Full Press Release Details
Phone: (410) 269-2610
PHARMATHENE UPDATES STATUS OF
ANTHRAX VACCINE CONTRACT
ANNAPOLIS, MD - April 7, 2014
- PharmAthene, Inc. (NYSE MKT: PIP) announced today that it has received notice from the Department of Health and Human Services
(HHS), Biomedical Advanced Research and Development Authority (BARDA), advising the Company of its decision to de-scope the current
SparVax anthrax vaccine contract through a partial termination for convenience. BARDA will provide additional guidance
to PharmAthene on the contractual changes, following which PharmAthene will evaluate its options with respect to its SparVax
PharmAthene has been developing SparVax
to address a requirement for a modern anthrax vaccine based on state-of-the art vaccine technology. The decision follows an In
Process Review (IPR) meeting where, despite the Food and Drug Administration (FDA) placing SparVax on clinical
hold, PharmAthene reported progress on the SparVax program. Since the previous IPR meeting in 2011, PharmAthene
has demonstrated the following achievements:
Phase 1 and Phase 2 clinical trials involving
770 healthy subjects have demonstrated that SparVax appears to be well tolerated and capable of producing an immune
These studies suggest that three doses
of SparVax should be sufficient to induce protective immunity. Non-clinical animal studies of SparVax
have demonstrated the capability to protect rabbits and non-human primates against lethal anthrax aerosol spore challenge.
Eric I. Richman, President and Chief Executive
Officer, stated, "We believe that SparVax is the most advanced next generation anthrax vaccine currently
in development and we intend to explore all of our options, including seeking partnering or financing opportunities to continue
our development efforts. We await more information from BARDA."
PharmAthene's rPA anthrax vaccine
program has been supported by funding from the National Institute of Allergy and Infectious Disease, National Institutes of Health,
and the Biomedical Advanced Research and Development Authority.
PharmAthene is engaged in the development
and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene's current
biodefense portfolio includes the following product candidates:
In May 2013, the Delaware Supreme Court
issued its ruling on the appeal in our litigation with SIGA Technologies, affirming the Delaware Court of Chancery's finding
that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back to the Delaware
Court of Chancery to reconsider the appropriate remedy and award of attorney's fees and expert witness costs in light of the Delaware
Supreme Court's opinion. For more information about PharmAthene, please visit www.PharmAthene.com.
Forward-Looking Statement Disclaimer
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 "will"; "potential"; "believe";
"anticipate"; "look forward"; "intend"; "plan"; "expect"; "estimate";
"could"; "may"; "should"; or similar statements are forward-looking statements. Such statements include,
but are not limited to those referring to the achievements and attributes of SparVax , the outcome of the SIGA litigation
and our ability to deploy our resources. PharmAthene disclaims any intent or obligation to update these forward-looking statements.
Risks and uncertainties include, among others, risks associated with the reliability of the results of the studies relating to
human safety and possible adverse effects resulting from 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; awards of government contracts
to our competitors; unforeseen safety issues; 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 annual reports on Form
10-K and quarterly reports on Form 10-Q under the caption "Risk Factors" and in its other reports filed with the U.S.
Securities and Exchange Commission. In particular, there is significant uncertainty regarding the level and timing of sales of
Arestvyr and whether and when it will be approved by the U.S. FDA and corresponding health agencies around the world. PharmAthene
cannot predict with certainty if or when SIGA will begin recognizing profit on the sale thereof and there can be no assurance that
any profits received by SIGA will be significant. In its May 2013 decision, the Delaware Supreme Court reversed the remedy ordered
by the Delaware Court of Chancery and remanded the issue of a remedy back to the trial court for reconsideration in light of the
Delaware Supreme Court's opinion. As a result, there can be no assurance that the Delaware Chancery Court will issue a remedy
that provides PharmAthene with a financial interest in Arestvyr and related products or any remedy. In addition, significant
additional research work, non-clinical animal studies, clinical trials, and manufacturing development work remains to be done with
respect to PharmAthene's product candidates. At this point, there can be no assurance that any of these product candidates
will be shown to be safe and effective and approved by regulatory authorities for use in humans or that PharmAthene will have sufficient
resources to develop any such products. Copies of PharmAthene's public disclosure filings are available from its investor relations
department and its website under the investor relations tab at www.PharmAthene.com.