Pozen, Inc. (MM)【POZN】株式ニュース

POZEN Announces Effectiveness Of Aralez Registration Statement On Form S-4 And Provides Update On Key Milestones For 2016 (12/28/15)

-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.

http://www.prnewswire.com/news-releases/pozen-announces-effectiveness-of-aralez-registration-statement-on-form-s-4-and-provides-update-on-key-milestones-for-2016-300197149.html

POZEN Reports Fourth Quarter & Year End 2013 Results

Company Confirms Strategic Goals of Maximizing Shareholder Value, Expense Control and Returning Excess Cash to Shareholders

http://finance.yahoo.com/news/pozen-reports-fourth-quarter-end-123000636.html

CHAPEL HILL, N.C.--(BUSINESS WIRE)--

POZEN Inc. (POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the fourth quarter and year ended December 31, 2013.

2013 and Recent Corporate Highlights

• In September 2013, POZEN and Sanofi US announced the signing of an exclusive license agreement for the commercialization of PA8140/PA32540. Under the terms of the agreement, Sanofi US will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN received an upfront payment of $15 million and will be eligible for pre-commercial milestone payments of up to $20 million and other future milestone payments and royalties on product sales. Sanofi US has responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. POZEN retains responsibility for obtaining approval of the NDA, after which time POZEN will transfer the NDA to Sanofi US.

• In November 2013, AstraZeneca AB and Horizon Pharma USA, Inc. (HZNP) announced that they entered into an agreement for Horizon to acquire the U.S. rights for VIMOVO® (naproxen / esomeprazole magnesium) delayed release tablets. Under the terms of the agreement, POZEN will continue to receive a 10% royalty on net sales of products sold in the United States, with guaranteed annual minimum royalty payments of $5 million in 2014, and $7.5 million each year thereafter, provided that the patents owned by POZEN which cover VIMOVO are in effect and no generic forms of VIMOVO are on the market. Also under the agreement, Horizon has assumed AstraZeneca’s right to lead the on-going Paragraph IV litigation for VIMOVO and will assume all patent-related defense costs relating to such litigation, including reimbursement for a specified amount of the cost of counsel retained by POZEN. AstraZeneca will continue to have rights to commercialize VIMOVO outside of the United States.

• The POZEN Board of Directors declared a special cash distribution of $1.75 per share to all stockholders of record as of the close of business on December 11, 2013, and payment was made on December 30, 2013. This distribution represented a surplus of corporate cash and was treated as a return of capital to stockholders.

• Results from POZEN’s Phase 1 study, PA10040-101, demonstrated that PA10040, POZEN’s proprietary combination of aspirin (100 mg) and omeprazole (40 mg), had comparable bioavailability, and is bioequivalent to a European Union (E.U.) reference listed enteric-coated (EC) aspirin (100 mg). The 100 mg dose of aspirin is most commonly used in Europe and in other ex-U.S. regions.

• Q4 2013 global net sales of VIMOVO by AstraZeneca, as defined under our agreement, were $25 million, up 36% vs. Q4 2012 and up 9% from Q3 2013. POZEN earned a royalty of $1.7 million in Q4 2013. Total 2013 net sales of VIMOVO were $91 million, up 42% from 2012, and POZEN earned a royalty of $6.3 million, up 30% year on year. We anticipate continued growth in VIMOVO sales and royalties this year.

Fourth Quarter Results

For the fourth quarter of 2013, POZEN reported total revenue of $4.7 million, resulting from $1.7 million VIMOVO royalty and $3.0 million from the amortization of the $15 million upfront fee for the licensing of PA. The upfront payment is being amortized over fifteen months starting in September 2013. For the fourth quarter of 2012, the Company reported total revenue of $1.4 million of VIMOVO royalty.

Operating expenses for the fourth quarter of 2013 totaled $6.9 million, as compared to $7.5 million for the comparable period in 2012. The decrease in operating expenses in the fourth quarter of 2013 was primarily a result of lower development and pre-commercialization costs for PA.

The Company reported a net loss of $(2.2) million, or $(0.07) loss per share for the fourth quarter of 2013, compared to net loss of $(6.1) million, or $(0.20) per share on a diluted basis, for the fourth quarter of 2012.

Twelve Month Results

For the twelve months ended December 31, 2013, POZEN reported revenue of $10.3 million compared to $5.3 million in 2012, up 93% year over year. The 2013 revenue is comprised of $6.3 million royalty revenue from sales of VIMOVO and $4.0 million amortization of the PA upfront licensing fee. The 2012 revenue is primarily royalty revenue from sales of VIMOVO.

Operating expenses for the twelve months ended December 31, 2013 were $27.1 million compared to $30.9 million in the same period in 2012. The decrease in operating expenses was primarily a result of lower PA32540 development and pre-commercialization costs, partially offset by PA deal related costs and higher intellectual property litigation costs.

For the full year of 2013, the Company reported a net loss of $(16.7) million, or $(0.55) per share compared to net loss of $(25.3) million, or $(0.84) per share on a diluted basis, for the same period in 2012.

Balance Sheet

At December 31, 2013, cash and cash equivalents totaled $32.8 million, after payment of the $53.6 million distribution on December 30, 2013.

2014 Strategic Direction

The Company was pleased to return $1.75 per share of surplus corporate cash to shareholders in 2013. For 2014, the Company’s areas of strategic focus are: obtaining FDA approval for PA8140/PA32540; transitioning all licensed know-how relating to PA8140/PA32540 in the United States and fulfilling all contractual obligations to Sanofi US; completing study PA10040-102, an additional Phase 1 pharmacodynamics study; preparing the regulatory filing document for PA product candidates in the European Union; finding partners for the PA asset in ex-U.S. territories; and controlling expenses. As part of controlling expenses, we have reduced our R&D staff and other costs and in the future will continue to reduce staff not required to support our ongoing business activities. Our board of directors and management team continue to explore potential ways to return value to our shareholders, including future cash distributions when we accumulate surplus cash as a result of receiving milestones and royalties from our commercial partners.

Fourth Quarter Results Webcast

POZEN will host a webcast to present fourth quarter and year end 2013 results and management’s outlook on Wednesday, March 5, 2014 at 11:00 a.m. (ET). The webcast can be accessed live and will be available for replay at www.pozen.com.

About POZEN

POZEN Inc. is a small pharmaceutical company that specializes in 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 in two years. 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.

POZEN is currently seeking strategic partners to help maximize the opportunities for its portfolio assets.

The Company'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 PA

POZEN has created a portfolio of investigational integrated aspirin therapies - the PA product platform. The products in the PA portfolio are being developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.

The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

Proposed PA8140/PA32540 Indications and Usage (Pending FDA Review and Approval)

PA8140/PA32540 Tablets contain 81 mg or 325 mg delayed release aspirin and 40 mg immediate-release omeprazole and are indicated for patients who require aspirin (1) to reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, (2) to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, (3) to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris, (4) in patients who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers.

Controlled studies with PA8140/PA32540 Tablets do not extend beyond 6 months.

About VIMOVO

VIMOVO® (naproxen / esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.