks these inflammatory compounds while encouraging production of cytokine Interleukin-10, which can suppress pro-inflammatory responses. Natura-alpha is in Phase 2 development as a treatment for ulcerative colitis, an inflammatory bowel disease characterized by chronic inflammation in the gastrointestinal tract.

“Today’s announcement reinforces Takeda’s continued commitment toward addressing the needs of patients with gastrointestinal diseases,” Asit Parikh, M.D., Ph.D., vice president of general medicine at Takeda, commented in a statement. “Natura-alpha is a strategic fit with our gastrointestinal portfolio, which also includes vedolizumab, Takeda’s investigational monoclonal antibody for the treatment of adults with moderately to severely active UC and Crohn’s disease.”

That’s not the only news for Takeda in the gastrointestinal market this month. On December 24, the company, along with Takeda Pharmaceuticals U.S.A., Inc., its wholly owned subsidiary, announced that the U.S. Food and Drug Administration (FDA) had extended the Prescription Drug User Fee Act Priority Review action date for the ulcerative colitis indication of vedolizumab. Takeda had submitted an amendment to its Biologics License Application on December 6 that included updated proposed labeling, and the FDA now has an action date of May 20, 2014 for this indication for vedolizumab, which is also under review as a treatment for adults with moderate to severe Crohn’s disease. On December 9, Takeda and Takeda Pharmaceuticals announced that the compound received a positive vote from the FDA’s Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees, who voted to recommend approval of vedolizumab for the treatment of both ulcerative colitis and Crohn’s disease.

SOURCE: Takeda press release