DUBLIN, Sept. 4, 2019 /CNW/ -- Endo International
plc (NASDAQ: ENDP) today announced that Novitium Pharma, LLC,
a partner of Endo's subsidiary Endo Ventures Limited, received
approval from the U.S. Food and Drug Administration for a room
temperature stable, AB-rated, generic equivalent of Swedish Orphan
Biovitrum's Orfadin® (nitisinone capsules). Endo's
operating company Par Pharmaceutical, Inc. expects to distribute
the product through specialty pharmacies beginning this month.
Nitisinone capsules are indicated for the treatment of adult and
pediatric patients with hereditary tyrosinemia type 1 (HT-1) in
combination with dietary restriction of
tyrosine and phenylalanine.
"We are pleased to offer this rare patient population suffering
from HT-1 the first and only bioequivalent and therapeutically
equivalent option to Orfadin® capsules. Additionally,
the product can be stored at room temperature which is an added
convenience to patients," said Domenic Ciarico, Executive Vice
President and Chief Commercial Officer, Sterile and Generics. "We
are proud to continue our tradition at Par of providing high
quality, affordable medicines to patients."
"Novitium has a history of impressive development and execution
skills and we are pleased to have several products under
development with them," said Brandon
Rockwell, Senior Vice President of Business
Development. "This first time generic approval is another
example of Par's strategic investment in business development and
execution on first-to-market and first-to-file products."
According to Swedish Orphan Biovitrum, global sales for
Orfadin® were approximately $85M over the last four quarters.
About HT-1
Hereditary Tyrosinemia type-1 (HT-1) is a rare and serious
inherited metabolic disease caused by the inability to metabolise
the amino acid tyrosine. Left untreated, HT-1 can cause hepatic,
renal and peripheral nerve damage. HT-1 affects at least 1 in
100,000 patients worldwide, with approximately 150 patients in
the United States.
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly
focused generics and specialty branded pharmaceuticals company
delivering quality medicines to patients in need through excellence
in development, manufacturing and
commercialization. Endo has global headquarters
in Dublin, Ireland, and U.S.
headquarters in Malvern, PA. Learn more
at www.endo.com.
About Par Pharmaceutical
Par Pharmaceutical, headquartered in Chestnut Ridge, NY, develops, manufactures and
markets safe, innovative and cost-effective generic pharmaceutical
and branded injectable products that help improve patient quality
of life. Par, among the top leaders in the U.S. generics industry,
possesses a portfolio that includes sterile injectables,
alternative dosage forms and many other differentiated products.
Par is advancing a robust research and development (R&D)
pipeline of potential products. Par is an operating company
of Endo International plc. Learn more at www.endo.com or
www.parpharm.com.
Forward Looking Statements
This press release may contain certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 and Canadian securities legislation, including the
statements from Messrs. Ciarico and Rockwell and other statements
regarding research and development outcomes, regulatory, marketing
and reimbursement approvals, efficacy, adverse reactions, market
and product potential and product availability. Statements
including words such as "believes," "expects," "anticipates,"
"intends," "estimates," "plan," "will," "may," "look forward,"
"intend," "guidance," "future" or similar expressions are
forward-looking statements. Because these statements reflect Endo's
current views, expectations and beliefs concerning future events,
they involve risks and uncertainties. Although Endo believes that
these forward-looking statements and information are based upon
reasonable assumptions and expectations, readers should not place
undue reliance on them, or any other forward-looking statements or
information in this news release. Investors should note that many
factors, as more fully described in the documents filed by Endo
with the Securities and Exchange Commission and with securities
regulators in Canada on the System
for Electronic Document Analysis and Retrieval, including under the
caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K
filings, and as otherwise enumerated herein or therein, could
affect Endo's future results and could cause Endo's actual results
to differ materially from those expressed in forward-looking
statements contained in this communication. The forward-looking
statements in this press release are qualified by these risk
factors. Endo assumes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise, except as may be required under
applicable securities laws.
View original
content:http://www.prnewswire.com/news-releases/endo-announces-approval-of-first-generic-orfadin-in-us-300911138.html
SOURCE Endo International plc