Shares of smartband and smartwatch maker Fitbit (FIT) are higher after the company announced it is expanding its strategic partnership with Humana (HUM) to drive healthy habits and manage chronic disease. STRATEGIC PARTNERSHIP EXPANSION: On Wednesday, Fitbit and Humana announced that they are expanding their partnership to help members adopt and implement healthy behaviors to help prevent and manage chronic conditions. Humana has selected Fitbit Care as a preferred health coaching solution for Humana’s employer group segment and through this partnership, over five million Humana members will have the potential to access Fitbit wellness solutions or health coaching. Fitbit Care is a connected health platform, launched today, that combines health coaching and virtual care, Fitbit’s wearable devices and self-tracking and personalized digital interventions. The Fitbit Care health coaching solution has coaches working with participants to create personalized care plans and connecting with members through multiple channels that include in-app communications, phone and in-person meetings. Users who already have health coaches can connect with them through the platform or they can opt for “a fully wrapped solution” where the company provides the technology and wellness advice. Fitbit and Humana also announced the availability of the Humana Go365 clock face on Fitbit Versa and Fitbit Ionic devices, making members’ Go365 activity data accessible right from the wrist. EXECUTIVE COMMENTARY: “Working with Fitbit, we have been able to provide our members with wearable devices, data and insights they can use to achieve their best health and wellness. By adding Fitbit Care’s new health coaching capabilities, we can offer even more personalized, meaningful support to our members who are focused on specific health goals, such as smoking cessation or weight loss, or the management or prevention of chronic conditions,” said Jeff Reid, Humana’s senior vice president of Wellness Solutions. “Fitbit’s intuitive technology and human coaches are powerful tools to engage and motivate members, creating more frequent, convenient touch-points that support our members beyond the walls of a doctor’s office.” Adam Pelligrini, general manager of Fitbit Health Solutions, said, “We’re already seeing proof points that the solutions we’re building are taking hold and are resonating with our health plan and employer customers.” Pelligrini added Fitbit already works with over 100 health plans and its health solutions business unit currently represents less than 10% of the company’s overall revenue. WHAT’S NOTABLE: Shares of Fitbit fell on September 12 after Apple (AAPL) unveiled its new Watch Series 4 at its product event. The device features a larger display, new user interface, digital crown with haptics, faster performance, louder speaker and electrical heart sensor with electrocardiogram app and an optical heart sensor. In addition, the company said it received Food and Drug Administration approval for the built-in ECG scanner and it is the first over-the-counter ECG product. Following the fall, Morgan Stanley analyst Yuuji Anderson told investors that he believes the drop “rightly reflects” concerns over the pace of software and sensor improvements at Fitbit. However, the analyst added that he is more concerned that the functionalities of Fitbit’s Versa and Charge 3 are not sufficiently differentiated to avoid cannibalization and their aggregate demand will not sufficiently offset legacy product declines. ‘SIGNIFICANT EVOLUTION:’ Craig-Hallum analyst Alex Fuhrman called Fitbit’s Fitbit Care launch a “significant evolution” in the company’s strategy to add value as a healthcare partner and to increase its recurring revenues. He also views the concurrent Humana (HUM) partnership announcement as evidence of the strong market demand for companies and healthcare providers to partner with Fitbit and integrate its data into users’ other care plans. PRICE ACTION: Fitbit is up 2.1% to $5.92 in morning trading.
Wednesday, September 19, 2018
Novartis, Tencent to partner, focus on cardiovascular disease
Bloomberg cites an email from Novartis (NVS) regarding its cooperation agreement with Tencent (TCEHY) in China.
Elanco initiated with a Buy at Gabelli
Gabelli analyst Kevin Kedra initiated Elanco (ELAN) with a Buy rating and 2020 private market value estimate of $32 per share, stating that he views the animal health market as attractive given that it is predominately cash-pay with lower development costs and longer product life cycles than human health. The operating margins at Elanco, which is a carve-out of parent Eli Lilly (LLY) expected to go public on September 20, lag the industry leader and Kedra sees a significant opportunity for margin expansion, he tells investors.
Merck cuts key cancer drug price for China launch, Caixin reports
Merck (MRK) will cut the price of one of its core cancer drugs in half for its China launch following a similar move by competitor Bristol-Myers Squibb (BMY), Caixin Global reports
Novartis’ Kymriah for adult lymphoma ‘to expensive to recommend,’ says NICE
https://thefly.com/landingPageNews.php?id=2792362
Piper more worried about AbbVie co-pay accumulator risk than California suit
While shares of AbbVie may move lower today on news of California’s insurance regulator suing the company over promotion of Humira, a more fundamental potential drag on Humira remains the advent of co-pay accumulators, Piper Jaffray analyst Christopher Raymond tells investors in a research note. The analyst sees the California lawsuit as more headline risk than anything but thinks “it may nevertheless serve as a minor overhang on shares.” He points out that new research this week by Drug Channels suggests that more than one-third of commercial lives are enrolled in plans that have implemented copay accumulators for 2018, higher than his prior best estimate of 17%. Raymond keeps a Neutral rating on AbbVie with a $100 price target.
https://thefly.com/landingPageNews.php?id=2792331
Tuesday, September 18, 2018
Drug combo shows promise for treating sleep apnea
During decades of lab experiments and dozens of clinical trials, scientists have searched in vain for drugs to defeat obstructive sleep apnea, the risky and increasingly prevalent condition in which a person’s upper airway repeatedly collapses during sleep, causing them to briefly stop breathing dozens or hundreds of times each night. Now, a new drug combination has reawakened hopes.
A team led by researchers in Boston has identified a pair of medications—approved for other uses and with solid safety records—that appear to work in concert during sleep to activate the muscles that dilate the upper airway. In a study of 20 patients, the scientists found that a combination of atomoxetine and oxybutynin, taken as two pills at bedtime, reduced patients’ frequency of airway obstruction—called the apnea-hypopnea index, or AHI—from a median of 28.5 hourly obstructions on placebo to 7.5 on the pills. In the 15 patients with the highest AHIs, the median reduction was 74%—and every patient experienced at least a 50% reduction, Andrew Wellman and Luigi Taranto-Montemurro at Brigham and Women’s Hospital in Boston reported today at the European Respiratory Society’s International Congress in Paris. Patients’ blood oxygenation also improved strikingly, the group found.
“We’ve never had a drug combination, or any sort of a drug, that consistently improved everybody’s AHI. That’s actually unbelievably exciting,” says Sigrid Veasey of the University of Pennsylvania (UPenn), a physician-researcher who studies sleep. It’s “a great first step,” adds Martina Mason, a sleep physician at the Royal Papworth Hospital in Cambridge, U.K., who co-authored a 2013 review of 30 previous, underwhelming drug trials.
The trial turned up one potentially problematic finding: Although the drug combination reduced patients’ AHIs, their number of subconscious arousals—the subtle awakenings that leave patients exhausted—remained high. But if this combination proves safe and effective in larger trials, it could free many sleep apnea patients from the current gold-standard remedy, the cumbersome “continuous positive airway pressure” (CPAP) machines that blow air into the throat to keep the airway open, but require users to wear a mask and headgear at night.
Mason, Veasey, and other sleep apnea experts caution, however, that the findings are extremely preliminary. They note that the pilot study, although double-blind and randomized, included just a small number of patients who took the drug combination for just 1 night.
The search for sleep apnea treatments has become pressing as its prevalence has grown, as widespread noncompliance with CPAP has been charted and as researchers have documented the disease’s long-term dangers. In addition to enduring daytime sleepiness, sleep apnea sufferers—some 13% of U.S. men and 6% of women aged 30 to 70—are at higher risk for depression, cognitive impairment, high blood pressure, heart attack, stroke, and premature death. The obesity epidemic is thought to be increasing the incidence of sleep apnea, though thin individuals can also be afflicted.
Wellman, a physician who has been studying sleep apnea since 2001, began to test various drugs for the condition in clinical trials more than 10 years ago. “I had given up, really,” he recalls. Then, in 2015, an enthusiastic postdoc, Taranto-Montemurro, arrived in his lab. Wellman reluctantly let him launch a new trial of a drug combination suggested by animal studies from other labs. “I wasn’t really happy about it,” Wellman says, “until all of a sudden the data started coming in.”
Atomoxetine, approved by the U.S. Food and Drug Administration in 2002 to treat attention deficit hyperactivity disorder, increases messaging in the brain by the excitatory neurotransmitter norepinephrine, whose levels normally fall off markedly during sleep. Giving a stimulating drug at bedtime seems counterintuitive. But animal work led by Richard Horner, a sleep physiologist at the University of Toronto in Canada, had shown that injecting rats with a norepinephrine-mimicking drug in an area of the brainstem that controls the hypoglossal nerve, which powers the upper airway muscles, improved activity of the genioglossus, a large tongue muscle that is critical for keeping the throat open. The drug was consistently effective only during nonrapid eye movement sleep, not during rapid eye movement (REM) sleep, when throat muscles are especially prone to relaxation and collapse, making sleep apnea worse.
The other half of the combination, oxybutynin, improves genioglossus responsiveness during REM sleep. Again, work by Horner’s team provided the crucial clue. It found that during REM sleep the neurotransmitter acetylcholine acts on certain receptors on the hypoglossal nerve to powerfully inhibit activation of the genioglossus. Oxybutynin, Wellman and Taranto-Montemurro knew, blocks acetylcholine’s action at the same receptors—and it had a long track record as a marketed drug used for decades to treat overactive bladder.
As the drug pair progresses through clinical trials, sleep apnea specialists will be watching to see whether the drugs actually reduce subconscious arousals and improve sleep quality. “What if you can improve the AHI, the obstructions, but the patients are as sleepy as they were before the treatment?” asks UPenn’s Leszek Kubin, a neurophysiologist who studies the mechanisms of sleep-disordered breathing.
The study researchers propose that the patients’ arousals may have been due to the invasive instrumentation attached to them during the night, and the associated discomfort. And they note that in the 13 patients with the highest AHIs, the number of arousals did decline a statistically significant amount on the pill combination.
Some are already betting that the drug pair, on which a patent for use in sleep apnea is expected to be published next month, will find a large and eager market. Apnimed, Inc., a new Cambridge, Massachusetts, company formed to commercialize the discovery, recently landed $25 million from Morningside Venture Capital in Newton, Massachusetts. It is planning a phase II trial involving more than 100 patients, to study dosing and side effects, says CEO Larry Miller. (Wellman and Taranto-Montemurro have a financial interest in the firm but are not involved with planning or running the trial.)
Sleep physicians note that side effects unrelated to breathing may make the drug combination a nonstarter for some sleep apnea patients. In a population at risk for hypertension and heart attacks, the stimulant effects of atomoxetine will have to be watched. And oxybutynin’s dampening effect on bladder muscle activity may prove problematic for a typical group with sleep apnea: “old men who have trouble urinating in the night,” says J. Steven Poceta, a sleep physician at the Scripps Clinic Torrey Pines in San Diego, California. Still, he says, he’s excited about the drug combination’s promise. “It could be great for a lot of people.”
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