Veru Inc. – Our Strategy
Veru is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. We are disease focused with a focus on providing care for prostate cancer patients. Prostate cancer has become a chronic disease with new challenges as prostate cancer develops resistance to current drugs and spreads throughout the body and as the patient suffers from the long-term side effects of these cancer treatments like hot flashes, bone loss and fractures, loss of libido, erectile dysfunction, loss of muscle strength and frailty. Accordingly, we are dedicated to the development and commercialization of products to address unmet medical needs for prostate cancer treatment and supportive care of prostate cancer. We are developing a pipeline of novel prostate cancer and prostate cancer supportive care medicines as well as urology focused specialty pharmaceuticals while continuing to sell our commercial products to help fund part of this development. Key elements of our strategy are as follows:
Develop and launch high value, novel biopharmaceutical products for prostate cancer and prostate cancer supportive care.
Our prostate cancer pipeline includes VERU-111, VERU-100 and zuclomiphene citrate, each of which addresses large potential markets relating to prostate cancer and prostate cancer supportive care. The potential U.S. market for oral cancer therapies in advanced prostate cancer is over $5 billion1. Recently we announced positive results from the fully enrolled but ongoing Phase 1b portion of the Phase 1b/2 VERU-111 trial for prostate cancer. In the Phase 1b portion of the trial, safety was demonstrated with no evidence of neutropenia or neurotoxicity and evidence of antitumor activity with durable PSA declines and some imaging evidence of tumor regression. The Phase 2 portion of the trial, which is currently enrolling, targets men who have metastatic castration resistant prostate cancer and who have also become resistant to novel androgen blocking agents, such as abiraterone or enzalutamide, but prior to proceeding to IV chemotherapy — also referred to as the prechemotherapy stage.
VERU-100 is a novel, proprietary peptide formulation for ADT with multiple potential beneficial clinical attributes addressing the shortfalls of current FDA-approved ADT formulations for the treatment of advanced prostate cancer. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist designed to be administered as a small volume subcutaneous 3-month depot injection without a loading dose. VERU-100 should immediately suppress testosterone with no testosterone surge upon initial or repeated administration—a problem which occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonists commercially approved beyond a one-month injection. VERU-100 is anticipated to enter a Phase 2 dose-finding study with a potential start date in the third quarter of calendar year 2020. The global market for ADT was $2.6 billion in 20182.
Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist that has successfully completed a Phase 2 trial (Stage 1 testing placebo, Zuclomiphene 10mg, and Zuclomiphene 50 mg) to treat hot flashes, a common side effect caused by androgen deprivation therapy (ADT) in men with advanced prostate cancer. Following an End of Phase 2 meeting with the FDA, we plan to advance zuclomiphene citrate to a Phase 3 clinical trial in men with advanced prostate cancer who experience moderate to severe hot flashes. ADT-induced hot flashes affect approximately 600,000 men in the U.S., representing estimated annual sales of $600-800 million for zuclomiphene in the U.S. alone.
Advance specialty pharmaceutical urology drugs that require only bioequivalence studies by taking advantage of information obtained in previous safety and efficacy studies conducted by other parties.
Veru is also advancing new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology such as TADFIN® for the administration of tadalafil 5mg and finasteride 5mg combination formulation dosed daily to treat lower urinary tract symptoms caused from BPH. Tadalafil (CIALIS®) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment BPH (finasteride 5mg PROSCAR®) and male pattern hair loss (finasteride 1mg PROPECIA®). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than by finasteride alone. The Company had a successful pre-NDA meeting with the FDA and expects to submit the NDA for TADFIN® in the fourth quarter of calendar year 2020 or early 2021.
Grow our commercial and public sector business.
Our commercial products include FC2, an FDA-approved product for the dual protection against unintended pregnancy and sexually transmitted infections, and the PREBOOST® 4% benzocaine medicated individual wipe for the treatment of premature ejaculation. Our Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the U.S. and globally. We are rapidly growing revenues in the U.S. market through prescription sales by utilizing our relationships with telemedicine and pharmacy internet providers and distributors, while continuing to pursue revenues in the public sector in key markets both in the U.S. and globally. In the global public health sector, we market 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. PREBOOST® is marketed online in the U.S. through a marketing arrangement under the Roman® Swipes brand name by Roman Health Ventures Inc. Roman is a leading telemedicine company that sells men’s health products via the internet.
Capitalize on expertise and reputation of our management team and board members.
Our management team has significant expertise and experience in oncology and urology as well as drug development, marketing and sales which will facilitate effective management of our clinical trials of drug candidates and product commercialization. In addition, we intend to capitalize on the strong reputations of the members of our management and board of directors with academic institutions, hospitals, physicians, pharmacists and distributors to expand our customer base and to introduce new products.
Be opportunistic.
We received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19, the global pandemic disease caused by the novel coronavirus SARS-CoV-2. We have initiated the study. Drugs that target microtubules have broad antiviral activity by disrupting the intracellular transport of viruses such as SARS CoV-2, along microtubules. Microtubule trafficking is critical for viruses to cause infection. Furthermore, microtubule depolymerization agents that target α & β tubulin subunits of microtubules also have strong anti-inflammatory effects including the potential to treat the cytokine release syndrome (cytokine storm) induced by the SARS-CoV-2 viral infection that seems to be associated with high COVID-19 mortality rates. The primary efficacy endpoint for the Phase 2 trial will be the proportion of patients that are alive and without respiratory failure at Day 29. Secondary endpoints include the measured improvements on the WHO Disease Severity Scale (8-point ordinal scale) which captures COVID-19 disease symptoms and signs including hospitalization to progression of pulmonary symptoms to mechanical ventilation as well as death.
The Company is also advancing new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology such as the Tadalafil and Finasteride Combination (TADFIN®) for the administration of tadalafil 5mg and finasteride 5mg combination formulation dosed daily to treat urinary tract symptoms caused by benign prostatic hyperplasia (BPH). Tadalafil (CIALIS®) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment of BPH (finasteride 5mg PROSCAR®) and male pattern hair loss (finasteride 1mg PROPECIA®). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than by finasteride alone5. The Company had a successful pre-New Drug Application (NDA) meeting with the FDA and the expected submission of the NDA for TADFIN® is the second half of calendar year 2020. The Company is also developing Tamsulosin XR capsules which is a formulation of tamsulosin, the active ingredient in FLOMAX®, which the Company has designed to avoid the “food effect” inherent in currently marketed versions of the drug6, allowing for potentially safer administration and improved patient compliance.
The Company’s commercial products include the FC2 Female Condom/FC2 Internal Condom® (“FC2”), an FDA-approved product for the dual protection against unwanted pregnancy and sexually transmitted infections, and the PREBOOST® 4% benzocaine medicated individual wipe for the treatment of premature ejaculation. PREBOOST® is marketed online in the U.S. through an exclusive marketing arrangement under the Roman® Swipes brand name by Roman Health Ventures Inc. Roman is a leading telemedicine company that discreetly sells men’s health products via the internet website www.getroman.com. The Company’s Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the U.S. and globally. In the U.S., FC2 is available by prescription through the Company’s multiple telemedicine and internet pharmacy partners and retail pharmacies, as well as OTC through the Company’s website at www.fc2.us.com. In the global public health sector, the Company markets 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.
- MME LLC, Prostate Cancer Market Revenues (2018)
“Delveinsight “Hot flashes associated with prostate cancer treatment: Market insights, epidemiology, and market forecast. December 2019” - MME LLC, Prostate Cancer Market Revenues (2018)
- Getzenberg, et al., “Efficacy of VERU-111, an oral alpha and beta tubulin inhibitor, in taxol responsive and resistant prostate cancer models”, EAU Poster, 2018
- Getzenberg, et al., “Determination of the ability of a novel, long-acting subcutaneous GnRH antagonist, VERU-100. to castrate without a testosterone surge in a rat model, GU ASCO Poster, 2020
- “Casabe, et al., “”Efficacy and Safety of the Coadministration of Tadalafil Once Daily with Finasteride for 6 Months in Men with Lower
Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia””, The Journal of Urology, Vol. 191, 727-733, March 2014.” - Flomax Tamsulosin Package Insert
Casabe, et al., “Efficacy and Safety of the Coadministration of Tadalafil Once Daily with Finasteride for 6 Months in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia”, The Journal of Urology, Vol. 191, 727-733, March 2014.
Board of Directors
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. (NASDAQ: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.
Harry Fisch, M.D., F.A.C.S. is the Founder, Vice Chairman of the Board, and Chief Corporate Officer of Veru Inc. and 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 current, 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.
Mario Eisenberger, M.D. has served as a director of the Company since October 2016. Dr. Eisenberger currently is the Dale Hughes Professor of Oncology at The Johns Hopkins University and has been in the full-time faculty since 1993. From 2010 to 2014, Dr. Eisenberger founded Oncology Trials Insights, Inc., a privately held clinical trials management company. Since 2010, Dr. Eisenberger has also served as an ad-hoc member of the Oncologic Drugs Advisory Committee of the FDA. Since 1988, he has served in advisory, strategic and data safety monitoring boards, including Bristol-Myers Squibb, Sanofi, Astellas, Schering Plough, Auguron, AKZO, Dupont, Rhone-Poulenc Rorer, Aventis, Jansen, Ipsen, Active Biotech, Medivation, Tokai, Xanthus, Cytogen, Ortho Biotech, Active Biotech, Merck-Sharp and Dohme, Tyme, Inc., Ferring and Bayer. From 1984 to 1998, Dr. Eisenberger held the position of head of the advanced prostate cancer committee and vice chair of the genitourinary cancer of the Southwest Oncology Group. From 1984 to 1993, he served as Professor of Oncology at The University of Maryland. From 1984 to 1989, he was the Chief of Oncology at the Baltimore VAH. From 1982 to 1984, he was a Senior Investigator at the Cancer Therapy Evaluation Program of the National Institute in charge of coordinating extramural clinical research in urological cancers. From 1976 to 1982, he served in the faculty of the University of Miami. Dr. Eisenberger obtained his M.D. at the Federal University of Rio de Janeiro Brazil in 1972 and is board certified in Internal Medicine and Medical Oncology.
Jesus Socorro has served as a director of the Company since March 2017. Mr. Socorro, a Florida-licensed C.P.A., is the Managing Principal of the Risk Advisory practice of Morrison, Brown, Argiz & Farra, LLC, a nationally recognized accounting and advisory firm headquartered in Miami, Florida, where he has been since March 2014. From August 1999 to November 2002 and from May 2004 to March 2014, Mr. Socorro worked in the audit practice of Ernst & Young LLP, most recently as an Audit Senior Manager. From November 2002 to November 2003, Mr. Socorro served as the Technical Accounting Manager for LNR Property Corporation (a then-NYSE-traded real estate finance company) and from November 2003 to May 2004, he was an Audit Manager with BDO Seidman, LLP. Mr. Socorro received his M.B.A. from Northwestern University J.L. Kellogg School of Management in 2007.Michael L. Rankowitz was elected director in March 2018. Mr. Rankowitz has held directorships with NF Investment Corp., Carlyle Funds, 1st Tee of Metropolitan New York, Discover Card, Clarent Hospital Corp., New York Racing Authority, International Dyslexia Association — New York Branch, Trinity School (New York) and Browning School (New York). From 1980 to 2001, Mr. Rankowitz was a managing director at Morgan Stanley, where he also served as co-head of Global High Yield and was responsible for risk management, research and sales for high yield, emerging markets, bank debt and distressed securities. He continues to be a Senior Advisor to Morgan Stanley. He has a B.S. in mathematics from the University of Vermont.
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. (NASDAQ: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.
Ms. Greco has served as Chief Financial Officer since March 2018 and as Chief Administrative Officer of the Company since December 2017. Ms. Greco served as Executive Vice President of Finance from October 2016 to March 2018 and 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.
Harry Fisch, M.D., F.A.C.S. is the Founder, Vice Chairman of the Board, and Chief Corporate Officer of Veru Inc. and 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 current, 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.
Mr. Gilbert has served as Executive Vice President Corporate Development since May 2018. Previously Mr. Gilbert served as Senior Vice President Corporate Development and Legal from January 2017 to April 2018. From 2015 to 2016, Mr. Gilbert was a consultant to the Company’s Board and CEO and charged with assisting with 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 Bachelor 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.
Gary Bird is Senior Vice President for Quality Oversight and is responsible for all CMC manufacturing activities to confirm regulatory and GMP compliance. His organization is responsible for creating a compliant quality system to meet US FDA expectations. He has over 30 years in the pharmaceutical and biotechnology industries with a broad area of expertise in regulatory affairs, quality system analysis, FDA compliance, team leadership, continuous improvement, and vendor relations.Throughout his executive career, Dr. Bird has held leadership positions at pharmaceutical and biotech-related organizations, including the Food and Drug Administration (CDER and CBER). Eli Lilly and Company, GTx Incorporated, Geno Rx, and his consulting firms PharmaConsult US and PharmaConsult Global, Ltd. He represented both FDA and Industry in the International Conference on Harmonization (ICH) negotiations activities in five different Quality topic areas. He has authored and delivered numerous lectures and training courses as part of his industry and consulting services on subjects including best manufacturing practices for biopharmaceutical products, introduction to GMPs, introduction to biosafety, and stability of biopharmaceutical products.
Dr. Bird holds a PhD in Entomology and Biochemistry from Mississippi State University.
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.
Domingo Rodriguez M.D. has served as Executive Vice President of Clinical Operations since April 2018.
Prior to joining Veru, Dr. Rodriguez was the Vice President of Global Development Operations at Mallinckrodt Pharmaceuticals from 2013 to April 2018 where he was a member of the Science and Technology Senior Management Team with his main responsibility being the clinical trial execution of all clinical-stage programs and indications both in the U.S. and abroad.
From 2004 to 2013, Dr. Rodriguez served in various positions at GTx, Inc., including Vice President of Clinical Operations.
Dr. Rodriguez brings more than 30 years of biotechnology, pharmaceutical and device experience to Veru Inc. in small, mid-size and large companies with expertise in Clinical Development, Medical Affairs, Due Diligence, Acquisitions, Integrations, FDA Inspections and Sales and Marketing.
Dr. Rodriguez has conducted global clinical development that includes oncology, male health and autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology, regenerative medicine, immunotherapy and neonatal respiratory critical care therapies, transplants, analgesics, pediatrics, orphan/rare diseases and devices.
Dr. Rodriguez completed medical school at CETEC University in the Dominican Republic.