|New Diabetes Drug Approved; ONSOLIS Relaunch Postponed|
|By Staff and Wire Reports|
|Monday, 12 March 2012 19:00|
The FDA has approved a new diabetes pill from Boehringer Ingelheim and Eli Lilly (NYSE:LLY) for patients who can't control their blood sugar with older medicines.
The agency said Monday it approved Tradjenta tablets for adults with type 2 diabetes. Type 2 is the most common form of diabetes, affecting up to 95 percent of the 24 million people in the U.S. with diabetes.
People with the disease have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications.
Tradjenta works by blocking the DPP-4 enzyme, which releases insulin-boosting hormones that help control blood sugar levels. Merck & Co. Inc. NYSE:MRK) and Bristol-Myers Squibb (NYSE:BMY) already market similar drugs in the U.S.
Merck's Januvia pill had sales of $954 million last year. Diabetes drugs accounted for $16.9 billion in U.S. sales last year, according to health care data firm IMS Health. The drugs made up the fourth largest prescription drug class by spending, behind cholesterol drugs.
The FDA approved the new medication as a stand-alone treatment or in combination with older diabetes drugs like metformin. Many diabetes patients have to combine drugs to manage their blood sugar levels.
Boehringer and Lilly submitted eight studies of the drug that enrolled more than 3,800 patients. The drug consistently improved blood sugar control when compared to placebo.
The most common side effects of the drug were respiratory infection, sore throat, muscle pain and headache.
Tradjenta, known by the generic name linagliptin, will be distributed with a medication guide explaining the drug's risks to patients.
FDA issued new testing guidelines for diabetes treatments in 2008 after data suggested that GlaxoSmithKline's (NYSE:GSK) diabetes pill increases the risk of heart attack. That drug, once a blockbuster medication for the company, is currently only available through a limited prescribing program.
Boehringer is headquartered in Germany, with U.S. offices in Danbury, Conn. Eli Lilly & Co. Inc. is based in Indianapolis.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two appearance issues raised by the FDA following a recent inspection of the Aveva manufacturing facility where ONSOLIS is produced.
The discussion with FDA centered on the formation of microscopic crystals and a slight fading of the color during the 24-month shelf life of the product. While these changes do not affect the product's underlying integrity or safety, the FDA believes that the fading of the color in particular may potentially confuse patients, necessitating a modification of the product and product specification before additional product can be manufactured and distributed.
An analysis by BDSI points to these changes being related to a specific excipient used in the manufacturing process that can be removed to resolve the problem. Importantly, the excipient in question is specific to the manufacture of ONSOLIS in the U.S. and is not used in the manufacturing process for BDSI's other products, BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX), where such developments have never been noted. In addition, it is not expected to impact the launch of BREAKYL (brand name for ONSOLIS in E.U.) later this year. BDSI intends to provide further guidance related to timing of resolution of this matter as discussions continue with FDA and additional information becomes available.
"While we are disappointed by this unexpected event, the impact is limited as U.S. sales of ONSOLIS were not yet material to BDSI's operations," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We are confident in our ability to work with our commercial partner, Meda, to make the necessary change to satisfy FDA's concerns. Importantly, while we remain optimistic about the long-term potential of ONSOLIS, BDSI's future value is based on the market potential of two Phase III products, BEMA Buprenorphine for chronic pain, which was recently licensed to Endo Pharmaceuticals for up to $180 million in milestone payments plus royalties, and BEMA Buprenorphine/Naloxone (BNX) for opioid dependence. BEMA Buprenorphine/Naloxone could become the next branded product to compete with Suboxone, which generated sales in 2011 of over $1.2 billion. Neither of these products is impacted by this development."
Allergan, Inc. (NYSE:AGN) confirms that U.S. District Judge Andrew J. Guilford, after conducting a full trial, ruled that Merz Pharmaceuticals and Merz Aesthetics violated California’s Uniform Trade Secrets Act and issued a permanent injunction against them.
ALR Technologies Inc. (OTCBB: ALRT) (the "Company"), a healthcare technology company, is pleased to announce that it will be hosting an investor meeting after the market closes on Monday, March 19, 2012 at 4:30 PM EDT.
Anacor Pharmaceuticals (NASDAQ:ANAC), announced today that its collaboration partner, the Drugs for Neglected Diseases initiative (DNDi), has commenced Phase 1 clinical studies of SCYX-7158 (also referred to as AN5568), the first new oral drug candidate discovered specifically to combat human African trypanosomiasis (HAT), also known as sleeping sickness. AN5568 was discovered utilizing Anacor’s boron-based chemistry and is Anacor’s sixth compound to enter human clinical development since the company was started ten years ago.
Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the fourth quarter and full year ended December 31, 2011 and outlined key objectives and milestones for 2012.
Aradigm Corporation (OTCBB:ARDM) (“Aradigm” or the "Company") today announced that the Company’s Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of Pulmaquin (dual release ciprofloxacin for inhalation) in non-cystic fibrosis bronchiectasis (BE) has been cleared by the U.S. Food and Drug Administration (FDA).
Astro-Med, Inc. (NASDAQ: ALOT) announces that the Board of Directors has approved the following organizational changes in its senior management team effective March 9, 2012.
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a developer of adult stem cell technologies and CNS therapeutics, announces plans to initiate a preclinical study assessing the efficacy of its NurOwn™ stem cell technology in patients with Multiple Sclerosis (MS).
Cannabis Science, Inc. (OTCBB:CBIS) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is pleased to announce its FDA progress resulting from the last meeting with the Company’s FDA Specialist team to officially determine that the target indication will be for a topical application for skin cancer.
CareView Communications, Inc. (OTCQB: CRVW), an information technology provider to the healthcare industry, announced today that the use of its Virtual Bed Rails™ application has helped hospitals reduce patient falls between 50% and 78% at reporting hospitals.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced results of a retrospective data analysis involving more than 93,000 patients that demonstrate the benefits of laparoscopic surgery over open procedures.
Deaf-Talk, Inc., dba DT Interpreting (PINKSHEETS: MGQG) (DTI), the industry leader in on-demand video sign language interpreting, today announced that, after a successful trial period, the Company has entered into a long-term agreement with a Pittsburgh, PA - based IT company, Sierra w/o Wires, Inc.(Sierra), to provide IT support, installations and hosting services for DT Interpreting's growing video conferencing services.
DHS Holding Co. (PINKSHEETS: DHSM) is proud to announce the appointment of Michael Rohling to CEO effective immediately.
Enzo Biochem Inc. (NYSE:ENZ) today reported improved results for the fiscal quarter ended January 31, 2012.
Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced the publication of guidelines that provide physicians with a framework for using PillCam COLON 2 in daily clinical practice.
ImmunoCellular Therapeutics (OTCBB: IMUC) today announced that its proprietary method for manufacturing ICT-107, its lead dendritic cell (DC) based vaccine for the treatment of glioblastoma multiforme (GBM), has demonstrated meaningfully enhanced efficiency, consistency and convenience, compared to other methods for producing DC-based immunotherapies.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has appointed Gwen A. Fyfe, M.D., and Norman C. Selby as independent members of its board of directors.
International Stem Cell Corporation (OTCBB:ISCO) www.internationalstemcell.com, a California-based biotechnology company focused on therapeutic, cosmetic and research products, announced today that it had obtained new capital financing and made important changes in the composition of its Board of Directors to ensure that Independent Directors hold the majority of Board seats.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of neurological complications of diabetes will be an exhibiting sponsor at the Diabetic Foot Global Conference (DFCon) from March 15-17 in Los Angeles.
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today discussed the use of the proprietary Cell-in-a-Box® technology, being acquired from SG Austria, as an adjunct to chemotherapy across a spectrum of cancer treatments.
Pfizer Inc. (NYSE:PFE) announced today that data from a Phase 3 study of Prevnar 13®* (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) met all study endpoints, showing immunogenicity and establishing a safety profile in children and adolescents aged 5 through 17 years.
PURE Bioscience, Inc. (NASDAQ: PURE) today announced that it will report results for the second quarter of fiscal year 2012 after market close on Friday, March 16, 2012.
Rockwell Automation, Inc. (NYSE: ROK) today announced it has purchased the assets of SoftSwitching Technologies, a leading provider of industrial power quality detection and protection systems, located in Middleton, Wis.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced its intention to offer, subject to market and other customary conditions, $500 million aggregate principal amount of convertible senior notes due 2019 to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).
Sionix Corporation (OTCBB: SINX) ("Sionix" or the "Company") announced today the formation of Williston Basin I, LLC ("Williston"), a Nevada limited liability company, of which the Company owns a 60% interest.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today that an overview of the Company’s business strategy will be given at the 24th Annual ROTH Conference, being held at the Ritz Carlton Hotel in Laguna Niguel, California.
Spire Corporation ("Spire") (NASDAQ: SPIR), a diversified global company providing solar photovoltaic equipment and systems, and biomedical processing services, announced today that it has completed the sale of substantially all the assets of Spire Semiconductor, LLC’s foundry services business for aggregate consideration of $8.5 million, as described in more detail below, to Masimo Semiconductor, Inc., a wholly owned subsidiary of Masimo Corporation ("Masimo").
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced the appointment of Dr. Dvorit Samid as Vice President of Medical Affairs.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that is has signed a definitive agreement to acquire substantially all the assets of TransPharma Medical Ltd. ("TransPharma"), a specialty pharmaceutical company focused on the development and commercialization of drug-products utilizing an innovative active transdermal drug delivery technology.