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."
Lundbeck will make a payment to PAION of EUR 8 million in connection
with the new license agreement. The payment will be capitalised and
depreciated.
About desmoteplase
Desmoteplase, the most fibrin-specific plasminogen activator known
today, is a genetically engineered version of a clot-dissolving
protein found in the saliva of the vampire bat Desmodus rotundus. It
has received fast-track designation from the U.S. Food and Drug
Administration for the indication of acute ischaemic stroke.
About Stroke
Stroke is the third leading cause of death in the industrialised
world and a leading cause of serious, long-term disability. In the US
alone, 700,000 people suffer a stroke each year, and around 20% of
them die within four weeks. For the US, the American Heart
Association expects the financial burden of stroke due to in-hospital
costs, long-term care programs and productivity losses to exceed 62
billion dollars in 2007 alone.
The content of this release will have no influence on the Lundbeck
Group's financial result for 2007 that will be announced 4 March
2008.
Lundbeck contacts
Investors: Media:
Jacob Tolstrup Anders Schroll
Director, Corporate Reporting Head of Communication
+45 36 43 30 79 +45 36 43 20 81
Palle Holm Olesen
Head of Investor Relations
+45 36 43 24 26
PAION contact
Investors & Media:
Dr Peer Nils Schroeder, Investor Relations / Public Relations
Tel. +49 241 4453-152
E-mail pn.schroeder@paion.de
________________________
Stock Exchange Release No 317 - 21 December 2007
About PAION
PAION is a biopharmaceutical company based in Aachen, Germany (listed
at Frankfurt Stock Exchange, Prime Standard, ISIN DE000A0B65S3). It
aims to become a leader in developing and marketing innovative drugs
for the treatment of stroke and other thrombotic diseases for which
there is a substantial unmet medical need.
About Lundbeck
H. Lundbeck A/S is an international pharmaceutical company engaged in
the research and development, production, marketing and sale of drugs
for the treatment of psychiatric and neurological disorders. In 2006,
the company's revenue was DKK 9.2 billion (approximately EUR 1.2
billion or USD 1.6 billion). The number of employees is approximately
5,300 globally. For further information, please visit
www.lundbeck.com
