Biotech Values

[DewDiligence]

MNTA—What is the situation for Lovenox ex-US? If I recall correctly, Sandoz has some sort of option on ex-US rights.

There is no Sandoz option per se; rather, in 2006 NVS/MNTA extended the 2003 Lovenox collaboration to include the EU (#msg-12222305). Whether the companies actually pursue Lovenox development in the EU is an open question, hwoever.

Unlike the FDA, which regulates Lovenox as a small-molecule drug, the European Medicines Agency (EMA) intends to treat Lovenox follow-on drugs as quasi-biosimilars. The EMA has published guidelines for Lovenox follow-on drugs that: i) require at least one clinical trial for a sponsor to obtain approval for marketing; and ii) undermine the case for an individual EU country to permit automatic substitution of a follow-on drug for branded Lovenox. These two aspects of the EU market make the business proposition for a Lovenox follow-on tenuous, IMO.

(For further details on the market dynamics and patent landscape in each the EU’s top-five countries, please see #msg-52625998.)

In so-called emerging markets, the business proposition for NVS/MNTA to develop a Lovenox follow-on is even weaker than in the EU because: i) Lovenox knockoffs already exist in some major countries (e.g. India); ii) automatic substitutability is out of the question; and iii) pricing for Lovenox-like drugs is even weaker than in the EU.

All told, I’ll be mildly surprised if NVS/MNTA opt to develop a Lovenox follow-on in the EU, and I’ll be very surprised if they opt to develop such a product in the rest of the world. (The latter but not the former would require a formal extension to the existing Lovenox development agreements between NVS and MNTA.)