MORGANTOWN – Groundbreaking pharmaceutical firm Yunigen welcomed a high-ranking Kenyan official to its R&D and manufacturing facility inside WVU Innovation Corp. on Friday.
Yungen leaders led Dr. Musalia Mudavadi, Prime Cabinet Secretary and Cabinet Secretary for Foreign & Diaspora Affairs for the Republic of Kenya on a tour of its facility to show him its capabilities and to announce the official launch of its new drug to help children born with sickle cell disease.
Wycliffe Omwancha, Yunigen president and chief scientific officer, led the tour – explaining what goes on in the series of suites and labs along the winding corridors of a lower floor of the former Mylan plant. Other Yunigen officials and a number of WVU leaders joined the tour.
Omwancha showed Mudavadi and the entourage rooms dedicated to capsule and pill formulation and forming. One of the machines can put out more than 1 million tablets per hour. “We can produce a lot of tablets within a very short time period, and we are very excited about that.”
Other suites are devoted to coating, testing, packaging and bottling, and boxing for shipping.
Yunigen developed and is launching to market a unique pediatric formulation of hydroxyurea: a prescription medication that reduces painful crises and the need for blood transfusions in children with sickle cell disease aged 9 months and older, the company explains on its website. Hydroxyurea may also lower the risk of complications, infections, and malaria.
Yunigen’s version is called Scedamin.
Charles Otieno, Yunigen CEO and vice president, also joined the tour and said the target for Scedamin is emerging markets where drugs are pricey, and quality is an issue.
He said that 70% of the120 million people worldwide living with sickle cell live in Africa; 240,000 are born each year with the disease and less than 2% are on treatment. And 50%-80% die before age 5. Patients aged 15 and up are almost totally disabled.
Treatment should start by age 9 months and continue for life, he said. While the hydroxyurea has been available for decades, there has been no affordable pediatric formulation. But Scedamin is portable and easy to store, requiring no refrigeration, it dissolves easily and is easy for the parent to administer. Current products are capsules that have to be broken to administer to children.
“Our dedication and our legacy is for us to deliver this drug to all these children,” he said. “Our philosophy is that no child will be left behind because of sickle cell disease and getting the right treatment.”
Otieno said Mudavadi came to the U.S. to attend the UN General Assembly and agreed to come to Morgantown to see the Yunigen site. Yunigen wanted him to see the capability of the facility and the game-changing product they’re making, and to get the word out to the people in Kenya and across Africa. who need to hear about it.
Yunigen began in California, where it still an innovation lab, he said. But they were looking for affordable R&D and manufacturing space, and the former Mylan plant was already FDA approved and equipped to make oral solids. Moving here instead of trying to build their own plant cut the time to bring Scedamin to market cut by two years.
“This is our home today, tomorrow and in the future.”
The day’s schedule didn’t allow Mudavadi time to take questions or make comments.
But Omwancha also addressed the site’s promise. “We are very excited because we have tremendous potential for growth,” he said. They have other products in the pipeline and the Innovation Corp. site has other suites they can expand into. “This facility offers us the potential to do so many other processes.”
Email: dbeard@dominionpost.com
