Imprimis Pharmaceuticals Begins Dispensing from FDA-Registered 503B Outsourcing Facility

Source: Imprimis Pharmaceuticals

Imprimis Pharmaceuticals announced that it has begun shipping its core sterile ophthalmic medications to select customers from its FDA-registered outsourcing facility without the need for a patient-specific prescription. Over the next few weeks, Imprimis’ flagship Dropless Therapy injectable and LessDrops topical formulations will become available to all customers. New and existing customers can register for an ImprimisRx 503B account at https://www.imprimisrx.com/503b-prereg/.

Imprimis’ New Jersey-based outsourcing facility, which is equipped with robotics for automated filling and labeling of products, will initially produce and dispense Imprimis’ core sterile ophthalmic medications in compliance with current good manufacturing practice (cGMP) requirements for outsourcing facilities. Imprimis customers are now able to purchase Dropless and LessDrops medications in convenient 20-unit boxes without the need for patient-specific prescriptions. To facilitate expected growth, the company is introducing a new integrated order and fulfillment system that provides “online shopping cart-type” functionality that bypasses customer service and moves orders directly to the facility’s fulfillment center. Increased production, labor and ordering efficiencies are expected to result in improved customer satisfaction and increased margins.  

“This is a significant milestone for our company. We believe sales and adoption of our core ophthalmic formulations will increase considerably as a result of simplifying the ordering process for physicians, hospitals, group purchasing organizations and surgery centers," Mark L. Baum, CEO of Imprimis, said in a company news release. "The new facility will accommodate those customers who prefer, or in some cases, require medications purchased from an FDA-registered outsourcing facility compliant with the highest quality standards. We are confident the investments we have made in infrastructure, improvements in operating efficiencies and our senior leadership team have positioned us to meet the current and anticipated increase in demand in our core ophthalmic business.”

“Through our commitment to quality and innovation, Imprimis is making strong inroads into the ophthalmic pharmaceutical business. We expect our market capture trends to continue and increase as we move more business through our New Jersey outsourcing facility. We also believe the New Jersey outsourcing facility will be instrumental in realizing an increase in margins from the current low 50 percent range to greater than 60 percent in 2017. Our ophthalmology business growth was 20% in the fourth quarter 2016 versus the third quarter 2016, with preliminary unaudited ophthalmology sales of $3.6 million in the fourth quarter of 2016. Over 1,450 customers have adopted our Dropless and LessDrops medications and we have serviced over 600,000 cataract and refractive surgeries since mid-2014. A growing number of high-volume ophthalmic surgery practices, hospitals and ambulatory surgery centers throughout the U.S. have become customers and we expect this number to significantly increase with the opening of our new FDA-registered cGMP outsourcing facility," Mr. Baum added.

Imprimis plans on expanding its ophthalmology program and introducing additional innovative medications in 2017 for glaucoma, wet age-related macular degeneration, diabetic macular edema, dry eye disease, and ocular infection and inflammation.

"Our ophthalmology business currently represents 60 percent of total revenues and we expect this to increase to 80 percent in 2017 and beyond. The efficiency of our model allows us to quickly innovate and safely deliver high-quality novel and clinically-relevant products to the market with less complications and at lower costs for our customers than our traditional pharmaceutical company competitors," Mr. Baum said.

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