Charities fighting to break pharma company’s hold on drug that can cure hepatitis C in three months

Médecins Sans Frontières (MSF) is working with a group of charities to challenge the patent on the hepatitis C drug sofosbuvir.

The patent is currently held by pharmaceuticals firm Gilead of Foster City, California. The company’s monopoly on the production of sofosbuvir means it can charge as much as €55,000 per 12-week treatment in Europe, for a drug that studies have shown costs less than $1 per pill to produce.

“With an estimated 80 million people worldwide living with hepatitis C, treatment should be available to everyone who needs it, no matter where they live – including in Europe”, said Dr Isaac Chikwanha, hepatitis C medical advisor for MSF’s Access Campaign.

“The price of sofosbuvir is keeping treatment out of reach for millions of people who need it, and treatment is being rationed or is just unavailable across the globe.”

“A drug that cures doesn’t do any good if the people who need it can’t afford it,” he added.

Image courtesy of MSF. Featured image courtesy of AJ Cann

Sofosbuvir forms the backbone of most hepatitis C combination treatments for people and is one of a range of oral ‘direct-acting antivirals’ to come to market within the last four years that has caused survival rates to skyrocket.

But countries where Gilead retains monopoly control over sofosbuvir cannot import or produce generic versions.

The patent challenge, which has been submitted to the European Patent Office, would seek to remove or shorten the length of a patent as well as promoting generic competition in order to dramatically reduce prices.

“Gilead’s patent monopolies on sofosbuvir are blocking access to affordable hepatitis C treatment, including generic versions, in many countries including those in Europe”, said Aliénor Devalière, EU Policy Advisor for MSF’s Access Campaign. “This patent can – and should – be challenged; the science behind sofosbuvir isn’t new.”

Image courtesy of BruceBlaus

Patents on sofosbuvir have already been revoked in China and Ukraine, and decisions are pending in other countries, including Argentina, India, Brazil, Russia and Thailand.

The patent challenge submitted to the European Patent Office could accelerate the availability of affordable generic versions of sofosbuvir in a host of nations within Europe.

“Successful patent oppositions have created access to life-saving drugs for millions of people in the past, and are now being employed as a legal measure to improve access to hepatitis C treatment,” said Yuanquiong Hu, Legal Advisor for MSF’s Access Campaign.  “MSF has filed or supported patent challenges in many countries.

“People all over the world, and in the projects where MSF works, need affordable access to life-saving medicines.”

Startup lays the foundation for personalised medicine

A startup is laying the foundation for future personalised medicine with the development of software that standardises data collection and combines previous research and data points into a single system.

The software, developed by Climedo based in Munich, Germany, is designed to resolve a significant roadblock on the journey to personalised medicine: the fact that research data is rarely stored in a way where it can be re-used.

“The status quo, at least in the German hospitals, is that they don’t have really nice software solutions which will standardise the data they’re gathering in terms of research studies,” explained Dragan Mileski, founder and CTO of Climedo.

“They do many research studies internally but they use Excel files and paper books, and then it’s difficult to reuse this data. Cooperation is a problem; security is a problem; many things are a problem.

“We think that the software will facilitate those processes, making them more efficient, and then in the future provide the basis layout for data-driven precision medicine.”

With the advent of affordable DNA sequencing, Mileski said that with the information that the software can collate, it should already be possible to determine the potential success of some treatments and make patient-specific decisions about their use.

“The DNA sequencing price has dropped really low, and especially in cancer research they’re analysing a lot of DNA sequences,” he said, adding that combining this information with specific patient details and previously collected data on cancer treatments would allow doctors to make informed decisions about how to treat a patient.

“When you have a lot of [the data], when patient number 1000 comes inside, they’ll be able to compare those parameters and say ‘in your case chemotherapy will not work: this therapy will work better for you’. So that’s our goal.”

Of course this isn’t the same as ‘true’ personalised medicine, which will require more data and improved technology, but Climedo does provide a vital first step towards this goal.

“To make very accurate and good decisions on complex problems, I think the whole technology is not yet there, plus the data is not enough to do this,” said Mileski, adding that the software would allow personalised medicine “for very specific types of cancer, for example breast cancer or bowel cancer.”

Climedo was incubated at LMU Entrepreneurship Center, which is a startup accelerator attached to Ludwig-Maximilians-Universität in Munich, one of the oldest universities in Germany.

Having initially worked while establishing the startup, before living off savings to get Climedo going, Mileski and his co-founder Sascha Ritz are now poised to move the company into its own offices.

Climedo has already secured its first contracts with German hospitals, and has also been the recipient of €95,000 scholarship to continue building the company.

“So far it’s going okay; it’s not perfect – it always can be better in the startup world – but it’s still not to the point of being disappointed,” said Mileski. “We see the potential, we see the need of the problem, and will do our best to provide our small impact. “