|GW Pharma Falls Following Sativex Trial; AbbVie Announces Results From Phase 3 Study of Investigational Medicine Elagolix|
|By Josh Gee|
|Thursday, 08 January 2015 18:57|
Shares of GW Pharmaceuticals PLC (ADR) (NASDAQ: GWPH) fell in Thursday’s premarket following disappointing results from its Sativex drug trial.
In this first trial, Sativex (as adjunctive treatment to optimized chronic opioid therapy) did not meet the primary endpoint of demonstrating a statistically significant difference from placebo.
The company reported the top-line results from the first of three Phase 3 trials for the investigational drug in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.
"Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population," stated Justin Gover, GW's Chief Executive Officer. "We have two additional pivotal Phase 3 trials ongoing which, if positive, would still allow us to submit a New Drug Application with the US FDA. We look forward to results from these two further studies later this year."
GW Pharmaceuticals recently traded at $67.51 in the premarket, down 5 percent.
AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced positive top-line results from the first of two ongoing Phase 3 clinical trials, designed to evaluate the efficacy and safety of elagolix in premenopausal women with endometriosis. Results from the trial show that after six months of treatment, both doses of elagolix (150 mg once daily and 200 mg twice daily) met the study's co-primary endpoints (p<0.001) of reducing scores of non-menstrual pelvic pain (NMPP) and menstrual pain (or dysmenorrhea), associated with endometriosis, at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale.
Endometriosis is associated with a multitude of symptoms, some of the most common of which include pain related to menstruation as well as chronic pelvic pain throughout the menstrual cycle, and is a leading cause of infertility. The World Endometriosis Research Foundation estimates that endometriosis affects one in ten women during their reproductive years, representing approximately 176 million women worldwide.
"Endometriosis is a condition in which the tissue that normally lines the inside of a woman's uterus grows outside the uterus, and is often associated with severe, and at times, debilitating pain," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. "The positive results from this trial represent a significant milestone in the development of elagolix as a potential new treatment option for patients suffering from endometriosis."
The observed safety profile of elagolix in this Phase 3 trial was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache, nausea and fatigue. While most AEs were similar across treatment groups, some, such as hot flush and bone mineral density (BMD) loss were dose-dependent. Overall discontinuation rates were similar across treatment groups and discontinuations specifically due to AEs were 5.9 percent, 6.4 percent, and 9.7 percent for placebo, 150 mg once daily and 200 mg twice daily, respectively.
The top-line results are from a six-month, group-level analysis. Patients in the trial will continue on in either post-treatment follow-up or a blinded six-month extension study. AbbVie intends to present detailed results from this trial at a future medical conference.
Trial Design -- The Phase 3 trial (M12-665) is a 24-week, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 872 women, age 18 to 49, with moderate-to-severe endometriosis-associated pain. It is being conducted at approximately 160 sites in the United States, Puerto Rico and Canada.
A second Phase 3, randomized, multinational, double-blind, placebo-controlled trial (M12-671) evaluating elagolix in patients with moderate-to-severe endometriosis-related pain is ongoing and results are expected in late 2015.
Adamis Pharmaceuticals Corporation (Nasdaq:ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease, allergy, oncology and immunology, announced today that it intends to offer shares of its common stock in an underwritten public offering.
Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR), a clinical-stage biopharmaceutical company, announced today the pricing of an underwritten public offering of 6,000,000 shares of its common stock at a price to the public of $29.50 per share. Alder is offering all of the shares of common stock.
Amedisys, Inc. (Nasdaq:AMED), one of America's leading home health and hospice care companies, today announced that Paul B. Kusserow, President and Chief Executive Officer, Ronald A. LaBorde, Vice Chairman, and Dale E. Redman, Interim Chief Financial Officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 14, 2015.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the second quarter ended November 30, 2014.
Athersys, Inc. (Nasdaq:ATHX) announced today that it will present at the Biotech Showcase™ 2015 to be held on January 12-14, 2015 in San Francisco, California, at the Parc 55 Wyndham San Francisco – Union Square.
Avalanche Biotechnologies, Inc. (Nasdaq:AAVL), a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today announced the pricing of its public offering of 2,399,457 shares of its common stock at a public offering price of $59.00 per share, before underwriting discounts, commissions and estimated expenses. 2,009,457 of the shares of common stock are being offered by Avalanche and 390,000 of the shares are being offered by existing stockholders.
Chembio Diagnostics Systems, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced the appointment of Paul Lambotte, Ph.D., as Vice President, Product Development.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced that aggregate top-line results from three pharmacokinetic (PK) and pharmacodynamic (PD) clinical trials in organ-impaired patients provided confirmatory support for the continued development of the company's first-in-class orally active pan-caspase protease inhibitor, emricasan.
Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2015 at 9:30 AM Pacific Standard Time.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science, has acquired all of the operations of HEKA Elektronik, or HEKA, a privately held biomedical instrumentation and software business with headquarters in Germany, for a total of approximately $6 million in cash.
Herborium® Group, Inc. (OTC Pink: HBRM), a Botanical Therapeutics® Company providing unique, all botanical medicines (Botanical Therapeutics®), announced today that its Amazon sales grew 54% over sales for the same period in 2013.
LHC Group, Inc. (Nasdaq:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that Keith G. Myers, chief executive officer of LHC Group, and Donald D. Stelly, president and chief operating officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, California, on Thursday, January 15, 2015.
LifeVantage Corporation (Nasdaq:LFVN), announced that Chief Science Officer Shawn M. Talbott, PhD, is presenting a poster abstract demonstrating a portion of the findings from the research being conducted by LifeVantage in the field of Nrf2, at The Biochemical Society's Focused Meeting entitled 'The Keap1/Nrf2 Pathway in Health and Disease' at Robinson College in Cambridge, UK.
MELA Sciences, Inc. (Nasdaq:MELA), developer of the MelaFind® system, a non-invasive software-driven image analysis device approved for use in the U.S. and the European Union to assist dermatologists in melanoma diagnosis, today announced that MELA Sciences' CEO Michael R. Stewart will present at the OneMedForum at the Marriott Marquis, San Francisco on January 13 at 2:00 p.m. PST.
Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company engaged in the manufacture and direct sale of premium-quality nutritional and personal care products, today announced that Hani Charles Soudah, M.D., Ph.D., of the Washington University School of Medicine in St. Louis, Mo., has joined Nature's Sunshine Products' ("NSP") Medical and Scientific Advisory Board.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today provided an update on operational and preliminary financial results for the year ended December 31, 2014.
Novavax, Inc. (Nasdaq:NVAX) today announced that Jill Hoyt has been named Vice President, Human Resources & Administration. Ms. Hoyt joined Novavax in February 2008 as Executive Director, Human Resources & Administration and has been instrumental in the successful growth of the company.
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced an update on its corporate activities and product pipeline.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live cell encapsulation technology, Cell-in-a-Box®, today announced that the Company is trading under its new ticker symbol "PMCB" effective today.
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed follow-on public offering of $75 million of its common stock.
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases, today announced publication of nonclinical data on PRT-201 (vonapanitase) in peripheral artery disease (PAD).
Revance Therapeutics, Inc. (Nasdaq:RVNC), a specialty biopharmaceutical company developing botulinum toxin products for the use in aesthetic and therapeutic indications, today announced publication in the peer reviewed journal, Dermatologic Surgery of positive data from its Phase 1/2 study of RT002 injectable botulinum toxin type A for the treatment of moderate to severe glabellar (frown) lines.
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing oncology therapeutics targeting cancer stem cells (CSCs) and tumor bulk, today announced the pricing of its previously announced underwritten public offering of 3,800,000 shares of its common stock at a public offering price of $15.75 per share.
VBI Vaccines (Nasdaq:VBIV) is pleased to announce its sponsorship support of Le Classique, a 3-on-3 ball hockey tournament being held in Winnipeg, Canada on February 5th – 8th, 2015. Now in its third year, Le Classique is expected to draw over 2,000 individuals seeking to broaden congenital cytomegalovirus ("CMV") public awareness.
Walgreens Boots Alliance, Inc. (Nasdaq:WBA) will visit the Nasdaq MarketSite in Times Square in celebration of the merger of Walgreens and Alliance Boots, and the listing of Walgreens Boots Alliance, Inc. on The Nasdaq Stock Market.