December 2016

Taro Pharmaceutical Industries Ltd. announced the sale of US rights to Keveyis (dichlorphenamide) to Strongbridge Biopharma plc (Strongbridge), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet need. Keveyis was approved by the US Food and Drug Administration (the FDA) in August 2015 to treat primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Keveyis has orphan designation status through August 2022.

Seattle Genetics, Inc. announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML). The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings. Seattle Genetics is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials.

Ligand Pharmaceuticals Incorporated, a biopharmaceutical company, has entered into a worldwide license agreement with Ono Pharmaceutical CoL, ltd. Under the license, Ono will be able to use the OmniRat, OmniMouse and OmniFlic platforms to discover fully human mono- and bispecific antibodies.  Ligand is eligible to receive annual platform access payments, development milestone payments and royalties for each product incorporating an OmniAb antibody. Ono will be responsible for all costs related to the programmes.