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

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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: 3% [?]

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: 3% [?]

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: 2% [?]

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: 5% [?]

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: 2% [?]

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: 3% [?]

UCB and Biogen Idec have discontinued a mid-stage trial of an investigational multiple sclerosis treatment which demonstrated “no clinically relevant benefit for patients”.

The companies said that a preliminary interim analysis of a Phase II study of CDP323 for the treatment of relapsing MS showed that patients enrolled in this clinical trial did not benefit as much as expected compared to placebo after a six-month treatment period. CDP323 is an orally-active small-molecule alpha-4 integrin inhibitor and UCB said that the results of this interim analysis will “trigger a re-valuation” of the compound. The Belgian firm added that it will take a “high double-digit million pre-tax euro” charge.

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As for Biogen, the company noted that no cases of the potentially fatal brain infection progressive multifocal leukoencephalopathy were noted. This is a relief given that just a day earlier, it was disclosed that the company’s flagship MS drug Tysabri (natalizumab), which is partnered with Ireland’s Elan Corp, has been linked to a 10th case of PML.

Neupro back on EU market
Better news for UCB came with the confirmation that the European Commission has lifted restrictions on its Parkinson’s disease drug Neupro (rotigotine), the Brussels-based firm’s transdermal patch for Parkinson’s disease.

A year ago supplies of the drug were limited to patients already on the medicine due to the discovery of crystallisation problems with the product. Those problems have been sorted out and a month ago, European Medicines Agency’s Committee for Medicinal Products for Human Use recommended a lifting of the restrictions. Neupro has also been cleared for use for the first time as a treatment for adults with restless leg syndrome.

Positive lacosamide data
Even more good news for UCB came with the release of pooled data presented at the International Epilepsy Congress in Budapest, which showed that the firm’s antiepileptic Vimpat (lacosamide) significantly improved seizure control, increased seizure freedom rates during the maintenance phase and enhanced quality of life and patient function, when used as adjunctive therapy.

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Elinor Ben-Menachem of Gothenburg University, noted that some 60% of people living with epilepsy have partial-onset seizures and around one-third remain uncontrolled, despite trying treatment with a range of drugs. These latest studies support the effectiveness of lacosamide in helping these patients, she added.

Source: PharmaTimes

Popularity: 3% [?]

Pfizer has offered concessions to European regulators to allay competition concerns over its proposed $68-billion acquisition of Wyeth, the European Commission said Tuesday. The EC, which gave no further details, extended its review period for the deal from July 6 to July 20.

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Spokeswoman Joan Campion of Pfizer remarked that “we previously said that a divestiture of certain animal-health assets may be necessary,” but she stated that the company will not identify the specific assets for competitive reasons. In addition, Campion explained that it is unlikely any divestitures would be worth more than 10 percent of the $4 billion in combined revenue generated by Pfizer’s and Wyeth’s animal-health units.

The company noted in April that it had received a request for additional information from the US Federal Trade Commission regarding the offer to acquire Wyeth. At that time, Pfizer said it still expected to close the deal by the end of the third quarter or during the fourth quarter of this year.

Source: FirstWord

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