[NOVAVAX INC. LOGO]
FOR IMMEDIATE RELEASE
COMPANY CONTACTS: Mitchell J. Kelly
President & CEO (Interim)
212-698-9600
Dennis Genge
Chief Financial Officer
301-854-3900
Denis O'Donnell, M.D.
Chairman of the Board
781-721-9526
NOVAVAX, INC.
FINANCIAL COMMUNICATIONS CONTACT: Alison Ziegler - General
Julie Tu - Investors
FRB|WEBER SHANDWICK WORLDWIDE
212-445-8300
NOVAVAX, INC. SUBMITS NEW DRUG APPLICATION FOR ESTRASORB(TM),
A NOVEL TRANSDERMAL, TOPICAL ESTROGEN REPLACEMENT THERAPY
JOHN SPEARS STEPS DOWN AS PRESIDENT AND CEO,
COMPANY INITIATES EXECUTIVE SEARCH FOR A REPLACEMENT
COLUMBIA, MD, SEPTEMBER 9, 2002 - NOVAVAX, INC. (NASDAQ: NVAX) today announced
that on September 9, 2002 the Company submitted a New Drug Application (NDA)
with the U.S. Food and Drug Administration (FDA) for ESTRASORB(TM).
ESTRASORB(TM), an estradiol topical emulsion, is an estrogen-only lotion-like
formulation being developed for short-term use in the reduction of vasomotor
symptoms, such as hot flushes, in menopausal women. The submission comes less
than five months after the FDA requested additional information with respect to
the Chemistry Manufacturing and Controls (CMC) section of the Company's initial
NDA filing.
"Since voluntarily withdrawing our initial NDA in April 2002, we have worked
diligently to generate and compile the information necessary to finalize this
submission," commented Dr. Denis O'Donnell, Chairman of the Board of Directors
of Novavax, Inc. "Additional laboratory work included validating a stability
indicating method and performing content uniformity testing. We are pleased to
have been able to complete this work in a timely manner and we believe the
submission should satisfactorily answer the FDA's CMC questions. It is important
to note that during the initial review process the review division communicated
no concerns regarding the efficacy or safety of ESTRASORB(TM). This makes us
hopeful that the enhanced submission will ultimately lead to a favorable review
by the FDA."
Dr. O'Donnell added, "While recently publicized studies have questioned the
long-term administration of hormone replacement therapy (HRT) products, we
continue to believe ESTRASORB(TM), which contains estrogen alone, may offer
significant potential, particularly given our novel topical delivery mechanism
and recommended short-term therapy. In particular, ESTRASORB(TM) differs from
the products used in the National Institutes of Health (NIH) Women Health
Initiative study in the following ways: (1) ESTRASORB(TM) utilizes a proprietary
transdermal delivery system, as opposed to oral administration; (2)
ESTRASORB(TM) contains a synthetic estrogen that is identical to the estrogen
women produce naturally, as opposed to conjugated equine estrogens combined with
a synthetic progestin; and (3) ESTRASORB(TM) is being evaluated for short-term
use for the relief of vasomotor symptoms associated with menopause, as opposed
to the long-term administration of HRT products in the NIH study."
Novavax and King Pharmaceuticals, Inc. have a co-promotion agreement for
ESTRASORB(TM) in the U.S. and Puerto Rico, while King has exclusive marketing
rights for ESTRASORB(TM) outside the U.S.
MANAGEMENT CHANGES
Separately, Novavax announced that John Spears has stepped down from the
positions of President, CEO and Director of the Company. Working closely with
the other members of the Executive Committee of the Board of Directors, which
includes Dr. O'Donnell, Gary C. Evans and Michael A. McManus, Mitchell J. Kelly
will serve as President and CEO on an interim basis until an executive search is
completed for a new CEO. Mr. Kelly previously served in those positions from
September 1998 until May 1999 and is the CEO of Anaconda Capital Management,
L.L.C. (ACM), an affiliate of which owns 9.1% of the outstanding common shares
of Novavax.
"Novavax is very grateful for John Spears' nearly three and one-half years of
service to the company. We are particularly thankful for the excellent work he
performed in leading the re-submission of the NDA for ESTRASORB(TM)," said Dr.
O'Donnell. "We are very hopeful that the Company has effectively answered the
FDA's prior CMC questions with regard to ESTRASORB(TM) and we are even more
excited about the potential for ESTRASORB(TM) in the HRT arena."
In addition, Novavax announced that James Mirto has resigned as Senior Vice
President and Chief Operating Officer. The Company does not anticipate, in the
near term, that it will seek a new COO.
ABOUT NOVAVAX
Novavax, Inc. is a specialty biopharmaceutical company engaged in the research,
development and commercialization of proprietary products focused on women's
health and infectious diseases. Novavax sells, markets, and distributes a line
of prescription pharmaceuticals and pre-natal vitamins through its specialty
sales force calling on obstetricians and gynecologists throughout the U.S.
Products include Nestabs(R), a line of prescription pre-natal vitamins,
Gynodiol(R) (estradiol tablets, USP), an oral form of estrogen replacement
therapy and AVC(TM) Cream (sulfanilamide vaginal cream) for vaginal bacterial
infections. Novavax's principal technology platform involves the use of
proprietary, microscopic, organized, non-phospholipid structures as vehicles for
the delivery of a wide variety of drugs and other therapeutic products. These
include certain hormone, anti-bacterial, and anti-viral products and vaccine
adjuvants. Novavax has several product candidates awaiting marketing approval,
in human clinical trials or in pre-clinical development, including
ESTRASORB(TM), a transdermal emulsion for estrogen replacement therapy,
ANDROSORB(TM), a transdermal testosterone emulsion in Phase I/II clinical trials
and ANDRO-JECT(TM), a long-acting subcutaneous injectable formulation of
testosterone that is in pre-clinical development. In addition, Novavax conducts
research and development on preventative and therapeutic vaccines for a variety
of infectious diseases, including smallpox and West Nile virus.
Statements made in this press release that state Novavax's or management's
intentions, hopes, beliefs, expectations, or predictions of the future are
forward-looking statements. Forward-looking statements include but are not
limited to statements regarding product sales, future product development and
related clinical trials and statements regarding future research and
development. Novavax's actual results could differ materially from those
projected in such forward-looking statements. Factors that could cause actual
results to differ materially from those in the forward-looking statements
include, among other things, the following: general economic and business
conditions; competition; unexpected changes in technologies and technological
advances; ability to commercialize and manufacture products; results of clinical
studies; research and development activities; changes in, or failure to comply
with, governmental regulations; and the ability to obtain adequate financing in
the future. Additional information is contained in Novavax's SEC report on Form
10K for the year ended December 31, 2001 incorporated herein by reference.
Statements made herein should be read in conjunction with Novavax's Form 10K.
Copies of these filings may be obtained by contacting Novavax at 8320 Guilford
Road, Columbia, MD 21046 Tel 301-854-3900 or the SEC.
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