Licensing

After a series of PI3k pileups, Genentech offloads a PhII-ready rival for firesale price

Why would Genentech, of all biopharma companies, out-license a PI3k inhibitor for only $5 million? That’s a question a few biotechs may be asking themselves this morning after seeing the terms in a deal between the biotech giant and little Australian biotech Novogen.

Genentech decided to offload GDC-0084 after completing a Phase I study of the drug for glioblastoma. Novogen ($NVGN) acknowledges that there have been several PI3k inhibitors in development, but says that this one is distinguished by its ability to cross the blood-brain barrier to reach the most common form of brain cancer.

Genentech is also handing over enough of the drug for Novogen to roll out a Phase II study next year, making it a player in PI3k.

That’s a nice little deal for Novogen. But it could be seen as the latest in a series of ominous turns for biotechs like Infinity, which are still trying to make progress in this field. Genentech is known for occasionally buying or licensing the particular drugs it needs to full out a packed pipeline. It’s not much at all known for handing out drugs that no longer fit.

But PI3k inhibition isn’t the lure that it once was, and big biopharma has been bailing out.

In April AstraZeneca simply cut AZD8835, a PI3K alpha/delta inhibitor in studies for solid tumors. And that move came just two months before AbbVie opted to spurn its $805 million collaboration with Infinity $INFI, even though their PI3K delta/gamma drug duvelisib had produced a positive set of data in a pivotal trial. It just wasn’t competitive enough.

TG Therapeutics also has an oral PI3k inhibitor – TGR-1202 – in the clinic.

All these retreats followed a major problem for Gilead’s first-in-class PI3k inhibitor Zydelig (idelalisib) which was approved in 2014. In March, though, the company was forced to stop 6 studies due to safety issues. And that came after the drug was clearly losing a race with J&J’s Imbruvica from J&J and AbbVie on leukemia and lymphoma. AbbVie and Roche’s venetoclax, meanwhile, is expected to gain market ground in CLL.

Imbruvica’s position on the market also was seen as a deal killer for duvelisib.

Add it all up and you can see how the PI3k field – once a hot prospect in R&D circles – has been decimated in recent months.


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RAPS Regulatory Convergence 2017