Monday, September 17, 2018
CVS Health price target raised to $101 from $90 at RBC Capital
RBC Capital analyst George Hill raised his price target on CVS Health (CVS) to $101 and kept his Outperform rating, citing the increased visibility of the company’s merger with Aetna (AET) after its recent comments that it expects the deal to close in early Q4. The analyst also points to “de-risked” CVS investment thesis as it pertains to pharmacy benefit managers rebates and the much higher relative multiples for managed care companies, even though he warns that investors may still be spooked by any potential steps that the White House takes to drive prescription drug prices lower. Hill notes however that the latest government funding bill pulled the text that required drug companies to disclose prices in their ads, implying that the political will to change status quo may be limited.
https://thefly.com/landingPageNews.php?id=2791327
Roivant launches Respivant Sciences
Roivant Sciences announced the launch of Respivant Sciences, a biopharmaceutical company focused on improving the lives of patients suffering from serious respiratory diseases. Respivant will be led by CEO Bill Gerhart, Executive Vice President for Clinical and Regulatory Ahmet Tutuncu, MD, PhD, and Executive Vice President for Development and Manufacturing Pravin Soni, PhD. Respivant’s pipeline is anchored by RVT-1601, an inhaled therapeutic being developed for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis. RVT-1601 is a mast cell stabilizer with pleotropic immune modulating properties delivered directly to the lungs via a handheld aerosol device that produces a soft mist for patients to conveniently inhale. In a Phase 2a clinical trial, RVT-1601 demonstrated a statistically significant reduction in cough frequency among IPF patients after 14 days of treatment. Respivant plans to initiate a Phase 2b study for RVT-1601 in the first quarter of 2019.
https://thefly.com/landingPageNews.php?id=2791347
Anthem initiated at Cowen
Anthem initiated with an Outperform at Cowen. Cowen analyst Charles Ryhee initiated Anthem with an Outperform rating citing its unique dominant position in most of its markets because of the Blue Cross/Blue Shield brand. This affords it flexibility to build out its own PBM and pursue a more partnership-based provider strategy, said Ryhee, who has a $318 price target on Anthem shares.
https://thefly.com/landingPageNews.php?id=2791349
AstraZeneca : Three-Drug Combination Meets 8 out of 9 Objectives in COPD Trial
AstraZeneca PLC (AZN.LN) said Monday that a phase 3 trial of a three-drug combination for the treatment of chronic obstructive pulmonary disease met eight out of its main objectives.
The Anglo-Swedish pharmaceutical company said that the results of the Kronos trial, which compared a combination of budesonide, glycopyrronium and formoterol with a number of rival therapies, was published in the journal The Lancet Respiratory Medicine.
The three-drug cocktail called PT010 showed a significant reduction of exacerbations in patients with the disease compared with rival therapy, the company said.
AstraZeneca said it plans on making a first regulatory submission for the drug in the second half of the year.
Wearable Health Monitors : Do They Work?
The explosion in smart devices — phones, watches, fitness gadgets and the like — has unleashed a wave of apps designed to manage chronic illnesses, detect behavioral diseases and manage pain. Most recently, Apple announced that apps due later this year will allow its Series 4 watches to perform electrocardiogram readings, or ECGs, and notify users of irregular heart rhythms.
The problem for consumers is knowing which apps — if any — actually work.
The Food and Drug Administration cleared the ECG app and irregular-rhythm notification feature on the Apple watch, but noted that the apps aren’t intended to replace traditional diagnosis methods. The agency said the ECG data displayed on the Apple watch is for informational purposes only and isn’t intended to be interpreted by the user without consulting a health-care professional.
Most apps on the market lack approval from the FDA, which hasn’t been able to keep up with the health apps being released, raising concerns that some apps could expose consumers to harm.
The FDA last September started working with Apple and eight other tech and medical-device companies — including Fitbit, Samsung and Verily Life Sciences, a subsidiary of Google parent Alphabet — to streamline approval of mobile medical apps. In the meantime, here is a status check on some of the areas where health-monitoring tools might make the most difference.
Measuring Heart Health
Smartphones and watches can collect data on the heart continuously, which promises to improve detection and treatment of heart disease.
For instance, devices that track heartbeat data can help doctors identify atrial fibrillation, a leading cause of heart failure and strokes. With a-fib, the upper two chambers of the heart beat erratically and at dangerously high speeds. Since symptoms come and go, it can be hard to detect, but watches worn for long periods have a chance of spotting it outside of a doctor’s office.
An ECG, the standard method of detecting a-fib, requires placing 12 electrodes on a patient’s body. The Apple Watch Series 4 will have electrodes built into the watch’s digital crown, which users touch for 30 seconds after opening the app to get an ECG reading, Apple says.
Another device, the KardiaBand watchband, also offers ECG capabilities and was cleared by the FDA in November. It was most effective in detecting a-fib when physicians looked at the results, rather than relying solely on the watch’s algorithms, according to a study by the Cleveland Clinic. The device’s instructions tell wearers to place their thumb over a spot on the watchband embedded with an electrocardiogram sensor, which records their heart rhythm.
But in the Cleveland Clinic study, about 35% of the recordings couldn’t be read by the watch’s algorithms, possibly because people didn’t press their thumbs down for the required 30 seconds. Electrophysiologists, however, looking at the same data, were able to accurately identify people with a-fib 100% of the time and people without a-fib 80% of the time. The electrophysiologists also beat the algorithm’s performance on recordings that it could read, correctly identifying people with a-fib 99% of the time, compared with the algorithm’s 93%.
“It’s a reminder for all of us in dealing with digital health that the patient is an active component of the equation and is part of the end results on how good these recordings are,” says Khaldoun Tarakji, an electrophysiologist who led the study. Dr. Tarakji says that with smartphone-based electrocardiogram monitors, the clinic can access recordings of patients’ heart rhythms no matter where they are. Doctors can also use the monitors to diagnose patients with intermittent episodes of a-fib, which are hard to catch, and follow up on patients who have had ablations, a procedure that removes diseased tissue from the heart to try to stop a-fib symptoms.
Another new tool on the market is machine-learning software called DeepHeart, which takes heart-rate, step-count and other data from an Apple Watch or similar device and calculates the risk that the wearer has one of several ailments, including a-fib, sleep apnea, hypertension or diabetes, according to Brandon Ballinger, co-founder of Cardiogram Inc., the company that built the software. DeepHeart’s diagnostic tests have FDA clearance, a status the agency assigns to tools that it determines are “substantially equivalent to another legally marketed device.”
For Apple Watch wearers, DeepHeart was 97% accurate in predicting a-fib for patients who had already been diagnosed (using an electrocardiogram, the standard for diagnosis) and were hospitalized for treatment, according to a study published earlier this year by Mr. Ballinger and researchers at the University of California, San Francisco. But it was only 72% accurate for patients who thought they had a-fib but hadn’t been diagnosed and hospitalized, the study said.
Outside the hospital, in what Cardiogram calls “the real world,” detecting a-fib is much harder, the company says. Motion, sweat and sunscreen can affect how successfully an Apple Watch, for instance, reads heartbeats. (Apple Watches have optical sensors which shine light into your wrist and measure how much light is absorbed. Between heartbeats, less blood flows, so less light is absorbed). Alcohol consumption and exercise also affect heart rate and can mask or mimic a-fib. Tests were conducted on earlier versions of the Apple Watch, through Series 2, but Cardiogram is now also compatible with Garmin and Android devices, Mr. Ballinger says.
Glucose Monitor
For more than 50 years, researchers have looked for ways to monitor glucose that don’t require people to prick their fingers and draw blood. Bodily fluids including urine, sweat, saliva, ocular fluids like tears, and interstitial fluids, which bathe cells, also contain glucose and are easier to get to than blood. But they can be challenging to work with.
Several companies are investigating minimally invasive or noninvasive glucose monitors, and a few have been approved by the FDA, but developing systems that don’t penetrate the skin has been challenging.
A glucose monitor from Dexcom Inc. that the FDA authorized for marketing in March uses a sensor about the width of a human hair that sits just under the skin and detects glucose in the interstitial fluid. It generates an electrochemical signal that’s read by a processor and converted into data that’s transmitted to a Dexcom receiver or a smartphone or watch. In 2016, a previous generation of monitors was recalled by the FDA because the receiver’s alarm didn’t sound when the glucose reading was high or low. But the company has since developed new technology, says CEO Kevin Sayer.
The new monitor uses some finger pricking, says Mr. Sayer, because “we’ve not seen anything sitting outside the body that delivers the accuracy that patients require.”
In a paper published earlier this year, Sunghoon Jang, chair of the department of computer engineering tech at NY City College of Technology at CUNY, surveyed a dozen emerging optical or electrochemical technologies that target both blood and other bodily fluids, including a contact lens that changes color depending on the level of glucose present in tears. But none of these techniques are commercially available, Dr. Jang says, showing how complicated it can be to develop reliable and affordable alternatives to more invasive ways of measuring glucose, which also continue to improve.
Tracking Blood Pressure
Researchers have long tried to improve on the traditional arm cuff to measure high blood pressure, which causes heart attacks and strokes.
By 2020, three billion people will have smartphones, “and a lot of people in this world have high blood pressure and don’t know it,” says Ramakrishna Mukkamala, a professor of electrical and computer engineering at Michigan State University.
Recently, a group he led created a way to take blood pressure with a phone, using the same principle as the blood-pressure cuff, which varies pressure on the arm. In a study published in March, the group used a modified smartphone case with two sensors, one that measured blood volume and one that measured applied pressure. Users steadily pressed their fingertips against the case to get a reading. The data was transmitted via Bluetooth to an app, which calculated blood pressure and displayed it.
In September, however, a proof-of-concept study done by Dr. Mukkamala and another set of authors showed that the same finger-pressing method can be applied to optical and force sensors that are already built into some phones — one sensor for taking selfies and one for displaying a 3-D touch feature.
The group has developed an iPhone app that guides fingertip placement and calculates blood pressure. Comparing the results against a traditional blood-pressure cuff, the app was less accurate than the arm cuff. But Dr. Mukkamala says it was comparable to a finger cuff, a device that’s been cleared by the FDA for measuring arm blood pressure but used primarily so far in research. Dr. Mukkamala hopes to market the phone technology, though he says it needs more work before it can be approved.
Another group is working on ways to test smartwatches that monitor blood pressure. At the National Institute of Standards and Technology, the Physical Measurement Laboratory is working with Tufts University’s School of Medicine to build a fake arm that reproduces the mechanical properties of blood pulsing through an artery and surrounded by human tissue. The arm could then be used to test new blood-pressure monitors that would be worn like a watch. NIST and Tufts expect to test optical sensors on the fake arm that block specific frequencies or colors of light. As the pressure changes, the color of light that is blocked also changes.
Hitachi’s 1st Compact Proton Therapy System to Go to Tokushukai Med Group
Hitachi, Ltd. (TSE: 6501) announced today that it has received an order for the compact proton therapy system from Tokushukai Medical Group, and the system will be installed at Shonan Kamakura Advanced Medical Center, which is planned to be built near Shonan Kamakura General Hospital. This is the first order for Hitachi’s dedicated compact proton therapy system.
Following the expansion of demand for proton therapy system with minimized footprint worldwide, Hitachi has developed dedicated single room proton therapy system (Single Room Solution). Single Room Solution features optimized system configuration, reducing the footprint to 70% of conventional solution, realizing installation in urban limited areas and contributing to lower the initial cost and shorten the lead time. Other features include spot scanning technology for treating certain forms of cancer and full rotating gantry with cone beam CT for precise patient positioning, sustaining high performance technologies in minimized footprint.
Tokushukai Medical Group, operating 339 medical facilities in Japan, is planning to build Shonan Kamakura Advanced Medical Center near Shonan Kamakura General Hospital, targeting to complete in September 2020. Four-story building with one basement floor will be comprehensive center for proton therapy, BNCT (Boron Neutron Capture Therapy), RI (Radioisotope) therapy and drug discovery research and support through the use of PET (Positron Emission Tomography).
Hitachi has been proactively promoting particle therapy business worldwide, supplying world-class facilities around the world with its highly reliable and proven particle therapy systems, which have treated more than 16,000 patients, and integrating Mitsubishi Electric Corporation’s particle therapy system business in June 2018. Under the new organization, Hitachi will provide products and services with higher performance and added value, including Single Room Solution and hybrid system combined with capability of proton and heavy ion therapy.
Morgan Stanley Global Healthcare Conference Update: Celgene, Merck, Gilead
The Morgan Stanley Global Healthcare Conference ran from September 12 through 14, with numerous biopharma companies making presentations, updating their operations and pipeline activities. Here’s a look a few of the highlights.
Celgene’s president Hematology & Oncology, Nadim Ahmed, and chief financial officer, David Elkins, sat down to talk with Morgan Stanley analyst Matthew Harrison. Ahmed noted that the company has been having a good year, and “raised guidance twice already.” In terms of its pipeline, they had a good summer with three positive Phase III trials. “We’ve all squared Revlimid in lymphoma, but especially exciting was luspatercept, a new molecule, one of our key potential blockbuster molecules delivering in MDS and beta-thalassemia.”
Ahmed went on to say over the next one to two years, they’re looking at regulatory submissions and approvals in the hematology/oncology space with four compounds.
Elkins cited three strengths for the company, noting its commercial execution and the underlying business doing so well. Secondly, “as you think through the pipeline and the number of late-stage products that we have come into market over the next 12 to 18 months is very exciting and then have that commercial vehicle as well to make the most of that.” And the third is Celgene’s capability, technical expertise and ability to leverage that with global alliances.
In particular, Ahmed and Elkins talked up the possibilities of luspatercept. Ahmed noted, “With luspatercept obviously we can simultaneously pursue two indications, taking two shots on goal. You don’t always deliver when you take two shots on goal. So, I think the thing that really excited us was to have positive Phase III data in both MDS and beta-thalassemia, and the fact now that we’ve shown in two distinct diseases we’ve been able to impact anemia.”
Merck & Co’s chairman and chief executive officer, Ken Frazier, and Roger Perlmutter,president of Merck Research Labs, spoke with several Morgan Stanley analysts. Frazier came right out of the gate by noting that although Merck definitely has a powerhouse with Keytruda, what he calls “a formidable opportunity,” its Lynparza and Lenvima and other early-stage assets are very strong as well. “This portfolio is the strongest portfolio I’ve ever seen inside Merck anchored by Gardasil,” Frazier said, “which is of course not a new vaccine, but is looked at through new eyes by public health authorities around the world in terms of gender neutrality, in terms of eliminating HPV disease and all the things that come along with it including cervical cancer.”
Perlmutter discussed Keytruda’s growth drivers beyond lung cancer. “I think everyone recognizes that Keytruda is the broader spectrum anti-neoplastic agent introduced into clinical practice probably since radiotherapy. And it has such a broad spectrum of activity that it causes problems in terms of prioritization. We’ve taken the position that we need first to enter those areas where we think we can do the most good for immunology responses in tumors. We begin with SAVAGE studies and advance into first line and ultimately into adjuvant and neoadjuvant.”
Permutter emphasized that Keytruda has been approved in 13 indications in eight different tumor types, including a broad indication for patients with microsatellite instability. It is currently under review for five major indications, including the expansion out of non-squamous into squamous cell carcinoma and an upcoming FDA target action as a combination treatment. “So the spectrum is very large. Hepatocellular carcinoma is coming along, and the combination studies as well. I think everybody in this audience knows that if you look at clinicaltrials.gov there are more than 850 studies that are using Keytruda and more are being added every single day.”
Gilead Sciences’ John McHutchison, chief scientific officer and Head of R&D, John Milligan,president and chief executive officer, and Robin Washington, executive vice president and chief financial officer, spoke with Morgan Stanley analyst Matthew Harrison. Milligan touted the company’s “terrific launch of Biktarvy, our HIV product,” for which they have great expectations. He also mentioned some new blood to the executive team, specifically Laura Hamill, coming on as executive vice president of Worldwide Commercial Operations.
Since Milligan announced in late-July that he was stepping down after 28 years with Gilead, Harrison asked him to reflect on his career with the company. Milligan said, “When I joined, I was the 32nd employee. We now have over 11,000 employees with employees around the globe. So, it’s really been phenomenal to be part of that growth and success story. You know, I’ve been a chief of something within the company for 16 years now and I’ve watched revenue grow from when I became CFO from $180 million to our peak of $32 billion.”
Hutchison discussed the company’s pipeline, noting they are expecting results from the Phase II programs, DARWIN and FITZROY, soon. These programs are evaluating filgotinib, a JAK1 inhibitor, in rheumatoid arthritis, Crohn’s disease and ulcerative colitis, as well as in other autoimmune and inflammatory diseases. In terms of the drug’s safety, Milligan said, “It’s been a very consistent drug. It’s a very well-behaved drug in terms of efficacy. It seems to be on the better end and everything that we look at. And on the safety profile, it’s on the better end.”
Discussing the company’s commercial activities, Robin Washington said, “As you’ve heard, we’re very confident in our business model. It’s generating significant operating cash flows and our belief is the right thing to do is to take those and reinvest them and continue to do deals.”
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