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Imprimis Pharmaceuticals (immy) Release: Strategic Agreement Launches Novel Drug Development Model


9/7/2012 10:05:19 AM

SOLANA BEACH, Calif., Sept. 7, 2012 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (IMMY: OTCQB) today announced a strategic development and investment agreement with Houston-based Professional Compounding Centers of America, Inc. (PCCA). The agreement will allow the companies to develop and share drug-formulation technology, with the goal of creating a new generation of treatments for muscle and joint pain, neuropathic pain and other conditions. PCCA also made a $4 million equity investment in Imprimis in a private transaction.

The agreement will give Imprimis exclusive non-PCCA-member access to PCCA's topical technologies and formulation know-how for delivering drugs directly through the skin. The arrangement is intended to identify development opportunities for new topical medications for new therapeutic applications.

Imprimis' lead drug candidate, Impracor, a topical non-steroidal anti-inflammatory cream, is expected to enter Phase 3 clinical trials early in 2013. When approved for sale, Impracor would be applied to the site of muscle or joint pain, delivering a clinical dose of medication to the affected area without potential side effects such as stomach irritation or liver problems that have been associated with ingestible, non-steroidal, anti-inflammatory drugs.

The company has also developed Accudel, a patented topical-delivery platform that can serve as a delivery vehicle for other medications.

"This agreement with PCCA will allow us to develop and implement an entirely new model for creating needed drugs for the treatment of a variety of conditions. Under this model, we will look for ways to repurpose or reformulate existing FDA-approved generic drugs, which would be delivered through our proprietary technologies," said Mark L. Baum, CEO of Imprimis. "We are very excited to enter a strategic relationship with such a well-respected company as PCCA, the largest pharmaceutical compounding organization in the North America."

PCCA provides a variety of products and services to its member compounding pharmacies, which work directly with prescribers to provide patients with specialized medications that are not available in either over-the-counter or prescription form. For the past 30 years, PCCA has been focused on supporting independent pharmacies by delivering a complete portfolio of compounding products, services, education and intellectual property.

PCCA has led in the research, development and study of topical and transdermal technology including its Lipoderm® family of topical bases the industry's only bases proven to deliver four drugs simultaneously.

Jim Smith, president of PCCA added: "Through this agreement, we will leverage our knowledge and products to bring new drugs to the market and ultimately heighten awareness and acceptance of topical drug delivery. By building bridges between compounding pharmacists and drug manufacturers, our members will be best positioned to strengthen the role of independent pharmacies in their communities while continuing to play their crucial role in personalized medicine. We are convinced this new model for the development of drugs is an important advancement for the pharmaceutical industry."

Imprimis drug-development strategy calls for repurposing or reformatting existing FDA-approved generic drugs to create new high-value FDA-approved manufactured drugs that address new therapeutic applications. In other words, generic drugs would be combined with Imprimis' patented delivery-technology to create entirely new medications for specific markets that are lacking these medicines.

"Once a potential new drug application has been identified, prior to making an investment, we hope to be able to identify the correct formulation and dosing to protect our investment in new patent applications," said Baum. "We plan to implement a clinical development and a thoughtful regulatory strategy prior to seeking partnerships to bring these market-tested proprietary compounded drug formulations to market. We believe this agreement is a win not only for our two companies, but for the pharmaceutical industry and the patients that it serves."

About Imprimis Pharmaceuticals, Inc.

Imprimis Pharmaceuticals is a specialty pharmaceutical company developing non-invasive, topically delivered products. Its innovative, patented Accudel cream formulation technology is designed to enable highly targeted site-specific treatment. Impracor, its lead pain-product candidate, uses the Accudel platform technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues, where the drug exerts its localized anti-inflammatory and analgesic effects. It intends to leverage the Accudel platform technology to expand and create a portfolio of topical products for a variety of indications. The Imprimis Pharmaceuticals, Inc. website is currently under construction and is expected to launch in September 2012.

About Professional Compounding Centers of America, Inc. (PCCA)

PCCA is the independent compounding pharmacist's complete resource for quality chemicals, equipment, ACPE-accredited training and education, pharmacy software, clinical and business consulting. Its membership includes more than 3,900 independent community-pharmacists in the United States, Canada, Australia and other countries around the world. PCCA's mission is to strengthen the role, position and skills of member compounding pharmacists so they can meet the unique healthcare needs of patients through exceptional service, high-quality products, shared innovations and education.

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 preliminary expectations and are subject to risks and uncertainties which may cause our 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 raise additional funding, our ability to acquire, develop or commercialize new products and to enter into strategic alliances and transactions, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission. 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.

Contact: Mark L. Baum
Imprimis Pharmaceuticals, Inc.
(858) 433-2800

SOURCE Imprimis Pharmaceuticals, Inc.



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