Nastech and Questcor Announce Submission of NDA for Nascobal(R) Nasal Spray
BOTHELL, Wash. and UNION CITY, Calif., Dec. 30 /PRNewswire-FirstCall/ --
Nastech Pharmaceutical Company Inc. , a leader in drug delivery technology, and
Questcor Pharmaceuticals, Inc. , a specialty pharmaceuticals product company,
announced today the submission to the U.S. Food and Drug Administration (FDA) of
a New Drug Application (NDA) seeking marketing approval for Nascobal(R)
(cyanocobalamin) Nasal Spray for treatment of vitamin B12 deficiency.
Nascobal(R) Nasal Gel and Nascobal(R) Nasal Spray were originally developed by
Nastech. Questcor owns worldwide rights to both products.
Nascobal(R) Nasal Gel has been approved and marketed in the U.S. since 1997 for
the treatment of various vitamin B12 deficiencies and has a proven track record
of safety and efficacy. Nascobal(R) Nasal Gel is indicated for use in patients
with pernicious anemia, Crohn's Disease, HIV/AIDS, and Multiple Sclerosis as
well as other malabsorptive conditions that can result in vitamin B12
deficiency. Symptoms of vitamin B12 deficiency include fatigue, weakness, sore
tongue, forgetfulness, weight loss, lack of coordination and difficulty walking. Left untreated, vitamin B12 deficiency may lead to anemia, intestinal problems,
and irreversible nerve damage. Questcor currently markets products to
neurologists and gastroenterologists.
"Nascobal(R) Nasal Spray is a more convenient, patient friendly dosage form that
is intended to provide equivalent safety and efficacy to Nascobal(R) Nasal Gel,"
stated Steven C. Quay, M.D., Ph.D., Chairman, President, and Chief Executive
Officer of Nastech.
"We are extremely pleased that Nastech has submitted the Nascobal(R) Nasal Spray
NDA for marketing approval on schedule," commented Charles J. Casamento,
Chairman, President, and Chief Executive Officer of Questcor. "The nasal spray
dosage form represents a natural line extension of the nasal gel product. The
approval of the NDA for the spray formulation along with the pending patent
application on the spray formulation could significantly extend the product life
of intranasal vitamin B12." In June 2003, Nastech divested Nascobal(R) to Questcor. The transaction
included all Nascobal(R) intellectual property, marketing rights, inventory,
trademarks, confidential know-how, contracts, and records. Under terms of the
divestiture agreement, Nastech will receive up to $18.2 million, including $14.2
million received to date. Nastech will also receive $2.0 million upon FDA
approval of the Nascobal(R) Nasal Spray dosage form and $2.0 million upon the
issuance of a U.S. patent. Nastech will continue to manufacture Nascobal(R) at
its FDA-approved, cGMP manufacturing facility in Hauppauge, New York, and in
Bothell, Washington upon FDA approval of that facility under terms of a long
term supply agreement.
ABOUT QUESTCOR Questcor Pharmaceuticals, Inc. is a specialty pharmaceutical company that
acquires, develops, markets and sells brand name prescription drugs through a
U.S. direct sales force and overseas distributors and marketing partners. Questcor currently markets five products in the U.S.: HP Acthar(R) Gel, an
injectable drug that is commonly used in treating patients with infantile spasm
and is approved for the treatment of certain central nervous system disorders
with an inflammatory component including the treatment of flares associated with
Multiple Sclerosis; Nascobal(R), the only prescription nasal gel formulation of
Cyanocobalamin USP (vitamin B12), that is approved for patients with severe
deficiencies of vitamin B12 caused by MS and Crohn's Disease; Ethamolin(R), an
injectable drug used to treat enlarged weakened blood vessels at the entrance to
the stomach that have recently bled, known as esophageal varices; Glofil(R)-125,
which is an injectable agent that assesses how well the kidney is working by
measuring glomerular filtration rate, or kidney function; and VSL#3(TM), a
patented probiotic marketed as a dietary supplement, to promote normal
gastrointestinal (GI) function. As part of a strategy to develop its products
globally, Questcor has entered into several contractual relationships with
public and private companies including: Ahn- Gook Pharmaceuticals of Korea;
Aventis Pharmaceuticals Inc. of Bridgewater, NJ; Beacon Pharmaceuticals, Ltd. of
Tunbridge Wells, Kent, United Kingdom; Dainippon Pharmaceutical Co. Ltd., of
Osaka, Japan; Nastech Pharmaceutical Company Inc. of Bothell, WA; Orphan
Australia of Melbourne, Australia and VSL Pharmaceuticals of Ft. Lauderdale,
FL.
QUESTCOR SAFE HARBOR STATEMENT Note: Except for the historical information contained herein, this press release
contains forward-looking statements that involve risks and uncertainties. Such
statements are subject to certain factors, which may cause Questcor's results to
differ from those reported herein. Factors that may cause such differences
include, but are not limited to, Questcor's ability to accurately forecast the
demand for each of their products, the gross margins achieved from the sale of
those products, the accuracy of the prescription data purchased from independent
third parties by Questcor, the sell through by Questcor's distributors, the
inventories carried by Questcor's distributors, and the expenses and other cash
needs for the upcoming periods, Questcor's ability to obtain finished goods from
its sole source contract manufacturers on a timely basis if at all, Questcor's
need for additional funding, uncertainties regarding Questcor's intellectual
property and other research, development, marketing and regulatory risks, and,
to the ability of Questcor to implement its strategy and acquire products and,
if acquired, to market them successfully as well as the risks discussed in
Questcor's report on Form 10-K for the calendar year ended December 31, 2002 and
other documents filed with the Securities and Exchange Commission. The risk
factors and other information contained in these documents should be considered
in evaluating Questcor's prospects and future financial performance.
The Company undertakes no obligation to publicly release the result of any
revisions to these forward-looking statements, which may be made to reflect
events or circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
ABOUT NASTECH Nastech Pharmaceutical Company Inc. is a leader in drug delivery. The Company
has developed a platform technology for delivering both small and large molecule
drugs by nasal administration. Intranasal drug delivery may lead to greater
drug efficacy, speed of action, improved safety, and patient compliance.
Nastech is developing a diverse product portfolio across multiple therapeutic
areas, including products targeted for the treatment of male and female sexual
dysfunction, obesity, pain management, osteoporosis, cancer, hepatic illnesses,
growth deficiency, and multiple sclerosis. Additional information about Nastech
is available at http://www.nastech.com/.
NASTECH SAFE HARBOR STATEMENT Statements contained herein that are not historical fact may be forward- looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended,
that are subject to a variety of risks and uncertainties. There are a number of
important factors that could cause actual results to differ materially from
those projected or suggested in any forward-looking statement made by the
Company. These factors include, but are not limited to: (i) the Company's
ability to successfully complete product research and development, including
pre-clinical and clinical studies and commercialization; (ii) the Company's
ability to obtain required governmental approvals, including product and patent
approvals; (iii) the Company's ability to attract and/or maintain manufacturing,
sales, distribution and marketing partners; and (iv) the Company's ability to
develop and commercialize its products before its competitors. In addition,
significant fluctuations in quarterly results may occur as a result of varying
milestone payments and the timing of costs and expenses related to the Company's
research and development program. Additional factors that would cause actual
results to differ materially from those projected or suggested in any
forward-looking statements are contained in the Company's filings with the
Securities and Exchange Commission, including, but not limited to, those factors
discussed under the caption "Risk Factors" in the Company's most recent Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q, which the Company urges
investors to consider. The Company undertakes no obligation to publicly release
the revisions to such forward-looking statements that may be made to reflect
events or circumstances after the date hereof or to reflect the occurrences of
unanticipated events, except as otherwise required by securities or other
applicable laws. DATASOURCE: Nastech Pharmaceutical Company Inc.; Questcor Pharmaceuticals, Inc.
CONTACT: Matthew D. Haines, Director, Corporate Communications, of Nastech Pharmaceutical Company Inc., +1-212-297-6198, or ; or Investors, Aline Schimmel, or Media, Kathy Jones, Ph.D., both of Burns McClellan, +1-212-213-0006, for Nastech Pharmaceutical Company Inc.; or Charles J. Casamento, Chairman, President & Chief Executive Officer, +1-510-400-0700, or Timothy E. Morris, Chief Financial Officer, +1-510-400-0700, or Investor Relations, +1-510-400-0706, all of Questcor Pharmaceuticals, Inc.
Web site: http://www.nastech.com/
|