|POZEN Announces Results for the PA8140-102 Study; Cynosure Prices Public Offering of Class A Common Stock|
|By Staff and Wire Reports|
|Friday, 16 November 2012 19:59|
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced the results from a Phase 1 study, PA8140-102, demonstrated that PA8140, POZENs proprietary combination of aspirin (81 mg) and omeprazole (40 mg), had comparable bioavailability relative to the reference listed product, enteric-coated (EC) aspirin (81 mg). In addition, based on predetermined criteria acceptable to the U.S. Food and Drug Administration (FDA), the study demonstrated that PA8140 is bioequivalent to EC aspirin (81 mg) using criteria for highly variable drugs. POZEN (POZN) has now completed all of the clinical trials it intends to include in the PA32540/PA8140 New Drug Application (NDA) package.
Based on earlier studies with PA formulations and discussions with the FDA, we made adjustments in the trial design, which improved our ability to both capture and measure blood levels of aspirin, as compared to the PA32540-115 trial, said Dr. John Fort, Chief Medical Officer. We believe that these results will satisfy the requirements set forth by the FDA for establishing a therapeutic bridge to EC aspirin (81 mg) for this lower strength of PA tablets.
Additionally, POZEN announced that it has successfully manufactured the PA8140 tablet batches required for the primary NDA stability program and that these batches met all predetermined specifications. Based upon the successful completion of these activities, POZEN is now targeting submission of the NDA no later than the end of April 2013.
If approved, the availability of both 81 mg and 325 mg doses of PA will allow us to provide physicians an option for virtually all of their secondary prevention cardiovascular patients who are at risk for gastric ulcers, dramatically improving the commercial opportunity for PA, said Liz Cermak, Chief Commercial Officer and Executive Vice President.
Cynosure, Inc. (NASDAQ:CYNO), a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, announced the pricing of an underwritten registered public offering of 2,600,000 shares of its class A common stock at a public offering price of $20.50 per share. In addition, El.En. S.p.A. is selling 600,000 shares of the Company's class A common stock at a public offering price of $20.50 per share. The offering is expected to close on or about November 21, 2012, subject to customary closing conditions.
Leerink Swann LLC, the underwriter for this offering, has the option for a period of up to 30 days from the date of the prospectus supplement to purchase up to an additional 240,000 shares from the Company and up to an additional 240,000 shares from El.En. S.p.A. at the public offering price less underwriting discounts and commissions.
The Company intends to use the net proceeds from the shares sold in this offering for general corporate purposes and to fund its potential acquisition of complementary products, technologies or businesses. The Company will not receive any proceeds from the sale of the shares by El.En. S.p.A.
The shares will be issued pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on October 26, 2012. A preliminary prospectus supplement and accompanying base prospectus related to the offering have been filed with the SEC. A final prospectus supplement related to the offering will be filed with the SEC. Copies of the final prospectus supplement, when available, and accompanying base prospectus may be obtained from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by calling (800) 808-7525, ext. 4814.
Bio-Path Holdings, Inc., (OTCQX: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced operational and financial results for the quarter ended September 30, 2012.
ICON plc, (NASDAQ: ICLR) (ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the publication and filing of a circular to shareholders convening an extraordinary general meeting to be held at 3.00 p.m. on December 17, 2012 at ICON plc Headquarters, South County Business Park, Leopardstown, Dublin 18, Ireland at which resolutions in connection with the proposed replacement of ICON’s NASDAQ listing for ADSs with a direct NASDAQ listing for ICON Shares will be considered and voted on.
Impax Laboratories, Inc. (NASDAQ: IPXL) and its wholly owned subsidiary, ThoRx Laboratories, Inc., today confirm that they have initiated a challenge of the patents listed in the Orange Book in connection with Opana® ER (oxymorphone hydrochloride extended-release tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg).
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with patented proprietary technology for the growing $4 billion Respiratory Market, is pleased to announce that it will release an Analyst Research Report on December 3, 2012.
Organovo Holdings, Inc. (OTCQX: ONVO) ("Organovo") a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, has reported on its financial results for the three and nine month period ended September 30, 2012.
Pfizer Inc. (NYSE: PFE) today announced top-line results of a double-blind, placebo-controlled, Phase 3 study evaluating both the 165 mg dose and the 330 mg dose of pregabalin controlled-release (CR) formulation in adult patients with partial onset seizures with epilepsy.
Remedent, Inc. (OTCBB: REMI), an international company specializing in research, development, and the manufacturing of oral care and cosmetic products, announced today that it will host a conference call on Tuesday, November 20, to update investors on the recent strategic developments.
Revolutions Medical Corporation (OTCQB: RMCP) announced today that the Company has entered into a vendor and distribution agreement with McKesson Corporation ("McKesson") for the distribution of the Company's RevVac™ auto-retractable vacuum safety syringe in the United States healthcare market.
The Board of Directors of Sigma-Aldrich Corporation (NASDAQ: SIAL) has approved a quarterly cash dividend of $0.20 per share.
XenoPort, Inc. (Nasdaq: XNPT) announced today that it will provide access via the World Wide Web to its presentation at the 24th Annual Piper Jaffray Health Care Conference.
To help the approximately 80 million American adults and children living with diabetes or pre-diabetes1, Walgreens (NYSE: WAG) (Nasdaq: WAG) and Take Care Clinics are offering free health testing for Hemoglobin A1C and blood glucose at more than 3,000 U.S. locations through the end of November, as part of American Diabetes Month® and the Walgreens Way to Well Commitment™.