- All-stock transaction valued at
approximately US$60 million, or US$1.55 per Transition Therapeutics
share
- OPKO to gain potential first-to-market
GLP-1/Glucagon dual agonist for type 2 diabetes and obesity and
phase 2 drug candidate for the treatment of androgen
deficiency
OPKO Health, Inc. (NASDAQ:OPK) and Transition Therapeutics
Inc. (NASDAQ:TTHI, TSX:TTH) announce the signing of a
definitive agreement under which OPKO will acquire Transition
Therapeutics, a clinical stage biotechnology company.
Under the terms of the agreement approved by the Boards of
Directors of both companies, Transition Therapeutics security
holders will receive approximately 6.4 million shares of OPKO
common stock. Based on the moving average price of OPKO common
stock for the five trading days preceding the signing of the
agreement, the transaction is valued at approximately US$60
million, or US$1.55 per share of Transition Therapeutics common
stock, based on current outstanding shares. The companies expect
the transaction to close during the second half of 2016, subject to
approval of Transition Therapeutics stockholders and other
customary conditions.
The Transition Therapeutics clinical portfolio includes:
- TT401, a once or twice weekly
oxyntomodulin for type 2 diabetes and obesity. We believe TT401 to
be the most clinically advanced drug candidate among the new class
of GLP1-glucagon receptor dual agonists. In a recently completed
phase 2 study of 420 patients with type 2 diabetes, subjects
receiving the highest dose of TT401 peptide once weekly
demonstrated significantly superior weight loss compared with
currently approved extended release exenatide and placebo after 12
and 24 weeks of treatment. TT401 also provided a reduction in
HbA1c, a marker of sugar metabolism, similar to exenatide at weeks
12 and 24. TT401 strengthens OPKO’s existing pipeline of
oxyntomodulin drug candidates for the treatment of type 2 diabetes
and obesity. OPKO’s MOD-6031, currently in a phase 1 study, is a
once weekly oxyntomodulin with a proprietary delivery system to
slowly release the natural oxyntomodulin, which allows the molecule
to penetrate the blood brain barrier. The potential of MOD-6031 to
interact with CNS, as well as peripheral receptors, is expected to
mimic the natural effect of oxyntomodulin for its effects on
satiety and weight loss.
- TT701 is a once daily oral selective
androgen receptor modulator for patients with androgen deficiency.
In a 12-week study of 350 male subjects, it resulted in
significantly decreased fat mass and increased lean body mass and
muscle strength without significantly changing prostate specific
antigen levels. The selective and antagonistic properties of TT701
appear to be well suited to provide anabolic therapeutic benefits
to specific patient populations, while potentially avoiding, or
even reducing, prostate hypertrophy.
- ELND005, a neuropsychiatric drug
candidate. ELND005 is an orally administered small molecule that
has completed phase 2 clinical studies in Alzheimer’s disease and
Down syndrome patients.
“This acquisition provides OPKO with two late stage drug
candidates, each of which holds exceptional market potential,”
stated Phillip Frost, M.D., CEO and Chairman of OPKO. “We believe
TT401, a once-weekly dual GLP1/Glucagon agonist that recently
showed success in a 420-patient phase 2 study, will complement
OPKO’s existing oxyntomodulin product candidate (MOD-6031), which
may provide enhanced therapeutic benefit through targeted
delivery.”
Dr. Frost added, “The selective androgen receptor modulator,
TT701, could meet an important need in patients who can benefit
from its anabolic effects without the risks associated with
testosterone products. We believe it fits well with our Claros® 1
point-of-care diagnostic products under development for
testosterone and PSA, which could serve as companion
diagnostics.”
“OPKO is ideally positioned to leverage the potential of
Transition’s clinical programs and bring these novel therapeutics
to market for the benefit of patients,” said Tony F. Cruz, Ph.D.,
CEO and Chairman of Transition Therapeutics, “Further, OPKO has a
strong pipeline of products coming to market that can provide
future value for Transition Therapeutics stockholders.”
About Transition
Therapeutics
Transition Therapeutics is a biopharmaceutical development
company advancing novel therapeutics for CNS, metabolic diseases
and androgen deficiency indications. The company’s wholly-owned
subsidiary, Transition Therapeutics Ireland Limited, has two
development programs: CNS drug candidate ELND005 for the treatment
of Alzheimer's disease and Down syndrome; and selective androgen
receptor modulator drug candidate TT701. Transition’s lead
metabolic drug candidate is TT401 for the treatment of type 2
diabetes and accompanying obesity. For additional information about
the Company, please visit www.transitiontherapeutics.com.
About OPKO Health
OPKO Health is a diversified healthcare company that seeks to
establish industry-leading positions in large, rapidly growing
markets. Our diagnostics business includes Bio-Reference
Laboratories, the nation's third-largest clinical laboratory with a
core genetic testing business and a 420-person sales force to drive
growth and leverage new products, including the
4Kscore® prostate cancer test and the Claros® 1 in-office
immunoassay platform. Our pharmaceutical business features
RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD
patients with vitamin D insufficiency, and VARUBI™ for
chemotherapy-induced nausea and vomiting (oral formulation launched
by partner Tesaro and IV formulation PDUFA date: January
2017). Our biologics business includes hGH-CTP, a once-weekly human
growth hormone injection (in phase 3 and partnered with Pfizer), a
long-acting Factor VIIa drug for hemophilia (in phase 2a) and a
long-acting oxyntomodulin for diabetes and obesity (in phase 1). We
also have production and distribution assets worldwide, multiple
strategic investments and an active business development strategy.
More information is available at www.opko.com.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements in this communication regarding the proposed
acquisition of Transition Therapeutics by OPKO, including any
statements regarding the expected timetable for completing the
proposed transaction, synergies, benefits and opportunities of the
proposed transaction, future opportunities for the combined company
and products, future financial performance, the potential for
Transition Therapeutics’ products, whether TT701 will serve an
important need in patients who can benefit from its anabolic
effects without risks associated with testosterone products,
whether TT701 can be used in conjunction with our Claros®1
products, and any other statements regarding OPKO's and Transition
Therapeutics' future expectations, beliefs, plans, product
candidates, objectives, financial conditions, assumptions or future
events or performance that are not historical facts are
"forward-looking" statements made within the meaning of Canadian
Securities Laws, of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. The words "anticipate," "believe," "ensure," "expect,"
"if," "intend," "estimate," "probable," "project," "forecasts,"
"predict," "outlook," "aim," "will," "could," "should," "would,"
"potential," "may," "might," "anticipate," "likely" "plan,"
"positioned," "strategy," and similar expressions, and the negative
thereof, are intended to identify forward-looking statements.
All forward-looking information are subject to numerous risks
and uncertainties, many of which are beyond the control of OPKO and
Transition Therapeutics, that could cause actual results to differ
materially from the results expressed or implied by the statements.
These risks and uncertainties include, but are not limited to:
failure to obtain the required vote of Transition Therapeutics’
stockholders; the timing to consummate the proposed transaction;
the risk that a condition to closing of the proposed transaction
may not be satisfied or that the closing of the proposed
transaction might otherwise not occur; the risk that a regulatory
approval that may be required for the proposed transaction is not
obtained or is obtained subject to conditions that are not
anticipated; the diversion of management time on
transaction-related issues; ability to successfully integrate the
businesses; the risk that any potential synergies from the
transaction may not be fully realized or may take longer to realize
than expected; new information arising out of clinical trial
results; and the risk that the safety and/or efficacy results of
existing clinical trials will not support continued clinical
development, as well as risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments. In addition, forward-looking
statements may also be adversely affected by general market
factors, competitive product development, product availability,
federal and state regulations and legislation, the regulatory
process for new products and indications, manufacturing issues that
may arise, patent positions and litigation, among other factors.
The forward-looking statements contained in this communication may
become outdated over time. OPKO and Transition Therapeutics do not
assume any responsibility for updating any forward-looking
statements. Additional information concerning these and other
factors can be found in OPKO's and Transition Therapeutics’
respective filings with the SEC, available through the SEC's
Electronic Data Gathering and Analysis Retrieval system at
www.sec.gov, and Transition Therapeutics’ filings with the Ontario
Securities Commission, available at www.sedar.com.. The foregoing
list of important factors is not exclusive. OPKO and Transition
Therapeutics assume no obligation to update or revise any
forward-looking statements as a result of new information, future
events or otherwise, except as may be required by law. Readers are
cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date hereof.
Additional Information and Where to Find It
Further information regarding the transaction will be contained
in an information circular that Transition Therapeutics will
prepare and mail to its stockholders in connection with the
Transition Therapeutics stockholders’ meeting. Transition
Therapeutics stockholders are urged to read the information
circular once it becomes available, as it will contain important
information concerning the proposed transaction. Transition
Therapeutics stockholders may obtain a copy of the arrangement
agreement, information circular and other meeting materials when
they become available at www.sec.gov and www.sedar.com.
This press release is for informational purposes only. It does
not constitute an offer to purchase shares of Transition
Therapeutics or OPKO or a solicitation or recommendation statement
under the rules and regulations of the Canadian securities
regulators, the United States Securities and Exchange Commission or
other applicable laws.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160629006586/en/
OPKO Health, Inc.:Tara Mackay,
305-575-4100Investor RelationsorMedia:Rooney & AssociatesTerry Rooney,
212-223-0689trooney@rooneyco.comorMarion Janic,
212-223-4017mjanic@rooneyco.comorInvestors:LHAAnne Marie Fields,
212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.comorTransition
Therapeutics:Tony Cruz, Ph.D., 416-260-7770 x223Chief
Executive Officertcruz@transitiontherapeutics.com
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