Selective PDE4 inhibitor is aimed at patients with severe COPD associated with chronic bronchitis.

The European Commission granted Nycomed marketing authorization for Daxas® (roflumilast). The drug is indicated as an add-on to bronchodilator therapy for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations.

Daxas reportedly represents the first new class of treatment for COPD in more than a decade. It is a selective phosphodiesterase 4 (PDE4) enzyme inhibitor. It is taken as an oral tablet once a day and is expected to be launched in European countries, starting with Germany and the U.K.

On April 26, Nycomed and Merck & Co. signed an agreement to co-promote Daxas in France, Germany, Italy, Spain, Portugal, and Canada. Nycomed will manufacture and distribute the finished product in all these countries. In addition, the two companies entered into an exclusive distribution arrangement for the commercialization of Daxas in the U.K. Nycomed will supply finished product and has retained a co-promotion option. For the U.S. the company signed a collaboration and distribution agreement with Forest Laboratories in August 2009. The NDA for Daxas was submitted in July 2009.

“Daxas is a novel therapy that improves lung function and most importantly reduces exacerbations,” says Klaus F. Rabe, M.D., lead author on various Daxas clinical trials from the University Medical Centre in Leiden, The Netherlands. “It has a unique mode of action that targets the underlying inflammation in COPD and is an important addition to the current options available to doctors and patients.”

Neil Barnes, M.D., professor of respiratory medicine at Barts and the London Hospital and Nycomed consultant, notes, “We have a large number of patients who remain symptomatic and have frequent exacerbations despite existing treatments, and for that more severe end of the spectrum we need new therapeutic options. The main additional benefit of Daxas on top of what is already achieved with bronchodilators is to reduce the number of exacerbations, or flare ups.”

The application to the EMEA was based on four Phase III trials in symptomatic COPD patients. In two placebo-controlled, 12-month studies involving over 3,000 patients, Daxas demonstrated statistically significant improvements on both co-primary endpoints: moderate-to-severe exacerbations and prebronchodilator FEV1.

The effect of Daxas was independent of concomitant use of long-acting beta2-agonist, according to Nycomed. In two supportive studies the drug also showed a statistically significant improvement compared to placebo on lung function over a six-month period when added to the bronchodilators tiotropium or salmeterol. Full data from all four studies was published in The Lancet in August 2009.

Source: GEN

Popularity: 2% [?]

Centocor Ortho Biotech, a division of Johnson & Johnson, announced today that it has acquired acquired RespiVert, a private company that’s developing small-molecule, inhaled therapies for the treatment of pulmonary diseases. RespiVert’s two lead compounds are RV-568 and RV-1088, potential treatments for asthma, COPD and cystic fibrosis. Both programs are entering clinical trials.

RespiVert will continue to lead development of the two lung drugs in collaboration with Centocor scientists. The company will remain in London, where it’s currently based. Financial terms of the deal were not disclosed, but Imperial Innovations Group, one of RespiVert’s VC backers, has made almost $14 million on the sale of its 13.4 percent stake in the developer.

“The RespiVert compounds offer the potential for a new class of medicines for patients with severe lung disease who are insensitive to inhaled corticosteroids,” says Centocor’s Susan Dillon, Global Therapeutic Area Head, Immunology. “The addition of RespiVert’s expert scientific team and discovery platforms for inhaled medicines strengthens our capabilities and further builds our pipeline of novel oral and biologic therapies for serious pulmonary diseases.”

Source: FierceBiotech

Popularity: 3% [?]

Galapagos NV (Euronext: GLPG) announced today that it has entered into a global multi-year strategic alliance with Roche (SIX: RO, ROG; OTCQX: RHHBY) to develop potential new therapies in COPD (chronic obstructive pulmonary disease).

[ad]

In the alliance, Galapagos will apply its target discovery platform to discover novel COPD targets. Galapagos is then responsible for the discovery and development of new small molecule candidate drugs against these targets. Roche will have an exclusive option to license each small molecule program after either clinical candidate selection or completion of Phase I clinical trials. In addition, Roche has an exclusive option to license the COPD targets for the discovery and development of antibodies against these targets. Upon exercise of each option, Roche will be responsible for the further (pre)clinical development and commercialization.

Under the terms of the agreement, Galapagos has received a research access payment of EUR 6 million from Roche. Galapagos is also eligible to receive discovery, development, regulatory and sales milestone payments that could potentially exceed EUR 400 million, plus royalties upon commercialization of any products covered in the agreement.

“This alliance with Roche on discovering novel COPD targets demonstrates the versatility of Galapagos’ target discovery platform in identifying novel targets across a wide range of therapeutic areas. We are excited that this collaboration will focus on both antibodies and small molecules as potential drugs for COPD,” said Onno van de Stolpe, CEO of Galapagos.”Roche’s vast experience in developing and commercializing antibodies makes it the perfect partner for this combined approach.”

“Galapagos’ track record in discovering novel therapeutic targets and its drug discovery expertise make it an ideal partner for our COPD discovery program,” said Satwant Narula, head of discovery for the inflammation area of Roche. “We feel confident that this alliance will bring new mode of action drugs for COPD into the clinic for Roche.”

About COPD COPD (chronic obstructive pulmonary disease) is a chronic lung disease characterized by difficulty breathing and persistent coughing. COPD includes the diseases commonly referred to as chronic bronchitis and emphysema. The primary causes of COPD are tobacco smoke and air pollution, which damage and irritate lung tissue, resulting in a narrowing of the airways.

COPD affects approximately 210 million people worldwide, with more than 5 million people dying of the disease each year. This number is expected to increase by more than 30% in the next ten years, due to an increase in tobacco use worldwide. Although the disease symptoms are manageable through the use of drug and oxygen therapy, there is currently no cure for COPD.

Source: Galapagos NV

Popularity: 3% [?]

A new vaccine against pneumonia may offer better protection from chronic obstructive pulmonary disease (COPD) patients than the currently accepted vaccine, according to recent research that will be published in the September 15 issue of the American Journal of the Respiratory and Critical Care Journal, a publication of the American Thoracic Society.

[ad]

Because pneumonia disproportionately affects patients with COPD and frequently causes exacerbations, the Centers for Disease Control currently recommend that all adults with COPD receive the 23-valent pneumococcal polysaccharide vaccination (PPSV23). However, the efficacy of PPSV23 is not well established in the COPD patient population.

“Reasonable effectiveness for this vaccine has been demonstrated in cohort studies in adults with lung disease,” said Mark Dransfield, M.D. of the University of Alabama at Birmingham and lead author of the study. “[However,] debate remains about its immunogenicity and effectiveness in COPD.”

Dr. Dransfield and colleagues sought to determine the efficacy of a newer type of vaccine, PCV7, a protein conjugate vaccine, which attaches a weak antigen (in this case, the pneumococcal polysaccharide antigen) to a stronger antigen (the diphtheria toxin) in the hope that the stronger antigen with provoke a more forceful defense from the immune system.

“Conjugated vaccines were originally intended for young children who respond poorly to polysaccharide antigens,” said Dr. Dransfield. “We wanted to see whether they could have a similar effect in the COPD patient population in whom immune responses may also be blunted.”

Results of the randomized open label trial of 120 adults with moderate to severe COPD showed that, while both the PPSV23 vaccine and the PCV7 vaccine were well-tolerated, the PCV7 vaccine produced superior immune responses on several measures of immunogenicity. Among patients randomized to take the PCV7 vaccine, the fraction exhibiting a twofold increase in serotype-specific IgG antibodies was higher in five of the seven serotypes tested. Blood drawn from patients who had received the PCV7 vaccine was also more effective at killing pneumococci in six of seven serotypes tested one month after vaccination.

[ad]

“We have shown that PCV7 induces a superior immune response to PPSV23 in COPD at one month post-vaccination,” concluded Dr. Dransfield. “Both vaccines elicit responses comparable to those previous observed in health elderly patients.” Older age and prior vaccination with PPSV23 dampened the efficacy of the PCV7 vaccine, however.

A vaccine in development that contains the capsule of 13 pneumococcal serotypes, called PCV13 (compared to PCV7 which has seven) is hoped to expand the coverage of the vaccine.

“We hope that future research will confirm the superior immunogenicity of PCV13 in COPD,” he added. “We also want to determine the relative duration of the immune response following PPSV23 and conjugate vaccination and to identify the immunologic correlates of protection against both invasive and non-invasive pneumococcal disease. We believe our data provide the rationale for further study of the clinical efficacy of protein-conjugate pneumococcal vaccines in the high risk COPD population.”

Source: GEN News

Popularity: 3% [?]

AstraZeneca is extending its alliance with Dynavax until July 2010 and will provide funding for research on a third drug candidate. The deal inked in September 2006 covers TLR-9 agonist-based therapies for the treatment of asthma and COPD.

AstraZeneca paid $10 million up front and committed to $27 million in research funding and preclinical milestones. The total value of the deal is $136 million. AstraZeneca has commercialization rights, and Dynavax retains the option to co-promote in the U.S.

[ad]

The partnership has resulted in one candidate, AZD1419, expected to enter Phase I in the second half of 2009. The nomination of this compound triggered a $4.5 million payment. The companies report that they are already working on a second molecule.

AZD1419 utilizes Dynavax’ immunostimulatory sequences technology and is designed to change the basic immune response to environmental allergens leading to a prolonged reduction in asthma symptoms.

Source: GEN News

Popularity: 2% [?]