(By Mani) Questcor Pharmaceuticals, Inc. (NASDAQ:QCOR) is set to get its next wave of growth from rheumatology market as it announced initial commercialization plans for H.P. Acthar Gel in the treatment of rheumatology-related indications.
Acthar, Questcor's primary product, is indicated for multiple FDA-approved rheumatology-related conditions, including its use as adjunctive therapy in psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis.
Acthar is also approved by the FDA as acute or maintenance therapy in selected cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).
Questcor, a specialty pharma company focused on providing prescription drugs for central nervous system disorders, believes Acthar has the potential to help patients suffering from serious, difficult-to-treat disorders.
Though entering rheumatology is an exploratory effort at this point, the market is encouraged by the company's near-flawless execution of past expansion efforts in neurology and nephrology. The entry is similar to past expansion opportunities including promotion of Acthar for 2nd-line use in a rare disease where limited other options exist, and where physicians and payors are less cost-sensitive.
Questcor has plans to expand initial commercial efforts into related neuromuscular disorders dermatomyositis (DM) and polymyositis (PM), which affect about 66,000 US patients.
"Assuming ~13K pts on Acthar at peak (5 vials/script), we est. ~$279M peak sales," Oppenheimer analyst Christopher Holterhoff wrote in a note to clients.
The initial commercial rheumatology focus will be for two neuromuscular disorders: dermatomyositis (DM) and polymyositis (PM). DM and PM are chronic idiopathic inflammatory disorders that affect muscles, skin and other organs mainly the lungs.
These diseases are considered to be associated with high morbidity with mortality rates as high as 40 percent to 50 percent. Higher mortality rates are correlated to the severity of muscle weakness and cardiac and lung complications.
The analyst, who has an "outperform" rating on Questcor shares, expects the company's efforts in DM/PM to generate revenues of $2.9 million in 2012, $32.1 million in 2013 before growing to about $279 million in peak year sales in 2020.
Meanwhile, Questcor intends to commercialize Acthar in psoriatic arthritis (PA), rheumatoid arthritis, and systemic lupus erythematosus (SLE) within the next 24 months, and commercialization in these indications would significantly boost the company's topline.
"Should QCOR capture all appropriate candidates for Acthar in approved rheumatology indications, it would represent a multi-billion dollar opportunity," Holterhoff added.