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APR Applied Pharma Research and DKSH Bring Innovative Migraine and Pain Treatment to Asian Patients

APR Applied Pharma Research s.a. (“APR”), the Swiss, independent developer of science driven, patent protected healthcare products, is today proud to announce the business partnership with DKSH, the leading Market Expansion Services provider with a focus on Asia. The partnership involves marketing, sales, distribution and logistics for APR’s patented Diclofenac 50 mg powder oral solution for acute migraine treatment and other pain areas, in Malaysia, the Philippines, Myanmar and Vietnam under the DKSH subsidiary Favorex.

This new solution in sachet form containing Diclofenac - a proven nonsteroidal anti-inflammatory drug (NSAID) - is based on the APR’s patented Dynamic Buffering Technology (DBT), which secures faster pain relief in common acute conditions such as migraine . The patented DBT includes a unique blend of Diclofenac and bicarbonate that creates a suitable microenvironment at gastro-intestinal level, avoiding precipitation of acid Diclofenac in the gastric environment and thus allowing a fast absorption without affecting overall tolerability and safety.

The current market size for pain relief preparations is significantly increasing in Asia . As the analgesics market trend is associated to an increasing patients’ attention for a fast and effective pain relief treatment, APR’s Diclofenac solution and its DTB technology grow in appreciation worldwide. In particular, some recent license agreements will allow the distribution of APR’s Diclofenac DBT on Asian markets, such as China, Macao, Hong Kong and Taiwan, thus making APR presence grow internationally stronger, thanks also to partners such as Novartis AG and Depomed in USA.

The Asian pain-relief market represents a promising business opportunity for our company. In countries such as Malaysia, the Philippines, Myanmar or Vietnam with a rising middle class, there is a growing request for Western pharmaceutical products, as they guarantee reliability and high quality standards- states Philippe Gautron, Regional Director, Own Brands Healthcare, Asia Pacific, DKSH.

We are proud of this new agreement, which will offer our partner DKSH great business opportunities while allowing us to further spread the Diclofenac products and our DBT technology in the promising Asian markets, - said Paolo Galfetti , Chief Executive Officer of APR – and we are confident that DKSH could make the same success of Diclofenac DBT in the USA. Approximately 100 million doses of APR’s Diclofenac drugs, included DBT, are sold every year in several countries worldwide, confirming the exclusive competitive advantage of APR’s formulation over conventional preparations.”

About Diclofenac Powder for Oral Solution

APR’s Diclofenac powder for oral Solution is based on APR’s patented Dynamic Buffering Technology (DBT): this exclusive technology includes a unique blend of Diclofenac and bicarbonate that creates a suitable microenvironment at gastrointestinal level, avoiding precipitation of acid Diclofenac in the gastric environment and, thus, allowing a fast absorption, without affecting overall tolerability and safety of the drug product. Pharmacokinetic data support its positive results in terms of an immediate and ready absorption in the gastro-intestinal tract, hence achieving a faster onset of action.

As shown in clinical trials on migraine patients(1,2,3,4) , APR’s Diclofenac powder for oral solution consistently provides a rapid relief from multiple acute pain symptoms (nausea, photophobia, phonophobia) in 2 hours by starting to work in just 15 minutes - at achievement of peak plasma levels-as well as a pain-free response lasting up to 24 hours, by targeting effectively inflammation. On the other hand, it comes in a convenient water-soluble formulation and has a favorable and tolerable side-effect profile, similar to placebo.

Moreover, Diclofenac powder for oral solution has been recently established as “effective” (Level A) for the therapy of acute migraine attacks by the AHS (America Headache Society), following an evidence-based assessment via a systematic review of Class I studies (www.apr.ch/news/new-patent-for-aprs-diclofenac-formulation-in-canada ).

1. Diener HC, Montagna P, Gács G, et al. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalalgia . 2006;26(5):537-547. 2. Lipton RB, Grosberg B, Singer RP, et al. Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: results from the International Migraine Pain Assessment Clinical Trial (IMPACT). Cephalalgia . 2010;30(11):1336-1345. 3. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia . 2013;33(9):629-808. 4. Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapies. Headache . 2015;55(1):3-20.

About APR – APPLIED PHARMA RESEARCH

APR is a Swiss, independent developer of science driven, patent protected healthcare products. The Company identifies, develops and licenses, value added products designed to address patient or consumer needs in niche or rare therapeutic areas on a global basis. In particular, APR’s business model is currently focused on two pillars: (i) internally developed and financed (alone or together with co-development partners) proprietary, value added products to be licensed to healthcare \ companies for their commercialization, and (ii) support to third party projects by offering added value R&D services under contract and fee for service arrangements. APR has a balanced pipeline of revenue generating branded products marketed in all major markets, combined with a compelling pipeline of products at different stages of development. APR has entered into licensing and partnership agreements with pharmaceutical companies in over 70 countries, with international sales on a worldwide basis.

For press releases and other company information, please visit: www.apr.ch

About DKSH

DKSH is the leading Market Expansion Services provider with a focus on Asia. As the term "Market Expansion Services" suggests, DKSH helps other companies and brands to grow their business in new or existing markets. Publicly listed on the SIX Swiss Exchange since 2012, DKSH is a global company headquartered in Zurich. With 780 business locations in 36 countries – 750 of them in Asia – and 30,320 specialized staff, DKSH generated net sales of CHF 10.5 billion in 2016. DKSH was founded in 1865. With strong Swiss heritage, the company has a long tradition of doing business in and with Asia and is deeply rooted in communities and businesses across Asia Pacific.

DKSH Business Unit Healthcare is the leading Market Expansion Services provider for healthcare companies seeking to grow their business in Asia. Custom-made offerings comprise registration, regulatory services, market entry studies, importation, customs clearance, marketing and sales, capillary physical distribution, invoicing and cash collection. Products available through DKSH Healthcare include pharmaceuticals, consumer health and over-the-counter (OTC) products as well as medical devices. With 120 business locations in 13 countries and around 9,740 specialized staff, Business Unit Healthcare serves over 150,000 customers and generated net sales of CHF 5.5 billion in 2016.

For media releases and other company information, please visit: www.dksh.com

Contact:

APR:
PAOLO GALFETTI, Tel: +41 91 695 70 20
CEO
paolo.galfetti@apr.ch
www.apr.ch
or
DKSH Healthcare
Kalle Siebring, Phone +66 2 220 9739
Manager, Group Communications
kalle.siebring@dksh.com
or
HAVAS PR MILAN:
Press Office
SARA BERNABOVI, T: +39 02 85457032
sara.bernabovi@havaspr.com

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