Almirall strengthens its respiratory franchise with a new generation of Chronic Obstructive Pulmonary Disease (COPD) treatment

April 11th, 2011 - New class of dual action long-acting Muscarinic Antagonist Beta-2 Agonist (MABA) has potential to change the paradigm of COPD treatment - Almirall is aiming at starting clinical studies during first half of 2012 - Almirall strengthens its position in the respiratory field with apositive development progress of another New Chemical Entity (NCE). LAS190792 is a new dual long-acting Muscarinic Antagonist β2 Agonist (MABA), which combines two bronchodilator mechanisms in a single molecule for the treatment of COPD. This new class of inhaled long-acting bronchodilators is expected to provide additional symptom relief in patients living with COPD, and to form the basis of so called triple combinations together with ICS (inhaled corticosteroids). The MABA franchise (MABA and MABA/ICS combination) offer the convenience of different mechanisms of action in one inhaler therapy, and is envisaged to become a future block buster in COPD.

“Almirall’s MABA (LAS190792) represents an exciting opportunity for the treatment of COPD and shows the strength of Almirall´s commitment to research in respiratory disease”, said Dr Bertil Lindmark, MD, PhD, and Chief Scientific Officer at Almirall.

MABA compounds offer the advantage over the two-molecule bronchodilator combinations (LABA/LAMA), in that MABA/ICS combinations can be developed with a reasonable size development programme.

In preclinical models, LAS190792 has shown to have a long duration of action and high anti-muscarinic activity combined with β2 agonism. The molecule shows very favourable drug properties and safety.

Almirall is planning to priorize the finalization of the pre-clinical phase, aiming at starting clinical studies during first half of 2012.

LAS190792 will be developed in the Genuair® inhaler, a novel, state-of-the-art, multi-dose dry powder inhaler... Almirall's Press Release -

Sanofi-aventis and Regeneron : Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer

March 10, 2011 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of aflibercept to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3% in the aflibercept arm compared to 8.9 percent in the placebo arm.


The treatment emergent adverse events (AEs) on the aflibercept arm with an incidence that was 10 percent greater than the control arm were stomatitis, weight decrease, hypertension, epistaxis and dysphonia. Grade 3 or 4 AEs that occurred at a frequency of at least 5 percent in patients who received aflibercept were fatigue, stomatitis, disease progression, hypertension, febrile neutropenia, dyspnea, neutropenia, and asthenia. AEs leading to treatment discontinuation occurred in 27.2 percent of patients in the aflibercept arm compared to 14.6 percent in the placebo arm. The types and frequencies of AEs reported in the aflibercept treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents... [PDF] Sanofi-aventis' Press Release - Regeneron Pharmaceuticals' Press Release -

Revalesio : research on the anti-inflammatory effects of RNS60 in Asthma

March 16, 2011 – Revalesio Corporation announced that research related to the use of RNS60, its novel anti-inflammatory, will be featured in two poster presentations at the Annual Meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in San Francisco on March 18-22.
AAAAI is the largest professional organization in the United States devoted to the specialty of allergy and immunology. It has nearly 6,500 members in the United States, Canada and 60 other countries.
Revalesio will present findings that demonstrate the novel anti-inflammatory activity of charge-stabilized nanostructures both in a preclinical model of allergic asthma and in cell culture experiments. These data suggest that Revalesio’s novel therapeutic RNS60 provides an opportunity for the development of a new generation of low-risk therapeutics for inflammatory pulmonary diseases.

In the preclinical model of asthma, RNS60 showed significant efficacy in the reduction of key inflammatory cytokines, including interleukin-6, interleukin-4, tumor necrosis factor-α (TNF-α), eotaxin and other cytokines known to be drivers of asthma. In addition to reducing inflammatory cytokines, RNS60 improved respiratory parameters compared to treatment with the inhaled corticosteroid budesonide... Revalesio's Press Release -