Omthera Pharmaceuticals Announces NDA Submission for Epanova™ for the Treatment of Patients with Very High Triglycerides

    Omthera Pharmaceuticals Announces NDA Submission for Epanova™ for the
              Treatment of Patients with Very High Triglycerides

PR Newswire

PRINCETON, N.J., July 9, 2013

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

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
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 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

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

Omthera Contact:
Christian Schade
Executive Vice President & Chief Financial Officer
Omthera Pharmaceuticals, Inc.
T: 908-741-4399

SOURCE Omthera Pharmaceuticals, Inc.

Press spacebar to pause and continue. Press esc to stop.