Biovest International Inc., of Tampa, Fla., received a loan package of $1.5 million to establish a manufacturing site in Coon Rapids, Minn., for BiovaxID, its personalized cancer vaccine aimed at treating non-Hodgkin's lymphoma. The loan is being provided by the state of Minnesota, the city of Coon Rapids and real estate developer JMS Holdings LLC and is earmarked to support the initial expansion of Biovest's existing 35,000 square foot manufacturing facility to accommodate production for the cancer vaccine.
Evolva Holding SA, of Reinach, Switzerland, announced the results of preclinical studies that demonstrated the efficacy of EV-077 in the prophylaxis and treatment of influenza. The dual thromboxane receptor antagonist and thromboxane synthase inhibitor showed prophylactic results similar to those of Roche's Tamiflu (oseltamivir phosphate) and was more efficacious than Tamiflu in treating the disease. The combination of EV-077 with Tamiflu provided added benefits over each treatment alone on all parameters tested. Evolva also is developing EV-077 for cardio-renal indications.
Genentech Inc., of South San Francisco, a unit of Roche AG, said the FDA granted a hearing June 28 to June 29 for the firm to present its views on why Avastin (bevacizumab) should remain FDA-approved for metastatic breast cancer. The drug gained accelerated approval for that indication in 2008, but four follow-up studies failed to demonstrate overall survival, and the agency proposed that the labeling be amended to remove the breast cancer indication. Until the conclusion of the proceedings, Avastin remains an approved therapy in combination with paclitaxel for first-line HER2-negative metastatic breast cancer. (See BioWorld Today, Feb. 25, 2008, July 19, 2010, and Dec. 17, 2010.)
OctoPlus N.V., of Leiden, the Netherlands, signed a contract with ESBATech, of Zurich, Switzerland, to develop a controlled-release formulation for a proprietary biological compound for ophthalmic applications. The project includes process development, scale-up and manufacturing for preclinical studies. OctoPlus didn't disclose financial details, but said the project will make a material contribution to its 2011 revenues. ESBATech is a biomedical research unit of Alcon Inc., of Hunenberg, Switzerland.
Sound Pharmaceuticals Inc., of Seattle, and scientists and clinicians at the University of California, Los Angeles, reported that p27Kip1 was found to be expressed in the adult and aged human inner ear, including the auditory and vestibular sensory organs. Those findings, presented at the Midwinter Meeting of the Association for Research in Otolaryngology in Baltimore, validated p27Kip1 as a key regeneration target in the deafened mammalian inner ear.
Sunesis Pharmaceuticals Inc., of South San Francisco, announced that the FDA has granted fast-track designation for vosaroxin, the company's lead drug candidate, for the potential treatment of relapsed or refractory acute myeloid leukemia (AML) in combination with cytarabine. Vosaroxin was granted orphan drug designation for the treatment of AML in 2009. Sunesis is enrolling subjects with first relapsed or refractory AML in a multinational Phase III pivotal trial of vosaroxin in combination with cytarabine. (See BioWorld Today, Dec. 22., 2010.)
Unigene Laboratories Inc., of Boonton, N.J., is accelerating the development of its lead proprietary anorexigenic peptide, UGP281. The company expects to file an investigational new drug application with the FDA for the obesity candidate and initiate Phase I trials in the first half of 2012. The peptide demonstrated substantial decreases in food consumption and weight in several in vivo preclinical studies, Unigene said, and it has a favorable pharmacological profile in terms of selectivity, safety and potency. The company doesn't expect the acceleration of the development program to impact its financial position.