HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced
that it is commencing shipment of generic Solaraze® (diclofenac sodium
gel, 3%), a first-to-file product, through Global Pharmaceuticals,
Impax’s generics division.
Impax was granted an exclusive license by TOLMAR, Inc. to commercialize
generic Solaraze® in the United States (U.S.) and its territories.
TOLMAR was the first company to file a substantially complete ANDA
containing a Paragraph IV certification with the last Orange Book listed
patent expiring August 11, 2015. TOLMAR’s ANDA is the first to obtain
U.S. Food and Drug Administration approval.
According to IMS Health (NSP), U.S. sales of Solaraze® (diclofenac
sodium) 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.
"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.
Source: Impax Laboratories, Inc.