News
Lundbeck obtains global exclusive rights to Desmoteplase New Phase III trial with Desmoteplase in acute ischaemic stroke planned.
- Lundbeck bearing all future development costs
- PAION retains co-promotion rights in certain countries
- PAION eligible for up to EUR 71 million in upfront and milestone
payments
Aachen (Germany), 21 December 2007 - PAION AG (Frankfurt Stock
Exchange, Prime Standard: PA8) and H. Lundbeck A/S today announced they
have entered into an expanded license agreement for Desmoteplase and that
a new clinical Phase III trial with Desmoteplase in acute ischaemic stroke is
being planned. The agreement is conditional and subject to Lundbeck's final
IP due diligence and certain outstanding IP related issues, which will be
completed no later than January 2008.
Under the terms of the new agreement Lundbeck obtains global exclusive
rights to Desmoteplase (now including North America) with full control of
development and commercialisation of the drug while bearing all future
development costs. PAION will have a supporting role in the future
development of Desmoteplase.
PAION retains an option to co-promote Desmoteplase in Germany,
Switzerland and Austria.
Within the new deal structure, PAION will be eligible for a total of up to
EUR 71 million in upfront and milestone payments, of which EUR 38 million
consist of pre-commercialisation milestones and EUR 25 million are due post
approval on first commercial sales and reaching undisclosed sales targets.
PAION will receive EUR 8 million upfront. In addition, PAION will receive
double-digit net royalties, which have been reduced compared to the previous
contract.
On 31 May 2007 PAION announced topline results of the DIAS-2
(Desmoteplase In Acute Ischemic Stroke) study with the compound
Desmoteplase. The DIAS-2 study showed a surprisingly high responder rate
in the placebo group with no difference compared to Desmoteplase on the
primary clinical efficacy endpoint. In DIAS-2, patients were eligible for
treatment only in case of a detectable penumbra (insufficiently perfused but
still salvageable tissue area around the primary location of stroke) of at least
20%, as identified by magnetic resonance imaging (MRI) or perfusion
computed tomography (pCT).
The patients, however, were not screened for presence of vessel occlusion in
the larger brain arteries using angiography. The data from the re-analysis of
angiographs from these patients demonstrated that, in contrast to the Phase II
studies, almost half of the DIAS-2 patients lacked visible vessel occlusion
before treatment.
When analysing patient subgroups using presence of vessel occlusion as
treatment criteria, a reduced response rate on the placebo group and a
positive effect of Desmoteplase versus placebo is observed, however not
statistically significant due to the small sample size. Additionally, pooled
results from the clinical Phase II and III studies (DIAS/DEDAS/DIAS-2) show
statistically significant efficacy in favour of Desmoteplase if patients without
visible occlusions in the large brain arteries are excluded. At the same time
the re-analysis also indicates that patients without a visible vessel occlusion in
the main arteries but with a large penumbra may also benefit from the
treatment with Desmoteplase. These novel findings are encouraging and
support continued clinical investigation in patients with acute ischemic stroke
within 3 to 9 hours after onset of stroke symptoms.
Lundbeck plans to present data to the regulatory authorities in order to gain
acceptance on the planned new clinical Phase III study expected to be
initiated by Lundbeck in the second half of 2008.
"Desmoteplase has the potential to treat patients with acute ischaemic stroke
up to nine hours after onset of symptoms. No treatment is available today that
allows patients to reach hospital and be diagnosed within this extended time
window," said Senior Vice President Anders Gersel Pedersen, head of
Development at Lundbeck. "The re-analysis of the DIAS-2 study indicates that
patients with a detectable blood clot can benefit from Desmoteplase and we
are very pleased to have reached an agreement on the further development of
the compound with our partner PAION."
"We are glad that Lundbeck shares our enthusiasm for Desmoteplase," says
Dr Wolfgang Söhngen, CEO of PAION AG. "We will continue to support
Lundbeck in achieving our mutual goal to deliver a new treatment opportunity
for stroke patients." He adds: "I would like to thank our clinical team for
conducting the subgroup analysis which turned out to be the key for the
continued development. We are proud that we were able to achieve a
turnaround for Desmoteplase and PAION within six months."
