Barr Granted Summary Judgment in Mircette Patent Challenge
Barr Granted Summary Judgment in Mircette Patent Challenge
December 7, 2001
Barr Granted Summary Judgment in Mircette Patent Challenge
POMONA, N.Y., Dec. 7 -- Barr Laboratories, Inc. (NYSE: BRL)
today announced that the Honorable Nicholas H. Politan, Federal District
Court, District of New Jersey, granted Barr a summary judgment in the
Company's challenge of the patents protecting Organon Inc.'s Mircette oral
contraceptive. The summary judgment found that Barr's product did not
infringe the patent at issue in the case. This clears the way for the U.S.
Food and Drug Administration (FDA) to grant Barr final approval to begin the
manufacture, sales and marketing of a generic version of Mircette.
"We are very pleased that the Judge has granted summary judgment," said Bruce L. Downey, Barr's Chairman and CEO. "Our generic version of Mircette, which was acquired as part of our merger with Duramed Pharmaceuticals, becomes the latest oral contraceptive in our growing franchise of female healthcare products." The Company said that, pending final FDA approval, it may be able to begin shipping the product as early as the end of January 2002.
Mircette is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Based on the most recent quarter, annualized sales of Mircette were approximately $144 million. Mircette is a 28-tablet regimen that represents a combination of desogestrel/ethinyl estradiol tablets and ethinyl estradiol tablets.
Duramed Pharmaceuticals filed its application for Mircette in May 2000, and the FDA accepted the application in July 2000, initiating the patent challenge case between Bio-Technology General Corp., which licenses Organon to produce Mircette, and Duramed. Oral arguments were heard in District Court in New Jersey in October 2001. Barr received tentative approval from the FDA for its generic version of Mircette last week.
Earlier this year Barr completed the merger agreement with Duramed, a developer, manufacturer and marketer of prescription drug products including women's health and the hormone replacement therapies. Barr expects the merger will accelerate the Company's drive to become a leading developer, manufacturer and marketer of proprietary and generic female healthcare products, including hormone replacement therapies and oral contraceptives.
Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Safe Harbor Statement: To the extent that any statements made in this release contain information that is not historical, these statements are essentially forward-looking. 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 timing and outcome of legal proceedings, including Eli Lilly's appeal to the Supreme Court; the difficulty of predicting the timing of U.S. Food and Drug Administration ("FDA") approvals; the court and FDA's decisions on exclusivity periods; market and customer acceptance and demand for new pharmaceutical products; ability to market proprietary products; the impact of competitive products and pricing; timing and success of product development and launch; availability of raw materials; the regulatory environment; fluctuations in operating results; and, other risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. Forward- looking statements can be identified by the use of words such as "expects," "plans," "will," "believes," "estimates," "intends," "may" and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements.
"We are very pleased that the Judge has granted summary judgment," said Bruce L. Downey, Barr's Chairman and CEO. "Our generic version of Mircette, which was acquired as part of our merger with Duramed Pharmaceuticals, becomes the latest oral contraceptive in our growing franchise of female healthcare products." The Company said that, pending final FDA approval, it may be able to begin shipping the product as early as the end of January 2002.
Mircette is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Based on the most recent quarter, annualized sales of Mircette were approximately $144 million. Mircette is a 28-tablet regimen that represents a combination of desogestrel/ethinyl estradiol tablets and ethinyl estradiol tablets.
Duramed Pharmaceuticals filed its application for Mircette in May 2000, and the FDA accepted the application in July 2000, initiating the patent challenge case between Bio-Technology General Corp., which licenses Organon to produce Mircette, and Duramed. Oral arguments were heard in District Court in New Jersey in October 2001. Barr received tentative approval from the FDA for its generic version of Mircette last week.
Earlier this year Barr completed the merger agreement with Duramed, a developer, manufacturer and marketer of prescription drug products including women's health and the hormone replacement therapies. Barr expects the merger will accelerate the Company's drive to become a leading developer, manufacturer and marketer of proprietary and generic female healthcare products, including hormone replacement therapies and oral contraceptives.
Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Safe Harbor Statement: To the extent that any statements made in this release contain information that is not historical, these statements are essentially forward-looking. 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 timing and outcome of legal proceedings, including Eli Lilly's appeal to the Supreme Court; the difficulty of predicting the timing of U.S. Food and Drug Administration ("FDA") approvals; the court and FDA's decisions on exclusivity periods; market and customer acceptance and demand for new pharmaceutical products; ability to market proprietary products; the impact of competitive products and pricing; timing and success of product development and launch; availability of raw materials; the regulatory environment; fluctuations in operating results; and, other risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. Forward- looking statements can be identified by the use of words such as "expects," "plans," "will," "believes," "estimates," "intends," "may" and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements.