Apricus Announces First Patient Enrolled in Phase 2a Clinical Trial for RayVa(TM); Keryx Announces Issuance of a New U.S. Patent for Auryxia(TM) Print E-mail
By Josh Gee   
Thursday, 04 December 2014 16:04
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 4, 2014.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the first patient has been enrolled in the Phase 2a clinical trial to evaluate RayVa™, Apricus' product candidate for the treatment of Raynaud's phenomenon secondary to scleroderma. RayVa combines alprostadil, a potent vasodilator, with Apricus' proprietary permeation enhancer DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities.

"Raynaud's phenomenon is a near universal feature of scleroderma and causes pain, loss of hand function and is associated with fingertip ulcerations and loss of finger substance. A topical therapy such as RayVa has the ability to improve blood flow locally without systemic adverse effects and has the potential to alleviate symptoms and possibly prevent finger injury," said Dr. James R. Seibold, an internationally recognized researcher in both scleroderma and Raynaud's phenomenon and the Principal Member of Scleroderma Research Consultants, LLC.

The randomized, double-blind, placebo-controlled, Phase 2a clinical trial is expected to enroll approximately 45 patients with Raynaud's phenomenon secondary to scleroderma. Each patient will receive applications of placebo and one of three different doses of RayVa, in a crossover design. This dose-ranging study will evaluate hemodynamics, skin temperature at the site of application, as measured by Laser Doppler and thermography, and symptomatic response following a standardized cold challenge. Other endpoints include safety and pharmacokinetic assessments.

"The dosing of the first patient in the RayVa Phase 2a clinical trial is a significant milestone for the Company, and importantly, for Raynaud's patients, as we seek to address with RayVa, the symptoms associated with this chronic condition," said Rich Pascoe, Chief Executive Officer. "Moreover, with the expected completion of the RayVa Phase 2a clinical trial, coupled with the anticipated start of the Phase 2b clinical trial of fispemifene in the first half of 2015 in men with secondary hypogonadism, Apricus is well positioned to drive value from its development-stage pipeline next year."



Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
announced today that the U.S. Patent and Trademark Office issued U.S. Patent No. 8,901,349 on December 2, 2014. The patent, which expires in 2024, claims a method of treating hyperphosphatemia comprising administering a therapeutically effective amount of an orally administrable form of ferric citrate to a subject, wherein the orally administrable form is prepared from a ferric citrate having a BET active surface area greater than about 16 sq. m/g. The patent also claims a broad category of orally administrable forms covering Auryxia, as well as other oral formulations that could be developed in the future.

On September 5, 2014, Auryxia™ (ferric citrate) was approved by the U.S. Food and Drug Administration for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

This newly issued patent further enhances the Company's key patent family, which includes U.S. Patent Nos. 7,767,851, 8,299,298, 8,338,642, 8,609,896, 8,754,257, 8,754,258, and 8,846,976 which expire in 2024, and U.S. Patent No. 8,093,423, which expires in 2026, before patent term extension. Each of these patents contains composition and method of use claims covering Auryxia.

Ron Bentsur, Chief Executive Officer of Keryx, commented, "The patent announced today represents our fourth U.S. patent issuance in 2014, and further fortifies the strength of our intellectual property position. This patent is significant in that it links orally administrable forms, including Auryxia, prepared from Keryx's unique API, having a surface area greater than about 16 sq. m/g." Mr. Bentsur added, "With the high surface area being a manufacturing specification for our API, we believe that the patent issued today provides another layer of substantial protection for Auryxia."

The Company continues to prosecute additional patent applications for Auryxia, which, if issued, would provide additional patent protection for Auryxia beyond 2030.  

In addition, the Company has filed its key patent families for Patent Term Extension, which, if granted, would add up to an additional 5 years to the patent protection for Auryxia. Following FDA approval, the FDA Substance Registration System adopted tetraferric tricitrate decahydrate as the name of the active ingredient approved for marketing by the FDA, to appropriately describe the Company's unique proprietary form of ferric citrate API.

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 the Securities and Exchange Commission has approved the Company's request to change its SIC code from 5160, Wholesale – Chemicals and Allied Products, to 5122,

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it will collaborate with the National Organization for Rare Disorders (NORD), a non-profit organization dedicated to helping people with rare diseases.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused primarily on the development of oncology therapeutics, today announced that it has appointed Alexander Zukiwski, M.D. to its Board of Directors.

Blue Line Protection Group, Inc. (OTCBB: BLPG) (OTCQB: BLPG)
, a leader in providing regulatory compliance, security consultation and protection services to high-value asset industries, today announced a new security contract with Agritek Holdings, Inc. and its new cannabis cultivation campus under development near Pueblo, Colorado.

ChemoCentryx, Inc., (Nasdaq:CCXI)
, a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, reported today that the European Commission has granted orphan medicinal product designation for CCX168, an orally administered inhibitor targeting the receptor for the complement protein known as C5a (C5aR), for the treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) (formerly known as Wegener's Granulomatosis, or WG).

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health, hospice care, home care, assisted living and urgent care companies, announced today that it will participate in the 25th Annual Oppenheimer Healthcare Conference on December 10, 2014, in New York, New York.

FluoroPharma Medical, Inc. (OTCQB: FPMI)
, a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that enrollment for this Phase II trial will be closing on December 15th.

Herborium® Group, Inc. (OTC Pink: HBRM)
, a Botanical Therapeutics® Company providing unique, all botanical medicines (Botanical Therapeutics®), announced today that its Black Friday and Cyber Monday sales results grew 80% over the same sales events in 2013.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that the Company will present at the 25th Annual Oppenheimer Healthcare Conference on Wednesday, December 10 at 8:00 a.m. Eastern Time at the Crowne Plaza Hotel in New York City.

LHC Group, Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has selected Dionne E. Viator, a proven healthcare executive with extensive industry experience and leadership, to serve as the Company's Executive Vice President, Chief Financial Officer and Treasurer, effective February 1, 2015.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
announced today that it will be participating in the Benchmark Company, LLC Micro Cap Discovery One-on-One Investor Conference at the Palmer House Hilton, Chicago, IL, on Thursday, December 11, 2014.

today announced that its award-winning iSpO2™ pulse oximeter is featured in the upcoming book "The Science of Fitness: Power, Performance, and Endurance," by three-time Tour de France champion Greg LeMond and co-author interventional radiologist Dr. Mark Hom, available at Amazon.com and the Elsevier Store.

MedAssets (Nasdaq:MDAS)
today announced that it will participate in the 25th annual Oppenheimer Healthcare Conference in New York City on Thursday, December 11th.

MRI Interventions, Inc. (OTCQB:MRIC)
today announces the addition of medical device veteran Wendelin Maners in the role of Vice President, Marketing, as CEO-elect Frank Grillo solidifies his management team.

NEMUS Bioscience, Inc. (OTC:NMUS)
reports that data recently presented at the American Association of Pharmaceutical Scientists (AAPS) meeting in San Diego by Dr. Soumyajit Majumdar, Associate Professor of Pharmaceutics, University of Mississippi, showed that a pro-drug formulation of Δ9-tetrahydrocannabinol (THC), in-licensed from the University of Mississippi, achieved company goals of significantly lowering intra-ocular pressure (IOP) in an open-angle rabbit glaucoma model.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that Nuvilex executives joined Thailand government officials at the grand opening of Austrianova's current Good Manufacturing Practices (cGMP) live-cell encapsulation facility within the Thai Science Park (TSP) in Bangkok, Thailand.

The Spectranetics Corporation (Nasdaq:SPNC)
will provide an overview of several transformative growth drivers within its Vascular Intervention and Lead Management businesses during its Analyst & Investor meeting today in New York City.

announced today that the Company has retained Lorin Rosen, Esq. of LAR Law Group PC to initiate the process of transitioning the Company from the OTC Markets Pink Sheets to the OTCQB by filing an S-1 Registration Statement with the Securities & Exchange Commission.

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