JERUSALEM, Nov. 30, 2015 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has signed definitive licensing and investment agreements valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. (“HTIT”) for exclusive rights to market Oramed’s oral insulin capsule, ORMD-0801, in China, Hong Kong and Macau. The agreements were signed at the Israel Knesset (Parliament).
The license agreement payments include a $3 million payment due upon execution of the agreement, $8 million in near-term payments subject to Oramed entering into certain agreements and the balance payable upon achievement of certain milestones. In addition, if all conditions are met, HTIT will pay a 10% royalty on net sales of the related commercialized products.
In addition to the contemplated payments under the license agreement, pursuant to the investment agreement, Oramed will issue to HTIT 1,155,469 restricted shares of Oramed’s common stock at a price per share of approximately $10.39 and $12 million in total, subject to customary closing conditions.
“China recently became the country with the largest number of diabetics in the world. Having signed these definitive license and investment agreements, our oral insulin capsule could help serve the growing population of people in China living with diabetes,” stated Oramed’s CEO Nadav Kidron. “In addition to the $50 million in milestone payments and investments, we believe the royalties on net sales throughout China will have a very significant impact on Oramed’s future revenues and earnings, upon market approval of ORMD-0801 in China.”
HTIT, which is partially owned by Sinopharm Group Company Limited, has state of the art insulin production facilities in Hefei, China. HTIT has a business focus which includes industrial investment and incubation services; high-tech product R&D; technology transfer and related consulting services.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). Having completed separate Phase IIa clinical trials, the company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).
For more information, please visit www.oramed.com, the content of which is not part of this press release.
Forward-looking statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss the closing of the issuance of the shares to HTIT, expected future milestone and royalty payments under the license agreement, our product’s potential to help serve the growing population of people in China living with diabetes, the significant impact that the expected royalties on net sales throughout China will have on our future revenues and earnings, upon market approval of ORMD-0801 in China, and our expected initiation of separate Phase IIb clinical trials in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration, and revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the satisfaction of closing conditions in the investment agreement prior to the issuance of shares to HTIT; meeting certain conditions and future milestones pursuant to the license agreement; risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.
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SOURCE Oramed Pharmaceuticals Inc.