Veru Announces Appointment of Joel Batten to Lead U.S. Infectious Disease Franchise to Focus on Hospitalized COVID-19 Patients
MIAMI, May 18, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced the appointment of Joel Batten as Executive Vice President and Head of its U.S. Infectious Disease Franchise effective May 23, 2022.
Most recently Mr. Batten has been the Head of the Respiratory Syncytial Virus (RSV) Franchise at Sobi North America where he was responsible for the Synagis business with gross revenue of approximately $600M and a team of over 160 employees. Mr. Batten led sales and marketing for the RSV Franchise as well as strategy for market access, distribution and patient access services. Prior to Sobi, he spent approximately 20 years in a number of positions of increasing responsibility at AstraZeneca / MedImmune and Sanofi Aventis in various infectious disease franchises including commercial infrastructure build-out, product launch, sales management, marketing, public health sales, and government affairs.
"Joel is an accomplished commercial leader with extensive knowledge in viral infectious disease product commercialization," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. "We are excited to have Joel join Veru at such a critical juncture in our Company's history as we build on the momentum of our positive Phase 3 sabizabulin for COVID-19 trial, our planned EUA submission, and the transition to delivering sabizabulin, if EUA is granted, to hospitalized COVID-19 patients at high risk for ARDS. Joel will be the head of our newly formed U.S. Infectious Disease Franchise and will be responsible for developing and leading all aspects of our U.S. go-to-market strategy for sabizabulin for COVID, if authorized, as well as planned future indications for other viral and ARDS-related and inflammatory diseases."
About Veru Inc.
Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (>= WHO 4-supplemental oxygen) at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety. Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths. After a pre-EUA meeting with FDA, the Company is in the process of submitting a request for FDA emergency use authorization. FDA granted Fast Track designation to the Company's COVID-19 program in January 2022.
The Company's late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.
Current studies on the two drugs include:
-- Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR >= 40% expression (third-line metastatic setting), and which has been granted Fast Track designation by the FDA. -- Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR >= 40% expression (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly is providing clinical supply of Verzenio(R) (abemaciclib). -- Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR 40% expression (third-line metastatic setting).
Veru's late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
Current studies on these drugs include:
-- Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy. -- Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone sensitive prostate cancer. -- Planned Phase 2b study of zuclomiphene citrate to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy.
Veru also has a commercial sexual health division - Urev, the proceeds of which help fund its drug development programs, comprised of 2 FDA approved products:
-- ENTADFI(TM) (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway. -- FC2 Female Condom(R) (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
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