Veru is the new company that is a result of the acquisition of Aspen Park Pharmaceuticals by The Female Health Company.

Veru is a biopharmaceutical company focused on urology and oncology. Veru utilizes FDA’s 505(b)(2) regulatory approval pathway to develop and commercialize drug candidates. FDA’s 505(b)(2) regulatory approval pathway is designed to allow for potentially expedited regulatory approval based on a previously established safety and efficacy profile of the product. Veru is developing products under the 505(b)(1) pathway as well, which is the traditional new drug application (NDA) pathway. The company is currently developing drug product candidates for benign prostatic hyperplasia (BPH or enlarged prostate), hot flashes associated with prostate cancer hormone treatment, male infertility and novel oral chemotherapy (alpha & beta tubulin inhibitor) for a variety of malignancies, including metastatic prostate, breast and ovarian cancers.

Veru markets and sells the FC2 Female Condom® (now available by prescription in the US including through the virtual doctor smartphone app “HeyDoctor” at www.fc2.us.com) and PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product for the prevention of premature ejaculation. The company’s division, The Female Health Company, is focused on the global public health sector FC2 business. This division markets the company’s Female Condom (FC2) to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world.

We’re

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Veru Inc.’s mission is to improve lives through innovative science and medicine as a leading biopharmaceutical company focused on urology and oncology, while enhancing stakeholder value.

Management Team

Mitchell S. Steiner, M.D., F.A.C.S. has served as President and Chief Executive Officer of the Company and as a director of the Company since October 2016. Dr. Steiner was the co-founder of Aspen Park and served as Aspen Park’s Chief Executive Officer, President and Vice Chairman of the Board from July 2014 to October 2016. From 2014 to 2016, Dr. Steiner was a consultant and then the President, Urology and member of senior management of OPKO Health, Inc. (NYSE:OPK) and had responsibilities for the launch, marketing, sales and reimbursement of 4Kscore prostate cancer test to urologists and primary care physicians. Dr. Steiner was also the co-founder of GTx, Inc., a men’s health and oncology public company, where he served as Chief Executive Officer and Vice Chairman of Board of Directors from 1997 to 2014. Dr. Steiner is a Board Certified Urologist and a Fellow of the American College of Surgeons and has held numerous academic appointments, including Assistant Professor of Urology, Cell Biology, and Pathology at Vanderbilt School of Medicine from 1993 to 1995 and Chairman and Professor of Urology, Director of Urologic Oncology and Research and the Chair of Excellence in Urologic Oncology at the University of Tennessee from 1995 to 2004. Dr. Steiner holds a B.A. in Molecular Biology and Chemistry from Vanderbilt University and an M.D. from the University of Tennessee. He performed his surgical and urologic training at The Johns Hopkins Hospital and postdoctoral research fellow in cell biology at Vanderbilt School of Medicine.

Dr. Harry FischHarry Fisch, M.D., F.A.C.S. has served as a director of the Company since October 2016. Dr. Fisch was the co-founder of Aspen Park and served as the Chairman of the Board and Chief Scientific Officer of Aspen Park from July 2014 to October 2016. From 1994 to 2016, Dr. Fisch served as the Chief Executive Officer and President of Millennium Sciences, Inc. Dr. Fisch has also had numerous academic and clinical appointments including Clinical Professor of Urology and Reproductive Medicine at Weill College of Medicine, Cornell University from 2009 to 2016, Director of the Male Reproductive Center at Albert Einstein College of Medicine/Montefiore Medical Center from 1998 to 1999 and Professor of Clinical Urology at Columbia University, College of Physicians and Surgeons from 1999 to 2009. From 2014 to 2015, Dr. Fisch hosted The Dr. Harry Fisch Show on Men’s Health on Howard Stern’s SiriusXM radio channel 101. Dr. Fisch is a Board Certified Urologist and a Fellow of the American College of Surgeons. Dr. Fisch holds a B.A. in Chemistry from the State University of New York at Binghamton, an M.D. from Mount Sinai School of Medicine, New York, and performed his surgical and urologic training at Albert Einstein College of Medicine/Montefiore Medical Center.

K. Gary Barnette, Ph.D. is the Chief Scientific Officer of the Company. Prior to joining Veru, Dr. Barnette was Sr. Vice President of Scientific and Regulatory Affairs at Camargo Pharmaceutical Services, LLC from 2012 to August 2018 and had responsibility of the oversight and development of scientific and regulatory drug development strategies across virtually all therapeutic areas, including urology, reproductive, oncology, cardiovascular, and analgesics/anesthetics. From 2000 to 2012, Dr. Barnette served in various positions at GTx, Inc. including Vice President, Clinical Development Strategy with responsibilities in regulatory, clinical, and clinical pharmacology in the development of drug products in urology (men’s health) and cancer supportive care. Prior to that, Dr. Barnette was a Clinical Pharmacology and Biopharmaceutics Reviewer at the US FDA, receiving numerous awards for review, mentoring, and serving on various FDA guidance development groups and FDA initiative task forces. Dr. Barnette holds a Ph.D. in Basic Pharmaceutical Sciences (Clinical Pharmacology and Pharmacokinetics) from West Virginia University, School of Pharmacy.

Mr. Gilbert has served as Senior Vice President Corporate Development and Legal since January 2017.   From 2015 to 2016, Mr. Gilbert was a consultant to the Company’s Board and CEO and charged with assisting the diversification strategy.  From 2012 to 2015 Mr. Gilbert was Vice President Corporate Development and General Counsel of Third Stream Bioscience Inc., a developer of a novel, topical antimicrobial technology.  From 2008 to 2012, Mr. Gilbert was Executive Vice President Development and General Counsel of NanoCarbons LLC, a developer of nanomaterials for the energy storage industry.  Prior to 2008, Mr. Gilbert worked nearly 20 years in a variety of officer roles in development and legal at Motorola Inc. and prior to that, Mr. Gilbert was a transactional and securities attorney at the large, multinational law firm, McDermott, Will & Emery.  Mr. Gilbert has successfully completed more than 100 different transactions in more than 25 different countries around the world, including a number of complex, cross-border transactions.  Mr. Gilbert holds a Bachelors of Science in Accountancy from the University of Illinois at Urbana-Champaign and a Juris Doctor from the University of California at Berkeley and has been a Guest Lecturer on Mergers & Acquisitions at the UCLA Anderson Graduate Business School as well as the Purdue University Krannert Graduate Business School.

Dr. Gosnell has served as Senior Vice President of Manufacturing, Preclinical and Pharmaceutical Development since February 2017. Dr. Gosnell has a Ph.D. in analytical chemistry and more than 30 years of experience in pharmaceutical manufacturing, development and sourcing. Dr. Gosnell has made significant contributions to several 505(b)(2) and 505(b)(1) NDAs including Celebrex®, Inspra®, Risperdal® Consta® and Vivitrol®. Prior to joining the Company, Dr. Gosnell served as Senior Director, Product Development and Analytical Sciences for GTx, Inc., where he advanced multiple drug candidates into successive clinical stages of development.  Earlier in his career, he was Director, Quality Technical Services (Analytical Development and Stability) for Alkermes, Inc., Analytical Team Leader for Pharmacia Research and Development and Senior Scientist at McNeil Specialty Products Company.  Dr. Gosnell began his career as Scientist with Miles, Inc., after earning a Doctoral degree in Analytical Chemistry from Oklahoma State University and a Bachelor of Science degree in Chemistry and Mathematics-Computer Science from Manchester College.

Ms. Greco has served as Chief Financial Officer and Chief Administrative Officer of the Company since October 2016. Ms. Greco served as Executive Vice President and Chief Financial Officer of The Female Health Company from December 2014 to October 2016 and served as Vice President and Chief Financial Officer of the Company from January 2013 to December 2014. Ms. Greco is a CPA with nearly 30 years of experience in public accounting with Ernst & Young LLP. From January 2011 to February 2012, Ms. Greco provided consulting services to Systems Research Incorporated as a recruiter of finance professionals. From March 2009 to January 2011, Ms. Greco was involved in a series of personal business ventures. From 1994 to March 2009, Ms. Greco served as an audit partner with Ernst & Young LLP. Ms. Greco joined Ernst & Young LLP in 1981.

Mr. Tayler has served as Executive Vice President of Global Operations of the Company since October 2016. Mr. Tayler served as Executive Vice President of Global Operations of The Female Health Company from December 2014 to October 2016 and served as Executive Vice President of Operations of the Company from September 2014 to December 2014. From July 2013 to September 2014, Mr. Tayler provided manufacturing and quality management consulting services in Asia as the owner of Lean Manufacturing Limited. From April 2009 to April 2012, Mr. Tayler served as Operations Director of Qingdao London Durex Company, a subsidiary of Reckitt Benckiser Group plc, a consumer health and hygiene company. Prior to its acquisition by Reckitt Benckiser Group, Mr. Tayler served in a variety of operations leadership positions with SSL International PLC, a manufacturer of healthcare products, for approximately eight years, most recently as Project Director of Qingdao London Durex Company from August 2007 to March 2009.

Mr. Kuhn joined Veru in January 2018. He is responsible for leading the company’s licensing and strategy execution. Mr. Kuhn’s thirty years of experience in commercial and strategy work for leading biologics, diagnostics, and device manufacturers have prepared him well for leading Veru’s strategy efforts.

During Mr. Kuhn’s career he has had the opportunity to lead sales, marketing, and strategy activities on a global basis for a number firms including Abbott, Johnson & Johnson, Boston Scientific, Smith & Nephew, Orthofix, and most recently ISTO Biologics. Prior to joining the Company, Mr. Kuhn served as the Chief Commercial Officer for Isto Biologics where he engineered the successful turnaround and sale of the commercial business to private equity. Earlier in is his career Mr. Kuhn held senior roles as Global Vice President Marketing at Orthofix and Smith & Nephew. In addition, Mr. Kuhn held roles as Director Marketing Peripheral Vascular Stents, and Director Marketing Indigo Medical (a JNJ Urology focused division).

Mr. Kuhn has a BA degree from Duke University and an MBA from Emory University.

Denise van DijkAs President of the Female Health Company, the global public sector division of Veru, Denise acts as the main liaison for ministries of health all over the world, large multilateral donors such as UNFPA and USAID and CBOs, NGOs and INGOs globally. Denise leads a team of business development managers, master trainers, project- and communication managers to install sustainable and context specific FC2 female condom education and distribution programs worldwide.  Half Dutch, half American: Denise is an accomplished professional with over 10 years of experience in market development and the designing, implementing, and monitoring / evaluation of global and community development programs focusing in particular on SRHR. Denise has extensive international experience in Africa, Latin America, North America  and Asia cultivating an exceptional ability to create partnerships with corporate/private partners, local NGOs, civil society groups and all levels of government. Denise specializes in public private partnerships and  sustainable PPP programming. She has worked with a diverse network of partners, including USAID, UNFPA, UNHCR, Dutch Ministry of Foreign Affairs, Ministries of Health and Education and other multilateral agencies in Africa, Latin America and Asia. She has worked in 38 countries worldwide and speaks 5 languages. Denise Holds a BA in Social Sciences and an MPhil in Development Studies from the University of Cambridge.