Par to acquire Edict
WOODCLIFF LAKE, N.J. — Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.
Par said it will acquire Edict Pharmaceuticals for up to $37.6 million in cash and Par’s repayment of certain additional pre-close indebtedness. Par noted the acquisition is subject to customary conditions and approvals; the drug maker expects to complete the transaction by the end of the year.
Edict currently has seven abbreviated new drug applications filed with the Food and Drug Administration and one ANDA filed in the name of a development partner with an additional 14 products in development.
"This transaction enhances Par’s already successful research and development infrastructure and demonstrates Par’s intention to continue to build out our product development platform," Par president Paul Campanelli said. "Also, Edict’s facility adds significant operational capacity and provides business continuity protection for our Spring Valley, N.Y., facility."
Sutent OKed as pancreatic NET treatment
NEW YORK — The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.
Pfizer announced Friday the approval of Sutent (sunitinib malate) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with locally advanced disease that can’t be removed through surgery. Pancreatic NET is a rare cancer reported in 2 million to 4 million people worldwide every year.
“We are delighted that Sutent has been granted approval by the FDA as an effective treatment option for individuals with pancreatic NET,” said Mace Rothenberg, SVP clinical development and medical affairs for Pfizer’s oncology business unit. This approval represents the third disease indication for Sutent, which was approved by the FDA in 2006 for treatment of patients with advanced kidney cancer and imatinib-resistant or intolerant gastrointestinal stromal tumor.
Imatinib is the generic name for Novartis’ drug Gleevec.
Mylan receives FDA approval for generic Depakote Sprinkle capsules
PITTSBURGH — The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.
Mylan said Monday that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures.
Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.