|Sanofi And Regeneron Report Positive Preliminary Phase 2 Results for Anti-PCSK9; Watson Confirms Appeals Court Decision Rejecting Teva's Injuction|
|By Staff and Wire Reports|
|Thursday, 10 November 2011 20:38|
Sanofi SA (NYSE:SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced positive preliminary results from the Phase 2 study program in which patients with elevated low-density lipoprotein cholesterol (LDL-C) were treated with REGN727/SAR236553. REGN727/SAR236553 is a high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).
Blocking the PCSK9 pathway is a mechanism for lowering LDL-C, the known risk factor for coronary artery disease. One Phase 2 trial studied patients with heterozygous familial hypercholesterolemia (heFH) with elevated cholesterol (LDL-C>/=100mg/dL) despite lipid lowering therapy (statins with or without ezetemibe). The objective of the study was to compare the effect of adding REGN727/ SAR236553 to the existing lipid lowering therapy in heFH patients.
Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed the United States Court of Appeals for the Federal Circuit affirmed the district court's June 16, 2011 denial of Duramed Pharmaceuticals, Inc.'s request for a preliminary injunction to prevent Watson from selling generic SEASONIQUE® (levonorgestrel/ethinyl estradiol (0.15 mg/0.03 mg) and ethinyl estradiol (0.01 mg)).
Watson launched Amethia™ (levonorgestrel/ethinyl estradiol (0.15 mg/0.03 mg) and ethinyl estradiol (0.01 mg)), its generic version of SEASONIQUE®, on July 28, 2011.
Amethia™ and SEASONIQUE® are indicated for the prevention of pregnancy.
Adolor Corporation (NasdaqGM: ADLR) today reported net sales of ENTEREG® (alvimopan) of $7.8 million for the three months ended September 30, 2011, a 20% increase compared to net sales of $6.5 million for the three months ended September 30, 2010.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today reported financial and operating results for the quarter ended September 30, 2011.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today presented longer-term data from the extensions of two pivotal phase 2 studies of Soliris®(eculizumab) in patients with atypical hemolytic uremic syndrome (aHUS): (i) a study in patients with a long duration of disease prior to receiving intervention with Soliris following chronic plasma exchange/infusion (PE/PI) and (ii) a study in patients with a shorter duration of disease prior to intervention with Soliris who had progressive clinical complications despite intensive PE/PI.
Aradigm Corporation (OTCBB:ARDM) (the “Company”) today announced financial results for the third quarter and nine months ended September 30, 2011.
ArQule, Inc. (NASDAQ: ARQL) and Daiichi Sankyo, Co. Ltd. (TSE 4568) announced today the execution of a license agreement for the development of a new AKT inhibitor called ARQ 092, the first compound to emerge from the companies’ November 2008 agreement to collaborate on research utilizing the AKIP™ (ArQule Kinase Inhibitor Platform) technology to generate novel, selective and potent small molecule kinase inhibitors.
Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in oncology, obesity, and regenerative medicine, today announced the publication of data from Ablaris Therapeutics, Inc.’s lead drug candidate, Adipotide™, demonstrating weight loss and reduction in body mass index and abdominal circumference in obese rhesus monkeys.
ArQule, Inc. (NASDAQ: ARQL) today reported its results of operations for the fiscal quarter and nine months ended September 30, 2011.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it has initiated a confirmatory pharmacokinetic study of a formulation of buprenorphine and naloxone utilizing BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology.
Biostar Pharmaceuticals, Inc. (NASDAQ GM: BSPM) ("Biostar" or "the Company"), a developer, manufacturer and marketer of pharmaceutical and health supplement products for a variety of diseases and conditions, today announced that it will issue its financial results for the third quarter and nine months ended September 30, 2011 on Monday, November 14th after the close of the market.
Cardica, Inc. (Nasdaq: CRDC) today announced that Bernard A. Hausen, M.D., Ph.D., the company's president and chief executive officer, is scheduled to present a corporate overview and update at the following conferences.
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced financial results for the third quarter ended September 30, 2011, and provided a business update including development progress with ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin currently under evaluation in a pivotal Phase III study, the HEAT Study, in patients with non-resectable primary liver cancer (hepatocellular carcinoma or "HCC").
Cerus Corporation (NASDAQ:CERS) announced today that it has signed a new two-year agreement commencing November 9, 2011 with the French national blood service, the Etablissement Francais du Sang (EFS), to supply INTERCEPT Blood System disposable kits for platelets and plasma.
Cisco (NASDAQ: CSCO) today announced the launch of its Cisco healthcare solution pilot in collaboration with the Government of Madhya Pradesh (MP) in Sehore.
Cytori Therapeutics, Inc. (NASDAQ: CYTX) will webcast their corporate presentation at the Lazard Capital Markets 8th Annual Healthcare Conference at 9:30 AM (ET) on Wednesday, November 16, 2011 in New York.
DHS Holding, Co. (PINKSHEETS: DHSM) -- Charlie Barrett, President and Chief Operating Officer, announced today that DHS Holding, Co. has extended their contract with UA Multimedia for an additional two years.
Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to improving the standard of respiratory critical care, today reports financial results for the third quarter ended September 30, 2011, as well as the status of the SURFAXIN® and AFECTAIR™ programs.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced two-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards SAPIEN transcatheter heart valve, which was approved last week by the United States Food and Drug Administration (FDA).
Eli Lilly and Company (NYSE: LLY) Chairman, President and Chief Executive Officer John C. Lechleiter, Ph.D., today said new trade agreements, effective public policies, and continued collaboration to bring innovation to patients are needed to assure improved health and economic prosperity in the Asia-Pacific region.
GenMark Diagnostics, Inc. (Nasdaq:GNMK) today reported financial results for the third quarter ended September 30, 2011.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today the appointment of William “Bill” Sibold as Head of Multiple Sclerosis and Rogério Vivaldi as Head of Rare Diseases.
GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based biopharmaceutical firm (the "Company") developing vaccines that prevent and fight Human Immunodeficiency Virus (HIV) infections, today announced its financial results for the nine months ended September 30, 2011.
GTx, Inc. (Nasdaq: GTXI) announced today that management will present a company overview on November 15, 2011 at the Lazard Capital Markets Annual Healthcare Conference in New York City.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that its Magellan™ Robotic System will be presented at the upcoming 38th annual VEITHsymposium™ November 16-20 at the Hilton New York in New York City.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today reported financial results for the three and nine months ended September 30, 2011 and the filing with the U.S. Securities and Exchange Commission (“SEC”) of the Company’s Quarterly Report on Form 10-Q.
Medtronic, Inc. (NYSE: MDT) announced today it will report financial results for the second quarter of its fiscal year 2012 on Tuesday, November 22, 2011.
Merck (NYSE:MRK), known outside the United States and Canada as MSD, today is hosting a R&D and Business Briefing.
Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that Dr. Mark Pykett, Neoprobe’s President and Chief Executive Officer, will deliver a presentation to institutional investors at 2:00 PM ET, Tuesday, November 15, 2011 at the Lazard Capital Markets Healthcare Conference, taking place at The Pierre Hotel, New York.
NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim results from its ongoing FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) study, showing patients experience a better overall quality of life while undergoing more frequent dialysis with the NxStage System One™, including more satisfaction with physical intimacy.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) ("Oncolytics") today announced the appointment of Gerard Kennealey, MD as Senior Vice President of Clinical Development and Chief Medical Officer (CMO).
Palatin Technologies, Inc. (NYSE Amex: PTN) will announce its first quarter, fiscal year 2012 financial results on Tuesday, November 15, 2011 before the open of the U.S. financial markets.
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces that data from its Phase 2 PV-10 metastatic melanoma study will be presented at the 2011 International Melanoma Congress on November 12, 2011, during the 5th Meeting of Interdisciplinary Melanoma/Skin Cancer Centres meeting.
Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended September 30, 2011.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced the Company's participation at the Lazard Capital Markets 8th Annual Healthcare Conference at the Pierre Hotel in New York CityNovember 15-16, 2011.
Star Nutrition, Inc. (PINKSHEETS: STAU), a California-based diversified health and wellness industry firm, announced today that the company will be attending the 19th Annual World Congress on Anti-Aging and Aesthetic medicine.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced third quarter 2011 financial results for the three month period ended September 30, 2011.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced results presented at the Chemotherapy Foundation Symposium showing that ganetespib can sensitize rectal cancer cells to chemoradiotherapy through inhibition of Hsp90.
UV Flu Technologies, Inc.(OTCBB: UVFT) (the "Company") is pleased to announce it has expanded its International Distribution by adding representation in Oman, and Sri Lanka, while continuing to expand its relationship with the Company's Distributor in India, Ormed Systems, a leader in medical equipment sales and services throughout India, as well as other parts of the world.
VirtualScopics, Inc. (NASDAQ: VSCP), a leading provider of quantitative imaging for clinical trials, today reported year to date revenues of $10,780,710 for the nine months ended September 30, 2011 compared to $9,883,190 in the comparable period in 2010, a 9% increase.
VisualMED Clinical Solutions Corp. (PINKSHEETS: VMCS) (FRANKFURT: VA6.F) announces quarterly results for the first quarter of fiscal 2012.
VIVUS, Inc. (NASDAQ: VVUS) today announced that multiple abstracts will be presented at the Sexual Medicine Society of North America (SMSNA) on November 12, 2011 in Las Vegas, NV.