SAN DIEGO and BEIJING,
July 9, 2018 /PRNewswire/
-- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage,
cancer-selective gene therapy company, and Beijing Apollo Venus
Biomedical Technology Limited, an affiliate of ApolloBio Corp., a
biopharmaceutical company focused on oncology (collectively,
"ApolloBio"), today announced the closing of an agreement providing
ApolloBio with the exclusive right to develop and commercialize
Toca 511 & Toca FC within the greater China region. ApolloBio has garnered all
regulatory approvals for the agreement and paid Tocagen the upfront
payment of $16 million.
![Tocagen Inc. (PRNewsfoto/Tocagen Inc.) Tocagen Inc. (PRNewsfoto/Tocagen Inc.)](https://mma.prnewswire.com/media/524567/Tocagen_Logo.jpg)
Under the terms of the agreement signed with ApolloBio in
April 2018, Tocagen is also eligible
to receive potential payments of $4
million in near-term development milestones, including a
milestone for the completion of enrollment in the ongoing Phase 3
Toca 5 study. Tocagen will be eligible for additional future
payments totaling up to $111 million upon meeting certain
development and commercial milestones. In addition, the agreement
provides for low double-digit tiered royalty payments based on
net sales. ApolloBio will be responsible for all development and
commercialization costs in the licensed territory.
"We're pleased to have completed our strategic partnership
agreement with ApolloBio, allowing us to expand the global
commercial opportunity for Toca 511 & Toca FC amidst important
recent developments in China to
facilitate patient access to medical innovations," said
Marty Duvall, chief executive
officer of Tocagen. "This partnership also strengthens Tocagen's
cash position to fuel our pivotal Phase 3 Toca 5 trial and our
pipeline-expanding R&D efforts."
"We are eager to collaborate closely with Tocagen and advance
the development of Toca 511 & Toca FC in greater China," said Dr. Weiping Yang, chief executive officer of
ApolloBio. "This partnership is an example of our commitment to
bringing novel immuno-oncology treatments to the large patient
population in China as soon as
possible."
About Toca 511 & Toca FC
Tocagen's lead product candidate is a two-part cancer-selective
immunotherapy comprised of an investigational biologic, Toca 511
and an investigational small molecule, Toca FC. Toca 511
(vocimagene amiretrorepvec) is a retroviral replicating vector
(RRV) that selectively infects cancer cells and delivers a gene for
the enzyme, cytosine deaminase (CD). Through this targeted
delivery, infected cancer cells carry the CD gene and produce CD.
Toca FC is an orally administered, extended-release formulation of
the prodrug, 5-fluorocytosine (5-FC), which is converted into an
anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD.
5-FU kills cancer cells and immune-suppressive myeloid cells in the
tumor microenvironment resulting in anti-cancer immune activation
and subsequent tumor killing.
About ApolloBio Corp.
ApolloBio Corp. is an innovative Chinese biomedical company
committed to research, development and commercialization of
innovative new medicines, accessing such new medicines through
in-licensing and in-house development. ApolloBio is focused on
pharmaceutical products with significant market potential in
China in the field of oncology;
providing efficient access for American biomedical companies to
enter into the Chinese market; and aiming to bring the newest and
best medicines across the globe to the Chinese patients. For more
information, visit www.apollobio.com.
About Tocagen Inc.
Tocagen is a clinical-stage, cancer-selective gene therapy
company developing first-in-class, broadly applicable product
candidates designed to activate a patient's immune system against
their own cancer. Tocagen's lead investigational product candidate,
Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3
trial for recurrent high grade glioma (HGG), a disease with
significant unmet medical need. The U.S. Food and Drug
Administration (FDA) has granted Toca 511 & Toca FC
Breakthrough Therapy Designation for the treatment of recurrent HGG
and the European Medicines Agency (EMA) has granted Toca 511 PRIME
(PRIority MEdicines) designation for the treatment of glioma. For
more information about Tocagen, visit www.tocagen.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
the payments we expect to receive from ApolloBio under the license
agreement, including the timing and amounts of such payments,
ApolloBio's development and regulatory capabilities and resources,
the development and regulatory environment for oncology candidates
and gene therapy candidates in the greater China region, and the market potential for
oncology products and gene therapy products in the greater
China region. Risks that
contribute to the uncertain nature of the forward-looking
statements include: ApolloBio's ability to obtain required currency
exchange and other approvals from PRC authorities for payments
under the agreement; the uncertain timing of obtaining such
approvals; regulatory developments in the greater China region, the
United States and other countries; ApolloBio's ability to
execute on its strategy, including the availability to ApolloBio of
sufficient capital for such purpose; the success, cost and timing
of ApolloBio obtaining approval to import Toca 511 and
Toca FC manufactured outside of the greater China region for use in clinical trials or for
commercial distribution; tariffs or restrictions that People's Republic of China (PRC) authorities
may impose on the import of pharmaceutical products manufactured
outside of the greater China
region; the amount of PRC withholding tax and value added tax that
ApolloBio will be required to deduct from any payments to us under
the agreement; the extent, if any, to which we are able to recover
any such withheld amounts; ApolloBio's diligence obligations and
resource commitments with respect to the development and
commercialization of other products in-licensed by ApolloBio from
third parties and ApolloBio's own internally-developed products;
timing, cost and success of our clinical trials and planned
clinical trials of Toca 511 & Toca FC, including the
ongoing Phase 3 clinical trial; timing and success of obtaining FDA
approval of Toca 511 & Toca FC; and the ability of
our R&D efforts to expand our pipeline and the costs of such
efforts. These and other risks and uncertainties are described more
fully under the caption "Risk Factors" and elsewhere in Tocagen's
filings and reports with the United States Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Tocagen
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Media Contact:
Pam
Lord
Canale Communications
pam@canalecomm.com
Investor Contact:
Elizabeth
Broder
Endurance Advisors
ebroder@enduranceadvisors.com
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SOURCE Tocagen Inc.