Top 20 World Pharma News of 2016 !!! ...
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Top 20 World Pharma News of 2016 !!! PART 1
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1. Roche

Roche launches imCORE, a global network of cancer immunotherapy centers of excellence

Roche

Roche

Roche (SIX: RO, ROG; OTCQX: RHHBY) has launched the global cancer immunotherapy Centers of Research Excellence (imCORE™) Network. This network brings together many of the world’s leading scientific and clinical experts in cancer immunotherapy to collaborate in investigating the most promising new treatment approaches. The goal is to rapidly initiate pre-clinical and clinical research based on the latest scientific discoveries and to aggregate and share data to accelerate the search for cures for people with cancer. The imCORE™ Network will focus on identifying approaches to expand the number of people who benefit from cancer immunotherapy by exploring new ways to activate a person’s immune system to fight their cancer.”We believe the fastest way to advance progress against cancer is through collaboration, and consistent with our values, the goal of imCORE is to facilitate access to new technologies and emerging data among the top researchers around the world,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “imCORE represents our most recent commitment to collaborate with the global cancer community to further understand the biology and immunology of cancer and to develop new treatments that may one day offer a cure for people with cancer.”

Roche will invest up to 100 million Swiss Francs to support basic and clinical research collaborations related to cancer immunotherapy. This investment is incremental to Roche’s on-going research and development of investigational medicines and treatment approaches in the field of cancer immunotherapy.

About the imCORE Network
imCORE is a global network of basic and clinical scientists from 21 leading academic research institutions in cancer immunotherapy who will work together with scientists from Roche and Genentech, a member of the Roche group in the United States, with the goal of developing potential cures for people with cancer. Roche is working in collaboration with the network on existing and new investigational medicines, diagnostic technologies and emerging data. The network will also closely collaborate to identify and prioritise the most promising new treatment approaches and to rapidly conduct clinical trials to accelerate progress in the field.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, Roche is investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

About personalised cancer immunotherapy (PCI)
The aim of personalised cancer immunotherapy (PCI) is to provide patients and physicians with treatment options tailored to the specific immune biology associated with a person’s individual tumour. The purpose is to inform treatment strategies that provide the greatest number of people with a chance for transformative benefit. PCI encompasses the search for reliable biomarkers that correlates with clinical benefit either as a monotherapy or in combination, and across a broad range of tumour types. The Roche PCI research and development programme comprises more than 20 investigational candidates, ten of which are in clinical trials.

PCI is an essential component of how Roche delivers on the broader commitment to personalised healthcare.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

2. Roche !

Roche delivers good sales growth in the first nine months of 2016

Roche

Roche

Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that Group sales increased 4% to CHF 37.5 billion. Sales in the Pharmaceuticals Division were up 4% to CHF 29.1 billion, driven by demand for breast cancer medicines Perjeta and Herceptin as well as for Actemra/RoActemra for rheumatoid arthritis. Sales in the US rose 3%, led by three immunology treatments Xolair, Esbriet and Actemra/RoActemra, as well as Activase/TNKase, and Perjeta and Herceptin for HER2-positive breast cancer. The recently launched medicines Tecentriq in bladder cancer and Alecensa in lung cancer have had a strong uptake. US growth was partly offset by a decline in sales of Tamiflu, Lucentis, Avastin and Tarceva. In Europe, sales increased 5% with Perjeta, Actemra/RoActemra and MabThera/Rituxan recording strong growth, especially in Germany and France. In the International region, the 4% growth was driven by the strategic cancer medicines portfolio. In Japan, sales were stable; mandated price cuts for reimbursed products were compensated by strong growth from Alecensa, HER2 cancer medicines and Actemra/RoActemra.Confirming data for key investigational Roche medicines
Two Roche medicines were granted breakthrough therapy designations (BTD) by the US FDA in October. BTD was granted to Actemra/RoActemra for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. In addition, Alecensa received BTD for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor. Also in October, the FDA approved the Lucentis prefilled syringe as a new method of administering the medicine to people with wet age-related macular degeneration and to people with macular edema after retinal vein occlusion.

In September, Roche presented new post-hoc analyses from three pivotal Ocrevus (ocrelizumab) studies at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The new data showed that Ocrevus consistently increased disease control both in patients with the relapsing form of multiple sclerosis and in those with the primary progressive form.

At the European Society for Medical Oncology (ESMO) annual meeting in October, Roche presented results from the phase III OAK trial with Tecentriq in metastatic NSCLC. The study met its primary endpoint, having established a survival benefit over chemotherapy, even in people with low or no observed levels of PD-L1 expression. These results add to the growing body of evidence that supported the FDA approval of Tecentriq as a new treatment for specific types of advanced NSCLC. In addition to OAK, Roche has seven phase III lung studies underway evaluating Tecentriq alone or in combination with other treatments in patients with early and advanced stages of lung cancer.

Commenting on the Group’s first nine months, Roche CEO Severin Schwan said: “We had continued good sales growth in both Pharmaceuticals and Diagnostics driven by our newly launched products, and our product pipeline is developing very well. Our cancer immunotherapy medicine Tecentriq has been performing strongly since May, when it was first approved in the US for people with advanced bladder cancer, and it has just received US FDA approval for previously treated metastatic non-small cell lung cancer. Based on our performance so far, I am confident that we will meet our full-year targets for 2016.”

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

3. Merck !

Merck announces new biopharma heads for North America and China

Merck

Merck

Merck, a leading science and technology company, today announced two appointments in two regions important for its biopharma business. Gary Zieziula will lead Merck’s biopharma business in North America and Marc Horn will take the helm of the biopharma business in China.Gary Zieziula (61) has been appointed President and Managing Director of the biopharma business in the U.S. and Canada, based in Rockland, Massachusetts, U.S., with immediate effect. In his role, he will be responsible for all areas of the company’s business including driving overall strategic direction and maximizing growth across the region. Zieziula joined Merck in 2014 as Chief Commercial Officer in the U.S., having spent more than 30 years in the pharmaceutical industry, including senior level positions at MSD, Bristol Myers-Squibb, Roche and Amag Pharmaceuticals. Zieziula holds a Bachelor of Science degree from the State University of New York at Buffalo and an MBA from Canisius College.

“As we look to grow our biopharma business in North America, including our progress in oncology and immuno-oncology, Gary’s vision, experience and customer-centric approach are critical to lead the company forward,” said Simon Sturge, Chief Operating Officer at the Healthcare business of Merck, whom Zieziula will report to.

Zieziula’s predecessor, Paris Panayiotopoulos, accepted a new position outside of Merck at the end of last year.

In the first nine months of 2015 net sales of Merck in North America amounted to € 1.9 billion, thereby accounting for 20% of Group sales. Healthcare sales in this region totalled € 1.1 billion in the first nine months of 2015. In the first nine months of 2015 Healthcare sales in North America represented two-thirds of Merck’s total sales in the region.

Marc Horn (41) will head the biopharma business of Merck in China as of April 1, 2016, as a Managing Director based in Beijing. He is currently the regional Chief Financial Officer (CFO) of Merck responsible for Eastern Asia, comprising China, Hong Kong, Japan, South Korea and Taiwan, for the three business sectors Healthcare, Life Science and Performance Materials.

Horn has more than 16 years of management experience in finance in the pharmaceuticals and chemicals industry, including positions at Bayer and Lanxess in Germany, China and Singapore. Horn graduated from Otto-Friedrich University of Bamberg, Germany, and University of Maastricht, Netherlands, with a Master’s degree in International Business Administration.

Allan Gabor, Mark Horn’s predecessor, has been promoted to President of the Asian-Pacific region for Merck’s biopharma business. In his new position, Horn will report to Gabor.

China is of importance to Merck currently and in future. Among others the company is building a € 80 million (650 million Yuan) pharmaceutical manufacturing plant in the Nantong Economical Technological Development Area (NETDA), in the Greater Shanghai region (Yangtze River Delta area). Completion of the facility, which will focus on bulk production and packaging of Glucophage, Concor and Euthyrox, is scheduled for 2016, with commercial production starting in 2017.

With an organic increase of 5.1%, sales in the Asia-Pacific region, where China is included, amounted to € 3.1 billion in the months January to September 2015. Representing a share of 33% of Group net sales, Asia-Pacific therefore became the Group’s top-selling region. Healthcare sales from January to September 2015 in the Asia-Pacific region reached around € 1 billion, representing one-third of group sales in this region.

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of € 11.3 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

4. Roche !

U.S. FDA grants Breakthrough Therapy Designation for Roche’s investigational medicine ocrelizumab in primary progressive multiple sclerosis

Roche

Roche

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM) for the treatment of people with primary progressive multiple sclerosis (PPMS). There are currently no approved treatments for PPMS, a debilitating form of MS characterised by steadily worsening symptoms and typically without distinct relapses or periods of remission.(1)”Ocrelizumab is the first investigational medicine for MS to be granted Breakthrough Therapy Designation by the FDA,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With no approved treatments for primary progressive MS, ocrelizumab has the potential to address an important unmet need. We are committed to working with the FDA to bring ocrelizumab to people with primary progressive MS as quickly as possible.”

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The designation is based on positive results from the pivotal Phase III study (called ORATORIO), which showed treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo. Top-line results were presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015.

Roche plans to pursue marketing authorisation for both PPMS and relapsing multiple sclerosis (RMS), a more common form of the disease, and will submit data from three pivotal Phase III studies to global regulatory authorities in the first half of 2016.

OCREVUSTM is the proprietary name submitted to global regulatory authorities for the investigational medicine ocrelizumab.

About ocrelizumab
Ocrelizumab is an investigational, humanised monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS. Based on preclinical studies, ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

In addition to ORATORIO, the Phase III clinical development programme for ocrelizumab includes OPERA I and OPERA II, which are randomised, double-blind, double-dummy, global multi-centre studies in people with relapsing forms of MS.

About the ORATORIO study in PPMS
ORATORIO is a Phase III, randomised, double-blind, global multi-centre study evaluating the efficacy and safety of ocrelizumab compared with placebo in 732 people with PPMS.(2) The primary endpoint of the study was time to onset of confirmed disability progression (CDP) sustained for at least 12 weeks.

CDP measures a sustained protocol-defined increase in a patient’s Expanded Disability Status Scale (EDSS) score. The EDSS is based on a physical and neurological exam of eight systems throughout the body. The functional systems include vision, coordination, limb movement, strength, thinking abilities, bowel and bladder control, sensation and walking ability.

About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure.(3,4) MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. Damage to these nerves can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to progressive disability.(5,6,7)

Primary progressive MS (PPMS) is a debilitating form of MS characterised by steadily worsening symptoms but typically without distinct relapses or periods of remission.1 Approximately one in 10 people with MS are diagnosed with the primary progressive form of the disease. There are no approved treatments for PPMS.

About Roche in neuroscience
Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease, Down syndrome and autism.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

1. MS International Federation. Types of MS. Available at: http://www.msif.org/about-ms/types-of-ms/.
2. F. Hoffmann-La Roche. ClinicalTrials.gov NCT01194570. National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT01194570.
3. Multiple Sclerosis International Federation. (2013). Atlas of MS 2013. Available at: http://www.msif.org/about-us/advocacy/atlas/.
4. National Institutes of Health-National Institute of Neurological Disorders and Stroke. (2015). Multiple Sclerosis: Hope Through Research. Available at: http://www.ninds.nih.gov/disorders/multiple_sclerosis/detail_multiple_sclerosis.htm#280373215.
5. Ziemssen T. (2005). Modulating processes within the central nervous system is central to therapeutic control of multiple sclerosis. J Neurol, 252(Suppl 5), v38-v45.
6. Hauser S.L. et al. (2012). Multiple sclerosis and other demyelinating diseases. In Harrison’s Principles of Internal Medicine (pp.3395-3409). New York, NY: McGraw Hill Medical.
7. Hadjimichael O. et al. (2007). Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain, 127(1-2), 35-41.

5.  YOGA !

Meditation, yoga and vegetarian diet linked to decline in plasma metabolites associated with inflammation and cardiovascular disease risk

In a novel controlled clinical trial, participants in a six-day Ayurvedic-based well-being program that featured a vegetarian diet, meditation, yoga and massages experienced measurable decreases in a set of blood-based metabolites associated with inflammation, cardiovascular disease risk and cholesterol regulation. The findings, published in the September 9 issue of Scientific Reports, represent a rare attempt to use metabolic biomarkers to assess the reported health benefits of integrative medicine and holistic practices. Senior author of the study, which included researchers from multiple institutions, was Deepak Chopra, MD, clinical professor in the Department of Family Medicine and Public Health at University of California San Diego School of Medicine and a noted proponent of integrative medicine.”It appears that a one-week Panchakarma program can significantly alter the metabolic profile of the person undergoing it,” said Chopra, whose foundation provided and managed funding for the study. “As part of our strategy to create a framework for whole systems biology research, our next step will be to correlate these changes with both gene expression and psychological health.”Study co-author Paul J. Mills, PhD, professor of family medicine and public health and director of the Center of Excellence for Research and Training in Integrative Health, both at UC San Diego School of Medicine, noted that alternative and integrative medicine practices, such as meditation and Ayurveda, are extremely popular, but their effects on the human microbiome, genome and physiology are not fully understood. “Our program of research is dedicated to addressing these gaps in the literature.”

“The researchers looked at the effects of a Panchakarma-based Ayurvedic intervention on plasma metabolites in a controlled clinical trial,” said first author Christine Tara Peterson, PhD, a postdoctoral fellow at UC San Diego School of Medicine. “Panchakarma refers to a detoxification and rejuvenation protocol involving massage, herbal therapy and other procedures to help strengthen and rejuvenate the body.”

The study involved 119 healthy male and female participants between 30 and 80 years of age who stayed at the Chopra Center for Wellbeing in Carlsbad, Calif. Slightly more than half were assigned to the Panchakarma intervention (the Chopra Center’s Perfect Health program, which typically costs $2,865 for a six-day treatment). The remainder to a control group. Blood plasma analyses, using liquid chromatography and mass spectrometry, were taken before and after the six-day testing period.

The researchers found that in the Panchakarma group there was a measurable decrease in 12 specific cell-membrane chemicals (phosphatidylcholines) correlating with serum cholesterol and inversely related to Type 2 diabetes risk.

“These phospholipids exert broad effects on pathways related to inflammation and cholesterol metabolism,” said Peterson. “Plasma and serum levels of the metabolites of phosphatidylcholine are highly predictive of cardiovascular disease risk.”

Application of a less stringent measurement standard identified 57 additional metabolites differentially abundant between the two groups of participants. The authors suggested that given the very short duration of the trial, the serum profile changes were likely driven by the vegetarian diet component of Panchakarma. They said further studies were needed to more fully understand the processes and mechanisms involved.

Deepak Chopra is founder of the Chopra Foundation and co-founder of the Chopra Center for Wellbeing. Paul Mills is director of research at the Chopra Foundation.

Peterson CT, Lucas J, John-Williams LS, Thompson JW, Moseley MA, Patel S, Peterson SN, Porter V, Schadt EE, Mills PJ, Tanzi RE, Doraiswamy PM, Chopra D.
Identification of Altered Metabolomic Profiles Following a Panchakarma-based Ayurvedic Intervention in Healthy Subjects: The Self-Directed Biological Transformation Initiative (SBTI).
Sci Rep. 2016 Sep 9;6:32609. doi: 10.1038/srep32609.

COURTESY – WORLD PHARMA NEWS



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