In 2016, we rounded up pharma news in the first, second, and third quarter of the year. Pharma news in the fourth quarter of 2016 mostly fit into two buckets: clinical trial data collection and chronic condition management. The latter focused especially on the diabetes and chronic respiratory disease spaces. Read on below for Q4 2016 news from a number of pharma companies from around the world.
Clinical Trials
One area where we saw a good amount of investment from pharma in the fourth quarter was digital tools to enhance data collection in clinical trials.
In early October Sanofi, through its investment arm Sanofi-Genzyme Ventures, invested in a $31 million round for Science37, which connects willing individuals to researchers so they can participate in clinical trials from their homes.
"We are excited to expand our investment mandate in the digital health space and to start this new initiative with Science 37, a leading company applying transformative digital techniques to clinical trial design and enrollment," Sanofi Genzyme BioVentures Managing Director Bernard Davititan said in a statement at the time. "This investment is fully aligned with Sanofi's digital strategy and provides an opportunity for us to play an active role in this area of the digital revolution."
Takeda Pharmaceuticals made a couple of moves in the clinical trial space. In late October Litmus Health, a company helping pharma companies use wearable devices to improve the efficiency of Phase I and II drug trials, announced a trial with the University of Chicago testing the effects of activity, sleep, and diet on Inflammatory Bowel Disease (IBD) patients. The trial will be funded via a grant from Takeda Pharmaeuticals.
Takeda also adopted the platform of Koneska Health, an early stage technology company that works with data gathered through mobile, wearable and other digital technologies to measure health indicators, to power some of the pharmaceutical company’s clinical trials using biosensors and wearables. The goal for Takeda is to develop what they call “digital biomarkers” – data gleaned from devices that continuously monitor patients’ vital signs, activity levels and sleep metrics. Ultimately, Takeda hopes such metrics will aid in decision-making and help establish endpoints to assess a patient’s functional status in an everyday setting.
The company also collaborated with German image analysis and data company Definiens for another aspect of clinical trials – tissue analysis. Using Definien’s cloud-based digital pathology platform VeriTrova, which allows for biomarker analysis, Takeda will leverage the technology reduce the normal analysis time from months to weeks.
Diabetes management
Several other digital health pharma news happened in the diabetes management space. Two different J&J business units made digital health headlines in the fourth quarter. In October – following prompting from security and IT firm Rapid7 – Johnson & Johnson, through its subsidiary Animas, reached out to users of the Animas OneTouch Ping Insulin Infusion Pump to inform them about security vulnerabilities and how to mitigate them. According to Rapid7, because the communication with the insulin pump is not encrypted, an attacker could theoretically trigger unauthorized insulin injections, potentially triggering hypoglycemia from up to two kilometers away.
In December J&J subsidiary LifeScan had better news: The FDA cleared the wireless integration of one of its blood glucose monitoring systems and WellDoc’s digital diabetes management platform for people with type 2 diabetes. The two companies originally teamed up in March 2016. The integrated system consists of OneTouch Verio Flex, LifeScan’s Bluetooth smart blood glucose monitoring system and companion app, and WellDoc’s FDA-cleared mobile diabetes management platform, BlueStar.
Also in the quarter, Common Sensing, a Cambridge-based company developing a smart connected insulin pen cap, announced that it will test its device in a clinical trial in collaboration with Joslin Diabetes Center, Sanofi, and Dexcom. The study of 125 subjects will be conducted by Joslin and funded by Sanofi. Patients will be given a Gocap from Common Sensing, a cap that fits on to a disposable insulin pen and can detect data on when the injector is used and how much insulin is left in it. They will also have a Dexcom CGM.
Eli Lilly (which also invested in the connected insulin pen space back in 2015) developed an app for people living with Type II diabetes who use Trulicity, the company’s once-per-week injectable diabetes medication that also works with a click-activated pen. The app, which has been fully functionally since September, is currently available free on iOS to anyone with a Trulicity prescription. The Trulicity app offers a few different features to aid those using the medication in their treatment: a virtual demo pen that mimics every feature, function and sound of the real Trulicity pen; weekly dosing reminders that users set for the day and time to take their medication, and the ability to instant message or call the Lilly Answer Center if they need any help with their medication.
Finally, Germantown, Maryland-based Senseonics, which is working on a long-term implantable continuous glucose monitor called Eversense, expanded its exclusive distribution agreement with Roche in December. Now, Roche will have exclusive rights to promote, market and sell the Eversense product line to diabetes clinics and patients in in most of Europe (excluding Scandinavia and Finland), the Middle East (except Israel) and Africa. This builds on the two companies’ previous agreement in May that awarded Roche the same privileges in Germany, Italy and the Netherlands.
Asthma and COPD
Adherium -- a New Zealand company with a close relationship with AstraZeneca -- was chosen to power the EU’s myAirCoach program, a multisite study funded under the EU's Horizon 2020 Framework for Research and Innovation initiative. For the next year, the Smartinhaler will be used at Imperial College London, University of Manchester, and Leiden University Medical Center to help patients manage their condition. The project is coordinated by the Center for Research and Technology in Greece. Earlier in the quarter, Adherium’s Smartinhaler was shown to increase medication adherence by 43 percent and reduce hospitalization by a factor of five, according to a new study conducted at Sheffield Children’s Hospital in the UK and published in the journal Thorax. The randomized control trial included 77 children with asthma.
Similarly Madison, Wisconsin-based Propeller Health, which offers a digitally-guided respiratory therapy platform and has worked with a number of pharma companies, teamed up with Medical International Research (MIR) to offer several of the Italian health technology company’s mobile and clinical spirometers alongside the Propeller system. Propeller also received FDA 510(k) clearance for its latest offering – a sensor that works with GlaxoSmithKline’s Ellipta inhaler. This marks the company’s eighth FDA clearance, and was born out of a partnership the company struck up with GSK last December.
Other pharma news
Early in the quarter, GlaxoSmithKline teamed up with the Weather Channel and Sickweather to create the Cold and Flu Tracker app, where people can get updates on cold and flu activity at a hyperlocal level. The app is also part of GSK’s overall campaign to launch the new Theraflu ExpressMax Caplets, and the Theraflu brand will also be the company’s first to leverage IBM Watson advertising. Through the websites or on their smartphone, consumers will have the ability to interact with the Theraflu ad via voice or text and ask Watson questions such as, “How long is the flu contagious?” which Watson’s chatbot will respond to.
Speaking of IBM Watson, the quarter also saw Teva Pharmaceuticals join forces with IBM in a three-year research collaboration that integrates with the Watson Health Cloud. The project builds on an existing alliance between the two companies and will focus on two key areas in healthcare: developing a systematic approach to discovering new uses for existing drugs and improving chronic disease management. They also collaborated with pharmaceutical company Celgene to develop a monitoring tool for adverse effects of medical drugs. The cloud-based Watson for Patient Safety tool will act as an automated drug safety service designed for fast collection and collations of large amounts of patient data from a number of sources including EHRs, medical claims databases and other information sources. Ultimately, the Watson for Patient Safety tool will enable pharmaceutical companies to quickly flag safety issues as soon as they occur.
The quarter also saw digital health investor and incubator StartUp Health sign a three year collaboration agreement with Janssen, a Johnson & Johnson division, to give Janssen's senior leaders more direct access to StartUp Health's network of digital health entrepreneurs and innovators.
The FDA is signalling that it might revisit its social media guidance after it gathers data on how effective it is to present risks in a link, as opposed to within a social media platform's restrictive character limit. The agency presented its plan for the study for comment in the federal registry in November. It will conduct four studies, two on Twitter and two on Google ads, with a total of 6,502 participants. The studies will test consumer behavior around an ad for a fictional weight loss drug and a fictional treatment for migraines.
