Josh Hattem co-wrote this blog post with Emily Mandell.
“That's the problem with the American dream: It makes everyone concerned for the day they're gonna be rich.”
–President Bartlett, The West Wing
Pharma companies may have a winning asset, a winning development plan and an important disease target with unmet needs, but only one product can be first to market, only one can be the most efficacious and only one will become the standard of care. If your asset is entering a disease area with similar efficacy to an established standard of care, or if your asset is one of multiple products in a class entering within one to two years of one another, it’s critical to have a clear understanding of what it will take to meaningfully differentiate, and to do this early enough—in phase I or II—so there's enough time to correct the development plan.
Joshua Hattem co-wrote this blog post with Emily Mandell.
The pharma industry faces a growing problem: The return on development investment is declining. The industry is compensating by pivoting to the next disease area (such as NASH) and technological frontiers (like cell and gene therapy). Pharma leaders may be disappointed if they believe that they can fix the problem by simply adding products to their pipeline that target these future opportunities. Take Gilead, which recently had to write down $820 million of its Kite Pharma acquisition as it cut Kite’s leading cell therapy for multiple myeloma. According to FierceBiotech, this decision to terminate the CAR-T’s clinical development “reflects the increasing competition in the anti-BCMA category.”
Christina Corridon co-wrote this blog post with Ross Shahinian.
In 2017, there were 46 novel drug approvals in the U.S., according to the FDA. However, the majority (67%) of these drug approvals represent later-to-market entrants that will be vying for share in an increasingly competitive landscape. For example, take Verzenio, Lilly’s CDK-inhibitor for HR-positive breast cancer, which was third to market after Pfizer’s Ibrance and Novartis’s Kisqali. Or Steglatro, the Merck and Pfizer fourth-to-market SGLT-2 drug, which came in after Invokana, Farxiga and Jardiance.