It is estimated that 10-15 million people in the U.S. have severe actinic skin conditions, the term used to describe damage to the skin
by chronic sun exposure. Current therapies relating to treatment of actinic keratosis (AK) lesions generate more than $1 billion in the U.S. annually
(Neidecker et al., Pharmacoeconomics, 27, 451-464,2009). These treatments include cryosurgery (liquid nitrogen), the chemotherapeutic topical drug
5-fluorouracil (5FU), immune modulators such as imiquimod, topical diclofenac (Solarase), and the use of light activated drugs. Additionally, a plant
derived phorbol ester-like compound under development by Peplin Pharma is in late stage clinical development. In almost every case, these therapeutic
approaches do not prevent actinic lesions from reappearing or new lesions appearing in different locations. Moreover, many AK lesions progress to skin
cancer and over $2 billion is spent on surgical and chemotherapeutic treatments for these skin cancers.
The incidence of AK lesions and skin cancer is expected to dramatically increase in frequency as the baby boomers enter their 60's and continue to occur
as these people live into their 80's and 90's. NPI believes that third party payers and patients are likely to be interested in a drug that prevents AK
formation, as current AK therapy is expensive and sometimes not fully reimbursed. Nia-114 would be indicated for use on a daily basis and its yearly use is estimated
to cost about the same as one visit to treat multiple AK lesions.
It is important to note that Nia-114 does not represent another treatment for AK, but rather a first in class agent for conjunctive therapy with cryotherapy
or other approaches used for AK irradication to achieve prevention of AK lesions, which
if successful would confer a unique competitive advantage. Additional competitive advantages include excellent tolerability and safety profile that allows a field
approach (i.e. full face) to therapy and allows long-term preventive treatment.