Mylan NV (MYL) Partnership Means The Race Is Back On For Mabion SA (MAB) And Its Billion Dollar Rituximab Biosimilar

A standard chemical based drug is relatively small and non-complex. When a company wants to bring out a generic, it can copy the chemical makeup of its target drug exactly, prove it works in a similar fashion by way of some simple studies, and submit for approval.

Biologics, on the other hand, of which Rituximab is one, are far more complex. They are derived from living organisms, and much larger in construct than chemical drugs. This makes them incredibly difficult to copy exactly, and that’s the root of the issue for the above mentioned big names that have been trying to bring a biosimilar Rituximab to market. They are tough to get right.

Mabion, to date, has developed and tested its biosimilar not just in a lymphoma indication, but also as part of a rheumatoid arthritis (RA) target, and said back in May that not only does its trials support the clinical equivalence of its candidate in both these indications, but it also demonstrates a superior safety profile. If this is the case, then it should have no problem getting through the EMA approval process.

Well, there was one problem.

When a company of Mabion’s size attempts to enter a market like this, even when some of the big names have dropped out, it’s going to need capital, or a deep pocketed partner, if it is to have any chance of commercial success. Novartis AG (ADR) (NYSE:NVS) is still very much in the race, as is South Korea’s CELLTRION INC KRW1000 (OTCMKTS:CONIF), the latter of which just teamed up with the above mentioned Teva on an distribution and commercialization partnership deal for its two lead biosimilar candidates, one of which is Truxima, its biosimilar Rituximab.

The partnership with Mylan NV (NASDAQ:MYL) solves this problem for Mabion SA (WSE:MAB).

The company is set to receive $10 million and additional payments for the implementation of the key steps of the deal in the total amount of up to $35 million, as well as royalties on sales. This upfront capital is nice, and it will no doubt ease shareholders’ dilution concerns, but the real win here for Mabion is that it puts the company firmly in the race to bring this drug to Europe.

So what’s next?

In a word, submission. Celltrion’s EMA submission is already with the agency, so the clock is ticking for Mabion if it wants to maintain a leadership position, but this move suggests that getting a marketing application with the EMA is just around the corner.

Note: This article is written by Mark Collins and was originally published at Market Exclusive.