June 3, 2018 – Kitov Pharma Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the Company has signed a definitive license and commercialization agreement for the Chinese market, granting exclusive rights to import, manufacture and distribute its lead drug candidate, Consensi™, in China to Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (Changshan Pharma), a Chinese public company traded on the Shenzhen Stock Exchange.
Consensi™, formerly known as KIT-302, is a combination drug intended to simultaneously treat pain caused by osteoarthritis, and hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. Consensi™ is comprised of two FDA-approved drugs, celecoxib (Celebrex®), a non-steroidal anti-inflammatory COX-2 inhibitor (NSAID) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc®), a calcium channel blocker for lowering blood pressure.
Kitov Pharma Ltd also announced that it has entered into definitive agreements with institutional investors providing for the issuance of 3,260,000 American Depositary Shares (ADS) at a purchase price of $2.50 per ADS in a registered direct offering. Kitov will also issue unregistered warrants to purchase up to 1,630,000 ADSs. The warrants will have a term of 5.5 years, be exercisable immediately following the issuance date and have an exercise price of $2.80 per ADS. The offering is expected to result in gross proceeds of approximately $8,150,000. H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering. The closing of the sale of the securities is expected to take place on or about June 5, 2018, subject to satisfaction of customary closing conditions. The ADSs described above were offered pursuant to a shelf registration statement on Form F-3 (File No. 333-215037), which was declared effective by the United States Securities and Exchange Commission (the “SEC”) on December 14, 2016. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
Upon receipt of marketing authorization in China, Changshan Pharma will have the exclusive right and license to import, manufacture, distribute, and sell Consensi™ in China, Taiwan, Hong Kong, and Macao. Changshan Pharma will be responsible for financing and seeking regulatory approval for Consensi™ in China. Under the terms of the agreement, Kitov is entitled to receive up to an aggregate of $3.5 million for U.S. FDA approval of Consensi™, which has a PDUFA date of May 31, 2018, and for China regulatory milestones; up to an aggregate of $6.0 million for predefined commercial milestones; and up to 12% royalties on net sales.
“We are extremely pleased to enter into this commercialization agreement for Consensi™ and look forward to building a long-term relationship with Changshan Pharma in China. Changshan Pharma has a strong track record of successfully launching and marketing pharmaceutical products in China,” said Dr. Gil Ben-Menachem, Kitov’s Vice President – Business Development. “This is the second commercialization agreement for Consensi™ in Asia, further confirming its global sales potential. Kitov continues to work diligently towards finalizing additional commercialization agreements in the U.S. and in other territories.”
“We believe that Consensi™ has substantial commercial potential in China and will provide significant benefit to Chinese patients. We are well-positioned to maximize the value of this product in the Chinese market, and look forward to seeking regulatory approval and launching Consensi™ in China,” said Mr. Shuhua Gao, Chairman and General Manager of Changshan Pharma.
The total annual NSAID market in China is estimated at hundreds of millions of dollars, according to IMS. Moreover, celecoxib sales in China represented 25% of the total NSAID market. In recent years, sales of selective COX-2 inhibitors (coxibs), and especially Celebrex® (Pfizer’s branded celecoxib), have been increasing in China at an annual rate of 25 percent.
About Kitov Pharma Ltd
Kitov Pharma Ltd (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development group of companies. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare and business professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s flagship combination drug, Consensi™, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoints for its Phase III and Phase III/IV clinical trials. NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd., is a novel patented small molecule designed to overcome cancer drug resistance that is currently in pre-clinical development. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
About Changshan Pharma
Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (Changshan Pharma) is a fully-integrated, publicly-traded (stock code: 300255) pharmaceutical company with headquarters in Shijiazhuang, Hebei, China. Changshan Pharma is a leading supplier of Heparin and Low Molecular Weight Heparin pharmaceutical products from its state-of-the-art manufacturing facilities. Changshan Pharma has a long history of international collaborations leading to a deep and diverse pipeline of innovative products across various therapeutic categories and dosage forms.