Assistant Managing Editor

Five months after a regulatory snag pointed to a delay with a partnered chronic obstructive pulmonary disease drug, Forest Laboratories Inc. picked up another drug that could offer near-term entry into the multibillion-dollar COPD market.

The New York-based company agreed to pay $100 million up front for U.S. rights to Nycomed A/S's Daxas (roflumilast), a phosphodiesterase 4 inhibitor under review for chronic obstructive pulmonary disease. Additional milestones were not disclosed, and Forest could not be reached for comment, though several news reports said Nycomed could earn up to $500 million upon regulatory and commercial achievements.

The Swiss firm also is entitled to royalties from U.S. sales.

A new drug application for Daxas was filed last month, based on data from four Phase III trials showing that the once-daily, oral treatment met study endpoints and demonstrated positive effects on exacerbation rates and pulmonary function in patients with symptomatic COPD.

No PDUFA date has yet been set, but a first-pass approval would mean Daxas could hit the market next year, giving Forest a potential blockbuster drug just in time to start offsetting declining sales of big-seller antidepressant Lexapro (escitalopram oxalate), which is set to lose patent protection starting in 2012. Sales of Lexapro made up more than half of the firm's $948.2 million in product revenue for the three-month period ending June 30.

Forest, along with partner Cypress Bioscience Inc., of San Diego, gained approval of Savella (milnacipran HCL), a dual reuptake inhibitor, in fibromyalgia in January, though some analysts have projected slow uptake of that drug as it competes with the likes of Pfizer Inc.'s Lyrica (pregabalin) and Eli Lilly and Co.'s Cymbalta (duloxetine). Other potential near-term products include ceftaroline, an antibiotic that has met endpoints in late-stage trials in community-acquired pneumonia and complicated skin and skin structure infections but faces an uphill regulatory battle amid the FDA's changing guidelines for antibiotics. (See BioWorld Today, Jan. 16, 2009.)

The company had hoped a 2006 deal with Laboratories Almirall SA, of Barcelona, Spain, would clear its way into the COPD space. Aclidinium bromide, an inhaled anticholinergic, met its endpoints in two Phase III trials, and the companies had planned an NDA submission late this year or early next. But the FDA threw a wrench into the works in March when it requested additional trials using more frequent dosing regimens and higher doses of aclidinium bromide.

The partners reported in April that they intended to unveil a plan for satisfying requests from the FDA - and European regulators - and projected a new filing timeline of late 2011/early 2012. But both companies also have earlier-stage COPD programs: Almirall has LAS100977, a long-acting beta agonist, while Forest is working on oglemilast, another PDE4 inhibitor, licensed from Mumbai, India-based Glenmark Pharmaceuticals Ltd.

Forest said work on oglemilast is ongoing in COPD, as well as asthma, and Howard Solomon, Forest's CEO, in a press release called oglemilast a "potentially complementary opportunity" to newly acquired Daxas.

Also in development, the company has linaclotide, which is under way in Phase III studies in chronic constipation and recently began Phase III testing in constipation-predominant irritable bowel syndrome. Linaclotide, a guanylate cyclase Type C receptor agonist, is partnered with Cambridge, Mass.-based Ironwood Pharmaceuticals Inc. in a potential $330 million deal. (See BioWorld Today, Sept. 18, 2007.)

Forest, which reported net income of $262.9 million for the three months ending June 30, ended the quarter with about $2.9 billion in cash, equivalents and marketable securities.

Shares of Forest (NYSE:FRX) closed Monday at $26.29, up 1 cent.

Published  August 11, 2009