3 Things In Biotech You Should Learn Today: July 14, 2017

Summary

• Biosimilars in oncology are go in the US.
• CTI therapy for myelofibrosis now under review in Europe.
• Pluristem cleared for enrollment in another country for its critical trial.

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep up with the rapid-moving world of biotech and pharmaceutical research.

Let's dive in!

Biosimilars in oncology are go in the US

A few days ago, we briefly discussed the documents given to Mylan (MYL) and Amgen (AMGN) as they moved into meetings with their oncology drug advisory committees (ODACs) to address any concerns relating to their biosimilar monoclonal antibodies: trastuzumab and bevacizumab respectively.

If you recall, I mentioned that it didn't appear that there should be any issues with the ODAC. And this prediction has now born out, as both ODACs unanimously accepted for most of the indications that MYL and AMGN requested.

The only one that the ODAC opted out of here was bevacizumab for the management of ovarian cancer, because the two approvals Roche (OTCQX:RHHBY) has in these indications maintain patent exclusivity through their orphan drug designation.

Looking forward: Unsurprising, yet pivotal news for the oncology community. Biosimilars have been hotly anticipated for a long time because of their potential to provide the strong standard of care we've had access to for nearly 20 years, but at a significantly reduced cost outlay. As more biosimilar versions of trastuzumab and bevacizumab are given the nod from the FDA, it's going to be very interesting to see what the economic impact is.

CTI therapy for myelofibrosis now under review in Europe

CTI BioPharma (CTIC) has been in the business of developing pacritinib, an inhibitor of Janus kinase 2 that acts in a similar manner to Incyte's (INCY) blockbuster drug ruxolitinib.

However, pacritinib development has had a fitful development, with questions about the safety of this agent, as well as how it might compete in the same marketplace as INCY.

But CTIC has moved itself toward the end game in myelofibrosis, at least in Europe. Recently, the company announced that the EMA has validated its marketing authorization application for pacritinib in the treatment of myelofibrosis and concomitant thrombocytopenia.

So the drug is now under review, and the next step will be consideration by the Committee for Medicinal Products for Human Use, which may flag issues that the company needs to address.

Looking forward: This is a little bit of a surprise; I had not expected to see pacritinib get going with the final stage of regulatory development this soon. At the same time, I'm sure that CTIC is highly motivated to move forward, as pacritinib is just about the last contender in the JAK2 inhibitor field. As I detailed in my Geron Corp. (GERN) competitor article, most other promising agents have fallen to the wayside, unfortunately.

Pluristem cleared for enrollment in another country for its critical trial

Pluristem (PSTI) is one of the pioneers in the regenerative medicine field, and it's focused much of its attention and resources on the development of one product: placental mesenchymal-like adherent stromal cells (PLX), with a phase 3 trial ongoing in the treatment of peripheral artery disease (PLX-PAD).

Slowly, but surely, PSTI has been gaining approvals to initiate enrollment in different countries for the use of PLX-PAD in patients with critical limb ischemia. The latest news is that PSTI has received authorization in Austria to begin recruitment into this study.

Looking forward: Why harp on a single site authorization in a country that's not usually a huge player in biotech? PLX-PAD has been selected to take part in a European initiative called the Adaptive Pathways project. Long story short, once PSTI enrolls 125 patients, the clock starts ticking toward interim efficacy review. And it is expected that the findings, if positive, 12 months out from enrollment of those 125 patients will be sufficient to gain conditional marketing approval in Europe. Therefore, every site counts, and that's just one more point of acceleration in PLX-PAD's development. In the press release, PSTI intimated that it hopes to increase the participating site number to 40 by the end of 2017, which will hopefully make for rapid recruitment of those 125 patients.

Exciting days with the FDA and EMA, with imminent drug approvals, new reviews, and exciting initiatives!

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