CHAPEL HILL, N.C.--(BUSINESS WIRE)--Sep. 14, 2015-- POZEN Inc. (NASDAQ:POZN), today announced that James P. Tursi, M.D. will be appointed Chief Medical Officer of POZEN, effective October 1, 2015. Dr. Tursi will report to
Adrian Adams, Chief Executive Officer of POZEN, and will be responsible for the oversight of the clinical operations, drug safety, medical and regulatory affairs functions. Dr. Tursi will also become Chief Medical Officer of Aralez Pharmaceuticals upon the anticipated business combination among Aralez, POZEN and Tribute Pharmaceuticals Canada Inc. He will play a critical role in the planned preparation of the re-submission of the YOSPRALA™ New Drug Application (NDA) in the United States, the Marketing Authorization Application (MAA) for YOSPRALA in Europe and the New Drug Submissions (NDS) for YOSPRALA and MT400 to Health Canada. Dr. Tursi will also serve on the executive leadership team. Dr.
John G. Fort will serve as Chief Scientific Advisor until the middle of next year.
"James brings significant depth and expertise managing clinical development programs and medical affairs to POZEN, and will be a valuable member of the leadership team," said
Adrian Adams, Chief Executive Officer of POZEN. "His extensive background and track record in clinical development, regulatory and medical affairs will be invaluable as we advance the YOSPRALA and MT400 regulatory submissions. We welcome James to the team and look forward to his contributions as part of Aralez's transformational strategy to accelerate growth and to drive shareholder value."
James P. Tursi
James Tursi has over 11 years of extensive experience developing pharmaceuticals across a number of therapeutic areas. Most recently he served as Chief Medical Officer of Innocoll AG where he was responsible for managing all clinical research and development, medical affairs and safety activities. Prior to joining Innocoll, Dr. Tursi served as Chief Medical Officer at Auxilium Pharmaceuticals Inc. from 2011 to 2015, where he previously held the position of Vice President of Clinical Research & Development from 2009 to 2011. He was responsible for oversight of clinical and nonclinical development programs, clinical operations, medical affairs and global safety activities. Dr. Tursi served as the clinical medical safety lead for all regulatory agency interactions with the FDA, Europe and Canada. Prior to Auxilium, he served as Director of Medical Affairs for GlaxoSmithKline Biologicals from 2006 to 2009 and directed all medical affairs responsibilities for cervical cancer vaccines in North America. Dr. Tursi entered the pharmaceutical industry in 2004 as a Medical Director for Procter and Gamble Pharmaceuticals until 2006. He worked on several products and therapeutic areas, which included female sexual dysfunction, overactive bladder, and osteoporosis. His responsibilities included clinical development and medical affairs. Dr. Tursi was a board certified OB/GYN and practiced medicine and surgery for over 10 years. Dr. Tursi received his doctor of medicine degree from the Medical College of Pennsylvania and completed his residency training at the Johns Hopkins Hospital. Dr. Tursi serves as a member of the board of directors of Agile Therapeutics.
POZEN Inc. is a specialty pharmaceutical company that to date 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.
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.
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, the planned preparation of the re-submission of the YOSPRALATM New Drug Application (NDA) in the United States, the marketing authorization application (MAA) for YOSPRALA in Europe and the New Drug Submission (NDS) for YOSPRALA and MT400 to Health Canada, and Aralez's transformational strategy to accelerate growth and to drive shareholder value. These forward-looking statements are based on POZEN'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 TSX; 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 our product candidates; costs and delays in the development and/or FDA approval of our 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 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; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in POZEN'sSEC filings and reports, including in its Annual Report on Form 10-K for the year ended December 31, 2014 and Form 10-Q for the quarter ended June 30, 2015 in Tribute's SEC filings and reports, including in its Annual Report on Form 10-K for the year ended December 31, 2014 and Form 10-Q for the quarter ended June 30, 2015 and in the registration statement on Form S-4 filed by Aralez on July 20, 2015, as amended August 19, 2015. We undertake no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or changes in their expectations.
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.
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Source: POZEN Inc.
Bill Hodges, 919-913-1030
Chief Financial Officer
Nichol Ochsner, 919-913-1030
Executive Director, Investor Relations & Corporate Communications