As is typical, the second day of the JP Morgan Annual Healthcare Conference—conducted virtually this year because of the pandemic—had plenty of news from the largest biopharma companies globally.
As is typical, the second day of the JP Morgan Annual Healthcare Conference—conducted virtually this year because of the pandemic—had plenty of news from the largest biopharma companies globally. Here’s a look at some of the top stories from Day 2.
Gilead Sciences’ Remdesivir
One of the big stories of day 2 was also a general news story—Gilead Sciences updated its 2020 guidance to reflect that its Veklury, better known as remdesivir, for COVID-19, was even more profitable than originally thought. One tidbit was that half of the people hospitalized in the U.S. with COVID-19 have received remdesivir, which helps explain why its anticipated total sales for 2020 are about $2.8 billion.
Otherwise, at JPM, the company inked a deal with Vir Biotechnology with plans to initiate a Phase II trial evaluating different combinations of Gilead’s selgantolimod, Vir’s interfering ribonucleic acid (siRNA), and a marketed PD-1 checkpoint inhibitor. VIR-2218 is a TLR-8 agonist. People in the trial with hepatitis B may also receive Gilead’s Vemlidy (tenofovir alafenamide fumarate, TAF). The focus of the study will be proportion of patients achieving a functional cure for hepatitis B.
Gilead is also planning to expand its HIV portfolio with lenacapavir. This could provide subcutaneous dosing twice a year instead of daily tablets.
Daniel O’Day, chair and chief executive officer of Gilead, said, “Lenacapavir is a long-acting game changer.”
Merck’s Post-Keytruda Future
As usual, the company’s chief executive officer, Ken Frazier, was questioned on how the company was preparing for loss of patent protection for its uber-blockbuster checkpoint inhibitor, Keytruda (pembrolizumab). Frazier downplayed the company’s concerns over patent protection for Keytruda. The drug’s sales grew from $55 million in 2014 to $7.2 billion in 2018, and are projected to rake in $24.3 billion in 2026, according to EvaluatePharma.
“The concerns around the Keytruda (loss of exclusivity), although they’re valid, I think they’re a little bit overstated,” Frazier said at the conference, having earlier said that “we see it as not as big an issue as I think some investors may see it.”
The questions about this at JP Morgan typically revolve around what mergers and acquisitions the company may make to bolster their pipeline in preparation for sales losses if and when biosimilars to Keytruda hit the market. Frazier, speaking on the M&A activity, said the company needs “to continue to focus on getting the best external science we can, both in oncology and outside oncology, to diversify our portfolio, and we’re going to continue to focus on that.”
And Frazier defends the company, noting that Merck had 120 deals in 2020 alone, but none of them are the type of big, transformational deals major shareholders are apparently looking for.
“I think what people are saying is, “We’d like to see you do something bigger and later-stage,” Frazier said.
Vir Biotechnology’s COVID-19 Antibody
In addition to Vir’s deal with Gilead, there was talk of its antibody against COVID-19, which it is developing with GlaxoSmithKline. The antibody is currently in Phase III testing. They also have another COVID-19 antibody in preclinical studies as well as a partnership with Alnylam on a silencing RNA (siRNA) therapy against COVID-19.
“So when the COVID outbreak began, we isolated antibodies from COVID patients,” said George Scangos, Vir’s chief executive officer. However, it was antibodies from SARS patients—a cousin of COVID-19—that led to their best treatment. The researchers felt that an antibody against SARS that could neutralize COVID-19 must recognize a shared epitope, which is to say, a part of the antigen that causes the immune response. The epitope they’re targeting isn’t as likely to mutate, they hypothesized.
The company expects readouts from both its COVID and hepatitis B programs this year. And its influenza A program, which is moving more slowly, is expecting to launch in the northern hemisphere in the fall.
“We were ready to go into Phase II in the southern hemisphere flu season, which began in the spring here, but we couldn’t because there was no flu,” Scangos said. “The social distancing that reduces COVID also eliminates flu.”
AbbVie’s Humira Patent Protection
In much the same way that Merck is defending its position for future patent protection loss for Keytruda, AbbVie is describing its plans when it loses its patent protection for Humira in 2023. Chief executive officer Richard Gonzalez noted that the mega-blockbuster drug played a key role in “defining the standard of care” but was also facing multiple biosimilar competitors in the U.S. in 2023. Skyrizi and Rinvoq, two new immunology drugs, are projected to bring in $15 billion in sales by 2025, which Gonzalez said would take care of most of the “heavy lifting” for expected Humira sales losses.
Pfizer and BioNTech’s Scale-Up of COVID-19 Vaccine Production
U.S.-based Pfizer and Germany-based BioNTech had the first COVID-19 vaccine approved in the U.S. and UK. But one question that came up at JPM was how were the two companies able to ramp up their 2021 manufacturing projection to 2 billion doses—enough for 1 billion people? The answer, Albert Bourla, chief executive officer of Pfizer said, was by doing things “very differently and very out of the box in manufacturing.”
Key to that was changes to how it partners on raw materials, and by redesigning its operational flow to improve capacity. The companies also redesigned new equipment and partnered with manufacturers on getting that equipment delivered fast. Bourla added, there are “so many initiatives we have put in place…. I have admiration for our manufacturing team as much as I have for our research team—it’s almost equally difficult to scale up manufacturing at that level so fast as it was to develop the vaccine.”
Mirum Pharmaceuticals’ Maralixibat for Cholestatic Pruritus
Foster City, California-based Mirum provided a corporate update, noting that it expects to complete the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for maralixibat in the first quarter of 2021. The drug is being developed for cholestatic pruritus associated with Alagille syndrome. They also have an ongoing review of the same drug in progressive familial intrahepatic cholestasis, type 2 (PFIC2) by the European Medicines Agency (EMA).
Mirum also expects to randomize patients in three clinical trials in the first quarter: the Phase IIa/IIb OHANA trial for intrahepatic cholestasis of pregnancy; the Phase IIb VISTAS trial of volixibat for pruritus associated with primary sclerosing cholangitis; and the Phase II EMBARK trial of maralixibat for biliary atresia. And in the second half of the year, it plans to launch a Phase IIb trial of volixibat for pruritus associated with primary biliary cholangitis.
As of the end of 2020, the company had $231.8 million in cash, cash equivalents and investments.
