Impax Laboratories Announces Litigation Against Shire Relating to Supply of Generic Adderall XR®
HAYWARD, Calif.--(BUSINESS WIRE)--Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has initiated litigation against Shire LLC and Shire Laboratories, Inc. ("Shire") in order to resolve recent and recurring supply issues of its authorized generic version of Adderall XR®. The Company is seeking to compel Shire to deliver duly ordered amounts of product under the parties' Settlement Agreement and License and Distribution Agreements.
Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said: "Since launching our generic product in October of 2009, we have experienced very strong customer demand, as reflected in our strong sales of the product earlier in the year. Because of Shire's failure to continue to supply us with product in accordance with our agreement, we have been unable to continue to satisfy our customers' demands, resulting in declining sales and market share for this product. Throughout the year we have made numerous attempts to resolve the ongoing supply issues, and based on representations by Shire, we anticipated a significant increase in our fourth quarter sales over third quarter levels. According to very recent statements by Shire, however, it appears that Shire has no intention of filling our open orders, and we therefore believe we had no alternative but to bring this lawsuit in order to protect the interests of our customers and shareholders."
In January 2006, Impax Laboratories entered into a Settlement Agreement and a License and Distribution Agreement with Shire as part of a settlement of patent litigation between the parties. Under the settlement, Shire permitted the Company to enter the market as Shire's authorized generic and market generic versions of Adderall XR® Capsules in the United States. On or about October 1, 2009, Global Pharmaceuticals, Impax's generic division, commenced sales of its authorized generic version of Adderall XR® Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30mg.
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 its 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: 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, results of operations and market value of its common stock, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, reductions or loss of business with any significant customer, the impact of competitive pricing and products and regulatory actions on the Company's products, the ability to sustain profitability and positive cash flows, the ability to maintain sufficient capital to fund operations, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the ability to successfully develop and commercialize pharmaceutical products, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, reliance on key alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, exposure to product liability claims 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.
Impax Laboratories, Inc.
Sr. Director, Investor Relations and Corporate Communications