Vertex Enters Agreement with GlaxoSmithKline for Phase 2 All-Oral Study; Anthera Announces the Acceptance of Phase 2b PEARL-SC Print E-mail
By Staff and Wire Reports   
Thursday, 01 November 2012 19:33

Below is a look at some of the headlines for companies that made news in the healthcare sector on November 1, 2012. Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced it has entered into a non-exclusive agreement with GlaxoSmithKline (NYSE:GSK) to conduct a Phase 2 proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing Vertexs nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and GSKs NS5A inhibitor GSK2336805. Vertex and GSK plan to initiate the study in early 2013, pending discussions with regulatory authorities. The study is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of VX-135 and GSK2336805. The companies will jointly fund costs associated with the study. There are no up-front or milestone payments associated with the agreement. VX-135 is an investigational uridine nucleotide analogue pro-drug designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. GSK2336805 is an investigational NS5A replication complex inhibitor being developed by GSK for the treatment of hepatitis C.

This agreement underscores our broad commitment to develop all-oral treatment regimens for people with hepatitis C using medicines within our own pipeline and by working in collaboration with other companies like GSK who share our commitment to further improve treatment of this disease, said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. We are focused on the development of new all-oral treatments for hepatitis C that have the potential to provide a high cure rate with only 12 weeks of treatment, and we look forward to the start of this study with GSK.



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Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH)
, a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced that an abstract of the results from the Phase 2b PEARL-SC clinical study examining the treatment effect of blisibimod in systemic lupus erythematosus patients has been accepted as a late-breaking poster presentation at the 2012 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP).

"We are pleased to have this opportunity to share the PEARLS-SC responder analyses and sub-population results with the rheumatology community," said Colin Hislop, MD, Anthera's Senior Vice President and Chief Medical Officer. "In PEARL-SC, blisibimod demonstrated a clinically meaningful treatment effect in patients with severe disease who continued to have active lupus despite corticosteroid use. This highlights blisibimod's potential to help patients with more active and severe disease as we move forward with our Phase 3 clinical trials."

The poster entitled, "Blisibimod, an Inhibitor of B Cell Activating Factor, in Patients with Moderate-to-Severe Systemic Lupus Erythematosus," is scheduled to be presented by Dr. Richard Furie on Tuesday, November 13, from 9 am 11 am Eastern Time (Presentation Number L6).


Also Thursday:


AeroGrow International, Inc. (OTCQB: AEROD)
("AeroGrow" or the "Company") announced that it has reached a new agreement with Amazon.com, the world's largest online retailer, to carry its AeroGarden® line of indoor gardening products.

Affymetrix, Inc. (NASDAQ:AFFX)
today introduced Axiom® Biobank Arrays, a flexible and high-powered functional biology solution for affordably genotyping large sample collections such as those screened at biobanks, genome centers, and core labs.

Alkermes plc (NASDAQ: ALKS)
today reported financial results for its second quarter of fiscal 2013, which ended Sept. 30, 2012, and the company provided improved financial expectations for its fiscal year 2013, which will be the first full fiscal year of the combined company, Alkermes plc (Alkermes), following the completion of the merger of Alkermes, Inc. with Elan Drug Technologies (EDT) on Sept. 16, 2011.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company focused on the development and commercialization of Feraheme® (ferumoxytol) Injection for intravenous (IV) use to treat iron deficiency anemia (IDA), today reported unaudited consolidated financial results for the third quarter ended September 30, 2012.

Array BioPharma Inc. (Nasdaq: ARRY)
will hold a conference call on Monday, November 5, 2012 at 4:30 p.m. Eastern Time to discuss submitted 2012 American Society of Hematology Annual Meeting abstracts on ARRY-520, a KSP inhibitor for multiple myeloma and ARRY-614, a dual p38/Tie2 inhibitor for myelodysplasticsyndromes.

ArQule, Inc. (NASDAQ: ARQL)
today reported its results of operations for the fiscal quarter and nine months ended September 30, 2012.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in Europe and Eurasia, announced today that it will host a conference call and live audio webcast at 4:30 p.m. EST on Thursday, November 8, 2012 to report its third quarter 2012 financial results and provide a corporate update.

BioTech Medics, Inc. (PINKSHEETS: BMCS)
announced that it has signed a Letter of Interest for a $5 million U.S. cross-marketing licensing contract for its patented SHBAN Alcohol Free Persistent Hand & Body Sanitizer with LifeBionix, Inc.

Celldex Therapeutics, Inc. (NASDAQ: CLDX)
today reported financial results for the third quarter ended September 30, 2012.

Cytori Therapeutics (NASDAQ: CYTX)
will provide a live webcast of its third quarter financial results and business update on Thursday, November 8, 2012 at 5:00 PM Eastern Time.

Emergent BioSolutions Inc. (NYSE: EBS)
announced today a growth plan designed to advance the company’s leadership position in the biodefense field and expand its product offerings in specialty pharma markets, thereby expanding revenues, growing net income and creating shareholder value.

Halozyme Therapeutics, Inc. (NASDAQ: HALO)
will webcast its Quarterly Update Conference Call for the third quarter 2012 on Thursday, November 8, 2012 at 4:30 p.m. ET/1:30 p.m. PT. Gregory I. Frost, President and Chief Executive Officer, will lead the call.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that it will release its financial and operating results for the third quarter ended September 30, 2012 after market close on Wednesday, November 7, 2012.

ICON (NASDAQ:ICLR)
(ISIN:IE0005711209) , a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the third quarter ended September 30, 2012.

ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC)
provided an update on recent 2012 achievements and anticipated milestones following the closing of its follow-on financing.

Incyte Corporation (Nasdaq: INCY)
today reported third-quarter 2012 financial results, including revenue from its first commercial product, Jakafi® (ruxolitinib), which was approved by the U.S. Food & Drug Administration (FDA) for the treatment of patients with intermediate or high-risk myelofibrosis (MF) in November 2011.

Life Technologies Corporation (NASDAQ: LIFE)
today announced results for its third quarter ended September 30, 2012. Revenue for the third quarter was $911 million, a decrease of 1.9 percent over the $929 million reported for the third quarter of 2011.

Life Technologies Corporation (NASDAQ: LIFE)
has received a Letter of No Objection from the U.S. Department of Agriculture -- Food Safety and Inspection Service (USDA-FSIS) for its RapidFinder™ STEC (Shiga-toxin producing Escherichia coli) Detection system.  

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP)
today announced financial results for the third quarter ended September 30, 2012.

Medicure Inc. (TSX VENTURE:MPH) (PINKSHEETS:MCUJ)
, announced today that, further to its news release of September 21, 2012, the TSX Venture Exchange (the "Exchange") has approved the consolidation of the Company's issued and outstanding common shares on the basis of one post-consolidation common share for every fifteen pre-consolidation common shares and the Company has proceeded with the consolidation.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
today announced its financial results for the quarter and nine months ended September 30, 2012. For the third quarter of 2012, the Company reported a net loss of $3.1 million, or $0.05 loss per share, compared to net income of $31.4 million, or income of $0.56 per fully diluted share outstanding, for the same period in 2011.

NeuroMetrix, Inc. (Nasdaq: NURO)
, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today announced the signing of a distribution agreement with OneSource Medical Group, LLC (OSMG) of Clearwater, Florida for its SENSUS™ pain management device.

Omeros Corporation (NASDAQ: OMER)
today announced that the first subject has been enrolled in the Company's Phase 1 clinical trial evaluating OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today reported its financial results for the third quarter 2012.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it will report financial results for the third quarter ended September 30, 2012 after the market closes today.

PAREXEL International Corporation (NASDAQ: PRXL)
announced today that it will be presenting at the Morningstar Conference in Chicago.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX)
today announced consolidated financial results for the quarter ended September 30, 2012 and provided updates on the commercial launch of EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain in the United States.

Rite Aid Corporation (NYSE: RAD)
today announced sales results for October.

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC)
today reported financial results for the third quarter of 2012 and recent accomplishments.

Sanofi (EURONEXT: SAN and NYSE: SNY)
and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that results from a Phase 2 trial of SAR236553/REGN727 in patients with primary hypercholesterolemia were published in the October 31, 2012 issue of the New England Journal of Medicine.

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 Company is undertaking a strategic strengthening of its sales force in the U.S.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP)
, a global pharmaceutical company, today announced that it will host a webcast and teleconference with senior management to discuss its financial results and operating highlights for the second quarter and nine-month periods ended September 30, 2012, on Thursday, November 8, 2012, at 5:00 pm Eastern.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
today reported results for the quarter ended September 30, 2012.




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