CHARLOTTE, N.C. —Premier Inc. (NASDAQ: PINC), through its ProvideGx™ program, is now supplying cysteine hydrochloride injection to providers, a critical drug for pediatric and adult patients that require total parenteral nutrition (TPN). Cysteine hydrochloride has been in shortage in the U.S. since 2015.
This FDA-approved New Drug Application (NDA) for cysteine hydrochloride injection is held by Exela Pharma Sciences, LLC, a U.S.-based manufacturer. Current supplies of cysteine hydrochloride injection are imported from Canada under special FDA rules that allow shortage drugs to be sourced abroad if no domestic supplies are available.
“This partnership is expected to allow Premier members to have uninterrupted access to the only domestic, FDA-approved version of cysteine hydrochloride injection – a first in the industry,” said Premier’s President, Michael J. Alkire. “This announcement, coupled with the other six drugs we have brought to market through the ProvideGx program, proves that we have a winning model for reliably sourcing shortage drugs and better insulating our members from market fluctuations that affect others. We are extremely proud of our track record for developing comprehensive solutions that holistically address the problem of drug shortages.”
The ProvideGx program is charged with identifying safe, high-quality supply sources for drugs that are or may be at risk of being added to the national drug shortage list. ProvideGx is the next step in Premier’s ongoing effort to help facilitate the availability of hundreds of high-quality products, including drugs for which there may be supply challenges. Premier is working with a robust pipeline of high-quality manufacturers to identify sources of product supply and to explore and implement solutions to address specific market needs.
Guided by Premier’s member health systems and the ProvideGx Committee, representing more than 1,000 hospitals across the nation, Premier today provides access to more than 100 drugs on the drug shortage list, with plans to introduce additional drugs from a target list of more than 60 shortage products in months to come, beginning with sterile generic injectables.
Cysteine hydrochloride is indicated to meet the nutritional needs of newborn infants requiring total parenteral nutrition (TPN), as well as adult and pediatric patients with severe liver disease who may require TPN. It can also be added to amino acid solutions for protein synthesis. Exela’s FDA-approved NDA for cysteine hydrochloride is labeled to contain no more than 120 parts per billion (ppb) or mcg/L of aluminum. The FDA has been advocating for reduced aluminum levels in many injectable products, including cysteine hydrochloride, particularly for neonatal patients. According to extensive literature and evidence, high aluminum levels put these patients at risk for aluminum toxicity, which has been associated with impaired neurologic development.
“This partnership is a game changer for us,” said Terry Webb, Vice President of Pharmacy Services at Adventist Health. “Having a safe, FDA-approved and domestic supply of cysteine hydrochloride will greatly benefit the newborn patients we serve. We commend the ProvideGx program for its efforts and stand behind Premier’s highly-effective strategy to combat drug shortages. With each partnership they announce, the ProvideGx program is delivering real results and creating a healthier pharmaceutical market.”
After a period of decline, drug shortages in America increased significantly in 2018, with an estimated 124 drugs currently at risk or not readily available for U.S. hospitals, according to the FDA’s drug shortage list. With wide-ranging effects on patient care, drug shortages can add time and expense as providers search for therapeutic alternatives and manage supplies, potentially delaying certain elective hospital procedures.
The financial terms of Premier’s agreement for cysteine hydrochloride were not disclosed. Revenues from this agreement are not expected to materially impact Premier FY 2019 results.
Matters discussed in this release that are not statements of historical or current facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Premier to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. In addition to statements that explicitly describe such risks and uncertainties, readers are urged to consider statements in the conditional or future tenses or that include terms such as “believes,” “belief,” “expects,” “estimates,” “intends,” “anticipates” or “plans” to be uncertain and forward-looking. Forward-looking statements may include comments as to Premier’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside Premier’s control. More information on potential factors that could affect Premier’s financial results is included from time to time in the “Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Premier’s periodic and current filings with the SEC and available on Premier’s website at investors.premierinc.com. Forward-looking statements speak only as of the date they are made. Premier undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date.