|Myriad's HRD Score Detects Loss of DNA Repair Function in Ovarian Cancer; Perrigo Receives FDA Approval To Market Mini Nicotine Lozenges|
|By Staff and Wire Reports|
|Wednesday, 10 October 2012 18:34|
Myriad Genetics (NASDAQ: MYGN) announced a study published in the British Journal of Cancer demonstrated the ability of the Company's Homologous Recombination Deficiency (HRD) Assay to detect loss of DNA repair in ovarian tumors. The study, entitled, "Patterns of Genomic Loss of Heterozygosity Predict Homologous Recombination Repair Defects in Epithelial Ovarian Cancer," confirmed, with highly statistically significant results, the relationship between Myriad's HRD score and tumors deficient in DNA repair.
"By measuring the HRD score in tumor samples we expect to be able to predict patient response to therapeutic agents that exploit deficiencies in DNA repair," said Jerry Lanchbury Ph.D., Chief Scientific Officer of Myriad Genetics Inc. "Through this best-in-class test we intend to provide patients and their healthcare providers with critical information regarding response to platinum drugs or PARP inhibitors across multiple cancers including breast, ovarian and other cancers."
Researchers at M.D. Anderson Cancer Center, University of California, San Francisco, University of Pittsburgh, University of British Colombia, Royal College of Surgeons in Ireland, and Myriad Genetics generated HRD scores in 639 ovarian tumor samples as well as 57 breast and pancreatic cancer cell lines. The data demonstrated that a high HRD score is highly correlated (p = 1.0 x 10^-48) with tumor deficiency in DNA repair.
The Perrigo Company (NASDAQ: PRGO) announced it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) to market over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor).
This ANDA approval represents the first approval for mini lozenge products that will be targeted for the store brand market. The mint flavored mini lozenge will be marketed under retailer and wholesalers' store, or own brand labels and is comparable to GlaxoSmithKline's Nicorette® Mini Lozenge. The product is indicated to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. "This approval strengthens Perrigo's leading store brand position in smoking cessation products, which also includes coated and uncoated flavored gums and lozenges," said Joseph C. Papa, Perrigo's Chairman, President and Chief Executive Officer. Nicorette® Mini Lozenge is selling at an annual rate estimated at over $30 million at all retail outlets. The product is expected to begin shipping in the next 90 days.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
Affymetrix, Inc. (Nasdaq: AFFX) today reported that based on preliminary financial data, the Company expects total revenue of approximately $80 million for the third quarter of 2012, with revenue of approximately $18 million from the eBioscience business.
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO, will present a corporate update at the 11th Annual BIO Investor Forum hosted by the Biotechnology Industry Organization (BIO).
Eco Ventures Group, Inc. (OTCBB: EVGI), an emerging producer of diversified sustainable alternative energy and resources, today announced Germany-based Energiepark Supitz GmbH ("EPS") has signed a contract to supply at least 90,000 metric tons of rapeseed oil to GGT Trading, Ltd, valued at a minimum €93 million, or approximately US$121 million, over the next 15 months.
Fibrocell Science, Inc. (OTCBB:FCSC), a biotechnology company focused on commercializing LAVIV, the first and only FDA-approved personalized cell therapy in aesthetic dermatology, and on developing innovative autologous cell therapies for additional aesthetic, medical and scientific applications, today announced that it has entered into a securities purchase agreement for a private placement financing with a select group of institutional investors and high net worth individuals, including NRM VII Holdings I, LLC, a Third Security, LLC affiliated fund.
GTx, Inc. (NASDAQ: GTXI) announced today there will be two scientific poster presentations on the effects of enobosarm, a selective androgen receptor modulator (SARM), on improving physical function and quality of life in middle aged and elderly cancer patients.
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, will present at the 23rd CPhI Worldwide/ICSE/P-MEC Europe/InnoPack meeting in Madrid on Wednesday, October 10 from 12:30pm-12:55pm.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its results for the third quarter ended September 30, 2012, will be released before the opening of the market on Tuesday, October 30, 2012.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced results from its Rapid Revenue Program, launched last May.
mPhase Technologies, Inc. (OTCBB: XDSL) reported today that it is completing arrangements, in cooperation with Invest In France, an agency of the French government, for a second round of meetings at the Grenoble Technology Cluster known as Minalogic (http://www.minalogic.org).
Rainbow Coral Corp. (OTCBB: RBCC) biotech subsidiary Rainbow BioSciences and Amarantus Biosciences (OTCBB: AMBS) have moved into the final stages of the terms for a deal.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2012 financial and operating results on Wednesday, October 24, 2012, before the U.S. financial markets open.
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that it raised 2012 aggregate partner company revenue guidance to a range of $185 million to $190 million.
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, will host its 6th annual Investor Day 2012, which is being held at The Yale Club of New York City.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that it has accepted an invitation and signed a formal agreement to participate in the European Union Oral Bioavailability Tools (OrBiTo) project.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the United States Patent and Trademark Office (USPTO) has extended by five years the U.S. Patent No. 6,028,071, which covers FOLOTYN® (pralatrexate injection).
Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced the closing of its previously announced private placement of $15.0 million aggregate principal amount of Senior Secured Convertible Notes (the "Notes"), with certain investors, including Celgene Corporation, RA Capital Management LLC, Deerfield Management Company, LP, Bay City Capital and HealthCap.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that key data from the Company’s multiple sclerosis (MS) franchise will be featured at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10-13, 2012.
Wright Medical Group, Inc. (NASDAQ: WMGI) today announced that the Deferred Prosecution Agreement (DPA) entered into effective September 29, 2010 with the United States Attorney’s Office for the District of New Jersey has expired.