The Difficult Transition Into Phase 3

Hurdle
The Hurdle Race to Phase 3

Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3.  Hence, not surprisingly, few small companies tackle Phase 3 programs on their own.  Unless an ‘angel investor’ with deep pockets commits to the compound and assures continuity of development, the search for a partner is a necessity.  This often becomes a drawn-out process and is likely to slow things down.  Time is never on the side of the drug developers but raising funds can really become the overriding concern even for companies with very innovative promising compounds.

But partnering with ‘Big pharma’ has its own downsides; it is not always a marriage made in heaven.  Issues of control, layers of decision-making and strategic portfolio priorities can cause delays and create complexity for a VC company unaccustomed to being the junior partner at the table.  A change, or a change in commitment, by senior management on either side may be all it takes to derail a program.

Case in point:  Nabriva probably hoped that its partnership with Forest would continue to fund their Phase 3 program for BC-3781, its most advanced pleuromutilin antibiotic.  This was not to be. When it was announced in July 2013 that Forest had stopped its partnership with Nabriva it did not create big waves.   After all, this collaboration was meant to be a ‘12-month collaboration’ from the start, providing development funds to Nabriva while in return giving Forest exclusive rights to acquire Nabriva.  When the time was up, Forest and Nabriva issued a boilerplate statement indicating that the ‘collaboration elapsed’ without providing an specifics [1].

So what made Forest lose interest and disengage?  We don’t know the details and are not going to speculate here except to say that this decision had probably not much to do with BC-3781, Nabriva’s lead compound. At the time of the initial ‘engagement’ in mid-2012, the Phase 2 program of BC-3781 had finished enrollment and results the Phase 2 ABSSSI trial were certainly already known internally.  Indeed, all efficacy markers of interest compared favorably to vancomycin.  Likewise, the safety results were positive and would support continued development at either BC-3781 dose tested [2].

So, it stands to reason that Forest knew the data, liked what they saw and did not mind shelling out $25 mio for ‘development activities’ and an option to buy Nabriva.  Still, the stars were not aligned for the BC-3781 to propel it into Phase 3.

Clearly, Forest has its hands full with other antibiotics closer to the market.  Ceftazidime/avibactam is in late phase development; it will compete in the market with Cubist’s ceftolozane/tazobactam and other newcomers.  Very recently, Forest acquired Furiex which brought JNJ-2, an anti-MRSA fluoroquinolone and Phase 3 drug, to the company. That’s quite a lot to lift, even with Actavis as a partner.

Now the search is on at Nabriva to find a new partner for BC-3781.  This should not be too difficult for a novel MoA drug with IV and PO formulations.  Stay tuned.

 


References: [1] http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=482175
[2] Prince.  Antimicrob. Agents Chemother. 2013: 10.1128

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One Reply to “The Difficult Transition Into Phase 3”

  1. Nabriva took a long time to get BC-3781 developed through Phase 2 – makes one wonder if there is some issue that we are missing. Same with some other antibiotics (omadacycline and radelzolid come to mind) which don’t seem to be stuck in Phase 2 for reasons unknown….

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