Apricus Receives FDA Clearance for Its Third OTC Drug. Shire Presents Positive Data from Fabry and Gaucher Disease Studies. Print E-mail
By Staff and Wire Reports   
Wednesday, 31 August 2011 19:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 31, 2011.

Apricus Biosciences, Inc. (Nasdaq:APRI)
announced its wholly-owned subsidiary, NexMed USA, Inc., has received clearance from the FDA for its third, over-the-counter drug, Diphenhydramine-D™, containing the Company's NexACT® technology.

They are also used to dry the oozing and weeping caused by poison ivy, poison oak and poison sumac and are sold under several third party brand names, most notably Demarest (Fougera & Co.), Benadryl Extra Strength Itch Stopping Gel (McNeill PPC, Inc.) and Derma-Pax (Recsei Laboratories, Inc.).

Apricus new Diphenhydramine-D™ product combines diphenhydramine hydrochloride and zinc acetate with DDAIP, the main ingredient in NexACT®, the Company's proprietary drug delivery technology. NexACT® temporarily loosens the tight junctions between skin cells allowing for improved permeation of a drug through the cells to the target area.


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Shire plc (NASDAQ:SHPGY), announced positive data from several studies designed to evaluate the safety of switching to REPLAGAL (agalsidase alfa) from Fabrazyme® (agalsidase beta) and the long-term safety and benefits of switching to VPRIV (velaglucerase alfa) from Cerezyme® (imiglucerase). Study results are being presented at the 2011 Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) held from August 30 - September 2 in Geneva, Switzerland.

Data Demonstrate Continued Safety and Tolerability of REPLAGAL for Switch Patients.  Six-month data from Shire's HGT-REP-059 study (U.S. treatment protocol) suggest that REPLAGAL at its licensed dose of 0.2 mg/kg every other week is well tolerated by Fabry patients switching from Fabrazyme (agalsidase beta). Safety events observed at six months among the 71 switch patients in this study were similar to those seen historically in those patients treated with REPLAGAL who had not switched from a prior enzyme replacement therapy.

Long Term Data Demonstrate Continued Sustained Efficacy and Safety Profile of VPRIV.  Additional data from Shire's long-term open-label, Phase I/II TKT025 extension study demonstrate continued improvement of bone mineral density (BMD) with VPRIV. This data show clinically meaningful and statistically significant improvements in lumbar spine BMD which were observed as early as 24 months [Z-score 0.39 (0.06, 0.72)] and femoral neck BMD as early as 33 months [Z-score 0.39 (0.16, 0.62)] in patients on VPRIV (n=10), during year three of therapy and despite significant baseline skeletal pathology.

This ongoing study was established to provide U.S. Fabry patients with access to REPLAGAL during the Fabrazyme (agalsidase beta) supply shortage, which has entered its third year. More than 2,600 patients are now being treated with REPLAGAL globally. This figure represents more than 75 percent of the treated Fabry patients worldwide.


Also Wednesday:


Abbott (NYSE: ABT) will present at the Morgan Stanley Global Healthcare Conference on Tuesday, Sept. 13, 2011.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the independent Data Safety Monitoring Board (DSMB) for the pivotal Phase 3 X-PECT study of perifosine in patients with refractory advanced colorectal cancer has completed a pre-specified interim analysis for safety and futility.

Affymax, Inc. (Nasdaq:AFFY) today announced the company’s participation at the following investor conferences during the month of September.

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the company will participate in the Stifel Nicolaus Healthcare Conference 2011, being held in Boston, Massachusetts, September 7 - 9, 2011.

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Morgan Stanley 2011 Healthcare Conference during September 13-14, 2011 at the Grand Hyatt New York.

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that company management will present an overview of the company at the Stifel Nicolaus Healthcare Conference in Boston, MA.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced that the company’s management will present a company overview at upcoming investment conferences.

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced its participation at three upcoming investor conferences.

BioMed Realty Trust, Inc. (the "Company") (NYSE: BMR) announced today that holders of the 4.50% Exchangeable Senior Notes due 2026 (CUSIP No. 09064AAA9) (the "Notes") of its operating partnership, BioMed Realty, L.P. (the "Operating Partnership"), which are fully and unconditionally guaranteed by the Company, have the right to surrender their Notes for purchase by the Operating Partnership pursuant to their option (the "Put Option") under the Indenture governing the Notes, dated as of September 25, 2006 (the "Indenture").

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that the company will present a corporate overview at the following investment conferences:

Caliper Life Sciences, Inc. (NASDAQ: CALP)
today announced the availability of the IVIS Spectrum CT, a breakthrough preclinical imaging system that integrates, into a single instrument system, advanced optical imaging and low dose microCT (micro computed tomography).  

Celgene Corporation (NASDAQ: CELG) announced its presentations at three upcoming investor conferences will be webcast live and will be available in the investor relations section of the Company’s Web site at www.celgene.com.

D. Medical Industries Ltd. (NASDAQ:DMED) (TASE:DMED) ("D. Medical" or the "Company"), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, today announced financial results for the three and six months ended June 30, 2011.

DURECT Corporation (Nasdaq: DRRX) announced today that management is scheduled to present at three upcoming healthcare conferences.

GenVec, Inc. (NASDAQ: GNVC) today announced that Paul H. Fischer, Ph.D., GenVec's President and CEO, will present a Company overview highlighting recent developments at the Stifel Nicolaus 2011 Healthcare Conference on Friday, September 9, 2011 at 8:35 p.m. EDT at the Four Seasons Hotel in Boston, MA.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its corporate presentation will be webcast from Baird’s 2011 Health Care Conference in New York.

GTx, Inc. (NASDAQ: GTXI) announced today that Dr. Mitchell S. Steiner, CEO, is scheduled to participate in a panel discussion on the topic “Finally, Lots of Options for Treating Prostate Cancer ” at Citi’s 6th Annual Biotech Day on Wednesday, September 7, 2011, at 11:00 a.m. ET.

Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), announced today that Idenix management will participate in a panel discussion at Citi's 6th Annual Biotech Day on September 7, 2011 at 10:00 a.m. ET at the Ritz Carlton, Boston, and present corporate overviews at the William Blair Life Sciences Conference on September 7, 2011 at 2:40 p.m. ET at the InterContinental New York Barclay, New York City and the Stifel Nicolaus Healthcare Conference on September 9, 2011 at 8:35 a.m. ET at the Four Seasons, Boston.

Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Dr. Joseph Kim, President and CEO, will present an overview of the company at three upcoming investor conferences:

LifeVantage Corporation (OTCBB: LFVN), makers of Protandim®, the Nrf2 Synergizer™ patented dietary supplement, announced today that Douglas C. Robinson, the Company's President and Chief Executive Officer, and Dr. Joe McCord, the Company's Chief Science Officer, will be presenting at the Rodman & Renshaw Annual Global Investment Conference, to be held on September 11-13, 2011, at the Waldorf Astoria in New York.

Mannatech, Incorporated (NASDAQ: MTEX), the leading innovator and provider of nutritional supplements and skin care products based on Real Food Technology® solutions, recently announced the reformulation of its omega-3 supplement to now include vitamin D.

Mediware Information Systems, Inc. (NASDAQ: MEDW) announced today that the Company will release the full year and fourth quarter financial results for its 2011 fiscal year on Wednesday, September 7.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that the Company plans to present at two investor conferences in September.

PAREXEL International Corporation (NASDAQ: PRXL) announced today that it will be presenting at the Robert Baird Healthcare Conference in New York.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company primarily focused on the pediatric market, today announced that Steven A. Elms has been appointed as a member of the Company’s Board of Directors, effective August 31, 2011.

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, will present at the Rodman & Renshaw 13th Annual Healthcare Conference in New York City on September 13, 2011 at 2:00 p.m. Eastern Time in the Starlight South room.

Repligen Corporation (NASDAQ: RGEN) announced today that the Company President and Chief Executive Officer, Walter C. Herlihy, Ph.D., will present a corporate update at the following investor conferences in September.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at three health care investment conferences during September 2011. Information of these conferences is provided below.

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that Gerald T. Proehl, president and chief executive officer, will make presentations at the following investment conferences.

TheDirectory.com, Inc. (PINKSHEETS: SEEK), today announced record setting results for its fiscal third quarter ending today August 31, 2011.

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced that Mihael H. Polymeropoulos, M.D., Vanda President and CEO will deliver a corporate presentation at the Stifel Nicolaus Global Healthcare Conference in Boston, MA on Thursday, September 8, 2011 at 4:25 pm Eastern Time.

VIVUS, Inc. (NASDAQ: VVUS) today announced that VIVUS management, including Leland Wilson, Chief Executive Officer; Timothy Morris, Chief Financial Officer, and Wesley W. Day, Ph.D., Vice President, Clinical Development, will participate in three investment conferences during the month of September.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, and BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company, today announced that they have dismissed all pending litigation between the Companies and announced plans to move XIAFLEX forward in the clinic for cellulite and human and canine lipoma as well as to collaborate on the initiation of further studies for XIAFLEX for additional indications.



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