Forest Labs Aims To Launch Once-Daily Namenda Ahead Of Generics
This article was originally published in The Pink Sheet Daily
Executive Summary
Alzheimer's line-extension is in Phase III, and first ANDA with paragraph IV certification for current twice-daily formula could be filed next fall.
|
Forest Labs is hoping to launch a once-daily version of its Alzheimer's therapy Namenda (memantine) prior to the launch of generic formulations of the current twice-daily product, according to VP-Investor Relations Charles Triano. Once-daily Namenda is now in Phase III, he noted during an Oct. 17 second quarter earnings call. "We expect that we would need one positive Phase III study to file a modified-release Namenda," Triano said. "If all were to go as planned, we could have that product on the market just a bit ahead of exclusivity expiration for the current twice-daily version of Namenda," he added. The first ANDA with paragraph IV certification for Namenda could be filed early as October 2007, according to Forest. Data exclusivity expires in October 2008, and FDA's "Orange Book" lists two patents for memantine expiring April 11, 2010, and March 25, 2014. The firm suffered a setback in its efforts to expand Namenda's indication last year when FDA deemed a supplemental NDA for treatment of mild-to-moderate AD patients to be "not approvable" (1 (Also see "Forest’s Namenda Gets “Not Approvable” Letter For Mild Alzheimer’s Indication" - Pink Sheet, 25 Jul, 2005.)). Namenda has been approved since 2003 for treatment of moderate-to-severe AD, and now is facing competition in the severe category following the recent approval of Pfizer/Eisai's Aricept (donepezil) for the indication (2 (Also see "Pfizer/Eisai’s Aricept Becomes First Treatment Approved For All Degrees of Alzheimer’s" - Pink Sheet, 13 Oct, 2006.)). Regarding its beta blocker nebivolol, which received an FDA "approvable" letter for hypertension earlier this year, Forest reiterated it is on track to file a response which includes pharmacokinetic and preclinical data to the agency by the end of the fiscal year; given a six-month review, the product would launch in the first half of fiscal 2008. Forest's FY 2008 begins April 1, 2007 (3 (Also see "Nebivolol Approval Could Come In Mid-2007, Forest Says" - Pink Sheet, 25 Apr, 2006.)). The firm also maintained prescription growth of its antidepressant Lexapro (escitalopram) is stable despite the entry of generic versions of Pfizer's Zoloft (sertraline) in late summer (4 (Also see "Lexapro Scripts Hold Up Against Competition From Generic Zoloft" - Pink Sheet, 11 Oct, 2006.)). Forest is awaiting word from FDA on its pending antibiotic Orapem (faropenem), which has a user fee date of Oct. 20. The company is seeking four indications - sinusitis, community-acquired pneumonia, acute exacerbations of chronic bronchitis and uncomplicated skin and skin structure infections - but has said it needs approval of the sinusitis and pneumonia indications to launch the product. Forest's Q2 2007 net sales were up 15% to $847 mil., and net income rose 18% to $241.1 mil. -Brooke McManus ([email protected]) |