CSL’s Seqirus expects to double flu vaccine production at NC plant

• Seqirus, a vaccine business owned by Australian biotech CSL, expects production of its influenza vaccine Flucelvax Quadrivalent at a North Carolina manufacturing plant to double now that the Food and Drug Administration has approved the company’s new cell-based manufacturing process.
• CSL became the world’s second largest flu vaccine manufacturer in 2016 with the launch of Seqirus, a unit that combined its existing vaccine arm, bioCSL, with Novartis’ global flu vaccine business, which the biotech bought in 2014 for $275 million.
• During CSL’s last fiscal year ending June 30, Seqirus revenue rose 23% year over year to $900 million. Driving that growth were seasonal flu vaccine sales in the U.S., as well as the launch of three flu shots: Fluad, Afluria Quadrivalent and Flucelvax Quadrivalent.

The most recent flu season was one of the worst in a decade. A Centers for Disease Control and Prevention database found that between Oct.1 and Feb. 3, the weekly percentage of outpatient visits to healthcare providers for flu-like illness ranged from 1.3% to 7.7% — often cresting well above the national baseline of 2.2%. In fact, the percentage stayed above that baseline for at least 11 consecutive weeks during the flu season.

Key to the outbreak was that vaccines were less effective against one influenza A strain, H3N2.

Regulators are already working to figure out why the vaccines weren’t very successful, and to ensure the 2018-19 flu season isn’t as severe. The FDA said early this year it would team up with the Centers for Medicare and Medicaid Services to comb through a database of 4 million patients to better understand the details of their vaccinations and whether or not they were hospitalized.

“This work, which is still underway, will try to better understand why overall effectiveness with both the cell-based and egg-based vaccines was less than optimal,” FDA Commissioner Scott Gottlieb said in a February statement. “We’re also looking at the difference in effectiveness in people 65 years and older who were vaccinated with high-dose influenza vaccine and adjuvanted influenza vaccine to see if effectiveness was better than in those vaccinated with standard dose vaccines.”

While regulators look for answers, manufacturers face pressure to produce not only better vaccines but more of them.

CSL is hoping Seqirus’ newly approved production process will help in that regard. Globally, most flu vaccines are created using chicken eggs. Seqirus itself uses egg- and cell-based processes to manufacture its products.

Both methods have their advantages, according to Gordon Naylor, president of Seqirus. Yet early data coming out of the last U.S. flu season suggests that the cell-based variety may have produced better vaccines.

“So it may be helpful in addressing the issue … where sometimes you have a lower level of matching between the circulating influenza virus and what the vaccine’s been made to protect against,” Naylor said of cell-based vaccine production in an interview with BioPharma Dive.

He noted, however, that it’s early to draw any definitive conclusions from the data. “We’re encouraged by what we’ve seen, and we’ll continue to investigate further,” he said, “and so what we may have here is this interesting situation where it may be a more effective vaccine using cells and we’ve actually been able to significantly increase the output of this vaccine.”

Seqirus’ Holly Springs, North Carolina-based manufacturing plant came to be through a flu vaccine partnership with the U.S. Biomedical Advanced Research and Development Authority, better known as BARDA. Flucelvax Quadrivalent is the only seasonal flu vaccine it produces, though the site also plays a role in safeguarding the U.S. should a flu pandemic occur.

The plant’s new manufacturing process improves the way cells are grown, including a change in the media, and should allow for double the output of Flucelvax Quadrivalent without adding new equipment, according to Naylor.

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WuXi adds new platform as business booms

• WuXi Biologics will launch a new bispecific antibody technology platform, dubbed WuXiBody, that the Hong Kong-based company boasts will cut costs and shorten development timelines by between 6 and 18 months.
• A contract development and manufacturing organization (CDMO), WuXi has been steadily adding business as it grows its production capacity, announcing in its first-half results that it has nearly 190 development projects currently ongoing, up from 134 a year previous. Notably, ten projects are now in Phase 3 and one is commercial-stage.
• That project pipeline could grow further, too. WuXi said investment in its cell line platform enables it to begin as many as 60 IND-enabling projects per year.

A string of deals and expansions in Wuxi’s manufacturing capabilities across China, the U.S., Ireland and Singapore has brought the company’s total capacity to around 220,000 liters. And with the U.S. OK of TaiMed’s HIV therapeutic Trogarzo (ibalizumab), WuXi is the first company in China to manufacture an approved biologic under a Investigational New Drug Application.

This growth is reflected in WuXi’s improving financials. Revenue grew to just over $154 million in the first six months of 2018, a jump of 60% from the same period a year prior. Adjusted net profits, meanwhile, nearly doubled to $43 million over the first two quarters.

WuXi’s ambitions don’t stop there — it already thinks of itself as a top 10 CDMO and hopes to grow further. Adding bispecific capabilities could help it reach new clients.

Company CEO Chris Chen hinted that WuXi might enter new areas like cancer vaccines.

Chen also noted that no clients transferred projects out of the company over the six-month period, while WuXi picked up six clinical-phase projects from EU and U.S. companies.

While the story of the Chinese biomanufacturing sector has been one of growth, the industry is also struggling to shed concerns over quality. Warning letters from the Food and Drug Administration to Chinese manufacturers have increased, and a vaccine scandal has led to fresh distrust as well as dismissal of several high-level regulators.

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Physician referral issues causing more out-of-network care

• Some providers aren’t properly referring patients, which could lead to inappropriate and out-of-network care, according to a new survey by Kyruus.
• The online survey of 200 primary care and specialty physicians found that 34% of out-of-network referrals could be avoided if providers had more information on other doctors’ specialties and areas of focus.
• Kyruus found that 77% of providers recognized the importance of keeping patients in-network for care coordination, but 79% admitted that they refer patients out-of-network.

Kyruus said the survey shows that improving referral processes can help health systems improve patient retention.

A leading theme in the report is that providers don’t have the information needed to make sure patients are getting clinically appropriate, in-network care. Nearly half of doctors surveyed said they have trouble determining who is in-network. The doctors estimated they could avoid one-third of out-of-network referrals if they had more information about in-network providers.

Another problem that can hurt patient retention is that 42% of patients leave a provider’s office without a necessary referral appointment booked.

A whopping 72% of providers acknowledge that they or their staff usually refer to the same provider for a specialty rather than figuring out whether there’s another provider with more specific expertise or who has an earlier appointment. On the flip side, 42% of providers said they’re not practicing at the top of their license most or all of the time, which the report said can hurt physician satisfaction.

Erin Jospe, chief medical officer at Kyruus, said knowing who’s in-network and their specialties is a long-held challenge for physicians. “This new research reaffirms the widespread need to empower physicians with better insights and capabilities, so they can make the best referrals for their patients and help guide their care more effectively,” she said in a press release.

Beyond care coordination and provider satisfaction, the issue of out-of-network care goes to balance billing, also called surprise billing, and rising out-of-pocket costs. A recent Kaiser Family Foundation report found that nearly 20% of inpatient admissions in large employer health plans include a claim from an out-of-network provider. Those claims are especially problematic for patients getting outpatient mental health services.

Rising out-of-pocket costs are causing Americans to delay healthcare. A recent Bankrate survey of 1,000 adults found that 22% said they or a close family member delayed necessary medical care because of the cost, and 77% said cost worries had led them to avoid care.

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Income surges for publicly traded health systems including HCA, Universal Health

Nashville-based HCA Holdings had the most profitable second quarter among publicly traded health systems with income of $820 million on $11.53 billion in revenue—a 25% increase compared to the second quarter of 2017.

Citing growth across the majority of its service lines, the health system giant was just one of several publicly traded health systems that saw profits surge last quarter by 20% or more compared to the same quarter in last year, according to a review by FierceHealthcare.

King of Prussia, Pennsylvania-based Universal Health Services reported a jump in profits in the second quarter to $226 million on revenue of $2.68 billion. That’s a 22% increase from $185 million in net income on $2.61 billion in revenue for the system, which has more than 350 acute care hospitals, behavioral health facilities and ambulatory centers across the U.S., Puerto Rico and the U.K.

Brentwood, Tennessee-based LifePoint Health and Franklin, Tennessee-based Community Health Systems both reported improved income despite lower revenue last quarter.

LifePoint reported profits of $52 million on revenue of $1.57 billion, up from $43 million on revenue of $1.59 billion.

Community Health Systems reported losses of $110 million last quarter on $3.5 billion in revenue in the second quarter. That represented an improvement of 25% compared to its losses of $137 million on $4.1 billion in revenue in the same quarter of 2017. The health system owns, operates or leases 118 hospitals in 20 states with approximately 20,000 licensed beds.

This quarter echoes what Axios’ Bob Herman found when he looked at profits among a collection of dominant nonprofit hospitals around the U.S.

Earlier this year, CNBC reported U.S. health systems were beginning to feel the pain of falling profits as patient care shifts toward outpatient settings and labor costs grow. That’s based on median hospital operating cash flow margin as measured by Moody’s Investors Service, which fell to 8.1% last year from 9.5% in 2017.

Moody’s projected for-profit hospitals would remain stable on higher earnings and flatter margins.

https://bit.ly/2wk1QSy

23andMe to shut off third-party access to its deidentified genomic data

Home DNA test kit maker 23andMe is cutting off third-party developers from directly accessing its deidentified genomic data, according to a report from CNBC.

In an email sent by the company to developers and obtained by the network, 23andMe said its open API will be disabled in the next two weeks, with apps only being able to access reports generated by the company and not the rich information generated by its consumers. Research partners will still be able to access the raw data.

23andMe first began granting data access to third-party developers in September 2012, as a way to crowdsource applications for its customers, while requiring individual-level consent for all information use.

The API has been used to integrate genomics into electronic medical records, clinical care and fitness and diet trackers, as well as providing entertainment through exploring ancestry or creating personalized pieces of art.

More focused research applications have included Pfizer’s use of the database to identify 15 genomic regions believed to be linked to depression.

Through an NIH-funded study published in Nature Genetics, researchers gathered data from more than 300,000 people in 23andMe’s database, with 75,000 self-identifying with depression diagnoses.

Pfizer ran further analyses using a replication dataset featuring another 150,000 people, with 45,000 diagnosed with depression, leading to the discovery of 17 single-nucleotide polymorphic variations from 15 regions reaching genomewide significance. Previously, an earlier study of 6,000 people with depression was only able to uncover two areas of interest.

According to the email cited by CNBC, 23andMe is updating its API program to “focus on apps that build on the interpretations and results” provided to its customers.

GlaxoSmithKline made a $300 million investment in 23andMe late last month, as part of a four-year, 50-50 collaboration deal using its genomic and phenotypic data to advance a number of product development programs and discover new drug targets. GSK will also analyze the database to validate its portfolio and support enrollment in its clinical trials.

The agreement features an option to extend the collaboration into a fifth year, with GSK becoming 23andMe’s exclusive drug target discovery partner.

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Bristol-Myers to sell immuno-oncology med Opdivo in China at half US price

After Bristol-Myers Squibb won the first immuno-oncology nod in China for its PD-1 star Opdivo in June, all parties were holding their breath for its price tag. After all, it would set a bar for other I-O therapies on their way to the key market.

And now we know. Opdivo will be priced in China at half its U.S. cost, according to local reports.

The drug will come in at retail prices of 9,260 yuan ($1,354) for the 100mg/10mL vial and 4,591 yuan ($671) for the 40mg/4mL dose, local business news organization Caixin reported, following rumors that first emerged on social media Monday. In the U.S., the larger vial costs about $2,600 to $2,800, and the smaller vial runs about $1,100, according to the drug pricing website GoodRx.

A Bristol-Myers Squibb spokeswoman wouldn’t confirm the reported price, and a media aide in China Tuesday told FiercePharma that the company is “working with the government to complete” the pricing process.

“The price of Opdivo will take the value of the medicine, affordability for Chinese patients and the high unmet medical needs into consideration,” the company said in a statement. It also promised to work with payers and third parties, through various programs, to open up Opdivo to more patients.

Caixin also reported that BMS might initiate a patient assistance program—a typical move for high-cost cancer drugs in China as well as the U.S.—which will offer patients six months of free treatment after they pay for the first five.

The Chinese price will be quite a bit lower compared with other parts of Asia, according to local reports. After a round of price cuts, the drug still costs about $2,500 in Japan. Its prices in Hong Kong and Singapore each came above $2,000 per vial.

A significant discount? Yes. But even at the much lower price, the cost is still a huge burden for Chinese patients. The drug will be given as a bimonthly injection at 3mg per one kilo of the individual patient’s weight. That means someone weighing 60 kg will need to pay 18,442 yuan every two weeks.

To put that in context, in Shanghai, the per capita annual disposable income in 2017 was a little below 59,000 yuan.

Opdivo could become less pricey for patients if it’s included on government-run insurance programs. However, Professor Yilong Wu, who led Opdivo’s Chinese-specific phase 3 trial that led to its approval, told The Paper (Chinese) that he doesn’t expect Opdivo will be considered for that coverage.

Compared to targeted therapies, PD-1 inhibitors cannot really pinpoint the perfect patients who benefit most, said Wu.

“Clinical trial results showed that, among five patients on Opdivo, only one really benefited from it,” he said. “It’s just that the duration of the benefit was long, which is why the drug was approved.”

Last week, China’s State Medical Insurance Administration unveiled a list of 18 cancer drugs that will be part of negotiations this year for adoption by the national medical insurance scheme. While Opdivo didn’t make that list, several other newly approved therapies did, such as AstraZeneca’s lung cancer drug Tagrisso and Takeda’s multiple myeloma treatment Ninlaro, as well as ALK-positive lung cancer therapies Zykadia by Novartis and Xalkori from Pfizer.

Based on previous talks, drugs usually need to take huge price cuts to win enlistment on the National Reimbursement Drug List and thus reach more patients. Last year, for example, the 36 drugs newly added to the roster took an average 44% discount.

As for the PD-1/PD-L1 fight in China, Merck & Co. just won Keytruda approval a month ago, and all eyes will now move to its pricing strategy. Besides, local players Zhejiang Hengrui, Innovent and Junshi Biosciences have candidates under priority review at the Chinese regulators.

https://bit.ly/2PyccHt

Monsanto faces 8,000 lawsuits on glyphosate

The number of U.S. lawsuits brought against Bayer newly acquired Monsanto has jumped to about 8,000, as the German drugmaker braces for years of legal wrangling over alleged cancer risks of glyphosate-based weedkillers.

Bayer had previously disclosed 5,200 such lawsuits against Monsanto, which it acquired in a $63 billion deal completed in June.

“The number of plaintiffs in both state and federal litigation is approximately 8,000 as of end-July. These numbers may rise or fall over time but our view is that the number is not indicative of the merits of the plaintiffs’ cases,” Bayer Chief Executive Werner Baumann told analysts in a conference call on Thursday.

Bayer shares have lost more than 10 percent since Monsanto was ordered on Aug. 10 to pay $289 million in damages in the first U.S. lawsuit over glyphosate-based weedkillers such as Roundup and Ranger Pro.

The legal headache adds to a number of distractions for Bayer, such as falling consumer care product sales and a rebuke on production practices from the U.S. drugs watchdog, as it seeks to strengthen its drug development pipeline and has begun integrating Monsanto into its organisation.

“While this is disappointing, it is not surprising. Indeed, in our litigation scenario analysis, we assumed a doubling of cases to 10,400,” said Alistair Campbell, analyst at brokerage Berenberg.

Bayer shares were down 1.8 percent at 1600 GMT while the German blue chip index <.GDAXI> was up 0.2 percent.

CEO Baumann reiterated Bayer’s view that the jury’s verdict on Aug. 10 was inconsistent with the science-based conclusions of regulators.

Bayer said it will initially petition the judge to reverse the jury’s verdict from Aug. 10, and “if necessary” challenge the ruling with California appellate courts, which will take at least a year.

When asked whether Bayer would consider settling cases out of court, he said: “We will vigorously defend this case and all upcoming cases.”

Bayer executives on the call stressed that demand for glyphosate and seeds for crops that tolerate the broad-spectrum herbicide had not been affected by the verdict.

“Nothing whatsoever has changed in the regulatory status of the product. There is simply very high demand, and has been for many decades for glyphosate. It is an invaluable tool for growers,” said Liam Condon, the head of Bayer’s newly enlarged Crop Science division.

Bayer also said on Thursday that it sees no reason to re-assess the legal risks from Monsanto.

Last week Bayer, which is retiring the Monsanto name, launched the integration of Monsanto into its organisation. That is seen as a daunting task even without the litigation, almost two years after it signed the $63 billion deal.

Bayer’s second-quarter results, due on Sept. 5, would include provisioning for legal defence costs but no money would at that point be set aside for any possible future damages, finance chief Wolfgang Nickl said.

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