DUBLIN, Sept. 20, 2016
/PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global
pharmaceutical company, today announced that the Company has
acquired Akarna Therapeutics Ltd., a privately held
biopharmaceutical company focused on developing novel small
molecule therapeutics that target inflammatory and fibrotic
diseases, for an up-front payment of $50
million, subject to certain adjustments, as well as
potential clinical, regulatory and commercial milestone payments
related to its lead development compound, AKN-083. In addition to
AKN-083, the acquisition also includes a portfolio of additional
development-stage FXR compounds.
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Non-Alcoholic Steatohepatitis (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 populationiii and NAFLD
affects more than 20% of the population worldwide.iv
AKN-083 is a potentially best-in-class preclinical farnesoid X
receptor (FXR) agonist in development for the treatment of NASH,
and is highly complementary to compounds in development by Tobira
Therapeutics, Cenicriviroc (CVC) and Evogliptin. Allergan announced
the acquisition of Tobira earlier today.
"The acquisition of Akarna adds to our strategic approach to
investing in innovation to advance the treatment of NASH for
millions of patients who currently do not have therapeutic options
to treat the disease," said Brent
Saunders, CEO and President of Allergan. "We look forward to
advancing this unique compound into later stages of development,
and to advancing our overall portfolio of NASH programs, as we
focus on bringing forward effective treatments for this critical
disease area."
"AKN-083 is a highly differentiated, selective FXR agonist which
is a strongly validated therapeutic mechanism for the treatment of
NASH," said David Nicholson, Chief
Research & Development Officer, Allergan. "In addition,
AKN-083 is a non-bile acid FXR agonist that in preclinical studies
has shown high affinity, potency and selectivity with a better
tolerability profile. These characteristics make AKN-083 a great
addition to our portfolio of assets for the treatment of NASH."
"We are excited to be working with Allergan, a company that
shares our vision to develop the best possible treatments for
NASH," said Raju Mohan, Ph.D.,
Founder and Chief Executive Officer, Akarna Therapeutics. "Allergan
shares our commitment to help patients with NASH live longer,
healthier lives."
Conference Call
Allergan management will host a
conference call to discuss the Tobira Therapeutics, Akarna
Therapeutics and other recent R&D acquisitions Wednesday, September 21, 2016 at 8:30 a.m. 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 populationv and NAFLD affects more than 20% of
the population worldwide.vi NASH is the fastest growing
cause of liver cancer and liver transplant in the
U.S.i 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 FXR
Farnesoid X receptor (FXR) is a nuclear
hormone receptor expressed in the liver, intestine, kidney and fat.
FXR has been closely studied over the past decade because of its
role as a master regulator of carbohydrate and lipid metabolism,
bile-acid homeostasis, inflammation and fibrosis, all of which are
associated with the pathology and progression of NASH. FXR is
recognized as a clinically validated target for NASH and other
liver diseases.
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.
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.
Notice to Investors
Allergan expects to commence a
cash tender offer to purchase all of the outstanding shares of
Tobira common stock. The tender offer for the outstanding common
stock of Tobira has not yet commenced. The description of the
Tobira acquisition 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.
i Anderson, C.D. Curr Surg Rep (2015) 3: 24.
doi:10.1007/s40137-015-0101-6.
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
iii Nonalcoholic fatty liver disease: A systematic
review. ME, Rinella. Journal of the American Medical Association,
2015, Vol. 313, pp. 2263-2273.
iv Sattar N, et al. Non-alcoholic fatty liver
disease. Available from: http://www.bmj.com/content/349/bmj.g4596.
v Nonalcoholic fatty liver disease: A systematic
review. ME, Rinella. Journal of the American Medical Association,
2015, Vol. 313, pp. 2263-2273.
vi Sattar N, et al. Non-alcoholic fatty liver
disease. Available from:
http://www.bmj.com/content/349/bmj.g4596.
CONTACTS:
ALLERGAN:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc