Adventrx Pharmaceuticals Inc., of San Diego, said the FDA has established a PDUFA date of Sept. 1 for its review of the Exelbine (ANX-530) new drug application. Adventrx is seeking approval of Exelbine for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small-cell lung cancer.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, will acquire the rights in and substantially all assets at Amgen Inc.'s, Fremont, Calif., development and manufacturing facility. The purchase price was not disclosed. The transaction has been approved by the board of directors of each company and is expected to close in March. The plant's 360 employees will join Boehringer Ingelheim, which is a contract manufacturer for Thousand Oaks, Calif.-based Amgen. Amgen, which obtained the Fremont facility through its 2006 acquisition of Abgenix, will continue to operate its South San Francisco facility.
Cellectis SA, of Paris, said its scientists, working in collaboration with the French National Center For Medical Research and the Institut de la Vision in Paris, used its meganucleases to prevent infection of cultured cells by a herpes simplex virus (HSV-1). Subsequent analysis of the treated cells showed that inhibition of HSV-1 infection by the anti-HSV-1 meganucleases was associated with cleavage of viral DNA. The research, published online in Molecular Therapy, offered the first proof-of-concept data showing that meganucleases can prevent viral infection, according to the company.
Depomed Inc., of Menlo Park, Calif., and Abbott Products Inc. agreed to mediate their dispute over the commercialization of DM-1796, an investigational, once-daily formulation of gabapentin for the management of post-herpetic neuralgia the type of pain that follows a bout of shingles. Abbott, of Abbott Park, Ill., recently informed Depomed that it does not consider itself obligated to launch and commercialize DM-1796, which was developed by Depomed and is licensed to Abbott Products in the U.S., Canada and Mexico for the treatment of pain. Depomed entered into the DM-1796 license agreement with Solvay Pharmaceuticals in November 2008. Abbott Products assumed the license agreement as a result of the acquisition of Solvay's pharmaceutical business by Abbott. The DM-1796 new drug application is under review by the FDA with a PDUFA date of Jan. 30. (See BioWorld Today, April 1, 2010.)
Ironwood Pharmaceuticals Inc., of Cambridge, Mass., and Protagonist Therapeutics Inc., of Redwood City, Calif., established a peptide drug discovery and development collaboration. Protagonist will use its disulfide rich peptide technology platform to design peptides against targets identified by Ironwood, which gains the right to advance such peptides through preclinical and clinical development and onto commercialization. Ironwood made an undisclosed up-front payment to Protagonist and will fund full-time equivalents for Protagonist's drug discovery activities during the collaboration period. Ironwood also will make milestone payments and pay royalties on sales of each product incorporating peptides identified by Protagonist, subject to achieving development and commercialization milestones.
Pervasis Therapeutics Inc., of Cambridge, Mass., said it is pursuing a matrix-embedded endothelial cell-based therapy (PVS-30200) to target and regulate cell stroma in order to prevent key processes that play a role in advancing solid tumor growth and metastasis. The firm entered an exclusive patent license agreement with the Massachusetts Institute of Technology for all discovery and development activities associated with cellular implants for cancer diagnosis, prognosis and treatment.
Protalix BioTherapeutics Inc., of Carmiel, Israel, presented preclinical data showing that PRX-102, its modified alpha-Galactosidase-A (alpha-GAL-A) for the treatment of Fabry disease, demonstrated preliminary efficacy in a Fabry animal model. Chemical modifications to the enzyme resulted in improved activity and enhanced bioavailability. Protalix plans to submit an investigational new drug application for the compound this year. In an in-vitro model of the stomach and intestines, the company's oral glucocerebrosidase (GCD) enzyme a naturally encapsulated plant cell-expressed form of GCD for the treatment of Gaucher's disease also demonstrated stability in the cell and protective capacity against degradation in the digestive tract. Rats fed with lyophilized carrot cells expressing GCD also accumulated the active enzyme in target organs the spleen and liver. Protalix has a $115 million profit-sharing deal with New York-based Pfizer Inc. for its Gaucher's disease drug Uplyso (taliglucerase alfa). (See BioWorld Today, Dec. 2, 2009.)