Ocrevus, Hemlibra offset Roche's biosim loss. But what about those lackluster Xofluza sales?

U.S. biosimilars are already eating into Roche's sales, as Herceptin and Avastin declined by double-digit percentages in the fourth quarter amid the first copycat launches. (Roche)

As biosimilars hit Roche’s Rituxan and Herceptin hard in Europe, growth from two new medicines have more than offset that sales loss. But not all new drug launches are proceeding as planned—and it'll need more help as copycats start taking a toll in the U.S.

Together, biosimilars to Roche’s top-selling cancer drugs cut into its top line by about $1.5 billion in 2019, Roche Pharmaceuticals chief Bill Anderson told reporters Thursday. Luckily for the company, growth from only two newer antibodies—multiple sclerosis treatment Ocrevus and hemophilia A therapy Hemlibra—are already more than enough to fill the gap.

Ocrevus and Hemlibra’s combined sales almost doubled in 2019 to CHF 5.09 billion ($5.24 billion). Their fourth-quarter numbers, CHF 1.04 billion for Ocrevus and CHF 459 million for Hemlibra, both beat the Street’s previous expectations.

But both meds could face threats of their own.

Now, Ocrevus is getting about 40% of new and switching patients, Anderson said, slightly up from 37% in the third quarter. As the remaining 60% is shared among about 15 other therapies, Anderson said Ocrevus could remain a leading choice for many years to come, thanks to its twice-yearly dosing convenience.

That may be true for now. For example, Novartis’ Mayzent, approved by the FDA mid-2019, only sold $17 million in the fourth quarter. Biogen’s newly approved Vumerity, while billed as a better-tolerated version of blockbuster Tecfidera, might grow at the expense of its predecessor, analysts have argued.

However, a recent physician survey conducted by SVB Leerink showed an “unanimous excitement” around Novartis’ repurposed cancer drug Arzerra, which recently beat Sanofi’s Aubagio in a phase 3. The physicians like that the drug offers “‘Ocrevus-like’ efficacy, with the convenience of self-administration.”

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As for Hemlibra, there’s the imminent threat from BioMarin’s gene therapy. That’s a key reason why Roche shelled out $4.3 billion to acquire Spark Therapeutics last year. But to hear Anderson tell it, gene therapy won’t eat much into Hemlibra’s revenues in the short term.

“We think that long term gene therapy makes a lot of sense for hemophilia—the potential to provide a cure that’s permanent,” Anderson said. But because hem A patients today are relatively “well-served” by recombinant factor VIII and Hemlibra, it will be hard for new ones to come in and steal share rapidly, he argued.

“While for some other diseases such as [Duchenne] muscular dystrophy, we might have to accept incremental benefit before we have that perfect cure, in hemophilia A it’s a really high bar,” he said.

He pointed to the fact that some patients might not respond to gene therapy because they have immunity against the viral vector carrying the therapeutic gene. “The challenge today is, if you get a gene therapy and it doesn’t benefit you, then you may be immunized for life and not be able to get a gene therapy in the future,” he said. “So we think a success rate approaching 100% is required.”

Besides, a lot of patients are still either not on any therapy or traditional FVIII, he added. That means the competition doesn’t necessarily have to come between Hemlibra and gene therapy.

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Moving into 2020, Roche will need a lot of help from its new drugs, as biosimilars to its megablockbuster trio of Herceptin, Rituxan and Avastin are expected to expand in the U.S. In the fourth quarter, Herceptin U.S. sales dropped 24% to CHF 533 million, as Avastin declined 11% to CHF 647 million, while Rituxan remained relatively stable.

After Amgen and Allergan launched Mvasi and Kanjinti—copycats to Avastin and Herceptin, respectively—in mid-2019, Teva and Celltrion made their Rituxan copy Truxima available in November, followed by Mylan and Biocon’s Herceptin copy, Ogivri. And Big Pharma Pfizer is now rolling out its versions to all three drugs at discounts ranging from 22% to 24%.

Already, Roche has fallen a bit short of market-watchers' forecasts. For the fourth quarter, Roche’s pharmaceuticals division racked up CHF 11.96 billion in sales, missing analysts’ consensus by about 2%, even though it represents a year-over-year revenue increase of 6%.

And though it’s true that Ocrevus and Hemlibra are driving growth for Roche, not every new launch is delivering on its promise.

Xofluza, a novel influenza med Roche licensed from Shionogi in the hope of buffering generic erosion to its Tamiflu drug, only collected CHF 10 million in 2019, down 29% year over year. In fact, if it weren’t for the international market, the drug would have done far worse. Its U.S. haul of CHF 8 million would mark a 42% decrease.

RELATED: Roche's flu med Xofluza drives drug resistance and may be a bad choice for kids, study says

Tamiflu was no better. Even though the older med’s 2019 full-year sales of CHF 377 million were flat compared with 2018, its U.S. sales plummeted 75% to merely CHF 43 million.

In a statement to FiercePharma, a Roche spokesperson said the “current U.S. demand for Xofluza is aligned to expectations and is following a positive trend.”

Roche has touted Xofluza’s ability to stop the flu in just one dose. The drug boasts a clinical win in the preventative setting in 2019. It showed it could decrease the possibility of contracting the flu after exposure by 86%. If approved, that indication would “be viewed favorably by payers as there are significant healthcare system and economic cost implications associated with the flu,” Barry Clinch, Roche’s global head of influenza and infectious disease product development, said at the time.

Editor's Note: The story has been updated with a comment from Roche on Xofluza sales.