Here’s What’s Moving Pieris Pharmaceuticals And Valeant Pharmaceuticals


Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) was a real mover at the end of the week last week in the biotechnology space, with the company putting out an update detailing a licensing agreement with Seattle Genetics, Inc. (NASDAQ:SGEN).

As per the release, the two companies will join forces with the goal of developing immuno-oncology treatments for solid tumors and blood cancers. Right off the bat, Pieris is taking a $30 million upfront payment from Seattle, as well as tiered royalties on net sales up to low double-digits, and up to $1.2b in total success-based payments.

In return for its cash commitments, Pieris is giving Seattle access to what it calls its agonistic costimulatory Anticalin proteins, which are (and we’re using the company’s technical description here) engineered versions of endogenous low-molecular weight human proteins called lipocalins.

The idea is that by combining these proteins with a targeting mechanism (so, in this instance, a tumor targeting antibody), they can be a highly effective tumor targeting asset and, at the same time, can be used to target a pretty wide range of cancers.

Seattle is bringing its ADCs to the table and the early research phase of the collaboration will see the two companies try out various combinations of Seattle’s ADCs and Pieris’ Anticalin proteins against preclinical cancer targets. Seattle is then going to pick its three favorite of these assets and push them forward towards commercialization.

As far as the market’s response to the development is concerned, Pieris is the real winner on this one. The company closed out around 20% up on its preannouncement market capitalization, trading at $8.59 at the close of play last week. In contrast, Seattle took a dip on Friday, closing out around 1% down on the session.

Another big mover at the end of last week was Valeant Pharmaceuticals International, Inc. (NYSE:VRX). The company announced on Friday that the FDA has informed Valeant that its PDUFA date has been extended for its New Drug Application for a drug called PLENVU. The extension adds three months on to this initial target, meaning the agency will now get around to publishing its decision by May 13, 2018.

The delay is rooted in the company’s submission of some additional data associated with the application. Plenvu is an investigational, novel, low-volume (1L) polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon and the company is developing it in collaboration with Norgine, through its wholly-owned subsidiary Salix.

These sorts of procedures have a pretty variable efficacy rate, with some patients not dealing well with the treatment. With Plenvu, Salix and Norgine think that they can reduce the concentration of the solution (it’s a bit more complicated than that, but in essence, that’s what the procedure involves) and, in doing so, can improve patients’ response rates and reduce the potential for unpleasant side effects.

At a glance, a delay like this seems to be a setback. In this instance, however, it’s not actually that bad of a development. Markets think there’s a higher chance of approval with the new data being considered as part of the application and there was a risk of the company receiving a CRL and a request for a complete resubmission, which would have added far more than three months on to the time-to-commercialization.

As such, and in line with the positive implications of a review of the recently submitted data as part of the already filed application, markets are trading up on the company in response to the update.

At the close of trade on Friday, Valeant was trading for a close to 2% premium to its pre-release market capitalization. Ahead of the bell on Monday, premarket activity has added a further percentage point to this boost, and Valeant will open the session today in and around $17.80 a share for a market capitalization of $6.19 billion.

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