A Dutch life science startup is collaborating with biotechnology companies to make it easier for patients with advanced chronic conditions and unable to get into clinical trials to access potentially life-saving drugs before they are cleared by regulators. MyTomorrows positions itself as a patient-focused company and recently raised $2.2 million from friends and family to expand the treatments available for this program to include amyotrophic lateral sclerosis or Lou Gehrig’s disease, multiple sclerosis and Parkinson’s disease, among others.
The company conforms to each country’s compassionate-use provision that spells out circumstances in which patients who are low on options can gain access to drugs not yet officially approved by regulators by working with their physician.
MyTomorrows co-founder and CFO Erdem Yavuz told MedCity News that so far it has signed deals with five biotech companies and expects to add 10 to 12 more this year. MyTomorrows charges a small fee to cover its costs and takes a 4 percent to 5 percent share in the royalties of a company’s drugs if they pass the muster of European regulators. So far, its service is only available in six countries: Belgium, France, the Netherlands, Turkey, Canada and the UK. Yavuz pointed out that the advantage for biotechs is they gain access to data faster. “We will only make money if these products [get approved],” he said.
MyTomorrows was founded in 2012 by Ronald Brus, the former CEO of Dutch vaccine manufacturer Crucell, which J&J acquired in 2010 for $2.5 billion. Yavuz said he was inspired to start the company because of his experience with his father who suffered from lung cancer and wanted to make it easier for others in that predicament to obtain drugs even if they are still in development.
Although patients first began receiving medication through the company in October last year, Yavuz declined to provide the number of patients using its service. He added that it hopes to expand its service to the U.S.
Although the U.S. also has provisions for compassionate use, the circumstances in which patients are given access to drugs in development has varied and has been fraught with ethical debate. Pharmaceutical companies may be reluctant to provide a seemingly promising drug if there’s a chance it could produce a bad outcome for patients and also complicate the business strategy for that drug. The U.S. Food and Drug Administration has to weigh in as well. One source of concern is that because the drugs are still in development they can produce serious side effects. The protocol in the U.S. is that the patient’s doctor has to apply to the FDA to gain access to an experimental drug and has to agree to manage the drug’s use. Patients sign off on informed-consent making it clear they are aware of the risks involved.
It can lead to a time consuming process and a frustrating and agonizing wait for patients.
The Wall Street Journal noted that 1,200 patients took part in the Compassionate Risk program in 2011 and noted that the FDA says it doesn’t track how many patients are helped by the drugs they receive through the program.