PRINCETON, N.J., July 9, 2013 /PRNewswire/ -- Omthera
Pharmaceuticals, Inc. (Nasdaq: OMTH), an emerging specialty
pharmaceutical company, today announced that it has submitted a New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) seeking approval for the marketing and sale of Epanova™ for
the treatment for patients with severe hypertriglyceridemia
(triglyceride levels greater than or equal to 500mg/dL).The
submission is based on the entire data set from Omthera's clinical
development program, specifically positive results from two Phase
III trials (EVOLVE and ESPRIT) examining the effectiveness of
Epanova in lowering very high triglycerides,
and in reducing non-HDL cholesterol in combination with a statin
for patients with high triglycerides. Both trials were
conducted under a Special Protocol Assessment with the US Food and
Drug Administration.
Omthera announced on May 28, 2013
that it had entered into a definitive merger agreement with an
affiliate of AstraZeneca PLC pursuant to which such affiliate of
AstraZeneca will acquire all of the outstanding shares of common
stock of Omthera for $12.70 per
share, or approximately $323 million.
In addition to the cash payment, each Omthera stockholder will
receive one Contingent Value Right (CVR) of up to approximately
$4.70 for each share of common stock
that they own, equating to approximately $120 million, if specified milestones related to
Epanova are achieved, or if a milestone related to global net sales
is achieved. This will bring the total potential acquisition value
to approximately $443 million.
About Omthera Pharmaceuticals, Inc.
Omthera Pharmaceuticals, Inc. is an emerging specialty
pharmaceutical company focused on the development and
commercialization of new therapies for dyslipidemia and the
treatment of cardiovascular disease. Epanova, currently the
Company's sole product candidate, is a late-stage, novel, omega-3
free fatty acid composition that meaningfully reduces
triglycerides, improves other key lipid parameters and is expected
to increase patient convenience with 2-gram once-a-day dosing with
or without meals. Epanova™ is a coated soft gelatin capsule
containing a complex mixture of polyunsaturated free fatty acids
derived from fish oils, including multiple long-chain omega-3 and
omega-6 fatty acids, with EPA, DHA, and docosapentaenoic acid being
the most abundant forms of omega-3 fatty acids. The Company has
completed pharmacokinetic and Phase III clinical studies to
investigate the safety and efficacy profile of Epanova™. In 2012
the Company reported positive results from its Phase III EVOLVE and
ESPRIT trials, both of which were conducted under Special Protocol
Assessment (SPA) agreements with the U.S. Food and Drug
Administration. Omthera holds worldwide rights to Epanova™ under a
license from Chrysalis Pharma AG, a privately held Swiss company
that is the owner of the product. For more information, please
visit http://www.omthera.com.
Important Information and Where to Find It
On June 13, 2013, the Company
filed with the Securities and Exchange Commission (the "SEC") a
definitive proxy statement in connection with the proposed
transaction (the "Definitive Proxy Statement") and, on June 14, 2013, the Company commenced mailing of
the Definitive Proxy Statement to its stockholders. INVESTORS
AND THE COMPANY'S STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE
PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC
WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT
INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE COMPANY.
Investors and stockholders may obtain free copies of the Definitive
Proxy Statement and other documents (when available) that the
Company files with the SEC at the SEC's website at
http://www.sec.gov. In addition, the Definitive Proxy
Statement and other documents filed by the Company with the SEC may
be obtained from the Company free of charge by directing a request
to Omthera Pharmaceuticals, Inc., Attn: Christian S. Schade, Executive Vice President
and Chief Financial Officer, 707 State Road, Princeton, New Jersey 08540.
Certain Information Concerning Participants
The Company and its directors and executive officers and certain
other persons may be deemed to be participants in the solicitation
of proxies from the Company's stockholders in connection with the
proposed transaction. Investors and stockholders may obtain
information regarding the names, affiliations and interests of the
Company's directors and executive officers in the Company's final
prospectus dated April 11, 2013 filed
pursuant to Rule 424(b) under the Securities Act with the SEC on
April 12, 2013 (the "Prospectus"),
and the Definitive Proxy Statement. To the extent holdings of
the Company's securities have changed since the amounts printed in
the Definitive Proxy Statement, such changes have been or will be
reflected on the Statements of Change in Ownership on Form 4 filed
with the SEC. These documents can be obtained free of charge
through the website maintained by the SEC at
http://www.sec.gov.
Safe Harbor for Forward-Looking Statements
This press release, in particular statements regarding the
proposed transaction between an affiliate of AstraZeneca PLC and
the Company, the expected timetable for completing the transaction,
future financial and operating results, benefits and synergies of
the transaction, future opportunities for the combined company and
any other statements about AstraZeneca PLC or Company managements'
future expectations, beliefs, goals, plans or prospects, includes
forward-looking statements that are based on certain beliefs and
assumptions and reflect the current expectations of the Company,
AstraZeneca PLC and their respective management. Statements that
are predictive in nature, that depend on or relate to future events
or conditions, or that include words such as "believes,"
"anticipates," "expects," "continues," "predict," "potential,"
"contemplates," "may," "will," "likely," "could," "should,"
"estimates," "intends," "plans" and other similar expressions are
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. Forward-looking statements involve known and unknown
risks, assumptions and uncertainties that may cause actual results
in future periods to differ materially from those projected or
contemplated in the forward-looking statements, and you should not
place undue reliance on these statements. Some of the factors that
could cause actual results to differ materially from current
expectations are: the ability to consummate the proposed
transaction; any conditions imposed on the parties in connection
with the consummation of the proposed transaction; the failure of
the Company's stockholders to approve the proposed transaction; the
ability to obtain regulatory approvals of the proposed transaction;
the occurrence of any event, change or other circumstances that
could give rise to the termination of the agreement relating to the
proposed transaction; the Company's ability to maintain
relationships with employees and third parties following
announcement of the proposed transaction; the ability of the
parties to satisfy the conditions to the closing of the proposed
transaction; the risk that the proposed transaction may not be
completed in the time frame expected by the parties or at all; and
the risks that are described from time to time in the Company's
reports filed with the SEC, including the Prospectus, in other of
the Company's filings with the SEC from time to time, including
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and
on general industry and economic conditions. If the proposed
transaction is consummated, our stockholders will cease to have any
equity interest in the Company and will have no right to
participate in its earnings and future growth. The Company
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Omthera Contact:
Christian Schade
Executive Vice President & Chief Financial Officer
Omthera Pharmaceuticals, Inc.
T: 908-741-4399
E: info@Omthera.com
SOURCE Omthera Pharmaceuticals, Inc.
