MORGANTOWN, W.Va. — One of the tenants of the West Virginia University Innovation Corp. in Morgantown is upstart drug maker Yunigen. Officials hosted a tour Friday and launched a ground-breaking pediatric treatment for sickle cell disease.
Yunigen officials, including Chief Executive Officer and Vice President Charles Otieno and President of Scientific Officer Wyclifee Omwancha, showed the entire manufacturing process to Dr. Musalia Mudavadi, Prime Cabinet Secretary and Cabinet Secretary for Foreign & Diaspora Affairs for the Republic of Kenya, WVU officials, and community leaders.
Yunigen established operations in the former Mylan Pharmaceuticals facility on Chestnut Ridge Road in March of 2023 to manufacture a rapid dissolvable Hydroxyurea tablet to treat pediatric sickle cell anemia patients in Africa. The company also has plans to manufacture high-quality generic drugs as well.
“Our goal and mission is to manufacture quality and affordable medications,” Otieno said. “Our target markets are emerging markets where we know the cost of medications is very pricey and quality is an issue.”
The key compound for the sickle cell treatment drug is hydroxyurea, first approved by the FDA in 1967 for cancer treatments. By 1984, the compound was being used to treat sickle cell, and in 1998, it was approved for sickle cell treatment by the FDA. In 2017, the compound was approved to treat children with sickle cell disease.
An estimated 240,000 children are born with the blood disorder each year, and a very small percentage are receiving treatment. Statistics show more than half will die before the age of 5, and in some cases, patients 15 years of age and older are almost totally disabled.
“The simplest molecule that was discovered almost three decades ago called hydroxyurea has never been in this market because of cost and a lack of a pediatric formulation,” Otieno said.
The drug, Scedamin, is a pediatric formulation of hydroxyurea that can be administered to children 9 months and older and reduces the pain and the need for blood transfusions.
“It is an easily dissolvable tablet, and it is easy for the mother to administer; it is easily portable; and it is easy for storage because the majority of the children are in rural areas,” Otieno said.
The company can manufacture oral solid-dose medication or capsules, and some of the formulations can include treatments for both hypertension and diabetes, for example. The company has the capacity and equipment to produce more than one million doses in an hour.
“We have the capability of mixing those drugs into one tablet,” Omwancha said. “We can have one drug on one layer, and we put the other one on the other layer.”
Dr. Mudavadi was in the United States for the United Nations General Assembly, and Yunigen officials wanted him to take the breakthrough treaty information back to Africa, where 70 percent of the people worldwide with sickle cell disease live.
Yunigen occupies 25,000 square feet in the facility and has plans for more products in the future.
“This is just the beginning,” Omwancha said. “We just showed you what is active right now, but in the pipeline we have other compounds we use in other processes that are very sophisticated.”