After patent expirations and other woes, Eli Lilly has been leaning on a stable of new drugs for growth. But after a trial failure for soft tissue sarcoma launch Lartruvo, the drugmaker is stopping promotion for the drug.
In a phase 3 trial, the drug failed to confirm an overall survival benefit for patients with advanced or metastatic soft tissue sarcoma, Lilly reported. The drug won its U.S. and European approvals based on a phase 2 trial that did show it could help patients live longer.
Now, Lartruvo is in crisis mode. Lilly is “working with global regulators to determine the appropriate next steps” for the med and is taking a pre-tax charge of $70 million to $90 million this quarter. For the year, it expects a 17-cent hit to earnings per share from the trial failure.
That's a blow to Lilly Oncology, which had booked significant sales growth for Lartruvo. After its 2016 launch, it delivered $203 million in 2017 and $221 million in the first nine months of 2018.
And that, in turn, could interfere with Lilly’s 2019 revenue estimate of $25.3 billion to $25.8 billion, announced last month—a figure that beat average analyst expectations of $25 billion. After patent losses in recent years, including for blockbuster Cialis, the company has been counting on new launches to chip in growth.
It's also made oncology a priority. The company last week made a splash at the J.P. Morgan Healthcare Conference with its move to acquire Loxo Oncology for $8 billion. With the deal, the company gets access to the FDA-approved “tumor agnostic” cancer med Vitrakvi, which treats patients whose tumors feature a neurotrophic receptor tyrosine kinase gene fusion, regardless of location in the body. Loxo sells the drug in a partnership with Bayer.
The Loxo deal also brings several pipeline meds: a follow-up TRK inhibitor, an oral BTK inhibitor and a RET inhibitor called LOXO-292 that has received an FDA breakthrough therapy designation. LOXO-292 could represent a 2020 launch opportunity, Lilly said.