Bentley Pharmaceuticals Receives Approval to Market Generic Versions of the Gastrointestinal Product, Lansoprazole, in Spain
June 21 2004 - 7:00AM
PR Newswire (US)
Bentley Pharmaceuticals Receives Approval to Market Generic
Versions of the Gastrointestinal Product, Lansoprazole, in Spain -
Launch Planned for Second Half of 2004 - EXETER, N.H., June 21
/PRNewswire-FirstCall/ -- Bentley Pharmaceuticals, Inc. (NYSE:BNT),
a specialty pharmaceutical company focused on advanced drug-
delivery technologies, which also manufactures and markets generic
and branded products in Europe, announced today that three of its
subsidiaries have been granted approval by the Spanish Ministry of
Health to market generic equivalents of lansoprazole in Spain.
Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar
have each received approval from the Ministry of Health to market
15-mg and 30-mg delayed-release dosage forms of lansoprazole in
Spain. Laboratorios Belmac will market its generic equivalent under
a branded trademark. The Company has made the decision to announce
these approvals prior to receiving product pricing because the
Spanish Ministry of Health has made this information publicly
available on its website. Lansoprazole belongs to a class of
gastrointestinal products used for treatment of various
gastrointestinal disorders. The product is marketed by TAP
Pharmaceutical Products, Inc. in the United States under the trade
name Prevacid(R). According to IMS data, the market size of this
class of gastrointestinal products in Spain is approximately $415
million and growing at an annual rate of 7%. In the Spanish market,
lansoprazole accounts for approximately $87 million and has grown
20% over the past twelve months. James R. Murphy, Bentley's
President and CEO, commented, "This is one of the most significant
product approvals that we and our licensees have received over the
past four years and will be complementary to our gastrointestinal
product line, which already includes a generic version of
omeprazole (equivalent to Prilosec(R)). We expect lansoprazole to
quickly emerge as one of our strongest selling products and we plan
to launch it during the second half of 2004." Bentley
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on advanced drug delivery technologies and pharmaceutical products.
Bentley's proprietary drug technologies enhance or facilitate the
absorption of pharmaceutical compounds across various membranes.
Bentley also manufactures and markets a growing portfolio of
generic and branded pharmaceuticals in Europe for the treatment of
cardiovascular, gastrointestinal, infectious and neurological
diseases through its subsidiaries, Laboratorios Belmac,
Laboratorios Davur and Laboratorios Rimafar; and manufactures and
sells active pharmaceutical ingredients through its subsidiary,
Bentley API. Copies of Bentley Pharmaceuticals' press releases and
other information may be obtained through Bentley's web site at
http://www.bentleypharm.com/ . Safe Harbor Statement under the
Private Securities Litigation Reform Act of 1995: This press
release contains forward looking statements, including without
limitation, statements regarding planned product releases which
assume favorable pricing not yet approved by government agencies,
future market expectations of existing pharmaceutical products,
future product approvals and the growth of our business. These
forward-looking statements are subject to a number of risks and
uncertainties that could cause actual results to differ materially
from future results expressed or implied by such statements.
Factors that may cause such differences include, but are not
limited to risks associated with expanding generic and branded drug
operations, changes in third-party reimbursement and government
mandates which impact pharmaceutical pricing, development and
commercialization of our products, the effects of economic
conditions, risks associated with international operations,
competition from other manufacturers of generic and proprietary
pharmaceuticals and other uncertainties detailed in Bentley's most
recent Annual Report on Form 10-K and its other subsequent periodic
reports filed with the Securities and Exchange Commission. Bentley
cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These
statements speak only as of the date of this document, and Bentley
undertakes no obligation to update or revise the statements, except
as may be required by law. DATASOURCE: Bentley Pharmaceuticals,
Inc. CONTACT: Michael D. Price, Vice President, Chief Financial
Officer of Bentley Pharmaceuticals, Inc., +1-603-658-6100; or
Investors - Jonathan Birt or Lanie Marcus, or Media - Sean Leous,
all of Financial Dynamics, +1-212-850-5600, for Bentley
Pharmaceuticals, Inc. Web site: http://www.bentleypharm.com/
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