(Adds details, background, analyst comments; updates shares)
By Natalie Grover
July 23 (Reuters) - Eagle Pharmaceuticals Inc won U.S. Food and Drug Administration’s approval for its drug that offers a quicker treatment for malignant hyperthermia, a life-threatening metabolic response triggered by anesthesia.
Shares of the company, which also received tentative approval for an injectable cancer drug earlier in July, jumped about 5 percent in early trading.
Eagle Pharmaceuticals said it will launch the drug, Ryanodex, in August. It will be the first product the company will market without a partner.
Ryanodex is being approved to treat the inherited condition that could provoke a severe reaction to inhaled anesthetics or muscle relaxant succinylcholine during surgery.
These reactions include rapid heart rate, elevated blood pressure, high body temperature, muscle rigidity and increased acid content in patients, and, if left untreated, can be fatal.
Ryanodex is an enhanced version of malignant hyperthermia’s sole antidote, dantrolene sodium.
The new formulation offers “convenience benefits such as fewer vials to reconstitute, a shorter administration time, and a lower fluid load for patients, which can translate into important safety benefits,” Cantor Fitzgerald analyst Irina Koffler said.
Ryanodex can be prepared and administered in under one minute by a single healthcare practitioner, while other treatments can take up to 15 to 20 minutes, the company said.
Koffler expects these characteristics will allow Ryanodex to capture the majority of the malignant hyperthermia market over time, and anticipates peak sales of $25.3 million in 2020.
Eagle Pharmaceuticals is also testing Ryanodex for use in exertional heat stroke.
The company said on Wednesday it will learn over the next four to six weeks if Ryanodex has been granted seven-year marketing exclusivity by the regulator. The FDA had designated Ryanodex as an orphan drug last August.
Orphan drug status is given to drugs intended to treat rare diseases, providing the developer with certain development incentives including a period of marketing exclusivity.
The FDA may approve an orphan-designated drug but withhold exclusivity if, for example, the drug is the same as an approved drug and is not shown to be clinically superior.
Eagle Pharmaceuticals’ blood thinner injection, Argatroban, is licensed to The Medicines Co in the United States and Canada.
The Woodcliff Lake, New Jersey-based company’s shares were little changed at $13.10 on the Nasdaq. (Reporting by Natalie Grover in Bangalore; Editing by Don Sebastian and Savio D‘Souza)