- Kitov to receive $3.5M milestone payments and 40% - 60% of net profit on sales of Consensi ™
- Coeptis to cover all CMC, sales, and marketing expenses
TEL AVIV, Israel, Jan. 03, 2019 (GLOBE NEWSWIRE) -- Kitov Pharma (NASDAQ/TASE: KTOV), an innovative pharmaceutical company, today announced it has signed an exclusive marketing and distribution agreement with Coeptis Pharmaceuticals for the U.S. market. Coeptis will commercialize Kitov’s combination drug, Consensi™, intended to simultaneously treat osteoarthritis pain and hypertension.
The agreement provides for total milestone payments from Coeptis to Kitov of $3.5 million, of which Kitov has already received the initial milestone upon execution of the agreement, and additional milestone payments are due upon completion of an agreed Chemistry, Manufacturing, Contol (CMC) plan and upon first commercial sales in the U.S. In addition, Kitov will be paid 40%-60% of Coeptis’ net profit on Consensi™ sales. The agreement is for a term of fifteen years and may be extended for additional two-year terms and includes customary provisions, as well as certain residual rights and obligations of the parties following termination.
Consensi™, under patent protection in the U.S. until 2030, is expected to be launched during 2019, and will be the only NSAID whose labeling indicates a reduction of blood pressure and consequent risk reduction of heart attack, stroke and death. For patients, Consensi™ treats two conditions simultaneously, thereby increasing convenience (one pill instead of two) and may offer lower co-pays. The therapy may contribute to improved patient compliance and improved patient health, thereby lowering overall health care costs.
The agreement with Coeptis is Kitov’s third licensing and distribution agreement as part of its worldwide commercialization plans for Consensi™. Kitov has previously signed licensing and distribution agreements for the drug in China and South Korea, and Kitov is currently evaluating additional commercialization agreements in major markets worldwide.
“This commercialization structure for Consensi™ is one that we believe optimizes Kitov’s near and long-term cash flows, enabling us to continue to develop and deliver additional innovative pharmaceuticals, while maximizing ROI for our shareholders. We are very pleased by the opportunity to work with Coeptis and its outstanding team of executives with strong track records in the pharmaceutical industry and look forward to Consensi™ creating better patient compliance and improved treatment for people living with osteoarthritis pain and hypertension,” Kitov’s CEO, Isaac Israel stated. “In the U.S., an estimated 44% of adults have both hypertension and osteoarthritis. Currently, these patients are not well served. We believe that successful commercialization of Consensi™ in the U.S. will be a transformational value-creating event for Kitov.”
David Mehalick, CEO of Coeptis, said, “Consensi™ will substantially improve treatment for patients living with two highly prevalent chronic conditions, delivering improved clinical outcomes and enhanced economics for healthcare providers. We anticipate launching Consensi™ in the second half of 2019 and expect to have it widely available to the millions of Americans who can benefit from this combination treatment.”
Full US Prescribing Information, including BOXED WARNING and Medication Guide is available at: www.consensi.com.
Indications and Usage:
Consensi™ is a combination of amlodipine besylate, a calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions.
Limitations of Use:
Consensi™ is only available in a celecoxib strength of 200 mg and is only to be taken once daily.
Important Safety Information (ISI) for Consensi™
The following ISI is based on the Highlights section of the U.S. Prescribing Information for Consensi™. Please consult the full Prescribing Information for all of the labelled safety information for Consensi™.
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
Consensi™ is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Consensi™ is contraindicated in patients with a known hypersensitivity to amlodipine, celecoxib or any of its inactive ingredients.
Consensi™ is contraindicated in patients with a known history of asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs and in the setting of CABG surgery.
Consensi™ is contraindicated in patients with known demonstrated allergic-type reactions to sulfonamides.
Significant warnings and precautions related to Consensi™ include the following:
Patients should be warned about the potential signs and symptoms of hepatotoxicity and hepatic failure. Physicians should discontinue Consensi™ if abnormal liver tests persist or worsen, or if clinical signs and symptoms of liver disease develop.
Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Physicians should carefully monitor blood pressure.
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.
Worsening angina and acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease, is possible.
Physicians should avoid use of Consensi™ in patients with severe heart failure.
Physicians should monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia, and avoid the use of Consensi™ in patients with advanced renal disease.
Patients should seek emergency help if an anaphylactic reaction occurs.
Consensi™ is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Physicians should discontinue Consensi™ at the first appearance of skin rash or other signs of hypersensitivity.
NSAIDs such as Consensi™ can cause premature Closure of Fetal Ductus Arteriosus.
Avoid use in pregnant women starting at 30 weeks of gestation.
Physicians should monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
Consensi™ is not recommended in patients with moderate or severe hepatic impairment or severe renal insufficiency.
Consensi™ is not recommended in Poor Metabolizers of CYP2C9 Substrates.
To report SUSPECTED ADVERSE REACTIONS, contact Kitov Pharma at 1-800-651-6606 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
About Coeptis Pharmaceuticals
Coeptis Pharmaceuticals, Inc. is a privately held biopharmaceutical company engaged in the acquisition, development and commercialization of branded and generic pharmaceutical products. The company owns an expansive portfolio of biotechnology assets encompassing a wide array of treatments including advanced innovations for cellular therapies such as CAR-T and CAR-NK with a focus on cancer, and various small molecule therapies for neurological based indications. Headquartered near Pittsburgh, PA, the company holds a robust pipeline of products in various stages of development and commercialization. http://www.coeptispharma.com (Information provided by Coeptis.)
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is an innovative pharmaceutical drug development company. 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, was approved by the FDA for marketing in the U.S. In addition, Kitov’s NT219, 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.
Forward-Looking Statements and Kitov's Safe Harbor Statement
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For further information, contact:
Deputy CEO & Chief Financial Officer