Furiex Pharmaceuticals, Inc.

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Tenax Therapeutics (Formerly Known As Oxygen Biotherapeutics, Inc.), Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced the appointment of four new members to its board of directors: June Almenoff, MD, PhD, Michael Davidson, MD, Delcan Doogan, MD, and Stuart Rich, MD. “We are thrilled to welcome June, Michael, Declan and Stuart to our Board of Directors,” said Anthony DiTonno, Chief Executive Officer of Tenax Therapeutics. “Together, these highly accomplished professionals will provide the Board with significant scientific and commercial perspectives that will prove invaluable as we execute on our long-term corporate strategy. Over the next several months, we expect to advance our two leading pipeline assets into late-stage clinical testing, so the expansion of our board to include such expertise from both the medical community and the pharmaceutical industry could not come at a better time for our company and our shareholders.” The Tenax pipeline includes two de-risked, Phase 3 ready drug candidates: (1) a reformulation of imatinib for the treatment of pulmonary arterial hypertension (WHO Group 1) with the potential to be the first disease modifying treatment for this indication, and (2) an oral formulation of levosimendan for the treatment of pulmonary hypertension (WHO Group 2), recently in-licensed from Orion. Intravenous Levosimendanwas already approved by the EMA in 2002 for treatment of acute heart failure. About New Board Members Dr. Almenoff is an accomplished biopharma executive with over 20 years of senior leadership experience. She served as President and Chief Medical Officer of Furiex Pharmaceuticals, which was acquired by Actavis plc (now AbbVie) for $1.2B. Furiex developed eluxadoline (Viberzi®), which is approved in both the United States and Europe. Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK) for 12 years, where she held various positions of increasing responsibility. She was a Vice President in the Clinical Safety Organization, chaired a PhRMA-FDA working group, and worked in the area of scientific licensing. Dr. Almenoff also led the development of pioneering systems for minimizing risk in drug development, which have been widely adopted by industry and regulators. Dr. Almenoff led or contributed to numerous regulatory submissions and product approvals. She is currently Chief Scientific Officer of RedHill Biopharma (Nasdaq: RDHL). She also serves on the investment advisory board of the Harrington Discovery Institute and the boards of Brainstorm Cell Therapeutics (Nasdaq: BCLI) and Kurome Therapeutics. Dr. Almenoff has strong expertise in translational medicine, clinical development, commercial strategy, and business development, and has previously advised biotech boards and management in these areas. . Dr. Almenoff received her B.A. cum laude from Smith College and graduated with AOA honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center and served on the faculty of Duke University School of Medicine. She is an adjunct professor at Duke, a Fellow of the American College of Physicians (FACP) and has authored close to 60 publications. Dr. Michael Davidson was the Founder and former Chief Scientific Officer of Corvidia Therapeutics, which was recently acquired by Novo-Nordisk for $2.1 billion. Dr. Davidson also serves as Clinical Professor and Director of the Lipid Clinic at the University of Chicago Pritzker School of Medicine. He is a leading expert in the field of Lipidology and was named in The Best Doctors in America for the past 10 years. Dr. Davidson was the co-founding Chief Medical Officer of Omthera Pharmaceuticals in 2008, which was later acquired by Astra Zeneca Pharmaceutical in 2013 for $443M. He also founded the Chicago Center for Clinical Research, which became the largest investigator site in the United States and was acquired by Pharmaceutical Product Development in 1996. His research background encompasses both pharmaceutical and nutritional clinical trials including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids. Dr. Davidson is board-certified in internal medicine, cardiology, and clinical lipidology and served as President of the National Lipid Association from 2010 to 2011. He received his BA/MS from Northwestern University and MD from The Ohio State University School of Medicine. Dr. Declan Doogan has over 30 years of industry experience in both major pharma and biotech. He was the Senior Vice President and Head of Worldwide Development at Pfizer, where many multibillion-dollar programs were delivered (e.g., Viagra, Lipitor and Zoloft). He has held a number of executive positions in Pfizer in the U.S., the U.K. and Japan. Since leaving Pfizer in 2007 he has been engaged in executive roles in small pharma. Declan was CMO and acting CEO of Amarin (AMRN: Nasdaq), transforming it from a failing neuroscience company to a vibrant cardiovascular company with a market capitalization of over one billion dollars before his departure. He is Chairman and co-founder of Biohaven (BHVN:NYSE) and an investor in emerging biotechnology and technology companies. He holds a number of Board appointments, principally in pharma companies, and is also a visiting professor at Glasgow University Medical School. Dr. Doogan received his medical degree from Glasgow University in 1975. He is a Fellow of the Royal College of Physicians and the Faculty Pharmaceutical Medicine and holds a Doctorate of Science at the University of Kent in the U.K. Dr. Stuart Rich joined the Company as Chief Medical Officer in 2021 from PHPrecisionMed (PHPM), where he was a co-founder and held the positions of Chief Executive Officer and Director from October 2018 until January 2021. Prior to PHPM, Dr. Rich served as the Chief Medical Officer (part-time) of United Therapeutics from October 2003 until December 2004. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine and as senior faculty of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. Dr. Rich was co-founder of the Pulmonary Vascular Research Institute and a member of the Board of Trustees, a U.K. based charity, and a member of the Board of Directors of the Cardiovascular Medical and Research Foundation, a U.S. based charity. Prior to Northwestern University, Dr. Rich was the Professor of Medicine and Chief of the Section of Cardiology at the University of Illinois College of Medicine in Chicago from July 1980 until July 1996, was Professor of Medicine at the Rush Heart Institute of the Rush University School of Medicine from July 1996 until September 2004, and was Professor of Medicine at the Section of Cardiology of the University of Chicago Pritzker School of Medicine from September 2004 until July 2015. Dr. Rich received his B.S. in Biology at the University of Illinois and his M.D. at Loyola University Stritch School of Medicine, and he completed his residency in medicine at the Washington University of St. Louis and his fellowship in cardiology at the University of Chicago. About Tenax Therapeutics Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit . About Levosimendan Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc. About Imatinib Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval. Caution Regarding Forward-Looking Statements This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. View source version on businesswire.com:

DUBLIN, July 1, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has completed the acquisition of Forest Laboratories, Inc. (NYSE: FRX) in a cash and equity transaction currently valued at approximately $28 billion. The combination creates one of the world's fastest-growing specialty pharmaceutical companies, with annual revenues of more than $15 billion anticipated for 2015. To view the multimedia assets associated with this release, please click: In conjunction with the close of the acquisition, Paul Bisaro, formerly Chairman and CEO of Actavis, has been named to the position of Executive Chairman of Actavis; Brent Saunders, formerly CEO and President of Forest, has been named CEO and President of Actavis; Robert Stewart, formerly President, Global Operations for Actavis, has been named Chief Operating Officer; Bill Meury, formerly Executive Vice President, Sales and Marketing for Forest, has been named Executive Vice President Commercial, North American Brands; and David Buchen, formerly Actavis' Chief Legal Officer, has been named Executive Vice President Commercial, North American Generics and International. "The combination of Actavis and Forest creates an innovative new model for success in the global specialty pharmaceutical industry, built to compete within today's evolving healthcare landscape," said Brent Saunders, CEO and President of Actavis. "Our business model is driven by a broad portfolio of strong brand, generic and OTC products, a commitment to development-focused, results oriented research and development and the size and scale needed to efficiently and cost-effectively meet the needs of our global customer base. The new Actavis is uniquely positioned to deliver exceptional long-term financial performance and expand access to pharmaceutical products for patients around the world. "Actavis' best-in-class commercial engine is powered by a specialty brand business that is now positioned to compete with the world's leading pharmaceutical companies, marketing more than 35 products across seven therapeutic market segments and maintaining blockbuster product franchises in five therapeutic categories, as well as a global generics business that remains an industry powerhouse, with operations in approximately 60 countries and a top 10 position in more than 25 markets across the world," Saunders added. Supported by our strong commitment to research and development of more than $1 billion annually, as well as our industry-leading global supply chain powered by generic DNA, focused on efficient and cost-effective delivery of the highest quality products with the highest level of customer service, we are positioned to drive continued long-term growth and value for our shareholders, customers and employees. With the acquisition now complete, we will immediately begin executing on our comprehensive integration plans to ensure we are leveraging our strengthened global organization to generate sustainable organic earnings growth from our newly expanded base." Financially Compelling Transaction Actavis continues to expect the transaction to generate double-digit accretion in 2015 and 2016, including approximately $1 billion in operating and tax synergies to be realized within three years following the close. These synergies exclude any additional revenue or manufacturing synergies, and are in addition to standalone synergies announced publicly by Forest as part of its Project Rejuvenate and acquisition of Aptalis. Actavis further expects to generate strong operating cash flow in excess of $4 billion on a pro forma basis for 2015, which would enable the Company to rapidly de-lever the balance sheet. Review of the Benefits of the Acquisition The combination of Actavis and Forest creates a new breed of specialty pharmaceutical company, with size and scale, a balanced offering of strong brands and generics, a focus on strategic, lower-risk drug development and a flexible, scalable business model that permits it to adapt quickly to ever-changing industry dynamics and drive sustainable, long-term organic growth. The combined Company begins operations with a defined global management structure, led by a combination of Actavis and Forest senior executives, which has been built to leverage the unique talents across the organization and capitalize on global growth opportunities. Dramatically Strengthens Actavis' Specialty Brands Business The close of the transaction creates a world-class specialty brands business competing across multiple market segments. On a pro forma combined basis for full year 2014, Actavis' brand pharmaceutical business now includes an approximately $2 billion revenue CNS franchise; Gastroenterology (GI) and Women's Health franchises valued at approximately $1 billion in revenue each; a Cardiovascular franchise that generates approximately $500 million in revenue; and Urology and Dermatology/Established Brand franchises approaching $500 million a year in revenue each; as well as emerging and sustainable portfolios in the Infectious Disease and Respiratory therapeutic categories. Delivers an Industry-Leading North American Sales and Marketing Organization The combined company's North American sales force has extraordinary marketing reach, with exceptional strength among primary care physicians, gastroenterologists, psychiatrists, cardiologists, neurologists and infectious disease specialists, in addition to its focus on OBGyn's, urologists, gastroenterologists and dermatologists. Using its innovative line-call strategy, the sales force is strongly positioned to leverage select products in the legacy Actavis Specialty Brands portfolio to the broader primary care physician base in the United States. Actavis is committed to using smart, focused promotion and a customer-focused sales culture to drive continued growth and ensure all of the Company's products achieve their full potential. Further Expands Actavis' Development-Focused Brand and Generic Pipeline The new Actavis has one of the strongest development-focused R&D organizations in the pharmaceutical industry, with an emphasis on strategic, innovative development of important durable products that will drive long-term value, and on being the partner of choice for new and existing development collaborations. The transaction strengthens Actavis' specialty brands pipeline, with more than 25 products in the near- or mid-term stage of development, including new exclusive product opportunities as well as a robust portfolio of next generation products. Actavis' innovative specialty brands pipeline now includes 16 product candidates at the Phase III or NDA stages of development, including treatments for Alzheimer's disease, cardiovascular disease, infectious disease, as well as treatments for Schizophrenia and bipolar disorders, treatments for COPD and an array of Women's Health conditions. The pending acquisition of Furiex Pharmaceuticals, Inc. is expected to further strengthen the pipeline, with Furiex's lead development product eluxadoline complementing the Linzess® and Asacol®/Delzicol® franchises to enhance Actavis' world-class GI business. The Company's investment in the development of innovative brand products is complemented by Actavis' unwavering commitment to invest in its best-in-class generic product development organization, which is a leader in the industry with approximately 220 Abbreviated New Drug Applications (ANDAs) currently filed in the United States, 60 of which are believed to be confirmed as new first-to- and more than 750 filings across the globe. Actavis has taken significant steps to dramatically enhance its development of generic injectable and inhalation products, and continues to focus on complementing its pipeline of solid oral dosage products with more complex modified-release and other dosage forms. Senior Leadership Team Built to Maximize Global Generic, Brand Opportunities Actavis' new senior management structure brings exceptional pharmaceutical talent that was available from both organizations to drive growth across the larger and more complex combined business. The leadership organization is structured to leverage the unique talents of the executive team across the organization to capitalize on global brand and generic growth opportunities, and to continue its focus on generating long-term, organic double-digit earnings growth. August 5th Conference Call and Webcast Information Actavis plans to more fully discuss the acquisition as part of its second quarter earnings conference call scheduled for August 5, 2014 at 8:30 a.m. Eastern Time. The dial-in number to access the call is U.S./Canada 877-251-7980, or from international locations, 706-643-1573. The Conference ID is 65351447. A taped replay of the conference call will also be available beginning approximately two hours after the call's conclusion and will remain available through 12:00 midnight Eastern Time on August 19, 2014. The replay may be accessed by dialing 855-859-2056 and entering Conference ID# 65351447. From international locations, the replay may be accessed by dialing 404-537-3406 and entering the same pass code. To access the webcast, go to Actavis' Investor Relations Web site at . A replay of the webcast will also be available. About Actavis Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world. Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world. For more information, visit Actavis' website at . Forward-Looking Statement Statements contained in this press release that refer to Actavis' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. For instance, any statements in this press release concerning prospects related to Actavis' strategic initiatives, product introductions and anticipated financial performance are forward-looking statements. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actavis' performance, at times, will differ from its goals and expectations. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the inherent uncertainty associated with financial projections; successful integration of the Forest acquisition and the ability to recognize the anticipated synergies and benefits of the Forest acquisition; the difficulty of predicting the timing and outcome of pending or future litigation and government investigations and risks that an adverse outcome in such litigation or investigations could render Actavis liable for substantial damages or penalties; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities or agencies; the impact of competitive products and pricing; risks related to fluctuations in foreign currency exchange rates; periodic dependence on a small number of products for a material source of net revenue or income; variability of trade buying patterns; changes in generally accepted accounting principles; risks that the carrying values of assets may be negatively impacted by future events and circumstances; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; risks and uncertainties normally incident to the pharmaceutical industry, including product liability claims and the availability of product liability insurance on reasonable terms; market acceptance of and continued demand for Actavis' products; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Actavis' facilities, products and/or businesses; changes in the laws and regulations, including Medicare, Medicaid, and similar laws in foreign countries affecting, among other things, pricing and reimbursement of pharmaceutical products and the settlement of patent litigation; and such other risks and uncertainties detailed in Actavis plc's periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on Form 10-K for the year ended December 31, 2013, Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 and Current Report on form 8-K filed on May 20, 2014 and from time to time in Actavis' other investor communications. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.CONTACTS: Investors: Lisa DeFrancesco (862) 261-7152 Media: Charlie Mayr (862) 261-8030 David Belian (862) 261-8141 To view the multimedia assets associated with this release, please click: SOURCE Actavis plc Help employers find you! Check out all the jobs and post your resume.

WILMINGTON, N.C.--(BUSINESS WIRE)--PPD, Inc. (Nasdaq: PPDI) today announced its wholly-owned subsidiary, Furiex Pharmaceuticals, Inc., filed a Form 10 registration statement with the Securities and Exchange Commission, or SEC, in connection with its previously announced spin-off. The filing is an important milestone toward completing the spin-off of its compound partnering business into Furiex Pharmaceuticals as an independent, publicly traded company.