Ironwood Pharmaceuticals and Alnylam Pharmaceuticals Enter U.S. GI Disease Education and Promotional Agreement for Alnylam’s Givosiran in Acute Hepatic Porphyria (AHP)

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY), the leading RNAi therapeutics company and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI healthcare company, announced today a U.S. GI disease education and promotional agreement for Alnylam’s givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the potential treatment of AHP. Givosiran has received Priority Review designation and Breakthrough Therapy Designation from the U.S. FDA, as well as Orphan Drug Designation in the U.S. The Prescription Drug User Fee Act (PDUFA) date for givosiran is set for February 4, 2020.

Under the terms of the agreement, Ironwood will provide AHP disease education to gastroenterologists and other healthcare practitioners that Ironwood currently calls on for LINZESS (linaclotide). If approved by the U.S. FDA, Ironwood clinical sales specialists will then begin givosiran promotional efforts, augmenting Alnylam’s broader commercialization activities.

“AHP is a rare disease with chronic, debilitating, and sometimes life-threatening attacks. Nearly all patients living with AHP consult at least one, if not several, gastroenterologists due to the recurring abdominal pain associated with their disease and are often misdiagnosed due to minimal disease awareness and a limited number of treatment options,” said Barry Greene, President of Alnylam. “As Alnylam prepares for the potential launch and commercialization of givosiran around the world, leveraging Ironwood’s U.S. GI commercial expertise and depth of relationships within the GI community represents a significant opportunity to expand medical education and diagnosis for patients with AHP.”

“We are excited about the opportunity to partner with Alnylam to increase awareness among healthcare providers about the devastating effects of AHP and, if approved, to then discuss givosiran as a potential new treatment option for patients suffering from this severe, potentially life-threatening disease,” said Tom McCourt, President of Ironwood.

The non-exclusive agreement covers an approximately three-year term. Ironwood will collaborate with Alnylam on AHP disease education designed to help ensure AHP patients are accurately diagnosed and to support access to treatment with givosiran once prescribed (assuming approval). Ironwood will receive fixed payments and royalties in the mid-teens percent on net sales generated from prescriptions or referrals from certain physicians related to Ironwood’s promotional efforts. Alnylam will maintain responsibility for all other aspects of givosiran, and retains all global development and commercialization rights.