Impax Laboratories Enters Into Development, Supply and Distribution Agreement with TOLMAR, Inc.

June 26, 2012
  • Impax will Commercialize up to Nine Products in 2012
  • Expected to be Accretive to Impax’s EPS in 2012

HAYWARD, Calif. & FORT COLLINS, Colo.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) and TOLMAR, Inc. today announced that they will collaborate on a multiproduct agreement for the development, supply and distribution of generic topical prescription drug products. As part of the Development, Distribution and Supply Agreement (the “Agreement”), TOLMAR will supply up to nine currently approved and marketed products, and Impax’s generics division, Global Pharmaceuticals, will commercialize these products following a short transition period. According to Wolters Kluwer Health, total U.S. brand and generic sales of these nine multi-source products were approximately $378 million in the 12 months ended May 2012. The Agreement also includes two additional generic topical prescription drug products of which one is currently in development and one is a first-to-file Abbreviated New Drug Application (ANDA) pending approval at the U.S. Food and Drug Agency (FDA).

Under the terms of the Agreement, Impax will pay TOLMAR $21 million upon the closing and up to $25 million in milestone payments, if certain commercialization and ANDA approval targets are met. In addition, Impax will pay TOLMAR a profit share for each product commercialized. The transaction is expected to be accretive to Impax’s earnings per share (EPS) in 2012.

“We are excited to further enhance our relationship with TOLMAR on these products as we continue to diversify our generic product portfolio,” said Larry Hsu, Ph.D., president and CEO of Impax Laboratories. “This represents Global Pharmaceuticals first opportunity to commercialize alternative dosage form products alongside our existing portfolio of tablets and capsules. Our business development activities will continue to focus on delivering growth from high-value products, technologies, and businesses in complementary dosage forms.”

Mike Duncan, CEO of TOLMAR, said: “We are very excited about this expansion of our already strong relationship with Impax Laboratories. This agreement is aligned with our long term strategy and we firmly believe that Impax Laboratories is the right partner for these products. From its inception in 2006, TOLMAR has been developing and introducing new products to the market through strategic partnerships. We look forward to working with Impax Laboratories as we continue to expand our product offerings in the generic dermatology space.”

Agreement Product Details

Approved ANDA products:

  • Betamethasone Dipropionate Cream (Augmented) 0.05%
  • Calcipotriene Topical Solution 0.005%
  • Fluticasone Propionate Cream 0.05% (not currently marketed)
  • Imiquimod Cream 5%
  • Lidocaine 2.5% / Prilocaine Cream 2.5%
  • Metronidazole Topical Gel 0.75%
  • Mometasone Furoate Lotion 0.1%
  • Mometasone Furoate Ointment 0.1%
  • Mometasone Furoate Cream 0.1%

Pending and Under Development ANDA products:

  • Diclofenac Gel 3% (generic to Solaraze®) – According to Wolters Kluwer Health, U.S. sales of Solaraze® 3% gel were approximately $131 million in the 12 months ended May 2012.
  • One ANDA topical product under development.

About Impax Laboratories, Inc.
Impax Laboratories, Inc. 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 branded products. Impax markets its generic products through its Global Pharmaceuticals Division and markets third-party branded products through the Impax Pharmaceuticals Division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at:

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 the Company’s revenues and operating income, the Company’s ability to successfully develop and commercialize pharmaceutical products, 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, increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, 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, 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 the Company’s intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s ability to manage the Company’s 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, any manufacturing difficulties or delays, 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 Impax 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.