‘SARAH’ – a French national collaborative randomized controlled trial of radioembolization with yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma is now open for recruitment

The start of SARAH, a new randomized controlled trial to directly compare the effectiveness of radioembolization with yttrium-90 resin microspheres (SIR-Spheres microspheres; Sirtex Medical Limited, Australia) versus sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals, Germany), a systemic therapy that is the current standard of care for patients with non-surgical advanced hepatocellular carcinoma (HCC), was announced today by the principal investigator, Professor Valerie Vilgrain MD, PhD, Department of Radiology, Beaujon Hospital, Assistance Publique – Hopitaux de Paris, Clichy and Universite Paris Diderot, Sorbonne Paris Cite, France.

SARAH (SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma)is a Phase III multi-centre prospective randomized open-labelled trial, which aims to recruit 400 patients in France with advanced HCC (Barcelona Clinic Liver Cancer stage C) with or without portal vein thrombosis and no extrahepatic spread, who are ineligible for surgical resection, liver transplantation or radiofrequency ablation; or whose disease has progressed or recurred after previous therapies.[1]

The primary goal of the study will be to assess if radioembolization with yttrium-90 resin microspheres provides an increased survival benefit compared to sorafenib in patients with advanced HCC.

Professor Vilgrain said: “Around 20 specialist cancer centres throughout France will be involved in this trial. SIR-Spheres microspheres were selected for the test arm of this collaborative trial, which is being promoted by the ‘Assistance Publique – Hopitaux de Paris’.”

In patients with advanced HCC, sorafenib is now the standard treatment. Its use is associated with an increased median overall survival (from 8 to 11 months in the SHARP trial) but 80% of patients also experience treatment-related adverse events.

Selective Internal Radiation Therapy (SIRT), also known as radioembolization, is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumours. It is a minimally-invasive treatment, in which millions of radioactive SIR-Spheres microspheres (diameter between 20-60 microns) are infused via a catheter into the liver, where they selectively target liver tumours with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue. There is a growing interest in radioembolization using yttrium-90 resin microspheres in this patient population, based on a substantial number of open-label single-group studies as well as a large multi-centre European analysis[2] of the long-term outcomes related to survival and safety of radioembolization using SIR-Spheres microspheres in patients with inoperable HCC. In 13 open-label single-group studies totalizing 400 patients with advanced HCC, the combined estimation of the median overall survival after radioembolization with yttrium-90 microspheres was of 15 months (min-max: 7 to 27 months).

SIR-Spheres microspheres are approved for use in Australia, the European Union (CE Mark), New Zealand, Switzerland, Turkey and several other countries including in Asia (e.g. India, Korean, Singapore and Hong Kong) for the treatment of unresectable liver tumours. SIR-Spheres microspheres are also indicated in the U.S. for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.

Professor Vilgrain said that: “The SARAH trial is testing the hypothesis that radioembolization using yttrium-90 resin microspheres can increase the median overall survival with fewer side effects and/or a better quality of life in comparison with sorafenib. We hope that the results of this study will help improve the prognosis for these difficult to treat patients”.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) occurs in people whose livers have become severely damaged or cirrhotic, due to conditions such as hepatitis and alcoholism. It is one of the ten most-common cancers in the world, with nearly 750,000 cases diagnosed annually, and the third-leading cause of cancer deaths.[3] It occurs with greatest frequency in regions where viral hepatitis B or C aremost often diagnosed, such as in Asia Pacific and Southern Europe.

Hepatocellular cancer can be cured by surgery, either by resecting the diseased parts of the liver, or by transplantation with a liver from a healthy donor. These interventions, however, are inappropriate for the great majority of patients, whose survival may range from a few months to two or more years depending largely on the state of their liver at the time of their diagnosis and the extent of tumour invasion.

References:

1) SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma (SARAH): http://clinicaltrials.gov/ct2/show/NCT01482442 .
2) Sangro B, Carpanese L, Cianni R et al on behalf of European Network on Radioembolization with yttrium-90 resin microspheres (ENRY). Survival after [90]Y resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A European evaluation. Hepatology 2011; 54: 868-878.
3) GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in 2008.
http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011.

Source: Sirtex Medical Limited

Contact : MHC Communication, Marie-Helene Coste, 38 avenue Jean Jaures – 94110 Arcueil, Tel. : +33(0)1-49-12-03-40 – Fax : +33(0)1-49-12-92-19, Email: mhc@mhccom.eu .

Other Lines Flat or Decreasing as Competition and Capacity Remain

Commercial insurance rates in Asia are expected to climb in regions affected by natural disasters following record insurance losses in 2011, according to a comprehensive report published today by Marsh. The report also predicts that as competition among insurers for market share in many other lines of insurance remains strong, rates will continue to decline.

Substantial catastrophe losses prompted many insurers to seek rate increases in 2011, most notably in the property market, Marsh said in its report, Navigating the Risk and Insurance Landscape: Asia Insurance Market Report 2012. In disaster-hit regions, rate increases of over 30 percent are being experienced for natural catastrophe and some property risks, especially flood risk.

The report notes that the continued inflow of insurance capital, as underwriters seek to grow their Asian business, is preventing any across-the-board increases in premium rates. Local and regional insurers remain competitive, as the indigenous industry continues to become more sophisticated.

“Although reinsurance costs have risen following last year’s record losses, they are not being passed on to most insureds,” said Alan Cheah, Marsh’s CEO for Asia. “In addition, capital inflow, continued growth in the construction sector, and a heightened awareness of insurance and risk management have combined to lessen the effects of last year’s catastrophes on the broader market.

“Aside from increased property insurance rate increases — especially for those insureds with significant loss histories or catastrophe exposures — rate reductions for risks such as construction, general liability, professional indemnity and financial institutions are still achievable.”

Directors’ and officers’ (D&O) liability for U.S.-listed Asian companies are still rising, continuing a trend that began in 2010 with a spike in U.S. Securities Class Action lawsuits against Chinese companies. Despite some recent data suggesting the volume of lawsuits has peaked, rates are still expected to rise in 2012.

Rates in Japan have stabilised following capacity withdrawal and rate rises for businesses with operations in areas affected by last year’s earthquake and tsunami. In Thailand, rates for property insurance increased in flood-affected areas but have remained stable for other lines of insurance.

Major findings of Marsh’s report include the following:

– Underwriters are taking a more cautious approach to business interruption, contingent business interruption and supply chain insurance following large losses after the Japan earthquake and Thailand floods.
– Rate reductions of between 5 percent and 20 percent for general liability classes are almost universal across the region as ample capacity and competition persist.
– There is increased interest in trade credit insurance, as Asian suppliers become increasingly wary of their trading partners’ credit worthiness in Europe and the U.S.

Marsh’s annual Asia Insurance Market Report, which provides detailed information on commercial insurance market trends and conditions for all major classes of business across eleven countries in Asia, including mainland China, Hong Kong, Indonesia, Japan, South Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam is available at www.insurancemarketreport.com. Clients can also use this link to access Marsh reports for other regions and for multinational companies globally.

About Marsh

Marsh, a global leader in insurance broking and risk management, teams with its clients to define, design, and deliver innovative industry-specific solutions that help them protect their future and thrive. It has approximately 25,000 colleagues who collaborate to provide advice and transactional capabilities to clients in over 100 countries. Marsh is a wholly owned subsidiary of Marsh & McLennan Companies (NYSE: MMC), a global team of professional services companies offering clients advice and solutions in the areas of risk, strategy and human capital. With 52,000 employees worldwide and annual revenue exceeding US$10 billion, Marsh & McLennan Companies is also the parent company of Guy Carpenter, a global leader in providing risk and reinsurance intermediary services; Mercer, a global leader in human resource consulting and related services; and Oliver Wyman, a global leader in management consulting. Follow Marsh on Twitter @Marsh_Inc.

The annual Financial Times Global MBA Ranking of business schools found that Hult provides students with the most International Experience, based on overseas curriculum and learning opportunities. This rank was further supported by Hult’s climb to #3 in International Business beating rivals such as Insead and London Business School.

“Hult students have the opportunity to learn and acquire international work experience by participating in our global campus rotation to Boston, San Francisco, London, Dubai or Shanghai,” said Dr. Stephen Hodges, President of Hult International Business School.

“Future leaders looking to accelerate their career would benefit from Hult’s global business education and the opportunity to develop real-world experience through international action projects.”

Hult also ranks among the top 10 business schools for International Mobility, which measures the ease in which students secure international employment upon graduation. Hult maintained its position in the top 20 for Career Progress based on its ability to advance student’s job prospects, and for the fourth year in a row, claimed a spot among the top 100 best global business schools with an overall rank of 65.

Dr. Hodges said: “Hult continues to expand its global footprint with the launch of our second campus in central London and the opening our campus in Shanghai. These efforts, combined with our global faculty and student body from over 120 nationalities, continue to reinforce our reputation as the world’s most international business school.”

About Hult International Business School
Hult is the world’s most international business school with campuses in Boston, San Francisco, London, Dubai, and Shanghai. The School offers a range of business-focused programs including MBA, Executive MBA, Master and Undergraduate degrees. Hult’s one-year MBA program is ranked in the top 30 in the world by The Economist and among the top 100 by the Financial Times. www.hult.edu.

Kartik Ram appointed General Manager of Adfonic for Asia-Pacific

Global mobile advertising marketplace, Adfonic, today cements its expansion into Asia-Pacific with the appointment of Kartik Ram as General Manager for the region. Operating from Singapore, Ram will lead all Adfonic’s business activities across Asia-Pacific, establishing the organisation’s on-the-ground presence and rapidly hiring new talent. According to Gartner, Asia-Pacific is currently the leading market in mobile advertising with revenues expected to grow to $6.9 billion by 2015.

London-headquartered Adfonic has experienced significant growth since its launch 2 years ago and now generates over 35 billion ad requests monthly for brands including; Skype and Warner Bros. Its network of publishers has grown to over 10,000 mobile sites and apps, reaching an audience of 200 million unique users monthly. The launch of operations in Singapore and Ram’s appointment follow rapid growth across Asia-Pacific where Adfonic is already driving over 8 billion monthly ad requests.

Having established a successful Indian office for global mobile marketing provider, Velti and occupied senior management positions with mobile internet service provider One97, Ram has broad experience in the mobile marketing industry. Ram has an MBA from the London Business School.

Kartik Ram said: “I am very excited to be joining Adfonic as it expands its global operations into Asia-Pacific. This is a savvy move for Adfonic but also represents a huge opportunity for brands in this market, which now have access to Adfonic’s comprehensive global mobile publisher inventory.”

Victor Malachard, CEO Adfonic, said: “We are delighted to announce the opening of our offices in Singapore and to welcome someone of Ram’s knowledge and experience of the mobile advertising market to the team. We serve ads to over 190 countries and Asia-Pacific has long been a priority for continued expansion.”

The launch of on-the-ground operations in Asia-Pacific follows Adfonic’s announcement last September that it had received an additional $7.5 million investment to support the company’s continued growth. In early 2011 Adfonic opened offices in Paris and New York and in November offices were opened in Madrid which also serve Latin America. A second US office recently opened in San Francisco. Adfonic plans to launch operations in Germany and Italy during early 2012.

Kartik will be attending Mobile World Congress, Barcelona, 27 February – 1 March (Adfonic stand number: 7A96); the MMA Forum, Singapore, 23 – 25 April; and ad:tech Singapore, 13 – 14 June.

Source: Adfonic

Kerry Ingredients & Flavours is expanding its customer center of excellence in Beloit, Wisconsin, to include a new Cell Science laboratory. Building on the success of its companion site in Almere, The Netherlands, the new Cell Science laboratory will incorporate state-of-the-art technologies and media supplementation expertise to engage globally with Kerry’s bio-pharma customers and technology partners.

“The new Cell Science laboratory expands our Media Enhancement Services capabilities for Cell Culture, Vaccines, Microbial Fermentation, and Diagnostics. Additionally, this new research and applications center with leading R&D expertise will advance our ability to customize cell media supplements to meet the evolving needs of the bio-pharma market globally,” stated Christopher Wilcox, Kerry’s Director of R&D overseeing Cell Culture & Media Supplementation technologies.

Kerry is investing more than $10 million in the expansion of the Cell Science laboratory and Kerry customer center of excellence, which includes a consumer nutrition center, extensive flavor labs and product ideation and customer collaboration suites.

“Expanding our Cell Science laboratory in the Kerry center allows us to advance our media ingredients and supplements portfolio while capturing greater synergies with Kerry’s extensive analytical, research, development and applications expertise,” stated Edmond Scanlon, President of Kerry’s pharma and bio-pharma ingredients business. “This ultimately helps us deliver greater innovation and overall value for customers.”

The expansion is expected to be complete by August 2012 and will add nearly 50 new jobs and an additional 30,000 square feet to the existing 260,000 square foot facility.

About Kerry Ingredients & Flavours
A division of Kerry Group, Kerry Ingredients & Flavours develops, manufactures and delivers innovative taste systems, functional ingredients and integrated solutions for the global food, beverage and pharmaceutical markets.

Serving the global pharmaceutical and bio-pharma markets under the trade name Sheffield Bio-Science, Kerry provides bio-pharma customers with a renowned product portfolio of media supplements including the industry-preferred HyPeps, Hy-Soy, NZ Amines, Primatones and Hy-Yests; as well as innovative new products such as Sheffield rInsulin ACF, Sheff-CHO ACF, Sheff-Vax ACF and Hy-Express systems.

Additionally, Kerry offers the pharmaceutical and nutrition markets a high quality excipient product line. including pharma-grade lactose, tablet coatings and pharma flavors, as well as custom developed innovative ingredient solutions to help customers succeed in the ever changing global marketplace.

www.kerry.com

CONTACT: Jim Egan of Kerry Ingredients & Flavours, +1-608-363-1200, jim.egan@kerry.com

Boston Scientific Corporation (NYSE: BSX) announces the creation of its Asia-Pacific regional organization that includes Australia, New Zealand, China, Hong Kong, India, Japan, South Korea, South East Asia, Taiwan and Turkey. The Company believes this pan-Asia business model will help drive growth by leveraging best practices in the region, accessing the strong pool of local talent, and collaborating with healthcare professionals and regulatory agencies throughout the region.

“During the past year, we have laid a solid foundation for consistent growth in the key emerging markets of China and India. Our strategic investments in these countries have already begun to generate results and expand our regional footprint,” said Hank Kucheman, Chief Executive Officer of Boston Scientific. “We will now work to leverage these results to streamline our organization and strengthen our market position across Asia, the world’s fastest growing region, by creating Boston Scientific Asia-Pacific.”

The organization will be led by Supratim Bose, Executive Vice President and President, Asia-Pacific for Boston Scientific. Before joining Boston Scientific in January 2012, Mr. Bose was Founder and Chief Executive Officer of Singapore-based Bose Consulting Group, which specialized in strategic management consulting services for the healthcare industry. Previously, he worked for nearly 30 years at Johnson & Johnson, where he concluded his tenure as the Company Group Chairman of its Medical Devices and Diagnostics (MD&D) business in 2009. In this role, he managed Johnson & Johnson’s MD&D companies throughout Asia-Pacific, including Japan, having pioneered its entry in all emerging markets in Asia, including China, India and Vietnam.

“I am honored to take on a leadership role in this newly created organization for such a well-recognized company and leader in the medical device industry,” said Bose. “Our mission is to serve more patients in every market in this region. We have an incredible opportunity for growth, and I am excited to lead this team in establishing a greater presence for Boston Scientific in Asia-Pacific.”

“Last year, Boston Scientific announced its plan to invest $150 million in China to build a facility for medical device manufacturing and healthcare provider training. Additional significant investments in India and other key markets in the region are planned,” added Bose. “A major emphasis for growth will be in our drug-eluting stent (DES) business where our current market share in much of Asia-Pacific is far eclipsed by the Company’s DES share in the U.S. and worldwide. We anticipate numerous planned product launches in the region in 2012, including the platinum chromium PROMUS Element? Stent platform, which is expected to launch in Japan by mid-year.”

About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with organizational structure, management transition plans, our market share, growth and business strategy, potential investments, product launch plans, and other factors described in Boston Scientific’s filings with the Securities and Exchange Commission.

CONTACTS:

Australia/New Zealand
Mark Wallwork
Managing Director
+61-2-8063-8131
mark.wallwork@bsci.com

China/Hong Kong
Rob Sandfelder
VP, China/Hong Kong
+862161415925
rob.sandfelder@bsci.com

India
Bob Neidermire
Country Director, India
+91-124-492-3300
bob.neidermire@bsci.com

Korea
Oh Kyung Yul
Country Director, Korea
+82-2-3483-1700
kyungyul.oh@bsci.com

South East Asia & Taiwan
Daphne Wang
Country Director, South East Asia & Taiwan
+886-2-2652-8133
wangd@bsci.com

SOURCE Boston Scientific Corporation

Global Managed-Care Offering to Help Bring Down Treatment Costs for 366 Million Diabetics

Actavis and Bioton (WSE:BIO) announced today that they have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be granted an exclusive licence to commercialise those products under the Actavis brand throughout the European Union and the United States of America, as well as in Albania, Bosnia & Herzegovina, Croatia, Iceland, Japan, Kosovo, Lichtenstein, Macedonia, Montenegro, Norway, Serbia and Switzerland. In Poland, both companies will offer the insulin products under their respective brands, Bioton being a Polish company.

The announcement, at a press conference in Warsaw today, was made jointly by Ryszard Krauze, Chairman of the Supervisory Board of Bioton, and Claudio Albrecht, CEO of the Actavis Group and Chairman of the Actavis Board of Directors.

Actavis has agreed to remunerate Bioton with the aggregate amount of EUR 55.5 million, of which EUR 22.25 million at signing today. The remainder (EUR 33.25 million) will be paid in instalments in accordance with agreed milestones relating to the registration process involving recombined human insulin (RHI).

Based on the sales volumes estimated by the parties, the Actavis’ revenues from the sale of the Insulins by Actavis into the markets in the initial period of 7 years from launch are expected to exceed EUR 1.5 billion. Pursuant to the agreement, the parties will share on an equal ’50/50′ basis the profits from the sale of the insulins performed by Actavis, as well as the development and registration costs related to Bioton insulins.

In addition to the above, the Bioton Group have also signed memoranda of understanding with Actavis for the sale of insulins in 24 additional territories, including Turkey and Australia. Actavis will pay an additional consideration of up to EUR 1,900,000, including EUR 1,000,000 at signing. Both parties expect that sales of Bioton’s recombinant human insulin by Actavis into some of the additional territories shall commence on the turn of 2012 and 2013. The profits from the sale of the insulins in these additional territories will again be shared on an equal basis (50/50). Formal documentation of these arrangements is expected to be concluded in the following weeks.

Actavis CEO Claudio Albrecht believes the new alliance will create tremendous value for Actavis and Bioton and their respective shareholders. “The recombinant- and analogue insulins alone should add around EUR 900 million (USD 1.2 billion) to our enterprise value. Thanks to the collaboration agreement with Bioton, we will be among the leading manufacturers of insulin, including analogue insulins,” predicted Albrecht.

Chairman of the Supervisory Board of Bioton S.A. Ryszard Krauze commented, “The cooperation with Actavis has a strategic importance for Bioton. We will jointly introduce modern insulins, including analogue insulins. For the last two years, we have been consistently increasing the sales of our products based on collaborations with leading global pharmaceutical firms such as Bayer HealthCare in China and GlaxoSmithKline in Russia. Today, we are pleased to welcome another large pharmaceutical firm to our group of partners – Actavis.”

DIABETES – A GLOBAL EPIDEMIC

New data released by the International Diabetes Federation (IDF) indicates that more than 366 million people worldwide are living with diabetes. Due to poor diet and sedentary lifestyles, diabetes is rapidly becoming a global epidemic, and the number of diabetes patients is expected to rise to a figure in excess of 550 million by 2030. The World Health Organisation (WHO) projects that the global insulin market will grow from the present level of approximately USD 14 billion to USD 54 billion over that same period.

On average, a patient with diabetes type 2 takes almost 30 different medicines over the course of the disease. In light of that fact, the collaboration with Bioton represents a more fundamental and strategic concept in terms of treating diabetes, according to Claudio Albrecht.

“The diabetes idea for us is a much wider one than just promotion and sale of recombinant human insulin or insulin analogues,” he said. “We are encountering competitor giants when it comes to insulin and we have to maximise the competitive advantages that we clearly have. Bioton’s insulin products have a market presence of more than 10 years’ standing, with an excellent safety and efficacy profile. This puts us in a situation where we can overcome more easily any potential doubts that key opinion leaders might have when it comes to biosimilars.”

“Furthermore, we differ in one aspect very strongly in comparison with the originators,” Albrecht added, highlighting the extensive range of generic type-2 oral diabetes drugs that Actavis already offers. Actavis’ pipeline also includes high-value ‘gliptin’ products and several fixed dose combinations with Metformin.

COMPREHENSIVE CARE OFFERING

Albrecht noted that the opportunity to market a much broader portfolio in the context of diseases related to diabetes is a great one. “Actavis is the only company that can offer such a broad diabetes- and related diseases portfolio. We can tell payers that we cover the whole diabetes segment for a cost that is probably considerably less than they have been paying to date.”

CEO of Bioton SA S?awomir Ziegert said, “For Bioton, the collaboration with Actavis will, in addition to bringing direct financial benefits, fuel faster expansion into high-margin markets, while supporting the implementation of our product synergy strategy and further growth in the area of cardio diabetology. Patients value highly the unique and comprehensive care offered by Bioton, a package which includes insulin, injectors, glucometers, oral diabetes medicines and an educational programme. All these elements provide an opportunity to extend our collaboration with Actavis in many markets around the world.”

Contact:
Actavis Group
Frank Staud
EVP Corporate Communication
Mobile: +41-79-230-95-78
E-Mail: fstaud@actavis.com

Source: Actavis Group