News just hit the press in the biotechnology space that Shire plc. (NASDAQ:SHPG) has picked up the rights to a new drug from development stage biotechnology company AB Biosciences.
Here's a look at the deal and what it means for the company.
The drug in question doesn’t actually have a name yet, but it's a preclinical asset that's classed as an autoimmune candidate. It's part of a family of drugs classed as intravenous immunoglobulin (IVIg) therapies (well, sort of, more on this in a moment) and, if approved, it could be a real game-changer in the field of autoimmune healthcare.
The two companies haven’t disclosed the deal's specifics, but we know that Shire has paid an upfront fee to AB Biosciences, which is pretty standard for this sort of deal, and the latter is also in line to receive R&D and commercial milestones – again, a pretty standard arrangement.
Before we get into the specifics of the drug, it's worth touching on this market as it exists today. IVIg therapies are designed to boost the immune system and, as such, are used to treat patients suffering from a pretty wide range of conditions – dermatomyositis, lupus and others.
They are created using the plasma of thousands of healthy individuals, which is then mixed together and administered to the patient that needs the treatment.
There are a couple of problems with this treatment in its current format, however.
First, it's tough to create. Getting plasma from thousands of patients requires significant screening, meaning a large amount of time and effort goes into putting this sort of treatment together.
The second is linked – because of all the work that goes into creating this treatment, it's expensive. In the UK, it costs just shy of $9,000 per dose.
So how does the AB asset intend to build on this?
Well, the company has developed what's called an oligomeric Fc protein that is able to interact with all human Fcγ receptors. This means that it could potentially remove the necessity for thousands of different plasma donors, which, in turn, could dramatically reduce the effort and cost that goes into production of the drug.
Additionally, the two companies think they can develop the drug into an alternative administration asset, which could again reduce the burden on patients.
So what's next?
Well, as mentioned, this is an early stage treatment and – as yet – the concept is yet to prove valid in human clinical trials. With that said, Shire isn’t going to hang around and we're probably going to see the drug in the clinic at some point during the first half of 2018.
The next catalyst to watch, then, is an IND submission to the FDA (or to the EMA in Europe, depending on which region Shire wants to go after first) and a subsequent initiation of a phase I clinical trial, which will likely focus on safety associated with the new administration formulation.