Spain's Almirall has seen its share price slip after the firm and partner Forest Laboratories said that a filing in the USA of their chronic obstructive pulmonary disease treatment aclidinium bromide will be delayed.

The companies said that following consultation with the US Food and Drug Administration, additional clinical studies will be conducted on aclidinium to “provide further support for the selected regimens, including higher and/or more frequent doses”. They originally anticipated filing a New Drug Application in the fourth quarter of 2009 or the first quarter of 2010, “pending FDA feedback”.

Now Almirall and Forest say that timelines for the additional clinical studies and the future filing date of an NDA, “are being determined”.

The Spanish drugmaker’s stock has suffered since it announced results from two global Phase III studies of aclidinium, ACCLAIM/COPD I&II, in September last year. In both those trials, the drug, taken once-daily, showed a statistically significant difference versus placebo using a standard measure of pulmonary function, FEV1. However ACCLAIM/COPD II did not show a statistically significant in health-related quality of life compared with placebo as measured by the St George's Respiratory Questionnaire at week 52.

The news prompted a report from analysts at Citigroup which noted that this lastest delay “removes potential for any near-term aclidinium bromide revenue contribution" for Almirall. They also claimed that Forest may now re-examine the partnership.

Last month, the Barcelona-based firm posted a 3.8% rise in net income to 136.1 million euros for 2008, while sales climbed 13.9% to 902.8 million euros.

’Cosmetic’ changes to Savella formulation
Meantime, to add to Forest’s disappointing day, it was announced that the firm and partner Cypress Biosciences will not launch their recently-approved fibromyalgia drug Savella (milnacipran) this month as expected, due to a small formulation change.

Forest said it will start shipping Savella by the middle of the year now, having submitted a “minor post-approval cosmetic formulation change” to the US Food and Drug Administration. The companies expect a response from the agency by May at the latest.

Savella, which received US approval in January, is licensed from France’s Pierre Fabre, which originally developed and sells milnacipran outside the USA as an antidepressant.