Symplmed Announces FDA Orange Book Listing For Two Prestalia Patents

CINCINNATI--(BUSINESS WIRE)--Symplmed Pharmaceuticals announced today that two patents covering Prestalia® (perindopril arginine and amlodipine besylate) are now listed in the U.S. Food and Drug Administration’s (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The two Prestalia patents (6696481 and 7846961) offer product exclusivity until 2029.

The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug and Cosmetic Act.

About Prestalia

Prestalia contains perindopril arginine, an ACE inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with Prestalia.

Patients with moderate-to-severe hypertension are at a relatively high risk of cardiovascular events (e.g., stroke, heart attack, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient’s baseline blood pressure, target goal, and the incremental likelihood of achieving the goal with a combination product, such as Prestalia, versus a monotherapy product when deciding upon initial therapy. Individual blood pressure goals may vary based on the patient’s risk.

Important Safety Information for Prestalia

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue Prestalia as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury to or death of the developing fetus.

Prestalia is contraindicated in patients with hereditary or idiopathic angioedema, with or without previous angiotensin converting enzyme (ACE) inhibitor treatment, and in patients who are hypersensitive to perindopril, to ACE inhibitors, or to amlodipine. Rare cases of angioedema, including intestinal angioedema, have been reported in patients treated with ACE inhibitors. Do not co-administer aliskiren with ACE inhibitors, including Prestalia, in patients with diabetes.

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Prestalia, particularly in patients with severe obstructive coronary artery disease. In patients at risk of excessive hypotension, start Prestalia therapy under close medical supervision. Follow patients closely for the first 2 weeks of treatment and whenever the dose of Prestalia is increased or a diuretic is added or its dose increased. Monitor renal function periodically in patients treated with Prestalia. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.

The most common adverse events associated with Prestalia include peripheral edema, cough, headache, and dizziness.

Please read the Prescribing Information about Prestalia at http://www.prestalia-us.com/.

About Symplmed

Symplmed Pharmaceuticals is a privately held 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 patented technology platform, DyrctAxess^™, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON^® (perindopril erbumine) and Prestalia^® a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.symplmed.com.

Forward-Looking Statement

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.