|Opexa flies on FDA talks for MS drug. Santarus and Depomed resume supply of Glumetza|
|By BioMedReports.com Staff|
|Wednesday, 05 January 2011 19:55|
Heavy volume sent shares of Opexa Therapeutics, Inc. (NASDAQ:OPXA) soaring Wednesday after the cell therapy company developing Tovaxin for multiple sclerosis (MS), today announced the successful completion of two separate meetings with the U.S. Food and Drug Administration regarding the Company’s planned development program for the drug, a multiple sclerosis treatment that uses cells from the patient's own body to combat the disease. Positive feedback from those meetings has Opexa positioning Tovaxin for a pivital Phase III study and potential partners.
"We are very pleased with the outcome of our two recent FDA meetings regarding Tovaxin, the first ever personalized T-cell therapy for MS patients, as we believe we now have a well defined path forward for Phase 3 clinical studies," commented Neil K. Warma, President and Chief Executive Officer of Opexa. "Importantly, we believe the outcome of these meetings will contribute positively to our ongoing discussions with potential development partners due to the importance of the FDA’s feedback, as well as our ability to secure the necessary resources for the continued development of Tovaxin. We remain motivated to again treat patients in a clinical setting as we continue to believe Tovaxin is the most promising therapy in development for MS."
Shares of Opexa surged nearly 54%, gaining 84 cents to $2.40.
Shares of Santarus, Inc. (NASDAQ:SNTS) and Depomed, Inc. (NASDAQ:DEPO) both gained today after the companies announced the resumption of supply of GLUMETZA 500 mg to wholesalers and retailers. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus. GLUMETZA 500 mg and GLUMETZA 1000 mg are both distributed in the U.S. by Santarus through agreement with Depomed. GLUMETZA 1000 mg has remained available through pharmacies without supply interruption.
"We are pleased that GLUMETZA 500 mg is again fully available to patients and physicians," said Depomed president and chief executive officer Carl A. Pelzel. "We would like to thank everyone at Depomed, Santarus and other involved parties for their hard work on the corrective actions associated with the June 2010 recall at the wholesale level that led to the supply disruption and their efforts on the resupply."
Santarus president and chief executive officer Gerald T. Proehl said, "Our commercial organization is prepared and enthusiastic about promoting the GLUMETZA 500 mg dosage strength to physicians. GLUMETZA 500 mg plays an important role in the process of titrating new patients to the targeted optimal dose for metformin of 2000 mg daily. At the time of the supply interruption last June, GLUMETZA 500 mg comprised approximately 60 percent of GLUMETZA net sales and we expect it to be a significant contributor to Santarus’ future GLUMETZA promotion revenues."
As reported earlier today here on BioMedReports, Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) and its exclusive India-based distribution partner Jaiva Technologies, Inc. (JTI) and Jaiva's Indian subsidiary Gaur Diagno, Pvt Ltd (GDL) announced today it will target over 2.2 million people in potentially high cancer prone districts of northern India in phase I of its previously launched cancer education and screening program in India. Through the program GDL is actively commercializing RPC's Onko-Sure in vitro diagnostic (IVD) cancer test with the goal of the program to drive public education; raise market awareness; and sell Onko-Sure as a potentially life-saving cancer screening test. Based on response to initial program outreach, RPC now estimates test kit purchases in FY2011 to potentially reach 25,000 with revenues at an estimated US$10 million in FY2011 sales.
AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based therapeutics, announced today the formation of a collaboration with leading scientists at the Swedish medical university Karolinska Institutet to identify RNA-based therapeutic candidates for the treatment of Extensively Drug-Resistant Tuberculosis (XDR-TB). XDR-TB is a severe infection that occurs worldwide and represents a significant threat to global public health. One-third of the world's population carries the tuberculosis bacterium, and XDR-TB strains are highly and increasingly resistant to currently available treatments.
CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received governmental approval from the Ministry of Health Care and Social Development of the Russian Federation to begin enrollment of subjects for a Phase III clinical trial of Multikine in Russia. Russia is one of nine countries to participate in this global Phase III trial. The Phase III trial will be run at about 48 clinical centers. Three are expected to be located in Russia. The Phase III trial was started late last month in the United States. It is expected that all 48 clinical centers will be enrolling patients within a few months. Multikine is the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.
Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that it has signed a letter of agreement with Viropro, Inc., for the development of a biosimilar version of the monoclonal antibody drug rituximab (marketed by Genentech/Roche). Worldwide sales of rituximab in 2009 in all indications, including non-Hodgkin’s lymphoma and chronic lymphocytic lymphoma, were approximately $5.6 billion.
AdCare Health Systems, Inc. (NYSE Amex:ADK) , an Ohio-based long-term care, home care and management company, has been invited to present at the Sidoti Semiannual Micro-Cap Conference to be held at the Grand Hyatt Hotel in New York on January 10, 2011.Amicus Therapeutics (Nasdaq:FOLD) today announced that Chairman and Chief Executive Officer John F. Crowley will be presenting a business update and a review of the Company's expected key milestones for 2011 at the upcoming 29th Annual J.P. Morgan Healthcare Conference.