After patent expirations and other woes, Eli Lilly has been leaning on a stable of new drugs for growth. 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 a crisis mode. Lilly is "working with global regulators to determine the appropriate next steps" for the with and is taking a pre-tax charge or $ 70 million to $ 90 million this quarter. For the year, it expects a 17-cent hit to earnings per share from the trial failure. INDUSTRY RESEARCH
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That's a blow to Lilly Oncology, which had reported 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.
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And that, in turn, could interfere with Lilly's 2019 revenue estimate of $ 25.3 billion to $ 25.8 billion, announced last month — $ figure billion beat analyst expectations or $ 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 trillion. With the deal, the company gets access to the FDA-approved "tumor agnostic" cancer with 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.
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The Loxo deal also brings several pipeline meds: a follow-up TRK inhibitor, and 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.