Donderdag 5 maart jl. heeft het management van AbbVie een toelichting gegeven op de overname van Pharmacyclics. Bij die gelegenheid zijn diverse uitspraken gedaan die de manier van denken over de toekomst van de onderneming verraadt (en daarmee ook van hoe men aankijkt tegen een biotech met een RA-middel zoals Galapagos). Zoals bekend is de koers van het AbbVie aandelen de laatste tijd fors gedaald, vanwege de zorgen die beleggers hebben over de effecten van het aflopen van het octrooi van Humira.
Hieronder uitspraken die mij opvielen.
Rick Gonzalez, CEO AbbVie:
“We are also actively developing formulation and device enhancements which will provide further product differentiation. We recently completed the US and EMA regulatory submission for a new Humira formulation which we believe will enhance the patient experience. The U.S. submission was completed in late 2014, while the EMA application was submitted in early 2015. We expect regulatory decisions later this year.“
“I mean as we told you many, many times, we have a high level of confidence in our ability to be able to drive Humira and protect Humira and grow the franchise over time; and certainly you are starting to see elements of that play out as we're moving into this year, which is the time frame that we would have expected some of those elements to play out. The formulation is obviously one of those “
Gonzalez in antwoord op vragen van een analist:
“Then, Jeff, on the Humira formulation, obviously we are going to be careful about what we say about the formulation, both from a competitive standpoint and, frankly, we have to work with the regulatory authorities in order to gain approval of the products. So we want to work through that process. But what I would say to you is that we have been working on this formulation for quite some time. It is designed to enhance both the patient experience but also, I'd say, give some benefits that the current formulation does not have. Obviously we're doing that in a way to differentiate the current formulation to this – or differentiate a new formulation to the prior formulation. It's advancing as we would have expected, and we'll have, I think, more color on that as we get towards the end of the year."
Mike Severino , EVP R&D van AbbVie:
“This is Mike. With respect to RA, there is obviously strong rationale for BTK inhibition* in autoimmune diseases. It's early on in the development of those mechanisms. As you said, Pharmacyclics has a Phase 1 program that we have looked at. We feel very good about the steps that they've taken and the potential there, but again recognizing that it is very early. There is also potential in other autoimmune diseases that are driven by B-cells, diseases like lupus, for example.
So that's an area that we obviously know very, very well, an area where we have a lot of capabilities and we're going to continue to work with the Pharmacyclics team on that aspect of the program. With respect to induction and maintenance regimens with an agent like 199 and Imbruvica, I mean, obviously as we've said before, we view these mechanisms is very complementary, they both have very attractive features and there are a number of either combinations or sequences of therapy that we would view as scientifically very attractive “
Rick Gonzalez, CEO AbbVie:
“You can go out and buy a biotech company that has a very exciting asset, and it's in Phase 3 as an example, and you think you know what's going to happen; but you never really know until you're done. You can go through the regulatory process and never be 100% sure. This is an asset that's on the market today.” **
* Press release. Feb. 27, 2015 Pharmacyclics, Inc. today announced that longer-term toxicology studies for its newly developed Bruton's tyrosine kinase (BTK) inhibitor for rheumatoid arthritis, or RA, have been completed.
** Gedoeld wordt op Pharmacyclics met haar producten die nu omzet genereren.
Een paar voorlopige conclusies van mijn kant.
- AbbVie zal Humira kost wat kost verdedigen tegen biosimilars en nieuwe RA-middelen van derden.
- Nieuwe formuleringen en nieuw deeloctrooien moeten dat mogelijk maken.
- Niet valt uit te sluiten dat men - mede dankzij de overname van Pharmacyclics - in huis nog meer mogelijkheden ziet op RA-gebied.
- Een overname van een biotech met een product nog in het stadium van klinisch onderzoek, is een flinke gok, zo luidt de opinie van het AbbVie management.
Ik beschouw een en ander bepaald niet als een ernstig probleem voor Galapagos (en meer in het bijzonder voor filgotinib), maar - zoals ik al hier al eerder heb opgemerkt - euforie is een slechte raadgever.
Ik ben benieuwd wat andere forumleden denken over AbbVie’s strategie naar aanleiding van deze conferfence call.