CINCINNATI--(BUSINESS WIRE)--Symplmed announced today that it has acquired U.S. rights to ACEON® (perindopril erbumine tablets), an angiotensin converting enzyme (ACE) inhibitor approved to treat patients with high blood pressure (hypertension) and reduce the risk of heart attack in patients with stable coronary artery disease. This acquisition completes Symplmed’s ownership of the perindopril franchise in the United States.
ACEON is the first marketed product for Symplmed and is available through its proprietary web portal, DyrctAxess™, as part of a comprehensive hypertension-management offering. The Company anticipates adding to its perindopril franchise with FDA approval of its investigational drug Prestalia®, a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. If approved, this will be the first FDC of these two important medicines for the treatment of hypertension in the United States.
“The ACEON acquisition is an important milestone for Symplmed as we continue building our commercial presence in the United States," said Erik Emerson, President and CEO of Symplmed. “We look forward to supporting ACEON and its loyal patients while continuing to grow our product portfolio through the perindopril program and industry partnerships.”
ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of blood pressure-reducing medications. Common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain. ACEON is contraindicated in patients with hereditary or idiopathic angioedema. Rare cases of angioedema, including intestinal angioedema, have been reported. ACEON is also contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor.
ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Common adverse events leading to discontinuation were cough, drug intolerance and hypotension. Rare cases of angioedema, including intestinal angioedema, have been reported. ACEON is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor.
Important Safety Information for ACEON
WARNING: FETAL TOXICITY
|When pregnancy is detected, discontinue ACEON as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury to or death of the developing fetus.|
Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s proprietary technology platform, which powers the DyrctAxess™ web portal, enables direct delivery of medications to a patient’s home and eliminates the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach with the goal of providing all the medications necessary to manage a particular disease state to its DyrctAxess members. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine tablets) and Prestalia®, a fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate that is currently under review by the FDA. Symplmed also plans to expand its pipeline in six additional therapeutic areas. For more information, visit www.symplmed.com.
All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.