MIAMI--(BUSINESS WIRE)--Oct. 31, 2005--IVAX Corporation (AMEX: IVX) (LSE: IVX.L) (WSE: IVX), in response to questions, announced today that it is challenging the patents protecting AstraZenica’s Pulmicort(TM) Respules(TM) (budesonide inhalation suspension). IVAX believes that it is first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Pulmicort Respules, which is marketed by AstraZenica as a preventative-type medicine for children 12 months to 8 years of age with asthma. Based on IMS data, Pulmicort Respules had annual sales of approximately $561 million for the twelve months ended June 30, 2005.
IVAX filed its ANDA for budesonide inhalation suspension with the U.S. Food and Drug Administration (FDA) in late 2004. In September of 2005, IVAX amended its ANDA with paragraph IV certifications, alleging invalidity and non-infringement in respect of certain of AstraZenica’s patents relating to budesonide inhalation suspension, and also notified AstraZenica of such certifications. On October 26, 2005, AstraZenica filed suit against IVAX in the U.S. District Court for the District of New Jersey.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally.
Copies of this and other news releases may be obtained free of charge from IVAX’ website at www.ivax.com.
Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company’s business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; that the Company may not be the first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Pulmicort(TM) Respules(TM), the outcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
Contacts
IVAX Corporation, Miami David Malina, 305-575-6043 www.ivax.com
