Amag Pharmaceuticals Inc., of Waltham, Mass., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said they have agreed to mutually terminate their March 2010 license, development and commercialization agreement, which granted Takeda exclusive rights to market ferumoxytol in Canada, the EU and Switzerland, as well as certain other geographic territories (under the trade name Rienso outside of Canada where the product’s trade name is Feraheme). Amag now regains all worldwide development and commercialization rights for Feraheme/Rienso and receives an undisclosed payment in connection with the termination and also Takeda will provide certain transition services for up to 180 days after the marketing authorization transfer in each territory. Takeda has been commercializing Feraheme in Canada and Rienso in the EU for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease. In both of these territories, Takeda has submitted applications to expand the product’s current label to include all patients with IDA regardless of underlying cause. Amag said it will assess various alternative commercialization strategies for Feraheme in Canada and Rienso in the EU based, in part, on the pending regulatory decisions which are expected in 2015.
Biomarin Pharmaceutical Inc., of San Rafael, Calif., said it has been granted approval in Japan for the registration of Vimizim (elosulfase alfa) for the treatment of patients with mucopolysaccharidosis type IVA, also known as Morquio A syndrome. Vimizim received FDA approval for the treatment of patients with Morquio A syndrome in February.
Gilead Sciences Inc., of Foster City, Calif., said it has expanded its agreement with Janssen R&D Ireland, of Cork, Ireland, a unit of Johnson & Johnson, for the development and commercialization of a new once-daily single tablet regimen containing its tenofovir alafenamide (TAF) and emtricitabine, and Janssen’s rilpivirine. The original agreement was established in 2009 for the development and commercialization of Complera, marketed as Eviplera in the EU, which combines tenofovir disoproxil fumarate, emtricitabine and rilpivirine in a once-daily tablet. Gilead said it will initiate phase III studies of emtricitabine/rilpivirine/TAF in the coming months. Pending the product’s approval, Gilead will be responsible for the manufacturing, registration, distribution and commercialization of the regimen in most countries, while Janssen will distribute in approximately 17 markets. The companies have also amended a licensing agreement for the development and commercialization of a once-daily single tablet regimen for HIV containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir. Janssen will be responsible for further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide.
Ignyta Inc.. of San Diego, said the FDA has granted both orphan drug designation and rare pediatric disease designation for its lead product candidate entrectinib for the treatment of neuroblastoma. Entrectinib is an orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins.
Regenerx Biopharmaceuticals Inc., of Rockville, Md., said its strategic partner, G-treeBNT Co. Ltd., has filed an investigational new drug application with the Korean Ministry of Food and Drug Safety to conduct a phase IIb/III trial with RGN-259 (designated GBT-201 in Korea and the licensed Pan Asia territory) for the treatment of patients with dry eye syndrome. The compound is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is thymosin beta 4 (TB4). Based on two U.S. phase II trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures.
Soligenix Inc., of Princeton, N.J., said data demonstrating that the combination of Rivax and Velothrax induces protective immunity to both ricin toxin and anthrax toxin exposure has been published online in Vaccine. Rivax is a candidate vaccine for the prevention of exposure to ricin toxin using an antigen that is completely devoid of the toxic activity of ricin. Velothrax employs a derivative of recombinant protective antigen, termed dominant negative inhibitor (DNI), which is a candidate for inclusion in a next-generation anthrax vaccine. The combination treatment was compared to treatment with either Rivax alone or Velothrax alone. The combination treatment was able to provide protection against subsequent challenge with both ricin and anthrax toxin in animal studies. In contrast, mice administered the Rivax vaccine were protected from ricin challenge, but not anthrax toxin challenge, and mice administered Velothrax were protected from anthrax toxin challenge but not ricin challenge. These challenges were given at least six months after vaccination and titer levels from the combination were evaluated up to 200 days post-vaccination. The company performed these studies in collaboration with the Wadsworth Center, New York State Department of Health, under a $9.4 million cooperative grant from the National Institute of Allergy and Infectious Diseases.