Sphenopalatine Ganglion Stimulation in the Pathway CH-1 Study Reduces Headache Burden Before and After Sustained Periods of Cluster Attack Remission

BUDAPEST, Hungary, April 8, 2015 /PRNewswire/ — During the world congress of controversies in Neurology, CONy, Autonomic Technologies[TM] presented long term data* (18 months results) on a segment of the CH-1 study patients experiencing Cluster Headache Remission periods. While Sphenopalatine Ganglion (SPG) stimulation with the Pulsante[TM] microstimulator has already shown safety and efficacy on chronic cluster headache, long-term benefits of SPG stimulation in cluster patients with remission suggest that the therapy is beneficial during the episodic phase of patients’ cluster bouts.

“This data strongly suggest that SPG stimulation could be beneficial also to episodic cluster patients”, commented Prof. Miguel Lainez, Head of Neurology Department at Catholic University of Valencia and Professor of Neurology in the Catholic University of Valencia who presented the data on March 28th.

Pulsante microstimulator is the first electroceutical device that has documented efficacy in a long term RCT for the treatment of cluster headache. The Pulsante microstimulator is MR Conditional since 2012. The device is inserted through the gum with a minimally invasive technique that leaves no visible scars.

Autonomic Technologies 

Autonomic Technologies, Inc. (ATI[TM]) is a medical device company focused on the development and commercialization of innovative therapies for the treatment of severe headache. The company’s initial product, the Pulsante microstimulator, is CE marked in Europe for the treatment of cluster headache. The device is also under an IDE study in the US for the treatment of chronic cluster headache.  

ATI is headquartered in the San Francisco Bay Area and is backed by blue chip investors: Kleiner Perkins Caufield and Byers, InterWest Partners, Versant Ventures, Novartis Ventures, Aberdare Ventures, and the Cleveland Clinic.  http://www.pulsante.eu

Contact:
Eva Birle
+49(0)891395782711
birle@bskom.de

*Poster Presentation at 9th CONy Congress, Budapest, March 28th 2015 

Latin American Contract Research Organizations Set to Get More Local Outsourcing Opportunities

– Currently, multinational companies outsource a larger proportion of their clinical trials than local firms, finds Frost & Sullivan

SAO PAULO, April 7, 2015 /PRNewswire/ — As market penetration stood at only 64 percent in 2013, huge opportunities exist for contract research organizations (CROs) to expand their market share in Latin America (LATAM). Local contracts, which accounted for 21.6 percent of the total market size in 2013, will begin to contribute more to overall revenues. The local development of biosimilars, domestic pharmaceutical companies’ plans to increase the number of clinical trials to comply with regulations, and focus on geographic expansion will give rise to more local contracts for CROs in the region.

Research

Research

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New analysis from Frost & Sullivan, Latin American Contract Research Organization Market (http://www.frost.com/p849), finds that the market earned revenues of $438.5 million in 2013 and estimates this to reach $661.3 million in 2019 at a compound annual growth rate of 7.1 percent. The study covers phase I, phase II, phase III and late phase clinical development as well as biostatistics, central laboratory services and data management. Health economics studies, a part of late phase trials, will gain significant traction in the coming years, since they are utilized while deciding which new molecules to include in the list of reimbursed drugs considered by public health services and private insurance plans.

For complimentary access to more information on this research, please visit: http://corpcom.frost.com/forms/LA_PR_FValente_P849-52_27Mar15.

“Multinational pharmaceutical companies tend to outsource about 70 percent of their trials by adopting either a fully outsourced or function-to-function model,” said Frost & Sullivan Healthcare Consultant Sanjeev Kumar. “However, local pharmaceutical companies have lower outsourcing rates that range from 50 to 70 percent in countries across LATAM.”

In Argentina and Brazil, regulatory issues have restrained clinical development, thereby dampening the prospects of CROs in the region. Bottlenecks in the Agencia Nacional de Vigilancia Sanitaria (ANVISA) submission and approval processes have meant that protocol approval takes 12 to 15 months in Brazil and an average of 6 months in Argentina.

In addition, limited outsourcing among big pharmaceutical clients that can conduct in-house R&D and clinical drug testing has restricted CRO market growth. Nevertheless, as large, well-established CROs have begun to use specialized research technologies that can cater to the rising demand for drug development, pharmaceutical clients’ reliance on in-house R&D is likely to reduce considerably. Along with this trend, the rise of innovative therapeutic options as well as the need for increased drug efficacy and safety will promote market development.

“In order to better serve and become the preferred partner of bio-pharmaceutical companies, CROs in LATAM must make an effort to expand their range of services,” noted Kumar. “Mergers and acquisitions with local CROs will be a cost-effective approach to achieve this end.”

Latin American Contract Research Organization Market is part of the Life Sciences (http://www.lifesciences.frost.com) Growth Partnership Service program. Frost & Sullivan’s related studies include: Global Diabetes Drug Delivery Market, Global CRO Market, Global Stem Cell Market, and Global Infectious Disease Diagnostics Market. 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.

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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?

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Latin American Contract Research Organization Market
P849-52

Contact:
Francesca Valente
Corporate Communications – Latin America
P: +54 11 4777 5300
F: +54 11 4777 5300
E: francesca.valente@frost.com 

http://www.frost.com

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Development and Commercialization of Antibacterial Drugs to Speed Up

– The recently implemented GAIN Act is expected to lure companies back into R&D as well as attract new participants, finds Frost & Sullivan

LONDON, March 31, 2015 /PRNewswire/ — The growing threat posed by multi-drug resistant gram-negative organisms (MDR-GNBs) is lending a sense of urgency to the development of antibacterial drugs worldwide. Upcoming regulatory reforms to lower R&D costs and provide incentives for new drug identification will create attractive opportunities for pharmaceutical manufacturers.

New analysis from Frost & Sullivan, A Product and Pipeline Analysis of the Antibacterial Drugs Market, finds that nearly 80 percent of drugs currently in the pipeline are from smaller pharmaceutical and biotech companies, of which half do not have any commercialized products in the market. GlaxoSmithKline (www.gsk.com), AstraZeneca (www.astrazeneca.com) and Merck & Co (www.merck.com) are the only three established pharmaceutical organizations in the antibacterial drug space.

For complimentary access to more information on this research, please visit: http://corpcom.frost.com/forms/EU_PR_AZanchi_MABA-52_20Mar15.

“Thirty eight antibacterial drugs currently under development have the potential to address many, but not all, resistant bacteria,” said Frost & Sullivan Healthcare Senior Research Analyst Aiswariya Chidambaram. “Plazomicin and Eravacycline are two emerging compounds that have a broad-spectrum activity against most MDR-GNBs.”

Discovering new antibacterial drugs and identifying novel compounds that can successfully target bacteria is scientifically challenging. Given the high probability of failure and steep research and development (R&D) costs, big pharma companies that were once leaders are closing down their antibacterial research facilities.

Agencies such as the Food and Drug Administration (FDA) and the Infectious Diseases Society of America are deploying several initiatives to lure companies back into antibacterial R&D. The recently implemented Generating Antibiotic Incentives Now (GAIN) Act is expected to facilitate more efficient clinical studies and reduce barriers to market entry. In Europe, the Innovative Medicines Initiative (IMI) has launched two projects — Combatting Bacterial Resistance in Europe (COMBACTE) and TRANSLOCATION (molecular basis of the bacterial cell wall permeability) — that showcase an unprecedented partnership between industry, biotech organizations, and academia to fight antibiotic resistance.

“Further, collaborations in the form of public-private partnerships among industry, academia, investors and key opinion leaders will effectively address the vast unmet clinical and commercial needs in the antibacterial drugs market and quicken the journey towards commercialization,” concluded Chidambaram.

A Product and Pipeline Analysis of the Antibacterial Drugs Market is part of the Life Sciences Growth Partnership Service program. Frost & Sullivan’s related studies include: A Competitive Analysis of the Global Breast Cancer Therapeutics Market, A Product and Pipeline Analysis of the Opioid Therapeutics and Drug Delivery Market, A Product and Pipeline Analysis of the Lung Cancer Therapeutics Market, and Product and Pipeline Analysis of the Global Rheumatoid Arthritis Therapeutics Market. 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. 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
Anna Zanchi
Corporate Communications — Europe
P: +39.02.4851 6133
E: anna.zanchi@frost.com
http://www.frost.com

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Yale University and Novogen Release Data on Cantrixil Mode of Action

Key data confirming Cantrixil kills ovarian cancer stem cells

Unique action of inhibiting pro-survival mechanisms and promoting pro-death mechanisms

SYDNEY, March 30, 2015 /PRNewswire/ — US-Australian drug discovery company, Novogen Ltd, (ASX:NRT; NASDAQ:NVGN) and its subsidiary, CanTx, Inc., and Yale University, on March 27 released pre-clinical data on experimental anti-cancer drug, Cantrixil. The data was presented as an oral presentation by Professor Gil Mor MD PhD of Yale Medical School to the 62nd Annual Scientific Meeting of the Society of Reproductive Investigation in San Francisco, CA.

In both in vitro and in animal studies, Cantrixil, has proved highly effective at killing human ovarian stem (tumor-initiating) cells, cells that otherwise are highly resistant to standard of care cytotoxic drugs and which generally are believed to be responsible for diseases recurrence following initial therapy. Researchers have been keen to understand how the active ingredient in Cantrixil, TRXE-002, is able to achieve this effect where other drugs have failed.

The data shows that Cantrixil specifically activates the JNK-Jun pathway leading to mitochondrial damage and the induction of genes associated with cell death (apoptosis). In addition, Cantrixil blocks the survival pathway pERK.  The combination of these two cellular effects (down-regulation of pro-survival and up-regulation of pro-death pathways) provides a unique advantage to target chemo-resistant cancer stem cells.

Cantrixil is due to enter its first-in-man study in late-2015.  The study will enroll patients with the terminal condition, malignant ascites, associated with late-stage abdominal carcinomatosis of various types of cancer, but mainly targeting ovarian cancer and colo-rectal cancer.

About Cantrixil

Cantrixil is a cyclodextrin envelope containing the active ingredient, TRXE-002. The construct has been designed as an intra-cavity chemotherapy to be injected directly into the peritoneal and pleural cavities without causing local irritation or toxicity. Its purpose is to achieve high drug levels in the environment in which the cancer is spreading through the migration of the cancer stem cells are spreading. The ultimate primary indication of Cantrixil to be sought is first-line therapy of early-stage cancers of the abdominal cavity (eg. ovarian, uterine, colo-rectal and gastric carcinomas). Cantrixil will enter the clinic in later-stage cancers where the abdominal carcinomatosis has resulted in the terminal condition of malignant ascites.

Cantrixil is owned by CanTx, Inc.

About TRXE-002

TRXE-002 is a small molecule cytotoxic belonging to a family of compounds whose anti-cancer function is based on various biological effects including inhibition of trans-membrane electron-transfer mechanisms. TRXE-002 is pan anti-cancer acting, resulting in caspase-dependent apoptosis of both stem cell-like cancer cells and their daughter cancer cells. The compound has a high therapeutic index with little cytotoxic effect on non-tumor cells.

About CanTx, Inc.

CanTx is a joint venture company between Novogen and Yale University. Novogen has licensed the drug candidate, TRXE-002, to CanTx for use in Cantrixil. CanTx is based in New Haven, CT.

Further information is available on www.can-tx.com

About Novogen Limited

Novogen is a public, Australian-US drug-development company whose shares trade on both the Australian Securities Exchange (‘NRT’) and NASDAQ (‘NVGN’). The Novogen group includes US-based, CanTx Inc, a joint venture company with Yale University.

Novogen has two main drug technology platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP compounds have been designed to kill the full heterogeneity of cells within a tumor, but with particular activity against the cancer stem (tumor-initiating) cell.

The ATM compounds target the micro-filament component of the cancer cell’s cytoskeleton and have been designed to combine with anti-microtubule drugs (taxanes, vinca alkaloids) to produce comprehensive and fatal destruction of the cancer cell cytoskeleton.

The Company pipeline comprises two SBP drug candidates (TRXE-002, TRXE-009) and one ATM drug candidate (Anisina).

Further information is available on our website www.novogen.com

For more information please contact:

Corporate Contact

Dr. Graham Kelly

Executive Chairman & CEO

Novogen Group

Graham.Kelly@novogen.com           

+61 (0) 2 9472 4100

Media Enquiries

Cristyn Humphreys

Chief Operating Officer

Novogen Group

Cristyn.Humphreys@novogen.com

+61 (0) 2 9472 4111

Forward Looking Statement

This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934.  The Company has tried to identify such forward-looking statements by use of such words as “expects,” “appear,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “should,” “would,”  “may,” “target,”  “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements.  Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, Cantrixil and TRXE-002, and any other statements that are not historical facts.  Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to Cantrixil and TRXE-002, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, Cantrixil and TRXE-002, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to Cantrixil and TRXE-002, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K.  Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release.  Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.

Potential of Anisina to Become Major New Chemotherapy Confirmed by Coda Study

SYDNEY, March 19, 2015 /PRNewswire/ — Novogen announced on 18th March, 2015 that one of its oncology pipeline drug candidates, Anisina (ATM-3507), has achieved a major milestone in its development, confirming the concept that comprehensive destruction of a cancer cell’s cytoskeleton can deliver a powerful anti-cancer effect.

Dr Kelly was interviewed by Channel 7 health reporter, Dr Andrew Rochford about Anisina’s potential.  To view the interview click here… or visit the Novogen website.

The cytoskeleton (cell skeletal structure) is a common and validated target for anti-cancer therapy. The most commonly used drugs in chemotherapy target the cytoskeleton by destabilising one of its two key components, the microtubules. These drugs are known as ‘anti-mitotics’ and include the taxanes (paclitaxel, docetaxel) and the vinca alkaloids (vincristine, vinblastine). Collectively, these anti-mitotics have dominated chemotherapy for the past 30 years and look set to do so for many years to come.

The rationale behind the development of Anisina was that the anti-mitotic drugs only do half the job, because they leave the other major component of the cytoskeleton, the microfilaments, intact. It was reasoned that this half-complete destruction of the cytoskeleton by the anti-mitotic drugs accounted for their low rate of patient response for many tumor types and for the generally short-term response to therapy. Anisina was developed specifically to destroy the microfilaments and to work in combination with the anti-mitotic drugs to deliver comprehensive destruction of the cancer cell’s architecture.

Anisina targets a specific protein known as tropomyosin Tpm3.1 (previously known as Tm5NM1). Tpm3.1 is a protein that provides structural integrity to the microfilaments of a cell. It is present in both normal cells and cancer cells, the difference being that cancer cells have an increased reliance on this form of tropomyosin to survive.

It has been announced previously that anti-tropomyosin drugs in combination with anti-mitotic drugs boost the cancer-killing ability of a drug such as vincristine 20-fold in vitro against neuroblastoma cancer cells.

The next crucial step was to confirm that this powerful combined anti-cancer effect was transferable to animals. The study reported today confirms this.

This proof of concept study was done as part of the Children’s Oncology Drug Alliance (CODA) involving Australian charity, The Kids’ Cancer Project (Sydney), The University of New South Wales (Sydney), The Nationwide Children’s Hospital (Columbus, Ohio), and Novogen. The studies were conducted using cancer cells derived from children who had developed neuroblastoma.

The full details of these studies will be presented at the Eighth Annual Cancer Molecular Therapeutics Research Association (CMTRA) meeting in the USA in July of this year.

Justine Stehn PhD, Novogen Anti-Tropomyosin Program Director, said, “This was the crucial step we needed to bring Anisina into the clinic. We now are proceeding to bring Anisina into the clinic in 2016 into both adults and children. In adults we will be looking to use Anisina to potentiate the anti-cancer effect of anti-mitotics in cancers such as prostate, ovarian, lung, breast, colorectal and haematological cancers, as well as in cancers such as melanoma where anti-mitotics currently show little benefit.”

“But what particularly excites us from a CODA perspective is the promise that this technology holds in being able to achieve a potent anti-cancer effect in children where anti-mitotics currently are widely used, but being able to use lower dosages of anti-mitotics that hopefully will lower the risk of leaving children with side-effects with life-long consequences.”

Graham Kelly PhD, Novogen CEO and Executive Chairman said, “From the outset, the anti-tropomyosin technology platform has held the promise of delivering a major new chemotherapy, one that we saw becoming a standard companion drug to the most commonly-used drugs in chemotherapy. Today’s announcement just serves to reinforce that promise.”

“The promise of Anisina is that it is not a drug limited to working in a proportion of patients with a particular form of cancer, or one that is reliant on the over-expression of certain functions such as immune checkpoints or pro-survival mechanisms. Its promise lies in its ability to make the most widely-used chemotherapy drugs work better and safer in more forms of cancer and in more patients. Our objective is to see Anisina become one of the most widely used drugs in chemotherapy.”

About Anti-mitotic drugs

Anti-mitotic drugs are drugs that block cell division (mitosis). This a shorthand term to describe a family of drugs that embraces mainly the taxanes (paclitaxel, docetaxel, Abraxane) and vinca alkaloids (vincristine, vinblastine, Vineralbine) and which work by blocking the ability of cells to divide (mitosis). These remain among the most widely prescribed anti-cancer drugs after 35 years of use. Anti-mitotic drugs are standard of care for breast, prostate, lung, ovarian, colo-rectal, gastric and head and neck cancer, and many forms of leukaemia.

About the cytoskeleton

The cytoskeleton provides the architecture of a cell. It is a protein structure that gives a cell its shape, ability to move and to divide and to store and move internal structures. It has two main components: the microtubules and the microfilaments. The key component of microtubules is the protein, tubulin, which is the target of the anti-mitotic drugs, and whose destabilisation leads to prevention of cell division (mitosis). The key components of the microfilaments are the proteins, actin and tropomyosin.

About Tpm3.1

Tpm3.1 is a tropomyosin protein. Tropomyosins provide a rigid external scaffold to microfilaments that have a central actin core. Without this rigidity, the microfilaments are inactive. There are over 40 different forms (isoforms) of tropomyosin of which Tpm3.1 is one. Tpm3.1 is present in all cells; normal cells are able to survive and function without Tpm3.1; cancer cells are highly dependent on the presence of Tpm3.1 for their survival and function.

About Anisina

Anisina is a small molecule specifically designed to block the ability of Tpm3.1 to dimerize. By fitting into the C-terminus of the proximal Tpm3.1, it prevents dimerization of the N-terminus of the distal tropomyosin protein. Interruption of dimerization leads to the inability of the microfilaments in cancer cells to remain stable, resulting in their collapse.

About CODA

CODA’s mission is to accelerate development of innovative new therapeutic approaches to the treatment of chlldhood cancers and to take account of the fact that childhood cancers are different to adult cancers and that the lifelong consequences of cancer drug side-effects can be far more devastating in a child than in an adult.

CODA unites the research and resources of five organisations in Australia and the US.

The Australian members are:

  • The charity, The Kids’ Cancer Project
  • The originator of the anti-tropomyosin technology, the University of New South Wales and its commercial arm, NewSouth Innovations
  • Biotechnology company, Novogen Limited

The US member is:

  • Nationwide Children’s Hospital, Columbus, Ohio

Novogen is providing access to both its anti-tropomyosin and super-benzopyran drug technologies. Anisina is being evaluated for its ability to complement the action of standard chemotherapies in childhood cancers. TRXE-009 is being evaluated for its ability to treat brain cancers in children.

Further information on CODA is available at www.childrensoncologydrugalliance.org

About Novogen Limited

Novogen is a public, drug-development company whose shares trade on both the Australian Securities Exchange (‘NRT’) and NASDAQ (‘NVGN’).  The Novogen Group includes a New Haven CT – based joint venture company, CanTx Inc., with Yale University.

Novogen has two main drug technology platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs).  SBP compounds have been created to kill the full range of cells within a tumor, but particularly the cancer stem cells.  The ATM compounds target the microfilament component of the cancer cell and when used in conjunction with standard anti-microtubule drugs, result in comprehensive and fatal destruction of the cancer cell’s cytoskeleton.  Ovarian cancer, colorectal cancer, malignant ascites, prostate cancer, neural cancers (glioblastoma, neuroblastoma in children) and melanoma are the key clinical indications being pursued, with the ultimate objective of employing both technologies as a unified approach to first-line therapy.

Further information is available on our websites www.novogen.com

For more information please contact:

Corporate Contact

Dr. Graham Kelly

Executive Chairman & CEO

Novogen Group

Graham.Kelly@novogen.com           

+61 (0) 2 9472 4100

Media Enquiries

Cristyn Humphreys

Chief Operating Officer

Novogen Group

Cristyn.Humphreys@novogen.com

+61 (0) 2 9472 4111

Forward Looking Statement

This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934.  The Company has tried to identify such forward-looking statements by use of such words as “expects,” “appear,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “should,” “would,”  “may,” “target,”  “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements.  Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, Anisina, and any other statements that are not historical facts.  Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to Anisina, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, Anisina, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to Anisina, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K.  Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release.  Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.

Takeda Announces Publication in The Lancet of a Post Hoc Analysis of Data from the EXAMINE Cardiovascular Safety Outcomes Trial

OSAKA, Japan, March 10, 2015 /PRNewswire/ — Takeda Pharmaceutical Company Limited (Takeda) announced that a post hoc analysis of data from the global EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes trial was published in The Lancet. An analysis of data from the study showed that in patients with Type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 inhibitor (DPP4i) alogliptin compared to placebo did not increase the risk of heart failure (HF) outcomes. Alogliptin (n=201, 7.4%) compared with placebo (n=201, 7.5%) had no effect on the extended exploratory post hoc composite endpoint of CV death and hospitalized heart failure (HHF) (HR=1.00, 95% CI, 0.82, 1.21). Patients with a history of HF prior to randomization had a higher risk of HF outcomes in EXAMINE. The sub-analysis showed that the risk of the composite of CV death and HHF was not increased with alogliptin (n=107, 13.9%) compared with placebo (n=120, 15.7%) (HR=0.90, 95% CI, 0.70, 1.17). In patients without a history of HF at baseline, there was also no increased risk of the composite endpoint of CV death and HHF for alogliptin (HR=1.14 [95% CI 0.85-1.54], p=0.337) versus placebo, although there was in this sub group of patients a small absolute increase in HHF for alogliptin versus placebo (0.9%).

Alogliptin is the first DPP-4i to report out results on CV safety outcomes in Type 2 diabetes patients that are at high risk due to recent ACS. Heart disease, or cardiovascular disease (CVD), is the leading cause of morbidity and mortality in patients with Type 2 diabetes, and is responsible for between 50 and 80 percent of deaths in people with diabetes.

“Patients with diabetes are at significantly higher risk of having heart disease or suffering a stroke, and it is critical that diabetes treatments adequately manage glucose levels without adversely affecting cardiovascular outcomes, such as hospitalized heart failure and cardiac death,” said Faiez Zannad, MD, Professor of Therapeutics and Cardiology, Institut Lorrain du Coeur et des Vaisseaux, Centre d’Investigation Clinique Inserm, in France. “The publication of these post hoc analyses of data from EXAMINE is an opportunity to share findings that alogliptin compared with placebo did not increase the composite rate of cardiovascular mortality and hospitalized heart failure in this high risk population of patients with diabetes.”

The EXAMINE trial was designed to evaluate CV safety following treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care, in patients with Type 2 diabetes and a recent ACS. The EXAMINE trial’s primary composite endpoint (CV death, nonfatal myocardial infarction and nonfatal stroke) established non-inferiority of alogliptin compared to placebo in addition to standard of care, showing no increase in CV risk in a Type 2 diabetes patient population at high risk for CV events.

For the present study published in The Lancet, HF outcomes by quartile of baseline brain natriuretic peptide (BNP), as well as assessments of changes of N-Terminal proBNP (NT-proBNP) from baseline to six months were investigated. Patients in the highest quartile of baseline BNP were at the highest risk of HF outcomes; however, the risk of the composite endpoint of CV death and HHF was not increased with alogliptin (n=120, 17.5%) compared with placebo (n=121, 19.4%) (HR=0.90, 95% CI, 0.70, 1.16). Consistent with these outcomes, the change from baseline to 6 months for NT-proBNP was not different between alogliptin and placebo in this subgroup or in the overall study population.  

About the EXAMINE Trial
EXAMINE randomized 5,380 patients in 49 countries with Type 2 diabetes with an ACS within the previous 15-90 days. The EXAMINE primary endpoint of non-inferiority compared to placebo in addition to standard of care was met, showing no increase in CV risk in a Type 2 diabetes patient population at high risk for CV events based on the primary composite endpoint of CV death, nonfatal myocardial infarction and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin and placebo groups (in 11.3 percent of patients vs. 11.8 percent of patients during a median follow-up period of 18 months; HR, 0.96; upper boundary of the one-sided repeated CI, 1.16).

In the alogliptin group, 71.4 percent of patients received 25 mg, 25.7 percent received 12.5 mg, and 2.9 percent received 6.25 mg daily. Alogliptin doses were adjusted according to renal function: estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease formula > 60 ml/min/1.73 m2, 25 mg daily; < 60 ml/min/1.73 m2 but > 30 ml/min/1.73 m2, 12.5 mg daily; and < 30 ml/min/1.73 m2, 6.25 mg daily. Premature discontinuation of the study drug was similar in the alogliptin and placebo groups (20.9 percent of patients vs. 22.6 percent). The median duration of exposure to study drug was 533 days (interquartile range, 280 to 751 days). By the end of the study, the mean change from baseline in HbA1c was -0.33 percent and 0.03 percent in the alogliptin and placebo groups respectively, and the least square means difference in HbA1c between alogliptin and placebo was -0.36 percent (95 percent CI, -0.43, -0.28, p<0.001). In the analysis of the components of the primary endpoint, the hazard ratios were consistent with the overall result. Hazard ratios for death from any cause and CV death were consistent with the primary composite endpoint.

Takeda conducted the global EXAMINE trial in accordance with the United States (U.S.) Food and Drug Administration’s (FDA) 2008 Guidance, titled “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” for all new Type 2 diabetes treatments.

About Alogliptin
Alogliptin is a DPP-4i for the treatment of Type 2 diabetes in adults as an adjunct to diet and exercise. DPP-4is are designed to slow the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.

Alogliptin is approved as a monotherapy and also in fixed-dose combination (FDC) with pioglitazone and metformin HCl for the treatment of Type 2 diabetes in adults as adjuncts to diet and exercise. These therapies are not for treatment of Type 1 diabetes or diabetic ketoacidosis.

Alogliptin is available in many markets across Australia, China, Europe, Japan, Mexico, South Korea and the U.S.

Indication
Alogliptin is indicated in adults aged 18 years and older with Type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Important Safety Information

  • ALOGLIPTIN is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin-containing products such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.
  • Acute pancreatitis: There have been post marketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue ALOGLIPTIN.
  • Hypersensitivity: Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome have been observed for DPP-4 inhibitors. In clinical studies of alogliptin, anaphylactic reactions were reported with a low incidence.
  • Hepatic effects: Post marketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. Baseline liver test panel is recommended. If liver injury is detected, promptly interrupt ALOGLIPTIN and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart ALOGLIPTIN if liver injury is confirmed and no alternative etiology can be found.
  • Cardiac failure: Experience of ALOGLIPTIN use in clinical trials in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.
  • Hypoglycemia: Insulin and insulin secretagogues are known to cause hypoglycemia. A lower dose of the insulin or insulin secretagogue may be required to minimize the risk when used in combination with ALOGLIPTIN.
  • Most common adverse reactions: pooled phase 3 controlled studies (>1/10 frequency) with ALOGLIPTIN:  Upper respiratory infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux disease, pruritis, and rash.

Please see local prescribing information for ALOGLIPTIN.

About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, the more recent developments of alogliptin and the fixed-dose combinations (FDC) alogliptin and pioglitazone, and alogliptin and metformin HCl. The company’s strong, diverse diabetes portfolio and available medications mark important milestones in Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website, www.takeda.com.

Contacts:
Elissa J. Johnsen
Takeda Pharmaceuticals
+1-224-554-3185
elissa.johnsen@takeda.com

Takeda Pharmaceutical Company Limited
Corporate Communications Dept.
Tel: +81-3-3278-2037

Treatment of Primary Liver Cancer: SARAH Study Completes Enrolment, Results Expected Late 2016

Launched by the Assistance Publique – Hopitaux de Paris in December 2011, ‘SARAH’ – the French national collaborative randomized controlled study of yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma (HCC) has enrolled more than 400 patients; results expected late 2016.

PARIS, March 4, 2015 /PRNewswire/ — SARAH, a large French study of patients with advanced, inoperable primary liver cancer (hepatocellular carcinoma, or HCC) has completed patient enrolment, exceeding its 400-patient target, according to its principal investigator, Professor Valerie Vilgrain MD, PhD, Department of Radiology, Beaujon Hospital, Assistance Publique – Hopitaux de Paris (AP-HP) and Universite Paris Diderot, Sorbonne Paris Cite, France.

Logo: http://photos.prnewswire.com/prnh/20150304/732289-a
Logo: http://photos.prnewswire.com/prnh/20150304/732289-b

The randomized controlled SARAH study, sponsored by the AP-HP, directly compares the efficacy of selective internal radiation therapy (SIRT, also known as radioembolization) using yttrium-90 [Y-90] resin microspheres (SIR-Spheres®Y-90 resin microspheres, Sirtex Medical Limited, Sydney, Australia) versus sorafenib (Nexavar®, Bayer HealthCare Pharmaceuticals, Berlin, Germany), a systemic therapy that is the current standard of care for patients with inoperable advanced HCC. SARAH is the largest randomized study everto compare selective internal radiation therapyor any liver-directed therapy against the standard-of-care systemic therapy in the treatment of primary liver cancer.  The SARAH study team is delighted that  enrolment is now complete, with results expected in late 2016, Prof. Vilgrain said.

SARAH (SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma) is a Phase III multi-centre prospective randomized open-labelled study for patients in France with advanced HCC (Barcelona Clinic Liver Cancer stage C) with or without portal vein thrombosis and no extrahepatic spread, or whose disease has progressed or recurred after previous therapies; and who are ineligible for surgical resection, ablation or liver transplantation.[1],[2]

The primary goal of the SARAH study is to assess if radioembolization with Y-90 resin microspheres provides an increased survival benefit compared to sorafenib in patients with advanced HCC.  The study is also comparing the quality of life of patients and other measures such as the tolerability of the treatments.

Coordinated by Professor Valerie Vilgrain, more than 25 specialist cancer centres throughout France are involved in this study. SIR-Spheres Y-90 resin microspheres were selected for the test arm of this independent, collaborative national study. “Target enrolment was reached in around three years, which is remarkable for a single-country trial of this size in a hard-to-treat cancer with few proven therapeutic choices,” Prof. Vilgrain noted.

Sorafenib was established as the standard treatment for patients with advanced HCC following the results of the pivotal SHARP randomized controlled trial, which demonstrated an increased median overall survival from 8 to 11 months compared to placebo.[3] However, 80% of patients receiving sorafenib also experienced treatment-related adverse events.

SIRT with SIR-Spheres Y-90 resin microspheres is an approved treatment for inoperable liver tumours. It is a minimally-invasive treatment that delivers high doses of high-energy beta radiation directly to the tumours. SIRT is administered to patients by interventional radiologists, who infuse millions of radioactive microspheres (diameter between 20-60 microns) via a catheter into the liver arteries that supply blood to the tumours. By using the tumours’ blood supply, the microspheres selectively target liver tumours with a dose of radiation that is up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

Interest in a randomized controlled study of SIRT using Y-90 resin microspheres in this patient population was based on a substantial number of open-label single-group studies as well as a large multi-centre European study on the long-term outcomes related to survival and safety of SIR-Spheres Y-90 resin microspheres in patients with inoperable HCC.[4] In 13 open-label single-group studies with a total of 400 patients with advanced HCC, the combined estimation of the median overall survival after radioembolization with Y-90 microspheres was 15 months, with a range of 7-27 months.

Current Availability of SIR-Spheres Y-90 resin microspheres 

SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumors in Australia, the European Union (CE Mark), Argentina (ANMAT), Brazil, and several countries in Asia, such as India and Singapore. SIR-Spheres Y-90 resin microspheres also have a full Pre-Market Approval (PMA) by the FDA and are indicated in the United States for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.

About Hepatocellular Carcinoma 

HCC typically occurs in people whose livers have become severely damaged or cirrhotic, due to conditions such as hepatitis or alcohol abuse. It is one of the ten most-common cancers in the world, with nearly 750,000 cases diagnosed annually, and the second most common cause of cancer deaths.[5] It occurs with greatest frequency in regions where viral hepatitis B or C are most 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. However, the great majority of patients with HCC have disease which is too advanced for surgical interventions, and as a consequence their survival may range from a few months to two or more years depending largely on the state of their liver function 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. Vilgrain V, Abdel-Rehim M, Sibert A et al. Radioembolisation with yttrium-90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial. Trials 2014; 15: 474.
  3. Llovet J, Ricci S, Mazzaferro V et al for the SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. New England Journal of Medicine 2008; 359: 378-390.
  4. Sangro B, Carpanese L, Cianni R et al on behalf of European Network on Radioembolization with yttrium-90 resin microspheres (ENRY). Survival after 90Y resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A European evaluation. Hepatology 2011; 54: 868-878.
  5. GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx accessed 10 February 2015.

MicuRx Initiates U.S. Phase 2 Clinical Trial For Novel Antibiotic MRX-I

— Phase 1 Studies Confirm Superior Safety Profile of MRX-I Over Zyvox® —

HAYWARD, Calif. and SHANGHAI, Feb. 25, 2015 /PRNewswire/ — MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has received the approval from the U.S. Food and Drug Administration (FDA) to initiate Phase 2 clinical study in the United States for its lead drug candidate MRX-I. MRX-I, which demonstrated an enhanced safety profile over the market-leading comparator in Phase 1 studies, is an oral oxazolidinone antibiotic designed to treat infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

The Phase 2 double-blind, multi-center, active comparator-controlled clinical trial will enroll over 120 patients with acute bacterial skin and skin structure infections (ABSSSI) at multiple centers in the United States. Patients will be randomized to receive MRX-I or Zyvox® for a treatment period of up to ten days.

“We are pleased to initiate Phase 2 clinical trial in the United States. This complements the ongoing Phase 2 study of MRX-I in China and represents a significant milestone in our global development strategy, as MicuRx creates new antibiotics to address urgent medical needs,” said Zhengyu Yuan, Ph.D., president and CEO of MicuRx Pharmaceuticals, Inc. “This dual-country approach will allow MicuRx to maximize the commercial potential of MRX-I both in the U.S. and China.”

Data from two Phase 1 studies in China and Australia have confirmed that MRX-I was safe and well tolerated in healthy volunteers at all dose regimens, including 28-day repeated dosing regimen alongside Zyvox® comparator, with no evidence of myelosuppression which is typical for this class. Phase 2 study in China is scheduled for completion in mid-2015.

“This is an exciting moment for the company,” commented Dr. James Ge, M.D., Ph.D., executive vice president and chief operating and development officer of MicuRx. “With its favorable profile, MRX-I has the potential to be a safer option to effectively treat severe infections caused by drug resistant gram-positive bacteria. We are looking forward to positive outcome from these trials within a year, and the subsequent initiation of pivotal studies that will support concurrent drug registration in both the United States and China.”

About MicuRx Pharmaceuticals, Inc.
MicuRx (http://www.micurx.com) is discovering and developing novel antibiotics to combat infections due to drug-resistant bacteria. Positioned to capture the benefits of United States research and development expertise together with the high quality, cost-efficient discovery, preclinical and development infrastructure in China, the company has built a pipeline of discovery and development programs targeting Gram-positive and Gram-negative pathogens. The company has research and development facilities outside San Francisco, CA in the United States and in Shanghai, China.

Merck Serono and Sysmex Inostics Announce First Liquid Biopsy RAS Biomarker Testing Center Opens: Important Milestone for mCRC Patients

DARMSTADT, Germany and BARCELONA, Spain, Feb. 20, 2015 /PRNewswire/ —

  • Vall d’Hebron, Spain: first hospital to use liquid biopsy RAS biomarker testing technology 
  • Leading research center will use technology to evolve understanding of who will benefit most from targeted treatment to improve patient outcomes 
  • Liquid biopsy RAS biomarker test is on course to receive its CE mark in coming months to make it widely accessible for patients 

Merck Serono, the biopharmaceutical business of Merck, announced today that the first liquid biopsy RAS biomarker testing center has opened in Vall d’Hebron’s Institute of Oncology, Barcelona, Spain, and will initially test patients as part of its research program. This is an important milestone in making the new liquid biopsy RAS test available to patients with metastatic colorectal cancer (mCRC), and a significant step forward in Merck Serono’s collaboration with Sysmex Inostics GmbH, Hamburg, Germany. The liquid biopsy method, also known as blood-based biomarker testing, is a simplified and rapid approach for determining the RAS (KRAS and NRAS) mutation status of tumors, as it requires a single blood draw, rather than a tissue biopsy or surgical procedure.[1]

“We are excited that within less than one year of announcing our collaboration with Sysmex Inostics we are already making significant progress in bringing this new liquid biopsy RAS biomarker test to patients in one of Europe’s leading oncology centers,” said Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare, at the opening event in Barcelona. “Merck Serono is committed to improving patient outcomes and supporting clinicians in advancing the standard of care in metastatic colorectal cancer, and we are delighted that we will soon be able to offer a new method of RAS biomarker testing to the international oncology community.”

The liquid biopsy RAS biomarker test will help to advance precision medicine, and also has the potential to provide mutation status results within days, helping to guide treatment decisions.[1] Approximately half of patients with mCRC present with tumors with RAS mutations.[2] Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.[39]

The liquid biopsy RAS biomarker test is expected to receive its European Conformity approval (CE mark) in the coming months, making it accessible to a wider population of mCRC patients. The test will then be implemented in numerous medical centers across the world. The Vall d’Hebron Institute of Oncology will be the first test center of its kind, with further laboratories to be established throughout 2015, including in Australia, France, Germany, Italy and the UK, among others.

“This is a significant step in our collaboration with Merck Serono,” said Fernando Andreu, CEO of Sysmex Inostics. “We are pleased to have The Vall d’Hebron Institute of Oncology as the first institution to offer our highly sensitive OncoBEAM™ tests for blood-based diagnostics. This collaborative approach between Merck Serono and Sysmex Inostics, along with the reputation and expertise of Vall d’Hebron, is another major step in advancing personalized medicine for metastatic colorectal cancer patients and enhancing the value of our clinical OncoBEAM™ assays.”

Vall d’Hebron’s Institute of Oncology will use blood samples from mCRC patients to advance research into RAS biomarkers. The ability to test for these mutations at Vall d’Hebron with a potentially quicker and easier testing method could improve the standard of care for patients.

“As patients with metastatic colorectal cancer (mCRC) can respond differently to various treatments, it is important to understand more about the tumor, especially its biology and genetics,” said Professor Josep Tabernero, Director of the Vall d’Hebron Institute of Oncology. “Once this liquid biopsy RAS biomarker test has received its CE mark, it will become an important advance in testing mCRC patients and be a useful tool for treatment decisions. The liquid biopsy method can potentially save time, compared with current tissue-based RAS testing, and spares patients from a tissue biopsy or surgical procedure. We will only need a sample of blood, and we can then potentially provide results in 2-3 days.”

About Colorectal Cancer  

Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.[10] An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.[10] Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in menthan in women.[10]

About Sysmex Inostics 

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of the most sensitive and quantitative technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics’ BEAMing services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive plasma DNA based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, BEAMing tests (OncoBEAM) are available through a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics’ headquarters are located in Hamburg, Germany and Sysmex Inostics’ Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM blood testing and the BEAMing technology refer to http://www.sysmex-inostics.com or email info@sysmex-inostics.com.

About Erbitux 

Erbitux® is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN).

Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

About Merck Serono 

Merck Serono is the biopharmaceutical business 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 healthcare, life science and performance materials. The company has six businesses – Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials – and generated total revenues of € 11.1 billion in 2013. Around 39,000 Merck employees work in 66 countries to improve the quality of life for patients, to foster the success of 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, holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

References 

1. Diaz LA Jr and Bardelli A. J Clin Oncol 2014;32(6):579−86.

2. Vaughn CP, et al. Genes Chromosomes Cancer 2011;50(5):307−12.

3. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.

4. Schwartzberg LS, et al. J Clin Oncol 2014;32(21):2240-7.

5. Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3505.

6. Stintzing S, et al. Oral presentation at the 2014 European Society of Medical Oncology Annual Meeting, September 26-30, 2014. Abstract No:LBA11.

7. Van Cutsem E, et al. J Clin Oncol 2015;pii: JCO.2014.59.4812.

8. Erbitux® (cetuximab) SmPC, 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000558/WC500029119.pdf. Last accessed February 2015.

9. Vectibix® (panitumumab) SmPC, 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000741/WC500047710.pdf. Last accessed February 2015.

10. Ferlay J, et al. Int J Cancer 2015;136(5):E359-86.

For more information on Merck Serono in oncology and immuno-oncology, please visit: http://www.globalcancernews.com.

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).