HAYWARD, Calif. & FORT COLLINS, Colo.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) and TOLMAR, Inc. today
announced that the U.S. Food and Drug Administration (FDA) has granted
final approval of TOLMAR’s Abbreviated New Drug Application (ANDA) for
its generic version of Solaraze® Gel (diclofenac sodium-3%). TOLMAR was
the first company to file a substantially complete ANDA containing a
Paragraph IV certification, and Impax’s generics division, Global
Pharmaceuticals, intends to commercialize this first-to-file product
shortly. The last Orange Book listed patent expires August 11, 2015.
In June 2012, Impax Laboratories entered into a Development, Supply and
Distribution Agreement (the TOLMAR Agreement) with TOLMAR, Inc. Under
the terms of the TOLMAR Agreement, TOLMAR granted Impax an exclusive
license to commercialize generic Solaraze in the United States and its
territories. Under the terms of the TOLMAR Agreement, TOLMAR is
responsible for developing and manufacturing the product, and Impax is
responsible for the marketing and sale of the product.
According to IMS Health (NSP), U.S. sales of Solaraze® Gel 3% were
approximately $78 million for the 12 months ended September 2013.
Solaraze® is a registered trademark of PharmaDerm, a Division of
Fougera Pharmaceuticals Inc.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of central nervous
system disorder branded products. Impax markets its generic products
through its Global Pharmaceuticals division and markets its branded
products through the Impax Pharmaceuticals division. Additionally, where
strategically appropriate, Impax develops marketing partnerships to
fully leverage its technology platform and pursues partnership
opportunities that offer alternative dosage form technologies, such as
injectables, nasal sprays, inhalers, patches, creams and ointments. For
more information, please visit the Company's Web site at: www.impaxlabs.com.
About TOLMAR, Inc.
TOLMAR, Inc. is a northern Colorado based pharmaceutical research,
development, manufacturing and commercial operations company. TOLMAR
develops and manufacturers both proprietary and generic pharmaceutical
products. TOLMAR provides its customers with a competitive and
sustainable combination of product development and commercial services.
The company’s strengths include a proven development, clinical,
regulatory and manufacturing infrastructure with a highly trained and
experienced staff. Several of its marketed products are still in an
early stage growth mode. TOLMAR products are commercialized through
marketing partners in over fifty five countries worldwide, including
North America and Europe.
"Safe Harbor" statement under 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 forward-looking
in nature and express the beliefs and expectations of management. Such
statements are based on current expectations and involve a number of
known and unknown risks and uncertainties that could cause the Company’s
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, fluctuations in revenues and operating income, the Company’s
ability to promptly correct the issues raised in the warning letter and
Form 483 observations received from the FDA, the Company’s ability to
successfully develop and commercialize pharmaceutical products in a
timely manner, reductions or loss of business with any significant
customer, the impact of consolidation of the Company’s customer base,
the impact of competition, the Company’s ability to sustain
profitability and positive cash flows, any delays or unanticipated
expenses in connection with the operation of the Company’s Taiwan
facility, the effect of foreign economic, political, legal and other
risks on the Company’s operations abroad, the uncertainty of patent
litigation, the increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies, consumer acceptance and
demand for new pharmaceutical products, the impact of market perceptions
of the Company and the safety and quality of the Company’s products, the
difficulty of predicting FDA filings and approvals, the Company’s
ability to achieve returns on its investments in research and
development activities, the Company’s inexperience in conducting
clinical trials and submitting new drug applications, the Company’s
ability to successfully conduct clinical trials, the Company’s reliance
on third parties to conduct clinical trials and testing, impact of
illegal distribution and sale by third parties of counterfeits or stolen
products, the availability of raw materials and impact of interruptions
in the Company’s supply chain, the use of controlled substances in the
Company’s products, disruptions or failures in the Company’s information
technology systems and network infrastructure, the Company’s reliance on
alliance and collaboration agreements, the Company’s dependence on
certain employees, the Company’s ability to comply with legal and
regulatory requirements governing the healthcare industry, the
regulatory environment, the Company’s ability to protect its
intellectual property, exposure to product liability claims, changes in
tax regulations, the Company’s ability to manage growth, including
through potential acquisitions, the restrictions imposed by the
Company’s credit facility, uncertainties involved in the preparation of
the Company’s financial statements, the Company’s ability to maintain an
effective system of internal control over financial reporting, the
effect of terrorist attacks on the Company’s business, the location of
the Company’s manufacturing and research and development facilities near
earthquake fault lines and other risks described in the Company’s
periodic reports filed with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and the Company undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of whether
new information becomes available, future developments occur or
otherwise.
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Source: Impax Laboratories, Inc.