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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