-POZEN schedules stockholder meeting for February 2, 2016-
-Plan to re-file YOSPRALA™ New Drug Application early in the
second quarter; Approval and launch targeted in fourth
quarter-
CHAPEL HILL, N.C., Dec. 28, 2015 /PRNewswire/ -- POZEN
Inc. ("POZEN") (NASDAQ: POZN) today announced that the registration
statement on Form S-4 filed by Aralez Pharmaceuticals Inc.
("Aralez") on December 14, 2015 with
the U.S. Securities and Exchange Commission (SEC) has been declared
effective. Pozen also announced that it has scheduled its
stockholder meeting in connection with the pending transaction with
Tribute Pharmaceuticals Canada Inc. ("Tribute") for February 2, 2016. The company also provided
updates on several key milestones for YOSPRALA™ and Fibricor®.
POZEN is targeting submission of the New Drug Application
("NDA") for its investigational drug candidates PA8140/PA32540
(aspirin and omeprazole) delayed release tablets, also referred to
as YOSPRALA, with the Food and Drug Administration ("FDA") early in
the second quarter of 2016, focusing its efforts toward using its
previously designated secondary aspirin active pharmaceutical
ingredient ("API") supplier as its primary supplier in connection
with this NDA. Significant progress has been made with this
supplier which is a global leader in aspirin manufacturing. POZEN
will consider the inclusion of both aspirin API suppliers in the
NDA package for YOSPRALA. Assuming the Tribute transaction closes
shortly after the POZEN shareholder meeting, the company also plans
to begin promoting Fibricor in April with a 20 to 25 person sales
force ahead of the expected fourth quarter launch of YOSPRALA.
POZEN also announced that the FDA has completed re-inspection of
the manufacturing facility of its previously designated primary
aspirin API supplier and issued an additional 483 notice, citing
numerous observations. In an effort to respond to these FDA
observations as quickly as possible, the supplier has decided to
voluntarily stop production at this facility, thereby allowing the
manufacturer to focus its available resources on remediating these
observations. Production at this facility is expected to resume on
or about February 29, 2016.
"We are pleased to provide clarity on the timing of our
transaction with Tribute and on other important milestones,
including those relating to YOSPRALA and Fibricor," said
Adrian Adams, Chief Executive
Officer of POZEN Inc. "We spent considerable time working with our
previously designated secondary aspirin API supplier as a back-up
option and we are now pleased to move forward with them as the
primary source of our aspirin. We fully support the former primary
supplier's decision to dedicate all of its efforts to remediate the
FDA 483 observations and look forward to having them continue as an
additional supplier providing they are able to remediate the issues
identified by the FDA. Most importantly, we believe that we remain
on track for potential approval and launch of YOSPRALA in
2016."
Form S-4 / Proxy Statement Details
The Form S-4, which includes a proxy statement of POZEN, related
to the Tribute transaction described below and securities to be
issued by Aralez to the securityholders of POZEN in connection with
this transaction, was declared effective on December 28, 2015. The Form S-4 is available on
the SEC's website, and may be accessed at
http://www.sec.gov/Archives/edgar/data/1660719/000104746915009181/0001047469-15-009181-index.htm.
Upon completion of the Tribute transaction, which is expected to
occur in early February 2016, the
combined company will be named Aralez Pharmaceuticals Inc. and will
be domiciled in Canada.
POZEN's special meeting of its stockholders will be held on
February 2, 2016 at 8:30 a.m. EST, at the offices of DLA Piper LLP
(US) at 1251 Avenue of the Americas, New
York, New York 10020. This meeting is being held to seek
stockholder approval of the transaction agreement and related
matters. POZEN is expected to immediately begin mailing a proxy
statement/prospectus to its stockholders. This proxy
statement/prospectus on Form S-4 will provide information for POZEN
stockholders related to the transaction as well as instructions for
POZEN stockholders on voting. POZEN's stockholders of record as of
the close of business on December 23,
2015 are entitled to vote at the POZEN stockholder
meeting.
The Board of Directors of POZEN has unanimously recommended that
POZEN stockholders vote to approve the transaction to be considered
at POZEN's special meeting of its stockholders and the other
proposals set forth in the proxy statement/prospectus on Form
S-4.
Transaction Terms and Structure
POZEN has formed a new company, Aralez Pharmaceuticals Inc.
("Aralez"), organized under the laws of British Columbia, Canada. A Canadian
subsidiary of Aralez will merge with Tribute, through a
three-cornered amalgamation in a plan of arrangement, with Tribute
surviving as a wholly-owned subsidiary of Aralez. Similarly, an
indirect U.S. subsidiary of Aralez will merge with POZEN, with
POZEN surviving as an indirect wholly-owned subsidiary of
Aralez. At closing, each share of POZEN common stock will be
converted into the right to receive one Aralez common share and
each common share of Tribute (other than dissenting shares) will be
exchanged for 0.1455 of an Aralez common share. This exchange
ratio remains unchanged from the ratio announced when the parties
initially entered into the agreement and plan of merger. As a
result of the proposed transaction and before giving effect to the
contemplated financing, stockholders of POZEN will own
approximately 64 percent of Aralez and shareholders of Tribute will
own approximately 36 percent of Aralez, in each case prior to
giving effect to any exercise of any outstanding options or
warrants or vesting and delivery of any restricted stock units of
either company after the date hereof. As of December 7, 2015, POZEN had approximately 33.2
million common shares outstanding and 39.3 million fully diluted
shares and Tribute had approximately 126.2 million common shares
outstanding and 163.4 million fully diluted shares. The transaction
is expected to be taxable to the POZEN stockholders. It is a
condition of closing that the common shares of Aralez be approved
for listing on the NASDAQ and conditionally approved on the
TSX.
Additional Information and Where to Find It
INVESTORS AND SECURITYHOLDERS ARE URGED TO READ THE REGISTRATION
STATEMENT ON FORM S-4 AND THE RELATED PRELIMINARY AND DEFINITIVE
PROXY/PROSPECTUS AS THEY CONTAIN IMPORTANT INFORMATION ABOUT
ARALEZ, POZEN, TRIBUTE AND THE PROPOSED TRANSACTION. Investors and
securityholders may obtain free copies of these documents (when
they are available) and other related documents filed with the SEC
at the SEC's web site at www.sec.gov. Investors and
securityholders may obtain free copies of the documents filed by
POZEN and Aralez with the SEC on POZEN's website at www.POZEN.com
under the heading "Investors" and then under the heading "SEC
Filings".
POZEN and Aralez and their respective directors and executive
officers may be deemed participants in the solicitation of proxies
from the stockholders of POZEN and shareholders of Aralez in
connection with the proposed transaction. Information regarding the
special interests, if any, of these directors and executive
officers in the proposed transaction are included in the proxy
statement/prospectus. Additional information regarding the
directors and executive officers of POZEN and Tribute is contained
in their respective Annual Reports on Form 10-K for the year ended
December 31, 2014 filed with the
SEC.
This communication does not constitute an offer to sell, or the
solicitation of an offer to sell, or the solicitation of an offer
to subscribe for or buy, any securities nor shall there be any
sale, issuance or transfer of securities in any jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction.
For full prescribing information refer to the individual product
websites.
About POZEN
POZEN is a specialty pharmaceutical company that has
historically focused on developing novel therapeutics for unmet
medical needs and licensing those products to other pharmaceutical
companies for commercialization. By utilizing a unique in-source
model and focusing on integrated therapies, POZEN has
successfully developed and obtained FDA approval of two
self-invented products. Funded by these milestones/royalty
streams, POZEN has created a portfolio of cost-effective,
evidence-based integrated aspirin therapies designed to enable the
full power of aspirin by reducing its GI damage.
On June 2, 2015, POZEN announced
the formation of Aralez Pharmaceuticals Trading DAC (formerly
"Pozen Limited"), a wholly-owned Irish subsidiary, to expand its
geographic footprint and increase its global presence, including
potential international sales, manufacturing and product
development.
POZEN's common stock is traded under the symbol "POZN" on
The NASDAQ Global Market. For more detailed company
information, including copies of this and other press releases,
please visit www.pozen.com.
About Tribute
Tribute is a specialty pharmaceutical company with a primary
focus on the acquisition, licensing, development and promotion of
healthcare products in Canada and
the U.S. markets.
Tribute markets Cambia® (diclofenac potassium for oral
solution), Bezalip® SR (bezafibrate), Soriatane® (acitretin),
NeoVisc® (1.0% sodium hyaluronate solution) Uracyst® (sodium
chondroitin sulfate solution 2%), Fiorinal®, Fiorinal® C, Visken®,
Viskazide®, Collatamp® G, Durela®, Proferrin®, Iberogast®,
MoviPrep®, Normacol®, Resultz®, Pegalax®, Balanse®, Balanse® Kids,
Diaflor™, Mutaflor®, and Purfem® in the Canadian market.
Additionally, NeoVisc® and Uracyst® are commercially available and
are sold globally through various international partnerships.
Tribute also has the exclusive U.S. rights to Fibricor® and
its related authorized generic. In addition, it has the exclusive
U.S. rights to develop and commercialize Bezalip® SR in the U.S.
and has the exclusive right to sell bilastine, a product licensed
from Faes Farma for the treatment of allergic rhinitis and chronic
idiopathic urticaria (hives), in Canada. The exclusive license is inclusive of
prescription and non-prescription rights for bilastine, as well as
adult and pediatric presentations in Canada. This product is subject to receiving
Canadian regulatory approval. Tribute also has the Canadian rights
to ibSium®, which was approved in Canada in June
2015 and two additional pipeline products including Octasa®
and BedBugz™, both of which are pending submission to Health
Canada.
Tribute's common shares are traded on the TSX Venture Exchange
under the symbol "TRX" and on the OTCQX International under the
symbol "TBUFF". For more detailed company information, including
copies of this and other press releases, please
visit www.tributepharma.com.
Cautionary Language Concerning Forward-Looking
Statements
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995:
This press release contains forward-looking statements under
applicable securities laws, including, but not limited to,
statements related to the anticipated consummation of the business
combination transaction among Aralez, POZEN and Tribute and the
timing and benefits thereof; the combined company's strategy,
plans, objectives, expectations (financial or otherwise) and
intentions, future financial results and growth potential,
competitive position, anticipated product portfolio, development
programs and management structure; the anticipated timing of the
YOSPRALA NDA filing; plans to submit the YOSPRALA NDA using the
previously designated secondary aspirin API supplier as the primary
supplier; the NDA application plan including the submission of both
manufacturers as alternatives; production at the former primary
supplier's manufacturing facility resuming on or before
February 29, 2016; the proposed
listing on the NASDAQ and TSX and other statements that are not
historical facts. These forward-looking statements are based
on POZEN's and Tribute's current assumptions and expectations and
inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
related to the parties' ability to complete the combination and
anticipated equity and debt financings on the proposed terms and
schedule; the combined company meeting the listing requirements on
the NASDAQ and Toronto Stock Exchange; risk that Aralez may be
taxed as a U.S. resident corporation; risks associated with
business combination transactions, such as the risk that the
businesses will not be integrated successfully, that such
integration may be more difficult, time-consuming or costly than
expected or that the expected benefits of the transaction will not
occur; risks related to future opportunities and plans for the
combined company, including uncertainty of the expected financial
performance and results of the combined company following
completion of the proposed transaction; disruption from the
proposed transaction, making it more difficult to conduct business
as usual or maintain relationships with customers, employees or
suppliers; the calculations of, and factors that may impact the
calculations of, the acquisition price in connection with the
proposed merger and the allocation of such acquisition price to the
net assets acquired in accordance with applicable accounting rules
and methodologies; and the possibility that if the combined company
does not achieve the perceived benefits of the proposed transaction
as rapidly or to the extent anticipated by financial analysts or
investors, the market price of the combined company's shares could
decline, as well as other risks related to POZEN's and Tribute's
business, including POZEN's inability to build, acquire or contract
with a sales force of sufficient scale for the commercialization of
YOSPRALA™ in a timely and cost-effective manner, the parties'
failure to successfully commercialize product candidates; costs and
delays in the development and/or FDA approval of the parties'
product candidates (including YOSPRALA), including as a result of
the need to conduct additional studies or due to issues with
third-party manufacturers, or the failure to obtain such approval
of POZEN's or Tribute's product candidates for all expected
indications, including as a result of changes in regulatory
standards or the regulatory environment during the development
period of any of its product candidates; the inability to maintain
or enter into, and the risks resulting from POZEN's dependence
upon, collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and
distribution of any products, including its dependence on
AstraZeneca and Horizon for the sales and marketing of VIMOVO®;
POZEN's dependence on Patheon for the manufacture of YOSPRALA 81/40
and YOSPRALA 325/40; the ability of POZEN and Tribute to protect
their intellectual property and defend their patents; regulatory
obligations and oversight; POZEN's inability to manufacture
products and reliance upon third-party manufacturers to supply it
with product candidates and commercial products, including
YOSPRALA; POZEN's ability to complete the YOSPRALA NDA filing
within the anticipated timeline; the ability of POZEN's third-party
manufacturers to comply with cGMP regulations or other FDA
regulatory requirements; POZEN's ability to qualify the primary or
secondary aspirin API suppliers; the ability of POZEN's now
secondary supplier to resolve the FDA 483 observations and resume
manufacturing operations; delays in obtaining FDA approval of one
or both of POZEN's aspirin API suppliers; the ability of our
contract manufacturers to maintain required regulatory approvals
and those risks detailed from time-to-time under the caption "Risk
Factors" and elsewhere in POZEN's SEC filings and reports,
including in its Annual Report on Form 10-K for the year ended
December 31, 2014 and any subsequent
Quarterly Reports on Form 10-Q, and in Tribute's SEC filings and
reports, including in its Annual Report on Form 10-K for the year
ended December 31, 2014 and any
subsequent Quarterly Reports on Form 10-Q. The parties undertake no
duty or obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or changes in their expectations.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
Contacts:
POZEN Inc.
Bill Hodges,
Chief Financial Officer
919-913-1030
Nichol Ochsner
Executive Director, Investor Relations
& Corporate Communications
919-913-1030
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SOURCE POZEN Inc.