On March 5, 2018 Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that it filed its Annual Report for 2017 on Form 20-F, including its full financial results for the year ended December 31, 2017 (Press release, Kitov Pharmaceuticals , MAR 5, 2018, View Source [SID1234524417]).
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Kitov also today released a Letter from Chief Executive Officer, Isaac Israel, regarding recent activities and plans:
"Dear Shareholders,
Following the publication of our Annual Report for 2017, I would like to share with you our major accomplishments during 2017 and our plans and expectations for 2018.
HIGHLIGHTS OF 2017:
Consensi
Our team made important progress on our lead drug candidate, Consensi (which we formerly referred to as KIT-302).
Consensi, a combination drug that simultaneously treats pain caused by osteoarthritis and treats hypertension, is comprised of two FDA approved drugs, celecoxib (Celebrex), an NSAID, for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc), a drug designed to treat hypertension. Hypertension is one of the side effects of using non-steroidal anti-inflammatory drugs, or NSAIDs, including celecoxib. Approximately 50% of the patients suffering from osteoarthritis in the US also suffer from hypertension, so industry sources estimate there are millions of patients that suffer from both conditions.
We made advances in several important areas:
Regulatory: The FDA filed our New Drug Application (NDA) for Consensi, following our submission of the NDA. We are very proud of the high-quality NDA package that was filed by the FDA. The FDA has set a PDUFA date of May 31, 2018 for Consensi.
Positive Clinical Trial Results: We announced the top-line results of our Phase III/IV randomized double-blind, placebo-controlled renal function clinical trial for Consensi. These results successfully validated the primary efficacy endpoint of our earlier successfully completed Phase III clinical trial. As such, we now have additional clinical evidence that establishes that adding celecoxib to amlodipine does not impair the blood pressure lowering effects of amlodipine. The trial also increased the total number of patients treated with Consensi, which we believe could increase the probability of ultimately receiving marketing approval for Consensi from the FDA.
Moreover, the Phase III/IV study strengthened the clinical evidence of the positive effect of Consensi on kidney function, which could provide us with a significant marketing advantage in the future.
Most importantly, we have advanced towards our goal of providing a safer NSAID, with the potential to be the first and only NSAID in the market which is both effective in lowering blood pressure and reduces the risk of kidney damage.
Commercial Partnership: We signed a definitive License Agreement for Consensi with Kuhnil Pharmaceutical Co. Ltd., a leading South Korean pharmaceutical company, for the territory of South Korea. Kuhnil will bear responsibility for and the costs of seeking regulatory approval for Consensi in South Korea. Under the terms of the agreement, we are entitled to receive payments upon achievement of certain predefined regulatory milestones, as well as double-digit royalties on net sales. Our relationship with Kuhnil and preparations for commercial launch in South Korea are proceeding as planned, and we have received our first milestone payment from Kuhnil.
South Korea is an important, attractive, gateway market into Asia, and we are very pleased with our choice of Kuhnil, which has the organizational and marketing infrastructure and capabilities for a successful commercial launch, which is expected to occur in 2019.
Patent Protection: We received a Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) related to claims expanding the patent coverage of Consensi to include oral dosage compositions containing both amlodipine and celecoxib. The Notice of Allowance should result in the issuance of an additional patent that would further strengthen Kitov’s proprietary position and long-term U.S. market exclusivity for Consensi.
TyrNovo: NT219 – Small molecule oncology drug
We acquired a majority stake in TyrNovo, a private oncology company, which is developing NT219, a small molecule drug that presents a new and exciting concept in cancer therapy by attempting to address a major problem whose solution has been elusive to date – tumors’ developing cancer-drug resistance. NT219 is a unique compound that is designed to prevent and reverse resistance to anti-cancer drugs through dual inhibition of STAT3 and IRS1/2, two signal pathways associated with drug resistance. Kitov’s current ownership in TyrNovo is 65% and we have a pending transaction to increase our stake in TyrNovo to approximately 92%, expected to be closed in the next few weeks.
We are very pleased with this acquisition, its progress during 2017 and, most importantly, its long-term potential. NT219 has demonstrated impressive efficacy in large array of pre-clinical models with several leading targeted oncology drugs, with chemotherapy drugs and with Immuno-Oncology drugs in various cancer types, including in combination with Keytruda. Our development program is of critical importance, as we prepare for the start of human clinical trials in 2019.
Furthermore, we received the FDA’s response to NT219’s pre-IND meeting package. In its response, the FDA agreed to our preclinical and clinical development plans for NT219, and we are considering the initiation of clinical studies in combination with gemcitabine (Gemzar) for the treatment of pancreatic cancer and/or in combination with osimertinib (TagrissoTM) for the treatment of non-small cell lung cancer (NSCLC).
Our goal is to develop NT219 in combination with approved oncology drugs to increase efficacy, expand target populations and treatment duration. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications, on our own or in collaboration with potential strategic partners. Our preliminary partnering discussions for NT219 have yielded positive feedback, and this will be a focus area for TyrNovo throughout 2018.
OUTLOOK FOR 2018
Our major goals for 2018 are:
●To submit to the FDA our study report for the recently completed Phase III/IV renal function clinical trial for Consensi. We believe the clinical study report is of major significance in that it could strengthen the drug’s labeling and support future marketing of Consensi.
●Receive marketing approval for Consensi from the FDA.
●To successfully expand our business development efforts for Consensi by entering into additional distribution or licensing agreements in the U.S. and other target markets, with an emphasis on China and other countries in Asia.
●Make significant progress towards finalizing the submission of an IND application for NT219 to the FDA in order to pave the way for the start of clinical trials in 2019.
●Continue to strengthen our patent protection for both Consensi and NT219 through the submission of various patent applications and the expansion of our existing patent families.
I want to thank you, our shareholders, for the trust you have placed in us. Our board of directors and management team is committed to continuing to unlock the substantial value in our business by leveraging our team’s deep regulatory expertise and drug development experience, complemented by targeted business development efforts, in order to maximize the potential of our therapeutic candidates.
This past year has taught us all at Kitov a great deal about our team’s special human qualities and its determination, dedication, and commitment to face any challenge.
We look forward to providing you with further updates on our continued progress throughout 2018.
Best wishes for a successful year.
Kind regards,
Mr. Isaac Israel
Chief Executive Officer"