Epoch 30: First-in-Class or Best-in-Class?

Is it better to be first or best?

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Hello Avatar! Welcome back for another week of biotech analysis. This week we have a guest writer.  Many of you follow us on twitter where we enjoy engaging with the biotwit community on a range of topics related to science, medicine, and business.  A few weeks back we shared some thoughts on the first-in-class vs best-in-class debate.  This led to a DM exchange with one of our followers.  The individual (who has 15+ years of pharma/biotech experience) sent us an analysis which we found interesting and we encouraged them to come share as a guest post.  Hopefully you will find this enjoyable, we will conclude with a few remarks of our own on the topic.

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FIRST-IN-CLASS VS BEST-IN-CLASS

BowTiedBiotech:  Before jumping into the analysis let us first set the stage for those of you not up to speed on the lingo by defining first-in-class and best-in-class in terms of therapeutic development.

First-in-class and best-in-class are terms used in therapeutic development to categorize drugs based on their novelty and superiority, respectively.

First-in-class (FIC):

First-in-class drugs are those that belong to a new and unique class of therapeutic agents, targeting a specific molecular pathway or mechanism of action that has not been targeted by any other approved drugs.

These drugs often represent innovative approaches to treating a particular disease or condition.

Example of a recent first-in-class drug approval:

Drug: Ocrelizumab

Indication: Ocrelizumab is a first-in-class monoclonal antibody approved for the treatment of multiple sclerosis (MS).

Significance: Ocrelizumab is the first drug to receive FDA approval for both relapsing forms of MS and primary progressive MS, offering a new treatment option for patients with these conditions. (Approved in 2017)

Best-in-class (BIC):

Best-in-class drugs are considered superior to other drugs in the same therapeutic class or category in terms of efficacy, safety, or tolerability.

They are often compared to existing therapies and show significant improvements in one or more aspects of patient outcomes.

Example of a recent best-in-class drug approval:

Drug: Venetoclax

Indication: Venetoclax is a best-in-class BCL-2 inhibitor approved for the treatment of chronic lymphocytic leukemia (CLL).

Significance: Venetoclax demonstrated superior efficacy and improved overall survival compared to standard of care in certain patient populations with CLL, making it a best-in-class option for these patients. (Approved in 2016)

It's important to note that the terms "first-in-class" and "best-in-class" can vary depending on specific therapeutic areas and ongoing research and development in the medical field. As new drugs continue to be developed and evaluated, the landscape of first-in-class and best-in-class drugs may evolve accordingly.

As a rule of thumb we consider a FIC drug one which is novel and approved 24-30 months ahead of any competitor.  BIC is anything that is superior which comes after 24-30 months.

There is an ongoing debate from a drug discovery perspective where it is best to focus.  FIC comes with higher risk and investors tend to reward companies showing progress with these approaches.  BIC is lower risk, but typically not as recognized by investors until much later in clinical development.   We will get into this in much more detail today.

With this out of the way we turn it over to our guest to take you through the analysis.  We will conclude with a few remarks of our own on the topic as well as a detailed quantitative analysis on this topic that was published in Nature this spring.

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There are 3 beliefs in pharma commercial forecasting/development that are so ingrained in the industry that they are never questioned. But, they’re wrong--at least in large blockbuster primary care markets. 

Myth #1: Winners are first to market 

Myth #2: Standard probability of success estimates by therapeutic area are accurate. 

Myth #3: You shouldn’t compete with yourself.