NEW YORK, May 31, 2012 /PRNewswire/ -- Citeline, the world's leading research authority on pharmaceutical clinical trials, updates, and intelligence recently reviewed the results presented at the American Thoracic Society (ATS) conference held May 18-23, 2012 in San Francisco, CA. The strong competition to launch the next fixed dose combination (FDC) blockbuster for chronic obstructive pulmonary disease (COPD) was of particular interest to reviewer Jennifer Stacey, Citeline's Analyst in Autoimmune/Inflammation.
In the absence of results from GlaxoSmithKline and Theravance's market-leading RELOVAIR program, top COPD trials data presented at the conference include results from Novartis' Phase III NVA237 GLOW2 trial and final Phase II data from Boehringer Ingelheim's olodaterol monotherapy program. Both drugs provided significant improvement in bronchodilation with once-daily dosing, and these studies supported the dose selections for their respective FDC trials. Mid-sized companies Almirall and Forest showed sustained success of their partnered aclidinium bromide drug program, while privately-held Pearl Therapeutics divulged eight clinical publications at ATS, revealing statistically significant efficacy results and future plans for their LAMA/LABA (glycopyrrolate+formoterol fumarate), PT003.
"The presentations at ATS this year provide further evidence of high competition to launch next generation FDC respiratory drugs. COPD has superseded asthma as the lead indication in the market race, most likely due to the FDA's new safety controls pertaining to limited use of all LABA-containing drugs in asthma as well as the unmet need for improved therapies for COPD," states Ms. Stacey, "Additionally, it appears that most companies are strategically conducting trials to launch their novel LAMA or LABA as monotherapy in advance of the registration of the associated FDC product."
Despite the notable omission of pivotal RELOVAIR trial data from this year's ATS proceedings, GSK and Theravance continue to be the trailblazers in the race to launch the next generation COPD therapy through their partnership in two key FDC programs, RELOVAIR (fluticasone furoate+vilanterol) and their LAMA/LABA combination ('719+vilanterol). With the patent expiry of Advair in 2011 and the looming expiration of Symbicort later this year, GSK has positioned itself as the front runner in capturing a large share of the future respiratory market with these two strong Phase III FDC drug programs and plans to submit regulatory RELOVAIR applications for COPD in the US and Europe in mid-2012. However, several competitors are riding on their heels, including Boehringer Ingelheim, Novartis, Almirall/Forest, and the up-and-coming Pearl Therapeutics, with strong FDC candidates in their pipelines.
"Pearl Therapeutics is only in planning stages for their Phase III FDC program and is certainly the underdog among the current competition, but their innovative PT003 product had stellar Phase II data at ATS and they announced plans for PT010, a triple combination therapy of LAMA (glycopyrrolate), LABA (formoterol fumarate), and an inhaled corticosteroid, in one of their presentations," comments Ms. Stacey. "They will be an exciting company to watch as competitors in the FDC respiratory market race cross the finish line for novel inhaled therapies in COPD."
Citeline (www.citeline.com) provides the world's most comprehensive real-time R&D intelligence to the pharmaceutical industry, covering global clinical trial, investigator and drug intelligence. Our data is drawn from over 20,000 unique sources and analyzed by the industry's largest team – over 250 full-time expert analysts and editors.
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