Novartis/Alcon pull CyPass Micro-Stent for surgical glaucoma from global market

Novartis International AG / Alcon announces voluntary global market withdrawal of CyPass Micro-Stent for surgical glaucoma . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Decision based on five-year data from COMPASS-XT long-term safety study
• Alcon advises ophthalmic surgeons to cease further implantation

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study.

The US Food and Drug Administration (FDA) approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year COMPASS study. The COMPASS study demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in subjects implanted with the CyPass Micro-Stent at the time of cataract surgery, as compared to subjects undergoing cataract surgery alone. At two years post-surgery, there was little difference in endothelial cell loss between the CyPass Micro-Stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss.[1], [2]

The COMPASS-XT study was designed to collect safety data on the subjects who participated in the COMPASS study for an additional three years, with analysis of the completed data set at five years post-surgery. At five years, the CyPass Micro-Stentgroup experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone.

“We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do,” said Dr. Stephen Lane, Chief Medical Officer, Alcon. “Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future.”

This voluntary market withdrawal applies to all versions of the CyPass Micro-Stent. Alcon will be communicating directly with ophthalmic surgeons with recommendations for evaluating and managing those patients who have already received a CyPass Micro-Stent and instructions for returning unused devices.

Contact Information for U.S. Customers

Customer Services	+1 800 862 5266 for assistance with product returns
Medical Information	+1 800 757 9785 for medical information on the CyPass Micro-Stent
Medical Safety	+1 800 757 9780 to report product complaints or adverse events

Customers located outside the U.S. should contact their local Alcon representative.

https://bit.ly/2wp7qUJ

Fosun Pharma 1H net down 7.6% to RMB1.56b; no div

Shanghai Fosun Pharmaceutical (02196) said its profit attributable to owners of the parent for the six months ended 30 June 2018 dropped 7.61% year-on-year to RMB1,560 million.

Basic and diluted earnings per share were RMB63 cents.

Revenue amounted to RMB11,767 million, an increase of 42.2% from a year earlier.

No interim dividend will be distributed.

https://bit.ly/2wplcXk

Google, Amazon, Microsoft and others have a long road ahead in healthcare

As tech giants start to forge paths into healthcare, they stand to put pressure on established healthcare IT firms to open up their systems and adopt data standards.

But change won’t happen overnight, and these outsiders will need to adjust too, gaining access to healthcare data and making it useful while potentially moving at a slower pace than they’re used to.

Recently, six tech giants—Google, Microsoft, Amazon, IBM, Oracle and Salesforce—pledged to work towards greater interoperability in healthcare, especially related to cloud- and AI-based technologies.

“They’re not the first to try to solve this problem of interoperability, and to date, no one’s had a lot of success,” said Daniel Farris, a partner and chair of the technology group at the law firm Fox Rothschild. “But clearly, they’re better positioned than most to solve the problem.”

To succeed, these six companies will need to learn a whole new industry. Meanwhile, they’ll bring a whole new mindset to that industry, one based on the widespread availability and sharing of data, Farris said.

“The tech companies tend to think about how else they can use the data, how they can use it for convenience and for cross-sales,” Farris said. “That’s just not something healthcare organizations or healthcare tech tends to look at.”

Healthcare organizations tend to focus instead of more traditional business models that involve owning data but not necessarily moving it around. “These new companies are more platform business models where they create value by facilitating transactions which requires data to move with less friction,” said Dr. James Woodson, CEO of Pulsara, which makes healthcare communication software.

Data is both a boon and a sticking point for outside tech companies. While they have experience moving around large amounts of data, they lack a lot of the specific healthcare data that healthcare companies like Epic and Cerner already have.

And they lack experience handling that data according to regulations, like HIPAA.

“Interoperability is about data more than apps, so that’s a major challenge for them to actually be effective in bringing about this change,” Farris said. “The way healthcare organizations address these things is almost completely opposite from the way the tech companies address these things.”

While big tech companies happily share data—and sometimes share that data with nefarious actors, as with Facebook and Cambridge Analytica—healthcare companies are less generous. That’s in part because they haven’t had many incentives to open up their architectures to more easily share information, said Bob Fuller, managing partner with data consulting firm Clarity Insights.

“The big tech companies are stepping up in a big way to fill that void,” Fuller said.

Healthcare companies and tech giants do have one major commonality in how they treat data transfers: standards. In their pledge, the six companies pointed specifically to open standards, such as FHIR, as a way to more easily exchange data.

Though the standard is much touted in the healthcare industry, many have yet to fully adopt it as a way to move data. The six tech companies are “sort of back-handedly saying the EHR companies are not moving fast enough and their APIs are not as robust as we need,” said Nick Hatt, a senior developer at Redox, an interoperability-focused software company.

The entrance of these big tech companies could steer traditional vendors towards standards and more capable APIs.

“These big companies are happy to agree on something for a standard and then they can compete on implementation,” Hatt said. “They’re saying, ‘we all agree that we’re going to do it this way, so we can push the competition to the right place, which is actually on the AI models and cloud services.”

FHIR is a way to get there. Once they have access to healthcare data, these companies could then use it for machine learning and AI models, including models for profiling patients, according to Dr. Shafiq Rab, CIO of Rush University Medical Center.

“If I can profile you, I can sell to you,” Rab said.

Most of the companies were mum about their specific plans and did not provide comments. Oracle, though, said it would draw on its data management and healthcare software to drive change in the industry. “Our one unique differentiator is that we combine clinical, financial, genomics and administrative data in a single platform,” said Andy Alasso, vice president of product management for Oracle Health Sciences.

Regardless of what they end up doing, as these six companies dive deeper into healthcare, they must be careful not to succumb to the woes IBM is facing with Watson Health, Fuller said. “Their marketing was way too far ahead of their capability,” he said. “You should be visionary in where you’re going but also pragmatic in what it takes to get there.”

That means these companies might have to move slower than they’re used to. “I think nothing dramatic is going to change in the next three to four years,” Hatt said. “IBM got out ahead with Watson Health, and by all accounts it’s been a disaster. The fail cycle for health systems is really long.”

There’s a big gap between healthcare developers and developers in the rest of tech, Hatt added. Because of that gap, the pledge plays an important part in showing that healthcare can act more like the tech industry, he said.

The pledge’s impact will depend on how these six companies interact with existing healthcare firms, which still mostly rely on closed, on-premise systems.

“Healthcare vendors are in a much better position now based on the current technology to be able to focus on interoperability issues,” Fuller said. “Legacy vendors need to come to grips with the fact that keeping closed systems is not going to be to their advantage.”

https://bit.ly/2BUs4RN

RNAi: The Monoclonal Antibody of the 2020s?

There’s been another milestone in the history of biotech: The world’s first RNAi gene-silencing drug, Alnylam Pharmaceuticals‘ Onpattro, got approved on August 10. That makes 2018 a landmark year. But another year—2014—may prove just as influential for the field and how it develops.

Alnylam…and RNAi itself…didn’t look like such a good bet four years ago as big pharma bailed out of RNAi en masse. Merck had acquired Sirna Therapeutics for $1.1 billion in 2006, flush with enthusiasm, but then entered a long period of silence with apparently little progress. It sold off a few key assets and patents to Alnylam in 2014 for $175 million before exiting the field. Rochedid something similar the same year, selling off assets to Arrowhead Pharmaceuticals that it had acquired in 2008. And Novartis, likewise, bailed out in 2014, citing “ongoing challenges with formulation and delivery and the reality that the current range of medically relevant targets where siRNA may be used is quite narrow.” The smart money, it seemed, was betting against RNAi.

Fast forward today, and that makes for a very interesting playing field. Expertise and intellectual property around RNAi have been unevenly concentrated in a few dozen smaller companies, many still private.

That’s a lot of potential opportunity and relatively few hands. To hear Alnylam talk about it, RNAi is now where monoclonal antibodies were around the turn of the century—kinks worked out and ready to explode. And it’s true that Alnylam alone could have as many as five RNAi products on the market by the end of 2020.

Other companies are heating up, too. This month, Sirnaomics announced it was launching its first clinical trial of an RNAi therapeutic in bile duct cancer—a potentially massive new frontier for the field. Other companies are looking at everything from heart disease to infectious disease. Gene silencing does indeed promise a new kind of access to our biology, including ways to modulate previously “undruggable” targets.

RNAi’s Not So Well-Kept Secret

But there is one lingering problem. The problem of getting RNAi into cells—the problem that caused big pharma to largely bail out of the field a few years ago—has been overcome using lipid delivery systems that are largely taken up in the liver. That’s why just about every advanced RNAi program relies on gene silencing that can take place in the liver alone, whether it’s shutting down transthyretin, PCSK9, COX-2, or antithrombin–all expressed largely or wholly in the liver.

There are some exceptions emerging. Quark Pharmaceuticals is developing siRNA drugs that are delivered to the eye, a largely closed biological system. miRagen is targeting microRNA to the skin, where clearance is likely to be slower. These and other alternatives may turn out to be successful—but that’s not yet established, and for now, there appear to be some clear limits on where RNAi can go.

That may be why big pharma isn’t quite kicking itself for bailing out too soon. With their preferred focus on cancer, large companies may be just as happy to come in as late-stage partners for the largely orphan indications that are likely to remain the focus on RNAi companies for the time being.

At the same time, as limitations go, gene-silencing in the liver isn’t a bad one. It opens up a lot of possibilities and gives smaller (or even mid-sized companies like Alnylam) plenty of freedom to operate and build large commercial businesses. This may not quite be like the birth of monoclonal antibodies, but RNAi is likely to become a significant therapeutic modality over the next decade.

https://bit.ly/2PKETRr

Health Watchdog Group Calls for Termination of Sepsis Treatment Trial

Citing safety concerns, a watchdog organization is calling on the National Institutes of Health (NIH) to halt enrollment in a clinical trial evaluating a treatment for sepsis that the organization said is risky and flawed.

STAT News first reported that Public Citizen’s Health Research Group has taken aim at the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS) trial. Public Citizen called the trial “deeply flawed, riddled with serious regulatory and ethical lapses” and urged the NIH to halt the trial.

Public Citizen said that patients in the clinical trial are being given one of two treatments for sepsis, both of which it said are risky. Neither of the medicines can be considered standard treatments, Public Citizen said in a statement. Public Citizen said usual care for sepsis, a life-threatening complication from an infection, doctors typically adjust doses of intravenous fluids and blood-pressure-raising medication. The organization said the CLOVERS Trial will not follow the typical care and will provide half the patients with the IV fluids and the other half with the blood pressure treatments. The organization said there is no control group being provided the standard of care, so researchers cannot “adequately determine if either of the experimental treatments is too unsafe to continue using.” Not only that, but the organization said the researchers will be unable to draw any significant conclusions without the comparison to the typical treatments for sepsis.

“Because no other group of patients in the trial is receiving the usual treatment for sepsis, researchers can’t ensure that the experiment isn’t causing increased deaths and organ failure. Sepsis is a life-threatening condition in which bacteria or their toxins get into the bloodstream, causing shock and organ failure,” Public Citizen said in its announcement.

Michael Carome, director of Public Citizen, called the trial design “disturbing.” He said its design is closer to an experiment that would be conducted on laboratory animals and not people.

“These human subjects are unwitting guinea pigs in a physiology experiment that will not advance medical care for sepsis and likely will harm many,” Carome said in a statement.

The CLOVERS trial is being run across 16 different institutions, including Cleveland Clinic Foundation, Beth Israel Medical Center and Vanderbilt University Medical Center. There are another 26 study sites that have not begun enrolling, Public Health noted. CLOVERS researchers anticipate enrolling up to 2,320 subjects by the trial’s projected completion in March 2021, the watchdog group said.

“The misalignments in CLOVERS between individual patients’ needs and treatments being given as part of the experiment are far outside the norms of sepsis treatment,” Carome said. “It is obvious they carry an unacceptable increased risk of organ failure and death and should be avoided.”

The trial, according to Public Citizen, is being funded by the National Heart, Lung, and Blood Institute (NHLBI) through its Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. The watchdog group is calling for a moratorium on all current PETAL Network trials and “any other NHLBI-funded clinical trials testing interventions in critically ill subjects until the multiple systemic breakdowns that permitted CLOVERS to be approved are fully understood and corrected.”

https://bit.ly/2ojx3BV

China Biologic Products Responds to Lawsuit Filed by Former Chairman

China Biologic Products Holdings, Inc. (NASDAQ: CBPO) (“China Biologic” or the “Company”), a leading fully integrated plasma-based biopharmaceutical company in China, today issued the following statement in response to a lawsuit filed against the Company in the Cayman Islands by Mr. David (Xiaoying) Gao, the former Chairman and CEO of the Company who was terminated for cause:

“We deeply regret that Mr. David Gao, acting individually in his personal capacity, has attempted to challenge the completion of the private placement that was announced on August 24. The Company is prepared to fend off meritless lawsuits like this and will take actions to seek actual and punitive damages from Mr. Gao in connection with his ill-intended lawsuit as well as any damages caused by breaches of his employment agreement. The Company continues to believe that the private placement transaction referred to in the lawsuit is beneficial to shareholders, through the additional capital and strategic partnerships which it will result in. The Company understands that the investors involved remain committed to the transaction, and, with their support, China Biologic will be very well situated to acquire and develop the leading technologies and assets that will help drive exceptional shareholder value for the long term. The Company has closed 3,800,000 shares in the private placement and will close the remaining in accordance with the transaction agreements.”

https://bit.ly/2wlbEg4

After years of upticks, HPV vaccination rates still lag far behind U.S. goal

Centers for Disease Control and Prevention officials have been pushing HPV vaccination, and in 2017—just as in the previous four years—those efforts yielded only a slight increase. About half of U.S. adolescents have been fully vaccinated against the cancer-causing virus, far short of the 80% officials are aiming for by 2020.

The figures come courtesy of the CDC, which reports 65.5% of adolescents received at least one dose of an HPV shot, while 48.6% completed the course. Both numbers represent about a 5% increase over 2016 and follow increases of about the same amount each year since 2013.

Merck & Co. controls the HPV vaccination market in the U.S. with its blockbuster shot Gardasil 9, thanks to GlaxoSmithKline’s decision to pull its rival shot, Cervarix, out of the market. Last year, the Merck vaccine captured $1.57 billion in the US and $2.3 billion around the world.

The CDC’s report comes in the wake of the agency’s move to change its HPV vaccine recommendations to a two-dose regimen instead of three, hoping to increase uptake. It’s “too early to assess” whether that change has affected vaccination rates, though, the CDC report said.

And even as the numbers represent an increase over 2016’s rates, coverage holes remain. Fewer adolescents in rural areas are getting the vaccines compared with their peers in urban areas. And boys still trail girls in HPV vaccination rates nationwide.

All in all, the figures come short of a HHS “Healthy People 2020” goal of an 80% coverage rate for boys and girls in 2020.

Alongside the report, the CDC released findings that about 43,000 people in the U.S. developed an HPV-associated cancer in 2015. The agency notes vaccination could prevent 90% of the cases and recommends boys and girls ages 11 to 12 receive two doses of the vaccine at least 6 months apart.

Despite Gardasil’s ongoing growth—and the U.S. efforts to amp up vaccination rates—it’s not the U.S. that Merck is touting as a source of expansion going forward. Executives figure the franchise can continue its upward march as other countries around the world promote HPV vaccination. As one example, the U.K. government just last month decided that, after years of protest by activists, the vaccine should be given to boys as well as girls.

https://bit.ly/2MW5cp3