LILLY’s LORABID (LORACARBEF) WILL CARRY AWP OF APPROXIMATELY $90

LILLY's LORABID (LORACARBEF) WILL CARRY AWP OF APPROXIMATELY $90 for 30 pulvules (200 mg). That sets the price for the new oral antibiotic at more than 50% above the current AWP price for 30 capsules of Lilly's previous generation cephalosporin product, Ceclor (cefaclor). On a daily-dose basis, however, Lorabid appears to be priced about 10% higher than Ceclor. The twice-daily recommended dose for Lorabid indicates a $6 per day charge for the product compared to a three-times-a-day dosing regimen for Ceclor, costing close to $5.50 per day. Lorabid was approved by FDA on Dec. 31, 1991. Lilly has delayed the introduction of the product for seven months apparently to prepare for a launch to coincide with the start of autumn respiratory and otitis media infection season. The company recently has begun to fill orders with wholesalers. According to initial labeling, Lorabid is being made by Lilly at its Carolina, Puerto Rico facility. An oral broad-spectrum anitbiotic, Lorabid is the first of the carbacephem class of synthetic oral beta-lactams. Lorabid labeling contains several specific indications not currently carried by Ceclor: treatment of acute maxillary sinusitis, and acute bacterial exacerbations and secondary bacterial infections of the lower respiratory tract. Lorabid also carries added information on the pediatric use of the product, beyond current Ceclor labeling. Lorabid labeling notes, for example, that "middle ear fluid concentrations of loracarbef were approximately 48% of the plasma concentration 2 hours after drug administration in children." The Ceclor labeling does not specify the level of concentration of the product in the middle ear. Both products are indicated for otitis media. Only the suspension formulation of Lorabid is version approved for otitis. A specific side effect profile for pediatric use is contained in Lorabid labeling, showing "significantly different" levels of reactions between adults and children. Rhinitis, for instance, occurred in 6.3% of the pediatric population and 1.6% of adults. The Lorabid launch for Lilly is noteworthy for two reasons: (1) Lorabid provides Lilly with a next-generation product to complement Ceclor as that product nears the end of its exclusive marketing period; and (2) the new generation product will test Lilly's pricing flexibility in the oral antibiotic market and its ability to trade up physicians to the newer generation product. Ceclor's patent is scheduled to expire this December. Lilly, however, maintains that the drug will remain protected until December 1994 due to an intermediate process patent the company holds for the antibiotic.

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