Sinovac Provides Updates on Pipeline Vaccines

BEIJING, March 17, 2015 /PRNewswire/ — Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today provided updates on the Company’s pipeline vaccines.

EV71 vaccine. The Company submitted supplementary documentation to the China Food and Drug Administration (CFDA) at the end of January 2015, as required following review of the new drug application (NDA) by an expert panel in November 2014. The CFDA has begun its review of the supplementary documentation. Sinovac maintains regular communication with relevant departments of CFDA, in order to be prepared for the upcoming on-site inspection, sample testing, and production and lot release after the product is commercialized. Once the on-site inspection and sample testing are successfully completed, Sinovac will receive the new drug certificate, production license and GMP license to begin commercial production of its EV71 vaccine.

EV71 is a virus that causes hand, foot and mouth disease (HFMD) and is the primary cause of most severe and fatal cases of hand, foot and mouth disease (HFMD) in China. According to the Chinese CDC, there were approximately 2.78 million reported cases of HFMD in 2014 and 508 fatal cases.

Please see the Company’s 20-F filing on April 16, 2014 at www.SEC.gov for a complete outline of the NDA process.

Other Pipeline Vaccines

Pneumococcal 23-valent polysaccharide vaccine (PPV). The Company obtained its clinical trial license in May 2014. Sinovac is currently completing clinical trial preparations and expects to start trials in the first half of 2015.

Varicella vaccine. The Company is currently preparing supplementary material for the clinical trial application, following review by an expert panel in November 2014. The Company expects to receive its clinical trial license in 2015. Sinovac filed the clinical trial application with the CFDA in January 2013.

Pneumococcal 13-valent conjugate vaccine (PCV). The Company obtained its clinical trial license in January 2015, having filed its application with the CFDA in March 2011. PCV is targeted for children under two years old. Sinovac will finalize its clinical trial protocols based on Good Clinical Practice (GCP) and related technical guidelines and initiate production and testing for vaccines to be used in clinical trial accordingly. The Company is required to commence the trials within three years after the license is issued.

Sabin-inactivated polio vaccine (sIPV). The clinical trial application for the vaccine was accepted by Beijing Food and Drug Administration in October 2014 and is under review by the CDE.

Hepatitis B vaccine and new generation of hepatitis A & B vaccine. The Company has completed pre-clinical studies for its proprietary hepatitis B vaccine and filed a clinical trial application in December 2014. Simultaneously, Sinovac is developing a new generation of its hepatitis A & B combination vaccine based on its individual hepatitis A and B vaccines. The new generation combination vaccine will contain a higher dosage of the hepatitis B component, 10ug and 20ug for pediatric and adult formulations, respectively, to enhance the vaccine’s immunogenicity. And the clinical trial application for the combined vaccine was submitted in December 2014.

Rubella vaccine. The Company obtained the clinical trial license in December 2014. This vaccine is expected to be developed as a measles, mumps and rubella (MMR) combination vaccine. The Company filed its application for clinical trial with the CFDA in April 2011.

Mr. Yin concluded, “The continued advancement of our vaccine pipeline is evidence of our strong R&D capabilities. With these capabilities and commercial execution strategies, Sinovac is well positioned to grow over the long-term. I am confident that our pipeline will continue to progress as we work towards our mission of providing protection against infectious diseases in China and other emerging markets.”

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), mumps and canine rabies. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. Sinovac has filed a new drug application with the China Food & Drug Administration for its proprietary enterovirus 71 vaccine, having been proven effective in preventing hand, foot and mouth disease in infants and children during its Phase III clinical trial. The Company is currently developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company has exported select vaccines to Mexico, Mongolia, Nepal, and the Philippines, and was recently granted a license to commercialize its hepatitis A vaccine in Chile. For more information, please visit the Company’s website at www.sinovac.com.

Contact

Sinovac Biotech Ltd.
Helen Yang / Chris Lee
Tel: +86-10-8279-9659 / 9696
Fax: +86-10-6296-6910
Email: ir@sinovac.com

ICR Inc.
Bill Zima
U.S: 1-646-308-1707
Email: william.zima@icrinc.com

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Data Storytelling Heats up with Tableau Public’s New Web Platform; Now Serving 90,000-plus authors

–36,000 people joined Tableau Public in 2014, including award-winning journalists, students, scientists, and data geeks

SEATTLE, March 12, 2015 /PRNewswire/ — 2014 was a marquee year for Tableau Public, as more than 36,000 new authors joined and published more data stories than ever before. Tableau’s free platform for creating, sharing and discovering data stories on the web now boasts more than 90,000 authors publishing 4,500 visualizations a week. A visualization of the national exchange and interest rates in the Dominican newspaper El Nacional became the first Tableau Public “viz” to pass five million views.

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Since its launch in 2010, authors have published more than 500,000 visualizations on Tableau Public  nearly half of which were published in 2014 alone. Tableau Public has become the go-to community for people everywhere to create and share their data visualizations with the world. Since its launch, people have published stories on topics ranging from contest election, to The World Cup and controversial policing policies to marine conservation.

Dr. Ramon Martinez, a specialist in health metrics at the Pan American Health Organization (PAHO), tracked the spread of the Ebola virus in West Africa using Tableau Public. Dr. Martinez’s work has been featured in The Huffington Post and Mashable.

“For many years I dreamed of using data to advocate about population health issues, keep an open dialogue with public health professionals and communicate health key messages to the public,” said Ramon Martinez, “Tableau Public has served as the tool and a platform to create and share data visualizations, presenting facts in an engaging way and turning my dreams into a reality today.”

New Web Platform to Improve Sharing and Discovery

Additionally, Tableau Public has launched a fully redesigned web platform to help people share and discover data stories. The site is currently available on open Beta at public.tableau.com.

The new web platform features:

  • New profile pages: Dedicated pages for authors that enable them to edit and manage their portfolio of visualizations and showcase their work with others.
  • New Viz Toolbar: Every visualization is automatically outfitted with a new toolbar that helps people interact and explore their own view of the story. People can edit, download, embed, navigate, or restore views.
  • New Resources and Gallery: An expanded set of sample data sets to help people get started now includes quality scores of British universities, popularity of cats and dogs in the U.S., Tuberculosis burden in the world and many others. Additionally, the updated site features a revamped gallery, a curated set of the best visualizations of all time.

In addition, the site’s improved responsive design, rebuilt search, improved publishing experience and searchable maps make Tableau Public a state-of-the-art platform for data stories on the web.

“We launched Tableau Public with the vision of giving people a place to express a new form of storytelling. We believe data is a great conversation starter that can be both emotive and rationale,” said Ben Jones, Director for Tableau Public. “We now have 90,000 of these world citizens who are helping us see and understand what’s happening around our world.”

Tableau Public consists of a free downloadable authoring tool to explore and visualize data, a cloud platform to host, share and embed interactive visualizations and a learning program that provides support and training to hundreds of thousands of data enthusiasts around the world.

Visit www.tableau.com/public to explore more data stories and download Tableau Public.

About Tableau
Tableau Software (NYSE: DATA) helps people see and understand data. Tableau helps anyone quickly analyze, visualize and share information. More than 26,000 customer accounts get rapid results with Tableau in the office and on-the-go. And tens of thousands of people use Tableau Public to share data in their blogs and websites. See how Tableau can help you by downloading the trial at www.tableau.com/trial.

Tableau and Tableau Software are trademarks of Tableau Software, Inc. All other company and product names may be trademarks of the respective companies with which they are associated.

Mundipharma Demonstrates Efficacy of BETADINE(R) Formulations against Ebola Virus

SINGAPORE, Feb. 10, 2015 /PRNewswire/ — Mundipharma has announced successful results from the testing of BETADINE® formulations against the Ebola virus. The testing was conducted at Marburg University, Germany.

BETADINE® products are used for skin disinfection and surgical skin preparations around the world for over 50 years and are known to have a broad antimicrobial efficacy.

The BETADINE® range includes products such as BETADINE® Antiseptic Solution, BETADINE® Surgical Scrub, BETASEPTIC® Alcoholic Antiseptic Solution (marketed as BETADINE® Alcoholic Antiseptic Solution in Asia) and BETADINE® Skin Cleanser which have been widely used globally, for skin disinfection and hand hygiene in hospitals and healthcare institutions in the prevention of various hospital and community acquired infections.

All tested BETADINE® formulations showed an excellent virucidal efficacy as well as fast virucidal activity against the Ebola virus demonstrating its potential in fighting the outbreak and in minimising the risk of human to human transmission.  

During the recent, and still not controlled, outbreak of Ebola in West Africa, most of the disease has spread through human-to-human transmission. According to WHO guidelines, hand hygiene is the most important infection prevention and control measure[1] as the skin is a routine source of infection transmission.

On 11 December 2014 Mundipharma announced an initiative to support the control of Ebola, donating supplies of BETADINE®, sufficient for more than two million hand washes in the Ebola treatment centres of West Africa.

Raman Singh, President, Asia Pacific, Latin America, Middle East, and Africa, commented: “The Ebola virus, amongst others, is a very real threat to many of the populations of the regions in which we work. Mundipharma is proud to be able to support efforts to curb these epidemics, demonstrating the breadth and efficacy of our products and helping to inform and educate those at risk.”

“The excellent results from our study with Betadine confirm its potential in the prevention and limiting the spread of Ebola. We are hopeful that these results from our research will bring great value to the medical community and society in the management of Ebola crisis. The race to stay ahead of viral epidemics is constant.” said Prof. Dr. Maren Eggers, the virologist who led the investigations.

®: BETADINE and BETASEPTIC are Registered Trademarks

About Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis. www.mundipharma.com.sg

Note:
[1] (WHO, August 2014).

European Hantavirus Diagnostics Market Tops US Market as a Result of Higher Disease Prevalence

— Frost & Sullivan says existing competitors’ dominance of the niche market raises entry barriers

MOUNTAIN VIEW, Calif., Jan. 27, 2015 /PRNewswire/ — The European Hantavirus diagnostics market is growing at a compound annual growth rate (CAGR) of 5.8 percent, outperforming the U.S. market, which registered 3.7 percent. The European market is more robust primarily due to Hantavirus’ high prevalence rates in Russia, Scandinavia, Finland and Belgium. However, the U.S. market has higher mortality rates (50 percent) associated with the disease, even though it has no more than 40 reported cases every year.

Frost & Sullivan (www.frost.com)

Frost & Sullivan (www.frost.com)

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New analysis from Frost & Sullivan finds the Hantavirus testing market in Europe and the U.S. were worth $5.5 million and $0.023 million respectively in 2013, and estimates this to reach $7.3 million and $0.028 million by 2018.

Gain complimentary access to portions of Frost & Sullivan’s European and US Hantavirus Diagnostics research: http://bit.ly/1CcRUYq

“Since Hantavirus diagnostics is a niche market, competitors such as Immunospec and FocusDx have an advantage in the U.S. because of their established clientele,” said Frost & Sullivan Healthcare Research Analyst Aishwarya Vivekanadan. “This is likely to raise the entry barriers for new participants.”

Owing to the severity of Hantavirus infections, there is an urgent need for rapid diagnostic tests that can be easily conducted and used in field conditions. Acknowledging this unmet demand, diagnostic companies have been striving to develop faster, sensitive and more accurate tests.

“Currently tests take hours to days to detect the virus, mainly due to the lack of sensitivity to the different strains of the disease,” said Vivekanadan. “There is a need for diagnostic tests that are not only efficient but can identify the various strains of this virus to better cure it. A faster and more sensitive diagnostic test will go long way in saving lives, especially in the U.S. where mortality rate is almost 50 percent.”

Scientists have already launched a new diagnostic method based on a highly dispersed immunoelectrode prototype amperometric immunosensor. This model has been employed successfully in field conditions for testing rodent sera.

The earnest research and development (R&D) initiatives of diagnostics companies can lead to the discovery of new ecological paradigms regarding the virus. It could also aid superior understanding of the nature of episodic zoonotic epidemics such as those caused by Ebola virus, SARS CoV, Nipah virus, Machupo virus, and hantaviruses that are still undiscovered.

European and US Hantavirus Diagnostics is part of the Life Sciences (http://www.lifesciences.frost.com) Growth Partnership Service program. Frost & Sullivan’s related studies include: Briefing for the Bracing Devices and Support Market in the United States, Long-term Care in Extended Facilities and Nursing Homes in the United States, Industry Financial Review of the Global Laboratory Research Tools Market, and Optimization and Efficiency Drive in Hospitals in Western Europe. All studies included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Our “Growth Partnership” supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

  • The Integrated Value Proposition provides support to our clients throughout all phases of their journey to visionary innovation including: research, analysis, strategy, vision, innovation and implementation.
  • The Partnership Infrastructure is entirely unique as it constructs the foundation upon which visionary innovation becomes possible. This includes our 360 degree research, comprehensive industry coverage, career best practices as well as our global footprint of more than 40 offices.

For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies?

Contact Us:     Start the discussion

European and US Hantavirus Diagnostics
9837-52

Contact:
Jennifer Carson
Corporate Communications – North America
P: 210.247.2450
E: jennifer.carson@frost.com

Twitter: @Frost_Sullivan
Facebook: facebook.com/FrostandSullivan
Linkedin: http://linkd.in/1nL4auZ

http://www.frost.com

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Nurses Call for End to Leprosy Discrimination

TOKYO, January 27, 2015 /PRNewswire/ — The Nippon Foundation and the International Council of Nurses jointly released Global Appeal 2015 in Tokyo on Jan. 27, calling for an end to the discrimination that people affected by leprosy continue to face in many parts of the world. It is the first time that the annual Global Appeal, now in its tenth year, has been launched from Japan.

As the world’s largest group of health professionals, nurses are committed to alleviating physical and mental suffering of all people, without prejudice, and recognize the importance of educating the public about disease – especially a misunderstood disease such as leprosy.

“Our message is clear: leprosy can be cured. Drugs kill the bacteria. Early diagnosis and treatment prevent disability. There is no reason to isolate anyone with the disease,” they stated in the appeal.

Japanese Prime Minister Shinzo Abe, who attended the launching ceremony, said, touching upon the history of the isolation policy which fostered discrimination, “We will make efforts to help people still in sanatoriums live comfortably and peacefully and resolve discrimination and prejudice against leprosy.”

Each year, over 200,000 new cases of leprosy are diagnosed around the world. Although the disease is completely curable, people with leprosy and even members of their families continue to face discrimination, affecting their prospects for education, employment, marriage and full participation in society.

To draw attention to this issue, the Global Appeal was initiated in 2006 by Yohei Sasakawa, chairman of The Nippon Foundation and also WHO Goodwill Ambassador for Leprosy Elimination and Japanese Government Goodwill Ambassador for the Human Rights of People Affected by Leprosy.

To date, the appeal has been endorsed by influential individuals and organizations including Nobel Peace Prize winners, faith leaders, the World Medical Association, the International Bar Association and now the nursing profession, who underscored the key message of Global Appeal 2015 with the words: “We support the right of people affected by leprosy to live in dignity as full members of the community, enjoying equal access to all their human rights.”

The Nippon Foundation is a committed partner in the fight against leprosy, conveying the message that leprosy is curable and treatment is free, and working toward the goal of a world without leprosy and the discrimination it causes.

Contact:
Natsuko Tominaga
PR Department
The Nippon Foundation
+81-3-6229-5131
pr@ps.nippon-foundation.or.jp

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nurses-call-for-end-to-leprosy-discrimination-300026096.html

Frost & Sullivan Releases Drug Launch and Phase 3 Trial Watch List for Top Therapeutic Areas

– Oncology, autoimmune and infectious diseases/vaccines are hot areas for novel therapeutics and in vitro diagnostics in 2015

MOUNTAIN VIEW, Calif., Jan. 13, 2015 /PRNewswire/ — The therapeutics market is buzzing with activity, as several promising therapies are progressing to Phase 3 clinical trials and many more are awaiting commercial launches. As more complex specialty products are launched, the spending on personalized medicine will grow beyond oncology into areas such as infectious diseases (virology) and cardiology.

Frost & Sullivan (www.frost.com)

Frost & Sullivan (www.frost.com)

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Frost & Sullivan examined promising therapeutics for 2015 finding that oncology, cardiovascular, autoimmune/anti-inflammatories, and infectious diseases will be the top areas of investments in 2015.

“In addition, pharmaceutical companies will be keen to invest in in-vitro diagnostics such as biomarkers; molecular, tissue, companion diagnostics; predisposition disease; and predictive testing,” said Frost & Sullivan Life Sciences Global Program Director Jennifer Lazar. “This is because drugs with companion diagnostics are expected to increase two- to three-fold over the next five years with increased focus on areas such as cardiology and inflammatory diseases.”

To connect with a Frost & Sullivan expert about ways your company can prepare for the anticipated disruptions slated for 2015, contact Jennifer Carson, Corporate Communications at Jennifer.Carson@frost.com.

Frost & Sullivan’s therapeutics’ watch list for 2015:

  • Puma Biotechnology’s tyrosine kinase inhibitor, neratinib, for breast cancer adjuvant therapy: In its Phase 3 ExteNET trial, neratinib demonstrated significantly higher disease-free survival rates compared to placebo after adjuvant treatment with Herceptin (trastuzumab) for early-stage HER2-positive breast cancer. This therapy is awaiting Food and Drug Administration (FDA) filing in the first half of 2015, and potential approval and launch in the second.
  • Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, nivolumab, for previously treated advanced melanoma patients: In its Phase 3 trial, CheckMate-066, the primary endpoint of overall survival (OS) was met. It emerged that the one-year survival rate was 73 percent for nivolumab against 42 percent for the chemotherapy, dacarbazine (DTIC) in patients with treatment-naïve BRAF wild-type advanced melanoma. The Prescription Drug User Fee Act (PDUFA) has set the likely date for FDA approval as March 30, 2015. This could translate to a launch in the second quarter of 2015.
  • Novartis’ selective IL-17A inhibitor, secukinumab, for the treatment of plaque psoriasis: The Phase 3 trial drug, FIXTURE secukinumab, was shown to be significantly more effective in clearing skin lesions than Pfizer’s Enbrel. In October 2014, the FDA’s advisory committee recommended approval for secukinumab.  Anticipate a successful product launch in the first quarter of 2015.
  • Novartis’ angiotensin receptor neprilysin inhibitor (ARNi), LCZ696, for the treatment of heart failure: LCZ696 has exhibited statistically superior data to enalapril. Expect this treatment to be introduced in the second half of 2015.
  • AbbVie’s ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin for the treatment of hepatitis C: This interferon-free, all oral regimen is supported by six Phase 3 clinical trials. This triple combination therapy will likely be commercially launched in Q1 2015.
  • GlaxoSmithKline’s RTS,S vaccine is expected to be the first malaria vaccine in the market. GlaxoSmithKline submitted a regulatory application to the European Medicines Agency (EMA) in July 2014; its launch is anticipated in 2015.
  • Sanofi Pasteur’s Dengue Vaccine is also expected to have a first-mover advantage, with FDA approval in 2015.
  • Ebola virus vaccines consisting of cAd3-ZEBOV by GlaxoSmithKline, PSC-1001 by Newlink Genetics Corporation, and potentially an unnamed vaccine developed by Johnson & Johnson are anticipated to be entering Phase 3 trials in 2015.

In addition to new molecular entity (NME) product launches, there are abundant opportunities for generic and biosimilar drugs due to the patent expiry of several blockbuster drugs in 2014 and 2015. Some of those include:

  • Otsuka Pharmaceutical’s Abilify (anti-psychotic)
  • Teva Pharmaceutical’s Copaxone (relapse-remitting multiple sclerosis)
  • Novartis’ Gleevec (chronic myeloid leukemia)
  • Forest Laboratories’ Namenda (Alzheimer’s disease)
  • Pfizer’s Zyvox (anti-viral) and,
  • GlaxoSmithKline’s Avodart (benign prostatic hyperplasia)

To entrench themselves in the market, technology developers could expedite the identification of biomarkers and targets for novel therapeutics. Additionally, pharma/biotech and ICT companies could enhance patient awareness of product launches.

Frost & Sullivan’s Life Sciences Growth Partnership Service program offers several studies that provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants. Download our most up-to-date Life Sciences brochure for free for details: http://bit.ly/1DPyHeh

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Our “Growth Partnership” supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

  • The Integrated Value Proposition provides support to our clients throughout all phases of their journey to visionary innovation including: research, analysis, strategy, vision, innovation and implementation.
  • The Partnership Infrastructure is entirely unique as it constructs the foundation upon which visionary innovation becomes possible. This includes our 360 degree research, comprehensive industry coverage, career best practices as well as our global footprint of more than 40 offices.

For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies?

Contact Us:     Start the discussion

Join Us:           Join our community

Subscribe:       Newsletter on “the next big thing”

Register:         Gain access to visionary innovation

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Jennifer Carson
Corporate Communications – North America
P: +1.210.247.2450
E: jennifer.carson@frost.com

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Facebook: facebook.com/FrostandSullivan
Linkedin: http://linkd.in/1nL4auZ 

http://www.frost.com

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EB Pharma Announces License Agreement for Investigational Drug, Tipifarnib from Janssen Pharmaceutica for Development in Hepatitis Delta (HDV)

PALO ALTO, California, Dec. 23, 2014 /PRNewswire/ — EB Pharma, LLC., a subsidiary of Eiger BioPharmaceuticals, Inc., today announced that it has executed an agreement with Janssen Pharmaceutica NV, (“Janssen”), for an exclusive license, to tipifarnib in the field of virology and a related, clinical stage back-up compound. EB Pharma is conducting clinical studies in patients infected with Hepatitis Delta (HDV) and will assess the efficacy and tolerability of tipifarnib as a potential new therapy.

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“This novel approach to treating HDV is the culmination of decades of research,” said Jeffrey Glenn, MD, PhD, Scientific Founder and Associate Professor of Medicine, Stanford University. “I think it has the potential to change the treatment paradigm for the worst form of human viral hepatitis, and offers new hope for these patients.”

“HDV is the least common but has the poorest outcome of all forms of viral hepatitis,” said David Cory, President and Chief Executive Officer of Eiger. “We are excited to license tipifarnib from Janssen and study a potential new therapy for this life threatening disease.”

About Tipifarnib
Tipifarnib is a well-characterized, late stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Tipifarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply. Since prenylation is a host process, not under control of HDV, and tipifarnib inhibits prenylation, there is also a theoretical higher barrier to resistance with tipifarnib therapy. Virus mutation, a common pathway to drug resistance, is not expected to be a potential pathway to tipifarnib resistance by HDV.

Tipifarnib is not approved for sale for any indication.

About HDV

Hepatitis Delta is caused by infection with the hepatitis D virus (HDV) and is considered to be the most severe form of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals with hepatitis B (HBV), leads to more severe liver disease than HBV alone, and is associated with accelerated liver fibrosis, liver cancer, and liver failure. HDV is a disease with a significant impact on global health affecting ~15 million people worldwide. The prevalence of HDV varies between different parts of the world. HDV meets criteria for Orphan Designation in the United States (less than 200,000 people), Europe (less than 5 in 100,000 people), and Japan (less than 50,000 people). Globally, HDV infection is reported to be present in approximately 4% – 6% of chronic hepatitis B carriers. In some parts of the world, including certain areas of China, Russia, Central Asia, Turkey, Africa, and South America, prevalence as high as 40% has been reported in HBV infected patients.

About EB Pharma

EB Pharma is a privately held subsidiary of Eiger BioPharmaceuticals, Inc., focused on the research, development and commercialization of innovative therapies in viral hepatitis. The company will focus on developing tipifarnib for the treatment of Hepatitis Delta Virus (HDV), the most severe form of viral hepatitis. Tipifarnib is not approved for sale. EB Pharma’s research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious liver diseases.

Investors: Jim Shaffer, Eiger Bio, Inc., +1-919-345-4256, jshaffer@eigerbio.com

 

Eiger Bio Receives Orphan Designation for Lonafarnib, a First In Class, Investigational Treatment for Hepatitis Delta Virus (HDV) Infection

PALO ALTO, California, Dec. 22, 2014 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. today announced that lonafarnib has been granted Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).  The U.S. Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition. Orphan Designation qualifies the sponsor of the drug for various development incentives. Orphan designation also provides for a period of market exclusivity or protection against generic entry. Lonafarnib is a first in class, investigational treatment for patients infected with hepatitis delta virus (HDV).

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“We are committed to developing a therapy for the most insidious form of viral hepatitis, Hepatitis Delta, particularly as no FDA-approved therapies are currently available,” said David Cory, President and Chief Executive Officer of Eiger.  “We are pleased that the FDA and EMA have granted Orphan Designation to lonafarnib as a first in class, potential new therapy for HDV, a disease with great unmet medical need.”

About Lonafarnib 
Lonafarnib is a well-characterized, late stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle.  Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply.  Since prenylation is a host process, not under control of HDV, and lonafarnib inhibits prenylation, there is also a theoretical higher barrier to resistance with lonafarnib therapy.  Virus mutation, a common pathway to drug resistance, is not expected to be a potential pathway to lonafarnib resistance by HDV.     

Lonafarnib is not approved for sale for any indication.

About HDV

Hepatitis Delta is caused by infection with the hepatitis D virus (HDV) and is considered to be the most severe form of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals with hepatitis B (HBV), leads to more severe liver disease than HBV alone, and is associated with accelerated liver fibrosis, liver cancer, and liver failure. HDV is a disease with a significant impact on global health affecting ~15 million people worldwide. The prevalence of HDV varies between different parts of the world. HDV meets criteria for Orphan Designation in the United States (less than 200,000 people), Europe (less than 5 in 100,000 people), and Japan (less than 50,000 people).  Globally, HDV infection is reported to be present in approximately 4% – 6% of chronic hepatitis B carriers. In some parts of the world, including certain areas of China, Russia, Central Asia, Turkey, Africa, and South America, prevalence as high as 40% has been reported in HBV infected patients.

About Eiger
Eiger is a privately held biotechnology company focused on the research, development and commercialization of innovative therapies in viral hepatitis.  The company is focused on developing lonafarnib for the treatment of Hepatitis Delta Virus (HDV), the most severe form of viral hepatitis.  Lonafarnib is not approved for sale.  Eiger’s research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious liver diseases.  For additional information about Eiger and its R&D pipeline, please visit www.eigerbio.com.

Investors: Jim Shaffer, Eiger Bio, Inc., +1-919-345-4256, jshaffer@eigerbio.com

Canopus BioPharma Inc. announces positive results from an In-Vitro live Ebola Virus study

LOS ANGELES, Dec. 19, 2014 /PRNewswire/ — Canopus BioPharma Inc. (OTC Pink: CBIA) today announces that it has completed crucial research in confirming efficacy of a prescription drug: CB008 for Ebola Virus inhibition.

Laboratories at the Texas Biomedical Research Institute in San Antonio Texas have demonstrated complete in-vitro inhibition of the live Ebola Virus strain Zaire at concentrations of CB008 that are achievable by oral administration. CB008 is only one of a family of prescription drugs which has been demonstrated by Canopus BioPharma to have potential in preventing Hemorrhagic syndrome and inhibiting Ebola Viral replication.

CB008 is an in-house codename for a well-established prescription drug first approved by the FDA in the early 1980’s for other medical indications. CB008 is an effective, safe treatment for Ebola Virus. Canopus BioPharma has signed a confidential agreement with a major pharmaceutical company who are reviewing the results and the possibility of expediting an Ebola non-human primate study. Following this, CB008 can progress to a human Ebola patient clinical trial in West Africa.

According to the CDC, the 2014 Ebola Virus epidemic is the largest in history and is effecting multiple countries. In this epidemic, 1 in 2 people who get the disease die from it. It can take up to 21 days for an infected person to develop symptoms from it. The highly contagious virus is spread through contact with an infected persons blood or body fluids.”What we have shown by the use of CB008 in tissue culture is how vulnerable these Ebola viruses are when you interfere with their mechanism of creating havoc both to epithelial cells and to the immune system,” said Dr. Leo Shanahan-Prendergast from Canopus BioPharma Inc.

Molecular Methods Rapidly Gain Ground in Infectious Disease Diagnostics, says Frost & Sullivan

— Convergence of immunodiagnostic and molecular tests will help meet demand in developed countries

MOUNTAIN VIEW, Calif., Dec. 11, 2014 /PRNewswire/ — Unique disease outbreaks across the globe are escalating the demand for screening and spurring the infectious disease diagnostic market.

Frost & Sullivan (www.Frost.com)

Frost & Sullivan (www.Frost.com)

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The market will continue to develop as unmet technological needs lead to the creation of faster, more capable platforms. Molecular diagnostics is growing the fastest among the infectious disease market segments, clocking a compound annual growth of 15.30 percent. Although these tests remain expensive, their efficiency and accuracy strengthen their use case.

New analysis from Frost & Sullivan’s Analysis of the Global Infectious Disease Diagnostics Market finds the market earned revenue of $7.91 billion in 2013 and estimates this to reach $12.77 billion in 2018. Hepatitis B, hepatitis C, tuberculosis, and sepsis tests will be the major revenue generators.

For complimentary access to more information on this research, please visit: http://bit.ly/1yzK6zo

Immunodiagnostics is another segment that continues to expand rapidly owing to cost-effective tests as well as the prevalence of hospital-acquired infections like sepsis and MRSA,” said Frost & Sullivan Life Sciences Industry Analyst Aish Vivekanandan. “Molecular methods and immunodiagnostics are expected to complement each other as the need for accurate and rapid diagnostic tests rises.”

While decentralized and rapid tests are a growing trend in the developed world, high costs affect the market in developing countries. Stringent regulations further complicate product development and marketing.

Another challenge is the low awareness of products among consumers across regions. Diagnostic companies must invest in clinical studies to prove the efficacy of their products and raise awareness among evidence-driven consumers, especially in the clinical field.

“Many participants are focusing their research on top industry requirements such as product automation, rapidity, specificity and accuracy,” noted Vivekanandan. “Companies are also striving to expand the scope of diseases their products cover in order to establish their foothold in the global infectious disease diagnostics market.”

Analysis of the Global Infectious Disease Diagnostics Market is part of the Life Sciences (http://www.lifesciences.frost.com) Growth Partnership Service program. Frost & Sullivan’s related studies include: Global In Vitro Diagnostics Market, US Hematology Diagnostics Market, Global Next-generation Sequencing Market, and Western European Companion Diagnostics Market. All studies included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

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Analysis of the Global Infectious Disease Diagnostics Market
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