ghp April 2015

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ghp April 2015

www.ghp-magazine.com

global health & pharma

Plus

The latest news from across the global healthcare & pharmaceutical industries

Consumer Trust is Key to Leveraging Data in a Connected World Global product strategy and design firm, frog, explores new rules for designing products and services with data

Why the Biotech Sector Continues to Outperform Strengthened Balance Sheets Will Sustain the Industry’s Solid Growth Post-M&A Scandals Facing Big Pharma



ghp editor’s note

global health & pharma

this month’s features

04 The latest news from

Welcome to the latest issue of Global Health & Pharma Magazine.

across the global healthcare and pharmaceutical industries

In this month’s issue, we take a look at the financial side of biotechnology and explore how the industry has sustained its upward trend in a first quarter that has seen the Nasdaq Biotech Index (NBI) beating the broader stock market’s performance by more than 12 percentage points. We also find out why poor recruitment practices when filling high-level positions can leave big pharma companies facing big problems following M&A activity. We get technical when we speak to design company, frog, about why consumer trust is key to leveraging data in a connected world and get a first-hand look at how IBM and Partners are transforming personal health with their new Watson Health Cloud. In our products section, the U.S. FDA grants priority review to AbbVie for investigational, all-oral, interferon-free therapy and Orexigen announces receipt of a paragraph IV certification notice. We continue to cover the most significant developments in research and development as Actavis reveals the outcome of its Topline Phase 3 clinical trial for Single-Dose DALVANCE® (dalbavancin) in the treatment of ABSSSI and Merck reveals results from its C-SURFER Phase 2/3 study of investigational chronic hepatitis C therapy, Grazoprevir/Elbasvir, in patients with advanced chronic kidney disease. And finally, we sit down with CEO, Marc Bell, to find out why his company, Benenden, was voted the UK’s most trusted healthcare provider for four years running between 2011 and 2014. We hope you enjoy the issue.

Mark Toon, Editor

inside this issue

10 Merck Announces Actavis Announces Trial Results

Company reveals outcome of Topline Phase 3 Clinical Trial for Single-Dose DALVANCE® (dalbavancin) in the Treatment of ABSSSI Page 8

Results from C-SURFER Phase 2/3 Study

12 Biotech Sector Continues to Outperform

16 Dangerous Liaisons 20 IBM & Partners to Transform Personal Health

Consumer Trust is Key to Leveraged Personal Data in a Connected World

Global product strategy and design firm, frog, explores new rules for designing products and services with data. Page 18

“The first 20 years of the Internet bred a paradigm that advertisers are out to mine our personal data for commercial gain and that high barriers for privacy are necessary and good.” Timothy Morey, Vice President of Innovation Strategy at frog (p18)

24 U.S. FDA Grants Priority Review to AbbVie

27 Orexigen Announces

Receipt of Paragraph IV Certification Notice

Global Health & Pharma 39A Birmingham Road Blakedown Worcestershire DY10 3JW Tel: +44 (0) 1234 567 890 Email: info@ghp-magazine.com Web: www.ghp-magazine.com


news

Warwick Analytics Helps Reduce Impurity Levels with Automated Analysis The software has reduced impurities in the production of a haemorrhoid treatment at a major pharmaceutical company. The Site Operational Excellence Lead at the plant where the product is made says: “The product is formed from a complex series of reactions from intermediate chemicals. It is very sensitive to many factors and has been a challenge to control the impurities for a long time.

The Site Operational Excellence Lead continues: “The pharmaceutical industry is highly regulated and we have to verify and document everything we do. So finding and validating the root causes which drove yield improvements was a key advancement and we are very pleased with the analysis that SigmaGuardian provided.

“Clearly it is imperative to better understand the factors which drive impurity formation so that we can maximise the quality and avoid rejections. Not only does this save on the expensive raw materials and process, but it is also better for the environment reducing waste product and energy.”

“We did not expect the results to be as good as they were, particularly with limited data we provided. Also the speed of calculation and the ease of interpreting the results was impressive too.”

So the company introduced SigmaGuardian software from Warwick Analytics, an automated root cause analysis tool, to identify where the underlying reasons for the impurity formation lay.

Warwick Analytics has developed their SigmaGuardian automated root cause analysis and Y Predictive Analytic software following a decade of academic research originating from Warwick University.

Although the initial dataset was small some inaccuracies, SigmaGuardian was able to employ its Information Retrieval technology to extract as much information from the data as possible, including logical inferences and derivative variables. From the first iteration, its ‘non-statistical’ predictive algorithm was able to generate and validate some strong signals without any hypotheses. Some of the results were expected and some were a surprise to the team. This led to a second iteration with more data.

About Warwick Analytics Warwick Analytics’ products are based on sophisticated algorithms that allow companies to automatically resolve product faults and process failures. Warwick Analytics’ patented technology (“RCASE” – Root Cause Analysis Solver Engine) is developed from more than a decade of academic research.

Warwick Analytics generated root causes to explain the factors which predicted both high yields as well as low yields. A Design of Experiments (“DoE”) was created from the results to validate the results. These concurred with the findings from SigmaGuardian and the relevant process changes could be implemented.

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Medical Marijuana Liquid Extract May Bring Hope for Children with Severe Epilepsy A medicinal liquid form of marijuana may show promise as a treatment for children with severe epilepsy that is not responding to other treatments, according to a study released today that will be presented at the American Academy of Neurology’s 67th Annual Meeting in Washington, DC, April 18 to 25, 2015. The study involved 213 people, ranging from toddlers to adults, with a median age of 11 who had severe epilepsy that did not respond to other treatments. Participants had Dravet syndrome and Lennox-Gastaut syndrome, epilepsy types that can lead to intellectual disability and lifelong seizures, as well as 10 other types of severe epilepsy.

“So far there have been few formal studies on this marijuana extract,” Devinsky said. “These results are of great interest, especially for the children and their parents who have been searching for an answer for these debilitating seizures.” The study was supported by GW Pharmaceuticals.

The participants were given the drug cannabidiol, a component of marijuana that does not include the psychoactive part of the plant that creates a “high.” The drug is a liquid taken daily by mouth. Participants all knew they were receiving the drug in the open-label study, which was designed to determine whether the drug was safe and tolerated well.

Appointments Brookdale Appoints Mark Parrell and Lee Wielansky to Board of Directors The appointments of Messrs. Parrell and Wielansky, which became effective on April 23, 2015, fill the vacancies created by the retirements from the Board of Mark J. Schulte, who had previously served as CEO and Co-CEO of the Company and had served as a director since 2008, and Dr. Samuel Waxman, who had served as a director since 2005. Following the changes, the Brookdale Board will remain comprised of nine directors, seven of whom are independent. Mr. Parrell brings over 20 years of real estate, capital markets, mergers and acquisitions and investment experience to the Brookdale Board. Since 1999, Mr. Parrell has worked at Equity Residential, an S&P 500 company focused on the acquisition, development and management of high quality apartment properties in top U.S. growth markets. He was appointed Executive Vice President and Chief Financial Officer of Equity Residential in 2007 after previously serving as Senior Vice President and Treasurer of the company. Mr. Parrell also served as a director of Aviv REIT, Inc., a publicly-traded healthcare REIT, from its initial public offering until it was acquired earlier this year. Mr. Wielansky has more than 40 years of commercial real estate investment, management and development experience. In 1983, Mr. Wielansky co-founded Midland Development Group, which focused on the development of retail properties in the mid-west and southeast and which was sold to Regency Centers Corporation. Subsequently, he has served as a Managing Director of Regency Centers Corporation and as the President and Chief Executive Officer of JDN Development Company, Inc., which was a wholly-owned subsidiary of JDN Realty Corporation, a REIT which was acquired by Developers Diversified Realty Corporation.

Researchers also measured the number of seizures participants had while taking the drug. For the 137 people who completed the 12-week study, the number of seizures decreased by an average of 54 percent from the beginning of the study to the end. Among the 23 people with Dravet syndrome who finished the study, the number of convulsive seizures had gone down by 53 percent by the end of the study. For the 11 people with Lennox-Gastaut syndrome who finished the study, there was a 55 percent reduction in the number of atonic seizures, which cause a sudden loss of muscle tone.

Since 2003, he has served as Chairman and CEO of the re-started Midland Development Group and he also currently serves as Chairman and CEO of Opportunistic Equities, which specializes in low income housing. Mr. Wielansky currently serves as Lead Trustee of Acadia Realty Trust, a publicly-traded REIT focused on the ownership, acquisition, redevelopment and management of commercial retail properties in the United States, and as a director of Isle of Capri Casinos, Inc. and Pulaski Financial Corp.

A total of 12 people, or 6 percent, stopped taking the drug due to side effects. Side effects that occurred in more than 10 percent of participants included drowsiness (21 percent), diarrhea (17 percent), tiredness (17 percent) and decreased appetite (16 percent). Study author Orrin Devinsky, MD, of New York University Langone Comprehensive Epilepsy Center and a Fellow of the American Academy of Neurology, said that these are early findings and larger, placebo-controlled, double-blind trials are needed to measure the effectiveness of the drug.

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news

New Website Makes Searching for Surgery Options Easier Than Ever Clinic Compare, one of the UK’s leading healthcare comparison sites has launched a new and improved website: www.cliniccompare.co.uk The new site is intended to make it easier than ever to research surgery options, get information on treatments and after-care and hear testimonials from patients and industry experts. Offering comparisons on procedures from IVF, to cataract surgery, to liposuction, the site boasts some of the UK’s most noted surgeons and clinics. Originally launched in 2009, Clinic Compare has helped over 400,000 patients to find the right clinic for their procedure. The updated website will even put patients directly in touch with their surgeon, something which Consultant Ophthalmic Surgeon, Valerie Saw sees as a real bonus: “It’s really important to be able to know that you can contact your surgeon if you’re worried about anything after the surgery or something doesn’t feel right.” Dan Tobin, Director at Clinic Compare said: “Clinic Compare is an unrivalled resource for people who want to make informed and safe decisions about their surgery options. We work closely with the UK’s leading specialists to make sure each patient feels guided through the process and in control of their procedure. “The new look website is so much easier to navigate, and has a host of new informative videos and Q&As.” One of the most popular new features of the website is the selection of new patient testimonials. Prospective patients can learn from people who have undergone the procedure; anything from what to expect from your initial consultation, to how the procedure felt, to what recovery time to expect. Helen Bonham, who used the new site to choose her recent surgery said: “I found the site very easy to use and got a response very quickly back. I was very pleased on how it worked for me and would recommend to anyone.” Ed Beardsell, Website Manager comments: “Choosing surgery is a big decision and it is important that patients feel informed and confident in their choices. We have always been a really useful resource for patients but the new site makes it much easier to access information and real customer reviews.” Clinic Compare’s new website is live now, why not take a look? www.cliniccompare.co.uk

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Sharp Uplift in Confidence Reported Amongst Pharmacists Capitalising on Growth Opportunities • Pharmacists remain bullish around to bid for more NHS services as short-term confidence increases • 92% of pharmacists plan to win or retain NHS services • Less than half of pharmacists see opportunity in primary healthcare reforms, while 44% view them as a threat. The expectation of higher profits and the opportunities for pharmacists to bid to provide additional primary healthcare services has seen confidence within the profession rise, according to the latest Lloyds Bank Commercial Banking Healthcare Confidence Index. The Healthcare Confidence Index was first published in August 2011 and is now in its sixth update. It canvasses opinions of primary healthcare providers; GPs, Dentists and Pharmacists, over the next one to five years to provide an insight into their attitudes and opinions and levels of confidence. A combined figure of both the short (12 months) and long-term projections (one to five years) is used to provide a measure of overall business confidence within the primary healthcare sector*. The results of the Index show that the majority (92 per cent) of pharmacists plan to win or retain NHS services at their pharmacy, marking a continuation of the strong optimism shown from the last survey in April 2014. The Index reveals that short-term confidence (over the next 12 months) amongst pharmacists has risen once again, reaching a peak of +13, showing a considered uplift in optimism when compared to the -23 result in the fourth edition of the survey. The upturn is reinforced by the fact that over three quarters (78 per cent) of pharmacists expect their profits to rise in the next 12 months, compared to less than half (46 per cent) of those surveyed a year ago. Meanwhile more than three quarters (78 per cent) are planning to grow their business, with the figure split equally between those who want to expand at their existing site (39 per cent) and those who wish to acquire new units (39 per cent). As the role of pharmacists continues to evolve, two

thirds (66 per cent) believe the ratio of income from NHS services versus Pharmaceutical Product Development income will increase. Further highlighting the increased optimism of the profession, more than half of the pharmacists surveyed (55 per cent) would encourage their son or daughter to enter the profession, compared to just under a third (32 per cent) last time. Ian Crompton, Head of Healthcare, SME Banking, Lloyds Bank Commercial Banking, said: “Pharmacists remain the most optimistic in the longer term of the healthcare professions surveyed, with more than two thirds looking to grow their business, including over a third of pharmacists that are planning to acquire additional units, a significant increase from the quarter of respondents we saw in the last survey. “Pharmacists are also the most bullish around bidding for new contracts with eight out of ten pharmacists keen to either start bidding or take on more than they already hold, and this bodes well for a continued positive performance within the sector as we move into the next wave of the Index.” A contributor to the Lloyds Bank Commercial Banking Healthcare Confidence Index, Kevin Nichols, Managing Director at The Pharmacy Consultancy, said: “Pharmacy is on the up in terms of both short and long-term confidence. Amid this positive outlook, the sector needs to be aware of the importance of providing more services, in-line with the growing need to increase their offering beyond their traditional role of dispensing medicines. “With strains on GPs’ surgeries on the increase, it is inevitable that there will be an increasing need for pharmacies to step up and take responsibility for certain primary healthcare services, which patients may in the past have been offered by doctors.”

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Appointments EUSA Pharma Appoints Lee Morley as Chief Executive and Industry Veteran Göran Ando to Board of Directors EUSA Pharma (EUSA), a recently-established profitable specialty pharmaceutical company with global reach, today announced the appointment of Lee Morley as Chief Executive Officer, and Dr Göran Ando as a Non-Executive Director. Bryan Morton, who established EUSA Pharma as founder and first CEO, will become Executive Chairman. Lee Morley joins from Jazz Pharmaceuticals plc (Jazz), where he was Vice President, Head of Commercial for Europe and International Markets. At Jazz, he had responsibility for the original EUSA Pharma business following its acquisition in 2012, until the recent launch of EUSA as a newly-established independent company with a portfolio of specialty hospital products, multi-national commercial infrastructure and the EUSA Pharma brand name, which were acquired from Jazz in March 2015. Lee brings to EUSA extensive commercial experience gained over 20 years in the pharmaceutical industry. Previously, he held several senior commercial positions at EUSA Pharma, prior to its acquisition by Jazz, including Regional Vice President, and was Director of Sales Effectiveness at the specialty oncology and critical care company Zeneus Pharma. He also held a number of management positions in sales and marketing at Merck, Sharp and Dohme (MSD), including UK National Sales Manager. He began his industry career at MSD as a Medical Representative, following his graduation from Kings College London with a degree in chemistry. Dr Göran Ando is Senior Advisor with EUSA Pharma’s lead shareholder, Essex Woodlands. He has over 35 years’ experience of the pharmaceutical industry, spent in a variety of senior international roles. He is currently Chairman of Novo Nordisk, the world’s leading pharmaceutical company focused on diabetes. He is also Chairman of Symphogen, and sits on the Board of Directors at Molecular Partners. Previously, he was CEO of Celltech Group plc prior to its acquisition by UCB Pharma, and was Head of R&D at Pharmacia / Pharmacia & Upjohn. Dr Ando holds a Bachelor of Arts degree from Uppsala University in Sweden and a Medical Degree from Linkoeping University (Sweden).


r&d

Actavis Announces Trial Results Company reveals outcome of Topline Phase 3 Clinical Trial for Single-Dose DALVANCE® (dalbavancin) in the Treatment of ABSSSI

Actavis plc has announced positive top-line results for study DUR001-303, a phase 3 study comparing a single 1500 mg dose of DALVANCE with the same total dose given as two-doses one week apart, for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA). Preliminary top-line data demonstrated the 1500 mg single-dose of DALVANCE achieved its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48-72 hours after initiation of therapy, as determined by a decrease of > 20% in lesion area relative to the baseline measurement (81.4% vs. 84.2 % for the single dose vs. the two dose regimen, respectively; Difference -2.9; 95% CI: -8.5, 2.8) Similar proportions of patients with Staphylococcus aureus infections at baseline were clinical responders at the 48-72 hour time-point within each treatment group (122/137 (89.1%) in the single-dose treatment group and 124/145 (85.5%) in the two-dose treatment group). “We are pleased with the results demonstrated in this trial. Single-dose dalbavancin has shown positive results for the treatment of serious skin infections and can be an important new treatment option for patients,” said David Nicholson, Actavis Executive Vice President, Global Brands R&D. In addition, the trial assessed the secondary outcome measures of clinical response at Day 14 (the EMA Primary Endpoint) as well as at Day 28. The single-dose of DALVANCE provided similar treatment efficacy to the two dose regimen in these secondary endpoints. 94.4% of patients in the single-dose DALVANCE arm and 94.0% of patients in the two-dose DALVANCE arm achieved clinical success at Day 14 (95% CI -3.5, 4.3). At Day 28, 84.5% of patients treated with a single-dose of DALVANCE achieved clinical success compared to 85.1% of those treated with the two-dose regimen of DALVANCE (95% CI -6.0, 4.8). Actavis plans to file a supplemental New Drug Application (sNDA) with these data in Q3 2015.

DALVANCE® (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus). DALVANCE is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. About Actavis Actavis plc, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world. Actavis markets a portfolio of best-in-class products that provide valuable treatments for the women’s health, central nervous system, eye care, medical aesthetics, gastroenterology, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally. With commercial operations in approximately 100 countries, Actavis is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.

About the DUR001-303 Trial This study was conducted pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA’s Guidance for Developing Drugs for Treatment of ABSSSI. DUR001-303 was a randomized, double-blind, double-dummy trial conducted in 698 patients at 62 sites in the United States, Europe and South Africa comparing a single 1500 mg intravenous (IV) dose of DALVANCE to the approved regimen of two-doses given one week apart (1000 mg IV on Day 1 followed by 500 mg IV on Day 8).

For more information, visit Actavis’ website at www.actavis.com.

The treatment-emergent adverse event rate for single dose dalbavancin was 22.3% compared to 21.1% for the two-dose regimen. The most commonly reported adverse events with an incidence >1% for the single dose of dalbavancin were nausea, headache, vomiting, diarrhea, and dizziness, similar in frequency to the two-dose regimen. Discontinuations due to treatment emergent adverse events were 1.7% and 1.4% for the single and two-dose regimens, respectively. About DALVANCE

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r&d

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r&d

Merck Announces Results from C-SURFER Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease Merck, known as MSD outside the United States and Canada, has announced the first presentation of data from C-SURFER, as well as the C-EDGE trials at the 50th annual congress of the European Association for the Study of the Liver (EASL) – held this April 22 to 25th in Vienna, Austria. “HCV affects approximately 130-170 million people worldwide, and 350,000 to 500,000 people die each year from HCV-related liver diseases. In Canada this translates to approximately 242,500 individuals infected with HCV,” explains Dr. Rejean Thomas, CEO and cofounder of the L’Actuel, Centre of Excellence for HIV and Hepatitis, located in Montreal. “The results from these studies provide hope for the patients with cirrhosis and advanced chronic kidney diseases. CKD represent an unmet clinical need especially for those on hemodialysis. There is a need for more effective treatment options in Canada for these patients.” C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1. The C-SURFER trial is the company’s Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1 (GT1).1 Treatment-naïve patients and patients who failed prior pegylated interferon HCV therapy, with or without cirrhosis, all of whom had CKD stages 4 or 5, were enrolled.2 Following 12 weeks of treatment with grazoprevir and elbasvir, 99 percent (115/116) of patients in the pre-specified primary population for analysis of efficacy data achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12). 3 These data will be presented today at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (late breaking E-Poster #LP02). “There is an unmet medical need to treat chronic hepatitis C virus infection in patients with advanced chronic kidney disease,” said Dr. Howard Monsour, Jr., chief of hepatology, Houston Methodist Hospital, Houston, Texas, U.S.A. “In this trial, the first to investigate an all-oral ribavirin-free treatment regimen in treatment-naïve and treatment-experienced CKD patients, treatment with grazoprevir and elbasvir for 12 weeks was effective in this study population with HCV genotype 1 infection.” The ongoing C-SURFER Phase 2/3 clinical trial is a randomized, parallel-group, placebo-controlled study evaluating patients infected with chronic HCV GT1 with advanced CKD with or without liver cirrhosis. Patients were randomised to one of two study arms: •

Immediate treatment group (ITG), grazoprevir plus elbasvir (blinded) once-daily for 12 weeks (n=111);

Deferred treatment group (DTG), initially placebo (control arm) for 12 weeks followed by a four week follow-up period and then treatment with grazoprevir plus elbasvir (open label) once-daily for 12 weeks (n=113).

In addition, 11 patients received grazoprevir plus elbasvir (open label) once-daily for 12 weeks with intensive pharmacokinetic sampling. Of the 122 patients who received grazoprevir plus elbasvir, 83 percent were treatment-naïve, 36 percent had diabetes, 18 percent had stage 4 CKD, 82 percent had stage 5 CKD, 75 percent were receiving haemodialysis and 45 percent were African-American. Among those patients

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r&d who received at least one dose of grazoprevir plus elbasvir, five percent (6/122) were excluded from the pre-specified primary efficacy analysis population, or modified full analysis set, due to missing data caused by death or early discontinuation for reasons unrelated to study drug. In the modified full analysis set, 99 percent (115/116) of patients receiving grazoprevir plus elbasvir achieved SVR12. One GT1b infected, non-cirrhotic, interferon-intolerant patient showed a viral relapse at follow-up week 12. Within the modified full analysis set, efficacy was consistent across the patient sub-populations assessed. In a supportive analysis of all 122 patients who received at least one dose of grazoprevir plus elbasvir in the ITG arms, including patients who did not complete the study for reasons not related to study drug, 94 percent (115/122) of patients achieved SVR12. “The broad clinical development program of Merck includes studies dedicated to bringing a once-daily regimen to diverse populations of patients infected with chronic HCV, including certain types of patients with co-morbidities, such as advanced chronic kidney disease,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories, a U.S.-based division of Merck & Co., Inc., Kenilworth, N.J., U.S.A. “These data highlight how emerging innovations in chronic hepatitis C treatment may lead to new options for patient populations in which it historically has been difficult to achieve high rates of sustained viral clearance.” No patients in the ITG arms discontinued treatment due to adverse events (AEs), while four percent (5/113) of patients in the comparator placebo phase of the DTG arm discontinued treatment due to AEs. The rates of serious AEs reported were 14 percent (16/111) in the ITG arms and 17 percent (19/113) in the placebo control DTG arm. The most common treatment-related AEs in the ITG arms and DTG arm (placebo) were headache (17%, 17%), nausea (15%, 16%) and fatigue (10%, 15%), respectively. There were four deaths reported during the initial treatment phase and the first 14 days of study follow-up. One patient (1%) in the ITG arm died from cardiac arrest (not considered related to study medicine) and three patients (3%) in the placebo group died from aortic aneurysm, pneumonia and an unknown cause.. About C-SURFER C-SURFER is a Phase 2/3 clinical trial evaluating Merck investigational grazoprevir plus elbasvir in patients infected with chronic HCV GT1 and with advanced chronic kidney disease (stages 4 and 5, including patients on haemodialysis) with or without liver cirrhosis, which are among those with HCV infection who are most difficult to treat, over 12 weeks. C-EDGE Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection. The company’s ongoing C-EDGE pivotal Phase 3 clinical trial programme is evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).[4] Patients in both the HCV infected, treatment-naïve (C-EDGE TN), and HIV/HCV co-infected, treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively). In addition, HCV infected, treatment-experienced patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent (97/105), respectively, and those treated for 16 weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent (97/105), respectively. These data were presented at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (Abstract #G07, E-Poster P0886 and E-Poster P0887). A paper detailing the findings of C-EDGE TN was published online in the Annals of Internal Medicine today. “Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options,” said Dr. Eric Lawitz, Vice President, Scientific and Research Development, The Texas Liver Institute and Clinical Professor of Medicine, The University of Texas Health Science Center, San Antonio, Texas, U.S.A. “These findings are important because they demonstrate that a single pill of grazoprevir/elbasvir taken once-daily achieved consistently high rates of SVR12 in the patient populations studied.” “At Merck, we continue to build upon our clinical experience using grazoprevir/elbasvir across diverse populations of patients infected with chronic hepatitis C virus,” said Dr. Eliav Barr.”We remain on track to submit a New Drug Application with the U.S. Food and Drug Administration in the first half of 2015.”

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industry innovation insight

Biotech Sector Continues to Outperform Strengthened Balance Sheets Will Sustain the Industry’s Solid Growth Positive clinical trial data, takeovers and a reduction in BB Biotech’s discount lead to another strong performance by the investment company in the opening quarter of 2015

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The biotechnology industry sustained its upward trend in the first quarter with the Nasdaq Biotech Index (NBI) beating the broader stock market’s performance by more than 12 percentage points. For BB Biotech the first quarter was likewise very pleasing. Its shares advanced by 31.0% in CHF, 49.1% in EUR and 33.9% in USD. Growing investor interest for its shares narrowed the discount to Net Asset Value (NAV), which rose by 10.6% in CHF, 27.5% in EUR and 13.0% in USD over the period. Net profit for the first quarter amounted to CHF 379.4 mn. Performance was mainly driven by clinical trial results, pipeline progress and M&A activity involving portfolio companies. Regulatory approvals and important clinical trial results will remain important market-moving factors for the biotech sector for the rest of the year. BB Biotech is pleased that many smaller and mid-sized biotech firms are raising capital by taking advantage of the current positive sentiment to go public or issue more shares through secondary placements. By strengthening their balance sheets, these companies have more money to invest in their pipeline projects and can retain full rights to their drug candidates and avoid having to outlicense their pipeline assets too early in the development process.

from over 20% to about 10% during the first three months of 2015. This reduction in discount combined with the double-digit gain in Net Asset Value (NAV) generated a positive total return for BB Biotech shareholders but volatility also increased in recent weeks. Overall, the total returns for BB Biotech shareholders were 31.0% in CHF, 49.1% in EUR and 33.9% in USD. The portfolio showed an overall gain of 10.6% in CHF, 27.5% in EUR and 13.0% in USD. Thanks to the continued positive portfolio performance, BB Biotech earned a net profit of CHF 379.4 mn for the first quarter 2015. BB Biotech’s performance was mostly driven by its midcap holdings, with the biggest contribution coming from the holdings in Pharmacyclics, Incyte and Neurocrine. With the exception of Novo Nordisk, the larger cap holdings did not keep up with benchmark performance in the first three months of 2015. All total return calculations include the capital distribution of CHF 11.60 per share according to BB Biotech’s proposed dividend policy and as approved by the shareholders at this year’s AGM on March 18, 2015. The distribution is a substantial increase of 65.7% compared to the dividend of last year, driven by the strong share price performance of 2014. Clinical data boosts portfolio performance

Sustained outperformance by the biotech sector The upward trend of the biotech sector continued in the first quarter of 2015 as the Nasdaq Biotech Index (NBI) gained 13.3%, clearly outperforming the S&P 500 Index, which ended the period with a gain of 1.0%. The continued sector outperformance brought volatility in March as the NBI climbed to new all-time highs mid-month before falling back 7% towards the end of the month. Capital flows into the biotechnology industry continue to be positive, a combination of equity fund flows, asset allocation, and very importantly significant capital inflows provided by acquisitions within the sector. Central bank actions were once again a major influence on global equity and currency markets. The US and Japan have pumped substantial liquidity into markets in recent years, and now the European Central Bank has started its own quantitative easing program.

Key drivers impacting BB Biotech’s first quarter 2015 performance included clinical trial results, pipeline progress and M&A activity. In contrast, quarterly results and financial guidance influenced share prices less. •

Cempra announced positive results for its lead oral antibiotic Solithromycin for the treatment of Community Acquired Bacterial Pneumonia (CABP). Solithromycin is a next generation macrolide addressing many resistant bacterial strains and is developed both in an intravenous as well as in an oral formulation. Additional Phase III data are expected in the next several months.

Intercept, a position opened in early 2015, updated further clinical data for obeticholic acid in NASH (nonalcoholic steatohepatitis) patients. The concerns about drug related increases in LDL levels could be well controlled if statin therapy was initiated. Additionally, favorable clinical data for the patient subpopulation was a positive indicator of a successful trial outcome because in the FLINT study, a registration study, the same patient population is being tested.

Neurocrine updated investors on their expanding pipeline (ENDO presentation). Progress by its CRF1 receptor antagonist called NBI-77860 (verucerfont) in adolescence females with congenital adrenal hyperplasia is likely to make 2015 the most “data rich” year in the company’s history.

European equities profited from a weaker EUR/USD exchange rate, as local economies are expected to improve and because companies’ lower currency cost base should have a positive impact on revenue and profit growth. In contrast, US equities have underperformed consequent to the strengthened US dollar. With the Swiss National Bank unwinding the currency peg of the Swiss Franc against the Euro on January 15, a massive appreciation of the Swiss Franc led to a steep share price correction of the Swiss equity market in the second half of January. Since BB Biotech is quoted in Swiss Francs, its shares were also affected. With the US dollar strengthening to almost pre-January 15 levels and the continued strong performance of the portfolio, BB Biotech shares recovered and delivered a double-digit total return for the January-March period. BB Biotech’s performance for the first quarter 2015 BB Biotech’s strong share performance in the wake of greater investor interest helped to narrow the discount

Product approvals continue to fuel revenue and future profit growth of the portfolio holdings. For the first quarter 2015, Novo Nordisk received FDA approval for Saxenda as an add-on therapy to diet and physical activity for chronic weight management in conjunction with weight related comorbid conditions. In addition, Novo Nordisk shares jumped on the company’s announcement that it would be re-submitting its Tresiba and Ryzodeg diabetes drugs for approval by the US FDA.

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First quarter portfolio actions The most significant portfolio action was selling the holding in Pharmacyclics into the AbbVie offer. AbbVie announced an acquisition bid for Pharmacyclics for approximately USD 21 bn. BB Biotech has a cash flow of CHF 166.9 mn on the sale of its entire Pharmacyclics holding in the first quarter. This alone covered BB Biotech’s cash requirement for the cash distribution as well as the share repurchase program. The cash requirements for the cash distribution was CHF 130.1 mn and the cash used for the share repurchase program amounted to CHF 10.2 mn in the first quarter 2015. One new position was opened in Q1, namely Intercept. This US company focuses on the development of synthetic bile acid analogs for the treatment of chronic liver diseases, namely the orphan disease primary biliary cirrhosis (PBC) and much larger indications, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The lead product obeticholic acid (OCA), a first in class farnesoid X receptor agonist, is expected to enter a registration study for NASH in the second quarter 2015. As for the existing portfolio, BB Biotech traded in the larger holdings, taking advantage of volatility on market worries around drug pricing, currency swings, and valuations. More importantly, BB Biotech participated in ten capital increases in the same time period. These transactions involved the smaller and midsized companies Synageva, Cempra, Alnylam, Radius, Intercept, Achillion, Neurocrine, Tesaro, Tetraphase and Novavax. Outlook Judging by the sector fundamentals, BB Biotech expects 2015 will be another pleasing year for biotechnology investors. Key clinical milestones such as Phase III results and product approvals will usher in new and important treatment options. Important regulatory decisions concerning its portfolio companies include: • • • • •

Lumacaftor (Vertex) for the treatment of cystic fibrosis carriers of the F508 deletion Praluent (Regeneron/Sanofi) for the treatment of hypercholesterolemia Sebelipase alpha (Synageva) for the treatment of lysosomal acid lipase deficiency Uptravi (Actelion): approval for pulmonary arterial hypertension Tresiba (Novo Nordisk): approval for type 1 and type 2 diabetes patients.

A few examples of important clinical trial results expected from portfolio holdings for the coming quarters include: • • • • • •

Rociletinib (Clovis) for non-small cell lung cancer patients Translarna (PTC Therapeutics) for Duchenne muscular dystrophy patients Eravacycline (Tetraphase) for treating complicated urinary tract infections Fix dose combination of GS-5816/Sovaldi (Gilead) for hepatitis C virus infected patients Duvelisib (Infinity/AbbVie) for relapse refractory CLL patients NBI-98854 (Neurocrine) for tardive dyskinesia

The strengthened balance sheets will allow those companies to invest into their pipeline assets and to maintain ownership of these drug candidates rather than having to partner these assets early on. Many of the portfolio companies now carry a lower refinancing risk than they did several years ago. In case of pipeline successes, these companies are expected to enjoy much higher valuations by having retained all rights to these molecules. The valuation of the established larger companies such as Celgene and Gilead reflects the different growth trajectories and risks of their businesses and remains at very attractive levels. BB Biotech expects that the combination of a worldwide low interest rate environment and a healthy acquisition appetite within the healthcare industry will result in further M&A activity for the coming years. Taking the higher capital independence of the smaller and midsized companies into account, further M&A activity appears more probable than licensing transactions as well. The discussion on drug pricing will continue with pharmacy benefit managers in the US trying to negotiate for lower drug prices and drug rebates. It is expected that the pressure will be highest on markets that are large and competitive, especially when multiple products with comparable efficacy results are launched within a narrow time frame. This will force companies to strive for product differentiation and is likely to benefit both the dominant players in certain indications as well as those companies that succeed in bringing innovative and clearly differentiated products to the market. BB Biotech’s portfolio holdings reflect these attributes. Its innovative portfolio companies are driving new important treatment opportunities and offer an attractive equity story. There has been a boom in pharmaceutical M&As during the first quarter of 2015, with the industry experiencing its highest levels of activity since 2009¹. But it is what happens after a merger that will inevitably result in the success or failure of such a major new direction. In the days, weeks, months, even years, that follow, cultural fit, strong leadership and the right innovation pipeline are just some of the almost infinite factors that need to be perfected and aligned to ensure a fully integrated, unified and profitable business. In the rush to make the most pressing decisions, one area that is often, or indeed nearly always, side-lined is the people – even the all-important board. At such a pivotal time, only the best decision-making from the most experienced leaders is good enough. But during some M&A processes, the two organisations merge their two boards rather than choosing the most appropriate members. The risks are much wider than poor decision-making. We recently spoke to HR directors in the UK’s largest pharmaceutical organisations and found that, of those who have been through a merger, over half (56 per cent) know of a board-level scandal that has not yet been revealed*. That is 22 per cent higher than the average for all the industries we investigated, including financial services, IT & technology, oil, gas and energy, professional services and retail.

While the debate continues around the longevity of biotech’s strong performance, inflows of capital into the sector is not subsiding, with the IPO window open and significant amounts of cash raised through secondary placements by smaller and midcap companies. BB Biotech welcomes these funding transactions as many companies have been able to bolster their balance sheets substantially.

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industry insight

Dangerous Liaisons Big pharma facing board-level scandals following M&A As Warren Buffet so succinctly states “it takes 20 years to build a reputation and five minutes to ruin it”. Financial performance and profitability are clearly at great risk from these hidden scandals, so why are pharma companies leaving so much to chance? And what other traps are they falling into when recruiting to high-level positions? The Untouchables While so much of pharma is highly regulated, recruitment processes are left to the discretion of each company. In some, complacency has crept in. Over half (53 per cent) of HR directors in the industry admit they ‘assume’ that candidates being considered for senior level positions have not lied about their history. In fact, in some cases (27 per cent), it is easier to go unchecked as a new CEO than a graduate. Instead companies tend to rely on a candidate’s industry reputation to make high-level hiring decisions. This is the case in nearly three-quarters (73 per cent) of pharma organisations –higher than in any other industry. Nearly half (47 per cent) of organisations rely on personal recommendations and three-fifths (61 per cent) of roles are won based on the individual’s connections. Rules of Engagement Fortunately there are a number of steps that can be taken to make sure that candidates are exactly who they say they are and can perform as required. Organisations should have a robust, transparent and auditable process for recruitment that is consistent and fair across the company. Thorough research should always be conducted before a high-level appointment or board merger. In addition to work and education history, this could include checks into criminal record and animal rights activism. In two fifths (40 per cent) of pharmaceutical firms, reputational risk is rising up the boardroom agenda but there is clearly still far more to be done to ensure that leaders are as exceptional as they need to be and that the recent M&A activity does not lead to unnecessary reputation and performance damage. As Warren Buffet adds “If you think about that, you’ll do things differently.” Steve Girdler, managing director EMEA at HireRight, the candidate due diligence company. ¹ Biotech buys get pharma M&A off to flying start in 2015, Reuters, March 5 2015 *Unless otherwise stated, all data is taken from The Untouchables: Protecting Your Organisation from Leadership Risk which is based on detailed interviews with 140 senior HR leaders in regulated and non-regulated UK companies with over 5,000 employees.

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5 avenue Marchand Abidjan Ivory Coast Phone: +225 20 30 60 50 Fax: +225 20 21 12 59 eyci@ci.ey.com

www.ey.com/FA

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innovation

Consumer Trust is Key to Leveraging Personal Data in a Connected World Global product strategy and design firm, frog, explores new rules for designing products and services with data.

In a new Harvard Business Review article titled, “Customer Data: Designing for Transparency and Trust,” executives from frog, the global product strategy and design firm, advise companies building products and services using personal data to develop customer trust in order to be successful. Timothy Morey, vice president of innovation strategy at frog, Allison Schoop, associate strategy director at frog and Theodore “Theo” Forbath, global vice president of digital transformation at Cognizant (and former frog) explore how the explosion of smart, connected products and subsequent exponential growth of personal data, have made it possible to tackle and solve complex challenges at more personal levels. “The first 20 years of the Internet bred a troubling paradigm that advertisers are out to mine our personal data for commercial gain and that high barriers for privacy are necessary and good,” said Timothy Morey, vice president of innovation strategy at frog. “As we move into an era of a more serious Web, where we tackle challenges such as healthcare, pollution and resource allocation—increasingly through the use of smart connected products that make up the Internet of Things—that paradigm just doesn’t hold anymore. Firms that behave in ways to gain our trust for access to these rich new streams of data, and are transparent in how that data is captured and utilized, will have a tremendous competitive advantage. They will be able to not only do good business, but also do more good for consumers.” In 2011 and 2014, frog surveyed a sample of 900 people in the United States, United Kingdom, Germany, China and India to gain an understanding of the general online population’s awareness of how their data is collected and used, how they value different types of data, their feelings about privacy, and what they expect in return for their data. Post-Snowden, NSA leaks and a series of major credit card breaches between 2011 and 2014, frog examined if consumer knowledge of tracking and surveillance had increased, and whether the expectation for greater privacy was at an inflection point. Results revealed it is not, and the convenience afforded by mobile apps and connected tools almost always trumps privacy concerns. Globally, just 5% of users claim to avoid using Web services.

various Web services, they see it as an inevitable cost of using web services today. So much so that 86% had not changed their behavior in any way. Globally, 41% of Germany respondents, 40% of U.K. respondents and 39% of India respondents and 58% of Chinese respondents also voiced concern over the NSA revelations, but felt that this was an inevitable cost of using the Internet. However, 47% of Chinese respondents and 24% of Germany respondents claimed they avoid using US based Web services as a result of the NSA surveillance revelations. While consumers may be concerned, and are not unaware of the fact their data is collected, there is a surprising lack of understanding about the specific types of information gathered. This is almost just as true today as it was four years ago. Even as data tracking has exploded with the widespread adoption of smartphones, only 25% of respondents in 2014 knew that their data footprints included information on their location. Regardless of mindfulness, a majority of respondents expect value in return for sharing personal information. Two thirds of respondents worldwide said they were comfortable sharing personal data that would be used to make the products and services they used better. Value offered in exchange for data can outweigh privacy concerns, however, the study found that if a firm is considered untrustworthy, it will find it difficult or near impossible to collect consumer data. This is particularly true for more sensitive types of data such as health histories, financial information and communication records. In fact, 97% of the people surveyed expressed concern that businesses and governmental organizations might misuse their data. The more trusted a brand is, the more willing consumers are to share their data. “If companies understand the worth consumers put on their personal information, they can offer value in exchange for it. But more importantly, making the exchange transparent will help build trust, allowing firms to build more interesting products and services with it,” Morey added. frog found forward-looking companies that are designing data privacy and security considerations into product development from the start, have tremendous competitive advantage and typically follow three principles – consumer education of how data is used, giving consumers control of their own data and delivering in-kind value.

The study further revealed that it is one thing to be concerned, and another to change behavior. In fact, 42% of U.S. respondents said that while they were concerned over revelations that the American National Security Agency had been collecting communications data from

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innovation

IBM and Partners to Transform Personal Health with Watson and Open Cloud

To dramatically advance the quality and effectiveness of personal healthcare, IBM is establishing a Watson Health Cloud that will provide a secure and open platform for physicians, researchers, insurers and companies focused on health and wellness solutions. The HIPAA-enabled Watson Health Cloud will enable secure access to individualised insights and a more complete picture of the many factors that can affect people’s health. 20 | ghp April 2015


innovation The future of health is all about the individual. With the increasing prevalence of personal fitness trackers, connected medical devices, implantables and other sensors that collect real-time information, the average person is likely to generate more than one million gigabytes of health-related data in their lifetime (the equivalent of more than 300 million books). However, it is difficult to connect these dynamic and constantly growing pools of information with more traditional sources such as doctor-created medical records, clinical research and individual genomes – data sets that are fragmented and not easily shared. A highly scalable and secure global information platform is essential to pull out individualized insights to help people and providers make timely, evidence-based decisions about health-related issues. “All this data can be overwhelming for providers and patients alike, but it also presents an unprecedented opportunity to transform the ways in which we manage our health,” said John E. Kelly III, IBM senior vice president, solutions portfolio and research. “We need better ways to tap into and analyze all of this information in real-time to benefit patients and to improve wellness globally. Only IBM has the advanced cognitive capabilities of Watson and can pull together the vast ecosystem of partners, practitioners and researchers needed to drive change, as well as to provide the open, secure and scalable platform needed to make it all possible.” Capturing Real-time Data to Optimize Personalized Decision-making IBM is collaborating with Apple, Johnson & Johnson and Medtronic to create new health-based offerings that leverage information collected from personal health, medical and fitness devices. The results will be better insights, real-time feedback and recommendations to improve everything from personal health and wellness to acute and chronic care. These relationships are non-exclusive, and IBM anticipates many more companies to leverage the Watson Health Cloud platform. IBM and Apple will expand their partnership with IBM Watson Health Cloud to provide a secure cloud platform and analytics for Apple’s HealthKit and ResearchKit. This will support health data entered by customers in iOS apps and also arm medical researchers with a secure, open data storage solution with access to IBM’s most sophisticated data analytics capabilities Johnson & Johnson will collaborate with IBM to create intelligent coaching systems centered on preoperative and postoperative patient care, including joint replacement and spinal surgery. Solutions will be mobile-based, accessing the Watson Health Cloud and leveraging IBM Watson’s cognitive capabilities. Johnson & Johnson will also look to launch new health apps targeting chronic conditions, which currently cost consumers as much as 80 percent of the $7 trillion global healthcare spend. Medtronic will leverage the Watson Health Cloud insights platform to collaborate with IBM around delivery of new highly-personalized care management solutions for people with diabetes. The solutions will receive and analyze patient information and data from various Medtronic devices including insulin pumps and continuous glucose monitors, and use this information to provide dynamic, personalized diabetes management strategies to patients and their providers.

Acquisitions Bolster Ability to Extract and Share Deep Insights To complement its existing capabilities, IBM has reached agreement to acquire Cleveland-based Explorys and Dallas-based Phytel, two healthcare technology companies that are widely recognized for their leadership in applying Big Data and analytics to help improve the quality of health for individuals and large population groups. A spin-off from the Cleveland Clinic in 2009, Explorys’ secure cloud-computing platform is used by 26 major integrated healthcare systems to identify patterns in diseases, treatments and outcomes. It integrates more than 315 billion clinical, financial, and operational data elements, spanning 50 million unique patients, 360 hospitals, and more than 317,000 providers. Market intelligence firm IDC just named Explorys global leader in Healthcare Clinical and Financial Analysis.

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Phytel develops and sells cloud-based services that help healthcare providers and care teams work together to ensure care is effective and coordinated in order to meet new healthcare quality requirements and reimbursement models. It was just named the leader in the population health management category by the 2014 Best in KLAS Awards: Software & Services. The acquisitions bolster IBM’s efforts to apply advanced analytics and cognitive computing to help primary care providers, large hospital systems and physician networks improve healthcare quality and effect healthier patient outcomes. Watson Health Unit and the Watson Health Cloud Build on Core IBM Strengths Building on strengths in cognitive computing, analytics, security and cloud, the new Watson Health unit aims to dramatically improve the ability of doctors, researchers and insurers to innovate by surfacing new insights from the massive amount of personal health data being created daily. The Watson Health Cloud platform allows this information to be anonymized, shared and combined with a dynamic and constantly-growing aggregated view of clinical, research and social health data. IBM and its vast ecosystem of clients, partners and medical researchers can surface new connections between these diverse and previously siloed healthcare data sets, and spur the creation of a new generation of data-driven applications and solutions designed to advance health and wellness. Individual patients and larger health populations alike will benefit as providers share and apply those insights in real-time to drive better, faster and less expensive treatments. The medical community is one of the earliest adopters of Watson cognitive computing technology, where IBM has collaborated with leading hospitals and research institutes including Memorial Sloan Kettering Cancer Center, University of Texas MD Anderson Cancer Center, the Cleveland Clinic, the Mayo Clinic and the New York Genome Center to advance Watson’s healthcare capabilities and to help transform how medicine is taught, researched and practiced. Innovative partners including Welltok, Modernizing Medicine, Pathway Genomics and GenieMD are already using Watson’s cognitive computing capabilities, giving rise to a whole new breed of health apps that are redefining how individuals and organizations think about personal health management. Cognitive computing systems learn and interact naturally with people to extend what either humans or machine could do on their own. They help human experts make better decisions by penetrating the complexity of Big Data. “Watson Health builds on years of collaborative relationships with leaders across the healthcare ecosystem,” said Michael Rhodin, senior vice president, IBM Watson. “The groundbreaking applications of Watson’s cognitive computing capabilities by medical clients and partners clearly demonstrated the potential to fundamentally change the quality, efficiency and effectiveness of healthcare delivery worldwide. We’re excited to broaden access to world-class technology and to work with our partners to transform health and wellness for millions of people.” IBM will open a headquarters location for the new unit in the Boston area and expand its Watson presence in New York City. It will dedicate at least 2000 consultants, medical practitioners, clinicians, developers and researchers to design, develop and accelerate the adoption of Watson Health capabilities. The new unit will include IBM’s existing Smarter Care and Social Programs practice, which was created three years ago following the acquisition of Curam Software, a leading provider of health and social program management solutions. IBM has received more than 1300 patents in healthcare, life sciences and medical devices. Its invention of the excimer laser used for LASIK surgery was awarded the National Medal of Technology in 2011, and Blue Gene, the first supercomputer to successfully model protein-folding, received the award in 2009.

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products

U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy 24 | ghp April 2015


products The New Drug Application (NDA) was accepted by the U.S. Food and Drug Administration (FDA) and is based on results from the PEARL-I study, which demonstrated up to 100 percent sustained virologic response rates at 12 weeks post-treatment with no discontinuations due to adverse events •

First all-oral, interferon-free therapy being evaluated by the FDA for patients with chronic genotype 4 (GT4) hepatitis C virus (HCV) infection AbbVie’s investigational regimen has been previously designated as a breakthrough therapy and received priority review by the FDA

Merck, known as MSD outside the United States and Canada, has announced the first presentation of data from C-SURFER, as well as the C-EDGE trials at the 50th annual congress of the European Association for the Study of the Liver (EASL) – held this April 22 to 25th in Vienna, Austria. “HCV affects approximately 130-170 million people worldwide, and 350,000 to 500,000 people die each year from HCV-related liver diseases. In Canada this translates to approximately 242,500 individuals infected with HCV,” explains Dr. Rejean Thomas, CEO and cofounder of the L’Actuel, Centre of Excellence for HIV and Hepatitis, located in Montreal. “The results from these studies provide hope for the patients with cirrhosis and advanced chronic kidney diseases. CKD represent an unmet clinical need especially for those on hemodialysis. There is a need for more effective treatment options in Canada for these patients.” C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1. The C-SURFER trial is the company’s Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1 (GT1).1 Treatment-naïve patients and patients who failed prior pegylated interferon HCV therapy, with or without cirrhosis, all of whom had CKD stages 4 or 5, were enrolled.2 Following 12 weeks of treatment with grazoprevir and elbasvir, 99 percent (115/116) of patients in the pre-specified primary population for analysis of efficacy data achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12). 3 These data will be presented today at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (late breaking E-Poster #LP02). “There is an unmet medical need to treat chronic hepatitis C virus infection in patients with advanced chronic kidney disease,” said Dr. Howard Monsour, Jr., chief of hepatology, Houston Methodist Hospital, Houston, Texas, U.S.A. “In this trial, the first to investigate an all-oral ribavirin-free treatment regimen in treatment-naïve and treatment-experienced CKD patients, treatment with grazoprevir and elbasvir for 12 weeks was effective in this study population with HCV genotype 1 infection.” The ongoing C-SURFER Phase 2/3 clinical trial is a randomized, parallel-group, placebo-controlled study evaluating patients infected with chronic HCV GT1 with advanced CKD with or without liver cirrhosis. Patients were randomised to one of two study arms: • Immediate treatment group (ITG), grazoprevir plus elbasvir (blinded) once-daily for 12 weeks (n=111);

Deferred treatment group (DTG), initially placebo (control arm) for 12 weeks followed by a four week follow-up period and then treatment with grazoprevir plus elbasvir (open label) once-daily for 12 weeks (n=113).

In addition, 11 patients received grazoprevir plus elbasvir (open label) once-daily for 12 weeks with intensive pharmacokinetic sampling. Of the 122 patients who received grazoprevir plus elbasvir, 83 percent were treatment-naïve, 36 percent had diabetes, 18 percent had stage 4 CKD, 82 percent had stage 5 CKD, 75 percent were receiving haemodialysis and 45 percent were African-American. Among those patients who received at least one dose of grazoprevir plus elbasvir, five percent (6/122) were excluded from the pre-specified primary efficacy analysis population, or modified full analysis set, due to missing data caused by death or early discontinuation for reasons unrelated to study drug. In the modified full analysis set, 99 percent (115/116) of patients receiving grazoprevir plus elbasvir achieved SVR12. One GT1b infected, non-cirrhotic, interferon-intolerant patient showed a viral relapse at follow-up week 12. Within the modified full analysis set, efficacy was consistent across the patient sub-populations assessed. In a supportive analysis of all 122 patients who received at least one dose of grazoprevir plus elbasvir in the ITG arms, including patients who did not complete the study for reasons not related to study drug, 94 percent (115/122) of patients achieved SVR12. “The broad clinical development program of Merck includes studies dedicated to bringing a once-daily regimen to diverse populations of patients infected with chronic HCV, including certain types of patients with co-morbidities, such as advanced chronic kidney disease,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories, a U.S.-based division of Merck & Co., Inc., Kenilworth, N.J., U.S.A. “These data highlight how emerging innovations in chronic hepatitis C treatment may lead to new options for patient populations in which it historically has been difficult to achieve high rates of sustained viral clearance.” No patients in the ITG arms discontinued treatment due to adverse events (AEs), while four percent (5/113) of patients in the comparator placebo phase of the DTG arm discontinued treatment due to AEs. The rates of serious AEs reported were 14 percent (16/111) in the ITG arms and 17 percent (19/113) in the placebo control DTG arm. The most common treatment-related AEs in the ITG arms and DTG arm (placebo) were headache (17%, 17%), nausea (15%, 16%) and fatigue (10%, 15%), respectively. There were four deaths reported during the initial treatment phase and the first 14 days of study follow-up. One patient (1%) in the ITG arm died from cardiac arrest (not considered related to study medicine) and three patients (3%) in the placebo group died from aortic aneurysm, pneumonia and an unknown cause.. About C-SURFER C-SURFER is a Phase 2/3 clinical trial evaluating Merck investigational grazoprevir plus elbasvir in patients infected with chronic HCV GT1 and with advanced chronic kidney disease (stages 4 and 5, including patients on haemodialysis) with or without liver cirrhosis, which are among those with HCV infection who are most difficult to treat, over 12 weeks. C-EDGE Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection.

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products

Orexigen Announces Receipt of Paragraph IV Certification Notice Orexigen Therapeutics, Inc. (NASDAQ: OREX) has announced that Orexigen and North American partner Takeda Pharmaceuticals have received notification of a Paragraph IV certification for certain patents for Contrave® (naltrexone HCl and bupropion HCl extended release) which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification resulted from the filing by Actavis Laboratories FL, Inc. of an Abbreviated New Drug Application (ANDA) challenging such patents for Contrave. Orexigen and Takeda plan to vigorously enforce Contrave intellectual property rights. In accordance with the Hatch-Waxman Act, Takeda and Orexigen have 45 days after effective notice of the Paragraph IV certification to file suit against the ANDA filer in order to obtain an automatic stay of FDA approval of the ANDA until the earlier of (i) 30 months from Takeda’s receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. About Contrave Contrave, approved by the United States Food and Drug Administration in September 2014, is indicated for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia). The exact neurochemical effects of Contrave leading to weight loss are not fully understood. Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system). Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of Contrave in conjunction with lifestyle modification in 4,536 subjects randomized to Contrave or placebo. In these studies, the most common adverse reactions (≥5 percent) seen in patients taking Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. The clinical trial program also includes a double-blind, placebo-controlled cardiovascular outcomes trial known as the Light Study. The primary objective of this study is to evaluate the occurrence of major adverse cardiovascular events (MACE) in overweight and obese adults with cardiovascular risk factors receiving Contrave. A second study, designed to address post-approval requirements in both Europe and the United States, is planned in order to further evaluate cardiovascular outcomes.

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professional services

Pennsylvania Insurance Department Returns More Than $66 Million in Restitution Payments to Consumers in First Quarter of 2015 Acting Insurance Commissioner, Teresa Miller, has announced that nearly 5,000 Pennsylvania consumers received $66.8 million in restitution payments or credits through the restoration of stolen funds, the payment of denied or underpaid claims, and the refunding of overcharged premiums during the first quarter of 2015.

In a new Harvard Business Review article titled, “Customer Data: Designing for Transparency and Trust,” executives from frog, the global product strategy and design firm, advise companies building products and services using personal data to develop customer trust in order to be successful. Timothy Morey, vice president of innovation strategy at frog, Allison Schoop, associate strategy director at frog and Theodore “Theo” Forbath, global vice president of digital transformation at Cognizant (and former frog) explore how the explosion of smart, connected products and subsequent exponential growth of personal data, have made it possible to tackle and solve complex challenges at more personal levels. “The first 20 years of the Internet bred a troubling paradigm that advertisers are out to mine our personal data for commercial gain and that high barriers for privacy are necessary and good,” said Timothy Morey, vice president of innovation strategy at frog. “As we move into an era of a more serious Web, where we tackle challenges such as healthcare, pollution and resource allocation—increasingly through the use of smart connected products that make up the Internet of Things—that paradigm just doesn’t hold anymore. Firms that behave in ways to gain our trust for access to these rich new streams of data, and are transparent in how that data is captured and utilized, will have a tremendous competitive advantage. They will be able to not only do good business, but also do more good for consumers.” In 2011 and 2014, frog surveyed a sample of 900 people in the United States, United Kingdom, Germany, China and India to gain an understanding of the general online population’s awareness of how their data is collected and used, how they value different types of data, their feelings about privacy, and what they expect in return for their data. Post-Snowden, NSA leaks and a series of major credit card breaches between 2011 and 2014, frog examined if consumer knowledge of tracking and surveillance had increased, and whether the expectation for greater privacy was at an inflection point. Results revealed it is not, and the convenience afforded by mobile apps and connected tools almost always trumps privacy concerns. Globally, just 5% of users claim to avoid using Web services. The study further revealed that it is one thing to be concerned, and another to change behavior. In fact, 42% of U.S. respondents said that while they were concerned over revelations that the American National Security Agency had been collecting

communications data from various Web services, they see it as an inevitable cost of using web services today. So much so that 86% had not changed their behavior in any way. Globally, 41% of Germany respondents, 40% of U.K. respondents and 39% of India respondents and 58% of Chinese respondents also voiced concern over the NSA revelations, but felt that this was an inevitable cost of using the Internet. However, 47% of Chinese respondents and 24% of Germany respondents claimed they avoid using US based Web services as a result of the NSA surveillance revelations. While consumers may be concerned, and are not unaware of the fact their data is collected, there is a surprising lack of understanding about the specific types of information gathered. This is almost just as true today as it was four years ago. Even as data tracking has exploded with the widespread adoption of smartphones, only 25% of respondents in 2014 knew that their data footprints included information on their location. Regardless of mindfulness, a majority of respondents expect value in return for sharing personal information. Two thirds of respondents worldwide said they were comfortable sharing personal data that would be used to make the products and services they used better. Value offered in exchange for data can outweigh privacy concerns, however, the study found that if a firm is considered untrustworthy, it will find it difficult or near impossible to collect consumer data. This is particularly true for more sensitive types of data such as health histories, financial information and communication records. In fact, 97% of the people surveyed expressed concern that businesses and governmental organizations might misuse their data. The more trusted a brand is, the more willing consumers are to share their data. “If companies understand the worth consumers put on their personal information, they can offer value in exchange for it. But more importantly, making the exchange transparent will help build trust, allowing firms to build more interesting products and services with it,” Morey added. frog found forward-looking companies that are designing data privacy and security considerations into product development from the start, have tremendous competitive advantage and typically follow three principles – consumer education of how data is used, giving consumers control of their own data and delivering in-kind value.

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up close with...

Benenden Personal Healthcare By: Marc Bell, Chief Executive, Benenden Voted the UK’s most trusted healthcare provider for four years running between 2011 and 2014, Benenden Personal Healthcare offers high quality discretionary personal healthcare services when you need them most. The NHS already offers excellent care, so we don’t aim to replicate these services. Instead we aim to relieve the stress of long waiting lists by complementing NHS care and helping achieve speedy diagnosis.

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up close with... Voted the UK’s most trusted healthcare provider for four years running between 2011 and 2014, Benenden Personal Healthcare offers high quality discretionary personal healthcare services when you need them most. The NHS already offers excellent care, so we don’t aim to replicate these services. Instead we aim to relieve the stress of long waiting lists by complementing NHS care and helping achieve speedy diagnosis. Benenden Personal Healthcare is a leading health and wellbeing community born out of the aspirations of ordinary people who grouped together in 1905, forming a low-cost mutual model that would provide high quality, affordable healthcare. Now, 110 years later, nearly 900,000 people still benefit from that very simple idea. Since 1905 we’ve been run for the good of our members, and these mutual principles will never change. Having worked with a wide range of organisations, we know that when it comes to healthcare provision, what really matters to employers is ensuring they have a healthy and happy workforce - and managing absenteeism is a key aspect of this. Reducing sickness absence and avoiding - where possible - the need to rely on temporary cover is crucial for them. Employers need that reassurance that health issues can be addressed swiftly, with the best available care and support for their staff to help those individuals back to work as soon as possible. So how can you tackle the healthcare needs of your employees? Traditional private medical insurance certainly has its place, but can be cost prohibitive for many organisations. The average cost of private medical insurance can be around £900 per person, per year, and often varies depending on age and medical history. At the other end of the price spectrum, health cash plans may also be considered. There is a broad range of plans available which can start at around £1 a week for limited coverage - offering more comprehensive cover as the price increases. However while cash plans may be perceived by staff to be a valuable benefit, typically the predominant usage will be on dental and optical care (around 75% to 80%) – which may not necessarily have an impact on reducing absenteeism. Another solution is to look at a discretionary healthcare provider such as Benenden Personal Healthcare which is only £8.45 per person, per month. All members pay into a mutual fund and can request access to a range of health services when they need to. This low-cost mutual model provides high quality, affordable healthcare - aimed at relieving the distress of long NHS waiting lists and helping members achieve prompt diagnosis and treatment. Benenden’s original mission in the early 20th Century was to provide affordable treatment for postal workers suffering from Tuberculosis before evolving into the organisation it is today: providing a wide range of discretionary services to a membership of almost 900,000 but retaining the same affordable and mutual ethos. Benenden Personal Healthcare’s plan specifically addresses the health issues that can have the most impact in terms of keeping employees away from work. Research suggests two of the key causes of absenteeism in the workplace are musculoskeletal problems and stress, so offering your staff the opportunity to request services such as physiotherapy treatment and counselling can have a real impact on levels of absence. We recently commissioned research in association with independent research company Mindlab, which discovered that a person’s ability to think critically, make decisions and perform reasoning tasks is significantly impaired under short-term stress. This demonstrates just how important it is that businesses ensure staff feel comfortable and are not put under undue stress while at work. Tackling stress levels will inevitably help towards creating a happier and healthier workforce, boost productivity levels and reduce staff absence. Managing absenteeism is an ongoing challenge for businesses and organisations of all sizes and is one that should be tackled proactively. Introducing a healthcare offering can have a real impact on how quickly staff return to work following a health issue – and importantly also demonstrates just how valued they are to their employer. We understand that employee ‘perks’ are one of the first things to suffer when times are hard. So while your organisation may be enduring pay freezes and job cuts, employer-paid business healthcare from Benenden is an affordable way to reward your team, help cut the cost of absenteeism and effectively manage stress. With just one plan to choose, one flat monthly fee to pay and no age or pre-existing medical exclusions to worry about, we’ve made it easy for organisations of any size to join Benenden. Qualifying business healthcare schemes will allow your employees to immediately request any of our discretionary health and wellbeing services including local consultation and diagnosis, treatment and surgery in clean and comfortable hospitals across the UK, and physiotherapy, as well as services such as a 24/7 GP Helpline and 24/7 Stress Counselling helpline. You can protect anyone under your membership and there are no upper age limits or restrictions based on medical history. As we are a mutual, not-for-profit healthcare provider, we don’t have shareholders, so you know that all money is invested in services for the benefit of members and their health. Our members experience healthcare with a difference. We put the needs of our members first – using discretion to listen to their needs and then doing everything we can to help you find the right road to recovery.

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