Sepracor, UCB file suit against Perrigo partner
ALLERGAN, Mich. A generic pharmaceutical company has filed for Food and Drug Administration approval of a generic version of a drug used to treat allergies and hives, provoking a lawsuit by the companies that control the branded version.
Perrigo Co. announced Wednesday that its partner, Synthon Pharmaceuticals, had filed for approval of levocetirizine solution in the 2.5-mg per 5-ml strength. The drug is a generic version of Sepracor’s and UCB’s Xyzal, which has sales of about $10 million a year, according to Wolters Kluwer Health data.
In response to the approval application, UCB and Sepracor filed suit against Synthon in the U.S. District Court for the Eastern District of North Carolina, alleging patent infringement. Synthon’s application contained a Paragraph IV certification, asserting that Sepracor’s patent is invalid, unenforceable or won’t be infringed by a generic version of Xyzal. As presumably the first company to seek approval for a generic version, Synthon could receive 180 days of market exclusivity after obtaining final approval from the FDA.
GSK to develop inflammatory disease treatments with Chroma Therapeutics
LONDON British drug maker GlaxoSmithKline will collaborate with fellow British pharmaceutical company Chroma Therapeutics to develop treatments for such inflammatory diseases as rheumatoid arthritis.
GSK announced Tuesday that it would work with Chroma to use Chroma’s proprietary esterase-sensitive motif technology, which uses amino acid esters to make drugs target cells that cause inflammatory diseases.
Under the terms of the collaboration with GSK’s Center of Excellence for External Drug Discovery, Chroma will seek to discover new pharmaceutical drugs in four discovery and development programs, receiving a “significant” up-front cash payment and an equity financing investment by GSK, as well as potential milestones, royalties and option fees, including possibly more than $1 billion in milestones.
“This agreement marks GSK’s continued efforts to access the best science and technology platforms worldwide,” GSK VP and head of the European CEEDD Shelagh Wilson stated.
Takeda completes acquisition of IDM Pharma
OSAKA, Japan Japanese drug maker Takeda Pharmaceutical Co. completed its tender offer for a company that develops cancer drugs.
Takeda announced Tuesday that it had completed its tender offer to acquire all outstanding shares of IDM Pharma for $2.64 per share, with about 86% of IDM shares tendered.
The two companies originally agreed to the acquisition in May, with Takeda showing particular interest in IDM’s malignant bone cancer drug Mepact (mifamurtide), which European regulators approved in March for marketing in the European Union, Iceland, Liechtenstein and Norway.