Rigel Shares Drop as Fostamatinib Fails Endpoint; Isis Announces Fast Track for ISIS-TTR Rx Print E-mail
By Staff and Wire Reports   
Thursday, 13 December 2012 19:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 13, 2012.

Shares of Rigel Pharma (NASDAQ: RIGL) have plunged more than 30 percent following news from its development partner AstraZeneca (NYSE: AZN) that fostamatinib achieved its primary endpoint but failed to achieve the secondary endpoint. Volume in Rigel is very heavy Thursday.

AstraZeneca today announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA).

OSKIRA-4 was a six month study evaluating improvements in signs and symptoms of RA in 280 patients who had never previously used a disease-modifying anti-rheumatic drug (DMARD), were DMARD intolerant or had an inadequate response to DMARDs and were randomised to receive fostamatinib as a monotherapy, adalimumab as a monotherapy, or placebo. Three dose regimens of fostamatinib were evaluated in OSKIRA-4: 100mg twice daily, 100mg twice daily for a month followed by 150mg once daily, and 100mg twice daily for a month followed by 100mg once daily.

OSKIRA-4 had two primary objectives – a superiority comparison to placebo at 6 weeks and a non-inferiority analysis against adalimumab monotherapy at 24 weeks as measured by change from baseline in DAS28 score (a composite endpoint assessing signs and symptoms of RA).

In the OSKIRA-4 study, fostamatinib as a monotherapy met the first primary objective, showing a statistically significant superior DAS28 score change from baseline compared to placebo at 6 weeks at the 100mg twice daily dose and the 100mg twice daily for a month followed by 150mg once daily dose, but not at the 100mg twice daily for a month followed by 100mg once daily dose.

The OSKIRA-4 study did not meet its second primary objective as all fostamatinib monotherapy doses were inferior to adalimumab monotherapy at week 24 based on DAS28. The adalimumab monotherapy ACR20 result at the 24 week endpoint was 59%.

The safety and tolerability findings for fostamatinib as reported in the OSKIRA-4 study were generally consistent with that previously observed in the TASKi Phase II programme.


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Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced the United States Food and Drug administration has granted ISIS-TTR[Rx] fast track designation for the treatment of familial amyloid polyneuropathy (FAP).  ISIS-TTR[Rx ]is an antisense drug in development with GlaxoSmithKline (GSK) for the treatment of transthyretin (TTR) amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues.  Isis and GSK recently amended the clinical development plan and financial terms relating to ISIS-TTR[Rx ]to support a registration-directed Phase 2/3 clinical study on ISIS-TTR[Rx], which is expected to start this month.

ISIS-TTR[Rx] is part of the Isis-GSK strategic alliance to develop RNA therapeutics for rare and infectious diseases.  Upon initiation of the Phase 2/3 study, Isis will receive a $7.5 million milestone payment and is eligible to earn an additional $50 million in pre-licensing milestone payments to support the Phase 2/3 study of ISIS-TTR[Rx.  ]In addition, Isis is eligible to receive regulatory and sales milestones and double-digit royalties on sales of ISIS-TTR[Rx].



Also Thursday:



Advaxis, Inc., (OTCBB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has received preliminary approval for $796,913 from the sale of certain net operating loss carryovers from prior years through the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority (NJEDA).

Amgen (NASDAQ: AMGN)
announced that its Board of Directors today declared a $0.47 per share dividend for the first quarter of 2013. The dividend will be paid on March 7, 2013, to all stockholders of record as of the close of business on Feb. 13, 2013.

A.P. Pharma, Inc. (OTCBB: APPA.OB)
, a specialty pharmaceutical company, today announced the appointment of Mark S. Gelder, M.D. as senior vice president and chief medical officer.

ArQule, Inc. (Nasdaq: ARQL)
today announced the commencement of patient dosing in a Phase 1 clinical trial with ARQ 087, an orally bioavailable, potent multi-kinase inhibitor with pan-FGFR (fibroblast growth factor receptor) activity.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)
, a specialty biopharmaceutical company, today announced top-line Day 30 data for collagenase clostridium histolyticum or CCH for the potential treatment, if approved by the U.S. Food and Drug Administration (FDA), of adult patients with edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite.

BioScrip, Inc. (NASDAQ: BIOS)
today announced that it has entered into a definitive agreement to acquire HomeChoice Partners, Inc. (“HomeChoice”), a leading provider of alternate-site infusion pharmacy services, for $70.0 million in cash.

GeoVax Labs, Inc. (OTCQB: GOVX)
, an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, was featured in five publications during the past two weeks, a period also marked by the observance of World AIDS Day 2012 on December 1.

HPIL Holding (OTCQB: HPIL)
filed, on Monday, December 10, 2012, a Form10-Q/A (the "10-Q/A") with the U.S. Securities and Exchange Commission (the "SEC") to amend its Form 10-Q for the quarterly period ended September 30, 2012, filed with the SEC on November 19, 2012 (the "10-Q").

Impax Laboratories, Inc. (NASDAQ: IPXL)
announced today that Bryan M. Reasons has been appointed senior vice president and chief financial officer (CFO).

Insmed Incorporated (Nasdaq CM: INSM)
, a biopharmaceutical company focused on developing and commercializing novel, targeted inhaled therapies for patients with high unmet need who are battling serious orphan lung diseases, today announced that the Company will be participating in the 31st Annual J.P. Morgan Healthcare Conference from January 7-10, 2013 at the Westin St. Francis Hotel in San Francisco.

Lpath, Inc. (NASDAQ: LPTN)
today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Mauna Kea Technologies (NYSE Euronext: MKEA)
, leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced today that Cellvizio® has received State Food and Drug Administration (SFDA) approval in China, one of the fastest growing, largest medical device markets in the world.

MediSwipe Inc. (OTCQB: MWIP) (OTCBB: MWIP)
, a merchant payment solutions and financial security products company for the medical health care industry, announced today that 800 Commerce, Inc. has filed the first amendment to the Form S-1 on Friday, December 7, 2012 with the Securities and Exchange Commission.

mPhase Technologies, Inc. (OTCBB: XDSL)
previously announced on Monday, that Pan European Networks has published a profile of mPhase Technologies.

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and MMRPro document management and imaging systems for healthcare professionals, today announced that it has received another Notice of Allowance, U.S. Serial No. 13/352,045, from the United States Patent and Trademark Office.

NewLink Genetics Corporation (Nasdaq: NLNK)
today announced that the results of a  Phase 1 dose escalation study with its proprietary HyperAcute Prostate Cancer Immunotherapy were published in the Journal of Immunotherapy.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today the release of $62.5 million from a restricted escrow account in relation to NuVasive's trademark dispute regarding the NeuroVision® trade name.

Oncolytics Biotech Inc. (TSX: ONC) (NASDAQ: ONCY)
today announced initial positive top line data from the first endpoint in its double-blinded randomized Phase III clinical study examining REOLYSIN in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers (REO 018).

Simulations Plus, Inc. (NASDAQ: SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that its board of directors has decided to accelerate a portion of the expected dividend payments for 2013, in light of uncertainty surrounding taxes on dividends.

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 promising clinical data from investigator-sponsored studies of ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, FOLOTYN® (pralatrexate injection), and belinostat, Spectrum’s novel histone deacetylase (HDAC) inhibitor.

Stevia Corp. (OTCQB: STEV)
("Stevia Corp" or the "Company"), a farm management company focused on the economic development of stevia, the fastest growing product in the alternative sweetener sector, is pleased to announce the expansion of its commercialization phase and first major crop harvest expected in Vietnam during first quarter of 2013.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA)
announced today that it has entered into common stock purchase agreements with members of its Board of Directors and various institutional investors for the sale of 7,000,000 shares of its common stock in an issuer directed, registered direct offering. Shares were priced at $8.60, the consolidated closing bid price as of December 12, 2012, for gross proceeds of approximately $60 million.

Teva Pharmaceutical Industries Limited (NYSE: TEVA)
announced today that Fitch Ratings have assigned to it an initial long term issuer rating of A-, with a stable outlook.

Therapeutic Solutions International, Inc. (OTCQB: TSOI)
announced today the signing of an agreement with Serene Medikal Dis Ticaret Limited Sirketi, a dental supply company headquartered in Izmir Turkey for the distribution of Therapeutic Solutions International's AMPSA products in Turkey.

ZELTIQ Aesthetics, Inc. (Nasdaq: ZLTQ)
, a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, announced it successfully secured an unopposed settlement and permanent injunction against Marco Hallerbach, MD, doing business as Dr. Hallerbach & Associates.



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