-
Acquisition of one clinical and three pre-clinical phase
development programs
-
Concurrent $42 million equity investment in Ignyta by Teva and
selected healthcare investors
-
Upon closure of the agreements, Teva will hold approximately 12% of
Ignyta common shares
-
Ignyta to host conference call and simultaneous webcast to discuss
the transaction at 5:00 pm ET (2:00 pm PT)
JERUSALEM & SAN DIEGO--(BUSINESS WIRE)--Mar. 17, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (“Teva”), a world
leading global pharmaceutical company, and Ignyta, Inc. (Nasdaq:RXDX)
(“Ignyta”), a precision oncology biotechnology company, today announced
the acquisition by Ignyta of the worldwide rights and assets relating to
four targeted oncology development programs in exchange for 1.5 million
shares (6%) of Ignyta’s common stock.
Concurrently, Ignyta has entered into stock purchase agreements with
Teva, and selected additional healthcare investors, whereby Teva will
purchase a further 1.5 million shares of common Ignyta stock at a price
of $10 per share in a registered direct offering. The other investors
will purchase an additional 2.7 million shares at $10 per share, valuing
the total offering at approximately $41.6 million.
“Teva has committed to finding novel ways for the ongoing development of
early clinical stage and pre-clinical oncology R&D programs, which hold
significant promise for cancer patients,” said Michael Hayden, Teva’s
President of Global R&D and Chief Scientific Officer. “Ignyta’s
capabilities and focus in oncology will give these assets the best
chance of realizing their potential for patients, and of maximizing
their value for Teva.”
“Acquiring these four development stage programs from Teva is truly
transformational for Ignyta and well aligned with our strategic focus on
developing first-in-class and best-in-class precision medicines to help
cancer patients with unmet needs,” said Jonathan Lim, M.D., Chairman and
CEO of Ignyta. “These oncology programs add critical mass to our
pipeline and further enable us to leverage our precision oncology
platform, including our proprietary multiplex diagnostic assays and our
CLIA certified, QSR compliant diagnostic laboratory. Furthermore, these
new assets complement our entrectinib development program and extend our
ability to target the majority of known oncogenic drivers across
multiple solid tumor indications. For example, in non-small cell lung
cancer alone, we believe that our product candidates have potential
activity against many of the most frequent oncogenic drivers in this
disease, and we plan to explore these opportunities through innovative
clinical trial designs such as master protocols.”
“We are also grateful to Teva and the financial investors who share
Ignyta’s precision oncology vision and invested in this latest
financing,” continued Dr. Lim. “We intend to use the funds to further
advance our precision oncology vision by developing targeted therapies
that provide meaningful benefit to specific populations of cancer
patients.”
Overview of Asset Acquisition Transaction
Under the terms of the asset purchase agreement with Teva, Ignyta is
acquiring all of Teva’s assets and worldwide rights relating to four
oncology development programs in exchange for 1.5 million shares of
Ignyta’s common stock. Teva has agreed not to sell or otherwise transfer
any of these shares until March 17, 2016, and Ignyta is required to
register the resale of these shares with the Securities and Exchange
Commission (SEC) prior to such date.
The development programs Ignyta purchased from Teva include:
-
CEP-32496, which Ignyta has renamed RXDX-105, a potent small molecule
inhibitor of BRAF, EGFR and RET that is currently in a Phase I/II dose
escalation clinical trial;
-
CEP-40783, which Ignyta has renamed RXDX-106, a potent, highly
selective, pseudo-irreversible inhibitor of AXL and cMET that is in
late preclinical development;
-
CEP-40125, which Ignyta has renamed RXDX-107, a nanoformulation of a
modified bendamustine with potential activity in solid tumors that is
in late preclinical development; and
-
TEV-44229, which Ignyta has renamed RXDX-108, a potent, selective
inhibitor of the atypical kinase PKCiota that is in preclinical
studies. Ignyta has also acquired next generation PKCiota inhibitors
in addition to the lead compound.
Ignyta also assumed all of Teva’s ongoing obligations under certain
contracts relating to the purchased programs, including the agreements
under which Teva in-licensed rights to the assets.
Concurrent Equity Financing
Teva has agreed to purchase 1.5 million shares of Ignyta common stock
for a purchase price of $10 per share, resulting in gross proceeds to
Ignyta of $15 million. Ignyta has also entered into stock purchase
agreements with several additional investors that will purchase an
aggregate of 2.7 million additional shares of Ignyta common stock. The
offering is expected to result in aggregate gross proceeds to Ignyta of
approximately $41.6 million. The offering closed concurrently with the
asset purchase. Ignyta did not use a placement agent in connection with
this transaction.
A shelf registration statement relating to the shares of common stock
issued in the offering was filed with, and declared effective by, the
SEC. A prospectus supplement relating to the offering will be filed with
the SEC. This press release shall not constitute an offer to sell or a
solicitation of an offer to buy any shares of common stock. No offer,
solicitation or sale will be made in any jurisdiction in which such
offer, solicitation or sale is unlawful.
Ignyta Slide Deck and Conference Call
Ignyta has posted a slide presentation relating to the Teva transaction,
its new development programs and the concurrent equity financing on the
Investors page of the company’s website at http://investor.ignyta.com.
On Tuesday, March 17, 2015, Ignyta will host a conference call with
interested parties beginning at 5:00 p.m. ET (2:00 p.m. PT) to discuss
the transactions and related matters. A live webcast of the conference
call will be available online on the Investors page of the company's
website at http://investor.ignyta.com.
The call will also be archived and accessible at that site for one year.
Alternatively, callers may participate in the conference call by dialing
(888) 734-0328 (domestic) or (678) 894-3054 (international), and
entering passcode 5138138.
Discussion during the conference call may include forward-looking
statements regarding such topics as, but not limited to, Ignyta’s
development plans for its new product candidates, its other product
candidates and discovery programs, the company’s financial status, and
any comments the company may make about its future plans or prospects in
response to questions from participants on the conference call.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
About Ignyta, Inc.
Ignyta, Inc., located in San Diego, California, is a precision oncology
biotechnology company pursuing an integrated therapeutic (Rx) and
companion diagnostic (Dx) strategy for treating cancer patients. The
company’s goal with this Rx/Dx approach is to discover, develop and
commercialize new drugs that target activated cancer genes and pathways
for the customized treatment of cancer. It aims to achieve this goal by
pairing each of its product candidates with biomarker-based companion
diagnostics that are designed to identify, at the molecular level, the
patients who are most likely to benefit from the precisely targeted
drugs the company develops. For more information, please visit: www.ignyta.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to migrate
users to our 40 mg/mL version; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from the research and development efforts
invested in our pipeline of specialty and other products; our ability to
reduce operating expenses to the extent and during the timeframe
intended by our cost reduction program; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the extent
to which any manufacturing or quality control problems damage our
reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 and in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and we assume no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Ignyta Forward-Looking Statements
This press release contains forward-looking statements about Ignyta
as that term is defined in Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Statements in this
press release that are not purely historical are forward-looking
statements. Such forward-looking statements include, among other things,
references to the development of Ignyta’s new or other product
candidates, the potential advantages and first-in-class or best-in-class
nature of these drug programs and the potential for Ignyta to establish
a leadership position in oncology personalized medicine and provide
benefit to cancer patients. Actual results could differ from
those projected in any forward-looking statements due to numerous
factors. Such factors include, among others, the inherent uncertainties
associated with developing new products or technologies and operating as
a development stage company; regulatory developments in the United
States and foreign countries; Ignyta’s ability to develop, complete
preclinical studies and clinical trials for, obtain approvals for and
commercialize any of its product candidates; changes in Ignyta’s plans
to develop and commercialize its product candidates; the potential for
final results of the ongoing Phase I/II clinical trials of entrectinib,
or any future clinical trials of entrectinib or other product
candidates, to differ from preliminary or expected results; Ignyta’s
ability to raise any additional funding it will need to continue to
pursue its business and product development plans; Ignyta’s ability to
obtain and maintain intellectual property protection for its product
candidates; the potential for the company to fail to maintain the CLIA
registration of its diagnostic laboratory or to fail to achieve full
CLIA accreditation of such laboratory; the loss of key scientific or
management personnel; competition in the industry in which Ignyta
operates; and market conditions. These forward-looking statements are
made as of the date of this press release, and Ignyta assumes no
obligation to update the forward-looking statements, or to update the
reasons why actual results could differ from those projected in the
forward-looking statements. Investors should consult all of the
information set forth herein and should also refer to the risk factor
disclosure set forth in the reports and other documents the company
files with the SEC available at www.sec.gov,
including without limitation Ignyta’s Annual Report on Form 10-K for the
year ended December 31, 2014 and subsequent Quarterly Reports on Form
10-Q.
Source: Teva Pharmaceutical Industries Ltd.
Teva IR:
Kevin C. Mannix, 215-591-8912
United
States
or
Ran Meir, 215-591-3033
United
States
or
Tomer Amitai, 972 (3) 926-7656
Israel
or
Teva
PR:
Iris Beck Codner, 972 (3) 926-7687
Israel
or
Denise
Bradley, 215-591-8974
United States
or
Ignyta:
Jacob
Chacko, 858-255-5959
United States
jc@ignyta.com