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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