BioCryst Announces Acceptance and Accelerated Review of the ORLADEYO™ (berotralstat) Marketing Application by the Israeli M...
June 16 2021 - 7:00AM
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that
the Israeli Ministry of Health has accepted the regulatory
submission of ORLADEYO for the prevention of recurrent attacks
in patients with hereditary angioedema (HAE) 12 years and older.
The Israeli Ministry of Health also has granted an accelerated
review. In addition, BioCryst has entered into a distribution and
supply agreement granting Neopharm Ltd., a corporation organized
under the laws of the State of Israel, the exclusive rights to
commercialize ORLADEYO in Israel.
“Neopharm is the right partner to help us
commercialize in Israel as we continue to bring oral, once-daily
ORLADEYO to HAE patients around the world. They have extensive rare
disease experience and proven commercial success in Israel, and
they understand the local regulatory environment,” said Charlie
Gayer, chief commercial officer of BioCryst.
“We are proud of our partnership with BioCryst
and excited to deliver a new and innovative treatment option to HAE
patients in Israel. The momentum gained from recent approvals of
ORLADEYO across the globe will support our commercialization
efforts to provide access to this important treatment,” said Efi
Shnaidman, general manager of Neopharm Israel.
Founded in 1941, Neopharm Israel is one of the
leading pharmaceutical companies in Israel, providing the Israeli
market with a wide range of products and integrated services for
patients in need, with a proven track record of successful market
access and launches. In addition to exclusive rights to
commercialize ORLADEYO in Israel, Neopharm Israel has exclusive
rights to commercialize in the Palestinian Authority.
About BioCryst
Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral,
small-molecule medicines that treat rare diseases in which
significant unmet medical needs exist and an enzyme plays a key
role in the biological pathway of the disease. Oral, once-daily
ORLADEYO™ (berotralstat) is approved in the United States, the
European Union, Japan and the United Kingdom for the prevention of
HAE attacks in adults and pediatric patients 12 years and older.
BioCryst has several ongoing development programs including
BCX9930, an oral Factor D inhibitor for the treatment of
complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the
treatment of fibrodysplasia ossificans progressiva, and
galidesivir, a potential treatment for Marburg virus disease and
Yellow Fever. RAPIVAB® (peramivir injection), a viral
neuraminidase inhibitor for the treatment of influenza, has
received regulatory approval in the U.S., Canada, Australia, Japan,
Taiwan and Korea. Post-marketing commitments for RAPIVAB are
ongoing. For more information, please visit the company’s website
at www.biocryst.com.
Forward-Looking StatementsThis
press release contains forward-looking statements, including
statements regarding BioCryst’s plans and expectations for
ORLADEYO. These statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. These statements reflect our
current views with respect to future events and are based on
assumptions and are subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Some of the factors that could affect
the forward-looking statements contained herein include: the
ongoing COVID-19 pandemic, which could create challenges in all
aspects of BioCryst’s business, including without limitation
delays, stoppages, difficulties and increased expenses with respect
to BioCryst’s and its partners’ development, regulatory processes
and supply chains, negatively impact BioCryst’s ability to access
the capital or credit markets to finance its operations, or have
the effect of heightening many of the risks described below or in
the documents BioCryst periodically files with the Securities and
Exchange Commission; BioCryst’s ability to successfully implement
its commercialization plans for, and to commercialize, ORLADEYO,
which could take longer or be more expensive than planned; the
commercial viability of ORLADEYO, including its ability to achieve
market acceptance; the results of our partnership with Neopharm may
not meet our current expectations; the FDA, Israeli Ministry of
Health or other applicable regulatory agency may require additional
studies beyond the studies planned for products and product
candidates, may not provide regulatory clearances which may result
in delay of planned clinical trials, may impose certain
restrictions, warnings, or other requirements on products and
product candidates, may impose a clinical hold with respect to
product candidates, or may withhold, delay, or withdraw market
approval for products and product candidates; BioCryst’s ability to
successfully manage its growth and compete effectively; risks
related to the international expansion of BioCryst’s business; and
actual financial results may not be consistent with expectations,
including that operating expenses and cash usage may not be within
management's expected ranges. Please refer to the documents
BioCryst files periodically with the Securities and Exchange
Commission, specifically BioCryst’s most recent Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on
Form 8-K, which identify important factors that could cause the
actual results to differ materially from those contained in
BioCryst’s forward-looking statements.
BCRXW
Contact:InvestorsJohn Bluth+1 919
859 7910jbluth@biocryst.com
MediaCatherine Collier
Kyroulis+1 917 886 5586ckyroulis@biocryst.com
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