Wednesday, October 29, 2014

Actavis-Forest - Are They Serious? - And - AZ Follow-up

It looks like the answer might be “yes.”  Actavis-Forest recently purchased Durata to acquire the recently approved long-acting, intravenous, glycopeptide antibiotic, dalbavancin, for $675 million or so.  I guess they were convinced that dalbavancin will be a big seller.  This is the second time dalbavancin has been sold.  The first was the sale of Vicuron with dalbavancin and anidulafungin (an antifungal) for $1.9 billion to Pfizer.  Dalbavancin failed to win approval at the FDA and Pfizer abandoned its further development.  Durata obtained dalbavancin from Pfizer.  The crazy part of the story is that George Horner was instrumental in the sale of dalbavancin to Pfizer when he was CEO of Vicuron and was also instrumental in leading the formation of Durata and its acquisition of dalbavancin back from Pfizer.  What goes around comes around!

Actavis-Forest – or at least Forest - thought that ceftaroline was going to be a billion dollar drug as well.  But it looks like ceftaroline sales are growing exceedingly slowly and if it earns $120 million in sales for 2014, four years following its approval in the US, it will be doing well. At the same time, Forest decided not to exercise their option to purchase Nabriva’s lefamulin, a novel pleuromutilin antibiotic available in both IV and oral formulations, that could have been in phase 3 trials for a year already. 

On the plus side, it is now clear that Actavis will file an NDA with the FDA using the data on ceftazidime-avibactam coming primarily from the recently completed trials in intra-abdominal infection plus data from in vitro, in vivo animal studies and from human pharmacodynamics. The urinary tract infection data will be submitted later as an sNDA according to the Actavis press release.

I am sure that there are many factors that Actavis-Forest have been considering in thinking about their commitment to the antibiotics space.  One factor may be that Actavis is headquartered in Europe.  Forest was an entirely US-based company with little in the way of ex-North American sales.  In their agreement with AstraZeneca for avibactam combinations, Forest was responsible for the US and AZ for everything else.  I believe that the relationship between the two companies was never a comfortable one on either side. Now that Actavis-Forest is based in Europe, the agreement with AZ becomes a little more bizarre. Wouldn’t it be an interesting turn-around in Actavis now purchases the entire avibactam franchise from AZ . . .

I, probably more than anyone, applaud the fact that Actavis-Forest remains committed to antibiotics.  But I have to say that I am a little confused by their strategy and their choices.  Their lack of an antibiotics discovery group remains a disadvantage for them. I also question their competence in the antibiotic marketplace. Yet here we are with Actavis having three potentially big selling antibiotics in their portfolio,  ceftaroline, dalbavancin and now ceftazidime-avibactam.  They have ceftaroline-avibactam (for which they have primary responsibility) lingering in phase II development as well as the rest of the avibactam portfolio including aztreonam-avibactam. I fervently hope that they can get it together enough to make a success of their endeavor in the antibiotics space.

In a follow-up to my previous blog on AstraZeneca and their seemingly imminent departure from antibiotics research, I can now add a few details. First, I have confirmed that researchers had been advised, at least informally, to find jobs elsewhere with two people having intimate knowledge of AZ research. Secondly, I am informed that as of about one month ago, there was not even a budget for the research group as of January 2015. AZ’s statements to the Wall Street Journal note that they have important drugs in development and they allude to their positive results from the ceftazidime-avibactam intra-abdominal infection trial.  At the same time they reiterate what they have been saying since March of 2013 – that anti-infectives will not be an area of focus for them and that they would be opportunistic in the anti-infective space.  That means, a far as I can tell, that they will try and partner, sell, spin-off or exit entirely.  So – in sum – I stand by my blog from last week.  I only hope that all of this leads to the continued development of their portfolio and that their researchers can continue to hunt for new antibiotics somewhere.

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