Opexa flies on FDA talks for MS drug. Santarus and Depomed resume supply of Glumetza Print E-mail
By BioMedReports.com Staff   
Wednesday, 05 January 2011 19:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 5, 2011.


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.

Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), jumped 7% today after the clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, announced that it has initiated a randomized Phase II clinical trial in patients with previously untreated stage IV pancreatic cancer. The open-label, multicenter trial is being conducted in the United States and will evaluate Peregrine's bavituximab, a phosphatidylserine (PS)-targeting monoclonal antibody with broad therapeutic potential, in combination with the chemotherapeutic agent gemcitabine versus gemcitabine monotherapy.

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.

BioDrain Medical, Inc. (OTC Bulletin Board:BIOR), producer of the FDA cleared Streamway™ system for automated surgical fluid disposal, announced today it is eligible for trading on the Over The Counter Bulletin Board (OTCBB).

BioMed Realty Trust, Inc. (NYSE:BMR) announced that it has acquired a life science research and development facility at 3525 John Hopkins Court comprising approximately 48,300 square feet in the Torrey Pines submarket of San Diego, California.

Boston Scientific Corporation (NYSE:BSX) today announced it has acquired Intelect Medical, Inc., a development-stage company located in Boston.

Dendreon Corporation (Nasdaq:DNDN) today announced that management will present at the 29th Annual J.P. Morgan Healthcare Conference in San Francisco on January 10, 2011 at 11:30 a.m. PT.

Entest BioMedical Inc. (OTCBB: ENTB) announced today it has completed the acquisition of the McDonald Animal Hospital (MAH) in Santa Barbara, California.Entest officially took control of MAH yesterday, January 4, 2011.

ERT (Nasdaq:ERES - News), a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced that its eC-SSRS (Electronic Columbia Suicide Severity Rating Scale) solution facilitates compliance with the newly introduced Food and Drug Administration (FDA) guidance document entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials."

Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced the start of a study in the United States for PillCam® COLON 2 capsule endoscopy.

Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced its participation in the 29th Annual J.P. Morgan Healthcare Conference to be held on January 9-13, 2011 in San Francisco.

Healthnostics, Inc., (PINKSHEETS: HNSS), announced record earnings for the nine months ending September 30, 2010, of $295,836 or $.002 per share on revenues of $619,389.

HORIZON HEALTH INTERNATIONAL CORP. (PINKSHEETS:HZHID) announced today that the Company's Chairman of the Board,Dr. Max Arella of Montreal QC tendered his resignation on December 31, 2010.

InfuSystem Holdings, Inc. (NYSE Amex:INFU), the leading provider of infusion pumps and related services, today announced that it will participate in the Sidoti and Company 2011 Micro Cap Conference, to be held Monday, January 10, 2011, in New York, NY at the Grand Hyatt New York Hotel in midtown Manhattan.

InoLife Technologies, Inc. (OTCBB: INOL), a service based healthcare products development, integration and marketing Company announces today the introduction of its DNA Predisposition Testing Product revealed at the A4M Anti-Aging and Biomedical Technologies Convention exhibited in Las Vegas on December 9-11, 2010.

Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the J.P. Morgan 29th Annual Healthcare Conference at the Westin St. Francis Hotel in San Francisco.Management is scheduled to present an overview of the Company on Wednesday, January 12, 2011 at 2:00 p.m. PT (5:00 p.m. ET).

MiMedx Group, Inc. (OTC Bulletin Board:MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today the completion of the purchase of Surgical Biologics, a leader in the development of tissue processing techniques for creating implants for a variety of surgical indications from amnion membranes.

OmniComm Systems, Inc. (OTCBB: OMCM), one of the fastest growing companies in the EDC and eClinical marketplace, today announced the appointment of Keith Howells as Vice President of Engineering.Mr. Howells will be responsible for the ongoing development of the TrialMaster®, eClinical, and TrialOne® product lines at OmniComm.

Oracle (NASDAQ: ORCL) News Facts - To help improve processes and sustain future growth, Ernest Health, an owner and operator of acute inpatient rehabilitation and long-term acute care hospitals, upgraded to Oracle's PeopleSoft Enterprise 9.1 for HR and financial management.

Spherix Incorporated (Nasdaq:SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its President, Dr. Robert Lodder, will be presenting at both OneMedForum SF 2011 and Biotech Showcase 2011.

Syneron Medical Ltd. (NASDAQ: ELOS) the leading global aesthetic device company, announced today that the Company will participate in the 13th Annual Needham Growth Conference on Wednesday, January 12, 2011, in New York City.

UV Flu Technologies, Inc. (OTCBB:UVFT) is pleased to announce the availability of the ViraTech UV-400 air purifier on two new sales websites, and that the Company is in talks to feature the product on a number of other e-commerce providers as early as the end of January.

Verenium Corporation (Nasdaq:VRNM), a pioneer in the development and commercialization of high-performance industrial enzyme solutions, today announced that James Levine, Executive Vice President and Chief Financial Officer, will present at the upcoming Piper Jaffray Sixth Annual Clean Technology & Renewables Conference.

ViroPharma Incorporated (Nasdaq:VPHM) today announced that Vincent Milano, president and chief executive officer of ViroPharma, will present at the 29th Annual J.P. Morgan Healthcare Conference at 6:00 P.M. ET (3:00 P.M. PT) on Wednesday, January 12, 2011.

 




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