- Eli Lilly laid out new plans Tuesday to focus its R&D resources in oncology on lead cancer candidate abemaciclib and six other early- to mid-stage assets, part of a strategy aimed at making the Indianapolis drugmaker more competitive in a therapeutic field already red-hot with new innovation and investment.
- Recognizing that standing out in oncology has become more difficult, Lilly will screen all of its R&D efforts against a stricter set of criteria, setting aside those programs that don't clear the higher bar.
- An examination of the existing pipeline earlier this year led Lilly to flag seven candidates — over a third of its oncology assets currently under development — that it plans to out-license or co-develop with a partner.
In announcing a new R&D strategy, Lilly signaled it intends to compete in oncology and build on a portfolio that currently lags behind leaders like Bristol-Myers Squibb, Merck and Roche. The drugmaker's revamped focus will also feature a more aggressive approach to business development that will target early-stage pipeline additions.
Central to the strategy will be identifying opportunities to establish foundational agents and combinations that give Lilly a chance to claim first-in-class or best-in-class status.
"We can't afford to spread ourselves so thin that we lack the speed and focus to accelerate the development of agents that meet this criteria," said Levi Garraway, Lilly's new head of oncology global development and medical affairs, on a July 25 earnings call.
Yet, competitive threats exist for Lilly's recently approved Cymraza (ramucirumab) and its CDK 4/6 inhibitor abemaciclib, currently under review at the Food and Drug Administration. And with four of the six assets marked for "priority internal development" in Phase 1, it is not clear if Lilly can carve out the kind of market edge it seeks.
Abemaciclib is Lilly's most important candidate in the near-term and a drug the company describes as potentially "best in class," even in light of strong clinical performances from Pfizer's blockbuster Ibrance (palbociclib) and Novartis' rival Kisqali (ribociclib) — two other CDK inhibitors.
Lilly filed abemaciclib for review with the FDA earlier this month, securing a priority review designation based on the MONARCH 1 and MONARCH 2 studies testing the drug as a second-line treatment of advanced breast cancer. A decision is expected in the first quarter of 2018.
More data from the MONARCH 3 study, which Lilly announced in April had met its goal, is expected later this year and could prove crucial in differentiating the drug from its competitors.
Among the pipeline projects Lilly plans to invest in more intensely are an ERK 1/2 inhibitor, a CHK1 inhibitor known as prexasertib, and a TIM-3 inhibitor that Lilly believes could be a promising agent to combine with PD(L)1 inhibitors.
Lilly's R&D restructuring occurs against the backdrop of a tightening market in diabetes — long the drugmaker's mainstay franchise — as well as looming patent expiries for drugs like Cialis (tadalafil) and Alimta (pemetrexed).
Perhaps more significantly, Lilly's hopes to secure approval for its arthritis candidate baricitinib were dashed by the FDA earlier this year and the drugmaker now expects a resubmission won't occur for at least another 18 months.
Oncology still represents a significant market opportunity that could help offset those challenges, but it also may be one of the most difficult areas to gain an edge in currently.
Elsewhere, Lilly's second quarter performance beat market expectations. Overall company revenues rose 8% to $5.82 billion from $5.4 billion in the same period a year prior, boosted by higher revenues from Trulicity (dulaglutide) and Taltz (ixekizumab). Higher uptake of new products like those two drugs prompted Lilly to raise its guidance range by $200 million, and the company now expects to earn between $22 and $22.5 billion for the year.