CORAL SPRINGS, Florida, October 21, 2013 /PRNewswire/ --
Market news updates for October Biotech leaders: Alliqua Inc. (OTCQB: ALQA), MiMedx Group, Inc. (NASDAQ: MDXG), Organovo Holdings, Inc. (NYSE: ONVO) Anacor Pharmaceuticals (NASDAQ: ANAC) and Pfizer Inc. (NYSE: PFE)
Alliqua, Inc. (OTCQB: ALQA) Forges Ahead with Lidocaine Transdemal Patch Efforts: A preclinical study commissioned by Alliqua ("the Company") concluded that the Company's investigational lidocaine transdermal patch compares favorably to the Lidoderm® (Lidocaine patch 5%) patch that is currently on the market. The overall study results indicate that Alliqua's patch is able to deliver in the pig a slightly higher amount of lidocaine than Lidoderm and to reach maximum delivery within a comparable period. No skin irritation occurred with either the Alliqua transdermal patch or Lidoderm patch. The study concludes that further development could result in Alliqua creating a commercial lidocaine patch that could be a generic version of the Lidoderm patch or provide better drug delivery resulting in a 505 (b)(2) approval. The study found that Alliqua's patch offers a higher peak plasma concentration (Cmax) of lidocaine than Lidoderm (4.96 +/- 1.16 ng/mL versus 3.03 +/- 1.92 ng/mL) and higher mean total area under the curve (AUCtotal) than the competing product (66.5 ng/mL-h versus 48.9 ng/mL-h). The mean period of peak concentration (Tmax) was 8.7 hours for Alliqua's patch versus 10.7 hours for Lidoderm.
To read the full press release, please go to: http://www.fnmprofiles.com/profiles-alqa.php
In further developments, the company has announced today that it has signed a distribution agreement with McKesson Medical-Surgical, by which their U.S. distribution network will stock and offer for sale Alliqua's SilverSeal® and Hydress® wound dressings to healthcare customers nationwide. David Johnson, Chief Executive Officer of Alliqua, said, "This encompasses expanding our distribution network within the U.S. for our SilverSeal® and Hydress® wound dressings. McKesson Medical-Surgical is one of the most well-known and respected health care distributors in the U.S. market. The expansion in distribution made possible by this agreement will assist customers with easy access to these products across the continuum of alternate site health care. "
To read the full press release, please go to: http://www.fnmprofiles.com/profiles-alqa.php
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced that the Food and Drug Administration ("FDA") has rescheduled its meeting with the Company to take place on October 28, 2013. This meeting to discuss the recent Untitled Letter MiMedx received from the FDA was initially scheduled for October 16, 2013, but was postponed due to the recent partial Federal Government shutdown.
Organovo Holdings, Inc. (NYSE: ONVO) develops three-dimensional (3D) bioprinting technology for creating functional human tissues on demand for research and medical applications. ONVO's 3D NovoGen bioprinting technology works across various tissue and cell types, and allows for the placement of cells in desired pattern. It offers NovoGen MMX Bioprinter, a commercial hardware and software bioprinter platform to create tissues for bioprinting research and development.
Anacor Pharmaceuticals (NASDAQ: ANAC) recently announced that the arbitrator appointed to resolve its dispute with Valeant Pharmaceuticals, Inc. (Valeant), successor in interest to Dow Pharmaceutical Sciences, Inc. (DPS), has issued an Interim Final Award in favor of Anacor, awarding Anacor $100 million in damages as well as all costs of the arbitration and reasonable attorney's fees. The parties may apprise the arbitrator of any issues not resolved in the Interim Final Award order within ten days, and responses to any such submission are due within fifteen days of the date of the Interim Final Award. If no submissions are made, this Interim Final Award will become final.
Pfizer Inc. (NYSE: PFE) announced recently top-line results from two phase 3b, placebo-controlled studies with Lyrica® (pregabalin) Capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN), respectively. The fibromyalgia study, A0081275 met its primary endpoint, showing a reduction in pain associated with fibromyalgia in patients who were treated concurrently with antidepressant therapy for comorbid depression. Separately, the painful DPN study, A0081269 did not meet its co-primary endpoints by sufficiently reducing DPN pain and DPN pain on walking compared to placebo.
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced three-year (144-week) efficacy and safety results from two pivotal Phase 3 studies (Studies 102 and 103) evaluating the once-daily single tablet regimen Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve patients with HIV-1 infection. Data show that after three years of treatment, Stribild demonstrated comparable efficacy to two standard-of-care HIV regimens, Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Study 102 and a protease inhibitor-based regimen of ritonavir-boosted atazanavir plus Truvada® (emtricitabine and tenofovir disoproxil fumarate) in Study 103. These data are being presented this week at the 14th European AIDS Clinical Society Conference (EACS) in Brussels, Belgium.
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