An inside look at Lilly's NYC expansion & focus on cancer immunotherapy
It’s official: Eli Lilly, long renowned for a commitment to R&D, is significantly expanding its presence in New York City, making it the pharmaceutical company with the most laboratory space in the Big Apple.
Lilly announced on Friday plans to create an immuno-oncology-focused hub and to build out its presence at its current location, the Alexandria Center for Life Science, which overlooks the East River, where Lilly’s NYC-based scientists have been focusing on the antibody work associated with the 2008 acquisition of ImClone.
The build-out, which will be completed during 2016, includes adding 30,000 square feet of lab and office space and expanding its workforce.
It had to be New York City
So why New York?
"We wanted to be able to leverage the incredible expertise in antibodies that we have here, as well as the pipeline and history that Lilly has in small molecules," explained Dr. Michael Kalos, Lilly's Chief Scientific Officer of Cancer Immunobiology, who is based in the New York office.
"Being able to locate in New York allows us to collaborate and be part of an incredibly rich academic infrastructure. We’ve met with every single academic center in New York. This couldn’t have happened anyplace else—not even Boston. All of the pieces fit together perfectly here."
Dr. Jan Lundberg, Executive Vice President of Science and Technology and President of Lilly Research Laboratories, agrees. "New York is unique because there are so many world-class academic and medical institutions here, but very few pharma laboratories," he told BioPharma Dive.
Bringing novel cancer treatments to market
Lillly’s expansion in New York is part of a larger mission the company has undertaken to revitalize its pipeline and gain approvals more rapidly. The underlying strategy is to be more efficient during the drug development process, including having a better understanding of diseases; trying to produce robust data during phase 2; and, finally, differentiating in phase 3.
It appears that Lilly’s commitment to this mission is starting to pay off. After a three-year period of hanging off the edge of the patent cliff while watching $9 billion worth of patents disappear (alonside revenues), Lilly is trying to come back strong. In fact, within the last 18 months, the company has had more approvals than it had in the previous 10 years.
Within the last year alone, Lilly received four FDA approvals for Cyramza (ramucirumab), for treatment of patients with three of the most deadly and most prevalent cancers—advanced metastatic gastric cancer, metastatic non-small cell lung cancer (NSCLC), and metastatic colorectal cancer.
Notably, Cyramza failed to show a survival benefit in women with metastatic breast cancer during clinical trials in 2013 and also failed in 2014 to show a survival benefit in patients with advanced liver cancer. Nonetheless, shortly after approval in the U.S., Cyramza was approved for the gastric cancer indication in the European Union, Korea, and Japan.
Pragmatic, yet optimistic
With respect to developing drugs in the oncology space, Lilly’s R&D team exudes a sense of extreme pragmatism. With roughly 20 cancer drugs in the pipeline, including late-phase candidates in gastric, lung, bladder, sarcoma, breast, and liver cancers, Lilly is optimistic that the current investigational roster could yield six approvals within the next five years.
"Cancer is truly a complex disease with more than 300 different subtypes, making it unrealistic to find a single broadly effective cancer cure," explained Dr. Greg Plowman, Lilly's Vice President of Oncology Research. "However, there is growing unmet need in cancer. In the last few years, we’ve seen major breakthroughs in genetics and immunology that are informing us about new ways to treat cancer—to help us understand the underlying drivers of cancer and how to harness the body’s immune system."
The broad development strategy, according to Dr. Plowman, is "to address cancer from different angles based on three pillars—cancer-cell signaling, microenvironment, and immunotherapy.
"By addressing each of these areas, our goal is to get an optimal outcome while avoiding resistance."
New hope for women with advanced breast cancer
In what seems like a bit of auspicious timing, on the same day that several of Lilly’s top researchers were meeting in the company’s New York location, the firm announced that it had received Breakthrough Therapy Designation for abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, which is being developed for patients with metastatic, hormone-receptor positive breast cancer.
Given the fact that October is Breast Cancer Awareness month, this announcement sparked hope that women with advanced metastatic disease—which includes roughly 40% of all women diagnosed with breast cancer either because of late diagnosis or recurrence—might soon have another treatment option.
Because abemaciclib was tested in women who had been treated with a median of seven prior treatments, the fact that phase 1 results demonstrated both efficacy and safety in this population was the basis of the FDA’s decision to grant the designation to Lilly, thereby expediting development and review.
"We think that this compound has properties that differentiate it from some of the competitor molecules used to treat breast cancer, and in this case, particularly as a single-agent treatment for women with hormone-receptor-positive disease," said Dr. Plowman.
Betting big on immunotherapy
Lilly has a rich history of being science-focused and R&D driven. In February 1946, Eli Lilly, grandson of founder Colonel Eli Lilly, laid the philosophy out very simply: "Research is the heart of the business, the soul of the enterprise."
The 2015 iteration of that spirit lives on in Lilly’s continued commitment to research. Last year, the company reinvested 24% of its revenues in R&D. It is also apparent in the R&D team’s forward-looking approach to clinical development. In this case, looking into the future of oncology means focusing on immunotherapy, which Lilly believes will soon become foundational therapy in oncology.
Dr. Lundberg reiterated a full-throated commitment to the immunotherapy clinical development program. "Going forward, immuno-oncology research will focus on new ways to harness the immune system and on combination therapies with targeted agents," he said. "Cancer is a complex disease. Our diverse research approach and expansion in New York will ultimately put us in a strong position to advance the delivery of innovative medicines to patients."