Lacerta Bio is a business development consultancy specializing in identifying, assessing, negotiating, and closing licensing and partnership opportunities for the pharmaceutical, biotechnology, and drug delivery industries.
We also work with and support internal business development teams with market research, competitive intelligence, financial modeling, and other support services.
If you need assistance finding or assessing business development and/or partnership opportunities, contact us at email@example.com.
Lacerta Bio is seeking parenteral products for in-licensing on behalf of a US-based client. Key criteria are: Products which can be developed via the 505(b)(2) regulatory process in the US No specific therapeutic area Injectable could be infusion, prefilled syringe, or related presentation Products already approved outside the US are especially welcome Delivery / formulationRead More»
Lacerta Bio is looking to transact a business acquisition opportunity in the injectables manufacturing sector. We are seeking manufacturing facilities which have the following criteria: Based outside the US (Europe, Canada, LatAm, Australia, New Zealand preferred) FDA or EU approved manufacturing of parenteral products Could be a stand-alone company which manufactures its own products, or the divestmentRead More»
Would You Like To Expand Your Business Into China? Or Perhaps You Seek An Investor or Development Partner? China is a large and growing opportunity for Western life science companies, as: Life Science in China is Booming – China’s life science industry has been growing at more than 20%+ per year, and is expect toRead More»
The product, formerly known as ABP-501, received approval for the multitude of indications which are also on the Humira label, such as psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and others.
What we find interesting is the clinical data package submitted in support of this approval:
Three PK similarity, safety, and immunogenicity studies in 203 health subjects
Phase III studies in 350 patients with psoriatic arthritis
Phase III studies in 526 patients with rheumatoid arthritis
Even with all of this data, the FDA makes it clear that “It has been approved as a biosimilar, not as an interchangeable product.”
This is the third biosimilar approved by the US FDA in 2016, following the approvals of biosimilars for infliximab (Hospira/Pfizer, approved April, 2016) and etanercept (Sandoz, approved August, 2016).
Analysts project infliximab biosimilar to exceed $200 MM in sales in the US alone, while sales of etanercept biosimilar are expected to approach $100 MM in the US.
The questions will now center on physician/KOL usage of these products over time, as well as payer enthusiasm.
For the latter, assuming a 10-20% discount relative to the branded versions, it is probable that this is welcome news for the payers.
Physicians, we suspect, will be more conservative in their approach, especially in the absence of data demonstrating that patients established on the branded version can be safely switched over to the generic.
It will also be interesting to see if physicians essentially base their decisions on the clinical data. In other words, will they prescribe Amjevita for psoriatic arthritis and rheumatoid arthritis, but not for Crohn’s Disease or ulcerative colitis?
It bears repeating that the market for adalimumab exceeds $14 billion. Adalimumab products already approved (or nearly approved) in the EU, India, Japan, South Korea, and other countries. Additional adalimumab biogenerics are in late-stage development in the US, and certainly in these other markets.
So we feel comfortable is saying that we have the beginnings of a US biosimilars market in 2016. We have multiple products in the category, and (eventually) multiple companies launching their own products within each individual molecule/market.
But it is also clear that this is a market segment that will only be for multinational companies like Amgen and Sandoz, with the resources to develop complex protein products via multiple Phase II and III clinical trials. This, in turn, will mean that price discounts relative to the innovator products will be modest for the foreseeable future.
Our recent trip to Stockholm and the Nordic Life Science Days conference was quite enlightening, especially as we publicly discuss drug prices (yet again). One presentation at NLSD by SwedenBio enlightened us on how a different system and society views drug pricing. From the Swedish socialist perspective, one of their aims (aside from job creation) is to provide their citizens
In our last post, we presented a model which helps us aggregate a series of variables which, in turn, help us understand why certain therapeutic areas or indications are of greater interest from a licensing perspective than others. Our aim with this model is to help companies with licenseable assets to frame their “stories” in
A triumvirate is a three-person (or three-group) organization which is established for a specific administrative task(s). In Ancient Rome, the First Triumvirate was established between Julius Caesar, Pompey the Great, and Marcus Crassus. Once Crassus dies, a civil war between Caesar and Pompey was fought, resulting in the death of Pompey and the establishment