Philips Electronics $650 Million Masimo Lawsuit is in Front of Jury; Keryx declares Issuance of a New U.S. Patent for Ferric Citrate Print E-mail
By David Fowler   
Wednesday, 01 October 2014 19:37
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 1, 2014.
Jurors immediately began debating whether Royal Philips NV (PHIA), the world’s biggest lighting company, ought pay up more than $650 million in damages to Masimo Corporation (NASDAQ:MASI) for infringing patents covering technology used in fingertip devices that assess blood oxygen and pulse rates applying light absorbtion.

Royal Philips states it does use the inventions for pulse oximeters, according to papers filed in federal court in Wilmington, Delaware. It says the patents are not validated and zero damages are warranted.

“The entire industry respects our patents,” lawyer Joseph Re, representing Masimo, assured jurors during a two-week trial.

Philips is lashing back at Masimo with allegations of there own, claiming Masimo, based in Irvine, California, is infringing a Philips patent and should pay Philips $169 million in damages. Jurors must as well choose that aspect of the case. “Should Masimo acquire $651 million for something it didn’t invent?” Philips lawyer Brian Rosenthal said. It’s Philips’s invention.’’

Masimo sued an Andover, Massachusetts, subdivision of Amsterdam-based Royal Philips in 2009, claiming it was wrong importing the oximeters in violation of the two U.S. patents.

“Philips agrees that it infringed,” said U.S. District Judge Leonard P. Stark in court papers. The company claims the patents are false as obvious and not properly composed, the judge said.

Philips New York shares fell 1.89 percent to $31.11 at 12:40 p.m. Masimo rose 12 cents to $21.40 in Nasdaq Stock Market trading.



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Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (14.39  +0.64 (4.65%) declared U.S. Patent and Trademark Office has issued U.S. Patent No. 8,846,976. The patent, which expires in 2024, claims a technique of addressing hyperphosphatemia comprised of administering a therapeutically effective amount of an orally administrable form of Ferric Citrate to a subject, wherein the orally administrable form is developed from a ferric citrate active pharmaceutical component having a built-in dissolution rate of at least 1.88/mg/cm2/min. In addition, U.S. Patent No. 8,846,976 contains claims directed to the FDA approved dosing and daily administration of Ferric Citrate.


On September 5, 2014, Ferric Citrate was okayed by the U.S. FDA for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

This recently issued patent further heightens the Company's key patent family, which includes U.S. Patent Nos. 7,767,851, 8,299,298, 8,338,642, 8,609,896, 8,754,257 and 8,754,258, which expire in 2024, and U.S. Patent No. 8,093,423, which expires in 2028, before patent term extension. All of these patents comprises composition and method of use claims covering Ferric Citrate.

Ron Bentsur, Chief Executive Officer of Keryx, pointed out, "The patent that issued now are important in that it links orally administrable forms of Ferric Citrate developed by Keryx's API having an intrinsic dissolution rate of at least 1.88/mg/cm2/min with a method of treatment consistent with the therapeutic claim in the package insert. Furthermore, the timing of issuance, which is merely 3 months after the issuance of U.S. Patent Nos. 8,754,257 and 8,754,258 last June, allows substantiating evidence of our rapidly growing patent portfolio."

The Company continues to pursue additional patent applications for Ferric Citrate, which, if issued, would build up the range of patent claims covering Ferric Citrate beyond 2030.

In the upcoming weeks, the Company plans to file for Patent Term Extension, which, whenever granted, would add up to an extra 5 years to the patent security for Ferric Citrate. Importantly, following FDA approval, the FDA Substance Registration System acquired tetraferric tricitrate decahydrate as the name of the active ingredient authorised for marketing by the FDA, to appropriately describe the Company's proprietary form of ferric citrate.

Mr. Bentsur added, "The novelty of our active ingredient is important because Patent Term Extension is granted for a drug if the drug's active ingredient has not been previously approved by the FDA." Mr. Bentsur added, "To our knowledge, no other approved drugs contain tetraferric tricitrate decahydrate as the active ingredient."



Also Wednesday:

 
Advaxis, Inc. (Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, announced that Dr. Robert Petit, its Chief Scientific Officer, moderated a panel discussion at the Pharmaceutical Strategy Conference on September 30, 2014 in New York.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced that Richard Pascoe, Chief Executive Officer, will present at the 13th Annual BIO Investor Forum on Wednesday, October 8, 2014 at 11:30 a.m. Pacific Time.

Argos Therapeutics, Inc. (Nasdaq:ARGS),
a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform, today announced that Jeff Abbey, president and chief executive officer, will present at the 13th Annual BIO Investor Forum on Wednesday, October 8th, 2014 at 8:30 a.m. Pacific Time.

Assembly Biosciences, Inc. (Nasdaq:ASMB)
announced today that on October 1, 2014, it entered into an agreement with institutional investors for the sale of 1,959,000 shares of its common stock at the price of $8.04 per share, resulting in $15.75 million in gross proceeds to the company.

Avalanche Biotechnologies, Inc. (Nasdaq:AAVL)
, a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today announced that Thomas W. Chalberg, Jr., Ph.D., Founder and Chief Executive Officer, will participate in the "Gene Therapy Ascending? Today's Advancements Over Past Hurdles" panel at the 13th BIO Investor Forum on Wednesday, October 8, 2014 at 10:30 am PDT in San Francisco, CA.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company applying its leadership position in the field of gene therapy and calcium dysregulation, today announced that Krisztina Zsebo, Ph.D., Chief Executive Officer, will present a corporate overview at the 4th Annual Partnering Forum, part of the Stem Cell Meeting on the Mesa to be held October 7-9 in La Jolla, CA.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
today announced that Chief Executive Officer Bob Palay will present at the 4th Annual Partnering Forum, part of the 2014 Stem Cell Meeting on the Mesa to be held October 7-9 in La Jolla, CA.

CytoDyn Inc. (OTCQB:CYDY)
, a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced the appointment of Carl Dockery to its Board of Directors effective September 26, 2014.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR)
today announced the Company has assumed operations of a 62-bed skilled nursing center in Greenville, Kentucky, effective October 1, 2014.

Galectin Therapeutics Inc. (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the Company's abstract titled "Early phase 1 clinical trial results of GR-MD-02, a galectin-3 inhibitor, in patients having non-alcoholic steatohepatitis (NASH) with advanced fibrosis" was accepted as an oral presentation at The Liver Meeting, the 65th Annual Meeting of the American Association for the Study of Liver Diseases.

GrowBLOX Sciences, Inc., a.k.a. GB Sciences (OTCQB:GBLX), a cannabinoid therapy research and development firm, has appointed Peter Emerson to serve as the senior advisor to CEO Craig Ellins.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
, a global developer, manufacturer and marketer of a broad range of solutions to advance life science, has acquired two privately held life science companies: Multi Channel Systems MCS GmbH, headquartered in Reutlingen, Germany, and Triangle BioSystems, Inc., based in Durham, North Carolina, for a total of approximately $11 million in cash.

IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT)
, a Canadian drug delivery company focused on oral drug delivery, today announced, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, that they have submitted a Marketing Authorization Application ("MAA") to the German Federal Institute for Drugs and Medical Devices ("BfArM") seeking European marketing approval of their oral thin film formulation of rizatriptan for acute migraines, under the brand name RIZAPORT®.

Intersect ENT (Nasdaq:XENT),
a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced that the Company has been added to the Russell 2000® index, effective as of the close of market today.

Islet Sciences, Inc. (OTCQB:ISLT)
, a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, and Brighthaven Ventures, L.L.C., d/b/a BHV Pharma ("BHV"), a privately held pharmaceutical company developing the SGLT2 inhibitor remogliflozin etabonate ("remogliflozin") for type 2 diabetes and non-alcoholic steatohepatitis ("NASH"), jointly announced today that, consistent with the letter of intent entered into by Islet Sciences and BHV on March 12, 2014, they have entered into a merger agreement that will combine the operations and development pipelines of the two companies.

Macrocure Ltd. (Nasdaq:MCUR)
, a clinical-stage biopharmaceutical company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that it will hold a Special General Meeting of Shareholders on Wednesday, November 5, 2014 for the purpose of ratifying the election of, and compensation payable to, the Company's external directors, Katherine Wolf and Yuval Yanai.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today its establishment of a melanoma scientific advisory board consisting of internationally renowned experts in oncology and in the development of novel therapeutics for melanoma.

Nuvilex, Inc. (OTCQB:NVLX),
a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that Kenneth L. Waggoner, the Chief Executive Officer, President and General Counsel of Nuvilex, has been appointed Chairman of the Board of Directors and that Prof. Dr. Walter H. Günzburg has been appointed to the post of Chief Scientific Officer.

Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that the company was added to the Russell 2000® Index as part of Russell Investments' quarterly addition of select initial public offering (IPO) companies.

Portola Pharmaceuticals (Nasdaq:PTLA)
today announced that its first Phase 3 study of andexanet alfa, a potential universal Factor Xa inhibitor antidote and U.S. Food and Drug Administration-designated breakthrough therapy, met its primary and secondary endpoints with high statistical significance. Andexanet alfa was well tolerated with no serious adverse events reported.

Portola Pharmaceuticals, Inc. (Nasdaq:PTLA)
today announced that it has commenced an underwritten public offering of shares of its common stock and expects to raise gross proceeds of approximately $160,000,000.

SmallCapVoice.com, Inc. today announced it conducted a new audio interview with PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions.

Radius Health, Inc. (Nasdaq:RDUS)
, a science-driven biopharmaceutical company focused on developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive cancers, today announced that it is commencing an underwritten registered public offering of shares of its common stock.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT), a Canadian drug delivery company focused on oral drug delivery, that they have submitted a Marketing Authorization Application ("MAA") to the German Federal Institute for Drugs and Medical Devices ("BfArM") seeking European marketing approval of RHB-103, an oral thin film formulation of rizatriptan for acute migraines, under the brand name RIZAPORT®.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that the company has initiated a study to confirm this quarter the successful transfer of production of the topical RT001 drug product to Revance's U.S. commercial manufacturing facility.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) today announced that certain of its subsidiaries (the "Issuers") plan to offer, subject to market and other conditions, $150 million aggregate principal amount of additional 5.5% senior notes due 2021 (such additional notes, the "Notes").

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) today announced that certain of its subsidiaries (the "Issuers") have priced and entered into an agreement to issue and sell, subject to certain conditions, $150 million aggregate principal amount of additional 5.5% Senior Notes due 2021 (such additional notes, the "Notes") pursuant to an effective registration statement on Form S-3 filed on May 20, 2013 with the Securities and Exchange Commission (the "SEC").

StemCells, Inc. (Nasdaq:STEM)
announced today that President and CEO Martin McGlynn will make a presentation on the Company's programs and operations at the 4th Annual Partnering Forum, part of the 2014 Stem Cell Meeting on the Mesa, to be held October 7-9.

Surgical Care Affiliates, Inc. (Nasdaq:SCAI)
announced today that Lisa Skeete Tatum has joined its Board of Directors effective October 1, 2014.

Vision-Sciences, Inc. (Nasdaq:VSCI)
, a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced the CE Mark approval and European launch of the company's next generation video bronchoscope and EndoSheath® technology.

Zafgen, Inc. (Nasdaq:ZFGN)
, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company has initiated the first Phase 3 clinical trial, in the United States, with its lead product candidate, beloranib, in the treatment of Prader-Willi syndrome (PWS).

Zogenix, Inc. (Nasdaq:ZGNX)
, a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) for a modified formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, which has been designed to have abuse deterrent properties.



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