Public Relations, Refissa™ brand
FDA approved, new formulation, fragrance-free, prescription cream available for the treatment of fine lines and wrinkles
(New Jersey, June 3, 2009) -- Spear Dermatology Products, Inc. announces Refissa™ a new formulation of Tretinoin, approved by the U.S. Food and Drug Administration (FDA). Refissa is the only 0.05% prescription strength, fragrance-free, emollient-based Tretinoin Cream. This topical Tretinoin cream helps to reduce fine facial wrinkles, rough skin, and irregular pigmentation. Refissa's emollient formulation is for patients with normal to dry skin, who should also protect their skin from the sun by wearing a daily sunscreen.
Most dermatologists view topical retinoids as the cornerstone of treatment for sun damaged skin and acne.1 Most retinoids, however, are formulated and indicated exclusively for the treatment of acne. Among topical retinoids, Tretinoin is the "Gold Standard" of treatments, and Refissa, formulated in a moisturizing base, is an ideal option for mature patients with drier photo damaged skin.
With the launch of Refissa, Spear Dermatology Products, Inc. is well-poised to be at the forefront of the booming prescription topical facial rejuvenation market. Total sales for this market exceeded $394m in 2002 and increased to more than $494m in 2007. It is expected that market sales will surpass $513m by 2012.2 Refissa stands out from all other facial rejuvenation products as it's the only 0.05% strength prescription Tretinoin cream on the market that is both fragrance-free and contains a moisturizing, emollient base that is proven to be clinically safe and effective.
Refissa has gone through the extensive testing required to earn FDA approval and offers patients a safe, cost-effective prescription alternative to expensive cosmetic surgery or procedures. A 40 gram tube of Refissa may last 2-3 months, depending on individual usage patterns and costs on average, less than $2.00 per day. Refissa will be available for distribution during the first week of June, 2009.
"Despite the recession, luxury items like skin care and anti-aging products continue to be in high demand," said Stephen Basile, Sr. Vice President Sales and Marketing, Spear Dermatology Products, Inc., "This growing shift of consumers opting to use less invasive skin rejuvenation products is fueling an ever-growing market for Baby Boomers who want to spend less to effectively treat their sun damaged skin and improve the appearance of their skin."
Refissa contains tretinoin, a derivative of vitamin A, and works deep at the skin's cellular level to increase collagen, which the body produces less of with age.3 According to K.L. Spear, MD, dermatologist and President of Spear Dermatology, "Refissa has been proven in a clinical trial to be effective in the treatment of fine facial wrinkles, tactile roughness of the skin, as well as irregular pigmentation from the sun."
Important Safety Information: Refissa 0.05% is a prescription medicine that may reduce fine facial wrinkles and mottled hyperpigmentation in patients who also protect their skin from the sun and wear sunscreen daily. Refissa does not eliminate wrinkles, repair sun damaged skin or reverse photo-aging. Avoid medicines that may increase your sensitivity to sunlight, ask your pharmacist. Do not use if you are pregnant, attempting pregnancy, or nursing. Refissa, early in treatment, may cause redness, itching, burning, stinging and peeling. Please see Full Prescribing Information at www.refissa.com.
About Spear Pharmaceuticals, Inc. and Spear Dermatology Products, Inc.
Spear Pharmaceuticals, Inc. is a specialty dermatology company that develops niche products available only by prescription. Spear Dermatology Products, Inc. commercializes products developed by Spear Pharmaceuticals. All of Spear's products are manufactured in the United States in facilities inspected and approved by the FDA. Products marketed over the last decade include those used in the treatment of acne, actinic keratosis, superficial basal cell carcinoma, fine facial wrinkles, tactile roughness of the skin, and hyperpigmentation. Spear is committed to the ongoing commitment of developing products that help patients restore their skin's health.
For more information about Refissa, visit www.refissa.com.
 Rabe JH et al. Photoaging Mechanisms and repair: J Am Acad Dermatol 2006: 55:1-19.
 Kalorama Information, August 2008. See Important Safety Information above.
 Rados C. Science meets beauty: using medicine to improve appearances. U.S. Food and Drug Administration Consumer Magazine. http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/features/2004/204_beauty.html 2004:38(2). Accessed October 2, 2008.
On April 11, 2008, Spear Pharmaceuticals, Inc. received FDA approval for, and began shipping, Fluorouracil Cream 5%, USP, (5FU), a generic equivalent to Valeant's Efudex® Cream. The FDA approved the ANDA (Abbreviated New Drug Application) based on Spear's 318 patient study proving bioequivalence to Efudex® for the precancerous Actinic Keratoses skin condition, the indication for which the product is overwhelmingly prescribed (approximately 98% of patients). The product is also useful in the treatment of superficial basal cell carcinoma.
Spear is pleased to be able to offer its generic 5FU product to our customers, physicians and patients. We look forward to bringing additional pharmaceutical products to market in the months and years ahead.
September 20th, 2005
SPEAR PHARMACEUTICALS RECEIVES ANDA APPROVAL FOR TRETINOIN CREAM USP, .05% (EMOLLIENT)
Spear Pharmaceuticals is very pleased to announce the approval of Tretinoin Cream USP, .05% (Emollient) effective September 15, 2005. The Spear product is therapeutically equivalent to Johnson & Johnson Consumer Companies, Inc.'s Renova® Cream. K.L. Spear MD, President of Spear Pharmaceuticals, states that "In receiving another first ANDA approval, we are pleased to have overcome the clinical and technical challenges this product presented."
Spear's Tretinoin Cream USP .05% (Emollient) is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin. Steve Basile, Senior Vice President of Sales & Marketing for Spear Dermatology Products, Inc., comments, "We realize that, based on the cosmetic nature of this product, the dynamics of the patient population, and the anticipated lack of third party reimbursement, Tretinoin Cream USP, .05% (Emollient) will not achieve penetration levels typically garnered in the generic marketplace. Therefore, Spear is exploring a number of strategic alternatives including, but not limited to, the branding and/or licensing of the product".
Once a strategic plan is finalized, Spear will notify the trade regarding product availability.
Contact Information: Michael Langer, Vice President, Marketing
Spear Dermatology Products, Inc.
For further information, e-mail us.
Renova™ is a registered trademark of OrthoNeutrogena, a Division of Ortho-McNeil Pharmaceuticals, Inc.
Spear Generics for the Retin-A® creams and gels for acne purchased by Triax Pharma effective 7-01-05
August 3, 2005
We are writing to inform you of changes that relate to the Spear Tretinoin Product Line. Effective July 1, 2005, the entire line of Spear Tretinoin Cream and Gel products has been acquired by Triax Pharmaceuticals, LLC of Mountain Lakes, New Jersey.
Since its inception in 2001, Spear Dermatology Products, Inc. has worked diligently to deliver a high quality, consistent product line. Our excellent service levels have allowed the product to always be in stock for you and for the patients for whom it has been prescribed. Additionally, we have been working to develop new products, some of which we plan to launch in the upcoming months. As such, it is important for you, and for Spear Dermatology Products, to maintain us as a current vendor in your system. Please continue to make payments to Spear on any outstanding invoices.
Rest assured that Spear and Triax are working closely together in order to ensure a smooth transition of the Tretinoin Product Line. A separate communication from Triax will follow that will provide additional details concerning your ongoing purchase of Tretinoin.
Triax will honor all open orders in the system. Additionally, you will continue to receive the Spear labeled products until any changes are made. There are no changes being made that affect the manufacturing or quality control of the products.
On behalf of Spear Dermatology Products, we want to thank you for your support of our Tretinoin line over the last four years. Additionally, I look forward to contacting you in the near future concerning new product launches. Should any questions arise, please feel free to contact us.
To Contact Triax: 1-866-48TRIAX Fax orders 888-556-7337
Spear Dermatology Products, Inc.