That TPM injectable antibiotic..., page-26

do you know what's involved getting Daptomycin TPM commercialised?

The $64 million question Turps. A bit like trying to answer how long is a bit of string. It depends upon multiple factors including court rulings on patents, regulatory pathways to be used, what data the FDA requires, how smoothly studies go, whether approval is given, how motivated and flush with money the sponsor is….

Firstly, it can’t go to market before the last standing Cubicin patent is cleared. Since the US court ruling last December to strike out four of the patents protecting Cubicin, there is one patent left standing (,071) and it expires in June 2016.

But, Cubist/Merck has unsurprisingly appealed and wants that decision reversed. Hospira (which stands to be first generic cab off the rank, a position which comes with 180 day exclusivity) has also appealed the court decision. It wants the remaining Cubicin patent ruled invalid on the basis that it contains a significant correction which is neither “clerical or typographical” in nature. The two parties are still duking it out and I guess the outcome will determine if Hospira is free to launch on market immediately; if it has to wait until June next year, as is the current position; or if it has a long wait until 2019 or 2020 before it gets its product to market. Whenever that is, other generic companies are able to follow six months after.

Other companies, by the way, who have already submitted ANDAs (bioequivalent generic drug approval applications) for Cubicin are Teva, Fresenius Kabi and Strides.

Which confuses the matter further. Strides submitted an ANDA for Cubicin in late August, 2013. But the way I see it, daptomycin reformulated with TPM would need approval via a 505(b)(2) pathway, meaning an NDA would need to be filed. Perhaps Strides was simply hedging its bets.

So what is required/what are the timeframes for a 505(b)(2)? A lifetime, it seems, if the product is an opioid patch…but daptomycin iv isn’t.

I found an interesting (2013) interview with an inventor from a US drug delivery biotech which was reformulating existing drugs using an improved solvent for insoluble drugs. Its first prescription product was to be a reformulation of Sandoz’s voriconazole iv, which is a first-line therapy for systemic fungal infections. In answer to the question of what needed to be done to bring the product to market, the answer was it would take 2 years all up, using a 505 (b) (2) pathway

• a toxicity study in small and large animals - 90 days.
• conducting a commercial formulization in parallel.
• conducting a bioequivalence study in about 48 healthy human volunteers - 60 days.
• tending to application requirements – 90 days
• FDA review - 10-months

Of course, the inventor may well have invented this…

As for whether Strides or Mylan have already submitted a 505(b)(2) NDA for TPM daptomycin iv – not that I have been able to find.