CORAL SPRINGS, Florida, February 4, 2014 /PRNewswire/ --
Market Briefing for leading pharma advancers along with clinical data reveals biotech company is on the verge of fulfilling glaring market need: Amarantus Bioscience Holdings, Inc. (OTCQB: AMBS), Pfizer Inc. (NYSE: PFE), IntelliPharmaCeutics International Inc. (NASDAQ: IPCI), Alcobra Ltd. (NASDAQ: ADHD), Horizon Pharma, Inc. (NASDAQ: HZNP) and Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA)
Amarantus Bioscience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced positive clinical data for Eltoprazine in a Phase 2a clinical study Adult Attention Deficit Hyperactivity Disorder. The results from the study demonstrated statistically significant improvements of both doses of 5mg and 10mg vs. placebo in a range of ADHD clinical measures."Following a thorough statistical review of the data announced by Psychogenics in 2008 by an independent clinical CRO retained for due diligence purposes, an updated study report was submitted in the Investigator's Brochure in 2010 that was better than originally reported," said David A. Lowe, PhD member of the Amarantus Board of Directors. "There is a significant need for non-stimulant ADHD treatments in the marketplace, especially in light of recent regulatory oversight of abuse of currently approved treatments. We believe Eltoprazine may fill this market need." The ADHD market is valued at over $3.5 billion dollars, with approximately 35 million prescriptions written annually.
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Eltoprazine is a 5HT1a/1b partial agonist small molecule drug candidate has a well-established safety profile, having been dosed in over 700 patients to date. The study entitled "The Effects of Eltoprazine on Symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in Adults: A Double-Blind, Multiple Dose, Crossover, Safety and Preliminary Efficacy Trial" enrolled 47 patients (48 enrollees were planned), with 36 patients completing the study. The study was conducted at 4 centers in the United States, including Duke University Medical Center, Riley Hospital for Children, NeuroScience, Inc. and UCI Child Development Center.
Pfizer Inc. (NYSE: PFE) has announced that the randomized Phase 2 trial [PALOMA-1] of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of palbociclib and letrozole compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or newly diagnosed metastatic breast cancer. "We are delighted with the final data, which suggest the potential for palbociclib to transform the standard of care for post-menopausal women with ER+ and HER2- advanced breast cancer. This is encouraging information for these women, who represent approximately 60 percent of the advanced breast cancer population," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. "We will discuss these results with the FDA and other regulatory authorities to determine next steps, with the goal of bringing a much-needed new medicine to patients."
IntelliPharmaCeutics International Inc. (NASDAQ: IPCI) a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, recently announced the receipt of approximately $3.1 million as its first payment relating to commercial sales of dexmethylphenidate hydrochloride extended-release capsules by its licensee Par Pharmaceutical, Inc. ("Par"). This represents the Company's share of profits for the 15 and 30 mg strengths of the drug product for the period commencing with the first commercial sales of those strengths on November 19, 2013 and ending December 31, 2013 under its License and Commercialization Agreement with Par. Future profit-share payments are expected on a quarterly basis, although the amounts of any such payments cannot now be determined and may vary significantly from time-to-time. All dollar amounts referenced herein are in United States dollars unless otherwise noted.
Alcobra Ltd. (NASDAQ: ADHD) an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, recently announced that Yaron Daniely, President and Chief Executive Officer of Alcobra, will provide a corporate overview at the BIO CEO & Investor Conference, being held at the Waldorf Astoria Hotel in New York City on February 10-11, 2014. The Alcobra presentation is on Monday, February 10 at 3:30pm Eastern Time.
Horizon Pharma, Inc. (NASDAQ: HZNP) has announced that on January 9, 2014 the Compensation Committee of its Board of Directors approved the grant of inducement stock options to purchase an aggregate of 363,900 shares of common stock to 93 new employees. Each stock option has an exercise price per share equal to $8.59, the fair market value on the grant date, and vests over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and 1/48 of the shares vesting monthly thereafter, subject to the new employee's continued service relationship with the Company. Each stock option also has a ten-year term and is subject to the terms and conditions of the Company's 2011 Equity Incentive Plan and the stock option agreement pursuant to which the option was granted.
Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) recently announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ™ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ™ is the first FDA approved medication for Non-24. Non-24 was first described more than 60 years ago, and is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder. "The FDA approval of HETLIOZ™ would not have been accomplished without the heroic efforts of blind patients and their advocates," said Mihael H. Polymeropoulos, M.D., Vanda's President and Chief Executive Officer. "We are committed to providing much needed support to patients with Non-24 and facilitating access to this new therapeutic option."
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