U.S. trial of COVID-19 blood plasma halted after no benefit found

 The U.S. National Institutes of Health (NIH) said on Tuesday that it has halted a trial of convalescent blood plasma in the treatment of patients with mild-to-moderate COVID-19 symptoms as it was unlikely to benefit this group.

The NIH said its decision was based on the findings of an independent data monitoring board. (bit.ly/3rbOIdh)

The health agency’s move comes less than two months after an international trial of convalescent plasma was halted as no benefit was found. Other studies conducted in India and Argentina have also found no apparent benefit for those severely ill with the disease.

The U.S trial had enrolled 511 of 900 participants, who were either given blood plasma from recovered COVID-19 patients or a placebo.

A recent analysis indicated no significant difference in the proportion of patients who needed emergency treatment, had to be hospitalized or died within 15 days of entering the trial, NIH said.

https://www.reuters.com/article/us-health-coronavirus-plasma/u-s-trial-of-covid-19-blood-plasma-halted-after-no-benefit-found-idUSKCN2AU29B

Facebook’s growth rate could be hit by Covid vaccines: CFO

 Facebook CFO David Wehner on Tuesday said the social media company’s advertising growth rate could be impacted as more consumers receive their Covid-19 vaccinations and shift their spending back toward services like travel instead of consumer goods.

We “expect some of consumer expenditures to shift back into services in places like travel as we get further into the year and people get vaccinated,” Wehner said, speaking at the Morgan Stanley Technology, Media and Telecom Conference. “That could impact us in terms of growth rate because we tend to under index relative to the overall economy in some of the service sectors.”

Wehner said that it is still tough to forecast for 2021 with so much uncertainty, but, in general, Facebook expects the growth in e-commerce ad sales to slow down. E-commerce was a key sector that fueled Facebook’s growth in the third and fourth quarters of 2020, Wehner said.

“The acceleration that we saw in the e-commerce growth side, that’s going to slow down because we’re not going to have the same drivers of acceleration pushing people to shift online,” Wehner said. “We do think that online is going to be a bigger component of people’s businesses going forward, so we think we’ll lock in those gains. But I don’t think the shift will be happening as quickly, so that’ll be somewhat of a headwind to our business.”

https://www.cnbc.com/2021/03/02/facebooks-growth-rate-could-be-impacted-by-covid-vaccines-cfo-says-.html

House to investigate One Medical's vaccination practices: report

 Congress is launching an investigation into concierge healthcare provider One Medical following allegations that the company has been administering COVID-19 vaccinations to ineligible patients, according to a new report.

The House Select Subcommittee on the Coronavirus Crisis plans to examine the San Francisco-based company's practices, NPR reported. This comes on the heels of an NPR investigation that found One Medical administered COVID-19 vaccinations to those with connections to leadership as well as ineligible patients.

"Despite being warned that the company's lax oversight of vaccine eligibility rules was allowing ineligible patients to jump the line, One Medical has reportedly failed to properly implement an effective protocol to verify eligibility and instructed staff not to police eligibility," wrote subcommittee Chairman James Clyburn in a letter sent to One Medical late Monday night, the publication reported.

The letter demands documents and information on One Medical's COVID-19 vaccination practices within two weeks, with a deadline of March 15. Among other topics, it seeks demographic breakdowns of COVID-19 vaccines administered to date and communications related to vaccination appointments arranged for those close to the company's executives, according to NPR.

The company has refuted the claims, and, during an earnings call last week, One Medical Chairman, CEO, and President Amir Dan Rubin said "any assertions the company broadly and knowingly disregarded eligibility guidelines are not true and in contradiction to its approach."

One Medical responded to news of the probe Monday, saying: "We remain dedicated to lending our time and resources to providing equitable and accessible care for the communities we serve, and are confident that we will be able to clear up these misunderstandings," according to NPR.

In a statement on its website, One Medical said it routinely turns people away who do not meet eligibility criteria.

"Our data currently shows nationally 96% of individuals vaccinated by One Medical have eligibility documentation and the remaining 4% generally were vaccinated in accordance with zero wastage protocols," the company said.

After reviewing internal communications, NPR found multiple instances across multiple states in which medical staffers working for One Medical sounded the alarm about improper procedures and lax oversight over eligibility requirements. "We are not policing," a top One Medical staffer told doctors and other medical providers after they raised concerns. One Medical claims that it does not knowingly permit ineligible patients to be vaccinated.

As the congressional investigation begins, numerous local public health departments have halted cooperation with One Medical based on investigations that found vaccination line-skipping. 

https://www.fiercehealthcare.com/practices/congress-to-investigate-one-medical-s-vaccination-practices-report

AbbVie bags option to buy Mitokinin for Parkinson's prospect

 AbbVie has landed an option to buy Mitokinin for a neurodegenerative disease pipeline led by a Parkinson’s disease prospect. The option positions AbbVie to buy Mitokinin upon the completion of IND-enabling studies on the biotech’s lead PINK1 compound. 

Mitokinin is based on technology discovered by Nicholas Hertz, Ph.D., and Kevan Shokat, Ph.D., at the University of California, San Francisco. In 2013, Hertz and Shokat co-authored a paper in Cell that described the use of a neo-substrate to increase the activity of PINK1. The approach represented a way to work around the lack of known allosteric regulatory sites for PINK1 and thereby treat an autosomal recessive form of early onset Parkinson’s.

Hertz and Shokat co-founded Mitokinin with Daniel de Roulet to take the science forward, leading to a series A round that attracted Mission BioCapital and Pfizer Ventures. Mitokinin used the money to take its Parkinson’s program to the IND-enabling stage while doing early-stage work on Huntington's and Alzheimer’s diseases. 

Now, AbbVie has signed up to help Mitokinin get to the next stage in its evolution. In return for the option to buy Mitokinin, AbbVie is making an upfront payment that will help the biotech take its lead program through IND-enabling studies. AbbVie has an option to buy Mitokinin once the IND-enabling work is complete. 

If AbbVie takes up the option, it will secure the rights to a drug that could unlock the therapeutic potential of PINK1. A body of evidence going back around 20 years links mutations to mitochondrial kinase PINK1 to Parkinson’s. PINK1 is involved in repairing mitochondrial dysfunction. Mutations to the kinase stop those repairs, leading to the buildup of improperly folded proteins in mitochondria associated with Parkinson’s. 

Multiple groups have identified PINK1 as a potential target, but the interest is yet to translate into clinical candidates. With AbbVie in its corner, Mitokinin could now lay the groundwork for a move into the clinic and secure an exit for its investors in the process. 

https://www.fiercebiotech.com/biotech/abbvie-bags-option-to-buy-mitokinin-for-parkinson-s-prospect

J&J’s next COVID vax challenge? Beating ‘66%’ perception to win vaccine-hesitant public

 With an FDA green light for emergency use, Johnson & Johnson’s COVID-19 shot now faces a communications hurdle. How will the company handle the comparisons with its vaccine rivals?

Already, there's wide and spreading chatter on social media and real-world word-of-mouth discussions about the J&J shot's 66% overall effectiveness rate. The company's response has been communication—and lots of it, with some help from its friend in public health.

J&J CEO Alex Gorsky, government officials—and even Pfizer board member and ex-FDA chief Scott Gottlieb—took to multiple media outlets on Sunday and Monday to lay out the detailed facts and nuances in the data.

Gorsky hit the media circuit Monday morning, appearing on CBS’ Good Morning America, NBC’s Today Show and CNBC news.

His repeated answer to the 66% question when compared to Pfizer and Moderna’s 95% and 94% effectiveness rates? Different trial timing—namely, after new variants emerged—and the global nature of J&J’s testing delivered different outcomes.

While 40% of its trial participants were in the U.S., another 40% were in Latin America and 15% were in South Africa, where almost all trial participants faced the more-contagious B.1.351 variant.

Plus, in all his interviews, Gorsky pointed to the vaccine’s 85% effectiveness rate against serious illness and 100% effectiveness at preventing death.

“Our data actually includes these most challenging, pernicious, virulent strains and what we saw was an 85% effectiveness rate in the severe disease,” Gorsky said on CNBC.

On Sunday, Anthony Fauci, NIAID chief and the White House's chief medical adviser, appeared on Meet the Press and Face the Nation with a similar message about reductions in hospitalizations and deaths.

The White House COVID-19 Response Team released a social media video featuring Fauci answering questions about the J&J vaccine. He opens the video by saying, “I would definitely take the Johnson & Johnson vaccine.”

Former FDA Commissioner Scott Gottlieb called the J&J vaccine effective in a media appearance on CBS’ Face the Nation Sunday. He said he would take the shot himself and urged people to be confident in its worth.

While J&J’s vaccine may face greater communications challenges than the first two COVID-19 vaccines did, the company and public health officials should continue to aim for transparency and simple, clear messages, experts said.

“One of the most important things is not overgeneralizing the message and saying ‘Oh, you should just get it whatever it is,’ ” said Rob Jekielek, managing director at The Harris Poll. “Because there are people who are hesitant because they don’t think they have enough access to information or they don’t understand it. So it’s really important to be specific. … [M]ost important, across the board, is that the vaccines directly address severe COVID-19.”

Vaccine makers should also look to make sure physicians and nurses on the front lines are informed, because they remain American’s most trusted sources of vaccine information, according to Harris Poll data.

“As you have new drugs coming in and new data being released, it’s going to cause confusion with people, but it’s particularly critical you don’t have that confusion with healthcare providers,” Jekielek said.

https://www.fiercepharma.com/marketing/j-j-s-covid-vaccine-gets-fda-ok-but-can-pharma-hurdle-66-perception

Lilly's Verzenio could hit $4.6B, thanks to early breast cancer win

 In the kinase inhibitor class of breast cancer drugs, Pfizer’s Ibrance has held a strong lead in market share—and sales—over Eli Lilly’s Verzenio.

But on the heels of Verzenio's strong showing in HR+/HER2- early breast cancer—and Ibrance's miss—one influential analyst figures the Lilly drug will quickly pick up steam. The upshot? About $4.6 billion in sales at the peak, significantly more than most pharma watchers now expect from the med.

Since its launch in 2017, Verzenio’s share of the market in metastatic breast cancer has been “steadily growing,” from 12% early last year to 20% now, Bernstein analyst Ronny Gal wrote in a Monday note to clients. And with a potential launch in HR+/HER2- early breast cancer, the drug's sales are set to ramp up considerably, he said. 

Lilly is “showing success with arguing for differentiation from Ibrance, and the growth will continue when the drug gains approval” in early breast cancer, the analyst wrote. The prediction comes after Verzenio posted impressive data in HR+/HER2- early breast cancer—and after Ibrance failed two studies in early breast cancer.

Pfizer’s drug won an FDA approval in 2015 and generated $5.4 billion in sales last year. Verzenio, for its part, scored an FDA approval in 2017—giving Pfizer a considerable head start—and brought in $913 million last year. 

While Pfizer’s drug is already on a strong sales trajectory, Gal says Lilly can expect Verzenio to not only pass the $1 billion blockbuster threshold but gin up billions more than that each year.

Ibrance will “retain market leadership” in metastatic breast cancer, Gal wrote, but he sees Verzenio snagging 28% of that market by 2024. With those share gains plus a potential FDA nod in early breast cancer, Bernstein analysts project $4.6 billion in Verzenio sales in 2024, significantly higher than consensus Wall Street estimates of $3.2 billion. 

Last summer, Lilly’s drug—added to standard endocrine therapy after surgery—showed it could significantly reduce the risk of cancer recurrence by 25.3% in patients with high-risk HR-positive, HER2-negative early breast cancer.

One expert said the findings would "change practice." The company filed the data with regulators in the fourth quarter of 2020, according to its recent annual SEC filing.

Meanwhile, Pfizer's Ibrance has failed two studies in early breast cancer. After the second failure, SVB Leerink analyst Geoffrey Porges wrote that there's “no saving adjuvant for Ibrance."

https://www.fiercepharma.com/pharma/look-for-eli-lilly-s-verzenio-to-reach-4b-after-early-breast-cancer-win-analyst

Hims & Hers upped to Buy by Citi

 From Neutral; target $23.

https://finviz.com/quote.ashx?t=HIMS