Mylan N.V. (NASDAQ:MYL)
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By Donato Paolo Mancini
A branded HIV drug that has been shown to reduce the risk of infection with the virus by 86% is proving too expensive for some at-risk European patients.
England's National Health Service thinks it has a solution.
By rolling out the treatment under the banner of a clinical trial, the NHS can use a low-cost generic version of the drug without infringing patents because drugs used in clinical trials are exempt from patent litigation under English law.
The high price of Gilead Sciences Inc.'s HIV drug Truvada has deterred many countries from providing the pill as a preventive treatment for people at high risk of contracting the AIDS-causing virus, doctors, activists and patients say.
Under the trial, the NHS will make a generic form of the drug, made by rival firm Mylan NV, available for at least 10,000 people. The generic isn't otherwise directly available in the U.K. The move could also pave the way for other European countries to follow suit.
"The unusual length, extent and nature of this 'implementation trial' may well set significant precedent for the unencumbered use of generics on the NHS," said Siva Thambisetty, an Associate Professor in Intellectual Property Law at the London School of Economics and Political Science.
The use of a trial in this manner is very rare in the U.K., but the unconventional move stands to deliver the drug at a significant discount.
Truvada costs patients about GBP355.73 ($461.69) a month when bought privately via the NHS, according to the most recent British National Formulary figures, while generics bought online usually cost a fraction of that.
The NHS declined to comment on commercial terms of the arrangement, citing confidentiality. Mylan said it has worked with Gilead to expand access to Truvada and its generic version around the world, and it is pleased to support the NHS for the clinical trial on PrEP. It didn't comment on how much the agreement was worth. Gilead Sciences declined to comment.
However, while the use of a clinical trial to circumvent patents and use generics could set a precedent for this is particular drug, it is unlikely to be used more widely because generics aren't typically available for new, high-price drugs. The reason generic drugs are widely available for HIV is because drug companies have allowed their development for use in low-income countries.
The Wall Street Journal first reported last week that the NHS would use the generic version of the drug for a large-scale clinical trial, with an allocated budget of GBP10 million.
Truvada and its generic version are used in PrEP, or pre-exposure prophylaxis, a regimen that people at high risk of HIV can use to protect against acquiring the virus. Its use has been linked to a decrease in new HIV diagnoses in England recently, a first since numbers started being recorded.
Sheena McCormack, a professor of Clinical Epidemiology at University College London, said that increased testing and a rise in PrEP use played key roles in this decline.
In England, the potential benefits of PrEP are widely acknowledged. But the state-funded health system has been reluctant to make Truvada available for preventive purposes because of its high cost, with a lengthy legal battle over who should pay for the drug in England lasting years.
In December the NHS announced it would put out a tender for the trial and would review proposals from a number of manufacturers, including those of generic versions of the drug.
"It was anticipated that a generic company would win, it's kind of what we've hoped," said Laura Waters, a doctor with the British HIV Association.
Activists have cautiously welcomed the NHS's decision to launch a trial using a generic.
"This is a good step forward. We've been waiting for years for PrEP to become more widely available," said Will Nutland, an HIV activist and honorary lecturer at the London School of Hygiene and Tropical Medicine.
But some caveats remain, he said: It is a trial, it isn't full access, and it is likely the 10,000 places on the trial will be filled quickly.
Mr. Nutland is among a handful of HIV activists who have been importing generic PrEP into the U.K. for personal use for several years in a bid to circumvent the high cost of the branded version of Truvada. He and others have also worked to make generic PrEP more widely available by having NHS HIV clinics test the purity of the drugs they import. But this depended heavily on how literate and wealthy PrEP users were, Mr. Nutland said. The NHS also said the trial would address the issue of drug penetration among demographics other than men who have sex with men.
PrEP is currently available in a number of European countries, including Belgium, France, and the Netherlands.
The move is likely to renew interest in generic PrEP elsewhere in Europe, activists and doctors say. In Ireland, where the import of generics is forbidden, shipments of generic drugs have been intercepted by customs.
"If the U.K. can do it, we can do it, too," said Julia Del Amo, a doctor and researcher at the Carlos III Institute of epidemiology in Madrid, Spain.
--Denise Roland contributed to this article
(END) Dow Jones Newswires
August 11, 2017 18:12 ET (22:12 GMT)
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