Allergan announced that it has submitted a new drug application to the US Food & Drug Administration (FDA) for oral tazarotene, a highly selective retinoid, for the treatment of moderate to very severe psoriasis.
"There continues to be a need for non-invasive therapies that are convenient for most patients with psoriasis," said Patricia Walker, MD, PhD, Allergan's vice president of skin care clinical research and development. "If approved, oral tazarotene may offer a novel approach to managing the disease."
The FDA filing is based on results from multi-center, double-blind, randomized, placebo-controlled studies of 12 weeks treatment with oral tazarotene (4.5mg daily) followed by 12-weeks post-treatment follow-up. In these studies, oral tazarotene demonstrated a statistically significant difference compared with placebo. In addition, significant improvements observed at the end of the treatment in all clinical measures were maintained during the post-treatment period. Clinical improvement with oral tazarotene was seen as early as four weeks, with significant improvement seen within eight weeks of treatment. These improvements continued to be observed throughout the 12-week post-treatment period. Fewer than five per cent of treated patients discontinued therapy due to side effects.
"People with psoriasis consistently tell us that they need additional treatment options for this painful and challenging, life-long disease," said Gail Zimmerman, president and chief executive officer of the National Psoriasis Foundation. "We look forward to the FDA review of this promising data on oral tazarotene."
As Allergan is in the early stages of a strong new product cycle with many recently approved products, it is the company's objective to focus on these core products and on core markets. In order to avoid the cost of building dedicated dermatology sales forces outside North America, Allergan will initiate a process to out-license the tazarotene molecule for indications in both psoriasis and acne outside North America.
In North America, Allergan will seek an acne development partner for the Phase 3 clinical trials. This decision is based on the size of the market for the acne indication, the potential in other channels outside of dermatology, as well as the cost of this clinical program compared with other significant opportunities in Allergan's portfolio. Allergan estimates the tazarotene acne development program would cost approximately $80 million to $100 million. Allergan will discuss its extensive portfolio of early- and late-stage clinical programs with the investment community on February 2nd in New York City at its "R&D Day."
"Given the promising Phase 2 data for oral tazarotene for the treatment of acne which was presented at the 2003 Summer American Academy of Dermatology meeting and the Phase 3 psoriasis data, we are confident that there will be significant interest and value derived from these partnering opportunities," said David Pyott, Allergan's chairman, president and chief executive officer.