You are currently viewing Oramed & HTIT Launch $ 70m Joint Venture to Market Oral Insulin Globally
  •  JV will have global marketing rights to oral drug delivery technology
  • HTIT to invest $60 million, Oramed to invest $10 million into JV
  • HTIT to provide a supply agreement for oral insulin capsule
  • JV to advance registration of oral insulin in the United States and other countries

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com) signed a non-binding term sheet with Hefei Tianhui Biotechnology Co. Ltd. (“HTIT“) to establish a joint venture (“JV”) based on Oramed‘s oral drug delivery technology. The proposed JV would focus on the development and worldwide commercialization of innovative products based on Oramed‘s oral insulin and POD™ (Protein Oral Delivery) pipeline and HTIT‘s manufacturing capabilities and technologies. The JV is subject to the execution of a binding definitive agreement.

“We are thrilled to further our relationship with HTIT, expanding the reach of our oral drug delivery technology to a global market,” said Oramed Chief Executive Officer, Nadav Kidron. “HTIT has successfully completed a Phase 3 oral insulin trial and submitted a New Drug Application (“NDA”) to the Chinese National Medical Products Administration (“NMPA“), with marketing approval currently pending in China. HTIT has state-of-the-art facilities, manufacturing capabilities, and the know-how needed to produce oral insulin on an international scale. This JV is a true opportunity to leverage our strengths as well as those of our partners to fast-track our pipeline towards commercialization.”

Failure of the USA FDA phase 3 study of the ORMD-0801 for type2 diabetes

In January 2023 the Oramed Pharmaceuticals Inc. stock dropped dramatically when the company announced that its US-based FDA phase 3 study of ORMD-0801 in treating type 2 diabetes failed to meet primary or secondary endpoints.

The Chinese clinical studies showed that for a subset population, the US FDA clinical trials actually succeeded!

In May 2023, the Phase III trials of oral insulin for type 2 diabetes in China by Hefei Tianhui Biotechnology (HTIT), a strategic partner of Oramed Pharmaceuticals Inc. under the supervision of the National Medical Products Administration (the Chinese FDA) succeeded. HTIT immediately followed up by submitting the Phase III trial data through a marketing authorization application to the National Medical Products Administration.

Following the good news from China, Oramed completed an analysis of the data from its U.S.-based, Phase 3 trial, ORA-D-013-1, for the treatment of type 2 diabetes. This analysis found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender, and body weight, responded well to oral insulin. These subsets exhibited an over 1% placebo-adjusted, statistically significant, reduction in HbA1c (glycosylated hemoglobin, hemoglobin that transports sugar –  a high level of HbA1c is indicative of diabetes) The significant impact of baseline BMI on the responder group within the U.S. Phase 3 trial aligns with the positive data from the HTIT trial in China. The U.S. subpopulation and the Chinese general trial population shared a very similar baseline BMI. In plain words, oral insulin’s efficacy drops significantly if the patient is overweight and under 52 years of age.

Scope of the Joint Venture

The JV would be responsible for developing, marketing, and commercializing drug products globally, focusing on Oramed‘s oral insulin and POD™ technology, as well as other assets in the Oramed pipeline. The parties intend for the JV to initiate a Phase 3 oral insulin trial in the United States.
Structure of Joint Venture

Oramed and HTIT would initially hold equal shares in the JV, with each owning 50% of the equity. The Board of Directors would initially consist of equal representation from HTIT and Oramed, ensuring that both parties have an equal say in decision-making. As part of the Joint Venture, HTIT will make an initial investment of $60 million, while Oramed will invest $10 million.

Ben Shapiro appointed to Oramed’s Board of Directors

Oramed appointed Mr. Benjamin Shapiro to its Board of Directors on May 1, 2023. The Board determined that Mr. Shapiro qualifies as an independent director under the listing rules of the Nasdaq Capital Market. Ben Shapiro is a successful entrepreneur and business professional who co-founded The Daily Wire, a successful, industry-leading, international media outlet in June 2015. Since May 2015, he is the host of “The Ben Shapiro Show,” a popular podcast, and he is the author of numerous New York Times best-selling books. Mr. Shapiro beneficially owns over four percent of Oramed’s outstanding stock, making him a significant shareholder in the Company.

About Oramed Pharmaceuticals Inc.

Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The company’s novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit www.oramed.com.

About HTIT

Hefei Tianhui Biotechnology Co. Ltd. (HTBT) has a state-of-the-art oral insulin manufacturing facility in Hefei, China.

HTBT is a high-tech company focused on biopharmaceutical product manufacturing and R&D with an emphasis on the oral delivery of therapeutic macromolecules. Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT) was founded on June 26, 2012, and its main business activities are the incubation of science and technology enterprises, technology transfer, consulting and services, and R&D and sales of high and new technology and products, etc. The company is cooperating with foreign advanced biotechnology enterprises such as Israeli enterprises on the management and operation of professional incubators in the biological medicine field and has introduced foreign projects such as the world’s most novel oral insulin capsules and a new generation of GLP-1 analogs.

Company Contact:
Zach Herschfus  Tel:+1-844-9-ORAMED or +1-844-9-672633
zach AT oramed.com

Source: Csion PR Newswire  Aug 2, 2023

 

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