May just answer some of the questions our recent doubters have about our plans
LOOKING FORWARD
Date February 22, 2013
The acromegaly candidate, ATL1103, might leapfrog the further advanced ATL1102 to become Antisense’s first marketed product. “It’s an orphan indication, acromegaly, so we’d benefit from the more streamlined clinical development path,” Mr Diamond says. “That’s probably going to be on the market before the MS drug, because the next phase of development for the MS drug would be phase IIb ... and phase III clinical trials in MS usually take a couple of years to do.”
He explains that obtaining approval for an acromegaly drug is relatively straightforward. “The goal with treating acromegaly is to normalise IGF-1. That’s also the way in which these drugs are approved: in regulatory trials all you have to do is show that you’re normalising IGF-1.” Consequently, Antisense expects to be able to seek approval of ATL1103 based on phase III trials, which would begin following the three-month phase II study and last around a year or 18 months. “It’s going to be quicker development,” Mr Diamond says.
Partnering
The company raised Aus$6.5m last March and is funded through to next year, Mr Diamond says, allowing completion of the forthcoming phase II trial of ATL1103. After that, it looks like it may follow the oft-travelled route of seeking partners.
In fact, Mr Diamond says, Antisense almost had a partner for its acromegaly candidate before phase II, but the potential licensee walked away. “The company went through full licensing due diligence with us.” However, it was subsequently decided that the discussions would be put on hold until the completion of the phase II clinical trial.
Negotiations with the undisclosed suitor could pick up where they left off, Mr Diamond said, if the phase II data are strong. “We expect them to be there and be interested in the data – we hope they will be – but we’re not expecting them to be the only prospect for licensing this drug.”
Partnership is not the only possibility for ATL1103, though. “Probably the more likely path would be to partner it at the end of the phase II clinical trial, but we’re aware that as this is an orphan drug indication the requirements for a phase III study are reduced. To be able to fund (development of) a product ourselves is not out of the question.
“At the completion of the phase II clinical trial we’d be looking to find partners, but what it also might present is an opportunity for us to raise money and go and complete phase III studies ourselves,” Mr Diamond says, as well as speculating that decent data would make Antisense a takeover target. “That’s something that we will contemplate,” he says.
OK i will not HIGHLIGHT any of the above take from it what you will but all scenarios are there.
FACT not FICTION
GO ANP
ANP Price at posting:
15.0¢ Sentiment: Buy Disclosure: Held
