Amgen looks to pipeline heavyweights sotorasib, tezepelumab along with biosimilars to boost sales volume

Amgen
Amgen has two big drug approvals on the horizon as it looks to boost its bottom line through sales volume. (Business Wire)

With a Biden Democratic presidency and same-party majority Congress now in power, Amgen is assuming—most likely correctly—that drug pricing pressures will continue.

Its plan? Drive growth through volume. That means focusing on its pipeline—in particular, a promising pair of novel candidates closing in on approval, along with expanding both international and biosimilar sales.

While Amgen executives discussed the volume strategy at the annual J.P. Morgan healthcare conference last month, the company's fourth-quarter earnings data, reported earlier this week, bore it out.

The Big Biotech's full-year sales grew 9% in 2020, driven by 15% volume growth, with product sales specifically up 8% on 13% volume growth, Murdo Gordon, Amgen's executive vice president of commercial operations, said. Some specific stats on volume: PCSK9 drug Repatha saw 67% year-over-year volume growth, prescriptions of psoriasis pill Otezla grew by 13% and, in the fourth quarter, migraine med Aimovig's volume grew 21%, Gordon said. He also pointed to sales of bone drug Evenity, which were up 85% year over year, driven by "strong volume growth."

After JPM, Gordon said in an interview that the volume strategy is “meant to acknowledge that we are an innovation-based company and that we also understand the market dynamic might continue to pressure net prices in a downward direction." He added that Amgen would end 2020 as it did 2019, with “net price reductions.”

RELATED: Novartis, Amgen and Mallinckrodt used aggressive price hikes to meet sales goals, congressional probe finds

When it comes to working with the Biden administration on pricing, Amgen CEO Robert Bradway said during his company's JPM presentation that Amgen “looks forward to working with the new administration” and lawmakers on “both sides of the aisle” on healthcare and drug pricing issues.

However, Amgen was recently blasted, along with Novartis and Mallinckrodt, by the House Committee on Oversight and Reform in a 41-page report on drug price hikes. The committee wrote in its October report that Amgen's pricing decisions “were driven primarily by the need to meet increasingly aggressive revenue targets” regarding immunology drug Enbrel and thyroid med Sensipar.

Amgen’s new volume focus for 2021 will home in on its most imminent approvals—two high-profile, first-in-class drugs. The first is KRAS-targeting sotorasib for non-small cell lung cancer, which Amgen filed for FDA approval in December. The second is a co-marketed product with AstraZeneca—TSLP-blocking tezepelumab to treat severe asthma, and in particular to serve patients with low eosinophil levels, where there is currently no treatment. Amgen plans to file for FDA approval in the first half of 2021.

RELATED: WCLC: Amgen's KRAS drug pads its case for approval with global filings underway

For sotorasib, Amgen is readying its commercial team with a starting educational focus on testing for the KRAS G12C mutation, Gordon said.

“For 40 years, they couldn’t do anything about it, so the test result sometimes is buried in the back of a pathology report, sometimes it’s not even asked for. About 50% of non-small cell lung cancer patients probably have a KRAS G12C test result somewhere in their diagnostic workup, but that’s clearly not good enough and we’ll have to drive that up into the 80 to 90% range,” Gordon said.

And the team has good data to back its testing push. Amgen last week reported sotorasib's biggest data set yet in patients with non-small cell lung cancer, showing the prospect curbed tumor growth in 81% of patients and shrank tumors in 37% of them.

Presenting at the World Conference on Lung Cancer, Amgen's data showed that along with shrinking tumors in more than one-third of patients, sotorasib eliminated all signs of cancer in three patients (2%). The numbers are similar to those seen from a smaller group of patients from a phase 1 study of sotorasib, where 32% of patients saw their tumors shrink and 88% had their tumors stop growing.

While novel mechanisms, both sotorasib and tezepelumab will enter competitive therapeutic markets. With tezepelumab, Amgen faces Sanofi and Regeneron’s barnburner Dupixent, which is already approved in eosinophilic asthma or oral steroid-dependent asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyposis. Dupixent is expected to top $12.5 billion in peak sales, with about $3.5 billion of that haul coming from asthma.

RELATED: Amgen exec: Biosims may have lagged in the U.S., but now they're paying off

At JPM, Gordon characterized the tezepelumab opportunity as “huge,” with more than 1 million uncontrolled asthma patients in the U.S. and 2.5 million globally in urbanized countries.

Biosimilars are another part of the Amgen volume story, with Amgen's copycats, including versions of Roche cancer blockbusters Avastin and Herceptin, now taking in about $2 billion annually. Amgen most recently launched Riabni, its biosimilar to Roche's Rituxan, in December.

Analysts noted Amgen's biosimilars ranked near the top of the its best sales increase performers, with Amjevita, Kanjinti and Mvasi—copies of AbbVie's Humira and Roche's Herceptin and Avastin—soaring 45%, 53% and 233%, respectively.