|Gilead Confirms Positive CHMP Opinion for Stribild; Baxter and Halozyme Announce Positive Opinion for HyQvia|
|By Staff and Wire Reports|
|Friday, 22 March 2013 18:46|
Gilead Sciences, Inc. (Nasdaq: GILD) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company's Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild® for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)). The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicines for use in the 27 countries of the European Union (EU).
“With its potency, tolerability and convenient once-daily dosing, we believe Stribild has the potential to be an important treatment option for patients new to therapy or with no known resistance to any of the three components of the product,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “We are pleased with today's positive opinion from the CHMP, and anticipate receiving a final decision from the European Commission on our application for Stribild in the coming months.”
The regulatory filing for Stribild is supported by 48-week data from two Phase 3 double-blind, active-controlled, randomized studies in which Stribild met its primary objective of non-inferiority compared to Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada (Study 103). In November 2012, data from Studies 102 and 103 were presented at the 11th International Congress on Drug Therapy in HIV Infection in Glasgow, United Kingdom. These data demonstrated that Stribild maintained high antiviral efficacy through 96 weeks of treatment. In all studies, Stribild was well tolerated and most adverse events were mild to moderate. The most common adverse events observed were nausea, diarrhea, upper respiratory tract infection and headache.
Stribild has received marketing approval in the United States, Canada, South Korea and Australia. To increase access to Stribild in the developing world, Gilead has granted its Indian manufacturing partners and the Medicines Patent Pool the right to develop and distribute generic versions of Stribild in 100 developing countries. These agreements include a complete technology transfer from Gilead of the manufacturing process for the single tablet regimen.
Baxter International (NYSE: BAX) and Halozyme Therapeutics (NASDAQ: HALO) announced the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC.
''This recommendation supports our efforts to improve the overall quality of care for patients. This therapy, when approved by the European Commission, would offer patients the option to administer their therapy at home, in a single subcutaneous site every three to four weeks, resulting in potentially lower systemic adverse reactions compared to intravenous treatments,'' said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. ''We look forward to introducing HyQvia as a new patient-friendly therapeutic option for immunodeficient patients.''
The application was based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a 3-or 4-week dose of the therapy in a single subcutaneous site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in the European Union later this year.
''Recognizing that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients,'' said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its chief scientific officer, Robert Lanza, M.D., will be delivering the “Robert M. Nerem Lecture” at the 17th Annual Hilton Head Workshop, "Regenerative Medicine: Technologies Enabling Novel Therapies" being held on Hilton Head Island, March 20-23.
Alliqua, Inc. (OTCQB:ALQA) ("Alliqua" or the "Company") today announced the initiation of a life-cycle management plan as the first phase in their portfolio expansion initiative.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application for Iclusig™ (ponatinib) for two indications.
Biogen Idec (NASDAQ: BIIB) announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommending a marketing authorization be granted for TECFIDERA™ (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS).
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it had settled its claims against Nordion Inc. (formerly MDS Inc.), headquartered in Ottawa, Canada, in a case pending in the United States District Court for the District of New Jersey, for a cash payment of USD 22.5 Million by Nordion to Dr. Reddy’s.
FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, announced today that it has received a patent covering a platform series of metabolic markers for PET and SPECT imaging.
GenVec, Inc. (NASDAQ: GNVC) announced financial results for the fourth quarter and year ended December 31, 2012. For the year ended December 31, 2012, the Company reported a net loss of $14.1 million, or $1.09 per share, compared with a net loss of $7.4 million, or $0.58 per share, for the year ended December 31, 2011.
Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of once-daily, oral AUBAGIO® (teriflunomide) for the treatment of adult patients with relapsing-remitting multiple sclerosis (MS).
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild® for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)).
Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that following Genzyme's request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application (MAA) for KYNAMROTM (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH).
Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, received official notification from the European Patent Office (EPO) and the U.S. Patent and Trademark Office (USPTO) that the company has been issued three key patents.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported a number of updates with respect to ILUVIEN® for chronic diabetic macular edema (DME).
SK3 Group, Inc. (OTC Pink: SKTO) today announces that its newly acquired subsidiary, Medical Greens™, has contracted for over $30 Million in annual licensing, management, and logistic services from collectives throughout California, after only its first full week of operations under SK3 Group, Inc.
VG Life Sciences, Inc. (OTC Pink: VGLS), a biotechnology company focused on leveraging its innovative platform technologies for the discovery and development of drug therapies for cancer, infectious disease, and inflammation, announced today that it has signed a two-year commitment to provide funding toward the operational needs of the company from current investor MedBridge, LLC, a leading provider of development, turnaround, partnership advising and revenue cycle management services for the medical and healthcare industries.