Shire Says Lifitegrast Did Not Meet Prespecified Co-Primary Endpoint; Dyax Receives FDA Orphan Drug Designation for DX-2930 Print E-mail
By Staff and Wire Reports   
Thursday, 05 December 2013 20:03
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 5, 2013.

Shire plc (NASDAQ: SHPG), the global specialty biopharmaceutical company, today announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution. OPUS-2 compared lifitegrast to placebo administered twice daily for 84 days (12 weeks) in dry eye patients with history of active artificial tear use within 30 days prior to screening. Lifitegrast met the prespecified co-primary endpoint for the patient-reported symptom of eye dryness (change in Eye Dryness Score from baseline to week 12) (p-value<0.0001). Lifitegrast did not meet the prespecified co-primary endpoint for the sign of inferior corneal staining score (change from baseline to Week 12) using fluorescein staining compared with placebo (p-value=0.6186).

"In this clinical trial, we note that lifitegrast showed a statistically significant improvement in the prespecified symptoms of dry eye disease and is the first drug to do so in a phase 3 clinical trial," said Flemming Ornskov, M.D., Chief Executive Officer, Shire. "We will be examining the totality of the data for lifitegrast in OPUS-2, as well as OPUS-1 and across the entire clinical trial program. We look forward to discussing the lifitegrast program with regulatory authorities."

The study also evaluated the safety and tolerability of lifitegrast based on occurrence of treatment-emergent adverse events (TEAEs). The most commonly reported TEAEs associated with lifitegrast were dysgeusia (altered sense of taste) (16.2% vs 0.3% for placebo), instillation site irritation (7.8% vs 1.4% for placebo), instillation site reaction (7.0% vs 1.1% for placebo) and visual acuity reduced (5.0% vs 6.4% for placebo). There were no ocular serious TEAEs or drug-related serious TEAEs. 93.2% of patients enrolled in the study remained for the entire duration of the 12-week clinical trial.



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Dyax Corp. (NASDAQ: DYAX)
announced the U.S. FDA has granted orphan drug designation to its drug candidate DX-2930, its fully human monoclonal antibody inhibitor of plasma kallikrein, for use in the treatment of hereditary angioedema (HAE).

Dyax is developing DX-2930 to be a long-acting, prophylactic agent that prevents HAE attacks. Development plans include a dosage formulation that will permit infrequent self-administration by small volume, subcutaneous injection. DX-2930 is currently being studied in a placebo-controlled, dose-escalation Phase 1 trial in normal individuals. Results from this study are expected in the first quarter of 2014.

“Through our experience in the development and commercialization of KALBITOR® (ecallantide), we have gained a deep understanding of the HAE market and patient needs,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “There is still a significant unmet medical need within the HAE community which we plan to address with DX-2930. Orphan drug designation is an important element of our development strategy for DX-2930 as we work to further improve the health and quality of life for individuals suffering from this painful and often debilitating condition.”

Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides FDA assistance in clinical trial design, an exemption from FDA user fees and eligibility for a seven-year period of market exclusivity in the U.S. after product approval.



Also Thursday:



ACETO Corporation (Nasdaq:ACET)
, a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, today announced that its Board of Directors has declared a regular quarterly dividend of $0.06 per common share.

Allerayde SAB, Inc. (OTCQB:ASAB)
today announced that the company achieved second place in the prestigious Galileo Masters Competition organized by the European Space Agency.

Pomerantz Grossman Hufford Dahlstrom & Gross LLP is investigating claims on behalf of investors of Ambit Biosciences Corporation (NASDAQ: AMBI).  

Amgen (NASDAQ: AMGN) will participate at the Oppenheimer 24th Annual Healthcare Conference on Tuesday, Dec. 10, 2013, at the Crowne Plaza in New York City, beginning at 9:45 a.m. Eastern Standard Time.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today a Company-wide operational excellence program designed to save $15 million to $18 million during the course of the next three years.

Biota Pharmaceuticals, Inc. (Nasdaq:BOTA)
today announced that it has commenced dosing patients in the Northern Hemisphere portion of its ongoing Phase 2, randomized, double blind, placebo controlled, parallel arm clinical trial of laninamivir octanoate (LANI).

Further advancing one of the largest Phase III trials for head and neck cancer in the world, CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has received approval from the Agency for Medicaments and Medical Devices of the government of Bosnia and Herzegovina to begin enrollment of subjects into the Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection).  

CEL-SCI Corporation (NYSE MKT: CVM)
today announced that it has signed a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for CEL-SCI’s investigational immunotherapy drug Multikine (“Leucocyte Interleukin Inj.”) in HIV/HPV co-infected women with cervical dysplasia.  Human Papilloma Virus (HPV) is the most common sexually transmitted disease.

Cerner Corp. (Nasdaq:CERN)
and Claritas Genomics announce that the companies will work together to advance personalized medicine by building tools and connectivity that will better integrate next generation sequence (NGS)-based diagnostic testing into health care practice.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that the American College of Obstetricians and Gynecologists (ACOG) has issued new guidelines indicating that chromosomal microarray analysis (CMA) is now recommended as the first-line genetic test in pregnancies showing fetal abnormalities on an ultrasound screen.

The Cooper Companies, Inc. (NYSE:COO)
today announced financial results for the fiscal fourth quarter and full year ended October 31, 2013.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP)
announced today the first dosing of a pilot bioequivalence study in healthy volunteers for ELI-201, the Company's twice daily abuse deterrent oxycodone/naltrexone product.

Endologix, Inc. (Nasdaq:ELGX)
today announced the pricing of its public offering of $75 million aggregate principal amount of convertible senior notes due 2018 in an offering registered under the Securities Act of 1933, as amended.

Fresh Start Private Management Inc. (OTCQB: CEYY)
, a leader in alcohol treatment and rehabilitation programs, announced today that the second clinic in California that will be offering their alcohol addiction program will open for business this Monday, December 9, 2013.

LHC Group Inc. (Nasdaq:LHCG)
, a national provider of post-acute care services, announced today that Keith G. Myers, chief executive officer of LHC Group, will present at the Oppenheimer 24th Annual Healthcare Conference in New York City, on Tuesday, December 10, 2013.

Ingen Technologies Inc. (OTC:IGNT), the holding company of two subsidiaries; a medical device manufacturing company selling its patented medical products worldwide, and a newly acquired growing telecom business providing services to major telecom companies worldwide, announces today that pursuant to a special meeting held by the Board of Directors on December 1st, 2013, the Board had majority vote to move all of the assets and liabilities, including shareholder equity and all of its note holders to a OTCQB listing.

KaloBios Pharmaceuticals, Inc. (Nasdaq:  KBIO)
, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a composition of matter patent covering certain antibodies targeting EphA3, including KaloBios' experimental anti-cancer monoclonal antibody (mAb), KB004.  

Karyopharm Therapeutics Inc. (Nasdaq:KPTI)
, a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, announced today that Michael Kauffman, Chief Executive Officer, will present at the Oppenheimer 24th Annual Healthcare Conference on Wednesday, December 11, at 2:45 p.m. ET.

Myriad Genetics, Inc. (Nasdaq:MYGN)
announced today that it will be hosting an investor event for research analysts and institutional investors on Thursday, December 12, 2013 at 8:30 p.m. EST in San Antonio, Texas.

Nature's Sunshine Products, Inc. (Nasdaq:NATR)
, a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today announced that Gregory L. Probert, Chairman and Chief Executive Officer, and Steve Bunker, Chief Financial Officer, will participate in the Wedbush 14th Annual California Dreamin' Consumer Conference to be held December 10, 2013 at Le Parker Meridien Hotel in New York City.

Pluristem Therapeutics Inc. (NASDAQCM: PSTI) (TASE:PLTR)
, a leading developer of placenta-based cell therapies, announced today that the Israeli Ministry of Health has approved the company’s request to initiate a Phase II study using its PLacental eXpanded (PLX) cells in the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).

The Johns Hopkins Health System has expanded its relationship with Premier, Inc. (Nasdaq:PINC) to support system-wide improvements in supply chain efficiency.

Receptos, Inc. (Nasdaq:RCPT)
announced today that the Company has completed a pre-planned interim analysis of the Phase 2 portion of RADIANCE, its Phase 2/3 trial of RPC1063 in relapsing multiple sclerosis (RMS).

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the Oppenheimer 24th Annual Healthcare Conference on Wednesday, December 11, 2013 at 7:45 AM ET.

TG Therapeutics, Inc. (Nasdaq:TGTX)
today announced that the following abstracts for TGR-1202, the Company's PI3K delta inhibitor, have been selected for poster presentation at the upcoming 55th Annual Meeting of the American Society of Hematology (ASH), to be held December 7 -10, 2013, at the Ernest N. Morial Convention Center, New Orleans, LA.



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