Merz Pharmaceuticals' Belotero(R) Balance PMA Filing Formally Accepted for Review by the FDA

Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merz's premarket approval (PMA) application for Belotero(R) Balance.

Belotero(R) Balance is a hyaluronic acid based monophasic gel dermal filler that utilizes a cohesive polydensified matrix (CPM(TM)) technology. This application seeks FDA approval for injection into mid-to-deep dermis for correction of moderate to severe wrinkles and folds.

"The FDA's acceptance for review of the Belotero(R) Balance PMA begins the application review process and signifies the beginning of Merz Pharmaceutical's firm footprint in the American aesthetics market," said Jack Britts, president and CEO of Merz Pharmaceuticals, LLC.

"Upon approval, Belotero(R) Balance will be an exciting addition to the dermal filler category," said Dr. Rhoda S. Narins, M.D., the lead investigator for the Belotero(R) clinical trials.

American Academy of Dermatology Recognizes Merz Pharmaceuticals

MEDERMA(R) CREAM PLUS SPF 30: First Scar Product to Receive AAD SEAL OF RECOGNITION(R)

GREENSBORO, N.C., - The American Academy of Dermatology (AAD) has honored Merz Pharmaceuticals with its first-ever recognition of a scar product for its sun-protection benefit. The AAD SEAL OF RECOGNITION(R) recognizes over-the-counter products for their sun-protection benefit based on review of independent testing results by an independent scientist and a panel of dermatologists to verify that the products meet stringent, evidence-based sun-protection criteria. Mederma(R) Cream plus SPF 30 is the first scar product to receive this distinction.(1)

According to the AAD, sun exposure is the most preventable risk factor for all skin cancers, including melanoma, and is primarily responsible for premature aging.

"Public health education is the first line of defense against skin cancer," said dermatologist David M. Pariser, M.D., president of the AAD. "The AAD SEAL OF RECOGNITION(R), awarded only to those products that meet stringent, evidence-based scientific criteria for sun protection, helps raise public awareness of the dangers of unprotected sun exposure. Scars are particularly sensitive to the sun's harmful ultraviolet A (UVA) and ultraviolet B (UVB) rays which can worsen the appearance of the scar. To help minimize the appearance of scars, it is imperative to protect the skin and apply sunscreen. The AAD recognizes that proper and regular use of broad-spectrum (UVA/UVB) protection sunscreens with Sun Protection Factor (SPF) 15 or higher, along with wearing sun-protective clothing and seeking shade, will help protect against sunburn and may reduce long-term damage to the skin caused by sun exposure."

"Mederma(R) Cream plus SPF 30 is the only scar product with SPF 30 that can help reduce the appearance of scars and protect them from sun exposure," said Mikael Svensson, Merz' Vice President of Medical and Aesthetic Dermatology. "Mederma(R) Cream plus SPF 30 is effective on scars resulting from surgery, injury, burns, acne and stretch marks. As the #1 doctor-recommended brand for scars for 10 years, Mederma(R) is a product that delivers on its promises. It's clinically proven to soften, smooth, and reduce the appearance of scars."

Tips for scar management:

Because scars are sensitive to sun, apply Mederma(R) Cream plus SPF 30 thirty minutes prior to heading outdoors, so the skin has a chance to absorb the protective ingredients. If outside, reapply every two hours, or after every significant sporting activity or water submersion.(2)

Pressure bandages and massages can flatten some scars if used on a regular basis for several months.(3)

If cosmetics are applied correctly, they can be very effective at covering up scars. The correct make-up will improve the appearance while nature completes the healing process.(4)

Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Di

SEATTLE, - Results from two prospective, double-blind placebo controlled multi-center studies in patients with cervical dystonia and blepharospasm, and pooled European efficacy and safety data in patients with focal dystonia and upper limb spasticity will be presented at the American Academy of Neurology's (AAN) 61st annual meeting in Seattle. The studies were sponsored by Merz Pharmaceuticals, which plans to file a Biologic License Application (BLA) for NT-201 in the USA in the near future.

"The data to be presented at AAN complement the European data. We now have robust U.S. data for Xeomin (the brand name for NT-201 in Europe) for the symptomatic management of movement disorders," said Eric Pappert, M.D., Vice President of Medical Affairs, Merz Pharmaceuticals, USA.

NT-201 is a botulinum neurotoxin type A free from complexing proteins approved for marketing in Europe since 2007 to treat various movement disorders, and recently approved in Canada for the indications of symptomatic management of blepharospasm, cervical dystonia and post-stroke spasticity of the upper limb. Through advanced manufacturing processes, NT-201 combines high biologic activity with low bacterial protein load, making it a neurotoxin therapy free from complexing proteins. In pre-clinical work, the exposure to complexing proteins has been found to heighten the immune system response to botulinum toxin.

"Xeomin - the proposed brand name for NT-201 -- potentially offers a new option to treat movement disorders. Because Xeomin combines high biologic activity with low protein load, it is a neurotoxin that is free from complexing proteins," said David M. Simpson, M.D., Professor of Neurology and Neuromuscular Diseases at Mount Sinai Medical Center in New York and a leading botulinum neurotoxin researcher.

The NT-201 data will be presented at the AAN's annual meeting. The data include poster p07.088, Efficacy and safety of NT-201 (Botulinum neurotoxin free from complexing proteins) in cervical dystonia, poster p07.081, Clinical efficacy in focal dystonia and overall tolerability of NT-201 (botulinum neurotoxin free from complexing proteins) and poster p07.091, Efficacy and safety of NT-201 (Botulinum neurotoxin free from complexing proteins) in Blepharospasm.

Joseph Jankovic, M.D. Professor of Neurology, Distinguished Chair in Movement Disorders, and Director of the Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine in Houston and a lead investigator of the blepharospasm study noted that "these promising data indicate that following approval, Xeomin will become an important treatment option for movement disorders."