05.09.2007 11:03:00
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Salix Pharmaceuticals Acquires Patent-Protected Metoclopramide-Zydis(R)
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that
Wilmington Pharmaceuticals has granted Salix the exclusive, worldwide
right to metoclopramide-Zydis®.
Metoclopramide is indicated for short-term (4-12 weeks) therapy for
adults with symptomatic documented gastroesphageal reflux who fail to
respond to conventional therapy and for the relief of symptoms
associated with acute and recurrent diabetic gastric stasis. Wilmington
Pharmaceuticals plans to file a New Drug Application for their Zydis
formulation of metoclopramide with the U.S. Food and Drug Administration
during the fourth quarter of 2007. The product has patent protection
until 2022, and additional patent protection pending that, if issued,
will provide patent protection until 2025. Salix is required to make a
small up-front payment to Wilmington, a regulatory milestone payment to
Wilmington upon NDA approval and to pay royalties to Wilmington on net
sales. Additionally, Salix has entered into a separate agreement with
Catalent Pharma Solutions to supply the product. Catalent’s
Zydis® technology is
a unique, freeze-dried oral solid dosage form that disintegrates rapidly
on the tongue and can be taken without water.
"Salix is expanding its product portfolio
with the acquisition of a fast-dissolving formulation of metoclopramide,”
stated Carolyn Logan, President and Chief Executive Officer, Salix. "Market
research indicates a high level of demand for a patient-friendly
formulation of this widely-prescribed agent. We believe the availability
of metoclopromide-Zydis®
should serve to increase patient compliance and, in many instances,
provide an economical alternative to emergency room visits and/or
intravenous infusion by patients suffering from nausea and gastric
distress.”
Commenting on the agreement, Eugene Haley, Chief Executive Officer,
Wilmington Pharmaceuticals, stated, "We are
very pleased with the opportunity to have Salix commercialize
metoclopramide-Zydis®.
Much like Salix, we pride ourselves in our specialized strategy to
create value while avoiding the cost and risk associated with much
larger and less-focused pharmaceutical product development. We are
confident that Salix will dedicate the marketing and sales expertise
necessary to optimize the commercial potential of metoclopramide-Zydis®.”
Wilmington Pharmaceuticals, LLC creates valuable new medicines while
avoiding the large development and support staff of traditional
pharmaceutical companies. Their efforts bring patient-friendly drug
delivery technologies to well-established drug products that are only
available in less than optimal dosage forms.
Catalent Pharma Solutions, headquartered in Somerset, NJ, is the world
leader in providing advanced dosage form delivery technologies. Catalent’s
Zydis® is the
fastest dissolving oral tablet in the world. Zydis®
is a unique, freeze-dried oral solid dosage form that can be swallowed
without water, because it dissolves rapidly on the tongue in less than
three seconds. Zydis®
offers the potential for added patient and consumer convenience,
enhanced drug performance and improved patient compliance.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription pharmaceutical products for the
treatment of gastrointestinal diseases. Salix’s
strategy is to in-license late-stage or marketed proprietary therapeutic
drugs, complete any required development and regulatory submission of
these products, and market them through the Company’s
150-member gastroenterology specialty sales and marketing team.
Salix markets COLAZAL®
(balsalazide disodium) Capsules 750 mg, XIFAXAN®
(rifaximin) tablets 200 mg , OSMOPREP™
(sodium phosphate monobasic monohydrate, USP and sodium phosphate
dibasic anhydrous, USP) Tablets, MOVIPREP®
(PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium
Ascorbate and Ascorbic Acid for Oral Solution), VISICOL®
(sodium phosphate monobasic monohydrate, USP, and sodium phosphate
dibasic anhydrous, USP) Tablets, PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN®
Azathioprine Tablets, USP, 75/100 mg , ANUSOL-HC®
2.5% (Hydrocortisone Cream, USP), ANUSOL-HC®
25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT®
Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT®
Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. SANVAR®
IR (vapreotide acetate), balsalazide tablet, encapsulated mesalamine
granules and rifaximin for additional indications are under development.
For full prescribing information on Salix products, please visit www.salix.com.
Salix trades on the Nasdaq Global Market under the ticker symbol "SLXP”.
For more information please visit our web site at www.salix.com
or contact the Company at 919-862-1000. Information on our web site is
not incorporated in our SEC filings.
Please Note: This press release contains forward-looking statements
regarding future events. These statements are just predictions
and are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These risks and
uncertainties include: reliance on third parties, including Eisai, for
sales outside the core markets we sell to ourselves; risks of
regulatory review, including specifically for balsalazide tablet, and
clinical trials; potential generic and other competition; market
acceptance for approved products; intellectual property risks; the need
to acquire additional products; and management of rapid growth. The
reader is referred to the documents that the Company files from time to
time with the Securities and Exchange Commission.
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