SAN DIEGO and FOUNTAIN
VALLEY, Calif., March 7, 2013
/PRNewswire/ -- Sorrento Therapeutics, Inc. ("STI"; SRNE: OB)
today announced that it has signed an exclusive option to acquire
IGDRASOL, a private company focused on the development of oncologic
agents for the treatment of metastatic breast cancer (MBC),
non-small cell lung cancer (NSCLC) and other cancers. If the
transaction is consummated, the combined company would form an
oncology franchise of potential products with Phase 2 data for
multiple solid tumor indications as well as two synergistic drug
discovery and development platforms.
IGDRASOL's lead compound, Cynviloq™, is a next-generation
micellar diblock copolymeric paclitaxel formulation creating a
stable, easy-to-administer injectable for effective delivery of
drug into tumor tissues. Cynviloq™ is currently approved and
marketed in several countries, including South Korea for MBC and NSCLC under the trade
name Genexol-PM®, and has completed Phase 2 testing for potential
advancement into registration trials in the U.S. IGDRASOL has the
exclusive U.S. distribution rights to Genexol-PM® from Samyang
Biopharmaceuticals, a South Korean corporation.
IGDRASOL is preparing for an "End of Phase 2" meeting with the
U.S. Food & Drug Administration (FDA) regarding Cynviloq™
targeted for the first half of 2013. As a formulation of
paclitaxel, Cynviloq™ is potentially eligible for approval via
FDA's 505(b)(2) bioequivalence regulatory pathway versus
albumin-bound paclitaxel (Abraxane®) in its currently approved MBC
and NSCLC indications. Abraxane® recently demonstrated overall
survival benefit in a pivotal phase 3 study as a first line
combination therapy with gemcitabine in advanced pancreatic cancer.
Abraxane® sales exceeded $400 million
in MBC in fiscal 2012, and are projected to achieve peak sales over
$1.6 billion in the U.S. alone.
In the transaction, STI also acquires a tocopherol polyethelyene
glycol succinate (TPGS)-based drug formulation technology, which
could serve as a foundation for novel, next-generation, targeted
therapeutics competitive against current antibody drug conjugates
(ADC). Effective immediately, STI will assume responsibility
for operating expenses related to development of these
next-generation antibody-formulated drug conjugates (AfDC). The
transaction will enable the combined team to leverage STI's
extensive human antibody G-MAB® libraries and preclinical antibody
programs, including those targeting metabolic, autoimmune and
infectious diseases, together with IGDRASOL's expertise in drug
formulation and drug development to deliver a strong pipeline of
targeted tumor therapies.
The transaction includes separate option, services and merger
agreements as well as an asset purchase agreement for a specific
asset. Upon the exercise of Sorrento's exclusive option evidenced
by closing the agreed upon merger agreement, STI will issue
76,199,171 shares of its common stock, and upon the achievement of
a specified regulatory milestone a payment of an additional
32,656,788 shares of common stock will be made.
"This transaction is transformational for STI, as early- and
late-stage product candidates, technologies and development
expertise combine to create an oncology franchise and pipeline with
tremendous value potential. This transaction also reflects our
commitment to improving the lives of cancer patients worldwide
through innovative medicines discovered and developed both in-house
and via external opportunities," said Henry
Ji, Ph.D., president & chief executive officer of STI.
"In particular, Cynviloq™ provides us with a high-value asset that
has near-term revenue potential in MBC and NSCLC, and longer-term
revenue potential in pancreatic, ovarian, bladder and gastric
cancers. These combined addressable markets represent more than 50%
of cancer cases in the U.S. Importantly, STI's overall business
model recognizes the importance of collaboration and partnering
with pharmaceutical and biotechnology companies to achieve its
corporate objectives."
Dr. Ji added: "We look forward to the opportunity to collaborate
with key members of the team responsible for the creation,
development and commercialization of the most successful branded
paclitaxel formulation to date, Abraxane®. This includes
Abraxis Biosciences veterans Dr. Vuong
Trieu, Dr. Kouros Motamed,
Dr. Larn Hwang, and George Uy, who
will give STI an outstanding core competence for the development
and commercialization of its in-house lead therapeutic
programs."
"We look forward to completing this transaction and becoming
part of the STI family," said Vuong
Trieu, Ph.D., chief executive of IGDRASOL. "Our experienced
development and commercial team is excited to combine efforts with
STI to develop and introduce a new, franchise oncology product in
Cynvoloq™ as well as a next-generation of targeted drug delivery
technology for unmet medical needs in cancer. Through our patented
formulation technology and STI's G-MAB® fully human antibodies, the
combined entity will be well positioned for long-term growth as a
targeted therapeutics company."
The option agreement has been approved by the boards of
directors of both companies and is subject to certain undisclosed
closing conditions.
About Cynviloq™
Cynviloq™ (or IG-001; a paclitaxel-loaded micellar diblock
copolymers) is a next-generation branded paclitaxel formulation
currently approved and on the market in several countries as
Genexol-PM®.
About Sorrento Therapeutics, Inc.
Sorrento Therapeutics, Inc. (STI) is a publicly-traded,
development-stage biopharmaceutical company focused on the
discovery, development and commercialization of novel and
proprietary biotherapeutics for the treatment of a variety of
disease conditions, including cancer, inflammation, metabolic and
infectious diseases. STI's objective is to identify drug
development candidates derived from its proprietary human antibody
libraries and, either independently or through partnerships,
advance selected targets into preclinical or clinical development.
In 2012, STI identified and further developed a number of potential
drug product candidates across various therapeutic areas, and STI
intends to select several lead product candidates to progress into
preclinical development activities in 2013. More information is
available at www.sorrentotherapeutics.com.
About IGDRASOL
IGDRASOL's lead therapeutic platform is Cynviloq™, a branded
micellar paclitaxel formulation which is free of cremophor and
human serum albumin (HSA), the excipients for Taxol®
(cremophor-based paclitaxel) and albumin-bound paclitaxel
(Abraxane®), respectively. Cynviloq™ combines the simplicity of
manufacturing and preparation of Taxol® and potentially the
albumin-mediated transport of paclitaxel. IGDRASOL intends to
conduct registration trials for multiple cancer
indications.
The executives of IGDRASOL are a group of pharmaceutical
veterans who believe that next-generation paclitaxel therapy will
present a paradigm shift in the delivery of chemotherapeutic
agents. To learn more about IGDRASOL's mission, please visit
its website (http://www.igdrasol.com). CRT Capital Group acted as
the financial advisor to IGDRASOL in this transaction.
Forward-Looking Statements
This press release contains forward-looking statements subject
to risks and uncertainties that could cause actual results to
differ materially from those projected. Words such as "plans,"
"believes," "expects," "anticipates," and "will," and similar
expressions, are intended to identify forward-looking statements.
Forward-looking statements include statements about the potential
combination of STI and IGDRASOL and the synergies and prospects for
a combined enterprise going forward; and the clinical development
and commercial potential of Cynviloq™. All such forward-looking
statements are based on STI's current beliefs and expectations, and
should not be regarded as a representation by STI that any of its
plans will be achieved. Actual results may differ materially from
those set forth in this press release due to the risks and
uncertainties inherent in STI's and IGDRASOL's businesses,
including: whether STI will have sufficient cash and other
resources to exercise the option and ultimately acquire IGDRASOL;
the potential that STI and the combined company may require
substantial additional funding in order to obtain regulatory
approval for and commercialize any oncology products; the risk that
delays in the regulatory approval or commercial launch of Cynviloq™
will enable competitors to further entrench existing products, or
develop and bring new competing products to market before the
approval, if any, of Cynviloq™; the scope and validity of patent
protection for Cynviloq™as well as STI's and IGDRASOL's platform
technologies, and the risk that the development or
commercialization of product candidates may infringe the
intellectual property rights of others; and additional risks set
forth in Sorrento Therapeutics' filings with the Securities and
Exchange Commission. These forward-looking statements represent
Sorrento Therapeutics' judgment as of the date of this release. You
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement and STI undertakes no obligation to revise or
update this press release to reflect events or circumstances after
the date hereof. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995.
Genexol-PM® is a registered trademark of Samyang Corporation.
Abraxane® is a registered trademark of Celgene, Inc. Taxol® is a
registered trademark of Bristol-Myers Squibb, Inc.
SOURCE Sorrento Therapeutics, Inc.
