(Adds details, background, analyst comments; updates shares)
By Natalie Grover
July 23 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
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
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)