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Tuesday, February 2, 2021

Primary care docs key to speeding COVID-19 vaccine rollout: study

 Vaccinating millions of Americans against the COVID-19 virus is proving to be a complicated process already plagued with many setbacks.

But there's already a ready-made vaccine distribution system that can be tapped into to accelerate the rollout, some experts say: primary care doctors.

Primary care doctors provide nearly half of all vaccines in the U.S. and their role may help assure successful delivery of the COVID-19 vaccines to communities across the nation, including rural and remote communities, according to a preprint study published in the Annals of Family Medicine."Bottom line, if we engage and activate the ready-made primary care practices, we can accelerate COVID-19 vaccine distribution and reach herd immunity through immunization sooner," said John Westfall, M.D., a co-author of the study and director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care.

"Vaccine manufacturers already know who orders vaccines and could deliver vaccines to those same primary care offices. Medicare knows who provides COVID-19 to Medicare beneficiaries and actually know how many beneficiaries get their vaccines from these practices. They could ship out that number of vaccines to each primary care practice for their seniors. Or do so in waves," Westfall said.


There’s growing frustration among medical groups about being shut out of the vaccine distribution process with primary care docs even missing out on getting the vaccines themselves.

The Medical Group Management Association (MGMA) is urging the Biden administration to include medical group practices in COVID-19 vaccine distribution strategies moving forward. A survey reflecting responses from 403 medical group practices showed 85% of independent practices actively seeking the COVID-19 vaccine for their patients received some as of Jan. 21-24. Nearly half (45%) of hospital- or health system-owned practices seeking vaccines still hadn't gotten any. Meanwhile, the majority of practices that have gotten the vaccine (54%) say they only received enough to vaccinate 1% or less of their patients.

The COVID-19 pandemic recovery will require a broad and coordinated effort for infection testing, immunity determination, and vaccination, the study authors said.

The study evaluated the delivery of vaccinations, using 2017 Medicare Part B Fee-For-Service data and the 2013-2017 Medical Expenditure Panel Survey at the service, physician, and visit level. The data shows that primary care physicians have played a crucial role in delivery of vaccinations to the U.S. population, including the elderly, between 2012-2017.

Overall, PCPs provided the most vaccinations (46%), followed closely by mass immunizers (45%), then nurse practitioners/physician assistants (5%). There were clusters of counties that had over 50% of vaccinations provided by PCPs throughout states such as Louisiana, Pennsylvania and Massachusetts, the study found.


In addition to physically administering vaccinations, PCPs can provide clinical and personal support to enable patients to understand their current COVID-19 immunologic status, how that may impact their vaccine decisions, and to counter vaccine hesitancy and misinformation, the study said.

There continues to be a high level of distrust in the COVID-19 vaccine among some populations. The new vaccines may face more vaccine hesitancy, misinformation, and refusal than other vaccines, the study said.

It's important to leverage the trusted relationship that primary care physicians have with patients when distributing the COVID-19 vaccine.

"Primary care practices may play an even more important role in vaccine counseling, building local community trust, and serving as a source of scientific knowledge about the COVID-19 vaccine," the study authors said.

Given its historic role in immunization counseling and vaccine delivery, primary care, in concert with public health agencies and community health organizations, is essential for immediate and sustainable population health efforts to address COVID-19 recovery, the study said.

https://www.fiercehealthcare.com/practices/primary-care-docs-could-be-key-to-accelerating-covid-19-vaccine-rollout-study

Prothena revives amyloidosis program nearly 3 years after flop

 Prothena canned its AL amyloidosis program in 2018 after it failed a midstage trial and a data monitoring committee deemed a separate phase 3 study doomed to fail. Now, the biotech is resurrecting the program after an analysis of the phase 3 data found the drug helped the sickest patients live longer.

That study, dubbed VITAL, tested the drug, known as birtamimab or NEOD001, against the standard of care in 269 patients with AL amyloidosis, short for amyloid light-chain amyloidosis. After terminating the study for futility, Prothena crunched the data and found that the sickest patients—those whose disease was classed as Mayo stage 4 at the start of the study—did significantly better on birtamimab than on placebo.

At the nine-month mark, the analysis found nearly three-quarters of the sickest patients on birtamimab were still alive compared to about half of the sickest patients taking placebo (74% versus 49%). Granted, these numbers are from just 77 patients, or 30% of the total patients in the trial, but they’ve convinced Prothena and the FDA that there is a future for this drug in these patients.

Under a Special Protocol Assessment agreement with the FDA, Prothena company will kick off a new phase 3 study in mid-2021. It will test the drug, known as birtamimab or NEOD001, in patients with Mayo stage 4 AL amyloidosis. The disease is similar to multiple myeloma in that it stems from dysfunctional plasma cells in the bone marrow. They produce an abnormal version of light chain, a protein that makes up antibodies.

“The normal job of immunoglobulin light chain is to combine with heavy chain to make immunoglobulins, or antibodies,” said Prothena CEO Gene Kinney, Ph.D. The abnormal light chain proteins don’t bind properly with the heavy chain proteins, fold incorrectly and build up in various tissues, most notably in the heart. Over time, this buildup can lead to life-threatening problems, including heart and kidney failure.

“When we talk about Stage IV patients—if we look to the literature—the predicted median survival of those patients is somewhere around six months following diagnosis,” Kinney said.

The standard of care includes chemotherapy and cell-killing drugs that were originally developed for multiple myeloma. These treatments focus on eliminating abnormal plasma cells and reducing the amount of disease-causing protein they produce.


“The limitation is probably obvious for patients who already have an appreciable amount of protein deposition in vital organs,” Kinney said. “It’s essentially turning off the faucet once the bathtub is full.”

Prothena hopes that adding its drug to those already in use will help the sickest patients recover organ function and live longer.

The new phase 3 study, known as AFFIRM-AL, will test birtamimab in 260 patients with AL amyloidosis affecting their heart and who have never been treated. Two-thirds of the patients will receive birtamimab, while the remaining third will receive the standard of care. The primary endpoint is death from any cause. The plan is to conduct an interim analysis when about half of the patients in the study have died, at which point an independent data monitoring committee will recommend it either continue or be stopped for overwhelming efficacy, the company said in a statement.

https://www.fiercebiotech.com/biotech/prothena-revives-amyloidosis-program-nearly-3-years-after-flop

CDMO Catalent trumpets biologics windfall courtesy of COVID-19

 The COVID-19 pandemic has taken a toll on top lines throughout the biopharma industry—but not for New Jersey-based CDMO Catalent,

Instead, the pandemic has been a growth "accelerator," CEO John Chiminski said Tuesday on his company's second-quarter earnings call. With more than 80 pandemic projects under Catalent's belt, he's not kidding. Virus-related drug and vaccine products have given a massive boost to the company's biologics business, and with more shot capacity on the way, Catalent's COVID-19 work shows no signs of slowing down any time soon.

Buoyed by production contracts with major COVID vaccine players Moderna, Johnson & Johnson and AstraZeneca, Catalent saw its biologics revenues hit $403.9 million in the second quarter of its 2021 fiscal year. That's a whopping 76% increase in constant currencies over the same quarter last year.

All told, biologics made up 44% of Catalent's total net revenue for the quarter, which ended December 31, 2020. Taking acquisitions out the equation, net revenues for the company's biologics unit—on deck to crank out pandemic vaccines as well as therapeutics—jumped 65%, while profits for the segment climbed 104% versus the same period in 2019. 

That boost comes courtesy of the company's vast network of COVID-19 manufacturing partners, CEO Chiminski said on a call with analysts. Two of Catalent's vaccine partners—AstraZeneca and Moderna—are already rolling out vaccines to the public, and the CDMO is on deck to manufacture Johnson & Johnson's shot in the U.S., too.


J&J just last week unveiled long-awaited phase 3 data on its single-dose vaccine, showing it was 66% effective overall in global phase 3 trials, with efficacy climbing to 85% in severe disease. 

To match the pandemic's breakneck speed, Catalent has hustled along a number of planned capacity expansions in Europe and the U.S., Chiminski explained. With new filling lines on the way, the company figures it can meet demand for COVID-19 vaccines from its trio of partners and fill out its non-pandemic customer orders without disruption, he said. 

The company recently completed the buildout of a high-speed filling line, plus other capacity expansions, at its Bloomington, Indiana, plant—where the company is producing Moderna and J&J's vaccines. Its team there is now working 24/7 to meet U.S. demand, Chiminski said. 


All told, the company is on track to produce 100 million Moderna doses for the U.S. by March, out of a total 200 million doses it figures it can deliver by the end of June. 

Another high-speed filling line in Bloomington, first announced in 2020, is set to come online in the fourth quarter of the company's 2021 fiscal year. That line will be devoted to the production of Moderna's shot, among other products, Chiminski said. 

Plus, the company is establishing a high-speed flexible syringe cartridge filling line in Bloomington, too. That project won't be used for COVID-19 work, so the company is eyeing completion in the back half of 2021, Chiminski said.  

Those upgrades come in addition to new manufacturing trains being added to Catalent's cell manufacturing facility in Madison, Wisconsin; plans to boost capacity in Anagni, Italy; and a fill-finish facility in Limoge, France, that the company expects to complete this year, Chiminski said. 


During the call, analysts pressed the company about whether the U.S. government could order Catalent to prioritize production of COVID-19 vaccines through the Defense Production Act—a move that caused issues for drugmaker Horizon Therapeutics late last year when Catalent was forced to divert manufacturing slots for thyroid eye disease med Tepezza in favor of pandemic products. 

The short answer is no, Chiminski said. With a new high-speed filling line in place in Bloomington and another on the way, the company says it's equipped to meet capacity for government-mandated production as well as non-COVID orders. 

Overall, the company raked in $910.8 million in second-quarter revenues, up 24% in constant currencies from the $721.4 million reported for the same quarter last year. Armed with a slew of successful COVID-19 contracts, the company has raised full-year guidance to a range of $3.8 billion to $3.9 billion, up from its earlier projection of $3.5 billion to $3.7 billion. 

https://www.fiercepharma.com/manufacturing/cdmo-catalent-trumpets-76-biologics-revenue-boost-courtesy-covid-19

Pfizer's new rare-disease meds reach blockbuster stage despite pandemic hurdles

 While the COVID-19 pandemic dominated headlines at Pfizer and beyond last year, behind the scenes, the company has been busy with its launch of rare heart disease meds Vyndaqel and Vyndamax. And those efforts are showing. 

Vyndaqel and Vyndamax, approved in May 2019 to treat cardiomyopathy caused by transthyretin mediated amyloidosis (ATTR-CM), passed the blockbuster threshold in their first full year on the market as the company has been working to raise awareness of the disease and boost diagnosis rates. In 2020, despite challenges from the pandemic, the meds generated $1.3 billion, up from $473 million the prior year. 

At the end of last year, the diagnosis rate among ATTR-CM patients was 21%, Pfizer CEO Albert Bourla said on Pfizer’s fourth-quarter earnings call on Tuesday. That compares with 2% from when the drugmaker launched its medicines, which carry list prices of $225,000 per year. 

At the end of 2020, more than 20,000 patients had been diagnosed, and 8,500 had received Pfizer's drugs, Bourla said, including some who received them at no cost. After COVID-19 shutdowns affected patient-doctor visits last year, Pfizer has seen an improvement in diagnosis rates since the third quarter, Bourla said—though the resurgence of COVID-19 cases might affect that recovery, he cautioned.


Aside from the rare-disease meds, several of Pfizer’s other growth products “contributed significantly” to the company’s performance last year, Bourla said. Revenues for blood thinner Eliquis jumped 17% to $4.95 billion, while biosimilar revenues jumped 68% to $1.53 billion. Cancer therapies Xtandi and Inlyta and anti-inflammatory agent Xeljanz all chipped in to growth, too. In all, Pfizer's sales swelled 8% last year to $41.9 billion.

For its part, Prevnar 13—the company’s pneumoccocal vaccine and best-selling product—benefitted outside of the U.S. as the pandemic drove vaccine awareness. The shot’s sales grew 11% outside the U.S. 

Meanwhile, thanks to Pfizer's move last year to spin off its Upjohn business—which it combined with Mylan to form standalone company Viatris—the pharma giant's “decade-long conversion into a pure-play" science-based company is now complete, Bourla said in a statement. 


It's that effort that enabled the company’s quick success with its BioNTech-partnered COVID-19 vaccine program, which will be a major focus for Pfizer looking forward. The company expects $15 billion in sales from the shot this year, and it’s focused on producing 2 billion doses with manufacturing partners. 

https://www.fiercepharma.com/pharma/pfizer-s-vyndaqel-vyndamax-reach-blockbuster-threshold-despite-pandemic-s-challenges

Pfizer to deliver 200M Covid vax shots to U.S. by May, sooner than expected

 Pfizer plans to deliver 200 million doses of its coronavirus vaccine to the U.S. by May, earlier than its initial forecast of July, according to slides published Tuesday by the drugmaker ahead of its fourth-quarter earnings call.

The company, which developed its vaccine with German drugmaker BioNTech, also said it can potentially deliver 2 billion doses globally by the end of this year now that health-care providers can extract an additional sixth dose of the vaccine from the vials. In December, the Food and Drug Administration said extra doses from vials can be used after doses were being thrown away due to labeling confusion.

Pfizer had delivered 29 million doses of its two-shot vaccine to the U.S. government as of Jan. 31, according to the company. As of Monday, 17 million of those Pfizer doses have been administered, according to the Centers for Disease Control and Prevention.

The company’s Covid-19 vaccine was the first approved for emergency use in the U.S.

Pfizer, like other coronavirus vaccine makers, has been struggling to meet the demand for shots that hopefully will help bring an end to the pandemic. It recently enlisted the help of French drugmaker Sanofi to help produce 100 million doses of its vaccine.

The update on its supply timeline comes hours after Pfizer said it expects to sell about $15 billion in coronavirus vaccine doses this year. The company also raised its full-year earnings guidance to between $3.10 and $3.20 from $3 and $ 3.10, citing “additional refinements” of its vaccine revenue forecast.

The company also said Tuesday it is “prepared to respond” if a Covid variant demonstrates evidence that it is resistant to its vaccine. In recent weeks, U.S. health officials, including Dr. Anthony Fauci, have said they are concerned that vaccines currently on the market may not be as effective in guarding against new, more contagious strains of the virus.

In the slides published, Pfizer said patients will “likely need to boost regularly to maintain immune response and to counter emerging variant strains.”

https://www.cnbc.com/2021/02/02/covid-vaccine-pfizer-plans-to-deliver-200-million-doses-to-us-by-may-sooner-than-expected.html

US FDA approval tracker: January

 The first month of 2021 saw the approval of Aurinia’s Lupkynis, one of the most valuable launches of the year, according to sellside sales forecasts. The drug, indicated for use in lupus nephritis, is Aurinia’s sole product, and with approval in the bag some believe that the prospect of a takeover has increased. Other approvals of note include an early decision on Exelixis/Ipsen’s Cabometyx in combination with Bristol Myers Squibb’s Opdivo in first-line renal cell carcinoma, which could help cement Opdivo as leader in the space by 2026. Elsewhere, Darzalex Faspro, the subcutaneous version of J&J/Genmab’s anti-CD38 MAb, gained approval in patients with newly diagnosed light-chain (AL) amyloidosis. Jefferies analysts forecast $2bn worldwide peak sales for Darzalex outside multiple myeloma, predominantly in amyloidosis. The other big regulatory news last month was a three-month delay to the FDA’s decision on Biogen’s Alzheimer’s project aducanumab, a move that many interpreted positively and caused Biogen’s shares to rise 5.5%.

Notable first-time US approval decisions in January
ProjectCompany 2026e sales by indication ($m)Outcome
Lupkynis
(voclosporin)
Aurinia1,092Approved
Cabenuva (cabotegravir + rilpivirine)GSK/J&J681Approved
Tepmetko
(tepotinib)
Merck KGaA492No decision yet
Verquvo
(vericiguat)
Merck/Bayer389Approved
Ansofaxine hydrochlorideLuye Pharma-No decision yet
Vocabria (oral cabotegravir)Glaxosmithkline-Approved
Sources: EvaluatePharma & company releases.

 

Supplementary and other notable approval decisions in January
ProductCompanyIndication (clinical trial)Outcome
XalkoriPfizerPaediatric patients with r/r systemic Alk-positive anaplastic large cell lymphoma (study ADVL0912 and A8081013)Approved
NplateAmgenHematopoietic syndrome of acute radiation syndromeApproved
EnhertuAstrazenecaHer2 +ve gastric or gastroesophageal junction (GEJ) adenocarcinoma (Destiny-Gastric01)Approved
XolairRocheSelf-administration option across all approved US indicationsNo decision yet
BotoxAbbvieDetrusor (bladder muscle) overactivity, paediatric patientsNo decision yet
EstelleMithraPrevent pregnancyNo decision yet
Darzalex FasproJ&J/GenmabAL amyloidosis (Andromeda, for use in combination with bortezomib, cyclophosphamide and dexamethasone)Approved
Opdivo plus CabometyxBristol/Exelixis1L  renal cell carcinoma (Checkmate-9ER)Approved (~1 month early)
Sources: EvaluatePharma & company releases.

https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-january

Pfizer sees $15bn of 2021 Covid sales; could it do $30bn?

 If Pfizer has got its sums right then the sellside might seriously have to lift forecasts for its Covid-19 vaccine Comirnaty. In today’s fourth-quarter earnings report the group said it expected to book $15bn of Comirnaty sales this year, but there is apparently room to approach a number twice as high. The $15bn forecast comprises only the 780 million or so doses Pfizer has already contracted for, including 200 million to the US for $3.9bn and 300 million to the EU. But the company can “potentially deliver around two billion doses by the end of 2021”, though because the market is subject to government contracting it says it is responsible not to bake such numbers into revenue forecasts. Pfizer is splitting Comirnaty gross margins 50/50 with Biontech, but will book sales globally except in Turkey and Germany, and expects a high-20s percentage pretax profit margin on the vaccine’s sales. In December the sellside saw Moderna’s mRNA-1273 as this year’s top-selling Covid-19 vaccine, and though some analysts now expect this to sell $11bn in 2021 Pfizer has jumped ahead; the first forecasts have also emerged for Astrazeneca’s AZD1222, from Leerink, which sees $1.9bn this year and $3bn in 2022.

https://www.evaluate.com/vantage/articles/news/snippets/pfizer-sees-15bn-2021-covid-sales-could-it-do-30bn