Biotech Values

[DewDiligence]

Musings on Generic Lovenox in the EU

…if and when a decision is made to apply to the EMEA for rights to market the Lovenox generic in the EU, will Sandoz or MNTA make that decision?

They will make the decision jointly, as governed by the Jul 2006 agreement between the parties. It’s doubtful that a Lovenox-biosimilar application in the EU would be undertaken unless both companies agreed on the rationale for moving forward.

Would that company also assume the responsibility of meeting EMA's criteria for approval, e.g., conduct of clinical trial(s)?

The design of such clinical trials would be a joint effort by NVS and MNTA. The requirements set forth by the EMA for LMWH biosimilars is detailed in:

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003927

(Note that the EMEA has been renamed and is now called the is now called the European Medicines Agency or EMA.)

Funding of these clinical trials by each party would be in proportion to the undisclosed profit split for Lovenox in the EU as specified in the companies’ 2006 agreement. (My guess is that the profit split is roughly 60% NVS, 40% MNTA.)

…I'm asking because if the answer is Sandoz, MNTA's plate being rather full may not be too material.

If a Lovenox biosimilar in the EU is a good business proposition, it will not be precluded by MNTA’s being too busy—this much I can guarantee! On the other hand, it is not clear that a Lovenox biosimilar in the EU is in fact a good business proposition because, in certain major EU countries, the product would be a branded drug that would have to be marketed rather than a substitutable generic as in the US. The need to market the product in these countries significantly reduces the profit margin and increases the risk that the product will end up with a small market share.

Below are the specifics in the five largest EU countries, which collectively have 2/3 of the EU’s population. (I obtained this information from various sources including SNY’s SEC Form 20-F.)

• Germany: For small-molecule drugs, substitution of a generic by the pharmacist or hospital formulary is allowed unless the Rx explicitly precludes it (the same as in the US). Whether Germany will allow automatic substitution by a Lovenox biosimilar is unclear; my guess is that they will not, and hence a Lovenox biosimilar in Germany will have to marketed as a branded drug. SNY’s Lovenox patent in Germany expires in Jun 2011.

• France, Spain: Automatic substitution is not allowed even for small-molecule generics, so it almost certainly will not be allowed for a Lovenox biosimilar; hence, a Lovenox biosimilar will have to be marketed in these countries as a branded drug. SNY’s Lovenox patent in has already expired in both countries.

• UK: Rx’s are generally written by a drug’s International Nonproprietary Name (INN) rather than the brand name; as long as a biosimilar has the same INN as the brand on which it is based, automatic substitution by the pharmacist or hospital formulary will probably be permitted. SNY’s Lovenox patent in the UK expires in Jun 2011.

• Italy: The situation is the same as France and Spain except that SNY’s patent expires in Jun 2011.

Dew