Aptalis Pharmaceutical Technologies - Drug Development and Delivery Technologies Platforms

The Aptalis Pharmaceutical Technologies (formerly Eurand Pharmaceutical Technologies) business specializes in product development that leverages our proprietary pharmaceutical technologies.

We utilize these technologies to develop novel prescription and OTC products with our partners that are designed to have advantages over existing products and address unmet medical needs.

We continue to work with partners to develop and supply our licensed and manufactured products. Integrated R&D and manufacturing teams in the US and Europe support projects from formulation through scale-up to commercial-scale manufacturing. Multiple facilities ensure that products can be efficiently distributed worldwide.

Oral drug delivery technologies

Aptalis Pharmaceutical Technologies has a strong track record of developing products using its proprietary drug formulation technologies. The company has one of the broadest ranges of pharmaceutical technology platforms in the industry, including:

• Taste masking
• Customized drug release
• Bioavailability enhancement

Aptalis Pharmaceutical Technologies is focused on the co-development of partnered products and the out-licensing of our products worldwide. Our team of formulation experts draws upon years of experience and a track record of success to meet our partners' formulation challenges.

Our track record of commercialization success includes products that are marketed in more than 50 countries around the world by our partners. Key products available for out-licensing are:

Ondansetron ER

Ondansetron ER is the first once-a-day formulation of the leading US oral 5-HT3 anti-emetic that provides therapeutic improvement over current treatments. 5-HT3 category prescriptions have a combined annual growth rate (CAGR) of 41%.

• Patient benefits: Single dose formulation is designed to minimize side effects of therapy and promote patient adherence, improving treatment results, and to reduce emesis-related patient anxiety, a risk factor for radiation-induced nausea and vomiting (RINV)
• Clinician benefits: Ondansetron ER is designed to provide therapeutic improvement over current treatments as identified by clinicians in market research

AdvaTab® Paracetamol (Acetaminophen) orally disintegrating tablet (ODT)

Launch-ready and formulated in a range of strengths for adult and pediatric dosing, AdvaTab Acetaminophen is a convenient, patient-friendly OTC pain reliever. AdvaTab Paracetamol (Acetaminophen) ODT is part of a new segment in the in the popular analgesic OTC market in the US and worldwide, by leveraging a successfully formulated and patient-friendly fast dissolving ODT.

Product developed according to European Pharmacopeia (EP) standards, complies with US OTC monograph standards, and is shown to be bioequivalent to the reference product. AdvaTab Acetaminophen ODT can be formulated in a range of dosages (80mg-500mg).

AdvaTab Temazepam ODT

Enhance your pipeline in a growing category with a novel, patient-friendly dosage form of a top-selling sleep aid. AdvaTab Temazepam is the first ODT formulation of a highly prescribed benzodiazepine. AdvaTab Temazepam is formulated in a convenient patient-friendly dosage form, potentially creating a new segment for the growing Rx sleep-aid market.

• 8.4 million US Temazepam prescriptions annually (IMS 2009-2010)
• 5% category compound annual growth rate (CAGR)

AdvaTab Hydrocodone / Acetaminophen ODT

The proprietary ODT formulation of Hydrocodone / Acetaminophen creates the opportunity for a partner to grow a new segment of the growing Rx pain market with the first and only ODT formulation of the most-prescribed drug combination in the US.*

As the first ODT formulation of the most-prescribed drug combination in the US (120 million prescriptions annually**), AdvaTab Hydrocodone / Acetaminophen fast dissolving ODT creates a unique market segment for a convenient, patient-friendly dosage form that facilitates accurate dosing and easier administration.

Formulated in two convenient dosage strengths, AdvaTab Hydrocodone / Acetaminophen's formulation and manufacturing processes are scalable achieve multiple dosage strengths.

*Based on information currently available in the public domain
**IMS data

Intellectual property

Our owned and in-licensed patent portfolio consists of over 900 granted patents and pending applications.

This portfolio is composed of patents with claims directed to our formulation technologies and related materials, processes, equipment and methods of manufacture. We also have many product-related patents, which contain more specific claims directed to particular drugs or classes of drugs in combination with our formulation technology.

Aptalis Pharmaceutical Technologies endeavors to offer the most effective patent protection possible to our partners based on our broad and diversified portfolio of Pharmaceutical Technologies.