Navigation Links
PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA
Date:5/22/2009

ANNAPOLIS, Md., May 22 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that the Company has submitted its comprehensive regulatory strategy to the U.S. Food and Drug Administration (FDA) outlining the non-clinical and clinical development plans for licensure of SparVax(TM), a next generation recombinant protective antigen anthrax vaccine.

The FDA submission is in response to recent amendments issued by the Department of Health and Human Services (HHS) on April 15th and 22nd, 2009, to solicitation number RFP BARDA 08-15, outlining a requirement to develop and procure 25 million doses of a next generation rPA anthrax vaccine for the country's civilian biomedical stockpile.

In September 2008, PharmAthene received notification from HHS that its proposal for SparVax(TM) had been deemed technically acceptable and within the competitive range for procurement consideration. Since that time, PharmAthene has been engaged in negotiations with HHS under the proposals process.

David P. Wright, President and Chief Executive Officer of PharmAthene, noted, "We are pleased to have met our stated goal of submitting our regulatory plan to FDA by May 21st, well ahead of the June 15th submission deadline. We feel we have presented a comprehensive and credible path for the ultimate licensure of SparVax(TM). We continue to maintain an ongoing dialogue with FDA, and anticipate an expeditious review of our development plan. In the meantime, activities under the SparVax(TM) program continue to advance uninterrupted under a development contract for SparVax(TM) originally awarded by the National Institute of Allergy and Infectious Disease (NIAID) and transferred to the Biomedical Advanced Research and Development Authority (BARDA) in April 2009. We look forward to the FDA's review of our proposal, and to the contract award decision by HHS for the advanced development and procurement of next generation rPA anthrax vaccines."

About SparVax(TM)

SparVax(TM) is a novel second generation recombinant protective (rPA) anthrax vaccine being developed for administration by intramuscular injection. Phase I and Phase II clinical trials involving more than 700 healthy human subjects have been completed and showed that SparVax(TM) appears to be well tolerated and induces an immune response in humans. These studies suggest that three doses of SparVax(TM), administered several weeks apart, should be sufficient to induce protective immunity. In preclinical studies SparVax(TM) has also demonstrated the capability to protect rabbits and non-human primates against a lethal aerosol spore challenge of the anthrax Ames strain.

About PharmAthene, Inc.

PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:

  • SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine
  • Third generation rPA anthrax vaccine
  • Valortim(R) - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
  • Protexia(R) - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
  • RypVax(TM) - a recombinant dual antigen vaccine for plague

For more information about PharmAthene, please visit www.PharmAthene.com.

Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; "should"; or similar statements are forward-looking statements. PharmAthene disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risk associated with the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates, unexpected funding delays and/or reductions or elimination of U.S. government funding for one or more of the Company's development programs, including without limitation our bid related to SparVax(TM) under the HHS Request for Proposals for an Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic National Stockpile, the award of government contracts to our competitors, unforeseen safety issues, challenges related to the development, scale-up, and/or process validation of manufacturing processes for our product candidates, unexpected determinations that these product candidates prove not to be effective and/or capable of being marketed as products, as well as risks detailed from time to time in PharmAthene's Forms 10-K and 10-Q under the caption "Risk Factors" and in its other reports filed with the U.S. Securities and Exchange Commission (the "SEC"). In particular, even with today's submission to the FDA, there can be no assurance that the Company will be awarded a contract under the solicitation under RFP BARDA 08-15. Further, significant additional non-clinical animal studies, human clinical trials, and manufacturing development work remain to be completed for SparVax(TM). At this point there can be no assurance that SparVax(TM) will be shown to be safe and effective and approved by regulatory authorities for use in humans.

Copies of PharmAthene's public disclosure filings are available from its investor relations department and our website under the investor relations tab at www.PharmAthene.com.


'/>"/>
SOURCE PharmAthene, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. PharmAthene to Host a Conference Call and Webcast on Wednesday, April 29th at 4:30 PM to Provide an Update on the SparVax(TM) rPA Anthrax Vaccine Program
2. PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)
3. PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop
4. PharmAthenes Recombinant Butyrylcholinesterase (rBChE) May Play A Neuroprotective Role in Alzheimers Disease
5. PharmAthene to Webcast its Third Quarter Conference Call on November 13, 2007 at 4:30 P.M. Eastern Time
6. Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)
7. Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
8. D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients
9. AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
10. U.S. Naval Medical Research Center Resubmits IND Application for Proposed RESUS Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
11. ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 Research and ... Market for Companion Diagnostic Tests" report to their offering. ... for Companion Diagnostics The World Market for ... personalized medicine diagnostics. Market analysis in the report includes the ... Market (In Vitro Diagnostic Kits) by Region (N. America, EU, ...
(Date:6/23/2016)... 2016  MedSource announced today that it has ... solution of choice.  This latest decision demonstrates MedSource,s ... their clients by offering a state-of-the-art electronic data ... nowEDC as the EDC platform of choice in ... "nowEDC has long been a preferred EDC platform ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a weight ... app plans to fix the two major problems leading the fitness industry today:, ... program , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can ... Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey ... cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
Breaking Medicine News(10 mins):