- The two companies signed a manufacturing operating agreement and a commercial agreement
- Lexaria sent a pre-IND meeting request letter to the US FDA and plans to file the full IND application in late 2022/early 2023
- The FDA has acknowledged Lexaria’s pre-IND request and responded with conditions prior to the target date of July 30, 2022
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has recently announced signing two agreements with BevNology LLC, the product and development arm of InterContinental Beverage Capital (“IBC”), operating its state-of-the-art lab and manufacturing facility just outside of Atlanta, Georgia. This announcement only furthers Lexaria’s leverage of the market, with the company’s patented DehydraTECH(TM) technology having already been embraced by several consumer packaged goods brands, with availability in over 7,000 stores throughout the United States and Japan, including direct-to-consumer online retail portals (https://ibn.fm/gLQzN).
The manufacturing operating agreement expands the production capabilities of Lexaria’s growing list of business-to-business clientele interested in purchasing DehydraTECH-powered active ingredients for packaged-goods brands. The new, state-of-the-art processing facility built by BevNology is operational, increasing and broadening production capabilities. This facility is currently serving Lexaria’s corporate clientele, with new equipment specific to DehydraTECH already installed.
The second agreement is a commercial license, empowering BevNology to offer the DehydraTECH products with active ingredients derived from hemp, including cannabidiol (“CBD”), under BevNology and partnered brands. The agreement is non-exclusive for powdered DehydraTECH formulations. For liquid formulations, the non-exclusivity is limited in the United States only, requiring certain minimum fee payments to maintain rights. Lexaria will receive royalties from BevNology for the utilization under this license, with exclusion only affecting Japan, the Republic of Korea, and the People’s Republic of China.
“These agreements build on a long-standing and very successful product development consulting relationship between Lexaria and the expert scientists and personnel at BevNology.” Lexaria CEO Chris Bunka said. “BevNology’s formulation and production capabilities are class leading, and we are confident that our new relationship with our trusted partner will propel new and exciting growth opportunities for both companies.”
In other recent news, Lexaria has filed its pre-IND meeting request letter with the United States Food and Drug Administration (“FDA”) to initiate communication with the FDA regarding Lexaria’s development of the company’s DehydraTECH-CBD for potential hypertension treatment. The FDA has responded to and confirmed the company’s letter, with a target date of July 30, 2022, and disclosed the conditions in which Lexaria must meet prior to the meeting. Lexaria anticipates filing the full IND application in late 2022/early 2023 (https://ibn.fm/MpKmr).
“We are excited to take this important first regulatory step with the FDA for the development of our DehydraTECH-CBD for the treatment of hypertension,” stated John Docherty, President of Lexaria. “Submission of this request letter initiates formal communication with the FDA regarding our IND clinical trial plans in order to help define the critical path for clinical development and marketing approval of our potentially very significant new hypertension therapeutic.”
The hypertension treatment market is valued at approximately $28 billion per year and is expected to grow as one of the world’s top health problems as a subset of a larger heart disease market (https://ibn.fm/sIjQJ). There are over 1.1 billion people in the world suffering from hypertension, with fewer than 1 in 4 having successful control over it. The potential market size increases if an affordable drug were available with few or no side effects. Some reports indicate drugs for hypertension and related conditions are among the highest-selling category of drugs in the world (https://ibn.fm/oAxXN).
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX