Spain’s privately-owned pharmaceutical company Almirall yesterday revealed it has inked a $60 million-plus US deal with Forest Laboratories for the new hope in its product pipeline, a muscarinic antagonist designed to provide long-acting control of chronic obstructive pulmonary disease symptoms. The company, which is number two in Spain after Pfizer, told PharmaTimes World News in an interview recently that its long-term vision is to become a robust player in the respiratory field and it hopes the code-named LAS34273 will help propel it onto that global stage.
Under the terms of the deal, Forest will pay Almirall an upfront payment of $60 million plus undisclosed future milestones and royalties on sales. The two companies will collaborate on the development and regulatory approval of LAS34273, while Almirall retains the right to co-promote the product at a future date. The Spanish firm has also agreed to give Forest first refusal on other Almirall compounds that could be combined with LAS34273.
Said Jorge Gallardo, chairman and chief executive of Almirall: “We are confident that this will be a successful partnership leveraging Forest’s proven skills in clinical development and marketing in the competitive US market. Both companies believe LAS34273 is a compelling product that has promising potential.” And the company hopes to grab a slice of the pie captured by Boehringer Ingelheim’s top-selling respiratory agent Spiriva (tiotropium bromide), which took pole position in the German firm’s 2005 results with sales of $1.2 billion.
“LAS34273 works in a similar fashion but has advantages in terms of fast onset of symptom control and low systemic exposure,” Almirall told PharmaTimes World News , adding that it is also delivered in a convenient multi-dose dry powder inhaler that “represents an improvement over currently available devices.” Certainly, in Phase II studies, LAS34273 has been shown to provide 24 hours of bronchodilation, and Forest says it was impressed by both the results of these investigations and the drug’s clinical profile. LAS34273 has now entered Phase III development in Europe and the USA to treat COPD – which represents a massive market as the fourth leading cause of death in the USA and associated with $32 billion in direct and indirect costs in 2002 alone.
Meanwhile, in Europe, where Almirall holds the number 36 spot in pharmaceutical ranking, the company plans to market the drug alone – helped by its 900-strong salesforce. This has been ramped up to coincide with the company’s recent £46 million link up with GW Pharmaceuticals for the latter’s cannabinoid product Sativex (delta-9-tetrahydrocannabinol plus cannabidiol) for pain control in multiple sclerosis.
And Almirall certainly appears to be stepping up the pace as LAS34273 makes another move towards the market, having appointed over the last two months alone Per-Olof Andersson as the new Executive Director for the R&D (formerly Vice President Clinical R&D in Pfizer Japan) and John Efthimiou as its new Global Medical Director for the R&D area. Dr Efthimiou was previously Head of Respiratory Clinical Development at GlaxoSmithKline, and has held roles at Chugai Pharma Europe as Director of R&D and with Novartis as Global Head of Exploratory Clinical Development Profiling.
Almirall has over 30 products marketed across 100 countries and specialises in inflammatory conditions, including asthma, psoriasis and rheumatoid arthritis. Its aim is to develop ‘best in class’ compounds rather than ‘first in class’ and around half of its 1 billion euro turnover in 2005 came from in-house developed drugs.