Shares of microcap pharmaceutical company Amphastar Pharmaceuticals (AMPH) - Get Report rose sharply Tuesday after the company said its glucagon injection emergency kit has been approved by the FDA for the abbreviated new-drug application (ANDA) required for generic drugs.
Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid.
"This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon," said Amphastar CEO Dr. Jack Zhang.
Amphastar shares jumped 11.5% to $21.21 in pre-market trading on Tuesday. For the year, the stock is down about 1.5%.
The company was able to demonstrate to the Food and Drug Administration that the synthetic peptide product was bioequivalent and therapeutically equivalent to Eli Lilly's (LLY) - Get Report Glucagon Emergency Kit for Low Blood Sugar.
"This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities," Dr. Zhang said.
The company estimates that U.S. sales for Eli Lilly's Glucagon kit were about $144 million and the overall U.S. sales of brand products containing glucagon for injection, 1 mg, were about $306 million for the 12 months ended September 30, 2020.
The Rancho Cucamonga, California-based company expects to launch its Glucagon for Injection Emergency Kit within the next two months.
Amphastar currently has four ANDAs filed with the FDA targeting products with a combined market size of about $1.4 billion. The company also has three biosimilar products in development with a total addressable market (TAM) of $13 billion, and nine generic products with a TAM of $12 billion.