Meda in-licenses exclusive rights to Ceplene

Meda in-licenses exclusive rights to Ceplene

Meda has in-licensed exclusive rights to Ceplene (histamine dihydrochloride)
from EpiCept Corporation, a US-based biopharmaceutical company. Meda's rights
cover Europe and several key markets in Asia including Japan, China and
Australia. Ceplene is indicated for remission maintenance therapy and prevention
of relapse in adult patients with Acute Myeloid Leukemia (AML). More than 16,000
new cases of AML are diagnosed in the EU every year. Most patients will suffer a
relapse within one year. 
 
Ceplene is an important advance in treating AML reoccurrence due to the lack of
alternative treatments.  In a multicenter study, Ceplene met its primary
endpoint of prolonging leukemia-free survival for AML patients in remission. The
difference between the treated and control group was highly statistically
significant (p<0.008).
   
Ceplene is approved by the European Commission as an orphan drug(1). In the EU,
orphan drugs receive 10 years of market exclusivity. Similar protection is
likely to be granted in other markets. 

 “Ceplene is a unique drug and we hope that Ceplene will be able to help
patients that today have few alternatives. There is also a good fit with our
pain product Onsolis, indicated for breakthrough pain in cancer patients”, says
Anders Lonner CEO Meda.

Ceplene is also under investigation for additional indications such as
Myelodysplastic Syndrome (MDS) and Chronic Myelogenous Leukemia (CML). 

In consideration of being granted the exclusive rights to Ceplene, Meda will pay
EpiCept 3 MUSD upfront and an additional 2 MUSD upon launch. EpiCept is also
eligible to receive 5 MUSD as a regulatory milestone. Sales based milestones
will be due once Ceplene reaches annual sales of 50 MUSD and 100 MUSD. The
milestone payments for those sales levels are 10 MUSD and 20 MUSD respectively.
EpiCept will receive a double digit royalty on net sales.

(1)Orphan drugs are defined as drugs that treat rare and life-threatening
conditions.

If questions, please contact:

Anders Larnholt, Vice President Corporate Development & IR	ph: +46 709-458 878


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products are sold in 120 countries worldwide and the company is represented by
its own organizations in more than 40 countries. The Meda share is listed under
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visit www.meda.se.