Zealand Pharma Turning peptides into drugs

1
Zealand PharmaTurning peptides into drugs
Presentation by Henrik Landwehr Head of HR
Operations development
2
Who am I ?

• Henrik Landwehr
• Head of HR Operations Development Zealand
  Pharma A/S.
• Why am I here?

3
Medicon Valley - the region

• Medicon Valley is all life science activities in
  the Greater Copenhagen area in Denmark and the
  Skåne region of Southern Sweden. Medicon Valley
  is one of the strongest pharmaceutical and
  biotechnological regions in Europe and comprises
  a dense cluster of universities, hospitals and
  more than 300 life science companies, of which
  more than 200 are RD based.

4

Zealand Pharma 2006

• Biopharmaceutical Company
• Discovery Development
• Peptide Based Drugs
• Founded in 1999
• Based in Copenhagen
• 3 programs in Phase II
• Industrial validation of RD engine via
  Sanofi-Aventis and Wyeth deals
• Approx. 65 employees
• Privately owned

5
Vision

• Vision 2005
• Drug candidates in development
• First license deals

6
Business Model

• 2011-2015
• Complete phase III
• Partnering during phase III
• Retain market rights in selected regions

• 2006-2010
• Complete phase II
• Partnering during phase II
• Retain market rights in selected regions

• 1999 2005
• From empty tubes quickly into early phase I/II
• Early out-licensing (preclinical-early phase
  I/II)
• No Zealand market rights

7
Our Values

• Team spirit
• Communication
• Flexibility
• Innovation

8
ZP Partnering Steps?

• Non-Confidential Opportunity Descriptions
• Confidential Data Package
• Summary Term Sheet Proposal
• Road Show Presentation
• Negotiations
• Contract

9
We focus on Peptides!

• The Pharmaceutical Market

Value of current peptide market gt USD 5B
Double digit growth rate!
Market Size
Current peptide Products target 23 primary
indications
gt300 companies are working on new peptide based
drugs
Peptide projects in preclinical development
target 64 primary indications
Small Molecules
Protein Products
Peptide Products
?
Peptides have turned fashionable!
10
We focus on Peptides RD!
Advantages
Peptide Qualities
Unique pharmacological properties
Allows novel therapeutic approaches (e.g., ZP10,
P120, ZP123, GLP-2)- Difficult to substitute with
small molecules
High selectivity
Better safety and tolerability
Predictable metabolism
Fewer adverse events
Validated effects in humans
Higher success rate
Strong peptide competences in region
Good recruiting ground
11
Our Clinical Pipeline
Name
Indication
Status
Next milestone
Targeted timing
Partner
ZP10
Type 2 diabetes
Phase II
PII further efficacy data
H1 2007
Sanofi-Aventis
ZP123
Ventricular arrhythmia
Phase II
PII efficacy data
H1 2007
Wyeth
ZP120
Acute heart failure
Phase II
PII efficacy data
H1 2007
In-house
ZP1846
Chemo-induced diarrhea
Pre-IND
IND
H1 2007
In-house
Three compounds moved from idea into Phase II
within six years
12
ZP10 for Type 2 diabetes improved GLP-1 agonist

Patient/clinician wish-list
ZP10 Target Profile
Effective reduction of blood-glucose
Effective reduction of blood-glucose
No hypoglycaemia (insulin chock)
No hypoglycaemia
No nausea
Reduction of nausea
Reduction of Weight
Weight loss
Long-acting
Longer duration of action
13
Our Clinical Pipeline
Name
Indication
Status
Next milestone
Targeted timing
Partner
ZP10
Type 2 diabetes
Phase II
PII further efficacy data
H1 2007
Sanofi-Aventis
ZP123
Ventricular arrhythmia
Phase II
PII efficacy data
H1 2007
Wyeth
ZP120
Acute heart failure
Phase II
PII efficacy data
H1 2007
In-house
ZP1846
Chemo-induced diarrhea
Pre-IND
IND
H1 2007
In-house
Three compounds moved from idea into Phase II
within six years
14

ZP123 (rotigaptide) for ventricular arrhythmia
(VA)

• Expected to prevent fatal ventricular arrhythmias
• Unique safety profile
• First-in-class mechanism of action

ZP123 theory
Arrhythmia
Signal
Acute myocardial infarction
ZP123
X
Cardiac cells
Cardiac cells
Cardiac cells
X
Signal
Signal
Signal
Gap junction
Gap junction
Gap junction

• Partnered with Wyeth
• Patent protected until 2021

15
Our Clinical Pipeline
Name
Indication
Status
Next milestone
Targeted timing
Partner
ZP10
Type 2 diabetes
Phase II
PII further efficacy data
H1 2007
Sanofi-Aventis
ZP123
Ventricular arrhythmia
Phase II
PII efficacy data
H1 2007
Wyeth
ZP120
Acute heart failure
Phase II
PII efficacy data
H1 2007
In-house
ZP1846
Chemo-induced diarrhea
Pre-IND
IND
H1 2007
In-house
Three compounds moved from idea into Phase II
within six years
16
A Novel Aquaretic with vasodilatory properties
ZP120
Target
Target Indication(s)

• ZP120 is indicated for the intravenous treatment
  of patients with acutely decompensated congestive
  heart failure (ADHF) who have dyspnea at rest or
  at minimal activity. In this population, the use
  of ZP120 improved dyspnea, increased diuresis,
  and reduced blood pressure.

Route of Administration

• i.v. infusion

Treatment Duration

• 24 hours

Pharmaceutical Formulation

• Liquid ready-to-use

Chemistry

• Peptide

17
ZP120 pharmacology Dual modality drug for acute
heart failure
Clinical need Rapid relief of severe dyspnoea
(shortness of breath)
ZP120
Vasodilators
Progression
Stress event
Acute heart failure
Severe dyspnea
Chronic heart disease
Peripheral vasoconstriction
Fluid overload
Progression
Diuretics
ZP120

• Significant market potential 6 million events a
  year in Europe and US
• Source American Heart Association Heart and
  Stroke Statistics Update 2005

18
Our Clinical Pipeline
Name
Indication
Status
Next milestone
Targeted timing
Partner
ZP10
Type 2 diabetes
Phase II
PII further efficacy data
H1 2007
Sanofi-Aventis
ZP123
Ventricular arrhythmia
Phase II
PII efficacy data
H1 2007
Wyeth
ZP120
Acute heart failure
Phase II
PII efficacy data
H1 2007
In-house
ZP1846
Chemo-induced diarrhea
Pre-IND
IND
H1 2007
In-house
Three compounds moved from idea into Phase II
within six years
19
Chemotherapy induced Diarrhea

Symptoms
ZP1846 Target Profile
Inadequate fluid retention
Fluid absorption
Inadequate nutritional absorption
Nutrition absorption
Intestinal atrophy damage
Regeneration stimulus
Enhancement of intestinal integrity
Increase of permeability
20
Working in the Industri

• Working in Teams with common goals
• You follow the project from Idea to Product.
• Your research results is important, and used!
• Better and faster carrier oppertunities Manager,
  Project leader or Specialist.
• Fixed employment.
• More ressources aviable.
• More stress an pressure for results and
  deadlines.
• You have to work on several projects
  simultaniusly.
• You loose the rights to your results.
• You do not have the same time to make research.

21
ZP Expectations to new employees !

• Higly skilled proffesional (Ph. D)
• Cooperative.
• Teamplayer.
• Open communication.
• Aware of personal strenghts and eventual
  weaknesses.
• Publications.
• The will to results.
• Ability to see the business perspective.
• Respect.