Dynavax Says Phase 3 Data on HEPLISAV; Novavax to Initiate Seasonal and Pandemic Influenza Trials Print E-mail
By Staff and Wire Reports   
Tuesday, 24 September 2013 18:44
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 24, 2013.

Dynavax Technologies Corporation (NASDAQ: DVAX)
announced immunogenicity and safety results of two Phase 3 trials (HBV-16 and HBV-17) of HEPLISAV(TM) investigational hepatitis B vaccine were published in the journal VACCINE accompanied by a Commentary from Drs. Stanley Plotkin and William Schaffner. The Commentary emphasizes the effect of 1018, the novel adjuvant contained in HEPLISAV, and concludes that the "results from these trials add to the body of evidence that 1018 can be an important new adjuvant for immunization against hepatitis B." These HEPLISAV data have been previously reported at medical conferences.

The article entitled "Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age" by Dr. William Heyward and colleagues, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in the US and Canada in over 2,400 subjects. The article concludes that HEPLISAV induced significantly higher seroprotection rates in all groups (including hyporesponsive populations) than the licensed comparator hepatitis B vaccine in a shorter two-dose schedule over one month while maintaining a similar safety profile.

The article entitled "Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease" by Dr. Robert Janssen and colleagues, describes the results from a Phase 3 clinical trial of HEPLISAV in over 500 participants with CKD in the US, Canada and Germany. The article concludes that three doses of HEPLISAV provided significantly higher seroprotection rates and earlier and more persistent seroprotection than the licensed comparator hepatitis B vaccine while maintaining a similar safety profile.


Novavax (Nasdaq: NVAX)
a clinical-stage vaccine company, announced it is finalizing details on costs and timelines for their next round of clinical studies with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) following successful completion of process improvement studies. Novavax is preparing to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under U.S. INDs. The pandemic study will include the use of Novavax' proprietary saponin-based adjuvant, Matrix-M™.

"Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal," said Stanley C. Erck, President and Chief Executive Officer, "Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9. We are especially pleased with BARDA's interest in the development of both of our pandemic vaccine candidates with the Matrix-M adjuvant, along with our seasonal vaccine program."

About the Novavax BARDA Contract--In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the contract's 3-year base period, valued at $97 million, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. Upon satisfaction of established milestones, the contract can expect to be extended for an additional 24 months, upon execution by BARDA of an Option One period, valued at $79 million in additional funding. The milestones under the Option One period would focus on completion of the pathway to product licensures from the U.S. Food and Drug Administration (FDA), including support for manufacturing scale-up. There is an additional contract option for vaccine production ($3 million).

Also Tuesday:

, an emerging biopharmaceutical company, announced a poster presentation at the American Society for Radiation Oncology Meeting, September 22-25, 2013, in Atlanta, GA.  

Advanced Cell Technology, Inc. (OTCBB:ACTC)
, a leader in the field of regenerative medicine, announced today that the company’s Chief Scientific Officer, Robert Lanza, MD, has been nominated to receive the prestigious Il Leone di San Marco award in Medicine.

The Alkaline Water Company Inc.(OTCBB: WTER)
, developers of an innovative, state of the art, proprietary electrolysis beverage process, packaged and sold under the trade nameAlkaline88, a premier alkaline drinking water for balanced lifestyles, is pleased to announce the appearance of CEO Steven Nickolas and the newest member of its Advisory Board, Brande Roderick, on the financial news network CEOLIVE.TV.

Array BioPharma Inc. (Nasdaq: ARRY)
today announced that its Chief Executive Officer, Ron Squarer, will speak at the NewsMakers in the Biotech Industry Conference.

Astro-Med, Inc. (NASDAQ: ALOT)
is announcing the worldwide release of its exclusive breakthrough laminating solution, Lustro-Lam, which is being marketed through its QuickLabel Systems business unit.

, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that it has received a commitment from Camber Capital Management, LLC to purchase an aggregate of $5 million of its common stock.

, a biopharmaceutical development company, announced today that it has filed the necessary regulatory submissions to commence a Phase 1/2 trial for BL-7010 - for the treatment of celiac disease - with the Finnish National Supervisory Authority for Welfare and Health (Valvira).

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has agreed to sell $600 million aggregate principal amount of 2.875 percent senior unsecured notes due Oct. 15, 2018 at a price equal to 99.498 percent of the principal.

Shareholder rights attorneys at Robbins Arroyo LLP announce that an investor of Edwards Lifesciences Corporation (NYSE: EW) has filed a complaint in the U.S. District Court for the Central District of California.

eHealth, Inc. (NASDAQ: EHTH)
, the nation's leading private online health insurance exchange for individual and family health insurance, today announced that it has entered into a relationship with Intuit Inc. (NASDAQ: INTU) in an effort to expand consumer enrollment in individual and family health insurance plans.

MiMedx Group, Inc. (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that Dr. Gary Stanziano has joined MiMedx as the  Company's Vice President of Medical Affairs.

MyMedicalRecords, Inc., a wholly owned subsidiary of MMRGlobal, Inc. (OTCQB: MMRF),  announced the filing of a complaint for patent infringement against Allscripts Healthcare Solutions, Inc.

Neogen Corporation (Nasdaq: NEOG)
announced today that its revenue for the first quarter of FY 2014, which ended Aug. 31, was $58,548,000, an 18% increase compared to revenue of $49,729,000 in the first quarter of last year.

OxySure Systems, Inc. (OTCQB: OXYS)
a medical technology company that has pioneered an FDA-approved solution to produce medically pure oxygen from dry, inert powders for emergency/short duration use today announced progress with regard to the CE Marking of its flagship product, the OxySure Model 615.

Plandaí Biotechnology, Inc. (OTCQB: PLPL)
, a producer of highly bioavailable plant extracts for industries including health, wellness, nutriceutical, and pharmaceutical, today announced that it has sold an exclusive license to Oasix, Inc., a Canadian company that develops and markets skin care products and also operates the Oasis Skin Institute in Alberta, Canada.

"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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