Hemispherx Biopharma (HEB), myTomorrows Enter Early Access Program Agreement
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Hemispherx Biopharma (NYSE: HEB) has executed an agreement with Impatients, N.V., a Netherlands based company doing business as myTomorrows, for the commencement and management of an Early Access Program (EAP) in all of Europe and Turkey.
myTomorrows, as Hemispherx' exclusive service provider in Europe and Turkey, will perform EAP activities in Europe and Turkey to include the supply of rintatolimod for the treatment of Chronic Fatigue Syndrome (CFS) to patients with an unmet medical need.
Govert Shouten, Ph.D, Co-Founder & CBO at myTomorrows, said "Rintatolimod for CFS fits perfectly with the raison d'être of myTomorrows. CFS affects as many people in Europe as in the US and there is no drug approved anywhere specifically for CFS. In clinical trials rintatolimod has shown promising results for certain CFS patients particularly those most severely affected.
As we do with other life-threatening and debilitating diseases such as cancer, MS, and depression, myTomorrows will set up and roll out the early access programs needed to help these patients.
Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx said "We are very pleased to be collaborating with myTomorrows to provide rintatolimod under these unique Early Access Programs. Not only will this collaboration create the possibility for physicians to use rintatolimod under certain circumstances, myTomorrows will collaborate with these physicians to capture data on patients treated and such data may add to our other efforts to gain full regulatory approval in Europe, Latin America, Australia, New Zealand as well as the U.S. and elsewhere."
myTomorrows was founded by physicians and experts from the pharmaceutical industry who want to facilitate early access to developmental drugs for patients with high unmet needs. Ronald Brus, M.D., was the former CEO of Crucell, a vaccine company acquired by Johnson & Johnson for $2.4 billion in 2011. Govert Shouten was previously Vice President, Business Development at Crucell.
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