|Avanir Announces Acceptance of NDA for AVP-825; Pfizer Achieves Primary Endpoint With Top-Line Results Of GENOTROPIN®|
|By Staff and Wire Reports|
|Wednesday, 26 March 2014 18:46|
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) of AVP-825, its innovative Breath Powered™ investigational drug-device combination product for the acute treatment of migraine.
As previously reported the company's 505(b)(2) NDA for AVP-825 includes data from one pivotal phase III clinical trial for the acute treatment of migraine. The NDA is also supported by data from a phase II placebo-controlled clinical trial for acute treatment of migraine, and two pharmacokinetic studies. Overall, the NDA includes safety data from 222 subjects who received AVP-825 in clinical trials, and references data from the extensive clinical use of sumatriptan over the past 20 years.
The acceptance of the NDA indicates that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014.
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.
The Breath Powered delivery technology is activated by user's breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent than through most other routes. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing or inhalation of sumatriptan powder into the lungs.
Pfizer Inc. (NYSE: PFE) announced top-line results from a Phase 3B study evaluating the 24-month efficacy of GENOTROPIN® (somatropin) on the height in small-for-gestational-age (SGA) children 24-30 months old. The primary endpoint of the study was achieved: there was a statistically significant difference at 24 months in change from baseline height between patients treated with GENOTROPIN and those in the untreated control group, as measured by height standard deviation score (SDS).
The study was intended to generate additional data regarding the safety and efficacy of GENOTROPIN treatment in subjects born SGA who fail to achieve catch-up growth by two years of age. The study results showed, after 24 months of treatment, the GENOTROPIN group had a statistically significantly greater gain in height SDS compared to the untreated control group.
The study was a controlled, multi-center study, randomizing SGA children to GENOTROPIN or an untreated control group. There were 43 participants from 16 centers in eight European countries, including Spain, Italy, Belgium, Switzerland, Czech Republic, Germany, Sweden and Netherlands. Participants in the study were between 24-30 months old and were randomized in a 1:1 ratio to receive GENOTROPIN 0.035 mg/kg/d or no treatment.
A total of 39 participants completed the study, with two GENOTROPIN participants and two control-group participants withdrawing from the study. A total of 14 serious adverse events were reported in eight participants. Two serious adverse events, occurring to one participant, were deemed to be related to treatment with GENOTROPIN. The adverse events observed in the study were consistent with the known safety profile of GENOTROPIN.
GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.
Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced that its management team will ring The NASDAQ Stock Market Closing Bell on Thursday, March 27, 2014.
Advaxis, Inc. (Nasdaq:ADXS), today announced that it intends to offer for sale shares of its common stock in an underwritten public offering.
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today that its stock has been approved to list on the Nasdaq Global Market, effective with the open of the stock market on Friday, March 28, 2014.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, announced today that it has been selected to present at the Cavendish Global Health Impact Forum taking place May 5-7 in New York, NY.
Amgen (NASDAQ: AMGN) will host a webcast investor meeting at the American College of Cardiology's 63rd Annual Scientific Session (ACC.14) in Washington, D.C. on Sunday, March 30, at 7 p.m. EDT.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced new data from three research programs which support its investigational lead compound onapristone to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2014, being held April 5-9 in San Diego, California.
Athersys, Inc. (Nasdaq:ATHX) announced today that the Company will present at the 2014 BIO Asia International Conference to be held at the Grand Hyatt in Tokyo, Japan, from April 8-9, 2014.
Bioheart, Inc. (OTCQB: BHRT), a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies, announced that it will enroll patients in a new study for degenerative disc disease (DDD).
Caliber Imaging & Diagnostics (OTCQB:LCDX), formerly Lucid, Inc., has appointed Joseph R. Williams as Vice President of Global Marketing, a newly created position, effective immediately.
Cancer Genetics, Inc. (Nasdaq:CGIX), a DNA-based diagnostics company focused on developing genomic-based oncology tests and services, reported financial results for the 2013 fiscal year and for the fourth quarter ended December 31, 2013.
Cesca Therapeutics, Inc. (Nasdaq:KOOL), an autologous cell based regenerative medicine company, announced it has submitted a pre-IDE (Investigational Device Exemption) information package to the U. S. Food and Drug Administration (FDA) for the use of the SurgWerks™ CLI Therapy designed to treat no option patients with late stage critical limb ischemia (CLI).
Hemp, Inc.'s (OTC:HEMP) wholly owned subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company, Inc., is pleased to announce that it has formed a strategic partnership via a signed Consultant Agreement with Hollund Industrial Marine, Inc. (OTC:HIMR), a natural resource project management company with a keen focus on underwater forestry.
Integrated Environmental Technologies Ltd. (OTCBB:IEVM), announced today that it received approval from the U.S. Environmental Protection Agency to market a new Excelyte™ product called Excelyte VET – which can be used to prevent Canine distemper.
M Line Holdings, Inc. (OTCQB:MLHC), a leading provider of products, assemblies and services to the precision high tech segment of both the aerospace and medical industries as well as a seller of high end pre-owned Japanese Computer Numerically Controlled Equipment, announced today it has signed two investment banking agreements with a leading New York-based investment banking firm to assist in acquisition financing and public offering.
Medicure Inc. (TSX VENTURE:MPH) (OTCQB:MCUJF), a specialty pharmaceutical company, today reported its results from operations for the quarter ended February 28, 2014.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, today announced that it has signed an agreement for a research collaboration investigating the potential of very small embryonic-like stem cells ("VSELs™") in treating difficult to heal wounds in an animal model of scleroderma.
RadNet, Inc. (Nasdaq:RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 250 owned and/or operated outpatient imaging centers, announced that Nastaran Fatemi, M.D., RadNet Medical Director for Southern California, will chair a panel discussion at the 7th Annual CME Conference of the International Society for Musculoskeletal Imaging in Rheumatology (ISEMIR).
Repligen Corporation (Nasdaq:RGEN), a technology leader in pre-packed columns for the cost-effective purification of biologic drugs, today announced the commercial launch of its OPUS® 45 cm diameter columns ("OPUS 45") with the largest capacity currently available on the market. OPUS columns, which now range from 1.2 cm to 45 cm in diameter, are delivered packed with chromatography media used to purify monoclonal antibodies and other biologic drugs.
Revance Therapeutics, Inc. (Nasdaq:RVNC), today reported financial results for the three and twelve months ended December 31, 2013.
SANUWAVE Health, Inc. (OTCQB:SNWV) today announced that the Company will release financial results for the year ended December 31, 2013 after the markets close on March 31, 2014.
Symmetry Medical Inc. (NYSE:SMA), a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that its Sheffield, UK manufacturing plant has returned to full operational activity following a minor electrical fire that occurred in its temporary Acid Shop on March 8, 2014.
Tengion, Inc. (OTCQB:TNGN), a leader in regenerative medicine, today reported its financial results for the fourth quarter and full year ended December 31, 2013 and provided a business update.
Theravance, Inc. (NASDAQ: THRX) announced today that Michael W. Aguiar, Theravance's Senior Vice President and Chief Financial Officer, is scheduled to present at the 13th Annual Needham Healthcare Conference on Wednesday, April 9, 2014, at 9:20 a.m. EDT.
uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced unaudited results for the financial year ended December 31, 2013.
Versartis, Inc., (Nasdaq:VSAR) an endocrine-focused biopharmaceutical company, today announced the closing of its initial public offering of 6,900,000 shares of its common stock at a public offering price of $21 per share, which included 900,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares.