Business Wire

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

Share

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.

Contact information

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

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

NetMedia Group takes over the management of financial platform Investing.com's European advertising space23.7.2019 08:07:00 CESTPress release

NetMedia Group, media B2B leader in Europe in the world of business information, and Investing.com, second largest financial services and information platform in Europe, are to form a partnership, with NetMedia Group handling the sales of advertising space for Investing.com. With average traffic of over 21 million unique users totaling over 175 million sessions in 31 countries, Investing.com is one of the top three global financial websites and has the most downloaded financial management app. For Investing.com, the aim of the new partnership is to maximize digital advertising revenue through the NetMedia Group's European teams. NetMedia Group's goal is to expand its advertising services by offering a new vertical market for finance, in order to boost the range of services it has available to decision-makers for upper socio-professional target groups. About NetMedia Group: NetMedia Group is a B2B media group located in five countries across Europe; it employs nearly 150 staff members a

Frost & Sullivan Names Luminati the 2019 Global Market Leader in the Enterprise IP Proxy Networks Market23.7.2019 08:00:00 CESTPress release

Luminati, the Israeli company that allows businesses to experience the web through the eyes of individual consumers throughout the world, today announced it has received a Market Leadership Award in the first independent analysis of the sector. Luminati’s enterprise IP proxy network (IPPN) services for global retailers, brand owners and advertising networks feature strongly in the report by analyst firm Frost & Sullivan. The report outlines a relatively new, but rapidly growing market and recognizes Luminati’s leading position in the provision of solutions that are increasingly important for businesses to remain competitive and compliant in the digital landscape. [S1] “The market for enterprise IP proxy network solutions is in its early growth stages, basically being invented by Luminati only a few years ago. With the more specialized targeting of customers by demographics and location, companies are finding it more difficult than ever to do competitive analysis and verify advertising,

LifeSpan BioSciences Releases Best-In-Class PathPlus™ Top Performing Immunohistochemistry Antibodies for Cancer Targets23.7.2019 08:00:00 CESTPress release

LifeSpan BioSciences, Inc. (LSBio™), the industry leader in molecular pathology, today announced the first release of its PathPlus™ series of antibodies. These 565 antibodies were selected from among thousands tested and identified to be the best performing reagents for immunohistochemical detection of 200 high-value cancer targets in formalin-fixed paraffin-embedded human tissues. Antibody validation has become an industry roadblock as thousands of antibodies have become available to customers who face difficult choices in determining which antibodies are the best performers for each application, including immunohistochemistry, flow cytometry, ELISA, Western blot, or immunofluorescence. Antibodies that perform well in one assay, such as IHC, may not be the most specific reagent for another assay, such as flow cytometry. “Identifying the optimal reagents to use in their experiments is a pain point for researchers,” said LSBio CEO Heather Holemon. “There is a tremendous need to identify

IDEMIA Will Present Its H1 2019 Financial Results to Investors on July 30, 201923.7.2019 07:00:00 CESTPress release

IDEMIA, the world leader in Augmented Identity, today announced that it will present its H1 2019 financial results to investors on Tuesday July 30, 2019. Yann Delabrière (CEO) and Laurent Lemaire (CFO) will be presenting the financial results and taking questions the same day at 3:30 pm CET (2:30 pm London Time / 9:30 am New York Time). For more information, please refer to our website: https://investors.idemia.com/ About IDEMIA IDEMIA, the global leader in Augmented Identity, provides a trusted environment enabling citizens and consumers alike to perform their daily critical activities (such as pay, connect and travel), in the physical as well as digital space. Securing our identity has become mission critical in the world we live in today. By standing for Augmented Identity, an identity that ensures privacy and trust and guarantees secure, authenticated and verifiable transactions, we reinvent the way we think, produce, use and protect one of our greatest assets – our identity – whet

Gain Therapeutics SA Announces Award Notification of a €1.4M Grant Support From Eurostars-2 Together With the Institute for Research in Biomedicine and Neuro-Sys SAS After Having Scored 2nd Among 325 Eligible Applications23.7.2019 06:30:00 CESTPress release

Gain Therapeutics SA, a biotechnology company discovering and developing novel therapeutics to target lysosomal enzymes involved in inborn errors of metabolism and in central nervous system (CNS) diseases, today announced that together with Dr. Maurizio Molinari from the Institute for Research in Biomedicine, Bellinzona (Switzerland) affiliated to the Università della Svizzera italiana (USI) and Neuro-Sys SAS in Gardanne (France), it has received funding support from Eurostars-2 joint programme with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. This grant will further strengthen Gain Therapeutics’s novel therapeutic approach for targeting rare diseases in the CNS, where lysosomal misfolded enzymes lead to sever clinical phenotypes, where no treatment is available and/or high unmet medical needs still do afflict patients, families and carers. This funding will support the development of the drugs portfolio of Gain Therapeutics for the

iBASIS Accelerates Growth With JC Geha as Chief Operating Officer23.7.2019 06:00:00 CESTPress release

iBASIS, provider of communications solutions for operators and digital players worldwide, today announced the appointment of JC Geha as its COO. He will take his new post effective August 1, and be based at iBASIS’ headquarters in Lexington, Massachusetts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190722005757/en/ JC Geha (Photo: Business Wire) Formerly Senior Vice President, Head of International Technology and Services for Deutsche Telekom, and of Managed Services for Ericsson, Geha brings to iBASIS an impressive track record of profitable growth, technology and digital transformation expertise. His expertise spans 25 years of deep global industry relationships across the United States, Europe, Middle East, and Africa. Geha will lead iBASIS’ global operations, engineering, IT, and product development. He will report to iBASIS’ CEO and founder of the Group Tofane Global, Alexandre Pébereau, with the responsibility of g