Jyong Biotech Ltd. says it plans to establish a potential new manufacturing facility and US operations centre in Texas.
The initiative is intended to support the company’s US operations and position it for the potential future commercialisation of its proprietary investigational drug candidates, if approved.
Following an evaluation of factors including government policies, market conditions, workforce recruitment and logistics, Jyong Biotech has submitted a facility and operations plan to local government authorities in the State of Texas and is preparing to commence formal communications with the relevant government agencies regarding the relevant procedures.
The company selected Texas based on factors including competitive land costs, a favourable corporate tax structure, state tax exemptions and manufacturing incentives. The company said it expects the proposed facility to possess pharmaceutical manufacturing capabilities, and it is also evaluating whether the proposed facility may include additional production lines for health supplements, subject, among others, to further planning, regulatory requirements and available funding.
“We believe establishing manufacturing capacity in the United States will support our long-term commercial plans,” said Fu-Feng Kuo, chairwoman and chief executive officer of Jyong Biotech.
“Texas offers a favourable business environment and potential state tax incentives, which we believe will allow us to build the infrastructure needed to support the potential commercial activities and operations of our drug candidates, if approved.”
The US is Jyong Biotech’s highest-priority market due to favourable drug pricing dynamics and the broader international recognition of FDA-approved pharmaceuticals. The company believes FDA approvals for its product candidates, if obtained, may facilitate regulatory filings in other markets; however, approval in any other jurisdiction is not assured.
According to a 2012 review in the Canadian Urological Association Journal, approximately 8.7m American men are potential candidates for treatment of BPH-related LUTS each year. According to a 2015 review published in The Canadian Journal of Urology, approximately 12.2m US men were actively managed for BPH/LUTS as of 2015. Based on that review’s breakdown of this actively managed population, the company believes there is a potential commercial opportunity.
Approximately 35% of actively managed patients are in watchful waiting and receive no pharmacological therapy, and represent the company’s intended primary target population, if new drug candidate is approved. Also, an estimated 9.1% of actively managed patients have discontinued drug therapy and returned to watchful waiting, representing a potential secondary target population.
For the 54.8% of actively managed patients taking chemical medications, the company believes new drug candidate, if approved, could potentially be evaluated as a combination or alternative therapy.
“Our commercial strategy in the US targets a significant patient population,” Kuo said.
“With nearly 35% of patients in watchful waiting and almost 10 percent discontinuing drug treatment, we believe our drug candidates, if approved, will address this unmet medical need.”
Jyong Biotech does not currently have any approved drug products available for commercial use in any jurisdiction.