Raziel Announces China Market License Agreement with Fosun Pharma for RZL 012
Milestone payments of up to $74 million plus tiered royalties on future sales
Sep 17, 2020, 08:00 ET
REHOVOT, Israel, Sept. 17, 2020 /PRNewswire/ -- Raziel Therapeutics, a Pharmaceutical company developing next-generation novel prescription products for the medical aesthetics market announces licensing of its disruptive technology, RZL-012, to Fosun Pharma for milestone payments of up to $74 million, based on development, regulatory and net sales achievements plus tiered royalties on future sales.
RZL-012 is an injectable drug product indicated for aesthetic treatment of adults having moderate to significant submental fullness, commonly referred as a double-chin. The compound is injected subcutaneously into submental fat tissue in a single injection session by trained physicians. RZL-012 destroys fat cells, resulting in fat volume reduction and improved appearance of the chin area. In a recent Phase 2a study conducted in the US, RZL-012 demonstrated a significant improvement in chin appearance following a single injection session and a very good safety profile. Submental fat treatment is the first indication for RZL-012 among many potential aesthetic treatments.
Today Mr. Alon Bloomenfeld announced that Raziel Therapeutics has entered into a license agreement with Tianjin JuveStar Biotech Co., Ltd., (JuveStar), a company invested and incubated by the venture capital arm of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, stock code: 600196.SH, 02196.HK). The agreement provides JuveStar with exclusive rights to develop and commercialize Raziel's proprietary RZL-012 for Injection in mainland China, Hong Kong, Macau and Taiwan (the Territory). RZL-012 is the first, long-lasting single treatment injectable product for aesthetic and therapeutic applications. The mode of action of RZL-012 is also relevant for other potential future aesthetic indications such as excessive abdominal and flank fat. The injectable is also being developed for fat disorders such as lipomas, Dercum's disease associated lipomas (rare disease) and lipedema.
Under the terms of the agreement, Raziel Therapeutics will receive potential payments (including upfront and R&D milestone payments) of $27 million between now and marketing approval in the Territory. Raziel is also eligible to receive additional potential sales milestone payments of up to $47 million, as well as tiered royalty payments on future net sales. JuveStar will be responsible for conducting necessary clinical studies (Phase III), marketing and sales in the Territory, while Raziel will be responsible for manufacturing the drug substance and finished drug product for both the clinical and commercial activities in the Territory. There will be no transfer of intellectual property.
"Fosun Pharma is one of the leading healthcare companies in China, with expertise and access to both the aesthetic and therapeutic markets. We see Fosun Pharma as an ideal partner to commercialize RZL-012 in the fast-growing aesthetic Chinese market, said Alon Bloomenfeld, president and chief executive officer at Raziel Therapeutics. Fosun Pharma already has a growing portfolio of products in facial aesthetics, the field in which we plan to gain the first approval for RZL-012. We look forward to working with the Fosun Pharma team on the clinical, regulatory and commercial pathways to introduce RZL-012 to this important, developing geography."
"We are pleased to partner with Raziel to bring a truly next generation fat melting injectable to China," said Mr. Wu Yifang President and CEO of Fosun Pharma, "The collaboration will enrich Fosun Pharma's pipeline in the field of Medical Cosmetology and provide more options for the unmet clinical needs of the market."
About Submental Fullness
Submental fullness is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look. Submental fullness can affect adults – both women and men – of all ages, weights and genders. Influenced by multiple factors including aging and genetics, submental fullness is often resistant to diet and exercise. According to a 2015 survey by the American Society for Dermatologic Surgery, 67 percent of consumers are bothered by submental fullness.
About RZL - 012
RZL-012 is the first product to seek approval for fat disorders such as Dercum's disease. Aesthetic applications include but are not limited to subcutaneous intra-fat injections for improving the appearance of moderate to significant submental fullness, commonly referred to as double chin. RZL-012 is a small molecule entity having a formulation with no human and no animal related components. When injected into subcutaneous fat, RZL-012 destroys fat cells and reduces fat volume. Once destroyed, those cells can no longer store or accumulate fat.
About Fosun Pharma：
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a leading healthcare group in China. Fosun Pharma has built a strong root in China and developed a global operation strategy, with pharmaceutical manufacturing and R&D being the largest and core business segment, together with strong presences in medical devices and diagnostics, healthcare services, pharmaceutical distribution and retail.
With R&D innovation as core driving factor, Fosun Pharma continues to optimize its pharmaceutical operations across both innovative and generic drugs. The company has established international R&D centers for excellence in areas such as innovative small molecule drugs, high-value generic drugs, biologics, and cell-therapy.
Under guidance of our 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma follows the brand concept of Innovation for Good Health and strives to be a leading enterprise in the global pharmaceutical and healthcare markets.
For more information, please visit: www.fosunpharma.com.
About Raziel Therapeutics.
Raziel Therapeutics is an emerging Israeli based pharmaceutical leader developing a disruptive technology for the treatment of aesthetic and therapeutic conditions linked to fat disorders. Raziel has developed a unique proprietary compound by obtaining a License from the Hebrew university. The company's lead compound, RZL-012, is in phase 2 clinical development for a broad range of aesthetic and therapeutic indications. More information on Raziel Therapeutics may be found at https://raziel-therapy.com/
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the anticipated receipt of payments and potential receipt of development and sales milestones, as well as royalties on potential future sales of RZL-012 under the license with Fosun Pharma; the timing and conduct of regulatory, developmental and commercial activities to be conducted under the license with Fosun Pharma; the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates, the initiation, design, timing and results of our clinical studies, and related results and reporting of such results, including the Phase IIb, III study of RZL-012 statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans and statements about our ability to obtain regulatory approval with respect to our drug; and potential benefits of our drug product candidate.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the fact that we may not receive any milestone, royalty or other payments from Fosun Pharma, our dependence on Fosun Pharma to timely and successfully develop and commercialize RZL-012 in the China market, that we may not obtain the anticipated financial and other benefits of the license agreement with Fosun Pharma; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. These forward-looking statements speak only as of the date hereof. Raziel disclaims any obligation to update these forward-looking statements.
CONTACT
Alon Bloomenfeld CEO
[email protected]
SOURCE Raziel Therapeutics
