FDA approves Forest’s COPD drug
pharmafile | July 25, 2012 | News story | Sales and Marketing | COPD, FDA, Forest, Tudorza Pressair
US regulators have approved Forest Laboratories’ new chronic obstructive pulmonary disease (COPD) drug.
Tudorza Pressair (aclidinium bromide) has been given the green light by the FDA for the long-term maintenance treatment of COPD-related bronchospasm – the narrowing of those airways.
The dry powder inhaler, used twice-daily, helps muscles in that area to stay relaxed – a key point for sufferers from COPD, which is a condition characterised by breathing difficulty.
Encompassing chronic bronchitis and emphysema, COPD is usually caused by smoking, affects 210 million people worldwide and is predicted to be the third leading cause of death anywhere by 2020.
Tudorza Pressair joins several drugs licensed to treat COPD in the US, among them AstraZeneca’s Symbicort, Boehringer Ingelheim and Pfizer’s Spiriva and GlaxoSmithKline’s blockbuster Advair (Seretide in the UK), the biggest-selling drug in the market.
Into what is already a relatively crowded arena, GSK and US biopharma firm Theravance have recently submitted their investigational COPD drug Breo (Relvar in Europe) to the FDA and European authorities.
Advair is about to lose patent protection, a fate which has already befallen Forest’s antidepressant Lexapro and awaits its Alzheimer’s brand Namenda in a couple of years.
All this means Forest is pinning considerable hopes on Tudorza Pressair, which analysts have estimated could make around $200 million in sales by 2015.
The US firm is trying to keep its eye on another ball at present too – Carl Icahn, the activist investor famed for his aggressive tactics, is urging shareholders to vote in favour of his four board nominees.
Icahn, who is often termed a corporate raider because of his attempts to take control of various companies by increasing his share ownership and influence, has already been vocal about the potential fall-out from Lexapro’s ‘patent cliff’.
Icahn has been particularly scathing about what he sees as management failures in successfully pursuing Forest’s pipeline activities.
Adam Hill
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