FAUL Faulding Resolves US Patent Litigation With Hoechst Marion Roussel, Inc.,.UNDERDALE, South Australia--(BUSINESS WIRE)--May 4, 1999-- Faulding's Generic Version of Cardizem Car·di·zem (kär d -z m(R) CD to be Marketed Under License. International pharmaceutical and health care company F H Faulding & Co Limited (Faulding) today announced it has entered into a settlement of its patent litigation with Hoechst Marion Roussel, Inc. (HMRI HMRI - Her Majesty's Railway Inspectorate HMRI - Hospital Medical Records Institute HMRI - Hunter Medical Research Institute (Newcastle, New South Wales, Australia) HMRI - Huntington Medical Research Institutes (Pasadena, CA) HMRI - Hyundai Maritime Research Institute) relating to Faulding's Abbreviated New Drug Application (ANDA ANDA - Abbreviated New Drug Application (to the FDA) ANDA - Active Non-Destructive Analysis ANDA - Arkansas Negro Democratic Association ANDA - Asociación Nacional de Actores (México) ANDA - Association of National Dance Agencies ANDA - Austrian National Defense Academy (German, Landesverteidigungsakademie, Austria)) for diltiazem diltiazem /dil·ti·a·zem/ (dil-ti´ah-zem) a calcium channel blocker that acts as a vasodilator; used as the hydrochloride salt in the treatment of angina pectoris, hypertension, and supraventricular tachycardia. hydrochloride extended-release capsules, Faulding's proposed generic version of Cardizem(R) CD brand capsules. Cardizem(R) CD is indicated for the treatment of hypertension and chronic stable angina. According to IMS America, U.S. brand sales in 1998 were approximately US$630 million. Under the agreement, all claims and counterclaims asserted by the parties will be dismissed, and Faulding has been granted a license under HMRI's patent to market its generic version of Cardizem(R) CD upon Faulding's receipt of final approval of its ANDA from the US Food and Drug Administration. As part of the settlement, Faulding acknowledged that the HMRI patent on Cardizem(R) CD is valid and enforceable, and agreed to pay a royalty to HMRI on its sale of the product in the US market, once the Faulding product is launched. The settlement did not involve any immediate monetary payment by either party. Faulding received tentative approval of its ANDA for this product in October 1998. The approval was characterized as tentative due to the pendency of the patent litigation between Faulding and HMRI and the entitlement of Andrx Corporation to a 180-day period of generic market exclusivity with respect to the product. With the resolution of its patent litigation, Faulding will be able to market its product after the 180-day exclusivity period has expired. The initiation of the exclusivity period will occur either with the commercial launch of the Andrx product or the entry of a final, non-appealable judgment of non-infringement or invalidity of the HMRI patents in Andrx's pending court case. Andrx received final FDA approval of its ANDA in July 1998, but has not yet launched the product. At the present time, no other competitor has received final or tentative approval of an ANDA for a generic version of Cardizem(R) CD. Faulding is a diversified world-wide health and personal care company, listed on the Australian Stock Exchange. Faulding's principal businesses are generic oral and injectable pharmaceuticals, consumer health products, the provision of distribution and retail management services to pharmacies and logistics management services to hospitals. Faulding markets its products to and has representation in over 70 countries. N.B. Faulding Company Announcements are posted to the Faulding website www.faulding.com Note: Cardizem(R) CD is a registered trademark of Hoechst Marion Roussel, Inc. |
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