Premier, Exela Establish Reliable Supply of Key Drug

Two North Carolina life science companies have teamed up to resolve a multi-year, national shortage of an important drug.

Premier of Charlotte and Exela Pharma Sciences of the Caldwell County city of Lenoir have established a reliable supply of cysteine hydrochloride. 

It's used in amino acid solutions to meet the nutritional requirements of patients who require parenteral nutrition, or intravenous feeding. The product had been in continual shortage since 2015.

Cysteine hydrochloride was de-listed from the U.S. Food and Drug Administration’s drug-shortage website in September, two months after Premier’s ProvideGx program arranged a supply deal with Exela. The program identifies safe, high-quality supply sources for drugs that are, or may be, at risk of being added to the national drug shortage list.

“We are proud of our collaboration with Exela,” Michael J. Alkire, Premier’s president, said in a news release. “We hope to replicate this success for many other drugs currently in shortage.”

Exela is currently the only FDA-approved manufacturer of cysteine hydrochloride injection. Its new formulation contains less aluminum than prior versions of the drug, reducing the risk of associated central nervous system and bone toxicity in patients with renal impairment, including pre-term infants.

“Not only have we helped stabilize this market and ensured a reliable supply for patients nationwide,” Alkire said, “we did so with an FDA-approved, U.S. manufactured product labeled with the lowest aluminum content to date.”

Introducing cysteine hydrochloride injection “is one of the high points of our company history,” said Phanesh Koneru, Ph.D., LL.M., president and chief executive officer of Exela.

“At Exela, our mission is to expedite the availability of affordable medicines,” Koneru said. “Through the process of bringing cysteine hydrochloride injection to the market, we worked collaboratively with the FDA to secure our approval, and with ProvideGx to ensure we had a viable sales channel once we were cleared for production.”

Premier’s ProvideGx program, guided by health systems with more than 1,000 hospitals across the nation, has led to a reliable supply of several critical shortage drugs in 2019 including metoprolol, sodium bicarbonate, diphenhydramine, hydromorphone, lidocaine, morphine and thiamine. The company plans to introduce additional drugs from a target list of more than 60 products in coming months.

ProvideGx is part of Premier’s ongoing effort to ensure the availability of hundreds of high-quality products, including drugs that may have supply challenges. Premier tries to insulate its members from supply fluctuations that may affect the market at large.

Drug shortages in the United States increased significantly in 2018, with an estimated 113 drugs currently at risk or not readily available for U.S. hospitals, according to the FDA’s drug shortage list. Drug shortages can affect patient care and add time and expense as providers search for therapeutic alternatives and manage supplies, potentially delaying certain elective hospital procedures.

Premier is a healthcare improvement company allied with about 4,000 U.S. hospitals and health systems and about 165,000 other providers and organizations. Its goal is to help its members improve healthcare outcomes while reducing costs. The company has comprehensive databases of actionable data, clinical best practices and efficiency improvement strategies.

Exela, established in 2005, is a specialty pharmaceutical company focused on developing, manufacturing and marketing generic and proprietary injectable and sterile ophthalmic products. Its facility, compliant with current Good Manufacturing Practices (cGMP), consists of 20,000 square feet of cGMP manufacturing space, 17,000 square feet of cGMP warehousing space with 240,000 additional square feet for future expansion, and 15,000 square feet of laboratory space.