|07-02-2002, 04:53 PM||#1|
Join Date: Jul 2001
Nastech Announces FDA Approval of Nascobal(R) Labeling Supplement for B12 Deficiency
Nastech Announces FDA Approval of Nascobal(R) Labeling Supplement to Include Maintenance of Hematologic Status in Patients With HIV Infection, AIDS, Multiple Sclerosis and Crohn's Disease
BOTHELL, Wash., July 2 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq:NSTK) announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement to the Nascobal(R) NDA that states that Nascobal can be used in patients with HIV, AIDS, multiple sclerosis, and Crohn's disease, conditions which can result in vitamin B12 deficiency, and for which Nascobal is indicated to maintain hematologic status. Nascobal(R) is FDA approved and has been marketed in the U.S. by Schwarz Pharma since 1997.
Nascobal(R) (Cyanocobalamin, USP) Gel for Intranasal Administration safely and effectively maintains therapeutic serum levels of vitamin B12. Nascobal can be self administered through a simple non-injection delivery system. Compared to other methods of vitamin B12 maintenance therapy, patient convenience is enhanced, as fewer physician office visits are required for maintenance therapy.
"Because of intestinal inflammation, people with Crohn's disease may have difficulty absorbing vitamin B12," stated Rodger L. DeRose, president and CEO of the Crohn's & Colitis Foundation of America (http://www.ccfa.org/). "For these patients, Nascobal may offer a more convenient way to receive supplements of this important nutrient."
Significant peer-reviewed published clinical research supports the importance of the maintenance of proper vitamin B12 levels in this diverse group of patients. For example:
* In a study of over 300 patients that were sero-positive for the human
immunodeficiency virus, participants with low serum vitamin B12
concentrations (< 120 pmol/L) had significantly shorter AIDS-free time
than those with adequate vitamin B12 concentrations (median AIDS-free
time = 4 vs. 8 y, respectively, P = 0.004). With the high cost of
therapy and the toxicity associated with AIDS treatment, any process
that extends the time from sero-positivity to AIDS is significant and
may contribute to the overall health and well being of this patient
* In one study, over 70 percent of AIDS patients had either frank vitamin
B12 deficiency or had an abnormal Schilling test, a test of vitamin B12
oral absorption. In addition, up to 30 percent of late stage AIDS
patients have an AIDS associated dementia complex, including a
myeolopathy, that has recently been shown to be associated with an
abnormality of the vitamin B12-dependent transmethylation pathway, the
pathway by which the body maintains the myelin-sheath (or insulation)
that surrounds nerves.
* Literally all Crohn's disease patients who have had a surgical resection
have vitamin B12 deficiency. Deficiency even predates surgery, probably
due the malabsorption caused by the disease itself. One study found up
to 60 percent of patients with Crohn's disease who had not had surgery
had signs of vitamin B12 deficiency.
* In one study of over 200 consecutive multiple sclerosis (MS) patients
over 20 percent had abnormally low serum vitamin B12 levels. Cerebral
spinal fluid levels of vitamin B12 are also reduced in patients with MS
and some investigators speculate that vitamin B12 associated
transmethylation may be an important component in the demyelination that
is characteristic of MS.
"We are extremely pleased that the FDA has approved a broader label for Nascobal," stated Steven C. Quay, M.D., Ph.D., Chairman, President, and Chief Executive Officer of Nastech. "Nastech has identified important market opportunities for Nascobal and is exploring ways to significantly grow the product."
In the U.S. alone there are approximately 500,000 patients with Crohn's disease, of which approximately 175,000 are candidates for vitamin B12 therapy. Among the nation's 800,000 HIV and AIDS patients, between 10 and 20 percent, or 80,000 to 160,000 people are vitamin B12 deficient. Finally, over 350,000 people in the U.S. have multiple sclerosis. Symptoms of vitamin B12 deficiency include fatigue, weakness, sore tongue, forgetfulness, weight loss, lack of coordination and difficulty walking. Vitamin B12 deficiency may lead to anemia, intestinal problems, and irreversible nerve damage.
Patients or physicians seeking additional information on Nascobal should contact Gerard Cignarella at Nastech Pharmaceutical Company Inc. toll-free at 1-888-627-2579, or email firstname.lastname@example.org, or visit our website at http://www.nastech.com/nascobal.
Nastech currently manufactures Nascobal at its FDA approved cGMP facility in Hauppauge, New York.
Nastech Pharmaceutical Company Inc., recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using "Formulation Science," a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to improve efficacy and safety, and to provide new therapeutic options. Additional information on 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 and Section 21E of the Securities Exchange Act of 1934, 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 and/or the Company's partner's ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company's and/or the Company's partner'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 and/or the Company's partner's ability to develop and commercialize products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of the timing of 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 those factors discussed under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K.
Contact: Matthew D. Haines
Director, Corporate Communications
Noonan Russo Presence Euro RSCG
David Walsey, 212-845-4257 (investors)
Glenn Silver, 212-845-4259 (media)
[This message was edited by seneca on Jul 02, 2002 at 08:13 PM.]