LILLY’s CECLOR CD COULD EXTEND CEFACLOR PATENT PROTECTION INTO 2007

LILLY's CECLOR CD COULD EXTEND CEFACLOR PATENT PROTECTION INTO 2007 based on the Nov. 6, 1990 issue date of a patent for a sustained- release matrix formulation of cefaclor. An NDA for the twice-a-day version of the antibiotic Ceclor has been pending at FDA since November 1991, Lilly said Jan. 22. On Jan. 18, the company announced that the new formulation had been launched in the U.K. as Distaclor MR. Cefaclor, marketed as Ceclor in the U.S., is sold under the name Distaclor in the U.K. Lilly would not project a U.S. launch date for the new formulation. However, in its announcement of the U.K. launch, Lilly said that "we hope this is only the first of several launches for this product in 1993." Approvals for the new formulation have been received in Italy, France and Spain, and applications are on file in most international markets, Lilly added. A timely approval of twice-a-day cefaclor in the U.S. could reduce the vulnerability of Lilly's Ceclor franchise to generic competition in the U.S. Ceclor is likely to top the $1 bil. mark in worldwide sales for 1992. Lilly disclosed 1990 sales of $825 mil. and said in its 1991 annual report that sales had increased by more than $100 mil. The basic cefaclor patent expired in December. Lilly, however, maintains that a patent on a key intermediary in the production of cefaclor will prevent generic competition at least until December 1994. The company also has cited the significant capital investment required to manufacture cefaclor as a deterrent to generic competition. In addition, Lilly recently launched a new cephalosporin antibiotic, Lorabid (loracarbef), to continue its antibiotic franchise ("The Pink Sheet" Aug. 17, 1992, T&G-4). No generic versions of cefaclor have yet been approved by FDA. At least one generic manufacturer, Biocraft, has publicly declared its commitment to marketing a generic cefaclor ("The Pink Sheet" April 22, 1991, p. 8). With Ceclor CD, Lilly is pursuing the evergreening strategy exemplified by Pfizer's Procardia XL. The once-a-day version of nifedipine has become a $1 bil. product in its own right, based on an initial cheaper per day price than immediate-release Procardia, improved patient convenience and a perceived therapeutic superiority. The Lilly-developed sustained-release cefaclor "provides patients with the advantage of reduced dosing frequency, from three to two times daily," Lilly said. An abstract of Lilly's patent for a sustained-release cefaclor states that the "invention provides a matrix composition for sustained drug delivery which is comprised of an active agent, a hydrophilic polymer and an enteric polymer." The formulation "aids in retarding drug release in regions of low pH," the abstract states. "This marks the first time an antibiotic's formulation has been changed to create a longer-acting product," Lilly declared. The new formulation "reflects the continued commitment of Lilly to the cefaclor molecule through the '90s." The company did not disclose whether it is developing other sustained-release products using similar technology.