Par
Pharmaceutical Companies, Inc. (NYSE: PRX) today announced it has received
final approval from the U.S. Food and Drug Administration of its
Abbreviated New Drug Application for propranolol hydrochloride (HCl)
extended release (ER) capsules in 60-, 80-, 120- and 160 mg dosage
strengths.
Propranolol HCl ER is the generic equivalent of Wyeth Pharmaceuticals'
Inderal(R)LA and is used to treat hypertension, angina pectoris due to
coronary atherosclerosis, migraine and hypertrophic subaortic stenosis.
Annual U.S. sales of Inderal(R) LA are approximately $215 million.
Par's propranolol ER is the product of a strategic partnership
established in 2002 with Nortec Development Associates, Inc., an innovator
in the development of controlled release process technologies. Under terms
of the agreement, Par will market, sell and distribute the product in the
U.S. and retain the majority of profits realized from its sale. Propranolol
HCl ER will be manufactured collaboratively by Glatt and Par.
"Propranolol HCl ER makes use of Glatt's CPS Technology(R), proprietary
drug delivery technology that can be used in the development and
manufacture of drug products with controlled release properties," said Eric
M. Mittleberg, Ph.D., executive vice president, Pharmaceutical Research and
Development. "This propranolol HCl ER capsule is an example of a very
difficult-to-develop, therapeutically equivalent product, now being made
available to patients for the first time as a generic product."
"This challenging product has been available for generic competition
for many years, and this first successful generic development and launch
was enabled by Glatt's innovative drug delivery technologies and
unsurpassed controlled release capabilities," said Oliver W. Mueller,
executive vice president, Glatt Pharmaceutical Services.
Dr. Mittleberg added: "This partnership has enabled Par to continue to
better leverage its R&D resources, and we look forward to continuing this
collaboration, allowing our complementary skills and expertise to be used
to develop difficult generic products for the benefit of patients and
health care providers."
"This product is the result of a team effort combining the best skills
of Nortec, Par and Glatt to bring to market a very challenging generic
equivalent," said Kenneth Olsen, founder, president and CEO of Nortec
Development Associates, Inc. Nortec, founded in 1984 as a third-party
contract R&D company, holds controlled-release patents and has licensed
other controlled-release products to companies outside the U.S.
Glatt is a worldwide supplier of pharmaceutical technology, services
and equipment, and specializes in controlled release solid dosage products.
For other company information, visit glattpharmaceuticals.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets
generic drugs and innovative branded pharmaceuticals for specialty markets.
For press release and other company information, visit
parpharm.
Certain statements in this press release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995. To the extent any statements made in this news release contain
information that is not historical, these statements are essentially
forward- looking and are subject to risks and uncertainties, including the
difficulty of predicting FDA filings and approvals, acceptance and demand
for new pharmaceutical products, the impact of competitive products and
pricing, new product development and launch, reliance on key strategic
alliances, uncertainty of patent litigation filed against us, availability
of raw materials, the regulatory environment, fluctuations in operating
results and other risks and uncertainties detailed from time to time in the
Company's filings with the Securities and Exchange Commission, such as the
Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.
parpharm