Imprimis Pharmaceuticals to Launch its New Hep-Lido-A and Lyophilized Tri-Mix Compounded Formulations at the American Urological Association Annual Meeting in New Orleans
Introducing the Defeat IC™ Education Campaign for Interstitial Cystitis and the ED Free™ Education Campaign for Erectile Dysfunction
Additionally, Imprimis expands distribution to 42 states with recent licensure for North Carolina
SAN DIEGO, May 8, 2015 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company focused on the development and commercialization of proprietary compounded drug formulations, today announced its participation in and the launch of its Defeat IC™ and ED Free™ educational campaigns at the American Urological Association ("AUA") Annual Meeting in New Orleans, LA, May 15-19, 2015.
Imprimis Pharmaceuticals will be hosting an informational Defeat IC™ and ED Free™ Open House Reception on Saturday, May 16, 2015, 7:30–9:30 pm at the Galvez Restaurant, The Atrium Ballroom, 914 Peters Street, New Orleans. Mark L. Baum, CEO of Imprimis Pharmaceuticals, will present the company's vision for its newly launched urology business. Physicians will present their experiences with the company's urologic compounded formulations for the treatment of interstitial cystitis (IC) and erectile dysfunction (ED). Participants will include: Frank J. Costa, MD (Monroeville, PA) and C. Lowell Parsons, MD (San Diego, CA). Interested parties may register to attend the Defeat IC and ED Free open house informational reception by contacting Erica Soto at [email protected] or by visiting here.
Additional information about Imprimis and its proprietary urologic treatment options at AUA will be available to conference attendees at the Imprimis Booth #2309.
Imprimis recently received licensure to dispense compounded drug formulations in North Carolina. ImprimisRx compounding pharmacies are currently licensed to distribute in an aggregate of 42 states. The company recently commenced construction efforts to build a section 503B outsourcing facility in New Jersey, which will be federally registered with FDA.
Mark L. Baum, CEO of Imprimis stated, "Our team is excited and has been busy preparing for the launch of our Defeat IC™ and ED Free™ campaigns at the upcoming AUA Annual Meeting, the largest meeting of urologists in the world. Education has been an important component of our sales and marketing efforts for our ophthalmic formulations launched in early 2014 and we plan to continue this focus with our urology business. Our new urologic compounded formulations will provide physicians and their patients with important treatment options for IC and ED. The AUA Annual Meeting provides the perfect place to introduce attendees to our innovative compounded drug formulations and we look forward to visiting with physicians and their staffs at both our Saturday evening reception and our exhibit booth."
Mr. Baum added, "We are pleased to also announce that our pharmacies are now able to dispense our compounded drug formulations in North Carolina. The state represents a large market opportunity for both our ophthalmology and urology businesses. We look forward to calling on physicians who have been waiting for our pharmacies to be able to fill prescriptions and ship to their state."
ABOUT THE AMERICA UROLOGICAL ASSOCIATION
Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association ("AUA") is a leading advocate for the specialty of urology, and has more than 21,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy. Through its annual meeting and other year-round educational offerings, the AUA sets the highest standards for urology education worldwide. Now in its 110th year, the AUA Annual Meeting is the largest gathering of urologists in the world and provides unparalleled access to groundbreaking research, new guidelines and the latest advances in urologic medicine. For more information, please visit http://www.auanet.org/.
ABOUT HEP-LIDO-A FORMULATION AND IC
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 Guidelines, bladder instillations are considered a second-line treatment option when self-management treatments do not provide relief from IC symptoms. Hep-Lido-A's new user-friendly kit includes a hydrophilic catheter and ready to-use compounded sterile pre-filled syringes compounded by an Imprimis pharmacy, providing added convenience for in-office instillation as well as for patients who perform at-home instillations.
Interstitial cystitis (IC), also known as painful bladder syndrome, 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 women1,2 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.3 For more information, visit www.DefeatIC.com.
Imprimis' Hep-Lido-A compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.
ABOUT LYOPHILIZED TRI-MIX FORMULATIONS AND ED
According to the AUA, intracavernous vasoactive injections are considered the most effective treatment for erectile dysfunction. Imprimis' Tri-Mix (phentolamine papaverine and prostaglandin) are lyophilized compounded formulations provided in a powder-like form in single-dose vials that can be conveniently transported and stored prior to reconstitution and self-administration for the treatment of ED. Tri-Mix formulations provide for room temperature storage and dosing in single-dose vials.
ED is a condition that affects as many as 30 million men in the US.4 ED occurs mainly in men over the age of 40 and the incidence rate can increase with age, comorbidities and even level of education.5,6 There are more than 600,000 new cases of ED in the US annually in men ages 40-69.7 Men who are diagnosed with ED are typically put on oral phosphodiesterase type 5 inhibitors as a first line treatment, such as Viagra®, Cialis® or other similar drugs.
Imprimis' lyophilized Tri-Mix compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.
| 1. |
Berry SH, et al. Prevalence of symptoms of interstitial cystitis/painful bladder syndrome among adult females in the US. Available at: http://www.ichelp.org/Page.aspx?pid=824. Accessed February 6, 2015. |
| 2. |
Clemens JQ, et al. Prevalence of painful bladder symptoms and effect on quality of life in black, Hispanic and white men and women. J Urol. 2007; 177(4): 1390-1394. |
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Interstitial Cystitis Association. Available at: http://www.ichelp.org. Accessed February 6, 2015. |
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Impotence: National Institutes of Health Consensus Development Conference Statement. Dec 7-9, 1992; 10(4): 1-31. Available at http://consensus.nih.gov/1992/1992Impotence091PDF.pdf. Accessed May 6, 2015. |
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Thompson IM, et al. Erectile dysfunction and subsequent cardiovascular disease. JAMA 2005; 294(23): 2996-3002. |
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Johannes CB, et al. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000; 163(2): 460-463. |
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National Institutes of Health (NIH) Consensus Conference. NIH Consensus Development Panel on Impotence. Impotence. JAMA. 1993; 270(1): 83–90. |
IMPRIMIS PHARMACEUTICALS
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.
SAFE HARBOR
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.
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