Melinta Therapeutics Acquires U.S. Rights to TOPROL-XL® (metoprolol succinate) from New American Therapeutics

MORRISTOWN, N.J.--(BUSINESS WIRE)--Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today that it has acquired the U.S. rights to TOPROL-XL^® (metoprolol succinate) and its Authorized Generic (AG) through an agreement between Melinta and New American Therapeutics Inc.

TOPROL-XL^®, approved by the FDA in 1992, is a cardioselective beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensives; the long-term treatment of angina pectoris; and the treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins.

Said Christine Ann Miller, President and Chief Executive Officer, Melinta Therapeutics, “This acquisition immediately expands and diversifies our existing portfolio and serves as fuel for accelerating our long-term growth strategy and enhancing our profitability. We will continue to aggressively pursue portfolio expansion that aligns with our mission of providing innovative therapies for acute and life-threatening illnesses.”

“We are extremely proud of our work to provide access to this lifesaving medication,” said Michael Anderson, CEO, New American Therapeutics. “Melinta shares this same commitment to patient access. And they demonstrate that commitment through an impressive supply chain and distribution network that ensures this medication will continue to be available for those patients who need it.”

Melinta has begun the integration process to bring TOPROL-XL^® into the company’s existing production, distribution and commercialization structure to ensure this important medication will continue to be made available without interruption.

Terms of the transaction were not disclosed.

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: BAXDELA^® (delafloxacin), KIMYRSA™ (oritavancin), MINOCIN^® (minocycline) for Injection, ORBACTIV^® (oritavancin), and VABOMERE^® (meropenem and vaborbactam) and a commercial-stage cardiovascular product: TOPROL-XL^® (metoprolol succinate). With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Visit www.melinta.com for more information.

TOPROL-XL^® is a registered trademark of AstraZeneca Pharmaceuticals LP and is used with permission.

About TOPROL-XL® (metoprolol succinate)
TOPROL-XL® is a beta-adrenergic blocker indicated for the treatment of:

• Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions
• Angina Pectoris
• Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure

IMPORTANT SAFETY INFORMATION
Contraindications

• Known hypersensitivity to product components.
• Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker.
• Cardiogenic shock or decompensated heart failure.

Warnings and Precautions

• Abrupt cessation may exacerbate angina pectoris or myocardial ischemia. Reduce dosage gradually over a period of 1 to 2 weeks and monitor the patient. Warn patients not to discontinue without their physician’s advice.
• Heart Failure: Worsening cardiac failure may occur during up-titration.
• Bronchospastic Disease: Avoid beta blockers.
• Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of TOPROL-XL. Patients with first-degree atrioventricular block, sinus node dysfunction, conduction disorders (including Wolff- Parkinson-White) or on concomitant drugs that cause bradycardia (digitalis glycosides, clonidine, and diltiazem and verapamil) may be at increased risk. Monitor heart rate.
• Pheochromocytoma: Initiate therapy with an alpha blocker.
• Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing noncardiac surgery. Do not routinely withdraw chronic beta blocker therapy prior to surgery.
• Diabetes and Hypoglycemia: May mask tachycardia occurring with hypoglycemia.
• Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm.
• Peripheral Vascular Disease: Can precipitate or aggravate symptoms of arterial insufficiency.
• Patients may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.

Adverse Reactions
Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash.