Bentley Announces Product Approvals in Spain and Ireland
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Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical
company focused on advanced drug delivery technologies and generic
pharmaceutical products, today announced five generic product approvals
from the Spanish Ministry of Health and an approval for simvastatin from
the Irish Medicines Board.
In Spain, Laboratorios Davur, as well as two other Bentley subsidiaries,
Laboratorios Rimafar and Laboratorios Belmac, received approval for
alendronate weekly. Alendronate is used in the treatment of osteoporosis
and bone loss, and is the generic version of Fosamax®,
which is currently marketed by Merck & Company, Inc. According to IMS
Health, Inc., annual brand sales in Spain for alendronate weekly are
approximately $89 million (USD).
Laboratorios Davur and Laboratorios Rimafar each received approvals in
Spain for cardiovascular products including lovastatin 20 mg. and 40 mg.
tablets, as well as enalapril in combination with hydrochlorothiazide
(HCTZ). Lovastatin is marketed in the United States by Merck & Co. under
the trade name Mevacor®,
and is prescribed for control of cholesterol levels. The annual market
size in Spain for lovastatin is approximately $14 million (USD),
according to IMS Health. Enalapril with HCTZ is an anti-hypertensive
medication combined with a diuretic. The product is marketed in the
United States by Merck & Co. under the trade name, Vaseretic®.
The Spanish market size for enalapril with HCTZ is approximately $34
million according to IMS Health.
Laboratorios Davur also received product approvals in Spain for
glucosamine and aceclofenac. Glucosamine is a treatment for
osteoarthritis available over-the-counter in the United States, but only
by prescription in Spain. Aceclofenac is a non-steroidal
anti-inflammatory prescribed as a treatment for diseases including
osteoarthritis and rheumatoid arthritis. According to IMS Health, the
annual markets for glucosamine and aceclofenac in Spain are
approximately $39 million and $24 million (USD), respectively.
In Ireland, Bentley’s subsidiary, Bentley
Pharmaceuticals Ireland, received approval to market generic
simvastatin. The product will be manufactured at Bentley’s
facilities in Spain. Simvastatin is the generic version of Zocor®,
which is marketed in the United States by Merck & Co. The annual market
for simvastatin in Ireland is estimated by IMS Health at approximately
$10 million (USD) annually.
"Receiving multiple approvals in Spain and
Ireland for these generic drugs strengthens our product portfolio, and
is an important step forward in our strategy to grow within and outside
of Spain by leveraging the low-cost, highly efficient manufacturing
capabilities of our Spanish subsidiaries,”
said John Sedor, president of Bentley Pharmaceuticals. "We
look forward to capitalizing on future opportunities in the growing
European generics market, and expect the benefits of these approvals and
new launches to enhance our fourth quarter results.”
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on advanced drug delivery technologies and generic
pharmaceutical products. Bentley’s
proprietary drug delivery technologies enhance the absorption of
pharmaceutical compounds across various membranes. Bentley manufactures
and markets a growing portfolio of generic and branded generic
pharmaceuticals in Europe for the treatment of cardiovascular,
gastrointestinal, infectious and central nervous system diseases through
its subsidiaries -- Laboratorios Belmac, Laboratorios Davur,
Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also
manufactures and markets active pharmaceutical ingredients through its
subsidiary, Bentley API. Additional information regarding Bentley
Pharmaceuticals may be obtained through Bentley’s
website at 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 Bentley’s
new product approvals in Spain and Ireland, the potential impact of
these approvals on Bentley's results of operations and Bentley’s
opportunities in the European generics market. 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 the timing and
nature of regulatory approvals, changes in third party reimbursement and
government mandates which impact pharmaceutical pricing, 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.
