Raptor's PROCYSBI(TM) Receives U.S. Orphan Drug Exclusivity; XOMA's Development Partner SERVIER Launches Proof-of-Concept Clinical Program for Gevokizumab Print E-mail
By Staff and Wire Reports   
Tuesday, 25 June 2013 18:59

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 25, 2013. Raptor Pharmaceutical Corp. (Nasdaq: RPTP) announced that the Office of Orphan Product Development at the Food and Drug Administration (FDA) granted Raptor orphan drug exclusivity for PROCYSBI™ (cysteamine bitartrate) delayed-release capsules for the management of nephropathic cystinosis patients age six and older. The exclusivity period began on the date of FDA approval, April 30, 2013, and lasts seven years subject to certain exceptions.

"This decision was the outcome of a productive and cooperative process with the FDA. We believe the issuance of orphan drug exclusivity highlights an appreciation that PROCYSBI is an important new therapeutic option for nephropathic cystinosis patients," stated Thomas E. Daley, chief business officer of Raptor. "The exclusivity also adds incremental protection alongside our issued patents listed in the FDA's Orange Book with expirations in 2027."


XOMA Corporation (Nasdaq: XOMA)
, a leader in the discovery and development of therapeutic antibodies, announced its development partner, SERVIER, has launched its own independent Proof-of-Concept (POC) clinical program to evaluate the safety and efficacy of gevokizumab, a potent modulator of interleukin-1 beta (IL-1 beta). XOMA launched a similar POC clinical program in November 2011, which included studies in three separate indications: moderate to severe inflammatory acne vulgaris, erosive inflammatory osteoarthritis of the hand, and non-anterior scleritis. SERVIER has selected several indications across multiple therapeutic areas.

"SERVIER believes gevokizumab has the potential to treat a wide range of indications beyond Behçet's uveitis, non-infectious uveitis, and cardiovascular diseases," stated John Varian, Chief Executive Officer of XOMA. "We are impressed with the breadth and depth of SERVIER's development plan. The first indication they are studying is polymyositis/dermatomyositis. Once SERVIER's POC program is fully underway, we anticipate gevokizumab will be undergoing safety and efficacy evaluations in over a dozen potential indications between SERVIER's and our efforts."

"This POC in polymyositis/dermatomyositis is paving the way for gevokizumab in a new area of pathologies with clear unmet medical needs. The strong existing scientific rationale for the role of IL-1 beta modulation in this disease is making us particularly committed for moving forward this study," indicated Dr. E. Canet, MD, PhD, President R&D of SERVIER.

For Dr. Jean-Philippe Seta, Chief Executive Officer of SERVIER, "Our core mission is to offer patients suffering from debilitating inflammatory diseases new therapeutic solutions. Gevokizumab has the potential to be one such solution."

Also Tuesday:

Amicus Therapeutics (Nasdaq:FOLD)
today disclosed a preclinical Chaperone-Advanced Replacement Therapy (CHART™) program for Mucopolysaccharidosis Type I (MPS I), a lysosomal storage disease caused by missing or deficient alpha-L-iduronidase (IDUA) enzyme.

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 announces achievement of a major milestone with the initiation of a Phase 1 clinical trial with its lead compound, AHRO-001.

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
today announced that the European Commission has approved NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.  

BioLife Solutions, Inc. (OTCQB: BLFS)
, a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, and HemaCare Corporation, (OTCPK:HEMA), a leading supplier of blood derived cells and components for research and clinical applications, today announced a strategic relationship wherein HemaCare will market BioLife's HypoThermosol® and CryoStor® biopreservation media products and HemaCare's blood derived cells to the research and clinical communities.

Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR)
, a leader in functional, renewable plant proteins, reported results for the fiscal fourth quarter and year ended March 31, 2013.

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX),
a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, announced today that it has received a letter from The Nasdaq Stock Market ("Nasdaq") on June 25, 2013, granting a 180-day extension period in which to regain compliance with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum closing bid price of at least $1.00 per share.

Cereplast, Inc. (OTCQB:CERP)
, a leading manufacturer of proprietary biobased, compostable and sustainable bioplastics, today announced an update on the restructuring of its global operations.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it will be included in the Russell 2000®, Russell 3000® and Russell Global Indexes at the close of market on June 28, 2013, according to a preliminary list of additions posted June 14, 2013 on www.russell.com/indexes.

Competitive Technologies, Inc. (OTCQX:CTTC)
today announced two recent sales of Calmare® medical devices, one to a military hospital and one to a physician practice, both located in the Northwest region of the United States.

DATATRAK International, Inc. (OTCQX: DTRK)
, a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced MMS Holdings Inc. is now a DATATRAK Connect™ Partner.  

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from a new pooled analysis of phase III data for the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for approval of the Maestro® Rechargeable System's VBLOC® vagal blocking therapy as a treatment for obesity.

Flexpoint Sensor Systems, Inc. (OTCQB: FLXT)
, recently announced that they had completed all tasks included in the Phase One development of a disposable directional colonoscope application with Haemoband Surgical, Ltd., a Northern Ireland-based company specializing in unique medical technologies.

IsoRay, Inc. (NYSE MKT: ISR)
, announced today that it has entered into an exclusive international distribution agreement with Aurora BioScience for the distribution and sale of IsoRay's complete product line in Australia and New Zealand.

MMRGlobal, Inc. (OTCQB: MMRF)
today announced that it has received another biotechnology patent, this one in Hong Kong.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA)
, a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 8,470,318, entitled "Polypeptides With Enhanced Anti-inflammatory and Decreased Cytotoxic Properties and Related Methods," to The Rockefeller University. Momenta is the exclusive licensee of the patent.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, a developer of clinically-relevant fluorescence imaging solutions for use in surgical and outpatient wound care procedures, today announced that Dr. David Martin, the company's Vice President, Investor Relations and Corporate Development, will present Novadaq's corporate overview at the 8th Annual JMP Securities Healthcare Conference. Novadaq is scheduled to present on July 9th at 3:00 p.m. Eastern Time at the St. Regis Hotel in New York City.

In conjunction with its Investor Day being held in Boston, PAREXEL International Corporation (Nasdaq: PRXL) announced forward-looking earnings expectations for the fourth quarter of Fiscal Year 2013 (ending June 30, 2013), for Fiscal Year 2013, and for Fiscal Year 2014.

PTC Therapeutics, Inc. (Nasdaq: PTCT)
today announced the closing of its initial public offering of 9,627,800 shares of common stock at a public offering price of $15.00 per share, before underwriting discounts, including 1,255,800 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discount.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA)
announced today that the company's management will be participating in a non-deal roadshow hosted by RBC Capital Markets, LLC on July 9-11, 2013 in New York, New York.

Santarus, Inc. (NASDAQ: SNTS)
and Pharming Group NV (NYSE Euronext: PHARM) announced that new data from a pivotal Phase III clinical study with RUCONEST® (recombinant human C1 esterase inhibitor) for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE) were featured in a poster presentation yesterday at the European Academy of Allergy and Clinical Immunology (EAACI) & World Allergy Organization (WAO) World Allergy & Asthma Congress in Milan, Italy.

Walgreen Co. (NYSE:WAG) (NASDAQ:WAG)
today announced earnings and sales results for the third quarter and first nine months of fiscal year 2013 ended May 31.

In conjunction with National Migraine Awareness Month and in recognition of the significant unmet needs of migraine sufferers, Zogenix, Inc. (Nasdaq:ZGNX) is launching a new and improved SUMAVEL® DosePro® Migraine Toolbox to support patient education and empowerment.

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