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Patented new treatment scheme for type-1 diabetes – generating additional sales with existing pharmaceuticals ● Düsseldorf/Melbourne, 2010
Patented new treatment scheme for type-1 diabetes –generating additional sales with existing
pharmaceuticals
● Düsseldorf/Melbourne, 2010
● BvA-TeC is a start-up company which will give type-1 and type-1.5 diabetes patients worldwide access to a new, patented treatment scheme.
● 80% of patients were able to stop taking artificial insulin after completing the treatment.
● Current potential for the treatment scheme is at about 90 million patients worldwide (diabetes type1- and type-1.5). Due to aging, sedentary lifestyle and unhealthy diets the number of diabetes patients is rising worldwide.
● The treatment scheme is based on combined use of existing medications: Bacillus Calmette-Guérin (BCG), Famciclovir, Fragmin-D, Alpha-antitrypsin, Interleukin-12.
● Pharmaceutical companies, who produce the pharmaceuticals used in the treatment scheme, get the opportunity to generate additional turnover of about 57 billion Euros within the next 10 years.
An opportunity to generate addition sales
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● Result of 20 years of research and development work by German scientist Prof. Ulrich von Arnim
● Stopping the immune reaction against the insulin-producing islet cells by reprogramming natural killer T-cells, so the body can produce new islet cells that settle in the pancreas and produce insulin.
● 80% of patients were able to stop taking artificial insulin – dramatically improved lifestyle quality for patients
Treatment scheme
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Prof. Ulrich von Arnim
Treatment scheme: Process
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● Scheme uses a combination therapy of already existing medications– Bacillus Calmette-Guérin (BCG)– Famciclovir – Fragmin-D– Alpha-antitrypsin– Interleukin-12
● Total cost of medications of about 17,000 Euros per treatment/patient in 12 months
Treatment scheme: Medications used
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Studies were conducted jointly with the Universities of Tübingen and Heidelberg and the Charité Medical School of Berlin in Germany, the University of Manchester in the UK and the University of Uppsala in Sweden.
Treatment scheme: Efficacy proved in clinical studies
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Period Study phase
Subjects
Efficacy
Trial registration number
1990–1992 I 1,000 83% (pre-study)1994–1996 II 2,000 82.5% WO/1987/0013851997–2002 II/III 7,000 80.7% WO/1994/0189882003–2006 IV 6,000 80.8% WO/1994/018988
● Prof. Ulrich von Arnim holds worldwide patent for the new treatment scheme
● Assessment of specialized financial auditor Ralph Villiger, Avance, Basel GmbH estimates value of patent at 1 billion Euros (start of commercialization)/10 billion Euros (terminal value possible)
Treatment scheme: Patent
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● Total costs estimated with 65,000 Euros, incl. 17,000 Euros for the medications per treatment and patient
● Probability of more than 98% that treatment will be covered by German statutory health system (GKV) (acc. to leading law firm Clifford Chance)
– Insulin dependent diabetes is primarily defined as a childhood disease– 90% of medications prescriptions for children are off-label (acc. to leading
health insurer AOK)– Additionally sustainable cost savings of more than 100,000 Euros per
patient’s lifetime will lead to acceptance and support by health insurers.
● Cost analysis will start in cooperation with German University end of 2010, results will be the basis for negotiations with health insurers.
Treatment scheme: Costs
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BvA-TeC: Gives access to new treatment scheme
BvA-TeC will be founded to commercialize the patented treatment scheme on a worldwide scale:
●Selling licenses to manufacture and market the medications
●Training, support and consulting of doctors who treat patients worldwide
●Treatment and testing of patients at own model hospitals/laboratories
●Research & development at own hospitals/laboratories
●Effective marketing & communication worldwide to create a strong demand and make the new treatment becoming a standard practice
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BvA-TeC: Initiators/Managers
Prof. Ulrich von Arnim (born 1960) ● Doctoral thesis in London on multiple sclerosis
diagnostics ● Managing director of WISRO International, a
successful biotech company● Department of Biochemistry and Molecular Biology
at Monash University in Melbourne
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Peter Schiftan(born 1941)
David Meggs(born 1949)
Larry Green(born 1950)
BvA-TeC: Business Plan (2010-2021)
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YearPatients
treated/year
Revenues in €/year
Total costs in €/year
Net Profit in €/year
2011 30 1,629,101.33 2,229,525.00 -420,296.572012 5,794 122,676,202.67 105,638,485.41 11,926,402.082013 21,514 389,904,912.25 265,390,421.11 87,160,143.802014 52,954 653,590,458.92 376,685,100.02 193,833,751.232015 105,514 945,652,538.92 410,428,897.66 374,656,548.882016 174,034 1,334,026,689.33 441,565,861.11 624,722,579.762017 255,694 1,808,126,956.00 518,378,153.77 902,824,161.562018 348,034 2,354,608,106.00 464,907,401.41 1,322,790,493.212019 445,654 2,944,094,139.33 524,106,004.75 1,693,991,694.212020 548,554 3,572,348,056.00 587,181,396.41 2,089,616,661.712021 654,154 4,222,619,222.67 652,208,513.08 2,499,287,496.712022 759,754 4,878,576,139.33 717,804,204.75 2,912,540,354.21
BvA-TeC: Structure
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6,00%
Dividends
94,00%Licence FeesDividends
BvA-TeC S.E. Design, Licensing, Manufacturing,
Distribution of Test Kit
DIARESOLVE Holding S.E.Business Management
VA Holding S.E.Intellectual Property Holder
GmbH Germany Corp. USA
LicensingHospital
Training Center
Laboratory
Hospital
Training
Laboratory
● Currently about 90 million diabetes type-1 and -1.5 patients worldwide ● Increase by 2.5% per year to about 380 million diabetes patients until
2025 (WDF)
Source: International Diabetes Federation and own calculation. Incidence and prevalence for type 2 refer to adults of age between 20 and 79 years (4.3 bn. worldwide).
Cooperation with pharmaceutical companies: Market potential
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Europe (top 5) USA / Canada global
Diabetes new cases 556,000 798,000 7,636,000Diabetes existing cases 20,664,000 29,680,000 284,000,000Diabetes existing cases 2030 (forecast)
24,100,000 40,000,000 438,000,000
Diabetes Type 1 new cases 57,300 61,200 1,242,000Diabetes Type 1 existing cases 1,920,000 2,066,000 41,917,000
Additional sales of 57 billion Euros within 10 years with existing medications
Cooperation with pharmaceutical companies: Potential sales
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Year Patients treated/year
Sales of Pharm. Companies (17,000 Euros/patient)
2011 30 515,100.00 €2012 5,794 98,491,200.00 €2013 21,514 365,731,200.00 €2014 52,954 900,211,200.00 €2015 105,514 1,793,731,200.00 €2016 174,034 2,958,571,200.00 €2017 255,694 4,346,791,200.00 €2018 348,034 5,916,571,200.00 €2019 445,654 7,576,111,200.00 €2020 548,554 9,325,411,200.00 €2021 654,154 11,120,611,200.00 €2022 759,754 12,915,811,200.00 €
Total 57,318,558,300.00 €
● SICAR fund with a total volume of 2 billion Euros
● Participation in licensing agreements through SIF cell
● Non-asset-shares of BvA-TeC (10%-share)
● Licenses to manufacture and market the used medications
Offer for pharmaceutical companies
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tbd.
All in all an attractive business
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Strength Weaknesses
First mover „healing diabetes“ Worldwide patent (= protector of intellectual property) Sustainable cost savings for national economies and
health insurers Successful test phase III Better life for patients
Organizational structure/management capacity has to be built up
Financing
Opportunities Threats
Market potential of 90 million patients worldwide Additional turnover with existing products for
pharmaceutical companies Cost savings potential for health insurancy system
Prejudices/opinions among scientific community and patients („no healing for diabetes ...“)
