| SPECTRACEF® Line Extensions
SPECTRACEF is an integral part of Cornerstone’s current sales strategy, as well as its sales growth strategy for the future. To protect and expand SPECTRACEF’s market share, Cornerstone has developed SPECTRACEF 400 mg, a higher dose tablet for the adult market, and is developing Spectracef Once Daily, a new oral solid dosage form, and SPECTRACEF Suspension, an oral suspension for the pediatric market.
SPECTRACEF 400 mg
SPECTRACEF 400 mg is a single 400 mg tablet, twice-daily dosage of SPECTRACEF for which Cornerstone received approval from the FDA in July 2008. Cornerstone believes that patients will find taking one 400 mg tablet twice daily to be more convenient than taking two SPECTRACEF 200 mg tablets twice daily. SPECTRACEF 400 mg is indicated for acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia. Cornerstone expects to launch SPECTRACEF 400 mg in the fourth quarter of 2008.
SPECTRACEF Once Daily
SPECTRACEF Once Daily is a single tablet, once-daily dosage of SPECTRACEF. Cornerstone filed an IND with the FDA in July 2008 for SPECTRACEF Once Daily, which has since been approved by the FDA, and expects to commence a clinical trial in the fourth quarter of 2008 to evaluate the pharmacokinetic profile of a formulation of SPECTRACEF Once Daily developed by Patheon Inc. If the results of this pharmacokinetic trial is favorable, Cornerstone expects to commence two clinical trials in the first quarter of 2009 to evaluate the safety and efficacy of this product candidate designed to form the basis for an NDA submission to the FDA in 2010 for the treatment of acute bacterial exacerbations of chronic bronchitis with COPD. Cornerstone is designing this trial as superiority, randomized studies of patients with acute bacterial exacerbation of chronic bronchitis. A superiority trial must show that the test product is statistically better than the comparator, which may be a placebo. Cornerstone anticipates that, if approved based on the results of these clinical trials, the FDA will grant SPECTRACEF Once Daily a three-year period of marketing exclusivity under the Hatch-Waxman Act.
Cornerstone believes that the once-daily dosage of this product candidate would be more convenient for patients than taking SPECTRACEF twice daily and would increase compliance. Among oral solid cephalosporins, only Cedax and Suprax have a once-daily dosage. Most macrolides and quinolones also have a once-daily dosage option.
SPECTRACEF Suspension
SPECTRACEF Suspension is an oral, liquid suspension of SPECTRACEF. Cornerstone expects to submit an NDA in 2009 for use of this product candidate by children with pharyngitis or tonsillitis based on the results of a number of previously conducted clinical trials. Two of these clinical trials compared the safety and efficacy of orally administered cefditoren pivoxil with an FDA-approved product, penicillin VK, using a non-inferiority design. Each clinical trial was a Phase III, randomized, double-blind, active-controlled, parallel-group, multicenter study of outpatients with streptococcal pharyngitis or tonsillitis. In the first clinical trial, 503 patients received either cefditoren pivoxil or penicillin VK. Of these, a total of 364 patients were considered microbiologically evaluable for efficacy at a post-therapy visit and 352 patients were microbiologically evaluable for efficacy at a subsequent follow-up visit. All 503 patients were included in the safety analyses. In the second clinical trial, 508 patients received either cefditoren pivoxil or penicillin VK. Of these, a total of 364 patients were considered microbiologically evaluable for efficacy at a post-therapy visit and 355 patients were microbiologically evaluable for efficacy at a subsequent follow-up visit. All 508 patients were included in the safety analyses. In each of these trials, cefditoren pivoxil was well tolerated with no significant adverse events reported. In the first trial, both treatment regimens were effective in resolving the clinical signs and symptoms of streptococcal pharyngitis or tonsillitis, but cefditoren pivoxil was statistically superior to penicillin VK in eradicating Streptococcus pyogenes. In the second trial, cefditoren pivoxil was equivalent to pencillin VK in resolving the clinical signs and symptoms of streptococcal pharyngitis or tonsillitis and in eradicating Streptococcus pyogenes.
In addition, Cornerstone expects to commence additional clinical trials in 2009 for SPECTRACEF Suspension in acute otitis media and submit an sNDA for this indication in 2010. Cornerstone is designing these clinical trials as superiority, randomized studies of patients with acute otitis media to evaluate the safety and efficacy of SPECTRACEF Suspension. If its NDA is approved, Cornerstone will have the option of launching SPECTRACEF Suspension for the pharyngitis and tonsillitis indications while the clinical trials in acute otitis media are ongoing. Cornerstone anticipates that, if approved based on the results of these clinical trials, the FDA will grant SPECTRACEF Suspension a three-year period of marketing exclusivity under the Hatch-Waxman Act for acute otitis media.
According to Wolters Kluwer Health, second and third generation oral cephalosporin suspensions generated approximately 7.8 million prescriptions in 2007 and approximately $750 million in sales, including suspension products containing cefdinir that generated approximately 5.6 million prescriptions and approximately $580 million in sales.
According to Wolters Kluwer Health, during the 54 week period ending May 16, 2008, pediatric specialists generated approximately 5 million second and third generation oral cephalosporin suspension prescriptions, or 64% of these prescriptions, and family practice specialists generated approximately 1.4 million prescriptions, or approximately 17% of these prescriptions.
Proprietary Rights
SPECTRACEF 400 mg, SPECTRACEF Once Daily and SPECTRACEF Suspension are covered by the same U.S. patents as SPECTRACEF 200 mg. Meiji also has applied for a U.S. patent that, if issued, would include claims to enhanced oral absorptivity for SPECTRACEF Once Daily. This patent application has been published and is currently pending. If issued, this patent would expire in 2023. Cornerstone’s rights to market and develop SPECTRACEF 400 mg, SPECTRACEF Once Daily and SPECTRACEF Suspension are subject to its license arrangements with Meiji.
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