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CSC Pharmaceuticals Announces the Launch of the Innovative Migraine and Pain Treatment Developed by APR Applied Pharma Research

Migraine

Migraine

BALERNA, Switzerland–(BUSINESS WIRE)–APR Applied Pharma Research’s patented formulation of Diclofenac 50 mg
powder oral solution for migraine treatment and other pain areas is now
available in Russia, promoted and commercialized with the brand
Dialrapid by the leading pharmaceutical company CSC Pharmaceuticals.

Estimates indicate that migraine prevalence in Russia is quite high,
affecting almost 30 million of adult population, while around 2% of them
suffer from chronic migraine with clinical manifestations for more than
ten days per month. Chronic headache is quite common as well, accounting
for 10% of the adult population.

Currently available NSAID and analgesics formulations, which together
with triptans are commonly used as therapy for migraine and severe
headache, leave unaddressed the need for a fast effective and tolerable
treatment. Moreover, this need leads often patients and physicians to
still rely on traditional formulation such as injections, with clear
practical downsides. This formulation indeed showed a positive growth
rate (+20%) within the total market of NSAIDs equal to almost 300 mio €.

APR’s exclusive water-soluble in sachet form of Diclofenac, based on the
company patented Dynamic Buffering Technology (DBT), is particularly
suitable for the management of migraine as well as severe headache and
other acute conditions, as it secures significantly faster pain
relief and rapid onset of action than NSAIDs conventional preparations,
associated with a favorable side-effect profile.

The unique advantages of this powder formulation have been formally
acknowledged by the International Headache Society, which strongly
recommends it as a first line treatment for migraine attacks, as well as
by the Russian local guidelines for migraine therapy.

To support the launch of Dialrapid and its awareness among physicians
dealing with migraine, CSC is carrying out a comprehensive set of
activities, which span from the participation to main congresses with
lectures by top-notch Russian KOLs, to educational programs on a
regional basis in cooperation with headache and pain centers, digital
tools and the promotion to pharmacists.

“We are proud to make this unique and innovative formulation of
Diclofenac available for healthcare professionals and patients in
Russia. We believe that APR’s patented in sachet form can be the right
answer to the demand of more effective and specific treatment for severe
headache and migraine, as it offers the fastest pain relief action
combined with excellent tolerability and a convenient water-soluble
formulation. We are confident that we can make this drug the gold
standard therapy for headache, thus becoming the reference company in
this market
.” said Mr. Sergey Beloborodov, General Director of CSC
Pharmaceuticals.

“We are very pleased to see our patented product on the Russian
market. Actually, this launch allows us to further spread the Diclofenac
products and our DBT technology on a worldwide basis as it follows the
remarkable success in the USA and the future distribution in the
promising Asian markets, China and Malaysia to name a few, where the
product is being registered. We are confident that, thanks to the
partnership with CSC, Russia could contribute to the proven track record
of success of APR’s Diclofenac formulation
.” said Paolo Galfetti,
CEO of APR.

About APR’s 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.

1. Diener HC, Montagna P, Gács G, et al. Efficacy and tolerability
of diclofenac potassium sachets in migraine: a randomized, doubleblind,
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 s.a.

APR is a Swiss independent pharma company focused on development and
global commercialization of innovative, research-driven products
designed to address unmet needs in specialized therapeutic areas and
rare diseases. APR combine pharmaceutical development expertise with
proprietary drug delivery technologies to realize solutions that
meaningfully improve the lives of people with rare diseases and empower
families through novel approaches to disease management. A diverse and
balanced portfolio of revenue-generating products in all major markets
is complemented by a robust pipeline of innovative products at different
stages of development for the treatment of recessive metabolic
disorders, as well as rare dermatological and ocular diseases. Products
are directly commercialized by APR through inhouse sales and marketing
teams in strategically important countries across Europe and a growing
worldwide network of commercial partners.
For more information
about the company, please visit the website: www.apr.ch

About CSC Pharmaceuticals

CSC today is a dynamically developing pharmaceutical company of full
cycle, based on advanced technology of the pharmaceutical industry. We
have built our name and reputation that is supported at a high level and
we continue to develop. CSC has been on the market for 30 years,
millions of people have already been helped thanks to our products, and
millions still to help. We implement and promote modern high-quality
pharmaceutical products. Our products contribute to improve the health
and quality of patients’ life. CSC shares a strong sense of
responsibility for business and takes work with the maximum
responsibility in all the areas.

Contacts

APR Applied Pharma Research s.a.:
Elisabetta Bianchi, Corporate
Communication Manager
elisabetta.bianchi@apr.ch
+41
91 6957020

CSC Pharmaceuticals:
Denis Troitskiy
Product manager
d.troitskiy@cscpharma.ru
+7-499-311-67-71

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