Merz, Inc. Announces the Completion of the Acquisition of ONMEL™ Oral Treatment for Fungal Infections of the Toenail in Patients with a Normal Immune System

The addition of ONMEL™ reflects Merz, Inc’s commitment to leadership in antifungal therapy

GREENSBORO, N.C.--(BUSINESS WIRE)--Merz, Inc. (U.S. affiliate of Merz Pharma Group) today announced the completion of the acquisition of ONMEL™ (itraconazole), an azole antifungal that is indicated for the oral treatment of onychomycosis of the toenail caused by Trichophyton rubrum or T. Mentagrophytes in non-immunocompromised patients. ONMEL™ is the only FDA-approved oral treatment dosed in a once-a-day 200mg single tablet of itraconazole. ONMEL™ uses Meltrex^® (melt extrusion) Technology.

“Onychomycosis is difficult to treat because human nails grow slowly and receive very little blood supply”

Onychomycosis is a fungal infection of the toenails or fingernails that cause the nail to thicken, discolor, disfigure, and split. Half of all nail disorders are caused by onychomycosis, and it is the most common nail disease in adults.

“Onychomycosis is difficult to treat because human nails grow slowly and receive very little blood supply,” said Alan B. Fleischer Jr, MD, Executive Director of Dermatology at Merz Pharmaceuticals, LLC.

“The acquisition of ONMEL™ fits with our vision to continue our leadership in antifungal therapy,” said Jim Hartman, vice president, dermatology of Merz, Inc. “Merz currently has the #1 branded prescription topical antifungal, Naftin^® in the U.S. marketplace. ONMEL™ is the perfect addition to our antifungal product portfolio.”

About ONMEL™

ONMEL™ (itraconazole), an azole antifungal, was approved by the FDA in April 2010 and is indicated for the treatment of onychomycosis of the toenail caused by Trichophyton rubrum or T. mentagrophytes in non-immunocompromised patients. Recommended dosing is one 200mg tablet once daily for 12 consecutive weeks.

IMPORTANT SAFETY INFORMATION

Boxed WARNING: CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS

Do not administer ONMEL™ for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur during administration of ONMEL™, discontinue administration.

Drug Interactions: Co-administration of cisapride, pimozide, quinidine, dofetilide, levacetylmethadol (levomethadyl), felodipine, oral midazolam, nisoldipine, triazolam, lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) or methadone with ONMEL™ is contraindicated. ONMEL™, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), methadone or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors.

Please see Full Prescribing Information, including Medication Guide for more information.

CONTRAINDICATIONS

• Do not administer for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
• Do not administer for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy.
• Co-administration of cisapride, dofetilide, ergot alkaloids such as dihydroergotamine, ergotamine, ergometrine (ergonovine), and methylergometrine (methylergonovine); felodipine, levacetylmethadol (levomethadyl), lovastatin, methadone, oral midazolam, nisoldipine, pimozide, quinidine, simvastatin, and triazolam with ONMEL™ is contraindicated.
• Anaphylaxis and hypersensitivity have been reported with use of itraconazole. ONMEL™ is contraindicated in patients who have shown hypersensitivity to itraconazole products.

WARNINGS AND PRECAUTIONS

• Cases of CHF, peripheral edema, and pulmonary edema have been reported with itraconazole administration among patients being treated for onychomycosis and/or systemic fungal infections.
• Cardiac Dysrhythmias
• Cardiac Disease
• Hepatic Effects
• Calcium Channel Blockers
• Neuropathy
• Hearing Loss

ADVERSE REACTIONS

• Most common adverse reactions observed in the treatment phase of the onychomycosis clinical trial (>1%) are upper respiratory tract infections, increased hepatic enzymes, hypoacusis, headache, abdominal pain, diarrhea, nausea, fatigue, arrhythmia, cough, sore throat and back pain.
• Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death.

To report SUSPECTED ADVERSE REACTIONS, contact Merz Pharmaceuticals, LLC at 1-877-743-8454 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Concomitant administration of ONMEL™ Tablets with certain drugs metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) or transported by P-glycoprotein may result in increased plasma concentrations of those drugs, leading to potentially serious and/or life-threatening adverse events.
• Drug Interactions with the following drugs or classes of drugs may occur: Antiarrhythmics, Anticonvulsants, Anti-HIV Agents, Antimycobacterials, Antineoplastics, Antipsychotics, Benzodiazepines, Calcium Channel Blockers, Gastric Acid Suppressors/Neutralizers, Gastrointestinal Motility Agents, HMG CoA-Reductase Inhibitors, Macrolide Antibiotics, Oral Hypoglycemic Agents, Polyenes, Opiate Analgesics. Not all drug interactions are included in Highlights. See Full Prescribing Information for complete listing.

USE IN CERTAIN POPULATIONS

• Pregnancy: Based on animal data, may cause fetal harm.
• Nursing Mothers: Itraconazole is excreted in human milk.
• Pediatric Use: The efficacy and safety have not been established in pediatric patients. No pharmacokinetic data are available in children.

Please see full Prescribing Information for ONMEL™, including Boxed WARNING, available at www.merzusa.com.

About Merz, Inc.

Merz, Inc. is a focused specialty healthcare company that is responsible for developing and commercializing innovative products and solutions in neurology, medical aesthetics, and dermatology in the U.S. For more than 100 years, the development of our products has been based on our commitment to innovative medical approaches that earn trust among patients, physicians, customers and partners worldwide. Our ambition is to become a recognized leader in the treatment of movement disorders, as well as aesthetic and dermatologic conditions. Our pipeline is promising, and with new therapeutic options we will continue our commitment to improving patients’ lives.

About Merz Pharma Group

Merz Pharma Group is a privately owned company, founded in 1908 in Frankfurt, Germany. The companies of Merz Pharma Group are focused on medications for treating neurological and psychiatric illnesses and thereby assume a leading role in the field of Alzheimer’s disease research. Another important area of competency of Merz Pharma Group is Clinical Dermatology and Aesthetic Medicine. Merz Pharma Group is also active in the Health sector outside of the pharmacy. In the field of consumer products, with its established brands of tetesept^® and Merz Spezial^®, Merz Consumer Care is a leading provider of products for self-medication, nutritional supplements, and skin care.

Meltrex^® Technology is a registered trademark of Abbott Laboratories.