Quantcast

Eagle Pharmaceuticals, Inc. Expands Licensing Agreement for BENDEKA™ with Teva Pharmaceuticals International GmbH

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq: EGRX)
today announced that it has expanded its existing BENDEKA™ (bendamustine
hydrochloride) licensing agreement with Teva Pharmaceuticals
International GmbH (“Teva”). Under the terms of the revised licensing
agreement, beginning on October 1, 2019, Eagle’s royalty payment will
increase from 25% to 30% of BENDEKA net U.S. sales, provided that
BENDEKA’s orphan drug exclusivity has not been rescinded, withdrawn or
waived by such date. The royalty rate will increase by one percentage
point on each anniversary of October 1, 2019 until it reaches 32%, and
it will remain at 32% thereafter.

The revised agreement, effective April 13, 2019, also extends the U.S.
BENDEKA royalty term until it is no longer sold in the United States.
The previous U.S. royalty term was set to expire in 2025. The extended
term recognizes the strength of the bendamustine patents with expiries
through 2033, and the value of the product beyond the original ten-year
period. As part of the agreement restructuring, Eagle will continue to
manufacture BENDEKA for the U.S. market for so long as it is sold in the
United States and has agreed to assume a portion of the BENDEKA-related
patent litigation expenses.

“We are very pleased to deepen our relationship with Teva by extending
and expanding our licensing agreement for BENDEKA. This agreement
recognizes the long-term value of the product, which is supported by
orphan drug exclusivity through December 7, 2022 and an extensive patent
portfolio through 2033. Teva has been a strong commercial partner, and
we look forward to exploring additional areas of cooperation,” stated
Scott Tarriff, Chief Executive Officer of Eagle.

BENDEKA was granted orphan drug designation by the U.S. Food and Drug
Administration (FDA) and is approved for the treatment of patients with
chronic lymphocytic leukemia (CLL) and for the treatment of patients
with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed
during or within six months of treatment with rituximab or a
rituximab-containing regimen.

About Eagle Pharmaceuticals, Inc.

Eagle is a specialty pharmaceutical company focused on developing and
commercializing injectable products that address the shortcomings, as
identified by physicians, pharmacists and other stakeholders, of
existing commercially successful injectable products. Eagle’s strategy
is to utilize the FDA’s 505(b)(2) regulatory pathway. Additional
information is available on the Company’s website at www.eagleus.com.

Forward-Looking Statements

This press release contains forward-looking information within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, and other securities laws. Forward-looking statements are
statements that are not historical facts. Words and phrases such as
“will,” “expected,” “we believe,” “committed,” “plan,” “promise,” “may,”
“enables,” “potential,” and similar expressions are intended to identify
forward-looking statements. These statements include, but are not
limited to, statements regarding future events, including: the
performance of our marketed products, including BENDEKA; statements
regarding the collaboration between Eagle and Teva; statements regarding
royalty payments that Teva may be obligated to make in connection with
the revised licensing agreement; the ability to maintain BENDEKA’s
orphan drug exclusivity; success of Eagle’s commercial relationship with
Teva and the parties’ ability to work effectively together; whether
Eagle and Teva will successfully perform their respective obligations
under the revised licensing agreement and any other agreements in effect
between Eagle and Teva; the outcome of any litigation involving BENDEKA
or any litigation that may have an impact on BENDEKA or on our
relationship with Teva; and the strength and enforceability of our
intellectual property rights with respect to BENDEKA. All of such
statements are subject to certain risks and uncertainties, many of which
are difficult to predict and generally beyond Eagle’s control, that
could cause actual results to differ materially from those expressed in,
or implied or projected by, the forward-looking information and
statements. Such risks include, but are not limited to: the risk that
the benefits of the revised license agreement described above are not
realized; the continued willingness of Teva to collaborate with Eagle;
the risk that the conditions necessary for the increased royalty
payments to take effect will not be realized; the outcome of ongoing or
future litigation; the risk that Eagle’s orphan drug exclusivity for
BENDEKA may be rescinded, withdrawn or waived prior to the expiration of
such orphan drug exclusivity; Eagle’s ability to protect its
intellectual property; dependence on third parties; other risks inherent
to drug development and commercialization; and other risks described in
Eagle’s filings with the U.S. Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these
forward-looking statements that speak only as of the date hereof, and we
do not undertake any obligation to revise and disseminate
forward-looking statements to reflect events or circumstances after the
date hereof, or to reflect the occurrence of or non-occurrence of any
events.

Contacts

Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M.
Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: [email protected]

Read the full article

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.