Anacor Announces Completion of End-of-Phase 2 Meeting With FDA for AN2728; Integra LifeSciences Receives FDA Clearance for Integra(R) Print E-mail
By Staff and Wire Reports   
Thursday, 27 February 2014 21:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 27, 2014.

Anacor Pharmaceuticals (NASDAQ: ANAC)
announced it has successfully completed an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) for the topical treatment of mild-to-moderate atopic dermatitis with AN2728 Ointment, 2%, a novel boron-based phosphodiesterase-4 (PDE-4) inhibitor. Atopic dermatitis is a chronic rash characterized by inflammation and itch and affects 10% - 20% of infants and young children.

“We have reached agreement with the FDA on all major parameters for the Phase 3 trials, which we expect to initiate in the next 60 days,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. “Based on the clinical studies conducted to date, we believe AN2728 has the potential to offer patients and physicians a safe and effective topical treatment option for mild-to-moderate atopic dermatitis, providing a potential alternative to treating with topical corticosteroids or topical calcineurin inhibitors.”

Phase 3 Trial Design and Endpoints -- Anacor will conduct two multi-center, double-blind, placebo-controlled trials with approximately 750 subjects per trial randomized 2:1 (active:vehicle). Both studies will be conducted at multiple sites and enroll subjects ages two years and up with mild-to-moderate atopic dermatitis. Mild-to-moderate atopic dermatitis is defined as an Investigator Static Global Assessment (ISGA) score of 2 (“mild”) or 3 (“moderate”). The ISGA is a 5-point scale from 0 (“clear”) to 4 (“severe”). AN2728 Ointment, 2% will be applied twice daily for 28 days. The primary efficacy endpoint will be treatment success at Day 29, defined as an ISGA of “Clear” or “Almost Clear” with at least a 2-grade improvement from baseline. Secondary endpoints will include an ISGA of “Clear” or “Almost Clear” at Day 29 as well as time to treatment success. Safety evaluation will include reported adverse events, safety laboratory tests, and vital signs.

Anacor will also initiate a long-term safety trial to evaluate the safety of intermittent use of AN2728 Ointment, 2% for up to 12 months. Subjects who complete either Phase 3 trial will have the option to roll into the long-term safety trial until approximately 500 subjects are enrolled. At least 100 subjects will be enrolled for 12 months and at least 300 subjects will be enrolled for 6 months, during which time subjects will be treated as needed under the direction of the investigator.



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Integra LifeSciences Holdings Corporation (Nasdaq: IART)
announced the introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle. The system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and will be featured at the American College of Foot and Ankle Surgeons (ACFAS) 72nd Annual Scientific Conference, February 27 – March 2, 2014, in Orlando, Florida.

The Integra Titanium Bone Wedges may be used in corrective procedures, such as Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. They are composed of commercially pure titanium formed into a cancellous-like structure that mimics the strength and porosity of human bone. The Integra Titanium Bone Wedge is available in 15 different pre-shaped anatomical sizes, to accommodate various skeletal deformities in the foot.

"We're very pleased that we can now offer surgeons another option to complete our flatfoot correction portfolio," said Robert Paltridge, President, Extremity Reconstruction. "Our Titanium Bone Wedges provide more stability over allograft wedges. Additionally, our extensive line of pre-shaped bone wedge implants does not require custom shaping, which helps reduce surgical time."

Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Bone wedges are designed to provide bone grafting material for osteotomy corrections. They provide a scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. Ancillary plates are used to hold bone graft material in place and prevent it from expulsion.



Also Thursday:


Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced today that the company will participate in the Cowen and Company 34th Annual Healthcare Conference in Boston.

Amarin Corporation plc (Nasdaq:AMRN)
, a late stage biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for the quarter and year ended December 31, 2013, and provided an update on company operations.

Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases, today announced that John F. Crowley, Chairman and Chief Executive Officer, will present a corporate overview at the Cowen and Company 34th Annual Health Care Conference on Tuesday, March 4, 2014 at 10:00 a.m. ET.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that it has expanded its management team with the appointment of Lawrence A. Kenyon as Chief Financial Officer.

AtheroNova Inc. (OTCBB:AHRO)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced the release of preliminary findings from its Phase 1 clinical trial with its lead compound, AHRO-001.

Balchem Corporation (Nasdaq:BCPC)
reported as follows (unaudited) for the period ended December 31, 2013.

Celladon Corporation (Nasdaq:CLDN),
a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, announced today the full exercise and closing of the underwriters' option to purchase 825,000 additional shares of common stock in connection with Celladon's previously announced initial public offering of 5,500,000 shares of common stock, at a price to the public of $8.00 per share, bringing the total gross proceeds from the offering to $50.6 million before deducting underwriting discounts and commissions and other offering expenses payable by Celladon.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today that it will report financial results for the fourth quarter ended December 31, 2013, on Friday, March 7, 2014, before the market opens.

Codexis, Inc. (Nasdaq:CDXS)
, a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced the appointment of Patrick Yang, Ph.D., to its board of directors.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, today announced financial results for the three and twelve months ended December 31, 2013.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
, a global developer, manufacturer, and marketer of a broad range of specialized products to advance life science research, today reported financial highlights for the fourth quarter and full year ended December 31, 2013.

Hyperion Therapeutics, Inc. (Nasdaq:HPTX)
today reported net revenue of $18.6 million and $42.2 million for the fourth quarter and full year 2013, respectively. Hyperion's revenues are for sales of its two products for the treatment of urea cycle disorders, RAVICTI® (glycerol phenylbutyrate) Oral Liquid, launched on March 1, 2013 and BUPHENYL® (sodium phenylbutyrate) Tablets and Powder acquired on May 31, 2013.

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX),
a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the year ended December 31, 2013.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced the introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle.

LDR Holding Corporation (Nasdaq:LDRH)
, a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today reported its financial results for the fourth quarter and year ended December 31, 2013.

LipoScience, Inc. (Nasdaq:LPDX)
today announced that Howard Doran, President and Chief Executive Officer, and Lucy Martindale, Executive Vice President and Chief Financial Officer, will present at the Barclays Global Healthcare Conference at 11:15 A.M. ET on Wednesday, March 12, 2014, in Miami, FL.

Medical Marijuana Inc. (OTC Pink: MJNA)
and HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. – proudly announces that FOX 5 News San Diego featured the non-psychoactive industrial hemp cannabidiol (CBD)-rich hemp oil products that HempMedsPX™ represents in their recent news segment entitled, "Healing with Hemp." 

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK), a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer, today announced its fourth quarter and full year 2013 financial results.

MRI Interventions, Inc. (OTCQB:MRIC)
announced today that its novel ClearTrace® system for MRI-guided, catheter-based cardiac procedures will be featured in a presentation at the 7th Annual Western Atrial Fibrillation (AF) Symposium on Feb. 28-March 1 in Park City, Utah.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that the Company will present at multiple conferences in March.

Novavax, Inc. (Nasdaq:NVAX)
announced today the execution of a contract modification to extend the base period of performance of its current contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Novavax' recombinant seasonal and pandemic influenza vaccines.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, today announced the appointment of Russell ("Russ") Harrison to its board of directors, effective February 26, 2014.

QLT Inc. (Nasdaq:QLTI) (TSX:QLT)
announced positive preliminary results from its international, multi-center, Phase 1b clinical trial of repeated treatments of oral QLT091001 in subjects with Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) due to inherited genetic mutations in retinal pigment epithelium (RPE65) or lecithin:retinol acyltransferase (LRAT).

Salix Pharmaceuticals Ltd. (Nasdaq:SLXP)
and RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) today announced that they have entered into an exclusive agreement by which Salix has licensed the worldwide exclusive rights to RedHill's RHB-106 encapsulated formulation for bowel preparation and rights to other purgative developments.

Scientific Industries Inc. (OTCBB:SCND)
, announced that it has acquired from Fulcrum Inc., (the "Seller") its laboratory and pharmacy balance and digital scale business and related assets through an Asset Purchase Agreement with the seller and its principal stockholders, including its Chief Operating Officer.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today announced the pricing of an underwritten public offering of 4,650,000 shares of common stock together with two warrants to purchase one share of the company's common stock.

Surgical Care Affiliates, Inc. (Nasdaq:SCAI)
today announced that it will release its fourth quarter and year end 2013 financial results on Thursday, March 13, 2014, after the market closes.

Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, will announce financial results for the fourth quarter and year ended December 31, 2013 on Wednesday, March 5, 2013 after the markets close.

Salix Pharmaceuticals Ltd. (Nasdaq:SLXP)
and RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) today announced that they have entered into an exclusive agreement by which Salix has licensed the worldwide exclusive rights to RedHill's RHB-106 encapsulated formulation for bowel preparation and rights to other purgative developments.

The Spectranetics Corporation (Nasdaq:SPNC)
today reported financial results for the quarter and year ended December 31, 2013.

Vitacost.com, Inc. (Nasdaq:VITC)
, a leading online retailer of healthy living products, today reported financial results for the fourth quarter ended December 31, 2013.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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