A multiple sclerosis treatment critical to Bristol Myers Squibb's $74 billion acquisition of Celgene won Food and Drug Administration approval on Wednesday, giving patients who have the most common form of the neurodegenerative disease another option.
The regulator cleared the drug, which will be sold as Zeposia, based on the results of two studies that showed patients taking it were at significantly lower risk of disease relapse than those who received Biogen's Avonex, an older treatment.
Zeposia will compete directly with Novartis' fast-selling Gilenya as well as its newer drug Mayzent, which work similarly, and will launch into a shifting market. Copaxone, a drug made by Teva that's been the top multiple sclerosis treatment by sales, is now generic and others are nearing the end of their patent protection. Newer drugs from Roche and Biogen, meanwhile, have brought further competition, if not on price.
Bristol Myers said it is delaying Zeposia's launch because of the outbreak of the new coronavirus, a move that could reflect the drug's label warning against the increased risk of infection in patients who take it. The company will announce the price when it launches Zeposia, a spokesperson told BioPharma Dive.
Prices for multiple sclerosis drugs have risen steadily in recent years, even after accounting for rebates and discounts offered to insurers by drugmakers. Wall Street analysts forecast Zeposia could earn sales of more than $400 million by 2021.
The label recommends starting with an initial low dose of 0.23 milligrams once daily and gradually increasing to the maintenance dose of 0.92 milligrams once daily to lower the risk of reduced heart rate. This will give Zeposia an advantage over Gilenya, which requires physicians monitor patients for six hours after the first dose to guard against heart-rate irregularities.
A lack of monitoring requirements on the Zeposia label should "meaningfully improve its ease of administration" when compared to Gilenya, RBC Capital Markets analyst Brian Abrahams wrote in a Mar. 26 note to clients.
Zeposia's approval makes it more likely that former Celgene shareholders will see the full value of the deal offered by Bristol Myers. The drug was one of three experimental therapies which Bristol Myers linked to an add-on payment of $9 per share, which will be made only if all three win approval by certain deadlines this year and next.
Zeposia and a cancer cell therapy called liso-cel need to win approval by Dec. 31, 2020, while the Bluebird bio-developed ide-cel, another cell treatment, needs to secure a regulatory OK by March 31, 2021.
The multiple sclerosis drug, previously called ozanimod, had already been delayed by more than a year because of regulatory questions on clinical and non-clinical pharmacology data. But the Dec. 31 deadline was generous, given the FDA set a March 25 deadline for its decision.
The timing of regulatory decisions for liso-cel and ide-cel look increasingly tight, however. The FDA has shifted resources to regulatory issues surrounding the novel coronavirus pandemic and restricted employee travel, particularly to overseas manufacturing sites.
Liso-cel's manufacturing facility is located in Washington state, currently a hotspot for coronavirus infections, and inspections could therefore be delayed if scheduled for April or May, Mizuho analyst Salim Syed wrote in a Mar. 16 note to clients. The FDA has set an approval deadline of Aug. 17.
Even so, Syed estimated Bristol Myers has about 4 months of buffer should there be delays in the review to its application liso-cel. The cell therapy, which is for patients with relapsed or treatment-resistant lymphoma, has Priority Review and Breakthrough Therapy designations, which should speed its review.
Ide-cel, a treatment for advanced multiple myeloma, could have a tighter timeline. Bristol Myers hasn't said whether it's submitted an application, but previously stated it would occur in the first half of 2020. A Jun. 30 submission would put the pharma on track for a decision by the end of the year, giving another three months should there be delays in inspections. The manufacturing hub for ide-cel is in Summit, New Jersey, Syed said.