Imprimis Pharmaceuticals, announced that it has entered into a licence agreement, under which Imprimis acquired the US rights to commercially compound a patented combination of alkalised lidocaine and heparin from Urigen Pharmaceuticals, Inc.  Physicians in the US and abroad have been prescribing and instilling this compounded drug formulation in different dosages to treat individual patients suffering from interstitial cystitis, also known as painful  bladder syndrome (IC/PBS).  Compounded alkalised lidocaine and heparin instillation procedures have been reimbursable by private healthcare providers and to Medicare beneficiaries under CPT Code 51700.     

Urigen's patented formulation first became available in 2011 as a compounded drug.  Since then, there have been more than 125,000 instillation procedures completed in the US.  In 2014, the number of prescriptions written for individual patients for Urigen's compounded alkalised lidocaine and heparin formulation is estimated to exceed 110,000, generating approximately $6.5M in annual prescription sales.  To date, sales of this formulation have been generated without a dedicated national sales and marketing strategy.

According to the RAND IC Epidemiology Study (2009), the largest IC epidemiology study ever undertaken, and the BACH study (2009), the total addressable market for this debilitating chronic disease is estimated to be more than ten million women and men in the US.   

Under the terms of the agreement, Imprimis shall pay Urigen tiered royalties based on net product sales with a minimum annual payment per unit for each prescription dispensed.  The licence does not require any cash payment by Imprimis upon execution.  The license is non-exclusive for a period of six months, at which time Imprimis has the sole right to convert to an exclusive licence.  Once converted to an exclusive licence, Imprimis is obligated to make certain annual minimum payments.  The licence is for the US market only and covers certain US patent rights that extend through 2026.  The agreement contains provisions for the parties to remain long-term partners throughout the product lifecycle.

"The acquisition of the licence to compound Urigen's alkalised lidocaine and heparin formulation is an important milestone for our company and a win for the millions of women and men in the US suffering from IC/PBS, a chronic and debilitating disease," stated Mark L. Baum, CEO of Imprimis.  "We intend to build a dedicated national education and awareness program around IC/PBS and this important patented formulation.  Similar to the Go Dropless campaign we launched earlier this year for our Dropless Cataract Surgery programme in ophthalmology, we intend to create national awareness for this urology formulation through a Defeat IC campaign, which we expect to begin in early 2015.  The Defeat IC campaign will be aimed at physicians who treat the millions of patients in the US who present with IC/PBS symptoms.  We appreciate the work that has been done thus far with the Urigen team to ready ourselves for the launch of our Defeat IC campaign, and we look forward to continued collaboration with the Urigen team."

Compounded alkalised lidocaine and heparin may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.  

IC/PBS is a chronic disease state characterised by bladder pressure, bladder pain, and in some patients, lesions in the bladder, commonly referred to as Hunner's lesions.  Patients suffer from increased urinary urgency and frequency.  IC/PBS symptoms are often misdiagnosed as urinary tract infections in women and chronic prostatitis in men, or other medical conditions.  Patients are commonly prescribed antibiotics for the IC/PBS symptoms which often do not address the condition.

Two published journal articles describe the safety and efficacy of Urigen's alkalised lidocaine and heparin instillation in patients with IC/PBS. The article, Parsons, et al. 2012. International Society for Sexual Medicine, was a multicenter prospective, double-blind, placebo-controlled trial, and showed a statistically significant improvement in the reduction of pain (p=0.0363) and micturition urgency (p=0.0328) in patients with IC/PBS. The second published article, Parsons, 2005. Journal of Urology, studied the effect of two instillations (Group 1 = 1 per cent Lidocaine; Group 2 = 2 per cent Lidocaine) in IC/PBS patients in relieving urgency and frequency of micturition as well as pain. All patients in the study saw marked improvement in all three symptoms with a statistically significant response rate in Group 2 over Group.