Puma Biotechnology: EU Delivers A Blow – And An Opportunity
Summary
On January 23rd, the EU drug regulator signaled it will likely vote against approval Puma Biotechnology’s breast cancer drug, Nerlynx; Puma shares fell badly on the news.
The FDA approved Nerlynx in 2017 and gave it a cleaner label than most company watchers anticipated.
The EU market is cut off for now, but the US market remains a vast opportunity.
After the recent price drop, company shares look quite attractive; the mounting possibility of a buyout further colors the picture in Puma’s favor.
Puma Biotechnology (PBYI) took a nasty hit on January 23rd, when the EMA, the EU’s equivalent of the FDA, through up a serious roadblock to the approval of the company’s drug Nerlynx – also called neratinib – for the treatment of early-stage HER2-positive breast cancer. The agency’s Committee for Medicinal Products for Human Use, or CHMP, delivered a negative trend vote – in essence, an indication that the committee will not vote in favor approval when the final decision is made in February.
The decision was a bit of a shock, since the FDA approved Nerlynx with little fuss in 2017. It means a highly lucrative market for Puma’s breast cancer drug is now foreclosed – at least for the time being. But negative market reaction in the wake of the announcement does seem to be a bit overdone. The US market offers hugely lucrative opportunities for Puma to exploit, which does not yet seem fully reflected in the share price even now.
Let’s take a look at what precipitated the vote, and what it means for Puma and its shareholders going forward.
Spooked by Side Effects
The FDA has approved a broad label use for the drug, even as the EMA is unwilling to consider even a narrower sub-population. Puma’s own statementon the CHMP vote has done nothing to lift investors’ spirits:
“It is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe. CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival (iDFS) benefits observed to-date may lack sufficient clinical relevance.”
بیوتکنولوژی پوما : اتحادیه اروپا یک ضربه و فرصت را فراهم می کند – اخبار زیست فناوری
