When Bristol Myers Squibb nabbed Celgene's long-sought FDA nod for multiple sclerosis drug Zeposia, the COVID-19 pandemic was in full swing—not the ideal time for a launch. Now, the company thinks the time has come.
Zeposia (ozanimod) officially entered the crowded MS market, BMS said Monday. And the company believes it has some key advantages over competitors, including a couple particularly important as the novel coronavirus continues its spread.
Price, for one: The company has tagged Zeposia with an annual wholesale acquisition cost of $86,000, Tina Deignan, BMS’ U.S. head of immunology, told FiercePharma. That's lower than the $88,500-per-year sticker on Novartis’ rival S1P modulator Mayzent, which itself comes at a discount to the Swiss pharma’s older drug Gilenya.
In fact, Zeposia is now the lowest-priced oral option on the market, she said.
But the drug’s benefits don’t just lie in its price, Deignan added. It has shown an ability to address “not only the physical aspects of MS … but also the less well-understood and recognized cognitive issues associated with MS,” she said.
In clinical trials, Zeposia has proven it can significantly cut the annualized relapse rate among patients with relapsing forms of MS compared with Biogen’s Avonex (interferon beta-1a), lowering the rates to around 0.17 to 0.18 at 1 mg. Additional analysis on cognitive process speed also showed the drug could sustain improvement in more patients than the old drug did.
Deignan also pointed to the fact that Zeposia is the only drug in the S1P class that doesn't require genetic testing or cardiovascular monitoring after the first dose. For example, Mayzent patients need a CYP2C9 genotype test so physicians can prescribe the proper dosage. Patients with certain preexisting conditions are advised to undergo observation when they first start the med.
“The simplicity, the ease of initiation of therapy, is valuable at any time in a drug life cycle” and is even more important during COVID-19 when patients are socially distanced, Deignan said.
As with other oral drugs, including Mayzent and Biogen’s Vumerity, patients need a complete blood count before starting Zeposia. But removing some of the other initial hurdles can help patients start treatment faster, without quite so many visits to healthcare providers.
RELATED: Bristol Myers nabs long-sought FDA nod for Celgene's MS drug ozanimod, but pandemic delays launch
When it snagged the green light in late March, BMS said it would postpone the launch because of the pandemic. COVID-19 is still very much the present tense, and what has changed BMS’ mind?
At the point when Zeposia won its approval, the U.S. was just going into the COVID-19 crisis. Physicians and patients at the time were still trying to figure out how to function amid a pandemic—whether patients should go into their doctors' offices or see them via telemedicine, Deignan said.
Two months later, some parts of the country are opening up again. And for other parts, telemedicine is up and running, and physicians are feeling more comfortable with the remote pathway.
Now, building on Celgene’s years of previous interactions with physicians, BMS has formed a sales team with neurology and immunology experience. The commercial capability the company has accumulated also allows it to “dial up or dial down” face-to-face engagement with customers as needed, Deignan added.
Meanwhile, taking advantage of its immunomodulating mechanism, BMS is actively looking to expand Zeposia’s reach into other inflammatory diseases. Tuesday, the company said the phase 3 True North study testing Zeposia in moderate to severe ulcerative colitis has hit both primary endpoints and several key secondary targets. The drug showed “highly statistically significant” benefits over placebo for clinical remission at week 10 as an induction therapy and in maintenance at week 52.