A Treatment Revolution is Underway: All-Oral Therapies Transform Global Hepatitis C Antiviral Market

MOUNTAIN VIEW, California, July 29, 2014 /PRNewswire/ — Drug development for hepatitis C virus (HCV) antivirals has amplified with rising incidence rates and the intense need for curative therapy in the absence of a preventative vaccine. Change is underway as the market moves away from protease inhibitors and interferon regimens towards highly effective, easily-tolerated, interferon-free oral therapies.

Gilead’s mega blockbuster Sovaldi is the first of these novel therapies to launch into the market and is projected to hit close to $10 billion during its first year. Several strong competitors, however, are maneuvering aggressively to narrow the market gap by introducing a HCV antiviral that can outdo Gilead’s drug.

New analysis from Frost & Sullivan’s A Product and Pipeline Analysis of the Global Hepatitis C Virus (HCV) Antiviral Market expects robust demand for HCV antivirals as around 160 million people across the globe are chronically infected with HCV, and at least 350,000 die annually from HC-infected liver diseases such as liver cancer and conditions requiring transplantation. The United States alone accounts for nearly five million of the total HCV-affected population, with the majority being baby boomers entering the 65-plus age bracket.

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“Evidently, chronic infection with HCV remains a serious public health threat,” said Frost & Sullivan Healthcare Principal Analyst Randy Budros. “Until an efficacious preventative vaccine emerges, the patient strength will remain sizable due to the likelihood of high-risk behaviors from a substantial portion of the population and the emergence of resistant viral strains.”

While Gilead’s Sovaldi holds promise in fighting the HCV, its astronomical price – $84,000 for a 12-week course of treatment – has unleashed a firestorm of criticism from government agencies, patient advocacy groups, and payers. Indeed, the prohibitive price has triggered a Congressional request for Gilead to justify its pricing, which is projected to increase Medicare Part D spending by as much as $6.5 billion in 2015 alone.

“Gilead and other future market entrants have to create a compelling pricing rationale by driving home the potential cost savings from a high-performance, all-oral regime, zeroing in on the downstream cost saving such as the reduction of liver transplants,” noted Budros. “Equally crucial is the need to make HCV antivirals more affordable and accessible to patients.”

With recent clinical data showing close to 100-percent cure rates for Sovaldi, future contenders will be hard pressed to succeed in the marketplace. Competitors must aim to satisfy the until now unmet need for a once-daily, ribavirin-free, all-oral, pan-genotypic regimen that has a short treatment duration.

A Product and Pipeline Analysis of the Global Hepatitis C Virus (HCV) Antiviral Market is part of the Life Sciences (http://www.lifesciences.frost.com) Growth Partnership Service program. Frost & Sullivan’s related studies include: Product and Pipeline Analysis of the Global Therapeutic Lipid Modulators Market, A Product and Pipeline Analysis of the Global Diabetes Therapeutics Market, A Strategic Analysis of the Global Anti-obesity Prescription Pharmaceuticals Market, and Product and Pipeline Analysis of the Global Psoriasis Therapeutics Market. All studies included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

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Frost & Sullivan: Plant Health Improvement Agents Enable Growers to Do More with Less

— Smart fertilizers, PGRs, and bundled micronutrients are fast growing niche segments that will challenge bulk fertilizers in the market

MOUNTAIN VIEW, Calif., July 29, 2014 /PRNewswire/ — The plant health improvement agents (PHIA) market, which consists of micronutrients, synthetic fertilizers and plant growth regulators (PGRs), is growing steadily in North America mainly due to demand from the food, biofuel and plant-based chemicals industries. Rising healthcare costs combined with healthier eating trends have resulted in increased demand for high-value niche foods such as proteins, nuts, vitamins and minerals allowing for increased PHIA use in horticulture. The Renewable Fuel Standard and other regulations aimed at reducing carbon footprint through use of biofuels and natural products further support market demand.

Frost & Sullivan: Plant Health Improvement Agents Enable Growers to Do More with Less

Frost & Sullivan: Plant Health Improvement Agents Enable Growers to Do More with Less

New analysis from Frost & Sullivan, Analysis of the North American Plant Health Improvement Agents (PHIA) Market, finds that the market earned revenues of $15.45 billion in 2013 and estimates this to reach $19.66 billion by 2020. While synthetic fertilizers dominate the North American market with a 91.4 percent share, educated farmers are influencing the development and marketing of high-value products such as micronutrients and PGRs.

For complimentary access to more information on this research, please visit: http://bit.ly/1rwnrgr.

“Rapid advances in plant genetics and seed technology can outpace nutrient innovation and reduce dependence on standard bulk fertilizers,” said Frost & Sullivan Chemicals, Materials and Food Research Analyst Reuben Sequeira. “To sidestep this threat, PHIA market participants are developing new plant nutrient technologies, such as chelated and complexed micronutrients to complement the modern plant.”

However, fluctuating weather, planting and demand patterns in the region alter the balance of nutrient supply and demand creating price volatility in the PHIA market. While nutrient companies are adapting, this issue still affects upstream capacity utilization, especially as excess supply lowers nutrient prices for prolonged periods of time.

Companies that have sustained above-market growth in the midst of demand and price instability are those that maintain strong relationships with customers through well-developed distribution pipelines. These companies anticipate concerns and reduce risk through long-term contracts that ensure steady return on investment for growers.

“Such distribution partnerships will help suppliers meet growers’ needs with highly effective and advanced products,” noted Sequeira. “Innovative products, such as controlled-release fertilizers, micronutrient-bulk fertilizer blends, and targeted micronutrients will also morph into substitutes for bulk nutrients.”

Analysis of the North American Plant Health Improvement Agents (PHIA) Market is part of the Chemicals & Materials (http://www.chemicals.frost.com) Growth Partnership Service program. Frost & Sullivan’s related studies include: Analysis of the Western European Plant Health Improvement Agents Market, among others. All studies included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

Photo – http://photos.prnasia.com/prnh/20140729/8521404273

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Frost & Sullivan Applauds Gamma Medica for Improving the Quality and Efficiency of Breast Cancer Diagnosis with its Unique LumaGEM MBI System

MOUNTAIN VIEW, Calif., July 29, 2014 /PRNewswire/ — Based on its recent analysis of the breast imaging systems market, Frost & Sullivan recognizes Gamma Medica with the 2014 Global Frost & Sullivan Award for Product Leadership. Gamma Medica’s LumaGEM Molecular Breast Imaging (MBI) system provides breast images through the digital direct conversion of photons in gamma rays into electronic charges that form the image. It equips clinicians with MBI technology to detect tumors in women with dense breast tissue and plan treatment measures as early as possible.

Gamma Medica has demonstrated its dedication to improving the standard of care for breast cancer patients by offering the advanced cadmium zinc telluride (CZT) solid state detector technology in its LumaGEM MBI system.

“While other adjunct technologies such as ultrasound and magnetic resonance imaging are available, either their inability to locate microcalcifications or their low specificity can throw up inconclusive results,” said Frost & Sullivan Research Analyst Raghuraman Madanagopal. “On the other hand, Gamma Medica’s LumaGEM MBI system can efficiently locate lesions as small as 5 millimeters in size and help identify the tumor as benign or cancerous.”

The LumaGEM MBI system has the highest negative predictive value (NPV) among adjunct technologies used for breast cancer diagnosis, making it one of the most reliable systems for this purpose. It also has a high intrinsic spatial resolution of 1.6 millimeters and provides high-quality images that enable clinicians to locate tumors, measure them, and understand their functional and metabolic activities.

While there are shortcomings with every adjunct technology that is used for breast cancer diagnosis, the LumaGEM MBI system, with a high sensitivity of 91 percent and a high specificity of 93 percent, offers customers unprecedented precision. The LumaGEM MBI system utilizes a dual-head technology that effectively locates cancers in cases that previously were either inconclusive or determined to be negative on mammography images.

As the imaging is done on the mediolateral oblique and the cranio-caudal planes, it is easily comparable to mammography images. The scanning procedure in the LumaGEM MBI system uses minimal compression and is performed with the subject in a seated position.

“The LumaGEM MBI system has a small-sized gamma camera that is located closer to the breasts,” noted Raghuraman Madanagopal. “As a result, the amount of radiation required for obtaining images is less than one-third of the amount used in most breast-specific gamma imaging modalities. Frost & Sullivan research shows that this ability provides Gamma Medica a technological advantage over its competitors.”

“Gamma Medica is committed to making MBI a more widely used tool in the battle against breast cancer,” said Jim Calandra, president and chief executive officer of Gamma Medica. “We are pleased to have been recognized by Frost & Sullivan for our efforts and are excited to drive breast cancer diagnosis technology forward with highly advanced, patient-friendly and cost-effective tools.”

Gamma Medica has made its products commercially available throughout the United States, as well as in certain parts of Europe, and hopes to expand to other regions of the world. By utilizing innovative technologies and effective growth strategies, Gamma Medica has ensured a superior competitive position for itself in the global breast imaging systems market.

Each year, Frost & Sullivan presents this award to the company that has demonstrated innovation in product features and functionality that provides enhanced quality and higher value to customers. The award recognizes the rapid acceptance such innovation finds in the marketplace.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.

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CNH Industrial Inaugurates New Agricultural Equipment Manufacturing Complex in China

– CNH Industrial celebrated today the opening of its new manufacturing complex in Harbin, in Heilongjiang Province. It is the largest agricultural equipment production plant in Northeast China and will produce a complete line of products under its Case IH and New Holland Agriculture brands to support the Country’s agricultural needs, and the full cycle of corn, wheat, soybean and hay production.

HARBIN, China, July 29, 2014 /PRNewswire/ — CNH Industrial inaugurated its new manufacturing complex built in the area of its previous assembly plant in Heilongjiang Province, China. The biggest agricultural equipment manufacturing facility in Northeast China, the complex extends over a total area of 400,000 square meters of which 116,000 are covered. The vertically integrated manufacturing complex features the latest technology in fabrication and two state-of-the-art painting facilities. Automated Guided Vehicles (AGVs) are utilized for the assembly and testing of the finished products to guarantee the highest quality standards. Within the complex is a Customer Center with a spacious showroom to support dealers. In addition a Research & Development Center with a dedicated outdoor test track opened in September 2013 and houses the engineering team tasked with designing components and adaptations for the domestic market. These facilities are complemented by the nearby spare parts depot and Training Center.

The new manufacturing plant will produce a wide range of product lines: planters, tractors, combine harvesters and corn pickers with their headers, balers and hay tools. Its production will include a complete line of equipment for the mechanization of the full cycle of corn, wheat, soybean and hay production. Among its products will be the legendary Case IH Axial-Flow combine range adapted for local conditions and Case IH corn pickers entirely developed for the Chinese market, as well as the award winning New Holland T6000 and T7000 tractor ranges and BC5000 balers.

Richard Tobin, CEO of CNH Industrial, commented, “CNH Industrial has a strong and long standing relationship with China. Through our agricultural equipment brands we have been present in this country for more than 100 years, supporting the mechanization of its agriculture and gaining leading positions in the market for high horsepower tractors, large combine harvesters, cotton pickers, sugar cane harvesters and balers. Our new manufacturing complex here in Harbin represents an investment of over USD $100 Million and its inauguration marks an important milestone that confirms our commitment to the development of Chinese agriculture.”

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Merck Serono Initiates Phase II Study of Anti-PD-L1 Antibody MSB0010718C in Metastatic Merkel Cell Carcinoma

DARMSTADT, Germany, July 29, 2014 /PRNewswire/ —

  • First patient begins treatment in an international Phase II study investigating the efficacy and safety of MSB0010718C in patients with metastatic Merkel cell carcinoma (mMCC) 
  • mMCC is a rare and aggressive skin cancer lacking effective treatments  
  • MSB0010718C is also currently being explored in a seven cohort Phase I clinical trial for the treatment of solid tumors that aims to recruit 590 patients 

Merck Serono, the biopharmaceutical division of Merck, today announced the initiation of an international Phase II study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). This multicenter, single-arm, open-label study is being conducted in patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive type of skin tumor,[1],[2] who have previously received one line of chemotherapy. It is expected to recruit 84 patients across Asia Pacific, Australia, Europe and North America. The primary endpoint of the study is overall response.

The PD-L1/PD-1 pathway is implicated as a major mechanism by which tumors evade elimination by the immune system.[3] The PD-L1 molecule is expressed in many cancer types, including mMCC.[3],[4] MSB0010718C, which blocks the interaction of PD-L1 with its receptor PD-1, may have the potential to restore effective anti-tumor T-cell responses and thereby to inhibit tumor growth.

Immune mechanisms are implicated in the pathogenesis of MCC, with an increased risk observed in immunosuppressed individuals.[5] MCC also is associated with the presence of the Merkel cell polyomavirus, which may have a role in tumor formation.[6] Globally, the incidence of MCC is increasing, and outcomes for patients with this disease are poor.[1],[2] Therefore, new treatment approaches are required to improve the outcome of patients with this type of cancer.

“We believe that modulating the immune system by targeting PD-L1 represents a promising new approach in the treatment of this aggressive cancer, especially considering that many of the predisposing factors for mMCC seem to be related to functional disruptions of the immune system,” said Helen Sabzevari, Senior Vice President of Immuno-Oncology at Merck Serono. “Our anti-PD-L1 compound may present a potential new approach for the treatment of mMCC patients. The initiation of this Phase II study is an important milestone, as we endeavor to help those suffering from mMCC, a devastating disease with significant unmet need.”

In addition to this new study in mMCC, MSB0010718C is currently being explored in a Phase I clinical trial for the treatment of solid tumors. The study aims to recruit 590 patients and has enrolled 422 patients to date. On June 1, 2014, Merck Serono presented initial data from this dose escalation study in solid tumors at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago.[7] This study is currently recruiting patients into expansion cohorts in seven cancer types: castrate-resistant prostate cancer, colorectal cancer, gastric/gastroesophageal cancer, melanoma, metastatic breast cancer, non-small cell lung cancer and ovarian cancer.

References 

  1. Hughes MP, et al. Curr Dermatol Rep 2014;3:46-53.
  2. Kaae J, et al. J Natl Cancer Inst 2010;102(11):793-801.
  3. Lipson EJ, et al. Cancer Immunol Res 2013;1(1):54-63.
  4. McDermott DF and Atkins MB. Cancer Med 2013; 2(5):662-73.
  5. Bhatia S, et al. Curr Oncol Rep 2011;13(6):488-97.
  6. Feng H, et al. Science 2008;319(5866):1096-100.
  7. Heery CR, et al. J Clin Oncol 2014;32:5(Suppl.) Abstract No. 3064.

About MSB0010718C 

MSB0010718C is an investigational fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses.

About Merkel cell carcinoma (MCC) 

MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings. MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, arms, legs, and trunk. Risk factors for MCC include sun exposure and having a weak immune system (i.e., solid-organ transplant recipients, people with HIV/AIDS and people with other cancers, such as chronic lymphocytic leukemia, are at higher risk). Caucasian males over age 50 are at increased risk.

MCC tends to metastasize at an early stage, spreading initially to nearby lymph nodes, and then potentially to more distant areas in the body, including other lymph nodes or areas of skin, lungs, brain, bones, or other organs.

Current treatment options for MCC include surgery, radiation and chemotherapy. Treatment for metastatic or Stage IV MCC is generally palliative.

About Merck Serono 

Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.

For more information, please visit http://www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.

Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day.

Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

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Advanced First Aid Research Announces N95 Partnership with SilverACE Senior Activity Centres and Lions Befrienders to Help Elderly Combat Haze

SINGAPORE, July 29, 2014 /PRNewswire/ — Singapore healthcare company, Advanced First Aid Research, an innovator in first aid and burn relief solutions, today reinforced its commitment to supporting the health, wellbeing and preparedness of Singaporeans with the announcement of a sponsorship initiative in partnership with NTUC Health Co-operative’s SilverACE Senior Activity Centres and Lions Befrienders, designed to support the Nation’s most vulnerable citizens.

Goh Boon Han (left) from Lions Befrienders with Allen Loh (right), CEO of Advanced First Aid Research with the Aluminaid N95 masks.

Goh Boon Han (left) from Lions Befrienders with Allen Loh (right), CEO of Advanced First Aid Research with the Aluminaid N95 masks.

Ahead of the anticipated haze, Advanced First Aid Research has announced it will donate one N95 mask for each one sold through Unity Pharmacies nationwide. The donated masks will be supplied to vulnerable elderly, specifically those who are members of the SilverACE Senior Activity Centres (SACs). SACs are a government initiative to support the lower income elderly with weak family support.

Donated masks will similarly be distributed to elderly citizens by the Lions Befrienders support network which reaches over 5,000 seniors through the social and community programmes.

Advanced First Aid Research’s innovative N95 mask design features an electrostatic filter that delivers better ventilation, easier breathing and speaking due to its 99 per cent filtration efficiency against micron particles. The mask also offers longer, more lasting protection against the haze and other harmful gases in a way not catered for by standard masks.

Advanced First Aid Research CEO, Allen Loh, says: “While we sincerely hope that the projected haze does not adversely impact the health of Singaporeans, it’s important we ensure that those most in need of support are prepared well in advance, and don’t miss out during times of high demand. The mask with its high filtration efficiency is ideally suited for those most susceptible to haze conditions.

“This initiative in partnership with SilverACE Senior Activity Centres and Lions Befrienders complements the good work of other government agencies and organisations who are equally committed to protecting our nation’s health during the haze season as well as the Nation’s first aid preparedness overall.”

“As a Singaporean company, we understand the local challenges on the ground and have all experienced the limitations of the current products in the market. We are delighted to extend this partnership with SilverACE Senior Activity Centres and Lions Befrienders in a way that reinforces our overall commitment to improve the health and safety of Singaporeans,” Mr Loh added.

During the haze season, the number of patients admitted into hospital for respiratory problems increases by 20 per cent.[1] In general, the elderly, children and people with chronic lung disease and heart disease are more sensitive to the health effects of haze.[2]

Goh Boo Han, Executive Director, Lions Befrienders, says: “We are delighted to be a part of this initiative at a time when N95 masks are in demand due to the anticipated haze. We see this as a positive and proactive measure undertaken by a local company to help the needy and vulnerable elderly.”

Leon Luai, Head Clinical Services and Wellness for NTUC Health, who oversees the SilverACE SACs, says: “We work to empower the elderly to take charge of their health and avoid many of the common health problems they face today. For instance, we have self-help health check stations at our six SACs and we regularly conduct health checks for the seniors. We are happy to partner with Advanced First Aid Research to enable seniors from lower-income families to access quality N95 masks and to ensure that they can be protected during the haze.”

“We are pleased to be part of this meaningful initiative to do more to care for the health of our community. For every mask purchased, Unity customers can equip themselves and their families and also contribute to support needy elderly in Singapore during the haze,” said Bernard Lee, MD and Head, Pharmacy and Health food NTUC Health, who also oversees Unity pharmacies.

Unity pharmacies were among the first to bring in fresh supply of N95 masks during the peak of the haze last year, and they also brought the prices of the masks down to ensure that more working families would be able to obtain the item.

Advanced First Aid Research’s N95 masks are available now in Unity Pharmacies across Singapore in packs of 10 and 20 masks. A 10-piece pack retails for $18.80 while a 20-piece pack retails for $37.80. Advanced First Aid Research will donate a N95 mask to SilverACE Senior Activity Centres and Lions Befrienders for each one sold for the duration of the haze period.

1. Fiona Low, Asthma and Allergy cases up as haze worsens: Docs, The Straits Times. Available from https://www.healthxchange.com.sg/News/Pages/Asthma-and-allergy-cases-up-as-haze-worsens.aspx

2. Health Promotion Board, Impact of Haze on Health. Available from http://www.hpb.gov.sg/HOPPortal/health-article/HPB051226

Photo – http://photos.prnasia.com/prnh/20140728/8521404251 

For more information or to request an interview, please contact:

Dickson Tan

Gerald Leong

Edelman Public Relations

Edelman Public Relations

Dickson.Tan@edelman.com

Gerald.Leong@edelman.com

+6563472352

+6564941596

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