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Veru is building a highly differentiated portfolio of Prostate Cancer and Female Health Products

28 Feb Veru is building a highly differentiated portfolio of Prostate Cancer and Female Health Products

Veru Inc (NASDAQ: VERU), an oncology and urology focused biopharmaceutical Company developing novel therapeutics for the treatment of prostate cancer, announced the initiation of a pivotal Phase 2 clinical trial of VERU-111, a first-in-class, oral, selective antitubulin agent, intended for the treatment of metastatic castration and novel androgen blocking agent resistant prostate cancer.

VERU-111 has shown the potential to target and disrupt alpha and beta tubulin subunits of microtubules, which are primarily responsible for facilitating transport of growth factor receptors, cellular proliferation and metastases. The Phase 2 study open label, single arm study will evaluate the safety and efficacy of the candidate in 39 patients with metastatic castration resistant prostate cancer (mCRPC), who have also become resistant to a secondary novel androgen blocking agent such as abiraterone or enzalutamide.

The dosage of the phase 2 trials is based on the inputs from Phase 1b portion of the study conducted in 39 men, which demonstrated tolerability, and no incidences of neurotoxicity, hypersensitivity (allergic) reactions and febrile neutropenia. The trials key efficacy endpoints are radiographic imaging of progression-free survival and prostate-specific antigen (PSA) reductions.

Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru, commented,

“VERU-111 is initially targeting men who have metastatic castration resistant prostate cancer (mCRPC) 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. This prechemotherapy stage in men is currently one of the fastest growing unmet medical needs in advanced prostate cancer.  We are developing VERU-111 to be the next go to therapy in men with advanced prostate cancer who fail a novel androgen blocking agent.”

Furthermore the Company’s pipeline consists of Zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist, intended for the treatment of hot flashes in men undergoing androgen deprivation therapy (ADT) for prostate cancer. VERU-100, a long-acting gonadotropin-releasing hormone (GnRH) antagonist, which the Company intends to advance in to phase 2 trials in early 2020 and TADFIN, a combination of a PDE5 inhibitor and 5 alpha reductase inhibitor for the treatment of enlarged prostate, are the other pipeline candidates.

Veru Inc (NASDAQ: VERU)

Market Cap: $275.44M; Current Share Price: 4.26 USDChart
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Industry
Prostate Cancer is the second leading cause of death in men in the U.S, with over 1 in 41 men likely to succumb to the disease. According to an estimate by the American Cancer Society there would be 191,930 new cases of prostate cancer and 33,330 deaths from prostate cancer in 2020.

The current treatment options for the disease, which primarily affects the prostate gland, is removal of the gland surgically (Radical prostatectomy), Brachy Therapy (Implanting Radioactive Seeds into the prostate) and Conformal Radiation therapy in combination with hormonal therapy. In addition Chemotherapy and Androgen Suppression Therapy are used in cases of advanced cases of prostate cancer. The stage and grade of the disease along with the state of the patient with respect to age, existing illnesses and certain genetic factors determine the course of treatment.

A report by Datamonitor Healthcare estimates that the Total prostate cancer drug market will reach $13.5bn in 2024, growing at a CAGR of 8.6% from $6.4bn in 2015. The introduction of novel therapeutics and treatment methodologies, a rise in geriatric population and increased awareness will drive the growth in the market. However prohibitive treatment costs, adverse side-effects that include infertility may act as a deterrent for growth.

The prostate cancer market is a subject of extensive research and development that aim at treating the disease without causing adverse affects. We take a look at few emerging therapeutics that have the potential to transform the treatment landscape.

Company
Veru Inc is an Oncology and urology focused Biopharmaceutical Company, developing VERU-111, a first-in-class oral selective antitubulin, targeted at refractory metastatic prostate cancer. It works by inhibiting the microtubule assembly by selective binding and targeting of α and β subunits of microtubules.

Image Source: Company

Veru has been issued 7 compositions of matter patents that offer it protection until 2034 in the U.S along with 63 foreign granted or pending patents worldwide. It is also developing Zuclomiphene, which if approved, will be the first FDA approved drug for hot flashes caused by prostate cancer hormone therapy.

Image Source: Company

VERU-100 is a biologic and a proprietary GnRH antagonist for the treatment of advanced prostate cancer. It has completed a pre-IND meeting with the FDA in April 2019, followed by scaling up its manufacturing capacity by using contract manufacturing facilities. The Company intends to submit an IND in Q1 of 2020.

The Company markets female condoms through The Female Health Company, a division that services markets worldwide including public sector entities in over 140 countries, and the U.S prescription market. Additionally the company also sells Roman Swipes, which are medicated swipes intended for male genital desensitizing for the prevention of premature ejaculation.

Risk Assessment

  • There is a large unmet need for second line hormone therapies with a potential $5 billion annual market and an additional $ $4.8 billion annual market for IV-given taxanes and vinca alkaloids as per Decision Resources Group and Allied Market Research. This presents an excellent opportunity for growth, expansion and diversification. Veru is looking at the possibility of developing VERU-111 as an oral dosing alternative for other indications such as metastatic breast, ovarian, and pancreatic
  • Veru has a robust intellectual rights portfolio with 7 compositions of matter patents issued in the U.S, E.U and Japan and nearly 64 pending or granted foreign patents. The Company’s U.S patent expires in 2029, with a possibility of extension until 2034 and it has identified Polymorphs to extend time for composition of matter coverage.
  • According to the Company ADT drugs global sales in 2018 were $2.6 billion and Veru aims to capture 28 percent of the market share with its VERU-100, translating into peak sales of $750 million. Furthermore the Company has plans to submit an NDA for TADFIN in summer 2020.
  • Veru has signed a multi-year U.S supply and distribution agreement with Get Roman (Roman Health Ventures Inc), a telemedicine company that obligates it to purchase millions/year. While it’s FC2 Female Condom is a profitable venture right from 2006, with tenders from entities such as UNFPA, USAID, Brazil, and South Africa. The Company is now focusing on building its U.S prescription business through pharmacy and multiple telemedicine partners.
  • The company reported a 148% growth in prescription sales of FC2, in Q1, 2020, including a 66 percent increase in net revenues to $10.6 million from $6.4 million.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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    Source

    https://pipelinereview.com/index.php/2020022773902/Small-Molecules/Veru-Initiates-Phase-2-Clinical -Trial-of-VERU-111-First-in-Class-Oral-Advanced-Prostate-Cancer-Drug.html

    https://verupharma.com/wp-content/uploads/2019/10/Veru-Cantor-Fitzgerald-Global-Healthcare-Conference-10-2-19.pdf

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