Barr Receives Approval for and Launches Mirtazapine Orally Disintegrating Tablets, 15mg and 30mg
Thursday, December 18, 2003 09:06 AM ET Printer-friendly version
WOODCLIFF LAKE, N.J., Dec. 18 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc. (NYSE: BRL, news) today announced that it has received approval from the U.S. Food & Drug Administration (FDA) for Mirtazapine Orally Disintegrating Tablets, 15mg and 30mg, the generic equivalent of Organon, Inc.'s Remeron® Soltab™. The Company plans to launch its generic product immediately and believes that it is the first to file an application for the product and, consequently, is entitled to 180 days of generic exclusivity under the provisions of Hatch-Waxman.
"We are pleased to be the first company to receive approval to manufacture and market a generic version of Remeron Soltab and, under the provisions of Hatch-Waxman, we will enjoy 180 days of generic exclusivity," said Bruce L. Downey, Barr's Chairman and CEO. "This approval demonstrates our ability to develop barrier-to-entry products that utilize an orally disintegrating technology and highlights our ability to accelerate this development process to ensure that we reach the marketplace before competitors."
Barr filed an Abbreviated New Drug Application (ANDA) for mirtazapine orally disintegrating tablets in December 2001. The ANDA contained a certification that the patents listed in the Orange Book for mirtazapine orally disintegrating tablets were invalid or would not be infringed by Barr's product. Following receipt of notice from the FDA that its application had been accepted for filing, Barr notified Akzo Nobel, Organon, Akzo's pharmaceutical unit, and Cima Labs of its challenge to Organon's and Akzo's patents. On May 3, 2002, Cima Labs Inc. announced that Akzo and Organon had filed suit in Federal Court in New Jersey to prevent Barr from proceeding with the commercialization of this product. On or about April 23, 2003, the Court entered a stipulation of dismissal that Akzo and Organon had submitted with respect to the Akzo patent listed in the FDA's Orange Book on which Akzo's and Organon's complaint was based. As a result, Barr's application is no longer subject to a 30-month stay.
The Company also had filed counterclaims on two additional Akzo patents that were not listed in the FDA's Orange Book. The Company had asserted that these two patents were either invalid or would not be infringed by Barr's products. On or about September 30, 2003, the Federal Court in New Jersey dismissed the Company's counterclaim. The Court's dismissal ruling does not prevent the Company or Akzo from initiating a new lawsuit with respect to these patents. The Company believes that its mirtazapine orally disintegrating tablets do not infringe any valid claims of these patents. Nevertheless, if Akzo were to initiate suit with respect to these patents, and if Akzo were successful in that litigation, the Company could be liable for damages for patent infringement, which could have a material adverse impact on the Company's earnings and profitability.
Cima Labs Inc. developed and manufactures Remeron® SolTab™ for Organon. The Company's ANDA included a challenge to a Cima patent that Organon had listed in the Orange Book. Cima declined to file patent litigation against Barr's application within the 45-day period provided for by statute.
Mirtazapine Orally Disintegrating Tablets are indicated for the treatment of depression.
Remeron Soltabs, 15mg and 30mg, had annual sales of approximately $129 million for the twelve months ended October 2003.
Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Forward-Looking Statements
The following sections contain a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission..
Source: Barr Laboratories, Inc.
Contact: Carol A. Cox of Barr Laboratories, Inc., +1-201-930-3720, ccox@barrlabs.com |
