AstraZeneca has been leaning on its best-selling oncology med, breast cancer drug Faslodex, as it works to reassert itself in the field. But the U.K. company’s oncology aspirations hit a road bump today with the announcement it has settled patent litigation that will lead to a Sandoz generic nearly two years before Faslodex patents expire in the U.S.
The announcement was short and sweet, saying that a federal court in New Jersey on Tuesday entered a consent judgment filed by the two companies “which includes an injunction preventing Sandoz from launching a generic fulvestrant product until 25 March 2019, or earlier in some circumstances." The patents in the U.S. are set to expire in January and July 2021. Faslodex was first approved in 2002 to treat postmenopausal women whose cancer worsened after hormone therapy.
The drug is currently AstraZeneca’s top-selling oncology product, bringing in $704 million last year and $190 million in the first quarter of 2016, up 24% on higher demand. More than half those Q1 sales, $99 million, came in the U.S. And AstraZeneca ($AZN) is expecting even more growth from the drug after the FDA in March signed off on Faslodex in combination with Pfizer's ($PFE) Ibrance to treat some women with advanced or metastatic breast cancer.
The new indication also gave a boost to CEO Pascal Soriot's blueprint to grow revenues, with oncology being a pillar of that plan. When he was beating back Pfizer's unwanted advances two years ago, Soriot pledged to the company’s revenue would reach $45 billion by 2023, with about $12 billion of that tied to its most advanced cancer meds.
AstraZeneca has notched some wins on its way toward that goal. It has a very promising drug in its new targeted lung cancer pill Tagrisso, which the company has projected to hit $3 billion in sales. Approved in the U.S. last November, it generated $51 million in sales in the first quarter, with the U.S. representing 88% of the total. During the period, Tagrisso also received regulatory approvals in the E.U and Japan.
But it also has had some disappointments. Earlier this year, one of its pipeline candidates, CTLA-4 drug tremelimumab, flunked a solo challenge for mesothelioma.
The patent settlement with Sandoz, the generic division of Novartis ($NVS), comes even as there are reports that AstraZeneca might take another tack for growing its oncology holdings. Its name has emerged as possible suitor for Medivation ($MDVN), the maker of prostate cancer drug Xtandi, which Sanofi ($SNY) has been hot to buy but which also has attracted a host of other potential bidders. Sources this week said AstraZeneca was considering a $10 billion run at Medivation.
UPDATED: AZ stokes $45B sales hopes with expanded approval for breast cancer drug Faslodex
Bristol-Myers leads immuno-oncology race but Merck, AstraZeneca and Roche still have contender
UPDATED: In a setback, AstraZeneca's immunotherapy tremelimumab flunks mesothelioma test
AZ could jump into the Medivation fray with $10B bid: Report
Medivation opens its books to would-be buyers, including the formerly hostile Sanofi