Following Congressional Hearing Investigating Mylan and Epi-Pen, Imprimis Pharmaceuticals Founder and CEO Publishes Drug Pricing Monograph

SAN DIEGO, Sept. 22, 2016 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company dedicated to making drugs affordable through its Branded Compounding™ business model, published a 75-page well-referenced drug pricing monograph describing specific proposals that will drive competition, transparency and patient access by lowering drug costs for Americans. 

• Imprimis is known for its Imprimis Cares® program and a 99 cent alternative to the $750 per pill Daraprim®, which was introduced in October 2015 after Turing Pharmaceuticals increased the price of the drug by over 5,000 percent.  Imprimis made its 99 cent alternative to Daraprim using only FDA-approved components.  To date, Imprimis has dispensed more than 20,000 doses, representing a savings to patients and healthcare providers of more than $10 million when compared to purchasing Daraprim®.
• The company began combatting overpriced pharmaceutical prices in April 2014, when it first introduced Dropless Therapy® for use by prescription after cataract surgery.  Dropless Therapy is changing post-surgery care by allowing most patients to avoid weeks of tedious and expensive post-surgical eye drops.  A co-sponsored economic study with not-for-profit Cataract Surgeons for Improved Eyecare, conducted by Andrew Chang & Co. LLC demonstrated that Dropless Therapy could save Medicare, Medicaid and patients of up to $13 billion, assuming a cost of $100 per dose of Dropless Therapy.
• In May 2016, Imprimis introduced its patent-pending tiopronin delayed release compounded formulations, a lower-cost alternative to Thiola®, representing an estimated cost savings of over 80 percent compared to Thiola®, a chronic care drug which can cost in excess of $150,000 per year per patient.
• Under the Imprimis Cares program, Imprimis offers a customizable pentosan polysulfate sodium delayed release (PPS-DR™) compounded medication as an alternative to Elmiron® for the treatment of symptoms associated with interstitial cystitis, at a cost savings of 88 percent.
• Imprimis and its development team are currently working on adding a compounded alternative to the Epi-Pen®, which the company expects would be available at less than $100.

Imprimis' Founder and CEO, Mark L. Baum, an advocate of pharmaceutical compounding as a viable solution to the drug pricing crisis, has written a monograph, entitled, "Pharmaceutical Compounding: An essential piece of the healthcare reform puzzle", detailing current drug pricing issues and outlining 15 concrete proposals for consideration by policymakers.  The monograph can be downloaded here.  His proposed actions are designed to abate the problems of high priced and often unaffordable drugs, particularly old, off-patent drugs.  The monograph illuminates the key issues and what should be done to restore a competitive equilibrium in the drug markets.  Among the key passages in the monograph is the following:

"Federal and state drug regulatory policy must refocus its priorities on those things that are most important: taking care of patients, putting safety first, and addressing the nation's growing drug shortage, drug pricing, and drug accessibility problems.  Safe and effective compounding of necessary medications, by serving as the pin to burst the drug pricing bubble that has negatively affected the health and well-being of far too many Americans for too long, can be a critical part of these needed reforms."

Mr. Baum also comments on the actions of Martin Shkreli, former CEO of Turing Pharmaceuticals and other pharmaceutical CEOs that have taken advantage of the loopholes in current policy that have allowed many drug prices to skyrocket: 

"The proverbial 'bottom line' is that when Martin Shkreli called members of Congress 'imbeciles' in the spring of 2016, he was not necessarily hurling his vitriol at individual elected officials who were confronting him.  He was evidencing, in a crystal clear diction, his disrespect and disdain for the American people he sought to fleece through his drug pricing policies and his entire business model.  Shkreli is but one example of the many pharmaceutical executives and companies that betrayed the inherent social contract between the American pharmaceutical industry and Americans that bestowed on it so many unusual privileges. It is now up to the American people, our elected leaders and those who are charged with the important work of government agencies to prove Shkreli and the many others like him wrong.  Drug and healthcare policy must now encourage competition and work to the advantage of consumers.  We are not imbeciles; nor are we lemmings."

Mark L. Baum, Chief Executive Officer of Imprimis, stated, "Each day there is yet another example of older, off-patent drugs that experience significant price increases.  Yesterday it was news of Chicago-based Novum Pharma and its increase of an old off-patent drug Aloquin to more than $9,500 a tube, a more than 3,900% since its acquisition only 18 months ago.  Companies do this to consumers because current policy prevents competition, particularly for drugs like Aloquin.  We plan to leverage our record of success by bringing new, affordable compounded drug innovations to market in order to combat high drug prices.  We believe that by continuing our efforts we will provide greater competition in the U.S. prescription drug market, lower consumer prices for certain critical medicines, and provide greater access to safe, affordable drugs for all Americans."   

Mr. Baum concluded, "While holding Congressional hearings to gather testimony is important, at this point, taking action to solve the problem is paramount."

Commitment to Patient Access

Imprimis is committed to the company's mission, vision and values of providing patients with affordable access to the medications they need.  As with Imprimis' other formulations, the alternative to Thiola resulted from the needs of patients, physicians and payors for a lower-cost therapeutic solution.  Significant increases in drug prices, coupled with an increasing number of higher deductible drug benefit plans and some insurance companies simply refusing to cover costs altogether, make it difficult for many patients to gain affordable access to the medications they need.  Imprimis plans to continue to expand its Imprimis Cares formulary and introduce additional drug formulations for patient populations that may not have available alternatives to increasingly expensive FDA-approved medications.  To learn more about Imprimis Cares, please visit http://www.imprimisrx.com/why-imprimisrx/imprimis-cares/.  

About Imprimis Pharmaceuticals

Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to making drugs affordable through its Branded Compounding™ business model.  The company is focused on patient outcomes and affordability and offers high quality lower-cost custom compounded drugs in all 50 states.  Headquartered in San Diego, California, Imprimis owns and operates four dispensing facilities located in California, New Jersey, Pennsylvania and Texas.  For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com. 

Forward-Looking Statements

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 our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our 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 our 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.

All Imprimis 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.

Imprimis compounded formulations contain active pharmaceutical ingredients that are components of FDA-approved drugs.

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SOURCE Imprimis Pharmaceuticals, Inc.

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