Business Wire

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

Del

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

Om 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.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

The Smarter E Europe – Explore Sector Coupling for Yourself at Europe’s Largest Platform for the Energy Industry25.4.2019 09:53:00 CESTPressemelding

The innovation hub The smarter E Europe, encompassing the exhibitions Intersolar Europe, ees Europe, Power2Drive Europe and EM-Power, was launched in 2018 and has seen impressive growth ever since. It will be held for the second time from May 15–17, 2019 at Messe München and will now cover 10 exhibition halls, making it Europe’s largest energy industry event. This growth is due in large part to the upward trend in renewable energies. Since 2010, the proportion of energy generated worldwide from renewable sources has risen from 20 to 25 percent. By 2030, we’re looking at a jump to around 60 percent. In Germany, an average of 45 percent of all electricity generated already came from renewables in the first quarter of 2019. This dynamism is stimulating innovation and shaping the modern energy industry. The buzzword of the hour is sector coupling – a unification of the previously independent electricity, heating and transportation sectors. For instance, a photovoltaic (PV) installation in

The “One and Done” Era for Orphan Drugs: Evaluate Predicts 12% Growth, Driven by New Technologies, but Benefits Go to Big Pharma25.4.2019 07:00:00 CESTPressemelding

Scientific advancements will help propel the orphan drug market to a 12% CAGR to 2024, double the 6% rate expected for non-orphan products. In addition to recent breakthrough cell and gene therapy products like Yescarta and Luxturna, a number of “one and done” treatments for orphan diseases are approaching the market, including Novartis’s Zolgensma and bluebird bio’s Lentiglobin. The explosion of new technologies brings their high price points into greater focus — for example, the $425,000 per eye list price for Spark’s Luxturna is the value-based price agreed on with Spark and payers. In 2018, the mean cost for an orphan drug was 4.5 times that of a non-orphan product. Despite the clear advancements in treatment, however, those calling for reform of the Orphan Drug Act may gain further ammunition. Big pharma continues to entrench their position in the orphan market, as evidenced by Bristol-Myers Squibb’s bid for Celgene, Roche’s pending acquisition of Spark, and Novartis’s $8.7bn paym

NTT Group Increases Capital in NTT Global Data Centers Corp. to Further Strengthen Data Center Business25.4.2019 06:00:00 CESTPressemelding

NTT Communications Corporation (NTT Com), the ICT solutions and international communications business within the NTT Group (TOKYO:9432), NTT Urban Development Corporation, Nippon Telegraph and Telephone Corporation (NTT Corporation), NTT Finance Corporation announced today that it has increased its capital in NTT Global Data Centers Corporation (NTT GDC), a subsidiary company handling centralized global construction, management and equipment wholesales for NTT group data centers. NTT GDC is capitalized at 1.25 billion JPY, of which 60% will be had share by NTT Com. And three other NTT Group companies newly acquired shares in NTT GDC, namely, NTT Urban Development Corporation (20%), NTT Corporation (10%) and NTT Finance Corporation (10%), all as of today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190424006195/en/ NTT GDC oversees investment and asset-ownership functions for data center construction. Established last year

China Yiwu Imported Commodities Fair 2019 to Open in May25.4.2019 05:49:00 CESTPressemelding

China Yiwu Imported Commodities Fair 2019, the professional platform for international small commodities to enter China, will open on May 23-26, 2019 at the Yiwu International Expo Center in China’s small commodities paradise Yiwu City. The Fair of this year will cover an exhibition area of over 50,000 square meters, providing 2,000 international standard booths in 4 exhibition zones, namely Asia Pavilion I, Asia Pavilion II, European Pavilion and America-Australia-Africa & Cross-border Trade Pavilion. The imported commodities to be displayed will include household items, maternal and child supplies, beauty and personal care, crafts, home appliances, food and beverage, health and nutrition, fashion accessories, creative toys, stationery, sports goods, clothing and accessories. The Fair is expected to attract over 1,500 business companies and organizations from over 100 countries and regions across the world. The number of visitors and buyers will exceed 120,000. The Import Commodities

Biomedical Software Startup BostonGene Secures $50M in Series A Financing from NEC25.4.2019 01:00:00 CESTPressemelding

NEC Corporation (NEC; TSE: 6701) and BostonGene Corporation (BostonGene), a Boston, Mass-based biomedical software company, today announced a US$50M series A strategic investment in BostonGene by NEC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190424006170/en/ BostonGene, a pioneer in the use of biomedical software for advanced patient analysis, has discovered, developed, and patented a holistic approach to cancer treatment by defining the optimal therapy combination for individual patients, with a particular focus on immuno- and targeted therapies. BostonGene’s solution includes: Genome and transcriptome sequencing methods to create a patient’s molecular profile. Algorithms that estimate the immune fitness and cancer characteristics of a patient. A continuously updated expert-curated and Artificial Intelligence (AI)-driven database of cancer research and clinical information. Cloud-native software that delivers a patien

ABS, Google Cloud and SoftServe Partner to Demonstrate Feasibility of AI-enabled Corrosion Detection24.4.2019 15:57:00 CESTPressemelding

ABS, Google Cloud and SoftServe completed a pilot project applying artificial intelligence (AI) models to detect levels of corrosion and coating breakdown on ships and offshore structures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190424005822/en/ ABS, Google Cloud and SoftServe Partner to Demonstrate Feasibility of AI-enabled Corrosion Detection (Photo: Business Wire) The project successfully demonstrated the accuracy of AI in detecting and assessing structural anomalies commonly found during visual inspection. AI techniques could be further used to analyze images over time to understand corrosion and coating breakdown trends. “Digital innovation in AI will change how surveys and maintenance strategies are executed, driving more condition-based approaches to class and maintenance,” said ABS Chairman, President and CEO, Christopher J. Wiernicki. “We are building a future in which digital tools can remotely assess the co