Emerging Company in the Spotlight sponsored by JFK Communications.

BioNJ is pleased to shine the spotlight on one of our Innovation Members each month featuring their progress and work on behalf of Patients and their impact on the New Jersey life sciences ecosystem. This month’s Emerging Company in the Spotlight is Aprecia.

So many of our Members are making a dramatic impact on our State’s innovation ecosystem. We celebrate you! Aprecia is one such company.

3D Drug Printing
Aprecia’s 3DP technology is designed to support and enable drug development throughout the entire lifecycle — from early stage drug batches developed for use in animal testing, to quantities produced for use in clinical trials, all the way up to commercial-scale manufacturing of FDA-approved drugs. Its 3DP technology “assembles” pharmaceutical products layer by layer, without using compression forces and molds, eliminating the potential for drug or particle coating disruptions. Spreading thin layers of powder and depositing (“printing”) pre-programmed patterns of liquid droplets onto selected regions of each layer, the process is carried out repeatedly until the tablet is formed. 3DP allows for controlling tablet hardness, dispersibility characteristics, overall form/shape and taste masking.

ZipDose Technology
In 2007, Aprecia developed its orodispersible 3DP technology platform — Zipdose®. This technology utilizes 3DP to make high-dose medications easy to swallow. With the development of 3DP and Zipdose®, Aprecia established its primary R&D facility in East Windsor, NJ in 2011. And, in 2015, Aprecia’s first 3D printed drug product, SPRITAM, was approved by the FDA. Aprecia has added manufacturing capacity to support its expanding product pipeline and enhance its commercial capacity.

“The ideal partner for us serves a population of patients for whom medication administration is a barrier to adherence and for whom ease of administration is a value proposition,” said Christopher E. Gilmore, CEO, Aprecia. “These barriers are most commonly encountered with high-dose formulations combined with a patient population associated with low adherence or difficulty swallowing larger pills. When we can help patients improve adherence, we are hopeful that outcomes will improve, which is the goal for everyone,” he added.

For patients across a broad range of diseases who have difficulty swallowing, 3DP formulations fill this unmet medical need. From elderly patients who may experience dysphagia, to pediatric populations who will not swallow pills — especially formulations of 500, 750 and 1,000 milligrams — 3DP offers an elegant solution. With a simple sip of water, Aprecia’s 3DP technology enables even high-dose medicines to disperse in less than 10 seconds.

Aprecia is ideally positioned to serve pharma partners and offers a myriad of services along the manufacturing process — from early stage development through commercial-stage manufacturing and packaging. The organization is staffed to support rapid development, including identifying new applications for 3DP technology, developing, piloting, scaling and transferring new products for commercial manufacture. And, Aprecia experts can provide regulatory affairs and quality assurance and control support as well as analytical development, including validation and sample analysis and timely reporting, adhering to strict compliance and regulatory standards throughout development.

Aprecia’s technology is ideal for pharma partners who may be facing life cycle challenges. Compounds facing potential loss of exclusivity may be able to extend patient protection via 505 (B)(2) submissions. Aprecia’s 3DP patent extension opportunities include: new formulations, new indications, new dose forms and loads, combination drugs, next-generation and future drugs and OTC switches.

In addition to patent protection strategies, 3DP can also help partners reach into new therapeutic areas and patient populations by unlocking entirely new formulations and dosage forms. Aprecia is uniquely positioned to support new formulations, new indications, new patient populations and new dosage strengths.

SPRITAM® (levetiracetam)

Aprecia is the first company to ever receive FDA approval for a 3D printed drug. SPRITAM®(levetiracetam) tablets, for oral suspension, is FDA approved for the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures. This innovative product disintegrates in the mouth with a sip of liquid and offers a new option for patients, including those who may struggle to take their medicine.

SPRITAM® is formulated with Aprecia’s proprietary ZipDose® Technology, which combines the precision of 3D printing and formulation science to produce rapidly disintegrating formulations of medications. Manufactured in a regulated commercial scale facility, SPRITAM® is available in four unit-dose strengths, including 250 mg, 500 mg, 750 mg and 1,000 mg.

Aprecia is aggressively seeking to partner with innovative researchers, manufacturers and technology companies across the pharmaceutical life cycle. The company is on the lookout for opportunities to enhance the value of its 3DP technology platform and to advance the possibilities of pharmaceutical product development.

Aprecia is dedicated to growing in New Jersey because this is where the talent is located. Aprecia is poised for growth and is continually seeking new talent. Visit www.aprecia.com for more information.