|Gene by Gene, Ltd. and Myriad Resolve Patent Suit; Merck Said to Agree to $100 Million NuvaRing Settlement|
|By Staff and Wire Reports|
|Friday, 07 February 2014 18:32|
Gene by Gene, Ltd. and Myriad Genetics, Inc. (NASDAQ:MYGN), the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche, Inc., and the Trustees of the University of Pennsylvania (the "Patent Owners") have reached an agreement to settle the patent infringement lawsuit between them regarding BRCA testing.
Under the agreement and effective immediately, Gene by Gene will cease selling or marketing clinical diagnostic tests within North America that include analysis of the BRCA1 and/or BRCA2 genes as a standalone test or in conjunction with gene panels, but Gene by Gene will continue to offer such tests outside of North America. The Parties have also agreed that Gene by Gene may continue to offer its whole genome and exome products and services, which include the BRCA genes, as well as Gene by Gene's custom array products that test variants for inherited Mendelian disorders, including variants for BRCA1 and BRCA2, worldwide.
The agreement will continue until the earlier of February 12, 2016 or the last-to-expire valid patent claim in any of the BRCA patents involved in the case. In return, the Patent Owners have agreed to dismiss the patent infringement case against Gene by Gene without prejudice.
This settlement effectively ends the suit that was filed July 10, 2013, in which the Patent Owners alleged that the testing process employed by Gene by Gene infringes certain claims in patents owned by the Patent Owners covering synthetic DNA and methods-of-use related to the BRCA1 and BRCA2 genes.
Merck & Co. (NYSE:MRK) agreed to pay $100 million to settle several thousand lawsuits alleging the drugmaker’s NuvaRing contraceptive device causes potentially fatal blood clots, two people familiar with the accord said.
The settlement, which resolves cases in federal and state courts in Missouri and New Jersey, will provide an average payout of more than $58,000 a case and will be announced today, said the people, who asked not to be identified because they weren’t authorized to speak publicly about it.
Women accused Whitehouse Station, New Jersey-based Merck of selling NuvaRing knowing it posed a higher risk of heart attack-inducing blood clots than competing products.
The settlement allows Merck, the second-biggest U.S. drugmaker by sales, to pay less than Bayer AG (BAYN) and other competing contraceptive makers did to resolve lawsuits over their products. Bayer said last year that it has paid more than $1.6 billion to settle claims over its Yasmin and Yaz lines of birth-control pills. Women said Yaz also caused blood clots that led to strokes and heart attacks.
“Merck may be getting out much more cheaply than its competitors because proving the liability case against the NuvaRing device appears to be more difficult than against the other contraceptives,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview.
Lainie Keller, a Merck spokeswoman, declined to comment on the settlement in an e-mail. Roger Denton, a plaintiffs’ lawyer in St. Louis who is leading the consolidated NuvaRing cases, didn’t return a call seeking comment.
FDA Report -- NuvaRing is a hormonal-vaginal contraceptive that combines both estrogen and progestin in a ring to prevent pregnancy. The product, which was linked in a 2011 U.S. Food and Drug Administration report to a higher risk for blood clots, has been sold in the U.S. since 2001.
Merck opened today down 5 cents to $53.72 at 9:36 a.m. in New York Stock Exchange trading.
Merck reported fourth-quarter earnings this week that fell short of estimates. Earnings excluding certain items were 88 cents a share, 1 cent below the average of 15 analysts’ estimates compiled by Bloomberg. The company also forecast 2014 profit of $3.35 to $3.53 a share, compared with $3.48 projected by analysts.
Dozen Studies -- Lawyers for women suing over the NuvaRing product contend in court filings there are almost a dozen studies showing the type of progestin used in the device is twice as likely to cause blood clots. Such clots can block veins and cause heart attacks or travel to the lungs and cause other health issues.
The family of a Nebraska mother who used a NuvaRing device sued Merck in 2010 after the woman was found dead with a blood clot in her lung. Ann Tompkins’ family alleged in their suit that Merck misled users about the device’s health risks.
Women contend in court filings that Merck failed to provide proper warnings about NuvaRing’s higher clot risks on the device’s label to protect sales. Suits have been filed against Merck and Organon USA Inc., a unit that sold the device.
More than 1,500 NuvaRing suits were consolidated before U.S. District Judge Rodney Sippel in St. Louis in 2008 for pre-trial information exchanges. Sippel had set the first trial over the blood-clot claims for April.
Case Consolidation -- More than 200 suits also have been consolidated in New Jersey state court before Judge Brian Martinotti in Hackensack. Those cases also will be part of the settlement, the people said.
Last year, Martinotti threw out seven NuvaRing cases set as the first suits to go to trial in New Jersey after finding women couldn’t show the device caused their injuries.
The judge said plaintiffs also couldn’t show doctors wouldn’t have prescribed the birth-control device if Merck had included information about higher clot risks on its warning label.
The consolidated cases are In Re NuvaRing Products Litigation, 08-MD-1962, U.S. District Court, Eastern District of Missouri (St. Louis). The consolidated New Jersey cases are In RE: NuvaRing Litigation, BER-L-3081-09, Superior Court of New Jersey (Bergen County).
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that Ron Cohen, M.D., President & CEO, will present at the Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 11:35 a.m. at The Waldorf Astoria Hotel in New York.
The Board of Directors of AmerisourceBergen Corporation (NYSE: ABC) today declared a quarterly dividend of $0.235 per common share, payable March 3, 2014, to stockholders of record at the close of business on February 18, 2014.
Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, today announced that it will be holding its Annual Meeting of Stockholders on Thursday, April 17, 2014.
BD (NYSE: BDX), a leading global technology company, today announced the appointment of Amit Bhalla as Vice President, Global Strategy and Development.
Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), is proud to announce the worldwide release of the SensiFASTTM cDNA synthesis kit.
Cambrex Corporation (NYSE: CBM) announced that fourth quarter 2013 financial results will be released on Tuesday, February 11, 2014 before the market opens.
CEL-SCI Corporation (NYSE MKT: CVM) announced that Geert Kersten, Chief Executive Officer, will be presenting at the 16th Annual BIO CEO & Investor Conference on Tuesday, February 11, 2014 at 3:00 p.m. Hosted by the Biotechnology Industry Organization (BIO), the 16th Annual BIO CEO & Investor Conference will take place February 10-11 at the Waldorf Astoria in New York City.
Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA), a leader in the development of RNAi-based therapeutics, today announced that Douglas M. Fambrough, PhD, the Company’s President and CEO, is scheduled to present at the 2014 Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 1:00 PM ET in New York, NY.
Dyax Corp. (NASDAQ:DYAX) announced today that executive management will participate in the 2014 Leerink Global Healthcare Conference being held February 12-13, 2014 at the Waldorf Astoria in New York City.
Easton Pharmaceuticals Inc. (OTC: EAPH) a specialty pharmaceutical company that owns, designs, develops, and markets an array of topically-delivered drugs and therapeutic / cosmetic healthcare products, today announces It has finalized and closed on agreement to engage a leading legal consultant on medical marijuana.
eHealth, Inc. (NASDAQ: EHTH), America's first and largest private health insurance exchange, announced today that the company plans to release fourth quarter and fiscal year 2013 financial results on February 20, 2014.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that it will release its financial and operating results for the fourth quarter and full year ended December 31, 2013 after market close on Thursday, February 20, 2014.
iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, today announced that the Company will release financial results for the three and 12 months ended December 31, 2013, following the close of the market on Wednesday, February 19, 2014.
Ingen Technologies, Inc. (PINKSHEETS: IGNT) today announced a funding partnership with JSJ Investments. JSJ is a privately held boutique investment firm specializing in the structuring and provision of capital to small and developing OTCQB/QX and PINK sheet companies. JSJ is uniquely positioned to fund long-term growth strategies through a variety of funding arrangements.
Intelligent Living Inc. (OTCQB: ILIV), in its ongoing efforts to be a leading 21st century Health and Wellness company and its commitment to deliver best in breed services and products, announced its LOI with Green Roads of Florida, LLC a leader in the development of Cannabinoids(CBD's) and a herbal homeopathic manufacturer of products for conditions such as pain, migraines, psoriasis, sleep and spa therapies.
Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) today announced Dr. Sharon Mates, Ph.D., President and Chief Executive Officer, will present at the 16th Annual BIO CEO and Investor Conference on February 10, 2014 at 4:30 p.m. Eastern Time at the Waldorf Astoria New York.
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician group practice, will report its financial results for the fourth quarter and full year ended Dec. 31, 2013 on Thursday, Feb. 20, 2014, after the market close.
Laboratory Corporation of America® Holdings (NYSE: LH) today announced results for the quarter and year ended December 31, 2013.
MiMedx (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, today issued the following statement regarding a blog post published today on Seeking Alpha.
NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY), a clinical-stage biopharmaceutical company developing topical non-antibiotic anti-microbial products, today announced that NovaBay will have a booth at the Annual Dialysis Conference, held February 8-11, 2014 in Atlanta, GA.
Novelos Therapeutics, Inc. (OTCQX:NVLT) a pharmaceutical company developing novel agents for the treatment and diagnosis of cancer, is pleased to announce that it has closed the previously disclosed non-brokered private placement of two-year, 8% convertible debentures and warrants, raising gross proceeds of $4.0 million.
Plandaí Biotechnology, Inc. (OTCQB: PLPL), a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, today announced that it closed the license agreement with Diego Pellicer, Inc. which will permit the company use of the Diego Pellicer name for its Phytofare™ cannabis extract in medical and pharmaceutical marijuana applications.
PDL BioPharma, Inc. (NASDAQ: PDLI) announced today that it entered into exchange and purchase agreements with certain holders of approximately $131.7 million aggregate principal amount of outstanding 2.875% Convertible Senior Notes due 2015.
The Radiant Creations Group, Inc. (OTCQB: RCGP), developer of unique, proprietary scientific technologies for cosmetic and over-the-counter personal enhancement products and devices, is pleased to announce the Company has achieved and exceeded the funding goal established by management and reflected in the Company's Executive Summary, a copy of which can be obtained upon request.
Sirona (Nasdaq:SIRO), the dental technology leader, today announced its financial results for the quarter ended December 31, 2013.
Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company, today announced that the Company’s management will be hosting investor meetings during Citi’s 2014 Global Healthcare Conference.
TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that Michael Weiss, the Company's Interim Chief Executive Officer, will be presenting at the 16th Annual BIO CEO & Investor Conference being held at the Waldorf Astoria Hotel in New York City.
TESARO, Inc. (Nasdaq:TSRO) will announce its fourth quarter 2013 financial results on Wednesday, February 19, 2014, after the close of the U.S. financial markets.
United Treatment Centers Inc. (OTC Pink: UTRM): RedTruck SEO Inc DBA www.potnetwork420.com is a digital media company focusing exclusively on the Marijuana industry.
Vical Incorporated (Nasdaq:VICL) today announced that the company will provide an overview of its technologies, development programs, and outlook on Thursday, February 13, at 3:30 p.m. ET at the 2014 Leerink Global Healthcare Conference (New York City, February 12 – 13).