Researchers think they have a solution to drug prices
JEROME Zeldis remembers exactly how he felt when he heard about the US$ 84,000 ( RM336,000) price tag on a powerful new hepatitis C treatment three years ago.
“I was somewhere between annoyed and outraged,” recalled Zeldis, the former chief medical officer of the biotech juggernaut Celgene.
The cost of a 12-week course of Gilead Sciences’ drug Sovaldi triggered fierce pushback from insurers, politicians and the public, and helped spark a national debate on high drug prices.
As a physician, Zeldis had cared for hundreds of patients infected with hepatitis C and seen how, untreated, the virus ravaged people’s livers. That a high price could bar patients from easy access to a cure seemed unethical to him in the face of a rare public health opportunity to vanquish a disease that afflicts 150 million people globally.
“If we make it affordable . . . this epidemic can be cured,” Zeldis said. “I want to be bold – I want to treat 100 million people by 2030 - end of story. And there is really no reason why we can’t.”
Zeldis had been mulling hepatitis C therapies, and he believed it was possible to develop a medicine, sell it for a fraction of the price of Sovaldi and still make money.
So in 2014, Zeldis put US$ 1 million of his own money on the table to co-found Trek Therapeutics, a startup with the mission of creating a novel, affordable hepatitis C treatment for the world.
To attempt to produce an effective and safe treatment at a modest price, Zeldis and his cofounder, Ann Kwong, had to blow up the typical drug company model. The reality of the pharmaceutical industry is that executives answer to investors, not just patients. Creating new medicines is a high-risk, high-reward business in which companies invest huge amounts of money on uncertain payoffs. Shareholders demand extremely high profits in return.
Trek is taking a unique approach. The company is organised as a public benefit corporation - a relatively new type of corporate structure that places public welfare on equal footing with profit. Trek’s legal charter requires the board to weigh stockholder interests against the need to “provide therapies for the treatment of infectious diseases that are accessible and affordable.”
The company cuts costs by piggybacking on the work other companies have already done to develop and test drugs.
“What they proposed and introduced at the board meeting was quite a revelation, I think, for many of us who had been used to working with major pharmaceutical companies - the idea of a company with a different ethos,” said Geoffrey Dusheiko, an emeritus professor of medicine at University College London Medical School who joined the company’s clinical advisory board. “Their profit system will be different; they are trying to put access first - and are risking a great deal.”
Trek’s leaders are industry veterans with enviable track records in the failure-prone business of inventing new cures. The executive team has collectively launched seven antiviral drugs for previous employers and has deep expertise in hepatitis C. Their newest experiment is in business, not in a test tube: After years of working in established drug companies, they’re running a startup on a shoestring.
Instead of hiring a small army of scientists and building an expensive laboratory, Trek is a virtual, 10-person company that operates out of a small incubator space in Cambridge, Massachusetts. The company acquires experimental drugs that typically have been vetted through some degree of human testing.
Trek capitalised on the fact that, for years, drug companies had raced to develop new hepatitis C treatments, which meant there were promising drugs stuck halfway through the pipeline.The availability of these drugs de-risks Trek’s job considerably, cutting down on the cost and time of developing molecules from scratch.
If we make it affordable . . . this epidemic can be cured. I want to be bold – I want to treat 100 million people by 2030 - end of story. And there is really no reason why we can’t.
Trek has acquired or licensed five drugs so far, of which all but one have been through some human clinical trials. The company contracts with outside labs and clinics for additional testing.
Treatment of hepatitis C typically requires a combination of drugs, which meant that Trek could pluck drugs from different companies and bring them together in powerful new pairings. In fall of last year, Trek began a small clinical trial, using a drug called faldaprevir in combination with an experimental drug called TD6450 and ribavirin.
Trek hopes to get a medicine on the market in 2020. The company is still in the earliest stages and investors will have a long and risky wait for a return.
So far, the startup has raised US$ 9 million in its initial funding round and is seeking an additional US$ 50 million to fund the large trials needed to push drugs toward approval. That might seem like a lot of money, but in drug development it’s pocket change.
One study pegs the cost of developing and launching a drug at US$ 2.6 billion.
That work has been critiqued because of questions about the data and the analysis, which was done by a university group that receives funding from the industry.
At the other extreme, the non-profit Drugs for Neglected Diseases Initiative has estimated the cost of developing a drug for diseases that are overlooked because they affect poor people at less than US$ 170 million – critics argue the model won’t work for all diseases and it underestimates some costs.
To avoid the cost and uncertainty of challenging behemoth drug companies in the American market, Trek plans to focus on middle-income countries where new hepatitis C drugs have been slow to roll out, such as nations in eastern and central Europe. If they are successful at finding a new balancing point of profit and access – a true “if” – they hope their example could inspire companies working on other diseases to experiment with similar pricing models. — WP-Bloomberg
Jerome Zeldis, former chief medical officer of the biotech juggernaut Celgene