We had a successful year and are well on our way to transforming our company into a biopharmaceutical company. We have advanced several near-term and mid-term urology products at the same time to have “multiple shots on goal” to file drug approval applications, and to commercialize several drugs in oncology and urology. We have implemented an effective plan that is growing sales for our existing commercial products. We anticipate solid revenue growth from these commercial products.
With this strong foundation in place, it is time for our company to further articulate to our shareholders what our business plans and priorities, as this will inform our objectives and our goals for the next year and beyond.
Our strategy is to become known as “the prostate cancer company.” Rather than focusing on one drug class or on one research platform, we aspire to provide a “continuum of care” for prostate cancer patients. This means we expect our drug development and commercial activities to align with the clinical management of prostate cancer patients. Although prostate cancer remains the second most frequent cause of cancer deaths in men, advances in the diagnosis and effective treatments of prostate cancer have resulted in many men living longer, even decades, with the disease. Thus, prostate cancer is becoming a chronic disease with new challenges as the prostate cancer develops resistance to these current drugs and progresses and as the patient suffers from the long-term side effects of these treatments.
Accordingly, advanced prostate cancer care centers are being established across the country and the world, and urologists and medical oncologists are now actively managing all aspects of prostate cancer from monitoring for disease progression and modifying treatments, to promoting prostate cancer supportive care. Prostate cancer supportive care addresses the management of the various acute and chronic side effects of prostate cancer drugs, like bone loss and fractures, hot flashes, loss of libido, erectile dysfunction, loss of muscle strength and frailty.
The markets for prostate cancer treatment and prostate cancer supportive care are well-established as multi-billion-dollar markets and given our core expertise and the number and type of drugs in our pipeline, we believe we are uniquely positioned to understand, develop, and commercialize medicines for these unmet medical needs of prostate cancer patients.
Veru is developing and commercializing drug products for multiple unmet needs in advanced prostate cancer treatment with VERU-111 and in prostate cancer supportive care with Zuclomiphene citrate (VERU-944) for hot f lashes caused by androgen deprivation therapy.
With respect to these drug products, VERU-111, a novel, first-in- class, proprietary, next generation oral tubulin inhibitor, has advanced into an open label Phase 1b/2 clinical trial in men whose prostate cancer cannot be effectively treated with androgen blocking agents like abiraterone or enzalutamide. Zuclomiphene citrate is being evaluated in a Phase 2 clinical trial for the treatment of hot flashes caused by androgen deprivation therapy in men with advanced prostate cancer. These novel, proprietary, prostate cancer drug products are now in human clinical trials with clinical data results on efficacy and safety anticipated in the first half of 2019.
Our strategy is to become known as “the prostate cancer company” and to be supported in part by two sources of revenues:
First, we are establishing a specialty pharmaceutical business in urology by developing low cost, near-term pharmaceuticals using an expedited regulatory pathway known as 505(b)(2). The three drug products currently in clinical development that are utilizing this regulatory pathway are tadalafil/finasteride fixed combination tablets and tamsulosin XR capsules and sprinkles. Tamsulosin treats immediate symptoms of benign prostatic hyperplasia, or BPH in men with smaller prostates; whereas Tadalafil/ Finasteride combination tablets treat symptoms of BPH and shrink the size of the prostate in men who have enlarged prostates, as well as treating erectile dysfunction.
Second, we anticipate growing revenue from our commercial products: the FC2 Female Condom/FC2 Internal Condom®, and PREBOOST® (4% benzocaine wipes for premature ejaculation). For FC2, The Female Health Company Division has been able to grow public sector sales by winning 75% of the South African tender of approximately 30 million units per year over three years and also has significantly expanded its US business by a strategy that utilizes a contracted independent sales force and by partnering with a leading telemedicine marketing and sales channel. For PREBOOST®, we have a co-promotion and distribution agreement with Timm Medical Technologies, Inc., a specialty urology sales organization, as well as a partnership with a leading men’s health telemedicine company that discreetly sells men’s health products via the internet and social media.
We have accomplished quite a lot this past year to advance our business strategy. We paid for these activities this past year in part by the revenue produced from our FC2 Female Condom/ FC2 Internal Condom® business. We also successfully closed on an equity financing that allowed key pharma and biotech investment institutions to become shareholders in Veru including Perceptive Advisors, LLC, AWM Investment Company, Inc., Aspire Capital, and UBS O’Connor LLC to name a few.
In summary, we are poised to see open label clinical data for VERU-111, the novel, proprietary, first-in-class, oral tubulin inhibitor for refractory metastatic castration resistant prostate cancer, as well as top line clinical results for the Phase 2 clinical trial evaluating zuclomiphene citrate for the treatment of hot flashes caused by androgen deprivation, during the first half of 2019. We are committed to driving shareholder value by becoming “the prostate cancer company” by providing a “continuum of care” for prostate cancer patients.
Mitchell Steiner, MD FACS
President and Chief Executive Officer