Almirall Signs up Forest for Once-Daily LABA

Spain's mid-sized Almirall has won $75 million up front from Forest Laboratories, granting it U.S. rights to inhaled, once-daily long-acting beta agonist LAS100977, currently in Phase II trials.

The drug will be developed in combination with a corticosteroid for asthma and chronic obstructive pulmonary disease (COPD), using Almirall's multi-dose dry-powder inhaler, Genuair.

The agreement, which Forest announced Dec. 17, builds on an existing, 2006 partnership between the companies around long-acting muscarinic antagonist aclidinium (Eklira), whose initial efficacy studies in COPD disappointed but which remains in Phase III development using a twice-daily dose. ('The Pink Sheet' DAILY, Sept. 3, 2008).

Forest also has agreed to pay undisclosed milestones and sales-based royalties around LAS100977, and--as in the aclidinium deal--will assume the majority of development costs, according to Eduardo Sanchiz, chief executive for Corporate Development and Finance at Almirall.

Deal Boosts Almirall's Recovery But Combo Not First-in-Class

It's a good deal for Spain's Almirall, and has materialized within the timeframe that management promised. The company has been steadily clawing back credibility in the market place since its then-newly-listed stock was battered in mid-2008 following the lackluster data for aclidinium, widely perceived as a potential blockbuster that could transform the mid-sized group. (see 'Almirall: Adapting Primary-Care Focused R&D to a Specialist World,' IN VIVO, February 2008.)

The partners expect to start Phase IIb trials of the LABA-corticosteroid combination in 2010, confident of fast onset and 24-hour efficacy. Data generated thus far also show "very good tolerability in patients with stable asthma after multiple dosing," affirms Sanchiz.

But Almirall and Forest won't be the first, nor the only ones, seeking to tap the U.S. LABA/inhaled corticosteroid market with a once-daily offering. (Existing products combining the anti-inflammatory effects of a corticosteroid with LABA-induced bronchodilation are administered twice-daily; they include GlaxoSmithKline's Advair (salmeterol/fluticasone) and AstraZeneca's Symbicort ). GSK and partner Theravance in October 2009 began a 6000-patient Phase III program of their once-daily LABA in combination with fluticasone (the Horizon program). ('The Pink Sheet' DAILY, Oct. 28, 2009).

Novartis, meanwhile, is well into Phase II studies of QMF 149, which combines the LABA indacaterol with mometasone, also as a once-daily product ('The Pink Sheet,' May 25, 2009).

The Swiss group clearly has high hopes for that program, since it in May 2009 gained full worldwide development and marketing rights to it from Schering-Plough. In exchange, it relinquished to its former partner full rights to a fixed-dose combination of the LABA formoterol with mometasone ('The Pink Sheet' DAILY, May 19, 2009). Both Novartis and GSK have existing respiratory franchises and commercial presence that they're seeking to expand.

Forest : Rounding Out COPD Pipeline

So does Forest, however - albeit on a smaller scale. Indeed, for the mid-sized U.S. group, this deal is but the latest in its effort to expand its respiratory franchise as leading anxiety/depression drug Lexapro (escitalopam oxalate) faces patent expiry. In August, the U.S. group paid $100 million up front for U.S. rights to Nycomed's phosphodiesterase-4 enzyme inhibitor Daxas (roflumilast) for COPD, for which an NDA was filed in July ('The Pink Sheet' DAILY, Aug 10, 2009).

The new tie-up "rounds out a broad COPD pipeline that was recently augmented with Daxas," sums up Forest CEO and Chairman Howard Solomon in a release announcing the deal.

Besides, Citigroup analyst Joanne Jerman reckons the asthma and COPD markets are sufficiently large to accommodate multiple players--the U.S. LABA/inhaled corticosteroid market is currently worth over $5 billion and growing at a double-digit rate.

And perhaps the value lies in the device: Almirall has always believed its Genuair inhaler --developed from the established Novolizer -- to be well-differentiated, not least in its simplicity and easy-to-follow safety features. Developed using IP acquired from Meda AB in 2006, the device has a single activation step (one push of a button, in contrast to the multiple steps required for some marketed devices) and several feedback features telling the user that the dose was successfully inhaled.

- Melanie Senior (m.senior @elsevier.com)

This article is reprinted from "The Pink Sheet" DAILY –Dec 17, 2009

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