FDA Approves EVOLENCE®, a New Generation Collagen-Based Facial Filler

Herzliya, Israel and Morris Plains, NJ − The U.S. Food and Drug Administration (”FDA”) today announced the approval of EVOLENCE® for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. EVOLENCE® is a new advanced collagen-based structural dermal filler, and a first of its kind product. The introduction of EVOLENCE® marks the first dermal filler entry for the Aesthetics Group of OrthoNeutrogena. While new to the United States, EVOLENCE® has been available in other markets such as in Canada, Western and Eastern Europe, Israel, South Korea and Russia since 2004.

“EVOLENCE® represents a new generation of facial fillers, an innovative structural agent providing beautiful, immediate results by replacing the collagen lost with long-lasting, naturally sourced collagen,” said Annie Heremans, M.D., Ph.D., Vice President, responsible for the Company’s research and development of the Medical and Aesthetic Dermatology franchises. “We are pleased to enter the U.S. aesthetic space with a differentiated dermal filler designed for optimal patient outcomes. Given our rich heritage in skin care and and commitment to science, we anticipate EVOLENCE® will be a welcome addition to current aesthetic treatment options.”

EVOLENCE® will be introduced throughout the second half of 2008, in coordination with physician training, to ensure optimal patient satisfaction and outcomes.

EVOLENCE® represents a breakthrough in aesthetics. As one of nature’s most fundamental and abundant building blocks, collagen comprises up to 80% of the dermis and it helps maintain skin strength, structure and support. Collagen naturally breaks down as a person ages, leading to the appearance of wrinkles, lines and folds.

EVOLENCE®, and its proprietary GLYMATRIX™ Technology, uses naturally sourced collagen to replace the body’s lost collagen, adding volume and structural support in depleted areas, for a more naturally youthful appearance. In addition, no pre-test is needed, and GLYMATRIX™ Technology delivers longer-lasting durability than previous collagen dermal fillers.

Results are visible and immediate at the time of treatment, with minimal to no bruising or swelling, allowing physician and patient to gauge the amount of wrinkle correction with more precision. EVOLENCE® is recommended for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds, to be injected in the mid-to-deep dermis.

“We now have a collagen filler that does not require a pre-test and delivers immediate, beautiful and
natural-looking results that last with minimal to little downtime for the patient,” said Z. Paul ” said Z. Paul Lorenc, M.D., F.A.C.S., Assistant Professor of Surgery, New York University School of Medicine and Principal Investigator on the EVOLENCE® U.S. pivotal study. “EVOLENCE® consistent and predictable results for all patients with every treatment.”
About EVOLENCE®

EVOLENCE® is an advanced collagen-based structural dermal filler that provides long-lasting treatment of moderate to deep facial wrinkles and folds, such as nasolabial folds. The results of treatment with EVOLENCE® are immediate, with little to no downtime post-treatment and clinically proven to last through six months. Additional data for 12-month duration approval is being filed with the FDA.

Unlike other dermal fillers that use hyaluronic acid (HA), which absorb water to create their effect, EVOLENCE® is a true structural agent due to its three-dimensional collagen matrix. This collagen structure benefits patients as it is directly linked to the minimal bruising and swelling that might result. EVOLENCE® does not use chemicals for cross-linking like many other products do, but instead uses natural sugar to improve durability. EVOLENCE® collagen is cross-linked through its patented GLYMATRIX™ Technology using the natural sugar, D-Ribose. The GLYMATRIX™ process is designed to:

- Mimic naturally occurring collagen in the skin by creating a true structural framework with natural, durable cross-links to ensure filler longevity
- Provide consistent and predictable results
- Use natural ingredients for natural-looking results

The naturally sourced porcine collagen used in EVOLENCE® is the most genetically similar to human collagen and has been used safely and effectively for decades in various medical applications, including heart valve replacement.

This new generation collagen filler is intended for injection into the mid-to-deep dermis for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. The most common side effects of EVOLENCE®injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon.

EVOLENCE®® has undergone rigorous testing and has been demonstrated to be safe and effective through clinical studies. For more information on the product, visit www.evolence.com.
About OrthoNeutrogena, Aesthetics Group

EVOLENCE® is marketed in the United States by the Aesthetics Group of OrthoNeutrogena, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and part of the Johnson & Johnson family of companies. This innovative collagen structural dermal filler was developed by ColBar LifeScience, Ltd., a biotechnology company specializing in reconstructive medicine and tissue engineering. The company has perfected a technique in which collagen, a main building block of living organisms, can be purified and transformed so as to create a variety of products that are structurally stable and safe for medical applications. ColBar LifeScience Ltd., is also subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Aesthetics Group of OrthoNeutrogena
800.EVOLENCE (386-5362)
www.evolence.com

Source: OrthoNeutrogena

Nature: Beauty’s Favorite Muse
Sothys Introduces Eco-Certified Organic Beauty Range September 2008

New York, NY – Green living has gone from novelty to mainstream in just a few short years. Where organic food, clothing, and cosmetics were once looked upon with skepticism, they are now expected to perform equally if not better than their non-organic counterparts. Today, consumers are becoming increasing savvy about their eco-friendly purchases and require validation that the products they are using are truly friendly for their bodies and the environment.

Luxury skincare company Sothys began its organic movement in 2006 with the foundation of the Les Jardins Sothys™, a botanical garden in France. “Through the creation of the Sothys botanical garden in the Xaintrie region of France, a multitude of plants have offered unbelievable biodiversity, to the extent that it was named in the European Ecological Heritage of the Natura 2000 project,” says Sothys Chairman Bernard Mas. According to Mas, the creation of an organic beauty line has been a huge project for the entire company, “for Sothys to introduce an organic range, we knew we had to pair nature and science, which took a huge commitment – we didn’t want to put out anything less than a Sothys quality product.”

After two years of research partnered with the local University of Limoges in France, Sothys will introduce five new EcoCert approved organic products in September of 2008. In typical Sothys fashion, every product not only meets EcoCert standards, but also soars above and beyond expectations in terms of efficacy for the skin. According to Mas, “as organic products become more advanced, beauty consumers expect products to be top-of-the-line in terms of both their credibility and effectiveness. Through EcoCert, Sothys has created products that are not only effective in treating the skin but meet the highest standards of organic certification, which is an extremely important factor for consumers living the green lifestyle.”

The Beauty Garden Organic Range by Sothys
The Beauty Garden Range by Sothys will be growing over time, with their initial organic offering including a range of five face and body products formulated with natural ingredients each carrying the EcoCert Organic Cosmetics Label, which guarantees that 95% of the ingredients are of natural origin and a minimum of 10 percent of the ingredients come from organic farming. The Beauty Garden Range by Sothys contains between 99.5 percent and 100 percent natural ingredients. Between 10 percent and 100 percent of those ingredients were grown and harvested using organic farming methods.

Make-Up Removing Fluid with Cherry Bud
A fluid with a light consistency created to smoothly remove facial and neck makeup, while leaving the skin soft, clear and feeling fresh. Price $30

Floral Water with Angelic and Hawthorn
A soft and fresh lotion that’s ideal for completing make-up or mask removal, as well as tone the skin gently and evenly. Price $30

Comfort Mask with Helianthus and Rosemary
A mask for all skin types that awakens the radiance of the complexion, softens the skin and brings instant comfort and softness. Price $34

Gentle Face Care with Helianthus and Rosemary
A gentle facial cream infused with rosemary essential oil. Its texture instantly melts into the skin, providing comfort and radiance to normal and combination skin types, leaving the skin glowing with vitality. By protecting the skin, it helps delay the onset of the first signs of aging. Price $52

Milky Body Fluid with Cherry Bud and Lavender
A fresh and melting texture for a smooth and quenched skin, this body milk envelops the skin with a veil delicately scented with lavender essential oil. Price $36

Actives Organic Substances Found in the Sothys Beauty Garden Range
Each Beauty Garden product contains Sothys’ exclusive Vegetal Moisturizing Activator™ (VMA), which is a moisturizing complex derived from three plants (cherry trees, angelica and hawthorn) and combined with glycerin obtained from plants. VMA reinforces the barrier function of the skin by maintaining hydration of the stratum corneum and protecting the epidermis from outside aggressions. The barrier then protects the skin from environment and aging effects with a scientifically proven hydrating layer – tests performed by Sothys in conjunction with the University of Limoges found the VMA increased hydration of the skin by 34%, which reinforces the barrier function of the skin.

Organic Extract of Cherry Buds
The extract of cherry buds is rich in sugars and inorganic substances and also contains flavonoids. As is the case for all extracts of buds, its richness in growth substances confers regenerating and energizing effects on the skin. In addition, the composition of the extract of cherry buds is recognized for its hydrating properties, which makes it ideal for moisturizing, regenerating and energizing the skin.

Organic Extract of Hawthorn
Hawthorn is a shrub that blossoms in the spring. Hawthorn flowers are white and highly aromatic, which is the source of the organic extract. Hawthorn floral water alleviates stress, is antioxidant, anti-age and venotonic.

Organic Extract of Angelica
The extract of angelica is obtained from the root of the plant. It contains polyphenols, tannins, flavonoids and an essential oil, which helps limit the appearance the first signs of aging, bacteria, and relaxes the epidermis.

Plant Glycerin
Combined with the three plant extracts describe above, it is recommended for its anti-dryness and moisturizing properties.

Helianthus (Organic Sunflower) Oil
Sunflower oil contains essential fatty acids and is particularly rich in Omega-6 and Omega-9, which restore the youth and elasticity of the skin, and combat skin dehydration and aging. It hydrates the skin by reducing transepidermal water loss, restores lipids by reconstituting the fatty acid balance.

Essential Oil of Rosemary
The essential oil of rosemary is recognized as a tonic and stimulant, and can aid cell revitalization and has anti-wrinkle properties.

Essential Oil of Bulgarian Lavender
Essential oil of lavender is recognized for several properties including soothing, calming and relaxing, and aids in the regulation of the nervous system.

Beauty Garden® Organic Spa Treatment with VMA
Sothys introduces the Beauty Garden Organic Spa Treatment, a 40-minute facial performed with Beauty Garden professional products for all skin types. The treatment utilizes Sothys’ model for a combination of professional and home care treatments. The result is skin that is soft and radiant, thanks to consistency in treatment.

The Mas family believes that with the introduction of the Beauty Garden Range, they can help to raise the bar for beauty companies considering joining the organic movement, an achievement that would be a victory for everyone involved. According to Mas, “the Beauty Garden Range is Sothys’ way of melding family tradition with a socially conscious trend. Our beauty garden in France has enabled us to support ecotourism and research, through a love of beauty and the environment.”

ABOUT SOTHYS
In 1946, Sothys was a beauty institute in Paris, where a list of exclusive customers enjoyed fine French products created by Dr. Hotz, a medical biologist. Sothys was acquired by the Mas family in 1966 and chairman Bernard Mas decided to add to the beautiful Sothys range and increase its availability. By 1970 Sothys had entered the United States market under the direction of esthetician Christian Garces. Sothys became an instant hit for estheticians looking for a professional, results- oriented product line. Over two decades later, it continues to be the forerunner in an extremely demanding industry. Much of Sothys’ success is due to its focus on education. Not content to simply sell its products, Sothys offers continuous, complementary education to estheticians and therapists who want to learn not just about the products, but about the industry in general. At the Sothys headquarters in Miami, and at regional Sothys offices across the Nation, classes are offered, with topics ranging from hands-on body workshops to cosmetic chemistry.

Sothys
305.594.4222
www.sothys-usa.com

Source: Sothys