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: 3% [?]

Decision comes less than two weeks after FDA approval in the same setting.

OSI Pharmaceuticals and Roche report obtaining European Commission approval for Tarceva® as a monotherapy maintenance treatment in patients with advanced non-small-cell lung cancer (NSCLC) whose disease remains largely unchanged after platinum-based initial chemotherapy.

European sanction comes less than two weeks after FDA approval of Tarceva as a maintenance therapy. On April 16, the agency okayed the drug for patients with locally advanced or metastatic NSCLC that had not progressed after four cycles of platinum-based first-line chemotherapy. Tarceva is now approved in 109 countries for advanced NSCLC and 80 countries for pancreatic cancer, according to OSI and Roche.

“We are pleased that the European health authorities recognize Tarceva as a valuable option for lung cancer patients and their physicians when used in the first-line maintenance setting,” says Colin Goddard, Ph.D., CEO of OSI Pharmaceuticals. “We look forward to working with our partner, Roche, to advance the robust Tarceva life cycle program, which includes evaluating Tarceva in the adjuvant setting and as a first-line treatment for advanced NSCLC patients with an activating EGFR mutation as well as branching into other disease settings including liver cancer.”

EU approval was based on data from the Phase III Saturn study, an international, placebo-controlled, randomized, double-blinded trial that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress.

The trial showed that Tarceva given as a maintenance therapy immediately after first-line chemotherapy extended overall survival and improved progression-free survival in a broad patient population including squamous and nonsquamous histology compared with placebo.

Roche reported global sales of Tarceva reached CHF 1.3 billion in 2009 (about $1.22 billion), up 10% on 2008 and represented 3% of the firm’s overall global sales. In 2009, the drug was Roche’s eighth biggest selling pharmaceutical.

OSI says that its Tarceva-related revenues reached $359 million in 2009 compared with $335 million in 2008. The 2009 figure included Tarceva-related royalties of $146 million from Roche. Royalty revenues in 2009 were based on Tarceva net sales in the rest of the world of approximately $724 million.

Tarceva is a once-daily pill that targets the EGFR pathway. It is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell.

Source: GEN

Popularity: 3% [?]

Here’s the Health Blog’s little corner of the Greek debt saga: The nation’s government-run hospitals owe about $9.5 billion to drug and device manufacturers, the Financial Times reports.

Senior European pharma execs are flying to Athens for talks, and the industry wants the European Commission to find that Greece has broken EU late-payment rules. A deal may be worked out to restructure the debt; a similar deal in 2004 included a significant discount, the FT says.

The government last year set aside 1.1 billion euros to pay hospital debts; Goldman Sachs cited that move in a note it sent out Wednesday, arguing that Greece may need to revise up figures for its 2009 estimate. The government refuted that allegation. (For details, see the WSJ’s Real Time Economics.)

Meanwhile, hospital docs were among those who participated in a strike yesterday to protest austerity measures the Greek government wants to put in place as part of the effort to control the deficit.

Source: The Wall Street Journal

Popularity: 2% [?]

The European Commission sanctioned Baxter’s Celvapan H1N1 pandemic flu vaccine, produced using its Vero cell technology. The company claims the vaccine is the first cell culture-based, nonadjuvanted pandemic flu vaccine to get EU clearance.

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Baxter is currently carrying out clinical trials of Celvapan H1N1 and said that it will supplement the licensure postapproval with additional clinical program data. The company will also provide the EMEA with immunogenicity data from the first vaccination in adults within the next few days.

The current dosing schedule specified in the agency’s mock-up licensure for Celvapan using another virus strain involves two 7.5 microgram doses, given 21 days apart. Baxter said a trial in healthy adults will indicate whether a single dose may be enough for the Celvapan H1N1 vaccine. The trial will also determine whether a lower, 3.75 microgram dose is sufficient to induce the required immune response.

The EMEA implemented its mock-up licensure regulatory pathway for pandemic vaccines in 2004. The pathway allows companies to develop, evaluate, and register a pandemic vaccine candidate using an available influenza strain that has the potential to cause a pandemic. Once a flu pandemic occurs and the responsible strain is isolated, the mock-up licensure process allows for fast-track approval of the vaccine containing the actual pandemic strain.

Baxter was granted mock-up licensure for Celvapan using a different strain earlier this year. This vaccine was tested internationally through five completed clinical trials. The company received the causative pandemic H1N1 strain from the U.S. CDC in May and undertook preproduction testing and evaluation to assess the strain’s growth characteristics in the Vero cell culture technology.

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Commercial production was then started in early June, and Baxter initiated its license application for the final Celvapan H1N1 vaccine in July. Bulk Celvapan H1N1 vaccine is now produced at Baxter’s facility in the CzechRepublic and is subsequently sent to Austria for final formulation, fill, and finish.

Source: GEN News

Popularity: 4% [?]

The highest court in Europe sided with pharma today, ruling that regulators should reconsider their stand for discount drug traders. The court’s decision comes in a case filed by GlaxoSmithKline, but affects the entire industry and its efforts to combat so-called “parallel trading.”

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Here’s the background. Faced with the knowledge that discounters were buying meds in bulk in Spain–where prices tended to be lower–and reselling them in higher-priced markets in northern Europe, GSK hiked its Spanish prices on drugs destined for the export market. The European Commission decided that was a no-no, saying it violated antitrust rules.

A lower court overturned that EC decision in 2006, and now the European Court of Justice has upheld that ruling, saying that the EC has to reconsider whether that two-tiered pricing policy can be exempted from antitrust rules. GSK told Bloomberg that it doesn’t currently charge different prices in Spain, but “we are pleased with the outcome of the judgment.”

The industry as a whole should be pleased, a legal expert told the New York Times. “[T]oday’s judgment is good news for pharma companies,” said David Hull, who heads up the E.U. competition practices at Covington & Burling. Still, that doesn’t mean that two-tiered pricing will fly, however.

Source: FiercePharma

Popularity: 2% [?]

The European Medicines Agency has recommended to the European Commission that an additional vaccine against influenza A(H1N1) (’swine flu’), Celvapan from Baxter, be granted a marketing authorisation. Adoption of an authorisation decision by the European Commission is expected shortly. This recommendation follows the authorisation of Focetria, from Novartis, and Pandemrix, from GlaxoSmithKline, by the European Commission on 29 September 2009.

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As for Focetria and Pandemrix, this recommendation will allow the manufacturer to replace the flu virus strain in the current ‘mock-up’ vaccine with the A(H1N1)v strain causing the current pandemic.

Celvapan is a non-adjuvanted vaccine. This means that it does not contain ‘adjuvants’ to enhance the immune response. The Committee for Medicinal Products for Human Use (CHMP) is currently recommending a two-dose vaccination schedule, at an interval of three weeks, for adults, including pregnant women, and for children from six months of age. Clinical trials in adults and in children are ongoing, and more results will become available from mid-October 2009 onwards.

Vaccination strategies are decided by the government in each European Union (EU) Member State, taking the information provided by the Agency for each pandemic vaccine into account.

As with all medicines, rare adverse reactions may only be detected once the vaccine is being used in large numbers of people. The Agency has requested that Baxter implement the same plans as for the other pandemic vaccines, to actively investigate and monitor the safety of Celvapan as soon as it is being used across the EU, so that action can be taken as early as possible if a safety issue emerges. As part of this, the manufacturer has committed to carry out post-authorisation safety studies in about 9,000 subjects.

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The Committee will continue to evaluate all information that becomes available, and make further recommendations if necessary, to ensure that the benefits of all pandemic vaccines outweigh their risks, taking into account the spread and severity of the pandemic.

Other applications for marketing authorisations for pandemic vaccines are still under review.

Source: PHARMANEWS.EU

Popularity: 4% [?]

In an ambitious bid to improve on Europe’s position as a leader in the field of drug development, the European Commission and members of the European Federation of Pharmaceutical Industries and Associations announced plans to inject $228 million into drug discovery efforts.

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The money will be handled by the Innovative Medicines Initiative, which agreed at the beginning of this year on a $360 million package to support the search for new drugs. EU Commissioner for Science and Research Janez Potočnik says the money is intended to make the continent more attractive to the pharma R&D field. And the IMI has appointed Michel Goldman, a professor of immunology, as its chief agent provocateur in reforming the continent’s R&D infrastructure.

“We should see results from this exciting new research mechanism very soon and new innovative medicines should reach European patients faster,” said Potočnik.

Source: FierceBiotech

Popularity: 3% [?]

Roche reported Wednesday that the European Commission approved the expanded use of Avastin (bevacizumab) for first-line treatment of patients with advanced breast cancer in combination with sanofi-aventis’ Taxotere (docetaxel).

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Data from the AVADO study, a Phase III trial of the drug combination in 736 patients, showed improvement in progression-free survival with use of the drug in combination with Taxotere, compared with Taxotere alone.

Avastin is approved in the EU for first-line treatment of patients with advanced breast cancer in combination with paclitaxel, and for the treatment of advanced stages of colorectal, kidney, and non-small-cell lung cancers.

Source: FirstWord

Popularity: 7% [?]

The European Commission granted antitrust clearance to GlaxoSmithKline’s proposed $3.6-billion takeover of Stiefel, explaining that overlaps between the companies are limited to a number of dermatological products and would not significantly impede competition.

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Regarding the overlapping products, the EC ruled that “the combined firm would continue to face several strong, effective competitors with significant market shares.” The merger of GlaxoSmithKline and Stiefel was approved by the US Federal Trade Commission last month.

Source: FirstWord

Popularity: 3% [?]

The European Commission approved Novo Nordisk’s Victoza (liraglutide) for the treatment of type 2 diabetes in adults. The company hopes to launch the product in most of the EU over the next year, beginning in major markets such as Germany, the UK and Denmark, Novo Nordisk’s Chief Scientific Officer Mads Krogsgaard Thomsen said.

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In April, Victoza was issued a positive opinion by the EU’s Committee for Medicinal Products for Human Use, whereas an FDA advisory panel came to a split vote on whether to recommend the drug for approval. Krogsgaard Thomsen noted that the US is Victoza’s most important market, but added that there could be an equal number of patients taking the drug in Europe within 10 years, although the pricing of the treatment may be lower there.

Krogsgaard Thomsen said the compound should be able to gain a strong position in the GLP-1 market since studies have indicated that it is more effective than its closest competitor, Eli Lilly’s and Amylin’s Byetta (exenatide). However, he commented competition is bound to become more intense as “all companies want to have a stake in the GLP-1 field. That is why it is important for us to have approval now, and market early.”

Source: FirstWord

Popularity: 5% [?]