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Thursday, January 31, 2019

VALNEVA Positive Initial Booster, Final Phase 1 Data for Lyme Disease Vaccine

Valneva SE (“Valneva”), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, today announced positive initial booster data and final Phase 1 data for its leading, unique Lyme disease vaccine candidate VLA15.
To investigate whether a VLA15 booster will elicit an anamnestic response[1], Valnevaamended its Phase 1 study protocol during 2018, adding a booster dose in a sub-cohort of the Phase 1 study population. At the same time the full Phase 1 study population has been followed-up across all doses for up to one year, providing the final Phase 1 data.
The final Phase 1 data confirmed the safety and tolerability profile observed at all time-points, as reported in the interim analysis. VLA15 demonstrated a favorable safety profile and had no associated safety concerns. In addition, the final Phase 1 immunogenicity results indicated that the alum-adjuvanted formulations elicit higher immune-responses at all time-points, confirming the interim data findings. As expected, based on the interim Phase 1 data, antibody titres declined post Day 84 across all groups, trending towards baseline at approximately one year post initial vaccination.
To evaluate the benefit of a booster dose, 64 subjects across the two higher dose groups (48µg and 90µg, both with and without alum) from Phase 1 received a booster in the period 12 to 15 months after their initial dose in the primary immunization. These single re-vaccinations resulted in a significant immune- response, yielding OspA antibody titres at levels 2.7-fold (ST3[2]) – 5.8-fold (ST1) over the initial titres observed at Day 84 (geometric mean fold rise (GMFR)). These results are in line with published data from other OspA-based Lyme vaccines that had previously been in development.
Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva, commented, “These encouraging results support our current development plans and hypothesis for our leading vaccine candidate, VLA15.  As a result of these findings, we have included a VLA15 booster in the Phase 2 program that is now underway.
Addressing the significant, and growing, unmet medical need caused by Lyme disease is our top priority, VLA15 remains the only Lyme vaccine candidate in clinical development worldwide.”
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Novan Provides Business Update

  • End-of-Phase 2 meeting with FDA for molluscum granted and scheduled for early March
  • Active business development discussions ongoing around certain late-stage assets and broader dermatology platform
  • Dr. David Hebert joins Novan as Senior Director of Biometrics
  • John M. Gay, Vice President of Finance and Corporate Controller, appointed Principal Financial Officer and Corporate Secretary
 Novan, Inc. (“the Company” or “Novan”) (NASDAQ: NOVN) today provided an update on several aspects of its business.
Novan announces that it has been granted an end-of-Phase 2 meeting with the FDA in early March 2019 for the SB206 molluscum program. This meeting will enable Novan and the FDA to agree on a Phase 3 development plan for molluscum with SB206 12% once-daily as the active treatment arm. The Company intends to provide a further update after the meeting with respect to a path forward for the asset and indication.
Additionally, Novan is continuing to pursue several active business development discussions around certain of its late-stage assets, including SB206 for molluscum, and the broader dermatology platform.
To support the current business strategy and to expand its expertise in scientific translation and overall drug development, Novan continues to promote talent from within the organization as well as selectively add professionals from outside the Company. To that end, Novan is announcing the following organizational adjustments to the business:
Dr. David Hebert will join the Company’s clinical development team as Senior Director of Biometrics. Dr. Hebert will report to Dr. Elizabeth Messersmith, SVP and Chief Development Officer, and will have responsibility for overall statistical strategy, clinical design considerations and management of resources to ensure the high-quality capture of data, subsequent analysis, and the follow-on clinical and regulatory interpretation. Dr. Hebert joins Novan from UCB Biosciences, where he most recently served as Senior Director, Head of Global Statistical Sciences. Dr. Hebert has a Ph.D. in Biostatistics from the University of Texas Health Science Center at Houston and brings more than 20 years of biostatistics leadership and experience to the organization.
Novan’s Board of Directors has appointed John M. Gay to serve as the Company’s Principal Financial Officer and Corporate Secretary, effective as of January 31, 2019. Mr. Gay, who joined Novan in May 2018, will assume the role of Vice President of Finance in addition to continuing in the role of Corporate Controller. Mr. Gay has over 18 years of professional experience including finance and accounting positions with Valassis Digital, MaxPoint Inc., Deloitte and Arthur Andersen. Mr. Gay previously served as Corporate Controller of Furiex Pharmaceuticals, Inc., from its initial listing on the NASDAQ stock market through the execution of an acquisition agreement of the company by Actavis plc (Forest Laboratories, Inc.) in an all-cash transaction valued at approximately $1.1 billion. As Principal Financial Officer, Mr. Gay, along with Kelly Martin, Novan’s Chief Executive Officer, will be responsible for the overall financial activities of the Company.
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Roche sees 2019 sales, profit rise despite competition from copies

Roche expects sales and earnings to rise in 2019 as new drugs more than offset competition from copies of its $20 billion-plus per year trio of cancer medicines Rituxan, Herceptin and Avastin, the Swiss drugmaker said on Thursday.

Core operating profit last year climbed 9 percent to 20.5 billion Swiss francs ($20.65 billion), the company said. Sales rose 7 percent to 56.8 billion francs, just ahead of the 56.4 billion francs average estimate in a Reuters poll.
CEO Severin Schwan forecast “low- to mid-single digit” growth in 2019 sales and earnings-per-share, spurred by new drugs including Ocrevus for multiple sclerosis, Hemlibra for haemophilia A and cancer medicines Alecensa and Tecentriq.
“Almost 90 percent of our growth comes from newly launched products, demonstrating we are successfully rejuvenating our portfolio,” Schwan said.
Roche shares were indicated 1.2 percent higher.
The company proposed a dividend increase to 8.70 francs per share, from 8.30 francs last year.
Net profit rose 24 percent to 10.9 billion francs, as the company was helped by U.S. tax reform that lowered its tax rate.
One drag continued to be InterMune, which Roche spent $8.3 billion on buying in 2014 but which resulted in more than half the 3.3 billion franc impairment of goodwill and intangible assets in 2018.
Sales of Ocrevus more than doubled to 2.4 billion francs, while Hemlibra in its first full year on the market reached 224 million francs, which Schwan called “beyond expectations.”
Tecentriq, Roche’s cancer immunotherapy, posted 772 million in sales, up nearly 60 percent but still dwarfed by rival medicines Keytruda from Merck and Opdivo from Bristol-Myers Squibb.
Schwan said Bristol-Myers’s $74 billion offer for Celgene this month would not impact his strategy of focusing on smaller, bolt-on acquisitions.
“We are not into the mega-mergers,” he said.
The CEO said Roche continued to benefit from growing sales in China, which bought more older medicines whose sales have fallen elsewhere following patent expiries.
“Volumes have really soared,” he said. “I would expect the momentum to continue in 2019.”
Sales of Herceptin rose 1 percent to 6.98 billion francs, despite a 16 percent decline in Europe where biosimilar copies are impacting revenue. Avastin sales rose 3 percent, to 6.85 billion francs, while blood cancer medicine Rituxan – the hardest hit medicine, so far, from copies – slipped 8 percent to 6.75 billion.
Schwan is expecting biosimilar competition in the U.S. market to intensify from the second half of 2019.
Roche and partner AC Immune SA on Wednesday delivered bad news for their Alzheimer’s medicine crenezumab, calling a halt to two late-stage clinical trials after hopes of success faded.
Schwan called the result “disappointing”, but the consequence of taking risks on new medicines, saying that other work on Alzheimer’s would continue.
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GM halts operations at 11 Michigan plants after utility’s urgent appeal

General Motors Co said late on Wednesday it will temporarily suspend operations at 11 Michigan plants and its Warren Tech Center after a utility made an emergency appeal to users to conserve natural gas during extreme winter cold.

Fiat Chrysler Automobiles NV also said it had canceled a shift on Thursday at both its Warren Truck and Sterling Heights Assembly plants and was considering whether it would need to cancel additional shifts.
GM said it had been asked by Consumers Energy, a unit of CMS Energy Corp, to suspend operations to allow the utility to manage supply issues after extreme cold temperatures and a fire at a compressor station.
It said workers were told not to report for the shifts at its Orion Assembly, Flint Assembly, Lansing Delta Township Assembly and Lansing Grand River Assembly plants, as well as other stamping and transmission plants on Wednesday evening and early Thursday. GM said it was still assessing when employees could return to work.
Workers at its Warren Tech Center were also told to stay home on Thursday.
In a video message posted on Facebook, CMS Energy Chief Executive Patricia Poppe said large companies, including Fiat Chrysler, Ford Motor Co and GM, had agreed to “interrupt” production schedules through Friday to tackle the issue prompted by a fire at a Michigan facility and the record-breaking cold.
Poppe said the usage cuts by large businesses were not enough, and urged 1.8 million Michigan customers to turn down thermostats as much as they could to cut natural gas use in order to protect critical facilities like hospitals and nursing homes. “I need you to take action right now,” she said.
Ford Motor said it had also taken steps to reduce energy use at its four Michigan plants supplied by Consumers Energy, but added the situation remained fluid.
A spokeswoman said it had reduced heating levels at Livonia Transmission and Van Dyke Transmission, stopped heat treatment processes at Sterling Axle and shut down the paint process at Michigan Assembly.
Consumers Energy sent an alert to mobile phones in Michigan asking residents to reduce natural gas use.
In a Twitter message, Consumers Energy warned that “without additional reductions, we run the risk of not being able to deliver natural gas to families and critical facilities across Michigan – a scenario none of us want to encounter.”
Consumers Energy said a fire at a gas compressor station in Michigan’s Macomb County Wednesday forced it to halt gas flow from the compressor station until safety and damage assessments could be completed.
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Wednesday, January 30, 2019

HCA: $3.5B in capital projects still in pipeline following Mission acquisition

Even after a buying spree that includes the $1.5 billion acquisition of Mission Health, HCA Healthcare officials told analysts they have more than $3.5 million of capital spending in the pipeline they expect to bring online within the next two years.
Speaking during a fourth-quarter earnings call on Tuesday, Sam Hazen, the newly minted CEO of the Nashville, Tennessee-based health system, said the planned investments will further build inpatient and outpatient capacity within its local healthcare systems.
“These strategic investments in our business to expand our networks and improve our clinical capabilities are making it easier for patients to get high quality, convenient patient care in an HCA facility,” Hazen said during a fourth-quarter call with analysts.

Already, HCA was coming off the 19th straight quarter of same facility inpatient admissions, reporting earnings of about $1.1 billion in the fourth quarter, or about $3.01 per diluted share, more than double the $474 million, or $1.30 per diluted share, in earnings it reported in the fourth quarter of 2017. The company announced its revenues in the fourth quarter reached $12.3 billion, up more than 6% compared to $11.6 billion in the fourth quarter of 2017.
HCA reported its cash flows from operating activities were $2.175 billion, compared to $1.734 billion in the prior year’s fourth quarter. Its same facility equivalent admissions and same facility admissions increased 1.9% and its same facility revenue per equivalent admission increased 4.4%.
During the call, officials announced a cash dividend of 40 cents per share to their shareholders.

HCA reported $3.8 billion in earnings on $46.7 billion in revenue for the year ending Dec. 31, 2018, compared to $2.2 billion in earnings on $43.6 billion in revenue for the same period in 2017. Results for the year include gains on sales of facilities of $428 million, or $0.91 per diluted share.
The company recognized a tax benefit of $551 million for the year related to the impact of the Tax Cuts and Jobs Act, including $484 million due to a reduction in its effective tax rate and a $67 million favorable adjustment to its deferred tax assets and liabilities.
The company reported it incurred expenses and loss of revenues totaling $31 million due to the impact of Hurricane Michael on its Florida panhandle facilities. The company recorded a benefit of $49 million from an insurance recovery related to Hurricane Harvey business interruption losses in 2017.
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Changing prescribing practices could slash insulin costs

Sometimes simple methods for bending the healthcare cost curve have a way of hiding in plain sight.
A study published on Tuesday in the Journal of the American Medical Association adds to a growing body of evidence suggesting that human-derived formulations of insulin are as clinically effective at treating Type 2 diabetes as pricier “designer” analogues that get used more commonly.
That could offer patients relief from rising drug costs.
Given how the cost of insulin has risen rapidly across the board lately, that could be welcome news for a large and growing patient population. Of the several million Americans using insulin today, the vast majority find themselves on newer, higher-cost analogue formulations of the drug, according to the study’s lead author, Jing Luo, M.D., M.P.H., of Brigham and Women’s Hospital and Harvard Medical School.

The newer insulins have been modified for attributes such as more-rapid onset or longer duration, and they’ve been marketed aggressively enough to make them blockbuster medications for pharmaceutical manufacturers. Despite some indication that they may perform better with respect to some safety events, however, very little information existed to suggest they were clinically superior.
“We were wondering whether patients with Type 2 diabetes might do as well on older formulations that don’t have as ideal a profile of action, but are clinically comparable and come from the same manufacturers—so we think the quality is good—and they’re less expensive,” Luo said.
In terms of potential savings, the study notes that the cheapest human-derived insulins can cost as little as a tenth as much as analogue therapies. Other potential benefits to patients could include greater convenience, since specialized insulin formulations can require more than twice-a-day dosing.
An op-ed piece accompanying the study points out that the least-expensive human-derived insulins typically do not come in a convenient format. But Luo said the overall cost differential between analogue and human-derived formulations would likely be more than enough to justify switching in many cases.

The study’s conclusion isn’t particularly earth-shattering, Luo said. But despite the cost of insulin and the danger to patients for whom its growing expense might become an enticement to ration its use, neither payers nor clinicians have shown a broad inclination to change their prescribing practices yet.
This adds to the evidence that switching from analogue to human-derived insulin in a real-world setting could be safe and effective where some might not realize a viable alternative exists, Luo said.
“Unless you practice at a place like Kaiser, you’re more likely to have more clinical experience with newer analogue insulins,” he said.
Unlike situations such as dialysis, where CMS can play a role in dictating the cost of a drug, with insulin, the players are much more fragmented and decentralized. Luo said there have been entities willing to experiment, but the majority haven’t gotten there yet. And as much as he’d like these results to provide the tipping point that moves the industry toward wider use of human-derived insulin, he sees it more realistically as another data point in what’s likely to prove a longer-term journey.
At the very least, the study’s results may offer a useful path for physicians seeking ways to help patients struggling with higher insulin costs.
“For docs with patients who have issues paying for their insulin, this should make them feel more confident about switching patients to a cheaper, human-derived insulin prescription,” he says.
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Siemens Healthineers: FDA Clears 3T MRI System

The U.S. FDA has cleared the Magnetom Lumina 3 Tesla (3T) MRI scanner from Malvern, Pa.-based Siemens Healthineers. This scanner features BioMatrix patient personalization technology, which improves productivity while ensuring quality, Siemens officials say.
Moreover, the system has a wide, 70-cm bore and GO technologies powered by artificial intelligence (AI), which accelerate the entire MRI workflow. For example, a whole spine exam can be performed up to 20% faster compared to a conventional system. Tim 4G and Dot (Day Optimizing Throughput) engines support standardized, reproducible scan procedures. To further facilitate workflow efficiency, the system features an optional dockable table.
Additionally, new Turbo Suite acceleration packages can further reduce scan time on routine musculoskeletal (MSK) examinations of various parts of the body by up to 50%. The Magnetom Lumina will also offer the optional Innovision in-bore infotainment system, which is designed to move with the scanner table to not only create the illusion of an enlarged bore, but also to provide a video experience with strong sound quality.
“With the Magnetom Lumina, Siemens Healthineers is transforming care delivery by providing high performance with a strong return on investment,” says Jane Kilkenny, vice president of MR at Siemens Healthineers North America. “The patient experience is enhanced with a state-of-the-art infotainment system, lightweight and flexible coils, and new speed applications that enable the provider to get the patient on and off the table faster.”
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