The US Food and Drug Administration (FDA) 505(b)(2) pathway is an alternative route of approval to the 505(b)(1) for new drug entities or the 505(j) for generic products, intended to allow the approval of a drug which isn't new, but differs in several meaningful aspects.
San Diego, California-based compounding pharmacy Imprimis Pharmaceuticals is therefore looking to take advantage of this pathway for several products for which it claims it has developed a series of unique drug formulations that are either patented or have patent pending.
“Several of these drug formulations have potential significant commercial value and instead of offering them as compounded drugs we believe they should be developed through a traditional FDA approval pathway, specifically 505(b)(2), the pathway the FDA has allocated for new label opportunities for already approved drugs,” founder and CEO Mark Baum said during an end-of-year financial call this week.
He added the firm has begun looking into monetising these assets by entering discussions with confidential discussions with investment bankers, drug development experts, and pharmaceutical executives.
“Our discussions to date involve transactions with entities outside of Imprimis. Our core focus at Imprimis will remain within ophthalmology and our current commercialization business model.”
One big commercial opportunity is with H.P. Acthar Gel (repository corticotropin injection), an off-patent adrenocorticotropic hormone (ACTH) analogue extracted from the pituitary glands of pigs and used for patients with a number of conditions including lupus and multiple sclerosis.
The product, marketed by Mallinckrodt Pharmaceuticals, has been in the spotlight due to its price increasing from $40 (€37) a vial in 2001 to around $38,000 today.
“Acthar, which is a very old off-patent drug, with no generic competition had gross sales in excess of $1.3 billion last year,” Baum said.
“Potency and stability are known challenges for Acthar Gel. We are pleased that our patent-pending formulation, which has been in a stability study now for nearly six months, is showing that we do have a potent form of a synthetic 39 amino acid peptide chain adrenocorticotropic hormone.”