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The price for the most expensive Drug in the world could fall

It is one of the largest going to these fundraisers in Europe: the French Téléthon. Just in time for St. Nicholas day, the French TV broadcasts the 30-hour telethon to raise money for the development of new therapies for rare diseases. Also sick children to have their say. The impact: last year Alone, the Téléthon raised almost 70 million Euro.

The organization, AFM-Téléthon has become so large that it has its own research laboratory: Généthon. The approximately 200 employees focus mainly on basic research. And you made a breakthrough: they have developed a technique that used a Virus quasi as a Messenger, in the body of a sick people a defective Gene to be replaced.

With a Budget of 38 million euros, Généthon has the means to bring the invention to market. Therefore, the French completed in the year 2018 with the US Biotech company Avexis a license agreement for the use of the patents. Avexis to develop the means Zolgensma, the weakness against the most severe Form of genetically determined muscle, the spinal muscular atrophy (SMA), since this spring in the United States is approved.

Novartis is convinced of the prospects of the technology in such a way that the group took on Avexis in April for $ 8.7 billion. The money will be earned, therefore, Novartis set the price for the ground-breaking gene therapy Zolgensma with $ 2.1 million. This attracted international headlines, because this Product is the most expensive drug in the world.

Tricky price clause

However, the record high price could Slide. Because the license agreement between Avexis and Généthon, which is in the database of the U.S. securities and exchange Commission SEC available, contains an interesting clause. Under point 4.5 "French Patient Access" means: "The licensee (i.e., Avexis, d. ed.) will use reasonable efforts to provide to all licensed products for SMA in France, a price available to (...), which is not an obstacle for patient access."

thanks to this clause, the French have a lever to push the price for Zolgensma – at least in France. This could have consequences for the prices in countries such as Switzerland, where the authorities are laying down the reimbursement rates, among other things, the foreign prices of the draw.

The therapy with Zolgensma to about 2 million Swiss francs in costs. Photo: PD

the leaders of The Généthon answers, however, amazingly defensive on the question of whether you want to take advantage of the clause. "If the price for Zolgensma is too high or not, the need to find the French health authorities," says Généthon CEO Frédéric Revah. The clause was ultimately a kind of "potential opportunity for Appeal", should the authorities saw the price as too high.

In France, the Comité Economique des Produits de Santé (CEPS) specifies the medication price. Its Vice-Chairman Jean-Patrick Sales shall request only that Zolgensma is not yet approved in the EU. Therefore, "is Zolgensma not currently the subject of price negotiations in France". And Novartis, explains: "speculation about the possible pricing in individual countries, we do not comment on it."

alone of the French, has met with criticism

patient organisations, in the hope, however, to the clause in the contract: "I would hope that the French side uses the contract clause to achieve a sustainable and affordable price for Zolgensma, and that makes the result of the efforts publicly," says Nicole Gusset, President of SMA, Switzerland. "I'm afraid, however, that, as so often, only the list price in France is open to the public." The suspicion: France negotiated a hefty discount, it retains these, but for themselves.

The threat alone of the French gaining a foothold in France-criticism. "We are surprised that the leadership of AFM Téléthon, could consider to establish between the sick is a kind of discrimination, finally, the clause 4.5 relates to the contract, in French patients," criticized Luke Soubielle, President of the self-help organization Familles SMA France.

He suspects that the clause serve in the end only the image, in order to conceal that, thanks to the license agreement, Généthon forcefully Zolgensma is profiting. The contract provides that Généthon receives four million dollars at the time of contract signing. In addition, the laboratory receives payments from the Reach of certain milestones depend on the development, a total of 11 million dollars. For the third Généthon is involved with five percent of the sale proceeds.

practice test of the clause is from

Généthon-chief Revah defends himself: "My Problem is to find new resources." Therefore, the lab had to rely on such royalty income. In addition, the house could bring maturity without a Partner is not a drug to the market, it was too expensive. In most license agreements, Généthon would write such a clause into it, but so far, they had been never used.

Therefore, the Swiss refers to not-governmental organization of the Public Eye, the fact that the clause must pass the practical test. Nevertheless, the approach is worthy of imitation. "Many tax-funded inventions are sold without a guarantee that the resulting product is accessible or affordable," explains spokesperson Oliver Classen.

Only the fewest viewers of the French donation marathon, the Téléthon will probably have guessed that with your donations-developed innovations beibörsenkotierten at the end of big Pharma land.

Created: 26.11.2019, 19:37 PM

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