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.
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.