DUBLIN and SAN FRANCISCO, Sept.
20, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a
leading global pharmaceutical company, and Tobira Therapeutics,
Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company
focused on developing and commercializing therapies for
non-alcoholic steatohepatitis (NASH) and other liver diseases,
today announced that they have entered into a definitive agreement
under which Allergan will acquire Tobira for an upfront payment of
$28.35 per share, in cash, and up to
$49.84 per share in Contingent Value
Rights (CVRs) that may be payable based on the successful
completion of certain development, regulatory and commercial
milestones, for a total potential consideration of up to
$1.695 billion. The Boards of
Directors of both companies have unanimously approved the
transaction.
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NASH is a severe type of non-alcoholic fatty liver disease
(NAFLD), which is characterized by the accumulation of fat in the
liver with no other apparent causes.ii NASH occurs when
the accumulation of liver fat is accompanied by inflammation and
cellular damage.ii The inflammation can lead to fibrosis
(scarring) of the liver and eventually progress to cirrhosis,
portal hypertension, liver cancer and eventual liver
failure.ii
The acquisition adds Cenicriviroc (CVC) and Evogliptin, two
differentiated, complementary development programs for the
treatment of the multi-factorial elements of NASH, including
inflammation, metabolic syndromes and fibrosis, to Allergan's
global Gastroenterology R&D pipeline.
"The acquisition of Tobira is a strategic R&D investment
within a white space area of our global Gastroenterology franchise
and an opportunity to advance the development of novel treatments
for NASH," said Brent Saunders, CEO
and President of Allergan. "With the increasing rates of diabetes,
obesity and other metabolic conditions in the U.S. and in developed
nations globally, NASH is set to become one of the next
epidemic-level chronic diseases we face as a society. It is
important that we invest in new treatments today so that healthcare
systems, providers and patients have treatment options to face this
challenge in the coming years."
"With this acquisition, Allergan will now have one of the
strongest portfolios of development stage programs for the
treatment of NASH, with Cenicriviroc as the cornerstone. We
will continue to look for differentiated development-stage assets
that can bolster this position and enhance our commitment to
innovation in this disease," added Saunders.
Cenicriviroc (CVC) is a first-in-class, once-daily, oral Phase 3
ready potent immunomodulator that blocks two chemokine receptors,
CCR2 and CCR5, which are involved in the inflammatory and
fibrogenic pathways in NASH that cause liver damage and often lead
to cirrhosis, liver cancer or liver failure. In the Phase 2b
CENTAUR study, CVC demonstrated a clinically and statistically
significant improvement in fibrosis of at least one stage without
worsening of NASH, one of two key secondary endpoints, after one
year of treatment.
The acquisition also adds Evogliptin, an oral DPP-4 (Dipeptidyl
peptidase-4) inhibitor for the potential treatment of NASH.
Evogliptin is being studied in a Phase 1 trial assessing the
safety, tolerability and steady-state pharmacokinetic parameters of
the compound when administered with and without CVC. In NASH,
increased DPP-4 serum levels and hepatic DPP-4 expression is
correlated with disease severity.
"Both the CVC and Evogliptin programs provide highly
differentiated compounds that can make a significant impact in the
treatment of NASH, where today there are no approved therapies
available for patients," said David
Nicholson, Chief Research & Development Officer,
Allergan. "Importantly, NASH treatment may
well require a multi-therapeutic approach to address the
multiple factors of the disease. CVC has been shown in clinical
trials to provide significant improvement in liver fibrosis, the
hallmark of NASH. Liver fibrosis is associated with key long-term
outcomes, including overall mortality, liver transplantation and
liver-related events. Evogliptin, in preclinical models, has
been shown to decrease hepatic glucose production, improve hepatic
triglyceride content and steatosis, and reduce histologic markers
of inflammation of the liver. Together, these programs provide a
highly complementary potential therapeutic approach to address the
inflammatory, metabolic and fibrotic elements of NASH that the
medical community will need to treat this condition."
"I am extremely excited to see Tobira and Allergan come
together," said Laurent Fischer,
M.D., Chief Executive Officer, Tobira Therapeutics. "The
combination of our team's innovation in the NASH space and the
infrastructure, development expertise and world-class ability of
Allergan to market medicines will enable us to more rapidly develop
and commercialize needed medications for patients suffering from
NASH and other serious fibrotic diseases around the world."
"We are delighted that cenicriviroc will be rapidly advancing
into Phase 3 studies under the stewardship of Allergan, an industry
leader with world class capabilities in advancing novel treatment
options to patients across the globe, and I look forward to the
future success of this partnership," added Dennis Podlesak, Chairman of the Board of
Tobira.
Under the terms of the merger agreement, a subsidiary of
Allergan will commence a cash tender offer to purchase all of the
outstanding shares of Tobira common stock for $28.35 per share, plus one Contingent Value Right
to receive up to $49.84 per share in
future payments based on the successful completion of certain
development, regulatory and commercial milestones. The closing of
the tender offer is subject to customary closing conditions,
including U.S. antitrust clearance and the tender of a majority of
the outstanding shares of Tobira common stock. Holders of
approximately 36 percent of the outstanding shares of Tobira common
stock have entered into an agreement to tender their shares into
the tender offer. The merger agreement contemplates that Allergan
will acquire any shares of Tobira that are not tendered into the
offer through a second-step merger, which will be completed as soon
as practicable following the closing of the tender offer. Pending
approvals, Allergan anticipates closing the transaction by the end
of 2016.
Covington & Burling LLP is serving as Allergan's lead legal
counsel. Centerview Partners and Citi are serving as financial
advisors to Tobira and Skadden, Arps, Slate, Meagher & Flom LLP
and Gunderson Dettmer Stough Villeneuve
Franklin & Hachigian, LLP are serving as Tobira's legal
counsel.
Conference Call
Allergan management will host a
conference call to discuss the Tobira Therapeutics acquisition, and
other recent R&D acquisitions, Wednesday, September 21, 2016 at 8:30 AM EST. The number to call from within
the United States is (877)
251-7980, conference ID 85674735. From international
locations, the conference call can be accessed at (706) 643-1573
using the same conference ID. The call will also be webcast
and can be accessed through the companies' websites at
www.allergan.com. To access the slides go to Allergan's Investor
Relations Web site at http://ir.allergan.com. A replay of the
conference call will also be available by calling (855) 859-2056 in
the U.S. or (404) 537-3406 outside of the U.S., conference ID
85674735.
About Non-Alcoholic Steatohepatitis (NASH)
NASH is a
severe type of non-alcoholic fatty liver disease (NAFLD), which is
characterized by the accumulation of fat in the liver with no other
apparent causes.ii NASH occurs when the accumulation of
liver fat is accompanied by inflammation and cellular
damage.ii The inflammation can lead to fibrosis
(scarring) of the liver and eventually progress to cirrhosis,
portal hypertension, liver cancer, and eventual liver
failure.ii
NAFLD and NASH affect approximately 30% and 5%, respectively, of
the US population[iii] and NAFLD affects more than 20% of the
population worldwide.[iv] NASH is the fastest growing cause of
liver cancer and liver transplant in the U.S.[v] The increasing
prevalence of NASH is attributed to the growing obesity epidemic
and the disease is often diagnosed in patients who have diabetes,
high cholesterol or high triglycerides.iii There is
currently no approved treatment for NASH.
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a bold, global pharmaceutical company and a leader in a new
industry model – Growth Pharma. Allergan is focused on
developing, manufacturing and commercializing branded
pharmaceuticals, devices and biologic products for patients around
the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
65+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what it is right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live healthier lives
everyday.
For more information, visit Allergan's website at
www.Allergan.com.
About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on
the development and commercialization of therapies for
non-alcoholic steatohepatitis (NASH) and other liver diseases. The
company's lead product candidate, cenicriviroc (CVC), is a
first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5
in late-stage development for the treatment of NASH, a serious
liver disease that can progress to cirrhosis, liver cancer and
liver failure. CVC is also being investigated to address primary
sclerosing cholangitis (PSC), a disease which causes inflammation
and scarring of the bile ducts, eventually leading to serious liver
damage. Tobira's pipeline also includes evogliptin, a selective
DPP-4 inhibitor, which it plans to develop for NASH in combination
with CVC. Learn more about Tobira at www.tobiratx.com.
Tobira® is a registered trademark owned by Tobira Therapeutics,
Inc.
Allergan Cautionary Statement Regarding Forward-Looking
Statements
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2015 and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2016 (such periodic public
filings having been filed under the "Actavis plc" name). Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
Tobira Cautionary Statement Regarding Forward-Looking
Statements
All of the statements in this press release, other than
historical facts, are forward-looking statements, including,
without limitation, the statements made concerning Allergan's
pending acquisition of Tobira. As a general matter, forward-looking
statements are those focused upon anticipated events or trends,
expectations, and beliefs relating to matters that are not
historical in nature. Such forward-looking statements are subject
to uncertainties and factors relating to Tobira's operations and
business environment, all of which are difficult to predict and
many of which are beyond the control of Tobira. Among others, the
following factors could cause actual results to differ materially
from those set forth in the forward-looking statements: (i)
uncertainties as to how many Tobira stockholders will tender their
shares of Tobira common stock in the tender offer; (ii) the
possibility that competing offers will be made; (iii) the
possibility that various closing conditions for the transaction may
not be satisfied or waived; (iv) the risk that the merger agreement
with Allergan may be terminated in circumstances requiring Tobira
to pay Allergan a termination fee; (v) risks related to obtaining
the requisite consents to the transaction, including, without
limitation, the timing (including possible delays) and receipt of
regulatory approvals from various governmental entities (including
any conditions, limitations or restrictions placed on these
approvals and the risk that one or more governmental entities may
deny approval); (vi) the possibility that the transaction may not
be timely completed, if at all; and (vii) that, prior to the
completion of the transaction, if at all, Tobira's business may
experience significant disruptions due to transaction-related
uncertainty. Other factors that could cause actual results to
differ materially include those set forth in Tobira's SEC reports,
including, without limitation, the risks described in the Tobira's
Annual Report on Form 10-K for its fiscal year ended December 31, 2015 and Quarterly Report on Form
10-Q for the fiscal quarter ended June 30,
2016. Tobira assumes no obligation and does not intend to
update these forward-looking statements, except as expressly
required by law.
Notice to Investors
The tender offer for the outstanding shares of common stock of
Tobira referred to in this press release has not yet commenced. The
description contained in this press release is neither an offer to
purchase nor a solicitation of an offer to sell any securities. The
solicitation and the offer to buy shares of Tobira common stock
will be made pursuant to an offer to purchase and related materials
that Allergan intends to file with the Securities and Exchange
Commission. At the time the offer is commenced, Allergan will file
a tender offer statement on Schedule TO with the Securities and
Exchange Commission, and thereafter Tobira will file a
solicitation/ recommendation statement on Schedule 14D-9 with
respect to the offer. The tender offer statement (including an
offer to purchase, a related letter of transmittal and other offer
documents) and the solicitation/recommendation statement will
contain important information that should be read carefully and
considered before any decision is made with respect to the tender
offer. These materials will be sent free of charge to all
stockholders of Tobira when available. Additionally, Tobira and
Allergan will file other relevant materials in connection with the
proposed acquisition of Tobira by Allergan pursuant to the terms of
the merger agreement. All of these materials (and all other
materials filed by Tobira with the Securities and Exchange
Commission) will be available at no charge from the Securities and
Exchange Commission through its website at www.sec.gov. Free copies
of the offer to purchase, the related letter of transmittal and
certain other offering documents will be made available by Allergan
and when available may be obtained by directing a request to
Allergan's Investor Relations Department at (862) 261-7488.
Investors and security holders may also obtain free copies of the
documents filed with the Securities and Exchange Commission by
Tobira by contacting Tobira Investor Relations at (650)
351-5013.
INVESTORS AND STOCKHOLDERS OF TOBIRA ARE ADVISED TO READ THE
SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR
SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION WHEN THEY BECOME
AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER
OFFER OR MERGER, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.
iFrom NAFLD to NASH to cirrhosis-new insights into
disease mechanisms. Wree, A. Nat Rev Gastroenterol Hepatol. 2013
Nov;10(11):627-36
ii The National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK). Fatty Liver Disease (Nonalcoholic
Steatohepatitis).
https://www.niddk.nih.gov/health-information/health-topics/liver-disease/nonalcoholic-steatohepatitis/Pages/facts.aspx
iiiNonalcoholic fatty liver disease: A systematic
review. ME, Rinella. Journal of the American Medical Association,
2015, Vol. 313, pp. 2263-2273.
ivSattar N, et al. Non-alcoholic fatty liver disease.
Available from:
http://www.bmj.com/content/349/bmj.g4596.
vAnderson, C.D. Curr Surg Rep (2015) 3: 24.
doi:10.1007/s40137-015-0101-6.
CONTACTS:
ALLERGAN:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
TOBIRA:
Investors:
Ian Clements, Ph.D.
(650) 351-5013
Media:
Brewlife
Kelly Boothe, Ph.D.
(415) 946-1076
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SOURCE Allergan plc; Tobira Therapeutics, Inc.