The FDA asks for more diversity, $1B for injectors, $2B for a one-trick pony, and $68M to make DNA.
Find out more at
Antares + Halozyme
GSK + Sierra
About the Show
Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.
Welcome to Life Science Today, your source for stories, insights, and trends across the life science industry. I’m your host, Dr. Noah Goodson. This week, the FDA asks for more diversity, $1B for injectors, $2B for a one-trick pony, and $68M to make DNA.
The views expressed on Life Science Today are those of the host and guests. They do not necessarily reflect the opinions of any organizations with which they are affiliated.
Diversity Receives Guidance
The FDA has released guidance intended to increase racial and ethnic diversity within clinical trials. In recent years, FDA guidance has tended to steer towards broad approaches rather than specific instructions. The intent, as I understand, is to provide a framework towards success in a specific direction, without limiting the ability of independent organizations to drive creative solution. In the case of racial and ethnic diversity, there are ongoing issues in successfully and accurately reflecting the population of the United States in within clinical trials. We’ve talked about this recently on the show, so go back to episode 091 if you’d like to hear more. What is important here is that certain populations are historically and frequently poorly represented within the data derived from clinical trials. This may have meaningful implications when medications have variable outcomes depending on both genetic and socio-cultural forces.
The specifics of the FDAs approach are interesting. Rather than making a quota-based strategy or other limitations that may not apply in all circumstances, the FDA has recommended that sponsors provide a “Race and Ethnicity Diversity Plan” early in their clinical development process. This step could easily be taken by some organizations as a hoop to jump through with no meaningful change. But there is real potential to take it as an opportunity to think about the approach to clinical development and how that is likely to generate data representative of the population of the United States. It also allows the FDA more capacity in the long-run to reject data when it is derived from a narrow population band.
It is easy to throw sponsors and CROs under the bus here for not doing the right thing on their own. And while may be some truth to this, the reality is that the barriers to inclusion are rooted in a long history of injustice around healthcare that extends far beyond the bounds of clinical trials. This is why draft guidance like this should not be seen as a resolution to the issue or another box to tic, but as an opportunity to include unheard voices in your trial design. Maybe this approach will work, maybe not. But without intentional and concerted efforts from regulators and our industry to rectify the errors of the past we will continue to create drugs that are poorly tested on key segments of the population.
Antares Pharma Acquired by Halozyme Therapeutics for $960M
Halozyme Therapeutics is acquiring Antares Pharma for $960M in a cash purchase. Halozymes key assets and ENHANZE which is an enzyme that acts in the subcutaneous space to make fluid flow more easily. This allows for significantly increased injection volumes that would typically require intravenous delivery. Their other asset Hylenex is an adjuvant that increases dispersion and absorption of other injected drugs. The acquisition brings Antares suite of skills in developing drug device combinations together. While not as glamorous as developing new therapeutics, there is real financial opportunities in the refinement work associated with changing the experience of medicine. For these two companies with assets in increase injection capabilities, drug dispersion, and drug device development experience there are clearly significant alignments across the pharma space to develop licensed solutions. It’s a $1B buy that likely wouldn’t make sense to an individual pharma company but is well aligned in support various companies in making therapies more accessible to more patients.
GSK Builds Oncology Pipeline With $1.9B Acquisition of Sierra Oncology
GSK has made a bid to expand their oncology pipeline with the $1.9B Acquisition of Sierra Oncology. The cash deal brings Sierra’s late-stage program focus Myelofibrosis into the fold. Sierra has plans to submit their orally available monotherapy, Momelotinib, to the FDA as well as within the EU later this year with commercialization starting in 2023. There are some additional early-stage assets in their pipeline, but clinical trials have not begun, making Sierra a perfect one-trick pony acquisition. There is one asset, it’s thoroughly test in one indication, it’s submission ready. Sierra has done all the development work and now it’s time to hand off their asset to GSK. After all, Pharma companies are very good at commercial rollouts.
Ansa Biotechnologies Raises a $68M Series A
Ansa Biotechnologies has been hard at work building on the potential to leverage polymerase enzymes to build DNA sequences. The basic idea here is that the way we currently synthesize DNA is more expensive and time consuming that in absolutely needs to be. With DNA underpinning significant portions of the life science industry (for obvious reasons), improving on those processes has the potential to significantly shift multiple aspects of the industry. As it’s currently positioned this is truly a biotechnology company, not a pharma leaning organization.
Last week they received a massive bump with a $68M, venture backed series A. For companies like Ansa, particularly in this biotech market, it suggests to me their technology has reached the point where expensive scaled development is required. If they are successful in developing and commercializing a product or process that streamlines DNA synthesis using an enzymatic approach I suspect they would be steered towards a rapid acquisition into an organization with significant commercial reach, rather than progressing through their own public path.
To really solve DNA synthesis at scale any solution will need to be cost efficient, temporally efficient, and exceptionally reliable. Loss in any of those categories decreases the overall adoption curve, but you’ve probably got to meet some sort of arbitrary but still high minimum in all three and be exceptional at least one to create any kind of meaningful market movement. Time and more information about their underlying technical approach will be needed to make accurate predictions on how Ansa will differentiate.
Thanks for joining me for Life Science Today, your source for stories, insights, and trends across the life science industry. Learn more at LifeScienceTodayPodcast.com. If you like what you hear, please tell a friend. Once again, I’m Dr. Noah Goodson, I’ll see you next week.