Transcript Bionor Pharma
Disclaimer
This presentation includes forward-looking statements regarding Bionor Pharma ASA, including projections and expectations, which involve risk and uncertainty. Such statements are included without any guarantees to their future realization. Although Bionor Pharma ASA believes that the expectations regarding the Company reflected in such forward-looking statements are based on reasonable assumptions, no assurance can be given that such projections will be fulfilled. Any such forward-looking statement must be considered along with knowledge that actual events or results may vary materially from such predictions due to, among other things, political, economic, financial or legal changes in the markets in which Bionor Pharma ASA does business, and competitive developments or risks inherent to the Company’s business plans. Many of these factors are beyond Bionor Pharma ASA’s ability to control or predict. Given these uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. The Company does not intend, and does not assume any obligation, to update the forward-looking statements included in this presentation as of any date subsequent to the date hereof.
A brief introduction to Bionor Pharma
NORDIC HEALTH CARE CONFERENCE, DNB MARKETS, 6 DECEMBER 2012
STEEN KRØYER, CEO
This is Bionor Pharma
Norwegian led Proprietary platform Attractive portfolio 3 Experienced management World class advisors bionorpharma.com
Substantial investment
Bionor Pharma Pipeline
An attractive product portfolio with long term patents
4 bionorpharma.com
Advisory Boards
Providing independent clinical and scientific advice
Clinical Advisory Board
Richard Pollard, USA Jürgen Rockstroh, Germany Brian G. Gazzard, UK Barry S. Peters*, UK Guiseppe Pantaleo, Switzerland Robert R. Redfield, USA Dag Kvale, Norway Angus «Gus» Dalgleish, UK
Biographies available on bionorpharma.com
Scientific Advisory Board
Leiv K. Sydnes, Norway John E. Newbold, USA Kristian Prydz, Norway Knut Helkås Dahl**, Norway
Professors, except: *MBBS, DFFP, MD, FRCP ** MSc, PhD, ERT, DABT bionorpharma.com
bionorpharma.com
7
The history of AIDS
1968 –2012
Norwegian sailor, Arvid Noe dies of AIDS
1968
First US case of AIDS
1976
US Department of Health: “We will have a preventive AIDS vaccine within two years!”
1981 – 1983
First report on homosexual lifestyle association Hiv virus identified by Francoise Barre Sinousse, Pasteur Institute
bionorpharma.com
1986
Over 1 mill. HIV infected in the US First AIDS medicine “cocktail” approved by FDA (Antiretroviral therapy, ART)
1992
8
The history of AIDS
1968 –2012 1997
15% of new infected tied to blood donation New, improved ART, with less side effects
2000 2007
NIAID (National Institute for Allergy and Infectious Diseases) spends $680 million to combine 2 preventive vaccines, with marginal success
2009 – 2011 2012
First known HIV infected patient cured (“Berlin Patient”) Eradication strategy highlighted • Approx.35 mill HIV infected globally (1400 in Norway) • Most common treatments today: ART – one pill every day / HAART (Highly Active ART) – combination of several ART, to reduce resistance .
bionorpharma.com
9
The conventional treatment
And why we need new HIV treatments
Conventional HIV medicine (ART) effectively reduces virus, and prevents it from multiplying in the bloodstream.
However:
Does not destroy virus producing cells – puts the cells into resting state only Risk of serious, irreversible side effects, especially by long term use Resistance Not lasting effects - must be taken daily Limited access - only 1 in 4 who needs ART has access to it Does not cure HIV bionorpharma.com
Platform Technology
11
Our platform technology
With roots back to diagnostic product development in 1985 1
The Challenge with viruses
Viruses escape from attacks by the immune system by continuously changing its surface structures (proteins)
3
Capabilities
Prevents, treats, and potentially cures some of the world’s most deadly viruses
4
Bionor Pharma ´s focus
Vaccines for unmet medical needs, such as HIV, universal influenza and Hepatitis C
2
How our vaccines work
The vaccine redirects the immune system to detect and target specific structures of the virus that remain unchanged and vulnerable This results in removal of virus producing cells and reduction of virus level
5
Further potential
The technology provides a platform with potential for
5
of viruses diseases
bionorpharma.com
12
Vacc-4x
A new generation of HIV treatment
Peptides, chosen from unchanging parts of the virus Synthesized and modified to increase killing of HIV infected cells Produced by Bachem AG, Switzerland Harvard researchers have recently documented that a HIV vaccine should target the unchanging structures of the virus (Dahirel et. Al., PNAS 2011) Vacc-4x targets unchanging structures of the virus Kills and removes virus producing cells – immune system educated No adverse side effects No development of resistance bionorpharma.com
13
Immune activation is always required for AIDS to develop
Why do some people not get AIDS ?
Why do chimpanzees not get AIDS ?
Answer
: The only difference is that there is no evidence of immune activation (which is chronic and associated with inflammation, and has auto immune features).
How does HIV cause Immune activation ?
Can we switch it off ?
Answer
: This is the unique approach included by Bionor Pharma bionorpharma.com
14
Chronic immune activation is like background noise on the radio which prevents the signal from being heard!
Angus "Gus" Dalgliesh,
Member of Scientific Advisory Board bionorpharma.com
15
Vacc-C5
Improves the immune response
Targets unchanging structures of the virus Induces antibodies against HIV, which reduce hyperactivation of the immune system Prevent spread of the virus Improves the immune response Vaccine induced antibodies in animals First human trial approved, and started Q4 2012 Vacc-HIV: Combination of Vacc-C5 (inducing antibodies) and Vacc-4x (inducing killer T-cells), can thereby stimulate both parts of the immune system bionorpharma.com
16
What does this mean?
Antibodies to the C5 region of HIV prevent immune activation, and thereby prevent disease progression If we induce these antibodies (which is the aim of Vacc-C5), they could neutralize the disease Stopping activation will stop virus production bionorpharma.com
17
Other indications
Other indications in the product pipeline Vacc-HCV
Hepatitis C Vacc-HCV developed to treat and cure Market size: ~ 170 million patients Patent application filed June 2012 Potential partner to be identified
Vacc-FLU
Universal influenza vaccine: all pandemic influenza viruses Market size: ~ 500 million patients Preclinical development (including toxicology), planned finalized during 2013 Patent application filed June 2012 Potential partner to be identified
Cancer indications
Human papillomavirus (HPV, throat / cervical cancer) Cytomegalovirus (CMV, e.g. brain tumor) Patent applications filed June 2012 bionorpharma.com
Clinical studies
PERFORMED AND ONGOING
Vacc-4x: Completed clinical studies
Until mid 2012 1 - Open Study Phase I/II
, NO:
11 patients
, 100% immune response. Safe vaccine without side effects (1999-2000)
2 a - Open Study Phase II
, NO:
40 patients
(CD4 count at inclusion >300 cells/ μl), ART free period on average 31 months (2003-2004). Sustained CD4 counts, and transient reduction in viral load
2 b - Open Study Phase II Reboost
, NO (7 years after 2a):
26 patients
from 2a , with 2/3 of patients showing active memory response. Immune response enhanced after reboost with Vacc-4x (2010)
3 - Placebo-Controlled Study Phase II
, USA and Europe (18 centers):
135 patients
(CD4 count at inclusion >400 cells/ μl). Statistically significant reduction of HIV viral load in active group compared to placebo. Supportive immunological data (2008-2010 ) 19
4 - Open Study Phase I/II, Nasal Vaccination
, NO:
24 patients,
droplets of Vacc-4x in the nose, resulting in positive immune response. Potentially easier treatment and access for HIV patients globally (2011-2012) bionorpharma.com
HIV viral load
20 bionorpharma.com
Reduction of HIV viral load following vaccination with Vacc-4x
21 bionorpharma.com
Three new studies at sixteen sites
1 1 2 4 4 1 3
Vacc-4x + Revlimid Reboost with Vacc-4x Vacc-C5 phase I/II
23
Vacc-4x reboost
Reboost with Vacc-4x in patients from the phase II study Approval Q4 2012
USA + 4 European countries,11 clinics, ca. 40 patients
First patient enrolling
Dec. 2012
Design
Two immunizations of Vacc-4x while on ART, then up to 16 weeks of treatment interruption. Total study period 37 weeks.
Funded
Globvac (Norwegian Research Council) and Bionor Pharma ASA
Patient group
Participants from the previous phase II study with Vacc-4x
The primary endpoints
Changes in viral load compared to the previous study and immune responses to the vaccine
Aim of the study
To determine whether a lower viral load level (“set point”) can be achieved by re-boosting previously vaccinated HIV infected patients bionorpharma.com
Vacc-4x + Revlimid
®
Vacc-4x in combination with Celgene`s immune modulator Revlimid ®
24
Approved
Germany, August 2012, 4 clinics, approx. 36 patients (~12+24)
First dose group initiated treatment
October 2012
Design
First dosing-study with ~12 patients, determining “maximum tolerated” dose of Revlimid ®. Then 24 patients for 26 weeks.
Funded
Jointly with Celgene, owner of the blockbuster cancer drug and immune modulator Revlimid ®
Patient group
Well controlled viral load on conventional HIV medicine (ART), but failing to regain normal immune function (15-20% of all HIV patients)
Primary endpoints
Changes in the amount of CD4 T-cells and immune responses to the vaccine
Aim of the study
Determining whether the combination of Vacc-4x and Revlimid can result in improved response to Vacc 4x in HIV infected patients with poor immune recovery (low CD4 T-cells despite well controlled viral load on ART) bionorpharma.com
25
Vacc-C5
Clinical phase I/II study Approved
Oslo University Hospital, May 2012, 36 patients
First patient treated
November 2012
Design
“First time in man” open study, three different dose levels of Vacc-C5, each with two different adjuvants (supporting agents). Twenty six weeks study period for each patient.
Funded
Bionor Pharma ASA
Patient group
Well controlled on conventional HIV medicine
Primary endpoint
vaccine’s safety Evaluation of the
Secondary endpoint
Antibody responses to the vaccine.
Aim of the study
To determine whether antibodies to two specific , conserved areas of the HIV virus (C5 and gp41) are induced in HIV patients bionorpharma.com
Business Development
27
Two Critical Steps
STEP
1
Documentation process
STEP
2
Partnering process
bionorpharma.com
28
Information Gathering & Preparation
TPP’s
(For Key Assets)
Market & Commercial Research
(Navigant, BCG, McKinsey, KOL’s + Community Dr, etc. Market entry/ramp up, pricing, commercialization options)
IP Position
exclusivity) (Patents, Processes, Regulatory
Clinical/Regulatory FDA Clarity
Inflection Points) (Cost, Timelines,
News Flow
(Clinical Data, Patent Announcements, Other Application)
Financial Analysis
(Value, rNPV’s, MC Simulations, DCF’s, POS’s, Key Assumptions)
Non-Confidential Teaser Full Briefing Book Complete Data Room
S T E P
1
bionorpharma.com
29
Partnering Process
Identification of likely partners
(Vaccine Specific BD, Venture Sponsors w/in Big Pharma, others)
Diligence
(Access to Briefing Book, Data room, Management Q&A)
Partnering Solutions
(Research Agreements, License, M&A, which assets)
Indications of Interest & High Level Deal Terms Key Meetings
(Bio USA, JP Morgan, Regional Conferences, Others) bionorpharma.com
2-3 Potential partners Auction process Execute Deal
S T E P
2
Upcoming events
31
Financial summary
Secured funding until mid 2014
OSE: BIONOR Market Cap NOK 660 mill. / US$ 115 million Number of Shares: 198 million Private Placement was successfully closed 14 June 2012, with gross proceeds of NOK 57.6 million. This placement together with previous cash secures the funding of planned scientific and business related activities until mid 2014 Cash as of Q3 2012: NOK 126.7 mill. / US$ 22.2 million Annual burn-rate: NOK 60-70 mill. / US$ 10-12 million bionorpharma.com
32
Summary
Ongoing Clinical Studies and Business Development Process
Proven effect of technology platform and products Comprehensive clinical and preclinical program ongoing Partnering process next 12-18 months Exciting news flow during 2013
Visit bionorpharma.com for the latest information
bionorpharma.com
33
Thank you for your attention.
bionorpharma.com