Selten Pharma was founded in 2014 with a focus on developing treatments for rare and life threatening diseases.
Leo Gu: Co-founder, CEO & President
Leo Gu, Ph.D. has over 25 years of experience in biopharmaceutical industries. He previously served as the CEO of Melio and Pharmdel Pharmaceuticals, and has held executive level positions in several startup companies. He began his career at Syntex, and Roche. After Roche, he was a Vice President at IntraBiotics and served as an integral part of the team that helped it list on US public markets. Leo has successfully developed several marketed drugs such as CellCept, including two that had peak sales of over $1B per year, and has over 25 publications and 12 issued patents in drug discovery and delivery. Leo obtained his Ph.D. in organic chemistry from the University of California at Los Angeles.
Narinder S. Banait: Co-founder
Narinder Banait, Ph.D., J.D., has over twenty years of experience as an intellectual property attorney and as a research scientist in the pharmaceutical industry. He has previously served as a partner at Fenwick & West LLP. Narinder¹s experience is with patent preparation and prosecution, developing comprehensive patent portfolio strategies for companies, supporting IP litigation, merger and acquisition, and working with the venture capital community to fund and build life sciences start-up companies. Prior to entering the legal profession, Narinder was a research scientist at Roche and Syntex where he developed drugs for emesis, pain and anxiety disorders. Narinder has a Ph.D. in Organic Chemistry from the University of Toronto, was a post doctoral fellow in enzymology at Brandeis University and in physical organic chemistry at the University of California Santa Barbara and has a J.D. from Santa Clara University School of Law.
Paul C. Nakagaki, PhD., Director
Paul C. Nakagaki, Ph.D., has over twenty-five year’s experience in the pharmaceutical industry first at Syntex and then at Roche. He held such roles as an R&D scientist, project team leader, business development director, and the Head of Research Strategy. His teams directly supported the approval of Toradol® (ketorolac tromethamine) as well as line extensions of CellCept® (mycophenolate mofetil). He moved to Basel, Switzerland in 2000 to lead the Research Strategy group. In this capacity, he was responsible for the creation and implementation of the Research strategy and portfolio strategy. He also managed the Research and Development Committee, responsible for the transitions of projects from Research through Phase 2a. In 2001 and in 2006 he led the work teams for strategic evaluations as to how Roche managed innovation in the Research and Early Development space, culminating with the reorganisation of Roche R&D and the creation of the DBA (Disease Biology Area) model. Following a sabbatical as head of corporate strategy at a non-profit drug development company, Institute for OneWorld Health, Paul returned to Basel to lead Roche’s Group Research Strategy team with a focus on New Innovation Models, including Open Innovation. He most recently is the co-founder of TakeWing LLC, a healthcare consultancy supporting innovation, strategy, and change. Paul has a Ph.D. in organometallic chemistry from the University of Wisconsin and was a post-doctoral fellow in physical organic chemistry at the University of California Santa Barbara. Paul has served on the management board of the University of St. Gallen, RISE (innovation and entrepreneurialism) and on the Board of Directors of iRND3 (non-profit drug discovery).
Sunil Erraballi, CFO (IT/Finance)
Sunil Erraballi, MBA, has over 25 years of experience in the Pharmaceutical and Information Technology industry. He worked for Syntex, was the founder of Frontier Technology, Inc for over a decade and more recently was the Director of IT, Solutions Delivery for Onyx Pharmaceuticals(a subsidiary of Amgen). At Frontier Technology he focused on serving the Information Technology needs of Pharmaceutical clients ranging from Roche, Incyte, Novartis, Genentech and Johnson & Johnson among others. At Syntex he was involved in Drug Development Optimization program. One of the outcomes of this program was the development of the Clinical Drug Product Supply application which was deployed in Palo Alto and Edinburgh. Sunil began his Information technology career as a software engineer at Burroughs Corporation. He received his MBA (Finance) from Xavier Labor Relations Institute, Jamshedpur, India’s premier Management school and undergraduate degree in Accounting from Osmania University.
SAN CARLOS, CA and CAMPBELL, CA., January 9, 2016 - Selten Pharma, LLC. and VIVUS, Inc. (Nasdaq: VVUS) announced VIVUS' acquisition from Selten of exclusive, worldwide rights for the development and commercialization of tacrolimus and ascomycin for the treatment of Pulmonary Arterial Hypertension (PAH) and related vascular diseases. VIVUS assumes all development and commercialization responsibilities.
Selten has assigned VIVUS its license to a family of patents owned by the Board of Trustees of the Leland Stanford Junior University (Stanford) and all rights under a collection of patent applications owned by Selten. The licensed patent family includes U.S. Patent No. 9,474,745 and is directed to methods of using tacrolimus to treat PAH. The assigned patent applications are directed to additional compounds and methods for the treatment of PAH and formulations for tacrolimus. In March 2015, Selten received orphan drug designation for tacrolimus for the treatment of PAH.
VIVUS is responsible for all future financial obligations to Stanford under the Stanford license. Selten will receive an upfront payment, and development and sales milestone payments, as well as tiered royalties on future sales of these compounds.
"Pulmonary Arterial Hypertension is a degenerative disease with current treatment options that only address the symptoms to slow the progression of the disease. We are excited about the potential of tacrolimus and ascomycin to significantly improve the quality of life and life expectancy of PAH patients," said Seth H.Z. Fischer, VIVUS' Chief Executive Officer. "The move into PAH is the latest announcement in our effort to reshape VIVUS to build long-term stockholder value, and we look forward to additional announcements in the future."
"We are excited to partner with VIVUS to strive to bring new therapies to PAH patients who have limited treatment options," said Leo Gu, Ph.D., President and Co-CEO of Selten. "Early compassionate use of the licensed compounds demonstrate potential to go beyond symptom management and impact the progression of disease," he added.
"It has been a pleasure to collaborate with VIVUS on this strategic deal, and we are looking forward to these important therapies being developed and making a difference in patients' lives," said Narinder S. Banait, Ph.D., J.D. General Counsel, and Co-CEO of Selten. "Selten will continue to focus on rare diseases," he added.
About Pulmonary Arterial Hypertension (PAH)
PAH is a chronic life-threatening disease characterized by elevated blood pressure in the pulmonary arteries (arteries between the heart and lungs) due to severe constriction of these blood vessels. These high pressures make it difficult for the heart to pump blood through the lungs to be oxygenated. The symptoms of PAH are non-specific and can range from mild shortness of breath and fatigue during normal daily activity to symptoms of right heart failure and severe restrictions on exercise capacity and ultimately reduced life expectancy. PAH includes patients with idiopathic PAH, familial PAH, and associated PAH, which is related to certain conditions including connective tissue diseases, congenital systemic-to-pulmonary-shunts, portal hypertension, HIV infection, drugs and toxins. The current treatments for PAH involve calcium channel antagonists, prostacyclins, prostacyclin receptor (IP receptor) agonist, endothelin receptor antagonists, phosphodiesterase-5 (PDE5) inhibitors, and long-term anticoagulant therapy, with the aim to reduce symptoms and improve quality of life.
VIVUS is a biopharmaceutical company commercializing Qsymia® (phentermine and topiramate extended-release) capsules CIV for the treatment of obesity. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to potential change in our business strategy to enhance long-term stockholder value; risks and uncertainties related to the timing, strategy and success of the development and commercialization of tacrolimus and ascomycin for the treatment of Pulmonary Arterial Hypertension and related vascular diseases; and risks and uncertainties related to our ability to continue to identify, acquire and develop innovative investigational drug candidates and drugs. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2015 as filed on March 9, 2016 and as amended by the Form 10-K/A filed on April 22, 2016, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.
About Selten Pharma, Inc.
Selten Pharma, LLC. is a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases. The company has drug candidates in various stages of clinical and preclinical development. Selten's pipeline and product development strategy offers the possibility of rapid commercialization with lower risks than typical new chemical entities.
Selten Pharma, LLC.
Sunil Erraballi, CFO
Chief Financial Officer
VIVUS Investor Relations:
The Trout Group