Kitov Pharma Provides Update on Planned U.S. Launch of Consensi and Provides Three-Year Revenue Forecast - Seite 2

About Consensi

Consensi is a fixed-dose combination of amlodipine besylate, a calcium channel blocker for the treatment of hypertension, to lower blood pressure, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID) for the management of the signs and symptoms of osteoarthritis. The U.S. Food & Drug Administration (FDA) approved Consensi oral tablets for marketing and Kitov is partnered in the U.S, China and South Korea.

For additional information see DailyMed, Full Prescribing Information, including BOXED WARNING and Medication Guide.

Important Safety Information (ISI) for Consensi

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. CONSENSI contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with duration of use. Do not take CONSENSI right before or after a heart surgery called a “coronary artery bypass graft” (CABG). Avoid taking CONSENSI after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. NSAID medications, like celecoxib, cause an increased risk of bleeding, ulcers, and tears (perforation) of the esophagus, stomach, and intestines, at any time during treatment, which can occur without warning and may cause death. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

What is the most important information I should know about Consensi?

Consensi contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

• with increasing doses of NSAIDs
• with longer use of NSAIDs

Do not take Consensi right before or after a heart surgery called a “coronary artery bypass graft” (CABG).