The Aesthetic Guide Jan Feb 200 : Page 1

Merz GmbH and Co., KGaA (Frankfurt, Germany) January/February 2009 Circulation 20,000 www.miinews.com is a European pharmaceutical company with a histo- ry of compassion and innovation in healthcare that spans 100 years. In 2009 Merz will officially intro- duce a new aesthetic division of its U.S. based sub- sidiary, Merz Pharmaceuticals, LLC (Greensboro, N.C.). Among other endeavors Merz plans to intro- duce its own brand of botulinum toxin to the U.S., as well as a line of monophasic hyaluronic acid (HA) dermal fillers, which are already available in Europe. continued on page 3

Merz Enters U.S. Aesthetic Medicine Market

Kevin Wilson,

Merz GmbH and Co., KgaA (Frankfurt, Germany) is a European pharmaceutical company with a history of compassion and innovation in healthcare that spans 100 years. In 2009 Merz will officially introduce a new aesthetic division of its U.S. based subsidiary, Merz Pharmaceuticals, LLC (Greensboro,

N. C.). Among other endeavors Merz plans to introduce its own brand of botulinum toxin to the U.S., as well as a line of monophasic hyaluronic acid (HA) dermal fillers, which are already available in Europe.

As part of their launch into the U.S. aesthetic medicine market, Merz recently sponsored the development of a series of five point photonumeric scales for grading the skin aging process. The Merz Scales address the scientific need for standardization, validation and consistency of measurement that contributes to intellectual communication, education and the growth of the research community.

“Merz took an interest in the greater scientific community and put their weight behind a purely scientific endeavor. It was a phenomenal step for them to take and we are very impressed with them for doing this,” said Alastair Carruthers, M.D., a lead author of research on the Merz Scales and clinical professor of dermatology at the University of British Columbia (Vancouver, British Columbia, Canada). He and his wife Jean Carruthers, M.D., clinical professor of ophthalmology at the University of British Columbia and also lead author of research on the Merz Scales, practice aesthetic medicine in Vancouver.

“Beyond their long history, experience in healthcare products and excellent reputation, Merz’s sheer size and how they use it is what sets them apart,” conveyed Martin Kinsella, M.D., medical director of Re-enhance Skin and Body Clinic (Hale, Cheshire, England). “They are a proper pharmaceutical company with a widerange of effective, well-researched products for various fields of healthcare, but at the same time they offer a very select group of specialty products. By performing their own research and development, Merz makes sure things are done right.

They care about what they do and the people they serve.” “At Merz, we believe in the science of aesthetic medicine,” stated Jack Britts, Merz U.S.’s new president and CEO. “We understand the business of aesthetic medicine, but as a company we take the emphasis off of the aesthetic and put it on the medicine.We are mitigating the effects of aging — not just on the outside, but overall. Providing tools such as the Merz Scales and our other projects in development enables us to bring the science of aesthetics alive. There’s so much more to it than just the business of beauty.” “Our commitment can also be illustrated in other ways,” Mr. Britts continued.

“Merz manufactures products for Alzheimer’s disease and other neurological indications. We’ve also produced and marketed successful cosmeceuticals and other aesthetic products in Europe throughout our history. In the U.S. we currently have three immensely successful specialty products for dermatology: Mederma, the number one physician recommended treatment for scars; our Aqua Glycolic line of cosmeceutical creams and cleansers; and prescription Naftin* (naftifine Hcl, 1%), the number one branded prescription anti-fungal on the market. I think that with its entrance into aesthetic medicine, Merz U.S. is poised for tremendous growth over the next few years due to innovative products which will provide more choices to physicians and patients.” Mr. Britts was appointed president and CEO in September 2008. Though new to The field of aesthetic medicine, Mr. Britts’ pharmaceutical experience is extensive.

As vice president of gastrointestinal products for AstraZeneca U.S. (Wilmington, Del.) He had major involvement in the growth of Prilosec and Nexium. Mr. Britts also served as group senior vice president at Sepracor, Inc. (Marlborough, Mass.)

Where he was an instrumental player in the launch of the popular sleep aid Lunesta. “The prospect of taking the helm at Merz U.S. and spearheading the venture into neurology and aesthetic medicine domestically is exciting to me,” stated Mr. Britts. “I prefer specialty pharma at a mid-sized company over primary care and that fits the Merz philosophy. We are going to leverage our competence in clinical dermatology and pharmaceuticals to become a major player in the U.S. aesthetic medicine market, where growth has been phenomenal. This will be a fun place to make an impact.”

Another hallmark in Merz history was the 2003 development of Namenda** (memantine Hcl) for Alzheimer’s disease, the first of a new class of drugs called moderate affinity NMDA-receptor antagonists.

According to the Merz website for the drug, clinical data shows benefits in cognitive and psychomotor function, increased ability to perform tasks necessary for daily living, reduced dependence care and high tolerability. This landmark drug is currently available in the

U. S. (marketed by Forest Laboratories, Inc., New York, N.Y.) and Europe.

In essence, the Merz legacy began in Germany with founder Friedrich Merz, who in 1908 patented his first invention: a grease free, water soluble, pH-neutral base for topical therapies. “Merz started with skin therapy and it has continued to be a major part of our business ever since,” said Mary Ann Hauser, senior director of marketing for Merz Pharmaceuticals. “In 1953 Merz presented the first anti-wrinkle cosmeceutical at the international skincare convention in Paris, France and it was a huge hit.” According to Ms. Hauser, Merz put out a foaming mask cleanser in 1968 and from there the company moved into clinical dermatology with highly-respected scar treatment products. “Today we are excited to enter the aesthetic dermatology market with hyaluronic acid dermal fillers and a neurotoxin.”

Merz is taking all the necessary steps to successfully introduce and market their proprietary brand of botulinum toxin in the U.S. The product, called Xeomin in the neurology market, but still unnamed in the aesthetic market, is currently nearing the end of clinical trials. In addition, Merz plans to bring its highly successful line of injectable HA dermal fillers, called Belotero, to the U.S. Currently the line includes three products available for use in Europe: Belotero Soft, Belotero Basic and Belotero Intense, which is the newest of the three. “Belotero is the world’s first monophasic hyaluronic acid dermal filler,” noted Dr. Kinsella, who also serves as a trainer for use of Belotero products in England and is deeply involved in ongoing clinical trials for Belotero Intense.

Monophasic gel, as opposed to other bi-phasic products,” Dr. Kinsella explained. Merz hopes to introduce Belotero dermal fillers to the U.S. market in early 2010, pending completion of clinical trials and approval by the FDA.

In recognizing the need for a standardized, validated, consistent method to measure the skin aging process, Merz set forth to revolutionize aesthetic medicine by creating such a system. Merz Scales are perhaps the best example of the company’s commitment to the science of medicine.

Developed by an international team of top aesthetic physicians, the Merz Scales are a first-of-its-kind system in aesthetic medicine.

Heading up this team were Drs. Jean and Alastair Carruthers, both world-renowned luminaries with hundreds of publications and presentations between them. The two are probably best known for their pioneering work with botulinum toxin A for aesthetic medicine.

“Recent surveys have shown that the popularity of cosmetic procedures in the

U. S. has increased phenomenally, well beyond 400% over the past decade or so, with about two-thirds of those being less invasive non-surgical procedures,” said Dr. Alastair Carruthers. “This has driven the industry to new heights and companies are constantly developing new, exciting treatments that are safer and more effective than ever before. There is a clear need for standardized scales to measure the aesthetic aging process. Statistical measurement tools that are clear, validated and easy-to-use will be beneficial to researchers and practitioners across the globe.” The Merz Scales were published in the November 2008 supplement of Dermatologic Surgery (Dermatol Surg 2008 Nov; 34[S2]).

In addition to the Carruthers’, the team of physicians included Derek Jones, M.D., a board certified dermatologist in Beverly Hills, Calif.; Berthold Rzany, M.D., dermatologist and clinical epidemiologist in Berlin, Germany; Joel Cohen, M.D., board certified dermatologist in Englewood, Colo.; Martina Kerscher, M.D., a dermatologist in Germany; Timothy Flynn, M.D., board certified dermatologist in Cary,

N. C.; Corey Maas, board certified facial plastic surgeon in San Francisco, Calif.; and Gerhard Sattler, M.D., dermatologist in Darmstadt, Germany.

This team varied in gender, experience, field of specialty (dermatology, plastic surgery and ophthalmology) and age, but all are recognized as experts in their field. In August 2007, the group met With members of the Merz research and development team at the inaugural Scale Summit in Montreal, Canada, to discuss the development of a measuring system.

“We were discussing the lack of standardized methods to measure physical beauty as we age,” related Bhushan Hardas,

M. D., M.B.A., Merz Pharmaceuticals’ vice president of U.S. research and development.

“We saw this as a great opportunity to do something for the scientific community, so we focused on the most common locations that one notices aging of skin and began there.” In an effort to provide a reasonable scientific basis for standardization, the exhaustive validation process required these nine experts to repeatedly grade carefully selected sets of photographs.

Photographs included a variety of ethnic and skin types. Then the group performed a statistical comparison of these grades.

Rater comparison was done by bubble graph. “These grading tests took several days to complete. We didn’t grade each group of photos once, we tested everyone again the next day to check consistency,” said Dr. Jean Carruthers. “With our group of experts hailing from around the world and different fields within aesthetic medicine, we can feel a certain assurance that physicians everywhere will be able to adequately understand and successfully use the Merz Scales consistently, whatever their specialty or experience level.” This endeavor resulted in a series of five point grading scales. Although each scale is a bit different, experts chose to use five points, going from zero to four, based on a mutually agreed upon set of standards for usefulness. “The scales are stratified with five points, each point being easily differentiated and well described,” explained Dr. Hardas. “There is a low point, a midpoint and an endpoint. Any additional points would have created too much room for variability. Also, we only covered the span of aging that physicians would most commonly see in the clinical setting; therefore, skin at five years or ninety-five years of age is not represented.” “Many of these scales work for both the at-rest and dynamic phases, or have two components since the upper and lower lips, for example, age differently,” explained Dr. Jean Carruthers. “This system is flexible enough to deal with those issues.” According to Dr. Jean Carruthers, a grading system such as the Merz Scales offers the scientific community a standardized method of intelligently describing and discussing aging skin, which is essential. “The Fitzpatrick Skin Type scale is incredibly useful.

It’s an excellent standard for skin color that’s been successfully used for many years now,” she said. “When you consider the enormous increase in the number of physicians performing aesthetic procedures, it becomes more imperative that we have a standardized method of communication about a subject as large and important to our field as the appearance of aging skin in different areas of the body. The Merz Scales represent a leap forward by facilitating a productive, intellectual interpretation and discussion of the subject. They may also become an excellent teaching tool.” “Eventually, the Merz Scales will help us communicate with patients in every phase of the process, from pure description to management of expectations,” added Dr. Alastair Carruthers. “Our perception of what their lips look like at a given point in time, for example, may be very different from theirs. We will be able to show them pictures of other people for comparison. It will allow us to more accurately describe what we can achieve through various methods. Managing expectations is a major component of successful aesthetic medicine.” Currently, Merz Scales have been developed for the consistent aesthetic grading of brow positioning, crow’s feet, forehead lines, hands, lip fullness and marionette lines. “We actually worked on About a dozen different scales but excluded those we weren’t able to validate.

Clearly, more work is needed and we hope to be involved in that,” said Dr. Jean Carruthers. Development of scales for more indications using the same criteria is ongoing. According to Dr. Hardas, further work will be done on scales for ethnic minorities and broader areas of the face, led by Rainer Pooth, M.D., head of clinical dermatology research and development at Merz and Merz CSO Alexander Gebauer, M.D. Merz Pharmaceuticals has been nominated for the 2009 American Business Ethics Award (ABEA), which follows its November 2007 receipt of the Piedmont Business Ethics Award. “We’re very proud of our reputation and commitment to scientific and business ethics, transparency in our dealings, entrepreneurial spirit, and above all, genuine compassion for patients in need of our products,” said Mr. Britts. “We hope to finish the first quarter of 2009 with a bang, by introducing ourselves to the aesthetic community at this year’s American Academy of Dermatology meeting in San Francisco, Calif., where the Merz Scales will make their debut.” In addition to its German headquarters and U.S. business, the Merz Group currently operates branches in France, Great Britain, Italy, Luxembourg, Mexico, Austria, Russia, Switzerland and Spain.

Merz Group and its numerous subsidiaries are focused primarily on neurological and psychiatric illnesses, clinical and aesthetic dermatology, dental and orthodontic products, over-the-counter medication, personal hygiene products, healthcare facility hygiene products and some ancillary business services and manufacturing that is unrelated to healthcare.

“This past year was the best in Merz Group’s history. We’re hoping to eclipse that in 2009,” said Mr. Britts.

“Today, the world is undergoing an unprecedented process of political, economic and social change,” Mr. Britts continued.

“The economy is uncertain but new markets in many countries are opening up. The aesthetic market is still growing, especially in the U.S., despite an economic downturn. Aesthetic medicine will die without evidence based science and a continuously renewing process of innovation. Merz is committed to this belief and I am proud to be a part of this exciting phase of what will be a major addition to the Merz legacy.”

Publication List