• Cellartis AB, of Gothenburg, Sweden, a division of Cellectis SA, said it would become a partner in TissueGEN, a multinational stem cell project funded by the European Commission. TissueGEN aims to produce an in vitro, three-dimensional human disease tissue platform to provide therapeutics developers with cost-effective validation of potential regenerative medicine strategies. TissueGEN will oversee the in vitro generation of human 3D tissues derived from human induced pluripotent stem cells. (See BioWorld Today, Nov. 4, 2011.)

• Cipher Pharmaceuticals Inc., of Mississauga, Ontario, said it reached a sales milestone for Lipofen, its fenofibrate product, triggering a $1 million payment from Kowa Pharmaceuticals America Inc., a unit of Kowa Co. Ltd., of Nagoya, Japan.

• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, said it submitted a marketing authorization application for Scenesse (afamelanotide 16-mg implant) to the European Medicines Agency (EMA) covering use of the product as a prophylactic treatment in adults with erythropoietic protoporphyria. Scenesse received orphan drug designation in 2008 and will be reviewed under the EMA's centralized procedure. (See BioWorld Today, Dec. 21, 2011.)

• Cytos Biotechnology Ltd., of Zurich, Switzerland, said its convertible bond restructuring has been approved, enabling the firm to remain a going concern while it continues searching for a sustainable strategic solution. The firm has had trouble tapping the public markets, despite reporting positive Phase II data with CYT003-QbG10 in allergic asthma and allergic rhinitis. Last year, it put all other R&D programs on hold and cut 72 of 82 employees to conserve cash. (See BioWorld Today, Aug. 18, 2011.)

• DCPrime BV, of Amsterdam, the Netherlands, said it received orphan drug designation in Europe for DCP-001, a therapeutic vaccine, in acute myeloid leukemia (AML). The product is based on the firm's DCOne platform, which involves dendritic cell technology. It's in a Phase I/IIa study in AML.

• Depomed Inc., of Menlo Park, Calif., said partner Merck & Co. Inc., of Whitehouse Station, N.J., disclosed earlier this month that the FDA approved Janumet XR (sitagliptin and metformin extended-release tablets) in Type II diabetes. Depomed, which provided its metformin extended-release technology under a 2009 collaboration, is entitled to "modest" single-digit royalties on net sales of the product.

• Soligenix Inc., of Princeton, N.J., reported preclinical results showing its vaccine thermostabilization technology is able to produce stable vaccine formulations using adjuvants, protein immunogens and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. The studies were conducted with the company's aluminum-adjuvanted ricin toxin vaccine, RiVax.

• United Therapeutics Corp., of Silver Spring, Md., said it was notified that Sandoz Inc., a unit of Basel, Switzerland-based Novartis AG, submitted an abbreviated new drug application (ANDA) for a generic version of the 10 mg/mL strength of Remodulin (treprostinil) injection for pulmonary arterial hypertension. In its notice letter, Sandoz alleged that United Therapeutic's patents expiring in 2014, 2017 and 2029 are not valid, not enforceable and/or will not be infringed. United Therapeutics said it will "vigorously enforce its intellectual property rights relating to Remodulin." The firm has 45 days from receipt of the notice to commence a patent infringement lawsuit, which automatically would preclude the FDA approving the ANDA for up to 30 months or until a court decision that falls in Sandoz's favor. Remodulin is United Therapeutics' top-selling drug, posting $114.9 million in sales for the third quarter of 2011.