Forest Laboratories, Inc. and Almirall, S.A. recently announced positive top-line data on their chronic obstructive pulmonary disease (COPD) fixed dose combination candidate, aclidinium bromide (LAMA) and formoterol fumarate (LABA).
Two fixed dose combinations – aclidinium/formoterol (400/6mcg and 400/12mcg given twice a day) – were evaluated in the six month pivotal phase III study named AUGMENT COPD. Results showed that both combinations achieved a statistically significant improvement in the co-primary endpoints compared to placebo.
Forest Labs said that both doses were found to be well-tolerated with common adverse events including cough, headache, urinary tract infection and back pain among others. Aclidinium/formoterol was administered using Almirall’s inhaler Genuair (US trade name: Pressair)
The results presented from this study were consistent with results presented last month from another pivotal phase III study - ACLIFORM/COPD.
With both phase III studies generating positive results, Forest Labs intends to file for US and EU approval in the fourth quarter of 2013.
We note that the 400mcg formulation of aclidinium bromide is already approved under the trade name Tudorza (US trade name; EU trade name: Eklira). Tudorza, which gained Food and Drug Administration (FDA) approval in the US in Jul 2012, was launched in Dec 2012. Tudorza is approved for the long-term maintenance treatment of bronchospasm associated with COPD including chronic bronchitis and emphysema. Tudorza sales came in at $23 million in fiscal 2013. Forest Labs expects Tudorza sales of $90 million in fiscal 2014.
The successful development and approval of the fixed dose combination would help strengthen Forest Labs’ position in the COPD market. According to the World Health Organization (WHO), about 64 million people across the world suffer from COPD.
Forest Labs currently holds a Zacks Rank #3 (Hold). Forest Labs is facing tough times with Lexapro losing exclusivity. Moreover, the performance of new products, especially Teflaro, has been below expectations. Meanwhile, Namenda will face generic competition in early 2015 putting another $1+ billion at risk. Forest Labs has, however, made significant progress with its pipeline and should be on the lookout for additional deals in the next couple of years.
Companies that look better-positioned include Catalyst Pharmaceuticals Partners Inc. (CPRX - Snapshot Report), Elan Corporation and Cubist Pharmaceuticals (CBST - Analyst Report). While Catalyst Pharma is a Zacks Rank #1 (Strong Buy) stock, Cubist Pharma and Elan are Zacks Rank #2 (Buy) stocks.