Kyowa Hakko to receive potential $520 million from Amgen
THOUSAND OAKS, Calif. Amgen will pay Kyowa Hakko Kogyo up to $520 million for the rights to the company’s experimental antiallergic drug KW-0761, according to published reports.
Under the agreement, Amgen will make an upfront payment of $100. Kyowa Hakko will also receive up to $420 million in additional payments including a milestone payment for Amgen’s development and marketing of the antibody drug in the global market excluding Japan, China, South Korea and Taiwan. Kyowa will also receive royalties on the sales of the drug if it is successfully developed and marketed.
KW-0761 is currently being studied in inflammation and oncology settings. Kyowa Hakko has completed phase 1 early clinical studies of KW-0761 in allergic rhinitis patients, and is currently conducting phase 1 studies in lymphoma patients.
Amgen will initially acquire rights to develop KW-0761 in all non-oncology areas, while Kyowa Hakko will continue its development activities in oncology until the completion of the phase 2 clinical studies on patients.
Possible new FDA diabetes drug guidelines could delay approvals
SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.
The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.
That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.
FDA approves Ranbaxy’s generic version of Risperdal
NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.
Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.
Risperdal had sales of $924 million in 2007.