IBM to wind down Watson’s work in AI-based drug discovery

IBM is dropping its Watson programs aimed at artificial intelligence-based drug discovery and development due to poor financial returns, according to a report from Stat.

The news follows Big Blue’s decisions last year to move away from offering Watson in hospital management settings, not to mention the departure of the general manager of the division’s health-focused unit last October.

IBM has previously rolled out some high-profile partnerships, though not entirely in drug discovery, including with Pfizer, Novartis and Illumina in cancer research, as well as with Teva to explore drug repurposing. However, even with these deals, sources told Stat the initiative was still not bringing in enough money.

According to those sources, IBM employees were recently notified of the decision and have begun reassessing Watson’s prospects in the broader biopharma industry. More officially, the company said it will continue working with drugmakers who currently employ Watson for their R&D work.

“We are focusing our resources within Watson Health to double down on the adjacent field of clinical development where we see an even greater market need for our data and AI capabilities,” an IBM spokesman told Stat in a statement.

Outside of drug and clinical development, Watson Health recently inked a $50 million, 10-year investment into a collaboration with Brigham and Women’s Hospital and Vanderbilt University Medical Center to research public health issues and patient safety.

But over the past few years, Watson has been no stranger to stumbles. A 2017 investigation by Stat found that IBM’s Watson for Oncology initiative—which aimed to use AI and natural language processing of medical records to help recommend personalized courses of cancer treatment—was a long way from being able to meet its promises.

Though pitched by marketers as a way to generate new insight and approaches to care, the system has been beset by obstacles in interoperability and data collection—namely the labor-intensive work required by physicians and others to keep the program manually updated with treatment recommendations and data for only a handful of different cancers.

https://www.fiercebiotech.com/medtech/ibm-to-wind-down-watson-s-work-ai-based-drug-discovery-report

Allergan’s new concierge platform Regi finds medical aesthetic, spa treatments

Regi—short for regimen—is Allergan’s first-ever digital booking platform for aesthetic treatments. That includes Allergan-branded medical aesthetics like Botox Cosmetic and CoolSculpting, but also spa treatments like facials, waxing, laser hair removal and massages.

Available only in New York and Los Angeles for now, Regi lists spas, salons and plastic surgeons, complete with insider tips and scoops. Each business is vetted by Regi team members who visit the locations. Consumers who want services create a log-in to request bookings or appointments and a Regi concierge handles the request and responds.

The platform is Allergan’s second to come out of its digital ventures unit called Project Moonwalker. Its first project is Spotlyte, a digital content hub with information on medical aesthetics treatments, live chat and a connection to service providers.

The two projects align exactly with Allergan’s goal to break down two key barriers in medical aesthetics: lack of information and access to providers. Spotlyte addresses the lack of information, while Regi seeks to provide local access.

Alexandra Wilkis Wilson, senior vice president of consumer strategy and innovation at Allergan, said the company believes breaking those down has the potential to double the market in the next five to seven years.

“There is a clear demand for digital marketplaces and technology companies that are fulfilling consumer demand via immediate access to goods and services,” she said in an email interview. “… But there was no one place where a beauty enthusiast could book both a massage and an injectable treatment within one platform. With the launch of Regi, Allergan will interact directly with new consumers, many of which we expect to be urban, beauty-oriented millennial women.”

While Allergan’s Regi team vets the spa and salon listings, healthcare providers listed must also have an active Allergan account and provide a variety of Allergan products “as well as embody the Allergan spirit and demonstrate an understanding of technology and social media,” Wilson said.

https://www.fiercepharma.com/marketing/booking-beauty-allergan-s-new-concierge-platform-regi-finds-medical-aesthetic-and-spa

‘Old guard’ generics players yield U.S. lead to Indian up-and-comers

The U.S. generics world has changed.

Starting from around late 2018 to early 2019, traditional generics bigwigs Teva, Mylan, Novartis’ Sandoz, Amneal and Endo have lost out to a group of six competitors that include Indian drugmakers Aurobindo Pharma, Lupin, Dr. Reddy’s, Sun Pharma, Cipla and Canada’s Apotex in terms of weekly total prescriptions, Evercore ISI analyst Umer Raffat recently noted.

Within two years, what used to be a 12 million prescription advantage the “old guard” held has been overturned, and the “next six” now boast a lead of about 2 million as of the end of March.

“Of course, this is just aggregate TRx—it doesn’t reflect the high-value and complex launches, which is effectively where all the ‘old guard’ are positioning themselves for,” Raffat wrote in a recent note to clients.

Indeed, amid increased pricing pressure and competition in the generic arena, higher-margin complex generics and biosimilars have lately been put at the top of the growth agenda at Teva, Mylan and Sandoz, the top 3 U.S. generics players by total prescriptions in 2017.

“The old idea of ‘first in, last out’ or just waiting out lower-priced competitors until they give up and exit has died,” Wells Fargo analyst David Maris observed in an email interview with FiercePharma. “Companies are no longer trying to drive as much volume as possible, but rather are focused on the margin of those sales.”

Heavy investments in the development of complex generics may have happened earlier, but the three companies started publicly—and repeatedly—talking about it around 2018 when they realized that the U.S. pricing clampdown wasn’t going away anytime soon.

In contrast to Teva CEO Kåre Schultz’s recent comment that the “classical negative death spiral of pricing” in the U.S. generics market has ended, Maris said the negative generic drug pricing environment might have not bottomed out yet.

“While the pricing environment appears to be getting slightly better—from horrible to simply bad—it is still not back to what it was a few years earlier. That is, declines of 10% to 12% are the norm now, vs. the 5% to 7% declines seen historically,” he said. As a possible indication, after some other analysts upgraded Teva’s shares in February, the company’s stock has actually slid by about 25%.

Schultz took over struggling Teva in late 2017. Within that year, Teva’s total generics prescriptions didn’t really change much, according to Evercore’s data, and the segment’s revenues of $12.3 billion was 10% higher in local currencies compared with 2016. Profit, however, dropped 15% “mainly due to price erosion in the U.S. generics market,” the Israeli company said at the time.

In its 2017 annual report presented in February 2018, the company said its focus was “on developing complex formulations with complex technologies, which have higher barriers to entry.”

Mylan CEO Heather Bresch also used an investor day in April 2018 to tout the company’s efforts in hard-to-copy drugs. And in the company’s annual report for that year, Mylan said its allocation of R&D investment has “shifted away from commodity products, such as conventional oral solid dosage forms, to more complex or difficult-to-formulate products, such as biosimilars.”

Just as its U.S. generics prescriptions gradually declined—from the weekly amount of around 6 million in March 2017 to half of that in 2019—Mylan launched its generic version of Teva’s Copaxone in October 2017, and in January, it received FDA approval of Wixela Inhub, the first generic of GlaxoSmithKline’s inhaler Advair Diskus, a hard-to-copy drug-device combo that hadn’t seen any knockoff for a long time after patent expiration.

“Teva and Mylan have stated that they want to focus on profitability right now, and market share at the expense of margin is no longer a sound strategy,” said Maris, who covers both companies.

Novartis’ Sandoz embarked on a similar journey after Vas Narasimhan took over the CEO job in early 2018. Later that year, the company sold its declining U.S. dermatology and oral solids businesses to Aurobindo in a deal worth up to $1 billion. And it just recently rolled out Symjepi, an epinephrine injection that could challenge Mylan’s authorized generic EpiPen and Teva’s copycat.

Maris said the shift in the U.S. generics market has also to do with those companies that “are coming into established markets and some with lower cost structures or a greater comfort with lower margins and are simply winning business.”

But that doesn’t mean Indian companies are content with simple chemicals—there’s a clear trend that Indian pharmas are also moving to high-end products.

“Generally speaking, we have long said that the evolution of the market would be for traditional low-cost manufacturers to move up the value chain and take share, forcing the old guard to re-evaluate their business models,” Maris said.

Aurobindo, in its annual report for the 2017–18 fiscal year that ended last March, said one of its key priorities in the coming years is “building a robust pipeline of complex molecules,” and that its R&D initiatives range from conventional orals to injectable products and to more complex and advanced dosage forms as well. Aurobindo is currently the second-largest generics supplier by prescriptions, and it’s quickly catching up with Teva.

Lupin, which took over the No. 3 spot in terms of weekly U.S. generics prescriptions, has also suffered from sharp profit declines lately. And its plan to channel the pricing pressure? Complex generics and specialty pharma, CEO Vinita Gupta told FiercePharma in an interview last year.

While maintaining its presence in low-cost generics, the company is also investing heavily in high-barrier drugs. Last June, Lupin formed a partnership with Mylan on a biosimilar to Amgen’s Enbrel. And just a few weeks ago, that product was cleared by Japanese authorities.

Overall, Maris said the “old guard” firms are filing as many U.S. generic applications as before, but they’re being more careful about which ones they launch. Evercore’s Raffat echoed that point, saying that companies these days don’t always choose to launch generics even though they are receiving approvals at a similar or greater pace.

Generics have hit “a natural ceiling of penetration,” as they now account for about 90% of all U.S. prescriptions, Maris said. Still, the prescription decline seen among the “old guard” didn’t quite account for the increase in those “next six” identified by Raffat. Maris attributed that to a more fragmented market. And while Sandoz, Teva and Mylan are not yet replaceable, others are coming up strong and capturing growth often at lower prices, he said.

“[I]t is a brave new world for drug companies—branded and generics alike—facing new challenges to pricing and competition,” Maris said.

https://www.fiercepharma.com/pharma/generics-old-guard-pack-yields-u-s-scripts-lead-to-next-6-led-by-indian-firms-analyst

2 Nicotine Replacement Therapies Better than 1

Smokers who use two forms of nicotine replacement therapy (NRT), including a patch and nicotine gum, lozenges or other short-acting delivery treatments, are more likely to successfully quit smoking than those who rely on a single NRT, according to Cochrane reviewers.

In a report examining the efficacy and safety of different forms, deliveries, and doses of NRT for smoking cessation, Nicola Lindson, PhD, of the University of Oxford in England, and colleagues, concluded that there is now “high quality evidence” supporting the use of dual therapy, based on their review of 63 trials involving around 41,500 participants.

Using a nicotine patch and another form of NRT, such as a gum or lozenge, was associated with a 5% to 36% increase in the likelihood of successful smoking cessation versus using NRT alone.

Use of the higher dose of widely available nicotine gum (containing 4 mg of nicotine instead of 2 mg) and beginning NRT before the smoking quit date were also associated with a higher likelihood of successful smoking cessation, they wrote in the Cochrane Review.

Lindson told MedPage Today that earlier Cochrane reviews examining NRT, including one in 2018, also compared the treatment to placebo or no treatment at all. Those reviews confirmed the efficacy of NRT — available as skin patches, gum, nasal and oral spray, inhalers, lozenges, and tablets — in helping smokers kick the habit.

“That is now a settled question,” she said. “What we were really trying to do here is explore the best ways to use NRT to make it as effective as possible.”

In the analysis, 17% of smokers who combined a patch with another type of NRT successfully quit smoking versus 14% of smokers who used a single type of NRT.

“That may sound like a small difference,”but it is important to remember than giving up smoking is hard,” Lindson said. “So any increase in successful outcomes is important, especially on a population level.”

Review Details

The review included all randomized trials with follow-up of ≥6 months; trials comparing NRT to control or to other non-NRT pharmacotherapies were not included.

Quit attempts were considered successful when the participants had abstained from smoking for ≥6 months.

In all, 24 of 63 studies included in the analysis were judged to have a high risk of bias, but restricting the analysis to studies with a low or unclear risk of bias did not significantly alter the findings.

The analysis revealed there was high-certainty evidence that combination NRT (fast-acting form plus patch) results in higher long-term quit rates than single form NRT (risk ratio 1.25, 95% CI 1.15-1.36, I²=4%; 14 studies with 11,356 participants).

Also, there was moderate-certainty evidence indicating that 42/44 mg are as effective as 21/22 mg (24-hour) patches (RR 1.09, 95% CI 0.93-1.29, I²=38%; five studies with 1655 participants), and that 21 mg are more effective than 14 mg (24-hour) patches (RR 1.48, 95% CI 1.06-2.08; one study with 537 participants).

Results of five studies comparing 4 mg gum to 2 mg gum found the higher dose to be more effective (RR 1.43, 95% CI 1.12-1.83, I²=63%; 856 participants), but subgroup analysis suggested that only smokers who are highly dependent may benefit.

Nine studies examining the effect of starting NRT prior to quit day (pre-loading) — versus using it from quit day onward — exhibited moderate-certainty evidence, limited by risk of bias, of a favorable effect of pre-loading on abstinence (RR 1.25, 95% CI 1.08-1.44, I²=0%; nine studies with 4,395 participants).

There was high-certainty evidence suggesting that using either a form of fast-acting NRT or a nicotine patch results in similar long-term quit rates (RR 0.90, 95% CI 0.77-1.05, I² =0%; eight studies with 3,319 participants).

There was no evidence of an increased safety risk in people using two forms of NRT, or higher doses of fast-acting NRT, although the researchers did note that most of the studies did not examine safety.

“We also looked at how long NRT should be used for, whether NRT should be used on a schedule or as wanted, and whether more people stop smoking when NRT is provided for free versus if they have to pay for it. However, more research is needed to answer these questions,” the researchers wrote.

Lindson said many guidelines now recommend dual NRT to smokers who want to quit, and most smoking cessation specialists prescribe it. But she added that general practitioners and the public largely have not gotten the message that attempting smoking cessation with two forms of NRT can improve cessation success.

Not as Good as Vaping?

Smoking cessation researcher K. Michael Cummings, of the Medical University of South Carolina at Charleston, agreed that the Cochrane findings will come as no surprise to people in the field.

“Dual NRT treatment is common practice within the treatment community, but that doesn’t mean other clinicians and the public are aware of the benefits,” he told MedPage Today.

Cummings, who was not involved in the review, added that the evidence favoring higher doses of NRT, and starting therapy before a quit date, is also strong.

But he said even the best available, approved NRT therapies may prove to be less effective for smoking cessation than vaping, due to a key difference in delivery.

While patches, gum, and other approved NRTs deliver nicotine slowly, vaping products more closely mimic nicotine delivery from cigarette smoking. This is especially true for popular, high nicotine e-cigarettes like the JUUL brand.

Cummings cited a 2019 randomized trial of e-cigarettes versus NRT that found vaping to be almost twice as effective as NRT for smoking cessation.

But the study also revealed that 80% of participants randomized to vaping who quit smoking cigarettes were still vaping a year later (63 of 78 participants), while just 9% of those who successfully stopped smoking with NRT were still the therapy a year later (four of 44 participants).

The review was supported by Nuffield Department of Primary Care Health Sciences, University of Oxford, and the National Institute for Health Research (NIHR).

Lindson disclosed serving as managing editor for the Cochrane Tobacco Addiction Review Group, which is funded by the NIHR to the University of Oxford.

LAST UPDATED 04.18.2019

• Primary Source

  Cochrane Lebrary: Database of Systemic Reviews

  Source Reference: Lindson N, et al “Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessaton” Cochrane Review 2019; DOI: 10.1002/14651858.CD013308.

https://www.medpagetoday.com/primarycare/smoking/79309

Quest Launches New Consumer-Initiated STD Tests Through QuestDirect™

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today launched three new sexually transmitted disease (STD) laboratory test packages that individuals can purchase online for some of the most prevalent STDs in the United States. The new STD test packages are the first to be offered directly by Quest Diagnostics or any other major national laboratory to allow individuals to purchase tests at their discretion. These new packages have been designed to meet the needs of individuals who want accurate basic or comprehensive STD testing.

The services are available at QuestDirect.QuestDiagnostics.com.

The new services are designed to empower individuals to access STD screening when they are reluctant to engage their healthcare provider directly. Research by Quest Diagnostics shows that patients and healthcare providers often fail to discuss sexual behavior and STD risk.  According to a survey commissioned by Quest, 51 percent of females age 18-24 years say they don’t want to bring up for discussion the topics of sex or STDs with their clinicians and 49 percent claim their clinician has never asked if they want STD testing.

Rates of syphilis, gonorrhea, and chlamydia have climbed for four consecutive years in the U.S. and are at epidemic levels, with nearly 2.3 million cases of diagnosed STDs in 2017 alone, according to the U.S. Centers for Disease Control and Prevention. Half of all new STD cases are acquired by young people between the ages of 15-24, and one in four sexually active adolescents has a sexually transmitted disease.

“Too many people are not being screened for STDs, and one reason is reluctance to discuss risk with healthcare providers,” said Damian “Pat” Alagia, III, MD, FACOG, FACS, an OB/GYN and medical director of woman’s health for Quest Diagnostics. “Services that empower individuals to access STD testing extend physician-based care so more people can receive the evaluation and treatment they need.”

Clinical Grade Testing Made Easy

The STD test services are available in 45 states starting today through QuestDirect, an enhanced online consumer-initiated testing service provided by Quest Diagnostics to empower patients to manage and take control of their healthcare by purchasing health and wellness lab testing from the convenience of their home.¹ Test results are available on MyQuest, the company’s secure patient portal accessible on a smartphone, tablet, or desktop, typically within a week, and may be shared with the individual’s own physician.

Licensed physicians provide oversight for all lab tests, based upon the information that individuals provide to Quest. This includes ordering tests, if appropriate, and evaluating results once available. Individuals have the opportunity to speak with a physician to discuss any of the lab results. These physicians may provide treatment for certain conditions in some states and recommend further medical follow-up.

“Our research shows consumers believe that the ability to purchase certain tests and receive results would facilitate better communication with their physicians and improve their health. Greater access to accurate testing, diagnoses, and treatment is particularly critical in sexual and reproductive health, where medications can often quickly cure many common STDs,” said Cathy Doherty, senior vice president and group executive, clinical franchise solutions and marketing, Quest Diagnostics. “With these services, Quest is meeting consumers where they are, empowering them to access and take actions from diagnostic insights to improve their health.”

QuestDirect provides the convenience of access to the company’s national network of 2,250 patient service centers and uses the same clinical-grade lab technology and STD test services physicians order on behalf of patients. The packages include tests for chlamydia and gonorrhea, trichomonas, hepatitis B and C, syphilis and human immunodeficiency virus (HIV). Individual STD tests begin at $49 and the new STD test packages beginning at $199.

https://www.biospace.com/article/releases/quest-diagnostics-launches-new-consumer-initiated-std-tests-through-questdirect-/

Alexa: Tell me about Amazon’s ambitions in healthcare

Over the last two years Amazon’s healthcare plans have gone from being a closely guarded secret to underpinning a series of very public deals and product launches, with 2018 proving to be the tipping point.

The year before, all the chatter was focused on the company’s secret healthcare team and the disruptive potential of this, as-yet-unknown, unit. Then all the behind-the-scenes work started paying off.

Twelve months later and the company had made a series of high-profile healthcare appointments, moved into the medical retail sector, made further moves in digital health and established a joint venture with a blue-sky mission.

Keeping up this pace in 2019 would have been surprising, and the company looks to be letting last year’s deals and launches bed-in, but it did make one very interesting, voice-activated move this month.

Its smart-speaker Alexa significantly ramped up its healthcare potential after it gained the ability to transmit and receive health information in line with the US Health Insurance Portability and Accountability Act (HIPAA) and its data privacy and security provisions.

To showcase the new functionality, Amazon signed up a number of healthcare providers, payers, pharmacy benefit managers and digital health coaching companies to launch six new Alexa healthcare skills.

They allow certain users of the device to do things like ask Alexa when their prescription delivery will arrive, to schedule a doctor’s appointment and even check their last blood sugar reading and provide trend information on their blood sugar measurements.

Amazon’s first partners for this new type of Alexa healthcare skill are pharmacy services organisation Express Scripts, health service company Cigna, healthcare networks Providence St. Joseph Health and Atrium Health, digital health company Livongo (see video below) and Boston Children’s Hospital.

“Boston Children’s Hospital has long believed that voice technology has the potential to substantially improve the healthcare experience for both consumers and clinicians”

John Brownstein is chief innovation officer at Boston Children’s Hospital, whose My Children’s Enhanced Recovery After Surgery (ERAS) skill allows patients and caregivers to easily share recovery progress with their care team post-surgery.

“Boston Children’s Hospital has long believed that voice technology has the potential to substantially improve the healthcare experience for both consumers and clinicians,” he said. “We began this journey with one of the first Amazon Alexa skills from a hospital four years ago and are thrilled to participate in the initial launch of Amazon Alexa’s HIPAA-eligible service for developers.”

The hospital’s new Alexa healthcare skill was, he added, “just one example of how voice technology can extend the care and support of our patients beyond the four walls of the hospital”.

As a US-only, invite-only programme, it’s yet to fully hit the mainstream, but the direction of travel is clear to see, with Boston Children’s Hospital not the only organisation to have launched Alexa healthcare projects in recent years.

Others include a first aid skill from the Mayo Clinic and an information skill from WebMD in 2017 and a healthcare information skill from Cigna that arrived last year. The Answers by Cigna skill provides brief answers to more than 250 of the most commonly-asked healthcare questions and aims to improve the public’s health literacy.

With over 20% of Americans owning a voice-activated smart speaker, of which Amazon’s Echo is currently the most popular, there’s a good chance it could help with this, given that one third of adults in the US have either basic or below basic abilities to deal with health information, according to the Department of Health and Human Services.

Amazon’s healthcare plans and projects

The development of Alexa as a source for health information and tools is just one strand of Amazon’s efforts in healthcare and looking at its achievements in 2018 that I briefly mentioned above gives a sense of the scale at which it wants to operate within healthcare – and perhaps pharma.

The tech giant’s commerce roots were evident in its $1 billion acquisition of US online pharmacy PillPack last summer. The deal with PillPack could disrupt the traditional pharmacy market by delivering pre-sorted medicines and refills to customers’ doors and Amazon also showed interest last year in India’s second-largest pharmacy MedPlus.

It followed those activities with the October launch of an exclusive range of diabetes and hypertension devices. The Choice devices, produced by healthcare consultancy the Arcadia Group, included blood glucose monitors, blood pressure monitors and test strips to help people manage their conditions at home.

Amazon also began selling an exclusive line of Perrigo OTC products as part of its Basic Care range in a move that, as Business Insider suggested, could help strengthen the company’s association with healthcare in consumers’ minds.

The company already sells a huge variety of professional medical supplies, offering everything from scalpels to sample containers and even a hospital room, and its Amazon Business unit aims to be a major supplier to hospitals.

“When talking about the ‘GAFA’ (Google, Apple, Facebook and Amazon) bloc of technology companies and their efforts in healthcare it’s common to speculate as to how or when their non-pharma players will disrupt the sector”

On the digital front in 2018, Amazon’s Web Services unit joined a cloud computing initiative from the US National Institutes of Health (NIH) that aims to harness the power of commercial cloud computing for NIH biomedical researchers. And there was also the November launch of machine learning tool Comprehend Medical, which mines doctors’ notes and patient health records for data about a patient’s diagnoses and medications.

Last year also saw Amazon make a trio of headline-grabbing appointments, as it signed up the FDA’s former chief health informatics officer Taha Kass-Hout, cardiologist Maulik Majmudar and Atul Gawande, a surgeon and writer.

The latter was picked to head-up Amazon’s non-profit joint venture with Berkshire Hathaway and JPMorgan Chase, known for now as Haven, that launched with a mission to provide their employees with a better health plan.

When talking about the ‘GAFA’ (Google, Apple, Facebook and Amazon) bloc of technology companies and their efforts in healthcare it’s common to speculate as to how or when their non-pharma players will disrupt the sector. In Haven, which now wants to deliver “better outcomes, satisfaction and cost efficiency in care”, Amazon – and its partners – are certainly setting their sights high.

Amazon has come a long, long way since it was first incorporated in 1994 as Cadabra, Inc – a name swiftly dropped after a lawyer visiting Jeff Bezos pronounced it ‘cadaver’.

Thankfully, its prospects in health are, well, much healthier today and, 25 years after it began life as an online bookshop, the flurry of healthcare activity witnessed in the last 12-18 months could well reflect Amazon’s own commercial evolution into the ‘everything store’.

Alexa: Tell me about Amazon’s ambitions in healthcare

Mustang Bio rally lifts Fortress Bio

Fortress Biotech (NASDAQ:FBIO) is up 62% premarket on average volume in lockstep with the rally in subsidiary Mustang Bio (NASDAQ:MBIO) related to positive data from a clinical trial evaluating its lentiviral gene therapy in ten infants with bubble boy disease (lack of immunity).

Thinly traded MBIO is up 255% premarket on increased volume, albeit on turnover of only 56K shares.

https://seekingalpha.com/news/3451792-mustang-bio-rally-lifts-fortress-bio-62-percent-premarket