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Frequently Asked Questions

Q:Why did you seek to create a 3D printed drug?

Aprecia is committed to enhancing patients’ experience with medication. By combining the precision of 3D printing with formulation science, Aprecia’s ZipDose® Technology produces rapidly disintegrating formulations of highly prescribed medications.

Q:What were some of the challenges involved in making tablets in this manner?

The key to unlocking the potential of 3D printing (3DP) manufacturing as a platform for pharmaceutical use was designing and building our proprietary equipment while leveraging our exclusive worldwide license to the Massachusetts Institute of Technology (MIT) patent estate. Aprecia has achieved commercial scale production using our 3DP manufacturing system and processes, which is a FIRST in the highly regulated pharmaceutical industry.

Q:Will Aprecia be using 3D printers to help with other drugs?

Yes. Our initial development efforts are focused on a distinct line of products concentrated in select areas where patients may have a need for a rapidly disintegrating formulation of a high drug-load medication.

SPRITAM® (levetiracetam) is the first in our pipeline of central nervous system (CNS) products and successfully demonstrates the validity of our technology platform as well as our regulatory approach for future FDA submissions.

While the initial focus at Aprecia is the commercialization of products created through our ZipDose® Technology platform, we envision further innovation and new platforms that will produce different formulations using 3D printing.

Q:Do you expect 3D printers to be more commonplace in the manufacture of drugs over the next decade?

Yes. It’s not an “easy” technology to learn, but there is a high level of interest. Various forms of 3D printing (3DP) appear in technical publications on a regular basis. At Aprecia, we receive inquiries regarding both ZipDose® Technology and other pharmaceutical applications of 3DP. Currently, we are primarily focused on our in-house pipeline, but we may consider future development deals or strategic partnerships on technology if the proposition is compelling.

Q:How can I get one of your machines? Are 3D printers for pharmaceutical products available to the general public?

Our 3D printing technology is proprietary and not available to the general public. Therefore, no one will be permitted or able to use this technology to print drugs at home, in hospitals, or in pharmacies. SPRITAM® (levetiracetam) Tablets for Oral Suspension will initially be manufactured at Aprecia’s FDA-inspected and approved facility in East Windsor, NJ. Later, it will also be manufactured in our Blue Ash, OH, facility, which will also be FDA-inspected and approved.

Aprecia’s ZipDose® Technology platform has made it possible to print medication in a controlled manner at commercial scale (large quantities, rather than personalized pills). There should be no legal problems in identifying the source, should any issue arise, as our products are regulated in the exact same manner as other medications.

Q:Can your machines make any drug from scratch?

No. Our machines do not actually make active or inactive ingredients. They combine the ingredients to make the final dosage form. As with machines that produce tablets and capsules, ingredients must be separately supplied and formulated in order to make a final dosage form.

Q:Could your machines lead to abuse at home with people making their own drugs?

No. Our machines are not available to the general public and do not actually make active ingredients. Our products are made in an FDA-inspected facility and are part of the same regulated supply chain as other FDA-approved medicines.

Q:Is this the beginning of personalized medicine?

While personalized medicine may be on the horizon in some applications, our current focus is making medication that is easier to take by way of our unique formulation platform.

The FDA recently approved our first product made with ZipDose® Technology, called SPRITAM® (levetiracetam), a formulation of levetiracetam. SPRITAM is available in 4 approved dosage strengths: 250 mg, 500 mg, 750 mg and 1,000 mg. SPRITAM is available by prescription only and filled through the retail pharmacy outlet.

Q:Are there other fast-melt formulations on the market? How is yours different?

To be clear, SPRITAM® (levetiracetam) Tablets for Oral Suspension is not a fast-melt formulation. That said, the global market for fast-melt tablets grew to $11.5 billion in 2014; however, 94% of the dosage strengths in the US are below 50 mg of drug load. We estimate that roughly 50% of the solid oral dosage strengths approved in the US are above 50 mg of drug load, a zone where ZipDose® Technology has a unique capability.

Q:What is your business development plan? What does the future hold for Aprecia Pharmaceuticals Company?

We are currently using our ZipDose® Platform to develop a distinct set of products for the treatment of various conditions related to the central nervous system. Beyond ZipDose® Technology, Aprecia envisions the use of 3D printing (3DP) to create new formulation platforms that leverage the precision of the additive manufacturing process to create extended-release or multiphasic-release products. We foresee many product opportunities for our formulation platforms across multiple therapeutic categories and indications.

We will selectively seek partnerships to access markets outside the US for our own product line and to enable or enhance the products of other pharmaceutical companies for a share the economics. We will also seek to enter new lines of business, such as veterinary, over-the-counter, or nutritional products.