News/Press Releases

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.

PRESS RELEASE
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.
RenovaTM is a registered trademark of OrthoNeutrogena, a Division of Ortho-McNeil Pharmaceuticals, Inc.

August 3, 2005
Dear Customer:

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

Sincerely,

Spear Dermatology Products, Inc.
866-773-2779