AbbVie and Amgen settle a dispute over biosimilar Humira.
Noxxon Pharma-Merck collaboration takes off in pancreatic cancer.
Mesoblast reaches critical mass in its heart failure trial.
Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research. AbbVie and Amgen settle a dispute over biosimilar Humira
Companies developing biosimilars are looking to get in on some of the most lucrative markets in biotech. The companies that originally developed these drugs are, unsurprisingly, doing everything they can to hold onto their market positions for as long as possible.
One of those strategies is litigation, which AbbVie (NYSE:ABBV) has pursued for the sake of its TNF blocker adalimumab, branded Humira. Just before Amgen (NASDAQ:AMGN) received approval for a biosimilar version of adalimumab, ABBV filed suit, citing patent infringement and seeking to delay the launch of AMGN's version until March of this year, at least. And that was only on the basis of 10 of 61 alleged patent infringements.
But the companies have come to a big arrangement to settle the patent dispute. ABBV will grant AMGN non-exclusive license to adalimumab starting in October 2018 in Europe and in January 2023 in the United States. Then, AMGN will pay royalties to ABBV on sales of its drug. Looking forward: This is bittersweet news to me, and I'm heavily conflicted. On one hand, I'm very happy that this litigation mess has been resolved in some way, as it paves a way forward for biosimilars on the whole. Moreover, ABBV should have the right to vigorously defend its intellectual property. However, for the consumers, this threatens the biosimilar wave that we hope will help curtail ever-rising costs of healthcare. The IP portfolios of the originator molecules present a huge obstacle to moving forward, when there is a need to drive down costs of these drugs, which have been on the market for over a decade.
Noxxon Pharma-Merck collaboration takes off in pancreatic cancer
Germany-based company Noxxon Pharma is a developer of drugs called aptamers, short strands of DNA or RNA that bind proteins specifically. Think of them as a compromise between small molecule size and antibody specificity. Its lead agent, NOX-A12, targets a molecule called CXCL12, which contributes to a biochemical "wall" surrounding pancreatic cancer.
Let me back up on that...you may have noticed that with all the hullabaloo surrounding immune checkpoint inhibitors, there has been a notable absence of a "difficult-to-treat" tumor: pancreatic cancer. This is because these tumors have two things going against them. Many are not strongly immunogenic, so the immune system has a hard time seeing them. Furthermore, many tumors encase themselves in an immune-inaccessible microenvironment, putting up a shield that effectively stops immune checkpoint inhibitor activity.
This is controlled in part by CXCL12. So it makes perfect sense that Noxxon initiated a collaboration between itself and Merck (NYSE:MRK) to study pembrolizumab combined with NOX-A12 in patients with pancreatic cancer. Recently, Noxxon provided an update of the ongoing phase 1/2 trial, stating that it has enrolled 10 of the 20 patients it needs in part 1 of the study, which is designed to assess safety and potential for modulation of the tumor microenvironment.
All patients will then proceed to part 2, where they'll receive pembrolizumab and NOX-A12. The company hopes to have preliminary data from part 2 of the study in Q4 2018. Looking forward: You're seeing here one of the many nascent attack plans for immune checkpoint inhibition in pancreatic cancer. Combination strategies are being tested all over the place, but in this particularly tough-to-treat tumor field, the microenvironment is one of the main targets at this time. It is hoped that by breaking up the protective shell that pancreatic cancer encases itself in that the immune checkpoint inhibitor can do its job. Here's hoping!
Mesoblast reaches critical mass in its heart failure trial
Mesoblast (NASDAQ:MESO) is a company specializing in the development of mesenchymal precursor cells for several conditions, perhaps most notably heart failure. Its lead technique, branded NeoFuse, is currently being assessed in multiple trials enrolling patients with congestive heart failure.
Back in April, we saw encouraging interim results from the phase 3 trial, as the results passed a futility analysis, and the independent monitoring board recommended moving forward with the trial.
Now, MESO has announced that researchers from the Icahn School of Medicine have completed enrollment of patients in a phase 2b study assessing NeoFuse in patients with end-stage heart failure. This captures a pool of patients who are worse off than those in the phase 3 trial MESO is conducting. Looking forward: I remember the days when MESO made international headlines with a multibillion-dollar deal with Cephalon back in 2010, which was a huge validating milestone in regenerative medicine. It just goes to show you how long things can take to go from exciting, promising research that's making the news to reaching critical mass where the drug might get approved. With the phase 2b study reaching critical mass, I wonder if MESO will be able to incorporate the data it gets out of these end-stage CHF patients, assuming it is good. Being able to extend the indication would make its presumed entry onto the market all the more explosive. Thank you for tuning in to this digest! If you found it helpful at all, I hope you'll consider becoming a follower of mine on Seeking Alpha, as this will allow you to receive real-time email updates when new articles of mine go live, including new editions of "3 Things." Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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