Approvals in past 5 years: 8
Value of recent approvals: $99.77 billion
Percent of value from recent approvals: 45.9%
As cancer megablockbusters Herceptin, Avastin and Rituxan suffer from biosim attacks across the globe, Roche has been relying on a group of newer drugs launched since 2012 to fuel growth. Most of these products scored approvals in the past five years and fall into the areas of oncology and neuroscience.
Roche has ushered altogether eight novel molecular entities across the FDA finish line since 2016. These drugs have a combined net value of $99.77 billion, or 46% of the company’s entire marketed drugs portfolio, according to a recent tally from EvaluatePharma and Evaluate Vantage.
Leading the charge on Roche’s sales chart is multiple sclerosis therapy Ocrevus, which carries a present value of $27.2 billion, Evaluate says. After its FDA nod in March 2017, Ocrevus quickly reached blockbuster status in just its first four full quarters on the market, becoming what Roche CEO Severin Schwan called “the most successful launch in the history of Roche.” It’s now the top-selling drug at the company, with sales in the first half of 2021 at CHF 2.44 billion ($2.65 billion).
Because Ocrevus targets CD20-expressing B cells to control the neuroinflammatory disease, some patients delayed treatment during the early days of the COVID-19 pandemic out of fear that the drug may weaken their defense against the novel coronavirus. Now, Roche is seeing signs of recovery as U.S. new patient switches in MS reached 88% of pre-pandemic levels in May, Roche’s pharma chief Bill Anderson said during a recent conference call.
But the MS market is becoming increasingly crowded with new launches, including Novartis’ rival CD20 drug Kesimpta. To reinforce Ocrevus’ lead, Roche in September launched two phase 3b trials testing Ocrevus at higher doses in different forms of MS, in the hopes to see even better improvements in slowing disease progression.
Also in Roche’s neurology department, the company in 2020 rolled out spinal muscular atrophy therapy Evrysdi. The once-daily oral treatment is seen as a strong contender in the SMA market and a material threat to Biogen’s injectable Spinraza. In the first six months of 2021, Evrysdi ginned up CHF 243 million ($264 million) in global sales. Evaluate currently has $8.8 billion pegged to Evrysdi’s value.
Even as Herceptin, Rituxan and Avastin fall from the revenue altar, Roche remains an oncology leader. The company in 2016 introduced PD-L1 inhibitor Tecentriq and even though it’s not the most successful checkpoint inhibitor by sales, Tecentriq has chalked up some important first-in-class wins throughout the years. The med carries a massive value of $39.5 billion, Evaluate says, topping all of the other drugs included in this report.
Tecentriq in 2019 scored an FDA conditional nod in triple-negative breast cancer, making it the first immuno-oncology agent approved in the disease. That approval covered the combination of Tecentriq withBristol Myers Squibb’s chemotherapy Abraxane (nab-paclitaxel) for patients whose tumors express PD-L1.
But that use has come under scrutiny after a confirmatory trial pairing the PD-L1 inhibitor with the original paclitaxel formulation showed the combo did even worse than solo chemo at extending patients’ lives. An FDA advisory committee in April voted to keep the nod in place as Roche collects evidence from future TNBC trials using Abraxane.
Meanwhile, Tecentriq recently became the first I-O drug to show a benefit in post-surgery non-small cell lung cancer. In the IMpower010 trial, Tecentriq cut the risk of cancer recurrence or death after surgery by 34% in patients with PD-L1-positive, stage II to IIIA disease. The drug’s performance fell when PD-L1-negative patients were included, raising doubts about the breadth of a potential FDA approval as well as future physician acceptance.
Thanks to increased penetration in some first-line treatment settings, including small-cell lung cancer and liver cancer—both of which Tecentriq was the first I-O to reach—Tecentriq sales hit CHF 824 million ($900 million) in the second quarter. Tecentriq has surpassed Avastin as Roche’s second-largest oncology product by quarterly sales, next only to HER-2 drug Perjeta.
Another cancer drug that Roche believes has blockbuster potential is the anti-CD79b antibody-drug conjugate Polivy. First approved in 2019, the drug is currently competing with CAR-T therapies in the small market of third-line diffuse large B-cell lymphoma. But a phase 3 trial dubbed Polarix just showed a Polivy regimen could extend the time to cancer progression or death over the standard-of-care treatment R-CHOP in newly diagnosed patients. The front-line indication represents a $2 billion market opportunity, Anderson said during an investors’ call. Evaluate put Polivy’s value at $5.6 billion before the Polarix readout.
Outside of oncology and neurology, hemophilia A therapy Hemlibra represents another major growth driver for Roche. As an under-the-skin injection, Hemlibra has shown it can prevent bleeds at a dosing interval of up to once every month. First approved by the FDA in late 2017, Hemlibra has snatched 29% of patient share in the U.S., France, Germany, Italy, Spain and the U.K., according to Roche. That has translated into CHF 1.39 billion ($1.52 billion) in 2021 first-half sales. Hemlibra has an impressive net present value of $13 billion, Evaluate says.
The other drugs Roche launched over the past five years are neuromyelitis optica spectrum disorder therapy Enspryng, ROS1 & TRK cancer med Rozlytrek, and Shionogi-licensed flu drug Xofluza. Those meds carry present values of $2 billion, $883 million and $830 million, respectively.
The Blueprint Medicines-partnered RET inhibitor Gavreto wasn’t counted toward Roche's tally for this report. The Swiss pharma currently doesn’t record the drug’s sales.