Building a new franchise in a therapeutic from scratch poses a host of challenges, from whether to take the risk of entering a new area at all to whether and how to partner strategically with another company. It’s a challenge for both the biggest biopharma companies and emerging biotechs to evaluate how and when to enter new therapeutic areas and to try to ensure that their efforts will not only help patients in need but bring commercial success as well.
At a session titled “The Next Step: How Companies Build Successful Therapeutic Franchises from the Group Up” panelists from a range of companies shared stories about what works and what doesn’t in a discussion led by Meg Tirrell, biotechnology reporter for CNBC.
Speakers at the session include:
- Paul Fonteyne, President and CEO, Boehringer Ingelheim USA Corp.
- William Hait, Global Head, Janssen Research & Development LLC.
- Paris Panayiotopoulos, President and Managing Director, EMD Serono.
- Dave Ricks, Senior Vice President, Eli Lilly and Co.
David Ricks, senior vice president at Eli Lilly and Co., told the audience that it is difficult for a large drug developer to remain successful in a single therapeutic area for very long. “It’s very rare to stay in one area and consistently have success,’’ he said.
The decision to enter a new therapeutic area differs for emerging biotech companies and a larger company that may already have established franchises in multiple therapeutic areas. But one think companies both large and small need to do is to carefully evaluate early clinical results—something that not all companies do well.
“You really need to do your homework in early phase and be very careful about looking at differentiation [of the compound] in the early stage,’’ said Paul Fonteyne, president and chief executive officer of Boehringer Ingelheim USA Corp. “The worst thing you can do is fail in a Phase 3 trial. You need to really understand what the characteristics of the therapy are and what has to happen in the early trials.”
Asked by moderator Tirrell for some stories that illustrated the risks of entering new therapeutic areas, Ricks discussed how Lilly decided to pursue development of the therapy that would eventually become Cialis, which followed on the heels of Pfizer’s blockbuster success of Viagra, the erectile dysfunction treatment.
For Lilly, the decision to bring Cialis was a big and controversial move at the time. “It’s a sex drug, and we’re a modest Midwestern company,” Ricks said. While some cautioned against competing with a drug as successful as Viagra, Lilly officials believed Cialis would be differentiated in the market because its therapeutic effects lasted longer than competitor Viagra.
“In pharma, differentiation is everything, and there’s not much room in the budget for incremental improvements,” Ricks said.
When bringing a new therapy to market it’s also important that companies think about how the drugs will actually be used in practice by physicians to treat patients, not just how they performed in a clinical setting, said Boehringer Ingelheim’s Fonteyne. “Think about how drugs are used in the community and now just how they are used in a clinical setting,” he said.