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WILEX AG: Innovative Cancer Therapies
© WILEX AG
2
Forward looking statements
This communication contains certain forward-looking statements, relating to the Company’s business, which canbe identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”“should” “future”, “potential” or similar expressions or by general discussion of strategy, plans or intentions ofthe Company. Such forward-looking statements involve known and unknown risks, uncertainties and otherfactors, which may cause our actual results of operations, financial condition, performance, or achievements, orindustry results, to be materially different from any future results, performance or achievements expressed orimplied by such forward-looking statements.
Such factors include, among others, the following: uncertainties related to results of our clinical trials, theuncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, theabsence of sales and marketing experience and limited manufacturing capabilities, attraction and retention oftechnologically skilled employees, dependence on licenses, patents and proprietary technology, dependenceupon collaborators, future capital needs and the uncertainty of additional funding, risks of product liability andlimitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical andpharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements,currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, actsof war, and other factors referenced in this communication.
Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on suchforward-looking statements. We disclaim any obligation to update any such forward-looking statements toreflect future events or developments. RENCAREX® is a temporary development name.
This material is not intended as an offer or solicitation for the purchase or sale of shares of WILEX AG. This materialmay not be distributed within countries where it may violate applicable law.
© WILEX AG
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WILEX at a glance
Multi-drug
product
portfolio
Balanced R&D pipeline of which 2 compounds
are in pivotal registration Phase III trials
Strong IP Portfolio
Value
driven
strategy
Oncology focussed
Patient focussed therapies
targeting markets with high unmet medical need
Commercialisation through partnerships and alliances
Operational
excellenceExperienced management and staff with complementary backgrounds
and proven track record
Strong
financial
basis
Positioned for growth:
listed on Prime Standard of Frankfurt Stock Exchange
© WILEX AG
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Prevention of
Metastasis
after surgery
Treatment of
metastatic disease
Cancer disease life cycle
Patient selection for therapy
WILEX addresses markets
with high unmet medical need
… and patient focussed disease management
Diagnosis of
tumour
malignancy
Phase III
CA9-SCAN
Phase II
RENCAREX®
+ ILN / IFN
Phase II
WX-671
Phase III
RENCAREX®
Phase II
WX-671
© WILEX AG
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Broad late-stage oncology portfolio
Phase III
CancerWX-77x
~700,000
Pancreascancer
Breastcancer
WX-671
~338,000CA9-SCAN
(therapy guidingimaging agent)
~ 100,000-138,000
~ 43,000- 52,000
RCC*
Met. RCC
RENCAREX®
RENCAREX®
+ IFN / ILN2
Cases p.a.ApprovalPhase IIPhase IPre-clinicalIndicationProduct
*non-metastatic
**planned
Renal
mass
Head &
neck
cancer**
© WILEX AG
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RENCAREX®: tumour specific antibody
in Phase III development
U.S. and the EU in the indication RCCOrphan Drug
Status
ADCC (Antibody-Dependent-Cellular-Cytoxicity),
mode of action with proven track recordMode of Action
CA IX antigenTarget
Renal cell cancer (RCC)Indication
Chimeric monoclonal antibodyCompound
Class
Renal, bladder, head & neck, breast and colon cancerPotential
indications
RENCAREX® showed good safety, tolerance and
efficacy in Phase I and Phase II studies.
Development
status
© WILEX AG
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RENCAREX® Phase III study design approved by
FDA (IND) and EMEA (scientific advice)
For European filing expected end 2008 at the earliestResults
Disease-free survival objectively determined by e.g. computer tomography
Study end
point for
approval
Post surgical treatment of RCC to prevent metastatic RCC;
Patients who, prior to surgery, have large tumours, lymph node involvement, blood
vessel infiltration or highly aggressive tumours
Indication
International double-blind placebo controlled Phase III study ongoing;
More than 160 sites in North and South America and Europe initiatedStudy design
856 patients targeted for enrolment;
Over 80% enrolled to dateEnrolment
© WILEX AG
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Patient withsymptoms Urologist
CT Scan
CA9-SCAN: State-of-the-art molecular
imaging of cancer
Today
Surgery
CA9-SCAN
Follow-up
(Diagnosis)
Clear cell
RCC
Renal
mass
positive
negative
Patient withsymptoms
Urologist
Tomorrow
SurgeryFollow-up
(Treatment & Diagnosis)
© WILEX AG
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CA9-SCAN with excellent predictive accuracy
Imaging diagnostic of malignant tumours by means of PET / CTMode of action
CA IX antigenTarget
Renal massIndication
Radioactive labelled antibody for Positron Emission Tomography (PET) / CTCompound
class
Impressive proof of concept study
Specificity 100%
Sensitivity 94%
IND Phase III approved by the FDA,
SPA requested (recommended by FDA)
Development of CA9-SCAN for other cancer indications planned
Development
status
Pivotal registration trial; expected second half of 2008Results
Renal, head & neckPotential
indications
© WILEX AG
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WX-671: First of its class as specific
anti-metastatic approach
Anti metastatic, non-cytotoxic agentMode of action
Urokinase Plasminogen Activator (uPA) system and other serine proteasesTarget
Various solid cancerIndication
Oral small molecule serine protease inhibitor, orally available pro-drug of WX-UK1Compound
class
In preclinical studies highly effective in blocking metastatic spread and tumour growth
WX-671 (oral) and WX-UK1 (i.v.) tested in seven Phase I trials (>140 patients):
Shown to be safe and well-tolerated
Randomised Phase II programmes:
WX-671 plus Gemcitabine versus Gemcitabine alone in locally advanced, non-
resectable non-metastatic pancreatic cancer (ongoing)
WX-671 plus Capecitabine versus Capecitabine alone in first-line metastatic breast
cancer (planned)
Development
status
Preliminary results of WX-671 Phase II study in pancreatic cancer in 2008Results
© WILEX AG
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Guidance 2007; financial data
2007: 2.5 - 2.8 Mill. expected
Significant continuous growth
RevenuesCapital raised
~ 68 Mill. Euro private
~ 55 Mill. Euro IPO
Cash usage 2007
24 – 28 Mill. Euro
Infrastructure
53 staff
GLP & GMP facilities in Munich
Commercialization
Cash flow also expected in 2008
0,0
1,0
2,0
3,0
2005 2006 2007e
© WILEX AG
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Guidance 2007; news flow*
IBA cooperation on registration trial for CA9-SCAN
WILEX will apply for a SPA for CA9-SCAN
FDA approval of CA9-SCAN registration trial
*Approx. planning
Approval for Phase II trial for WX-671 in patients with pancreatic cancer
Start of Phase II trial for WX-671 (pancreatic cancer)
WX-671 Phase Ib head & neck cancer study results
Results of WX-UK1/Capecitabine breast cancer trial
Filing of Phase II study WX-671 (breast cancer)
Update of Phase III RENCAREX®- trial
Futility analysis of the Phase III RENCAREX® trial
2 new Supervisory Board members elected with in-depth drug development
and marketing expertise, experienced CBO nominated
2007 cost guidance reduced by ~4 Mill. Euro
CA9-SCAN
WX-671
Other
RENCAREX®
© WILEX AG
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Guidance 2008; financial calendar
*Approx. planning
20 February Annual report 2007 - Press / Analyst conference
10 April Quarterly report 1/2008
3 June Annual General Meeting
14 July Quarterly report 2/2008
13 October Quarterly report 3/2008
© WILEX AG
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Multi-drug
product
portfolio
Balanced R&D pipeline of which 2 compounds
are in pivotal registration Phase III trials
Strong IP Portfolio
Value
driven
strategy
Oncology focussed
Patient focussed therapies
targeting markets with high unmet medical needs
Commercialisation through partnerships and alliances
Operational
excellenceExperienced management and staff with complementary backgrounds
and proven track record
Strong
financial
basis
Positioned for growth:
listed on Prime Standard of Frankfurt Stock Exchange
Compelling Investment Proposition
© WILEX AG
15
Contact
WILEX AG
Grillparzerstr. 10
81675 Munich / Germany
Tel.: +49 (0)89-41 31 38-0
Fax: +49 (0)89-41 31 38-99
Email: [email protected]
Website: www.wilex.com
ISIN: DE0006614720 / Symbol: WL6 / Reuters: WL6G.DE / Bloomberg: WL6G.GR