|Repros Offers Results from Phase 2 Study of Proellex; Watson Pharma's Generic Lysteda Receives FDA Approval|
|By Staff and Wire Reports|
|Thursday, 03 January 2013 21:40|
Repros Therapeutics Inc.® (Nasdaq: RPRX) reported top line results from its Phase 2 study of vaginally administered Proellex in the treatment of symptomatic fibroids. The results from the study suggest the 12 mg dose may provide clinical benefit to women suffering from symptomatic uterine fibroids. The Company plans to request an end of Phase 2 meeting with the FDA as soon as practicable.
The primary endpoint in the study was change in Pictorial Blood Loss Assessment (PBAC). Secondary endpoints included change in Uterine Fibroid Symptom Quality of Life (UFSQOL) and change in fibroid volume by MRI assessment.
A total of 40 women were enrolled into the study into one of four groups, 3 mg (n=9), 6 mg (n=9), 12 mg (n=12) and 24 mg (n=10). The following table reports the data from those subjects that completed the study. Unexpectedly, the 24 mg dose exhibited lower exposure than the 12 mg dose which, the Company believes, may result from the hydrophobic nature of the active ingredient and the low volume of excipient used in order to prevent vaginal leakage. Based on these findings, the Company plans to only pursue the 12 mg dose in Phase 3. The MRI report for the 24 mg end of dosing visit is not available at this time but is not expected to be an improvement on the 12 mg dose. In the table, the larger the reduction (negative number), the better the result.
The Company has put in place an extension study to begin to build the 1 year exposure safety data base that will be required for an eventual NDA submission. To date, 15 of the 40 subjects have elected to enroll in the extension study.
Watson Pharmaceuticals, Inc. (NYSE: WPI) announced its subsidiary Watson Laboratories, Inc. – Florida has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for tranexamic acid tablets, the generic equivalent to Ferring Pharmaceuticals' Lysteda®.
Watson intends to begin shipping the product immediately. Lysteda® is indicated for the treatment of cyclic heavy menstrual bleeding. Ferring B.V. has filed lawsuits against Watson, alleging that Watson's ANDA product infringes U.S. Patent Nos. 7,947,739, 8,022,106, and 8,273,795. The litigations remain pending.
For the 12 months ending November 30, 2012, Lysteda® had total U.S. sales of approximately $25 million according to IMS Health data.
Align Technology, Inc. (NASDAQ: ALGN) announced today that the Company will report fourth quarter and fiscal year 2012 financial results on Wednesday, January 30, 2013 after the close of market.
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that is has launched Finasteride Tablets (1 mg), a bioequivalent generic version of Propecia® (Finasteride) Tablets in the US market on January 02, 2013. Dr. Reddy’s ANDA for Finasteride 1 mg Tablets has been awarded a 180-day period of marketing exclusivity in the U.S. on 2 Jan, 2013.
EasyMed Services Inc. (CNSX:EZM)(OTCBB:EMYSF)(MUN:EY6) ("EasyMed" or the "Company") is pleased to announce today that it has secured Depository Trust & Clearing Corporation (DTCC) eligibility for the Company's shares trading on Over the Counter Bulletin Board under the symbol EMYSF.
FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that Phase II Clinical trials will be conducted at Massachusetts General Hospital for BFPET™(18)F-TPP, the company's imaging agent under evaluation for measuring cardiovascular blood flow.
Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the launch of ManoView™ ESO v3.0, the newest version of esophageal manometry analysis software for Given Imaging's ManoScan™ ESO platform, a convenient test used to deliver a complete physiological mapping of esophageal motor function, from the pharynx to the stomach, with the single placement of a catheter.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) will be presenting at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 10, 2013 at 10:00 a.m. PT / 1:00 p.m. ET.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod Insulin Management System, today announced the sale of $85 million of its common stock pursuant to an underwriting agreement with Canaccord Genuity Inc.
InterMune, Inc. (NASDAQ: ITMN) today announced unaudited net sales of Esbriet® (pirfenidone) for the fourth quarter ended December 31, 2012.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that Arthur Sands, M.D., Ph.D., President and Chief Executive Officer, will present at the J. P. Morgan Healthcare Conference on Wednesday, January 9, at 9:30 AM PST in San Francisco.
Micrel, Inc. (NASDAQ: MCRL), an industry leader in high performance analog and high-speed mixed signal solutions, LAN and timing and communications solutions, has announced that it will be presenting at the 15th Annual Needham Growth Conference.
MetaStat, Inc. (OTCQB: MTST), ("MetaStat" or the "Company"), a life science company focused on understanding and treating systemic metastasis today announced that Warren C. Lau, President of MetaStat, will be presenting at the Biotech Showcase conference in San Francisco on Monday, January 7, 2013.
MediSwipe Inc. (OTCQB: MWIP), a patient security solutions and financial products company for the health care industry, announced today that the Company has relocated its corporate headquarters from South Florida to Birmingham, Michigan effective immediately.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") today announced that its patented MyMedicalRecords Personal Health Record (PHR) and telehealth portal will be showcased as part of 12 new Alcatel-Lucent (EURONEXT PARIS: ALU) (NYSE: ALU) cloud-based ng Connect services in the Alcatel-Lucent ng Connect Booth 31412 at the 2013 Consumer Electronics Show, January 8-11, in Las Vegas (see Alcatel-Lucent press release).
MYOS Corporation (OTCBB: MYOS), a company focused on the discovery, development and commercialization of products that improve human muscle health and performance ("MYOS"), announced today the appointment of Glen R. Fleischer as its Chief Executive Officer.
NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve treatment options for cancer patients, today announced the appointment of Mr. Brian Wiley as Vice President of Business Development.
Ohr Pharmaceutical (OTCQB: OHRP), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, announced today that Dr. Irach Taraporewala, Chief Executive Officer of Ohr Pharmaceutical, will be presenting at the Biotech Showcase 2013 conference, taking place at The Parc 55 Hotel in San Francisco on January 7-9, 2013.
OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that Punit Dhillon, President and CEO, will provide a corporate update and outline of anticipated 2013 milestones at Biotech Showcase 2013 on Tuesday, January 8 at 3:45 pm PT.
OPTIMIZERx Corp. (OTCQB: OPRX) is pleased to announce that the United States Patent and Trademark Office issued on December 25th, 2012 U.S. Patent No. 8,341,015, which provides the Company patent protection for SampleMD's eCoupon technology.
Palatin Technologies, Inc. (NYSE MKT: PTN) announced today it has received net proceeds of approximately $1.75 million of non-dilutive funding through the New Jersey Economic Development Authority's tax credit transfer program.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of directed audio products and solutions, announced today a collaboration with the California Hearing & Balance Center (the "Center") to investigate health applications of the Company's HyperSound ("HSS") audio technology.
PAREXEL International Corporation (NASDAQ: PRXL) will release financial results for the Second Quarter of Fiscal Year 2013 on Tuesday, January 29, 2013 after the close of the stock market.
Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus, will present a company overview at the 31st Annual J.P. Morgan Healthcare Conference on Thursday, January 10, 2013 at 11:30 AM PST at the Westin St. Francis Hotel in San Francisco, CA.
Revolutions Medical Corporation (OTCQB: RMCP) has prevailed in its case before the American Arbitration Association (AAA) against former manufacturer Medical Investment Group, Inc. (MIG) and former consultant Richard Theriault. AAA awarded the Company $770,000, in addition to interest, legal fees, and other arbitration costs, which will total close to $1 million dollars.
TNI BioTech, Inc. (PINKSHEETS: TNIB), a public company operating in the biotech sector, today announced that Noreen McGurrin Griffin, Chief Executive Officer, and Dr. Ronald Herberman, Chief Medical Officer, are scheduled to speak at the 6th Annual OneMedForum at the Sir Frances Drake Hotel, San Francisco, CA on January 7-9, 2013.