China Tightens Lockdown Measures As Omicron Spreads To Another Port City

 The situation in China continues to deteriorate ahead of the start of the Winter Olympics in Beijing as authorities have confirmed 2 cases of the omicron variant in yet another city. This time, the new outbreak is coming from Dalian, another important port city.

On Wednesday, China reported about 170 new locally transmitted cases, with 118 in central Henan province, 37 in the northern port city Tianjin, eight in northwestern Shaanxi province (where the capital city of Xi'an has been locked down for almost three weeks) and seven in the southern technology hub of Shenzhen, according to the National Health Commission. There have also been new cases of the omicron variant detected in Dalian, as we mentioned above.

Three Chinese cities remain completely locked down, while Tianjin is only partially locked down (it has also been sealed off from outsiders; only those with permission are allowed to arrive and depart).

Meanwhile, in Tianjin, a city just 130 km from Beijing, authorities are tightening lockdown measures in three districts to try and stop the spread of COVID. Their biggest fear, of course, would be an outbreak in the capital city just in time to upend the Winter Olympics (the last thing the CCP wants is a disastrous Olympic Games like Japan struggled with over the summer).

In Tianjin, restaurants, movie theaters, gyms and any other indoor sources of "entertainment" have all been closed. Its 14MM residents are also being required to undergo another round of city-wide mass testing.

Here's more details on the newest cases of omicron confirmed in Dalian, courtesy of Xinhua:

The two who returned from north China's Tianjin Municipality had tested negative for the virus when they left Tianjin on Jan. 8. They had reported negative test results on Monday, but both turned positive during the routine nucleic acid testing on Wednesday morning.

The two are college friends and had been in Jinnan District of Tianjin, a region hit hard by the recent virus resurgence in China, for about six days. They arrived in Dalian on Jan. 9 on an overnight train. Close contacts of the two have been put under medical observation and further epidemiological investigation is underway.

As a reminder, the cities under full lockdown include Xi'an, Anyang and Yuzhou. Goldman Sachs slashed its forecast for Chinese GDP growth in 2022 as the bank's analysts expect the burgeoning omicron wave to hamstring the Chinese economy. The Chinese media has insisted that the lockdowns aren't having a major impact on ports and chip manufacturers, but the notion that lockdowns wouldn't stifle economic growth is just a little too far-fetched to believe. Although a slowing commodity crunch has helped ease inflationary pressures in China.

What's more, Chinese health authorities have repeatedly confirmed new cases of omicron in increments of two. As we know, omicron doesn't spread like this. Where there are two cases, there are likely more. But if we have learned anything over the past two years, it's that China's numbers aren't to be trusted. Chinese authorities have suspended six more US flights in coming weeks amid a surge in passengers testing positive for COVID. This brings to 70 the number of cancellations this year.

https://www.zerohedge.com/covid-19/china-tightens-lockdown-measures-omicron-spreads-another-port-city

Positive Top-Line Results of Pfizer’s Phase 3 Study of Coadministration of PREVNAR 20™ With Pfizer-BioNTech COVID-19 Vaccine in Older Adults

 fizer Inc. (NYSE:PFE) today announced positive top-line results from a Phase 3 study (B74710126) describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.

Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine (n=190) or with placebo (n=191). Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo (n=189). The safety profile of co-administering PREVNAR 20 with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed with the Pfizer-BioNTech COVID-19 Vaccine booster dose.

https://www.pfizer.com/news/press-release/press-release-detail/positive-top-line-results-pfizers-phase-3-study-exploring-0

Philips warns Q4 sales will be 350 million euros less than forecast

 

Philips, the maker of medical equipment, warned on Wednesday that its fourth quarter sales would be about 4.9 billion euros, or 350 million lower than forecast, because of supply chain shortages.

"We are closely working with suppliers and governments to address the shortages in the healthcare supply chain and ensure they recognize the importance of prioritising life-saving medical equipment," Chief Executive Frans van Houten said in a statement.

https://www.marketscreener.com/quote/stock/PHILIPS-NV-6289/news/Philips-warns-Q4-sales-will-be-350-million-euros-less-than-forecast-37523702/

Back to Zoom: Omicron weighs on investment bankers' hustle

 Investment bankers who rushed to court clients in person after COVID-19 vaccines became available last year have been forced to cancel such gatherings at the start of 2022 as the Omicron variant rages.

Bankers say the impact on dealmaking will not be as severe as 2020, when the pandemic started and global mergers and acquisitions (M&A) activity fell to a three-year low. They expect the new surge to be short-lived and they have become accustomed to putting together deals virtually through online platforms such as Zoom.

Some fret, however, about losing the chance to cultivate relationships with executives socially. The timing is also poor for bankers hoping to win new assignments, as many large corporations review strategic changes at the beginning of the year.

"My motto has always been, if I'm not in front of my clients, someone else is. But I think this is just a different time. If people want to travel, and they are comfortable doing it, and they take precautions, I'm allowing people," said Drew Goldman, global head of investment banking coverage & advisory at Deutsche Bank AG.

Most of corporate America and Wall Street have asked employees not to come to the office this month, as COVID-19 cases in the United States repeatedly break new daily records. The vaccines have helped prevent hospitalizations and deaths, but infections have surged with the Omicron variant.

Other industries from healthcare to airlines to retail have been hit hard by Omicron. The World Bank on Tuesday cut its forecasts https://www.reuters.com/article/worldbank-outlook-idCAKBN2JL1EU for economic growth in the United States, the Euro area and China and warned that new coronavirus variants and other factors threatened the recovery in developing economies.

JPMorgan Chase & Co, Goldman Sachs Group Inc, Morgan Stanley and other big banks have encouraged staff to work from home to limit the spread of the virus. Some, such as Citigroup Inc, have gone further, implementing a "no jab, no job" policy to push employees to get fully vaccinated -- barring employees who receive an accommodation or exemption.

Many in-person meetings with bankers have been canceled by the companies themselves, according to interviews with six investment bankers who discussed the matter on condition that they and their clients are not identified. Some bankers have also canceled meetings on their own initiative.

It is a u-turn from last year, when bank CEOs, including JPMorgan's Jamie Dimon, Goldman Sachs' David Solomon and Morgan Stanley's James Gorman, urged bankers to use private corporate jets, if needed, to travel and meet clients.

Banks put on lavish dinners and wine-soaked meet-and-greets for clients. Some even rewarded staff with bonuses based on the number of clients they met.

It paid off. The value of M&A globally topped $5 trillion for the first time ever in 2021, according to Dealogic.

As with when the pandemic emerged in 2020, the toll is heaviest on young bankers, who learn their trade and develop contacts by working alongside and traveling with senior colleagues. The social distancing restrictions make it challenging for them to evolve from footsoldiers to rainmakers.

Given the Omicron wave's rapid pace, bankers are hoping to be back in the office and on the road come February.

"We have the chance to kind of go back to more normalcy, hopefully, in the next couple of weeks," said Deutsche's Goldman.

https://www.marketscreener.com/quote/stock/DEUTSCHE-BANK-AG-56358396/news/Back-to-Zoom-Omicron-weighs-on-investment-bankers-hustle-37526445/

JPM22, Day 2: Sage's double-duty anxiety drug; Dexcom shows off G7 sensor data; Better late than never for Enanta in COVID

 Welcome to Day 2 of the annual J. P. Morgan Healthcare Conference, gone virtual once more.

Here's your need to know. The deals began to flow as Amgen announced a team-up with Arrakis Therapeutics to develop a new class of RNA-targeting medicines, and Roche delivered a sizable investment in the liquid biopsy developer Freenome.

Yesterday's coverage of the conference's kick-off Day 1 is available here. And remember to check out tomorrow's Day 3 roundup, covering the on-the-ground skinny from Wednesday's action.

UPDATED: Tuesday 3:55 p.m. ET

It’s not too late to get a COVID-19 treatment into the clinic, according to late comer Enanta Pharmaceuticals. The biotech reasoned that omicron might not be the last variant of concern, Pfizer and Merck’s emergency authorized pills can’t fill all demand and the pandemic will turn into an endemic that still needs treatments.

That’s the logic behind Enanta's decision to enter the clinic next month with a protease inhibitor that it says is “very, very potent” against variants of concern, including omicron, in preclinical models, according to Jay Luly, Ph.D., CEO and president. The trial will test EDP-235 as a once-daily regimen of either 100mg or 500mg.

Tuesday 3:51 p.m. ET

Legend Biotech is nearing a big milestone with the approval of the J&J-partnered multiple myeloma CAR-T therapy cilta-cel expected in February. With that on the horizon, CEO Ying Huang, Ph.D., turned a lens to the biotech’s other R&D projects during a Tuesday presentation at J.P. Morgan. 

The biotech now has over 300 R&D scientists working on CAR-T therapies, TCR-engineered cell therapies, natural killer cell therapies, and other platform technologies. This includes both autologous and allogeneic approaches, or cells that come from a patients and are altered, or cells that are received from a donor and altered to make the treatment, respectively. 

The company kicked off a U.S. phase 1 trial for the CAR-T therapy LB1901 in two types of lymphoma in 2021. Other early-stage programs are underway in China. 

J&J and Legend also began a phase 3 study for cilta-cel in October 2021 for patients with multiple myeloma who have had multiple lines of treatment and are resistant to Bristol Myers’ Revlimid. This will compare cilta-cel with standard therapy in this indication. 

Tuesday 3:45 p.m. ET

There’s no need just yet to start dreaming up ways to repurpose the many PCR testing devices that have cropped up amid the COVID-19 pandemic—according to Hologic CEO Steve MacMillan, molecular testing is here to stay, even as the coronavirus follows its trajectory toward becoming a flu-like endemic disease in the next few years. 

“As we look forward, we totally believe that societies are going to want to truly track what is going on, and they’re going to need molecular testing,” he said. “Let’s face it: First off, the antigen tests don’t get properly reported, and more importantly, they just don’t work as well.” 

PCR tests, meanwhile—like those run on Hologic’s Panther analyzer—not only boast significantly higher sensitivity and specificity ratings than their antigen counterparts, but are also broadly trusted by hospitals, public health authorities and patients alike. “In virtually all things medical, the cream rises to the top, and the best tests prevail,” MacMillan said. “Molecular testing is the gold standard. It will be here for the long run, and we are going to be there with it.” 

As for what that long run will look like, MacMillan predicted, “This might look more like the pregnancy market, where people will use an at-home test, but you’re not going to decide you’re pregnant just based on a home test—you’re always going to reflex to the doctor.” 

Tuesday 2:20 p.m. ET

Dexcom provided a new look at clinical data from its upcoming continuous glucose monitoring sensor, the G7. “The performance of this product is something I never thought I would see in nearly 30 years in this business,” said CEO Kevin Sayer, adding that the device—at about 60% smaller than its predecessor, the G6—"comfortably" meets FDA standards. The company submitted the device for agency review last quarter, and is planning a global rollout coupled with new expansions into the Type 2 diabetes and fitness tracking markets. Story  

Tuesday 12:01 p.m. ET

Among a field of NASH biopharmas in the ‘show me’ stage of development for the non-alcoholic fatty liver disease, Akero Therapeutics hopes to be first to win an FDA nod. After failed NASH programs from Bristol Myers Squibb, Genfit, Enanta and Metacrine in recent quarters, Akero is moving forward with two phase 2b trials. One of those is expected to show some bearing in the third quarter of this year, President and CEO Andrew Cheng said during the biotech’s presentation at the annual J.P. Morgan Healthcare Conference on Tuesday.

The two phase 2b trials are testing efruxifermin’s ability to improve fibrosis associated with NASH, which affects millions of people in the U.S. The first trial, dubbed Harmony, is looking at patients with stage 2 and 3 fibrosis for 24 weeks and is slated for readout in the third quarter of this year. The second trial, Symmetry, is a 36-week study in patients with stage 4 fibrosis. The biotech will provide guidance “shortly” on the timing of that data; Akero has “less competition” in that stage of fibrosis, said Kitty Yale, chief development officer.

While both trials are testing efruxifermin at 28 mg and 50 mg, the longer-term plan will likely be 50 mg because “fibrosis improvement is better” at that dose, Cheng said. “You do lose a bit of glycemic control when you move to the 28 mg, and given that half of NASH patients are diabetic, it’s an important differentiator for the effects,” the CEO added.

In a phase 2a trial, the 50 mg dose delivered a 62% response rate, the company said in July 2020. That trial led Jefferies analysts to hail efruxifermin as best in class. Since then, Bristol Myers Squibb has dumped its own phase 2b NASH drug in November, and Genfit axed a phase 3 NASH trial in July 2020.

Tuesday 11:15 a.m. ET

Withings has snapped up its partner Impeto Medical to roll out new home-focused monitoring gadgets. Their first device, a smart upgrade of the bathroom scale, actually made its debut last week at the Consumer Electronics Show. The goal, after securing an FDA clearance and CE mark, will be to provide access to a simple daily analysis of biomarkers linked to common health conditions, as well as catch warning signs of potentially serious cardiovascular diseases and nerve damage. Story

Tuesday 10:40 a.m. ET

Sage Therapeutics expects the effect of zuranolone on anxiety to be “key” to the depression drug. Talking at JPM, Sage executives framed the effect of zuranolone on anxiety, a common comorbidity in depression patients, as a differentiator for their drug. “What we're seeing with zuranolone is the primary effect on depressive symptoms. In addition to that, you're seeing beneficial effects on anxiety symptoms. That's why you see ... patients who suffer from both symptoms having a really robust response to zuranolone in our clinical trials,” Jim Doherty, chief development officer at Sage, said. Sage expects to complete a rolling NDA in the second half of 2022.

Tuesday 9:00 a.m. ET

Amgen adds to the flurry of companies announcing new research partnerships, with a new $75 million upfront deal to research RNA degraders for difficult-to-drug targets with Arrakis Therapeutics. The two companies dubbed this a new class of medicines, which they hope will emerge from a combination of Amgen’s induced proximity platform discovery expertise and the small biotech’s RNA-targeted drug discovery platform. Story

Tuesday 8:45 a.m. ET

Thermo Fisher CEO Marc Casper offered a potentially unique perspective on the past 12 months: “2021 was awesome.” 

But then most people hadn’t recently closed one of the largest medtech deals of the year, with a $17.4 billion buyout of the contract research giant PPD. In his investor presentation, Casper described the move into clinical research services as a “natural extension” of Thermo Fisher’s efforts to serve its customers in biopharma. With the integration of the business underway, Casper said the company is now poised to support drugmakers from “the beginning of a scientific idea all the way through to an approved medicine,” by outfitting research labs, assisting in studies and delivering manufacturing hardware.

And while the outlay for PPD made up the lion’s share, Thermo Fisher spent a total of $24 billion on M&A over 2021, Casper said—spanning international viral vector producers, cell sorting machine developers, and the rapid PCR testmaker Mesa Biotech. Most recently the company acquired PeproTech for $1.85 billion, producer of ingredients used to develop and produce cell and gene therapies.

Tuesday 8:00 a.m. ET

The cancer blood testing company Freenome passed the $1 billion funding mark, courtesy of $290 million from Roche. The drugmaker has invested about $350 million in the liquid biopsy developer since its 2014 founding, CEO Mike Nolan told Fierce Medtech in an interview. Freenome’s first diagnostic, for spotting colorectal cancer, is currently undergoing clinical testing, but the company plans to pursue multiomics tests for a range of cancer types and in some cases multiple cancers at once. Story

https://www.fiercebiotech.com/biotech/jpm22-day-2

JPM 2022: AbbVie adjusts 2025 individual sales projections for Rinvoq and Skyrizi but not combined total of $15B

 Ahead of its state-of-the-company address at the J.P. Morgan Healthcare Conference, AbbVie took the unusual step of reconfirming its guidance for its blockbusters-in-waiting Rinvoq and Skyrizi, saying it expects the duo's sales to reach a combined $15 billion in 2025.

Why update an estimate that hasn’t changed?

While AbbVie expects the two to produce the same combined revenue, there has been some movement on the projection for each. The company reduced Rinvoq’s sales estimate for 2025 by $500 million and increased Skyrizi’s by the same amount.

The adjustment for Rinvoq is based on a warning attached to its label. The drug is approved in the U.S. for rheumatoid arthritis and just four weeks ago earned a second indication for psoriatic arthritis. As a drug from the JAK inhibitor class, it has come under scrutiny for safety concerns. Its new label will limit its use to patients who have already tried a drug from the TNF inhibitor drug class, while previously it could be used ahead of TNFs.

“We’ve seen the RA label and we’ve seen how we can perform with that label, and we’ve also seen increased confidence both from treating physicians and the investment community on the basis of that update,” said AbbVie president Michael Severino. “We have continued confidence in the profile based on the clear benefit and the overall benefit-risk that we have delivered.”

While the warning will blunt sales in the U.S., AbbVie explained that there are offsetting factors, as it now expects higher anticipated sales in international markets as well as higher anticipated global sales in ulcerative colitis and Crohn’s disease following positive phase 3 study readouts for Rinvoq.

“The data that we’ve read out, both in ulcerative colitis and Crohn’s disease, have exceeded our expectations,” Severino said. “And that’s true from both a safety and efficacy perspective.”

Meanwhile, Skyrizi’s tweaked guidance is a result of its continued strong performance in psoriasis, AbbVie said.

Sales projections for the two drugs are closely watched considering AbbVie’s cash cow, Humira, is set to face biosimilar competition in the U.S. in 2023. The treatment rang up $20.39 billion in 2020, its ninth straight year as the world’s best-selling drug.

AbbVie on Tuesday said that it expects Rinvoq and Skyrizi to cover all of Humira's indications plus atopic dermatitis.

“We fully believe that Rinvoq and Skyrizi at peak will be greater than Humira (in terms of sales),” AbbVie’s CFO Rob Michael said. 

Analysts at Piper Sandler reacted positively to the company’s projection.

“With this clarity on long-term revenue expectations for the immunology franchise now in hand, combined with commercial momentum from an emerging neurology franchise and the aesthetics business, we continue to view AbbVie as well-positioned for growth following Humira’s loss of exclusivity,” wrote Christopher Raymond in a note to investors. “We continue to view AbbVie as an essential biotech holding, and it remains our top large-cap pick.”

https://www.fiercepharma.com/pharma/abbvie-adjusts-2025-individual-sales-projections-for-rinvoq-skyrizi-but-not-their-combined

JPM22, Day 2: AbbVie's surprising aesthetics success; Eli Lilly's tirzepatide plans and more

 The 40th annual J.P. Morgan Healthcare Conference rolls on today with virtual presentations and Q&A sessions from some of the biggest names in biopharma. Be sure to check in throughout the day to get the latest happenings from the virtual conference.

To look back at Fierce Pharma's coverage from Day 1, click here. And check out Fierce Biotech's coverage here.

UPDATED: Tuesday, Jan. 11 at 7:05 p.m. ET

At the time of its Allergan acquisition, AbbVie had modest expectations for the aesthetics business that came with the transaction, expecting mid single-digit growth. Less than two years later, however, AbbVie is happy to have been wrong and to make an upward adjustment. The company now expects high single-digit revenue CAGR for its aesthetics franchise through 2029.   

“As we worked through the year, our original guidance for aesthetics in 2021 was $4.5 billion,” AbbVie president Michael Severino said. “On a Q3 call, we were at $5.1 billion, so we’ve seen just tremendous progress there.”

Severino said that the company originally thought that the success had much to do with pandemic recovery. But when it sustained through 2021, AbbVie realized investment drove much of the growth.

Efforts to retain current patients, gain new ones and help customers grow their practices have paid off along with more consistent promotional spending and enhanced digital products and services, the company said.

Boosting its presence in China and in its “mid-tier cities,” which are “the size of Chicago,” Severino said, also has had helped spur growth.

AbbVie now expects $9 billion in sales from its aesthetics business in 2029.

UPDATED: Tuesday, Jan. 11 at 6:52 p.m. ET

For GLP-1 meds like Eli Lilly’s forthcoming tirzepatide in diabetes, “the runway is wide, and the runway is long,” CEO David Ricks said Tuesday during a fireside chat. The class can expect to grow incrementally for “quite a bit longer” in its current treatment position, which is “after oral failure” and “before insulin,” Ricks said.

Increasingly, however, GLP-1 drugs are being used earlier in the course of a patient’s disease, Ricks said, and that’s something Lilly hopes to “accelerate” with tirzepatide. In the U.S., many patients who fail on metformin “go right to a GLP,” which suggests that shift is already underway.

Meanwhile, Lilly is “pretty bullish” about the potential of GLP-1s to disrupt the weight management field. Tirzepatide is angling for an approval in type 2 diabetes to start, but Lilly's goal is to eventually snag a use in obesity.

That would put the drug in competition with Novo Nordisk’s recent weight-loss launch Wegovy—and that isn’t necessarily a bad thing, Ricks said. Unlike diabetes, which can feel more like a “zero-sum game” at times, Ricks figures “having the two competitors talk about, do studies in and broaden access for obesity-related treatment as a real medical problem will be good for everybody.”

UPDATED: Tuesday, Jan. 11 at 2:02 p.m. ET

Amgen already considers its biosimilar business an “industry-leading franchise,” CEO Robert Bradway said —and not without good cause. The company has launched five copycat meds so far, which together reaped sales of around $2 billion for the first nine months of 2021. By 2030, the company expects to more than double that revenue, the CEO said.

Meanwhile, the company has a major biosimilar launch on the horizon in Amjevita, Amgen’s Humira analogue, which is poised to debut in the U.S. on Jan. 31, 2023. After that, Amgen expects to launch among the first wave of biosimilars to big-selling brands Stelara, Eylea and Soliris, Bradway said.

As for its own branded meds, Amgen is banking on momentum from a trio of approvals in 2021 for severe asthma therapy Tezspire, oral plaque psoriasis med Otezla and lung cancer drug Lumakras. On Tezspire, about 2.5 million patients with severe asthma are uncontrolled or eligible for treatment with a biologic, Bradway said. Roughly 1 million of those patients are based in the U.S. Meanwhile, a recent label expansion for Otezla to cover adult plaque psoriasis patients regardless of disease severity has opened the door to another 1.5 million patients for that med, the CEO said.

On the business development front, “external innovation has and will remain an important part of our strategy,” Bradway said. Just this morning, Amgen put up $75 million to partner with Arrakis Therapeutics on targeted RNA degraders for difficult-to-drug targets.

UPDATED: Tuesday, Jan. 11 at 1:16 p.m. ET

The “burning topic” at the top of Teva's J.P. Morgan Healthcare Conference presentation was, unsurprisingly, the status of the company’s ongoing opioid litigation, which has dogged the Israeli-American generics giant for years, CEO Kåre Schultz noted Tuesday. Teva took a blow in December when a jury in New York found the company contributed to the state's opioid epidemic. The drugmaker isn’t playing sitting duck, though: Teva has filed for mistrial, which essentially comes down to closing remarks, Schultz said. The company hopes to land a new trial, but if things don’t pan out, Teva plans to appeal the verdict, he added.

Meanwhile, Teva is still in talks with attorney generals and plaintiff lawyers to reach a nationwide settlement agreement, Schultz said. Overall, the company is “hopeful” that it will be able to reach such an agreement “in the coming year.”

Also on Tuesday, Schultz reflected on the growth of migraine med Ajovy. Ajovy is now the second leading migraine brand in Europe, with 27% volume market share, Schultz said. With that performance in mind, Teva now hopes for Ajovy to snag one-third of the market in Europe and in the U.S., up from a previous goal of about 25%.

Schultz also spoke about Teva’s biosimilar ambitions. The launch of rituximab biosimilar Truxima, which has been going “extremely well,” shows that Teva has biosimilars covered on the commercial front, Schultz said. Looking ahead, the company’s copycat portfolio “basically covers all the key biologics that go off patent over the next 10 years,” the CEO added.

UPDATED: Tuesday, Jan. 11 at 12:54 p.m. ET

A key strategy for Roche’s development of cancer drugs focuses on targeting the diseases earlier in their course to reach a potential cure, Roche’s pharma chief Bill Anderson said Tuesday. The Swiss pharma currently has nine phase 3 trials of PD-L1 inhibitor Tecentriq and ALK inhibitor Alecensa for uses around surgery to treat early-stage tumors. Among them, six are expecting readouts in 2022.

Tecentriq recently landed a first-in-class FDA indication as a post-surgery adjuvant treatment for stage II to IIIA non-small cell lung cancer (NSCLC) that expresses the PD-L1 biomarker. Still, doctors have suggested that they'll wait for more data from other PD-1/L1 inhibitors in NSCLC in the so-called adjuvant setting. And even if they started to use immunotherapy this early in the disease, most of them would reach for Merck’s market-leading Keytruda, a Jefferies survey had found. But Anderson argued Keytruda’s success in metastatic NSCLC doesn’t necessarily preclude an opportunity for Tecentriq in early-stage disease.

“We don’t think there’s a particular barrier,” Anderson said. Tecentriq has a relatively large market share in small cell lung cancer, Anderson noted, suggesting that doctors will use the Roche drug in adjuvant NSCLC if it turns in better data. The doctors will look for data from multiple PD-1/L1 contenders out there, Anderson acknowledged, which will be a factor in their treatment decisions.

Meanwhile, Merck just found out that Keytruda’s own adjuvant NSCLC trial, dubbed Keynote-091, met one of its two co-primary endpoints. The drug topped placebo at reducing the risk to disease recurrence or death in a wider range of patients with stage IB to IIIA disease, regardless of their PD-L1 status. However, in PD-L1-high patients, a population that historically respond better to PD-1/L1 inhibition, Keytruda’s benefit didn’t pass the statistical significance bar.

UPDATED: Tuesday, Jan. 11 at 11:35 a.m. ET

BioNTech CEO Uğur Şahin cast doubt on the need for COVID-19 vaccines that would defend against multiple variants. It's one "opportunity," he said Tuesday, but "at the moment we have a situation where we do not know what is the next variant."

Plus, Şahin said, "omicron infection and an omicron vaccine would most likely boost immune responses against all existing variants."

In 2021, the COVID-19 vaccine BioNTech developed with partner Pfizer accounted for 74% of the market share in the U.S. and 80% in Europe, the company estimates.

UPDATED: Tuesday, Jan. 11 at 11:20 a.m. ET

While global vaccine giants Sanofi and GlaxoSmithKline haven’t been at the center of pandemic vaccination efforts, the partners are still forging ahead in the field, Sanofi’s vaccines chief Thomas Triomphe said Tuesday.  

The companies have turned in positive interim booster data for their program and expect “good” final data for a booster dose, Triomphe said. Meanwhile, their phase 3 efficacy study for primary COVID-19 vaccination is set to read out in the first quarter of 2022. 

In flu, Sanofi doesn’t view mRNA technology as an immediate threat to its well-established portfolio, Triomphe said. The first-generation of mRNA tech is “doomed to fail” in flu, Triomphe said, so it won’t supplant traditional flu shots during the next couple of years.

As for Sanofi’s capital allocation and dealmaking priorities, CFO Jean-Baptiste Chasseloup de Chatillon said the company wants to build on its strengths. In immunology, Sanofi aims to build an industry-leading franchise, the CFO said. 

Sanofi has been on a multi-year campaign to save billions of euros annually, and each time the company scores some savings, it typically strikes a deal to “add science and value to our pipeline,” the CFO said. Story

UPDATED: Tuesday, Jan. 11 at 9:57 a.m. ET

Following bluebird bio’s split into two companies back in November, new CEO Andrew Obenshain reflected on the company’s decision to remove Zynteglo from the European market. Speaking with Fierce Pharma on the conference’s virtual sidelines, Obenshain said that was “one of the hardest decisions” for the company because it “ran against everything we stand for, which is getting the products to the patient.” 

Zynteglo, a one-time gene therapy for beta thalassemia, won approval in Europe in June 2019 and carried a price of $1.8 million. 

Bluebird removed the drug from Europe after it ran into reimbursement hurdles, and now Obenshain says the company has “unfinished business” in the region. The company would like to get the drug back on the market in Europe one day, but first it needs to scale its business.  

In the U.S., the drug is under FDA consideration in beta thalassemia but with the name LentiGlobin. The agency is set to decide on the drug in May. Story

UPDATED: Tuesday, Jan. 11 at 9:35 a.m. ET

While late to the races in the U.S., Novavax’s protein-based COVID-19 vaccine still has a major role to play around the world, Silvia Taylor, senior vice president, global corporate affairs and investor relations at Novavax, said in an interview. The company predicts most of its vaccine demand will come from three groups of individuals: Those who’ve yet to receive their first series of shots; people who need boosters; and kids. Weighing that trinity of primary, booster and pediatric need, there are some 5 billion “doses of demand” in the high-income market alone, Taylor said. Moving into middle- and lower-income countries, many of which have lower vaccination rates, that demand increases to more than 6.5 billion doses, she said.

For the primary vaccination market, Novavax predicts that its shot, based on an established vaccine platform, could help counter hesitancy among the unvaccinated. Novavax’s shot is “built on a well-understood technology platform that has been used in other vaccines, like HPV,” Taylor said. For those who haven’t been vaccinated due to lack of access, Novavax has pledged around 1.1 billion doses of its vaccine to the World Health Organization’s equitable vaccine distribution scheme COVAX. On the booster front, “there’s an emerging body of evidence, not only from studies done by others but from our own that we seek to grow, that shows we can be used as a booster,” Taylor said, referring specifically to heterologous boosting, in which a person receives a follow-up shot that’s different from their initial jab.

Novavax’s shot is one of many being studied in COV-Boost, a U.K.-based “mix-and-match” trial that’s evaluating heterologous boosting in people who previously received two doses of an authorized vaccine. Additional data from that study is expected in 2022, Novavax said in its presentation at this year’s virtual J.P. Morgan Healthcare Conference. Story

UPDATED: Tuesday, Jan. 11 at 8:40 a.m. ET

After GlaxoSmithKline last summer detailed plans to spin off its consumer health group in the middle of 2022, CEO Emma Walmsley opened the conference Tuesday by saying the U.K. pharma giant is ready for a "landmark year." After the spinoff, GSK's consumer health group is set to become the top overall consumer healthcare company globally, with 10 billion pounds ($13.58 billion) in annual sales and 23,000 employees worldwide. The independent company will sell 20 brands with annual sales of 100 million pounds or more, and its products will reach consumers in 100 countries.

As for what's left after the split, new GSK is gearing up for 5% annual sales growth through 2026 and is targeting operating profit growth of more than 10% over that period, Walmsley said. The pharma- and vaccines-focused conglomerate aims to haul in 33 billion pounds ($44.8 billion) in annual revenues by 2031. To get there, the company is counting on strong growth from its vaccines and specialty medicines franchises, while consumer healthcare is expected to stay "broadly stable."

The GSK team has flexed its scientific muscle in recent months and years, Walmsley said. The “compelling” phase 3 results for daprodustat to treat anemia from chronic kidney disease should enable a regulatory submission “in the coming months," the CEO noted. Plus, the company has a “potentially best-in-class" monoclonal antibody for COVID that’s designed to fight all potential variants. Lastly, the U.S. approval for long-acting Apretude ushers in a new dynamic in the effort to prevent HIV. 

A big part of GSK's growth story going forward will center on shingles vaccine Shingrix. Recently, though, mRNA stars Pfizer and BioNTech unveiled a plan to go after that disease target with their vaccine tech. Asked about the potential competition on Wednesday, GSK execs said any new entrant will have a high efficacy and safety bar to clear to vie for share against Shingrix.

https://www.fiercepharma.com/pharma/jpm22-day-2-glaxosmithkline-s-landmark-year-and-more