Former Allergan chief Saunders scoops up aesthetics company in $1.1B deal

 In a return to the beauty business, former Allergan CEO Brent Saunders sealed a $1.1 billion deal for a hot and trendy med spa facial company.

Saunders co-founded—and recently took public—Vesper Healthcare Acquisition, which is now snapping up HydraFacial with an expected close by mid-2021. The company is built on its proprietary and eponymous facial, a celeb-endorsed and popular beauty treatment described as a gentler alternative to microdermabrasion.

Vesper will pay $975 million at closing and up to $75 million in milestones pegged to future acquisitions. The deal will be funded with Vesper's current cash store, plus a private stock placement led by institutional investors such as Fidelity. HydraFacial will become a wholly-owned subsidiary of Vesper.

Saunders, a seasoned hand at M&A, has been in the hunt for a platform company since Vesper went public via a special purpose acquisition company (SPAC) in September. The public offering netted Vesper $400 million, with investors essentially buying into Saunders' track record—along with that of co-founder, CFO and former Allergan executive Manisha Narasimhan.

While SPACs allow two years to use that money for acquisitions, Vesper wasted no time nabbing its first deal in just over two months.

First, but definitely not last. The deal takes the “first steps towards building an enduring and significant company in beauty health,” Saunders said during a Wednesday investor call about the deal.

Saunders intends for Vesper to be a “real roll-up type of company” he told CNBC in October. Along with aesthetics, Vesper is targeting eye care, longevity and wellness categories.

It’s tempting to think Saunders may be looking to take on his former company Allergan, which is best known for its Botox injection, but boasts other aesthetics treatments as well. But he's repeatedly dismissed that idea. He told Bloomberg and CNBC he’s not looking to compete with his alma mater—now owned by AbbVie—and that there’s “plenty of room” for Vesper to co-exist with Allergan in the markets where he plans to invest.

That means similar aesthetics marketing tactics and a direct sales model. Wednesday's news release notes Vesper will drive growth for HydraFacial by improving aesthetician education, investing in sales and marketing, and beefing up its product roster.

While Saunders is right at home in medical aesthetics and eye care, he and Narasimhan also have plenty of merger and acquisition experience as well. Saunders was one of the most practiced M&A-oriented CEOs in pharma.

He most recently led Allergan through its $63 billion acquisition by AbbVie, but has overseen a handful of other major deals. In 2009, he was part of the executive management team at Schering-Plough when it merged with Merck. In 2013, as CEO of Bausch + Lomb, he engineered its acquisition by Valeant Pharmaceuticals (now known as Bausch Health).

Then, he stepped up to CEO at Forest Laboratories and quickly struck a 2014 merger deal with Actavis—and a year later, in that company's CEO seat, he led Actavis' merger with Allergan.

https://www.fiercepharma.com/pharma/back-to-beauty-former-allergan-chief-saunders-scoops-up-aesthetics-company-1-1-billion-deal

Pfizer COVID vax data raise some flags but won't scuttle FDA nod: analysts

 When the FDA released a 53-page briefing document on Pfizer’s COVID-19 mRNA vaccine candidate yesterday, most readers zeroed in on the shot’s high efficacy in a wide range of demographic groups. Wall Street analysts dug a bit deeper.

Their conclusion? A few red flags in the FDA documents will likely generate some discussion at Thursday's advisory panel meeting, but not enough alarm to scuttle an emergency authorization.

One major point of discussion at the meeting—where vaccine experts will offer their approval advice to the FDA—will be side effects that cropped up in the phase 3 trial, analysts predicted. The side effects were rare but inflammatory in nature. For example, there were more cases of appendicitis and Bell’s palsy among those who received the vaccine than in the placebo group.

Pfizer is planning three post-authorization surveillance studies, according to the briefing package (PDF). And the FDA will also have access to data gathered from a new Centers for Disease Control smartphone app called v-safe. Vaccine recipients will be able to opt-in to v-safe and use it to report any side effects.

J.P. Morgan analysts concluded that side effects reported in the trial wouldn't scuttle Pfizer’s emergency use authorization (EUA), because the stats lined up with numbers typical in the general population. The incidence of Bell's palsy, a type of facial paralysis, matched up with typical experience, the FDA said, though there were no cases reported in the trial's placebo group.

But side effects could matter once rival COVID-19 vaccines come before the FDA. “We have no major concerns with the safety profile highlighted in the briefing docs, though believe there is room for other competitors to differentiate” on side effects, the J.P. Morgan analysts wrote in a Tuesday note to investors.

Moderna’s mRNA vaccine, up for FDA panel review next week, will likely be Pfizer’s main competition, at least for now. Last week, scientists at the National Institute of Allergy and Infectious Diseases reported that no serious adverse events were seen among participants after day 57 in an early study of the shot. People dosed with Moderna’s vaccine also showed high antibody levels 90 days later—offering some comfort to infectious disease experts who have questioned the durability of mRNA vaccines.

The FDA briefing docs also highlighted how important it will be for patients to come back for a second dose. The phase 3 trial revealed that the vaccine was only 52% effective in the three weeks between the first and second dose, the analysts noted. Efficacy skyrocketed to nearly 95% a week after the second dose.

That two-dose requirement has already triggered some chatter among public health experts. Moderna’s vaccine will also require two doses, raising questions about how clinicians will keep track of who got which company’s shot—and how they’ll get patients to come back for the boosters.

In September, CDC Director Robert Redfield, M.D., predicted during testimony before Congress that sorting out the logistics of the two-shot COVID-19 vaccine regimen would prevent the country from returning to normal before the second or third quarter of 2021.

SVB Leerink analysts picked out another detail in the Pfizer briefing document: The previous infection offered just 37% protection against re-infections with symptomatic COVID-19. Granted, only seven cases of re-infection were reported in the trial, but the revelation that getting sick with COVID might not protect people from catching the virus again could be significant, the analysts said.

“We expect the committee will have several questions for the sponsors on this data, including the natural history of the patients, baseline serology, and whether any of the nine severe COVID cases in the placebo arm were re-infections.”

The FDA doesn’t have to follow the guidance of its advisory committees, but it usually does. SVB Leerink predicted the committee will vote in favor of an EUA for Pfizer’s vaccine, “and this should mark the beginning of an historic national vaccination effort over the next 12-18 months.”

https://www.fiercepharma.com/pharma/pfizer-s-covid-vaccine-data-raise-some-questions-but-shouldn-t-scuttle-fda-nod-analysts

FDA warns against wearing masks with metal during MRIs after patient is burned

 

A patient wearing a face mask with a metal part was burned while undergoing an MRI exam – prompting the Food and Drug Administration to issue a warning about the potential dangers of using such coverings.

“The FDA received an injury report for a patient who was wearing a face mask with metal during a 3 Tesla MRI scan of the neck. The report describes burns to the patient’s face consistent with the shape of the face mask,” the FDA said in its alert Tuesday.

The agency warned that patients should not wear any metal during an MRI, a well-known precaution that was apparently missed during the person’s neck scan.

“Given the increased use of face masks during the COVID-19 pandemic, the FDA wants patients and health care providers to be aware of the potential risk of face burns related to the use of patient face masks containing metal during an MRI,” the FDA said.

The agency noted that it is appropriate for a patient to wear a mask for an MRI exam during the coronavirus pandemic.

”Before the MRI begins, health care providers who perform MRI exams should confirm the face mask has no metal. Some face masks have metal strips to help shape the mask to the face of the user, nanoparticles, or antimicrobial coating, which may contain metal (for example, silver or copper),” it said.

“The metal could result in radio frequency (RF)-induced heating. This may represent a hazard for MR imaging during the COVID-19 pandemic.”

https://nypost.com/2020/12/09/fda-warns-against-metal-mask-after-patient-is-burned/

UK hospital deploys Microsoft AI to tackle cancer backlog

 Addenbrooke’s Hospital in Cambridge will be the first in the world to use an artificial intelligence tool developed by Microsoft that promises to cut the time it takes to analyse computed tomography (CT) scans, and allow treatment to start sooner.

The Project InnerEye tool was developed just down the road from Addenbrooke’s at Microsoft’s Cambridge research labs, and uses AI to highlight tumours and healthy tissue on patient scans, guiding an individual treatment plan.

The AI has been shown to speed up clinicians’ ability to perform radiotherapy planning for head and neck as well as prostate cancers 13 times quicker than manual methods, without compromising accuracy, according to a JAMA Network Open research paper.

Microsoft is making the tool freely available as opensource software to speed up its use by hospitals, though of course clinical use of machine learning models is subject to regulatory approval.

Up to half of the population in the UK will be diagnosed with cancer at some point in their lives, and of these, half will be treated with radiotherapy, with delivery guided by a CT scan to reveal where the radiation beams should be directed to minimise damage to other tissues.

Stacks of 2D images generated during a CT scan have to be reviewed by a radiation oncologist, a time-consuming process, but using Project InnerEye the time to complete that process can be cut by 90%, according to studies.

The AI’s conclusions will be checked and confirmed by a clinical oncologist before the patient receives treatment.

With charity Cancer Research UK estimating that as many as three million people in the UK have missed out on cancer screening tests during the pandemic, the AI could help reduce a “mounting cancer treatment backlog” according to Microsoft.

Lightening the workload of oncologists could also help prevent clinician burnout, which Microsoft says is happening across the NHS as a result of COVID-19. The hope is that quicker treatment could also help improve survival rates for some cancers, although there’s no hard evidence for that yet.

Yvonne Rimmer, consultant clinical oncologist at Addenbrooke’s, said: “There is no doubt that InnerEye is saving me time. It’s very good at understanding where the prostate gland is and healthy organs surrounding it, such as the bladder. It’s speeding up the process so I can concentrate on looking at a patient’s diagnostic images and tailoring treatment to them.

“But it’s important for patients to know that the AI is helping me in my professional role; it’s not replacing me in the process. I double check everything the AI does and can change it if I need to. The key thing is that most of the time, I don’t need to change anything.”

https://pharmaphorum.com/news/uk-hospital-deploys-microsoft-ai-to-tackle-cancer-backlog/

Astrazeneca’s vaccine looks increasingly like an also-ran

 Of the five questions about Astrazeneca’s Covid-19 vaccine project Evaluate Vantage posed last month, three remain unanswered after publication of a fuller analysis of interim phase III data yesterday. And the answers that have been provided make for uneasy reading.

For a start the headline-grabbing efficacy figure of 90% among patients who received a half-strength priming dose is still unexplained, with the researchers conceding that it is possible that chance might have played a part in this “intriguingly high” number. And data on older patients is still conspicuous by its absence – one of several holes that leave the jab’s chances of approval and labelling hard to judge. 

With reference to Vantage’s earlier piece looking at outstanding questions over AZD1222, here is a look at what we know now.

Why might a lower priming dose work better, and is this a real effect?

The researchers posited several possible explanations for the higher efficacy in the low-dose/standard-dose regimen, including lower levels of anti-vector immunity with the lower first dose, or differential antibody functionality or cellular immunity. No definitive reason was forthcoming, with Andrew Pollard, the director of the Oxford vaccine group, saying on a webcast that this seemed to be “something to do with that half dose priming the immune system in a different way”.

Also on the webcast, Astra’s head of biopharmaceuticals R&D, Sir Mene Pangalos, said that the company had not yet decided whether to do another trial investigating this dose, or what such a study might look like. So for now it is hard to know whether this odd finding will ever be proven. The more robust efficacy figure for the standard dose regimen was confirmed as 62%.

For which dose(s) will Astra be seeking approval?

Astra is dodging responsibility for this one. Professor Pollard said the focus of the regulatory review would be the two full doses, but added that the entire data package discussed in the paper, which covers the UK-based COV002 trial and the Brazilian COV003, had already been handed over to regulators. Therefore “it is entirely up to the regulators to look at the data and decide exactly what they think their label should say”.

Can Astra use these data to file for US emergency use authorisation?

Finally a concrete answer: almost certainly not. Astra’s base case assumption, according to its chief executive, Pascal Soriot, is that the US FDA will require US data, “but of course it’s for them to decide”. Oxford University’s Sarah Gilbert added that because readout depended on events the researchers do not know when the US trial data might become available. 

Moreover, aside from the FDA’s unwillingness to approve products with no US patient data, the standard dose regimen is not good enough. In the UK trial the efficacy figure in those receiving two standard doses was 60.3%, but the lower bound of the confidence interval was 28%, falling beneath the FDA’s criterion of 30%. 

The Brazilian data just about meet this threshold, with efficacy of 64.2% and a lower CI bound of 30.7%. US approval would therefore hinge on the FDA deciding that this, along with the better efficacy figures for the low-dose/standard-dose regimen in the UK trial, is good enough, but the chances of that seem slim.

What about safety?

The big news here is that investigators have finally admitted a case of transverse myelitis as being “possibly related to vaccination”. This occurred 14 days after the booster shot, and an independent neurological committee considered the most likely diagnosis to be of an idiopathic, short segment, spinal cord demyelination.

The neurological experts judged two other cases of this condition as unlikely to be related to the vaccine. Of these two probably unrelated cases, one was in a patient with previously unrecognised multiple sclerosis, and the other occurred in the control group.

There was one other potentially vaccine-related serious adverse event: a patient had a fever higher than 40°C, though they recovered rapidly and were not admitted to hospital. This subject remains masked to group allocation, so they might not have even received AZD1222. The subject continues in the trial, and received a second dose of either Astra’s vaccine or the control without a similar reaction.

It should be noted that the protocols for several of the AZD1222 trials, including COV002 and 003, call for at least some of the patients to be given prophylactic paracetamol to help guard against pain, fever, chills, muscle aches, headaches, and malaise.

This safety record is not exactly terrible, but is notably worse than anything that has been seen in the trials of the mRNA vaccines developed by Pfizer/Biontech and Moderna. Still, the reports of allergic reactions to the Pfizer jab that emerged in the UK today raise the spectre of post-approval events, which could occur with any vaccine candidate.

How did AZD1222 perform in older patients?

This is still a mystery. The low-dose/standard-dose regimen was not given to any patients aged over 55, and of those participants given two standard doses the proportion aged over 55 was just 21% in the UK trial and 11% in Brazil. In all, only five cases of Covid-19 included in the primary analysis occurred in subjects older than 55 years of age – too few to calculate efficacy in this population. 

This answer might come after more cases have accrued; if not, it will once more be a case of waiting for the US data. More than 20% of the 40,000-odd enrolees in the US study are aged over 60, Mr Pangalos said, a much larger older population than in the UK and Brazil trials, which enrolled just 1,006 and 412 over-55s respectively.

In the meantime, Astra pointed to the data it released three weeks ago showing similar antibody levels in older and younger patients. Based on this, Mr Pangalos said that Astra does not believe there will be a difference in efficacy across age groups, but the absence of concrete infection numbers in older patients is glaring.

If AZD1222 does score approval based on these data it will not be in the US and might not be in over-55s. It’s cheap and it’s easy to transport – but compared with trial data on the mRNA vaccines, neither AZD1222's efficacy or safety impresses.

https://www.evaluate.com/vantage/articles/news/trial-results/astrazenecas-vaccine-looks-increasingly-also-ran

NMC Health administrators sound out investors for flagship UAE hospitals

Administrators of troubled hospital operator NMC Health are sounding out potential buyer interest for its flagship business in the United Arab Emirates (UAE), three sources familiar with the matter said.

The potential sale of its biggest assets which would also include Oman, could generate around $1 billion, one of the sources said. It follows administrators Alvarez & Marsal’s launch in August of a process to sell NMC’s international business including its international fertility units.

NMC, which was founded by Indian businessman BR Shetty in the mid-1970s, became the largest private healthcare provider in the UAE but has run into trouble after short-seller Muddy Waters questioned its financial reporting and doubts emerged over the size of stakes owned by its biggest shareholders.

NMC went into administration in April following months of turmoil over its finances and the discovery that it had $6.6 billion in debt, well above earlier estimates.

The administrators will present two options to NMC’s creditors by February: either an outright sale of the assets or a business reorganisation, said the sources. Lenders will have to vote by April on which of the two options they opt for, added one of them.

Alvarez & Marsal declined to comment when contacted by Reuters.

Investment bank Perella Weinberg Partners, which did not immediately respond to a request for comment, sent out a teaser about a week ago for a wide auction process, said the sources, declining to be named as the matter is not public.

The teaser includes NMC Health in the UAE and Oman, Al Zahra Hospital in Sharjah, Fakih IVF and CosmeSurge, said one of the sources.

It was sent to a wide range of investors including regional strategic players and sovereign wealth funds, along with private equity players, the source said.

Expressions of interest in the assets are due by Dec. 15, including an indication of valuation, all the three sources said.

NMC’s lenders are seeking valuation expectations early in the process as they are keen to have a general idea before a formal sales process begins in January, they said.

They are also looking to ensure potential buyers are not taking advantage of NMC Health’s situation by bidding at distressed prices, one of the sources said.

https://www.reuters.com/article/nmc-health-ma/exclusive-nmc-health-administrators-sound-out-investors-for-flagship-uae-hospitals-sources-idUSL8N2IP3R1

Athenex: Oral paclitaxel linked to breast cancer survival benefit

 

• Athenex (ATNX -4.2%) has announced presentation of updated Phase 3 progression free (PFS) and overall survival (OS) data, demonstrating clinical benefits in efficacy and tolerability of oral paclitaxel vs. IV paclitaxel (IVP) in patients with metastatic breast cancer. Data were presented at the San Antonio Breast Cancer Symposium.
• In the intent-to-treat population, oral paclitaxel demonstrated a median PFS of 8.4 months vs. 7.4 months, with median OS of 22.7 months vs. 16.5 months.
• Safety analyses of as long as 112 weeks continue to demonstrate the reduction in incidence and severity of neuropathy favoring oral paclitaxel versus IVP: all grades of neuropathy were 22% vs. 64%, and severe neuropathy was 2% vs. 15%
• Oral paclitaxel has been granted Priority Review by the FDA for the treatment of metastatic breast cancer with action date of February 28, 2021.
• https://seekingalpha.com/news/3642969-athenex-says-oral-paclitaxel-associated-survival-benefit-study-shows