In the first nine months of
2001 the biopharmaceutical company MediGene (Neuer Markt: MDG) has
successful driven forward its corporate development. Currently, MediGene has
seven drug candidates in different stages of clinical development. These drug
candidates were developed using different technologies. The broad portfolio of
leading technologies continues to feed MediGene’s pipeline with novel drug
candidates in the field of cardiac and tumor diseases.
In the first nine months 2001 MediGene has increased its revenues (i.e.: other
operating income) by 75% to TEUR 5,883 compared to the same period of the
previous year. The significant increase in revenues is due to the excellent
progress made in the joint drug development projects with its partners Aventis
and Schering. Recently, Schering and MediGene modified their existing license
and cooperation contract. The amendment removes MediGene’s
reimbursement obligations to Schering. As a result, an amount of TEUR 2,300
has been realized as revenue which had previously been included in deferred
revenues.
The increase of investments into the clinical development of MediGene’s drug
candidates fortunately accompanied the considerable progress in the individual
clinical development programs. These value added investments led to a
planned increase in the loss of the period of the first nine months of 2001 in
comparison to the first nine months of 2000. EBIT in the first nine months 2001
amounted to TEUR -19,170 compared to TEUR –8,617 in the same period of
the year 2000.
[ in TEUR*]
9 Months2001
9 Months2000
Q III2001
Q III2000
Other
operating
income
5,883
3,352
3,037
1,039
R & D -
expenses
19,047
9,972
5,756
4,612
EBIT
-19,170
-8,617
-5,066
-4,450
Result before
income taxes
-15,154
-8,747
-4,221
-3,071
*TEUR = THOUSANDS OF EURO
Cash, cash equivalents and securities were TEUR 94,845 as of September
30th 2001, which corresponds to 81% of total assets. In the first nine months
the average net cash burn rate per month amounted to TEUR 2,265. The
number of employees has increased from 134 as of June 30, 2001 to 146 as of
September 30, 2001. 37 persons are employed at MediGene, Inc., San Diego.
In the most important area of MediGene’s business, i.e. the development of
innovative drugs for the treatment of cardiac and cancer diseases, the
company reached several important milestones in the first nine months: The
clinical development of Leuprogel™ was successfully completed. MediGene
will file for Marketing Authorization in Europe by the end of this year. In addition,
MediGene obtained very convincing results from a first phase 3 clinical study
with Polyphenon ™E concerning efficacy and safety. Polyphenon™E is
developed for the treatment of benign tumors of the genital tract, so-called
genital warts.
„With the successful completion of the first phase 3 clinical trial with
Polyphenon™E to treat genital warts, MediGene proved to be able to develop
efficacious treatments to the benefit of patients”, states Dr. Johanna Holldack,
COO, Research and Development.
„It is our primary goal to increase MediGene’s value by creating sustained
growth through the establishment of all steps in drug development. The success
in the development of our most advanced drugs Leuprogel™ and
Polyphenon™E will point the way for our future. We expect our first product
Leuprogel™, a drug for the treatment of prostate cancer, to be launched as
early as 2003. Currently, we are working at full stretch to establish a sales and
marketing team for both products“, explains Dr. Peter Heinrich, Chief Executive
Officer at MediGene, and adds: „MediGene will be in a position to exploit the
full commercial potential of biopharmaceutical product development, from the
molecular analysis of a disease including the discovery and development