SAN DIEGO, April 28, 2015 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company focused on the development and commercialization of proprietary compounded drug formulations, today announced it now has the exclusive US commercial rights to the patented compounded alkalinized lidocaine and heparin formulation ("Hep-Lido-A" or "HLA") for the treatment of interstitial cystitis ("IC"), commonly referred to as painful bladder syndrome ("PBS").
Imprimis was granted the non-exclusive US licensing rights for Hep-Lido-A from Urigen Pharmaceuticals, Inc. ("Urigen") in October 2014. Under the license agreement, Imprimis had the option to convert to an exclusive license between the six-month and one-year anniversary period from the date of the agreement. On April 24, 2015, Imprimis provided formal notice to Urigen of its intent to convert its commercial rights of Hep-Lido-A to exclusive for the remaining term of the agreement.
"We are pleased to now have the exclusive US commercial rights for our patented Hep-Lido-A formulation. In 2014, physicians wrote more than 80,000 prescriptions of Hep-Lido-A, generating an estimated $5.5 million in sales. In due course, we plan to capture substantially all of these legacy prescriptions, and have already begun sales to existing prescribers for their chronic care patients. Our focus going forward is to continue to serve the existing Hep-Lido-A prescribers and patients, and importantly to share their experiences with new prescribers and their patients in order to significantly grow this business. We have a positive and uplifting message we intend to share with new patients who are suffering with IC," stated Mark L. Baum, CEO of Imprimis.
Mr. Baum added, "Over the last several months, we have been busy building relationships with IC thought leaders and new physician customers. We are recruiting a team of seasoned urology sales and marketing professionals with experience and relationships in the IC community to lead our commercial activities. Our team is witnessing firsthand how Hep-Lido-A is benefiting patients and we are inspired and passionate about helping the millions of patients suffering with this debilitating chronic condition. We have partnered with leading IC advocacy organizations and our Defeat ICTM education campaign is gaining traction within the IC patient and physician communities. It is a very exciting time for our company and we look forward to exhibiting at the American Urological Association annual meeting next month in New Orleans and visiting with members of the urology community."
ABOUT IC AND THE HEP-LIDO-A FORMULATION
IC is a chronic disease state characterized by bladder pressure, bladder pain, urinary urgency, and/or urinary frequency. It is estimated that as many as 10 million men and women in the US alone suffer from IC with women making up 80% of those affected. In severe cases, patients may need to urinate up to 60 times per day. Most IC patients experience flares that can dramatically worsen IC symptoms. A flare-up may last anywhere from 2 to 7 days or longer depending on the severity. Patients may experience as little as one flare-up in a year to multiple flare-ups during the course of a month. Hep-Lido-A (alkalinized lidocaine and heparin) is a patented compounded formulation that is instilled directly into the bladder as an immediate treatment option for patients with IC. According to the American Urology Association bladder instillations are considered a second line treatment option when self-management treatments do not provide symptoms relief. Hep-Lido-A's new user-friendly kit includes a hydrophilic catheter, and ready to use sterile pre-filled syringes, providing added convenience for in-office instillation as well as for patients who perform at-home instillations. Instillation procedures, reimbursable by many private healthcare providers and Medicare beneficiaries, fall under CPT 51700. For more information, visit www.DefeatIC.com.
Hep-Lido-A may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.
San Diego-based Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to delivering high quality and innovative medicines to physicians and patients at accessible prices. Imprimis' business is focused on its proprietary ophthalmology and urology drug formulations. The company's pioneering ophthalmology formulation portfolio is disrupting the multi-billion dollar eye drop market, addressing patient compliance issues and providing other medical and economic benefits to patients. Imprimis recently launched its urology business, which includes a patented formulation to address patients suffering from interstitial cystitis. For more information about Imprimis, please visit the company's corporate website at www.ImprimisPharma.com; ophthalmology business websites at www.GoDropless.com and www.LessDrops.com; and urology business website at www.DefeatIC.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include risks and uncertainties related to Imprimis' ability to make commercially available its compounded formulations and technologies in a timely manner or at all; physician interest in prescribing its formulations; risks related to its compounding pharmacy operations; its ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of its formulations; its ability to obtain intellectual property protection for its assets; its ability to accurately estimate its expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for its technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE Imprimis Pharmaceuticals