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.
Follow the latest on Day 3 at JPM 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 annual growth 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.”
AbbVie originally thought that the success had much to do with pandemic recovery, Severino said. 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 COVAX, an equitable vaccine distribution scheme co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations and the World Health Organization. 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.