Mesoblast (MSB) - Headed to the sweet spot in diabetes care. Buy, Speculative. Current price $6.45. Target price $16.00 (Bell Potter Securities)

1. 31 January 2012
Analyst
Stuart Roberts 612 8224 2871
Associate Analyst
Mesoblast (MSB)
Tanushree Jain 612 8224 2849
Authorisation Headed to the sweet spot in diabetes care
Steve Goldberg 612 8224 2809
Recommendation Diabetes represents strong new upside for Mesoblast
Buy (unchanged) Mesoblast has initiated clinical work in Type II diabetes with the clearance of its IND by
Price the FDA. This follows on from highly favourable data in non-human primates which
was reported in November 2011 and January 2012. With diabetes so widespread and
$6.45 growing, there is huge potential value for MPCs in this space. The current standard of
Target (12 months)
care for diabetes of insulin therapy and/or oral diabetes medication have together
$16.00 (unchanged) created a global market worth ~US$34bn pa, serving 8% of the world’s adult
Risk population. By contrast heart failure is probably only a US$6bn global market. We see
Speculative success in diabetes as boosting confidence in other intravenous applications of MPCs
on which Mesoblast is now working on, such as anti-inflammatory disorders. We have
previously assumed no value from Mesoblast’s diabetes programme. We now apply a
Expected Return conservative 5% probability of clinical trial success for diabetes under our base case
Capital growth 148% valuation and a 10% probability of success under our optimistic case valuation, which
Dividend yield 0 equates to A$1.95 per share base case and A$4.84 optimistic case.
Total expected return 148%
Company Data & Ratios Investment view – strong news flow matches a strong
Enterprise value A$1,580.3 pipeline
m In view of the substantial opportunity of MSB’s cardiovascular and Bone Marrow
Market cap A$1,820.8
Transplant franchises and other pipeline opportunities in diabetes, eye diseases &
m
orthopedic becoming more substantial, we re-iterate our positive outlook on MSB. We
Issued capital 280.3m
value Mesoblast at A$10.91 base case and A$21.60 optimistic case. Our target price
Free float 100%
of A$16.00 sits at the mid-point of our DCF range. We expect significant news flow
Avg. daily vol. (52wk) 0.74m
over the next twelve months as assisting in the stock being re-rated to our target price
12 month price range $5.05-$10.04
including a) initiation of the Phase II diabetes trial; b) initiation of a pivotal trial in heart
GICS sector
Healthcare Equipment and Services
failure; c) completion of the Phase II spinal fusion trials; d) interim data from the EU
Phase II trial in Acute Myocardial Infarction; e) receipt of a Special Protocol
Disclosure: Bell Potter Securities acted as lead
manager in a May 2010 capital raising and a Assessment by the FDA for the BMT Phase III Trial; f) Interim data from Phase II
December 2010 selldown of stock and received
fees for that service. lumbar disc repair trial and g) potential licensing announcement for the diabetes
program.
Price Performance
(1m) (3m) (12m)
Price (A$) 7.34 9.65 5.89
Absolute Price
Absolute (%) -14.85 -35.23 6.11 Earnings Forecast
Rel market (%) -18.10 -36.30 17.55
Year end 30 June 2011a 2012f 2013f 2014f 2015f
$12.00
Sales (A$m) 15 27 27 27 337
$10.00 EBITDA (A$m) -12 -23 -44 -62 208
$8.00 NPAT (reported) (A$m) 91 -23 -38 -58 170
NPAT (adjusted) (A$m) -9 -16 -38 -58 170
$6.00
EPS (adjusted) (cps) -3.9 -5.5 -13.1 -20.1 58.8
$4.00 EPS growth (%) N/A N/A N/A N/A -392%
$2.00 PER (x) N/A N/A N/A N/A 11.0
EV/EBITDA (x) -133.1 -67.4 -35.7 -25.3 7.6
$0.00
Feb 10 Aug 10 Feb 11 Aug 11 Dividend (¢ps) 0.0 0.0 0.0 0.0 0.0
Yield (%) 0.0% 0.0% 0.0% 0.0% 0.0%
MSB S&P 300 Rebased
Franking (%) N/A N/A N/A N/A N/A
ROE (%) -1.7% -3.1% -7.9% -13.4% 27.5%
SOURCE: IRESS SOURCE: BELL POTTER SECURITIES ESTIMATES
BELL POTTER SECURITIES LIMITED DISCLAIMER AND DISCLOSURES
ACN 25 006 390 7721 THIS REPORT MUST BE READ WITH THE DISCLAIMER Page 1
AFSL 243480 AND DISCLOSURES ON PAGE 29 THAT FORM PART OF IT.

2. Mesoblast (MSB) 31 January 2012
Mesoblast – Headed for the sweet spot in
diabetes care
Mesoblast is initiating a Phase II Trial in Type II Diabetes. Mesoblast has announced
Mesoblast’s diabetes
trial will report that it has received FDA approval to run a Phase II trial in Type II diabetics evaluating the
results later this year effect of a single injection of MSB’s MPC. The trial is essentially a dose finding safety study
1
with the potential for an efficacy readout , randomising 60 patients with ‘poorly controlled
Type II diabetes’ (ie HbA1c over 7% and patients on metformin but not yet insulin
dependent) to either placebo (15 patients) or any of the three escalating doses (0.3, 1, or 2
million cells - 45 patients). The trial subjects will be evaluated at the 12-week mark. Type II
diabetes would be the first indication moving into human clinical trials from MSB’s
intravenous (IV) product franchise. We expect data late in 2012.
Why MSB’s diabetes application is poised for success. In our view MSB’s MPC
technology has a strong potential to upstage the current ‘standard of care’ for Type II
diabetes and also be effective in treating associated co-morbidities. Our belief stems from
work done in non-human primates that generated strong efficacy signals (see the next
section for details) and demonstrated the cardioprotective nature of MPCs. We expect that
in later stage clinical work Mesoblast will focus on late-stage patients with renal failure
where current treatment options are limited and the principal competition in a healthcare
economics sense is costly renal dialysis therapy (typical cost US$70,000 pa).
Diabetes represents strong new upside for Mesoblast. The current standard of care for
diabetes are insulin therapy and oral diabetes medication, which together have created a
global market worth ~US$34bn pa, serving 8% of the world’s adult population. We apply a
conservative 5% probability of clinical trial success for diabetes under our base case
valuation and a 10% probability of success under our optimistic case valuation. We value
diabetes opportunity for MSB at A$1.95 under our base case and A$4.84 under our
optimistic case. We also see success in diabetes as boosting confidence in other
intravenous applications of MPCs on which Mesoblast is now working on, such as anti-
inflammatory disorders. Big and Specialty Pharma companies are facing a huge patent cliff
over the next 6 years with key diabetes drugs including Amylin’s Byetta, Merck’s Januvia
and Novo Nordisk’s Victoza losing patent exclusivity. Consequently, we expect to see
licensing interest from the pharma companies as MSB moves with its diabetes offering into
Phase II trials and given the high costs involved in a Phase III diabetes trial, a strong
likelihood of MSB establishing a partnership prior to Phase III.
We Re-iterate our Buy Recommendation and $16 Price Target (Risk Speculative). In
view of the substantial opportunity of MSB’s cardiovascular and Bone Marrow Transplant
franchises and other pipeline opportunities in diabetes, eye diseases and orthopaedic
becoming more substantial, we re-iterate are positive outlook on MSB. We value
Mesoblast at A$10.91 base case and A$21.60 optimistic case. Our target price of A$16.00
sits at the mid-point of our DCF range. We expect significant news flow over the next
twelve months assisting in the stock being re-rated to our target price including a) Initiation
of the Phase II diabetes trial; b) Initiation of a pivotal trial in heart failure; c) completion of
the Phase II spinal fusion trials; d) interim data from the EU Phase II trial in Acute
Myocardial Infarction; e) receipt of a Special Protocol Assessment by the FDA for the BMT
Phase III Trial; f) Interim data from Phase II lumbar disc repair trial and g) potential
licensing announcement for the diabetes program.
1
That is, the primary endpoints will be those associated with safety and tolerability, although secondary endpoints like fasting blood glucose and C-reactive peptide will also be measured.
Note that the trial will evaluate a single injection of MPCs, which reflects conservatism on Mesoblast’s part. As MSB noted in presenting its heart failure data in mid-November, MSB’s cells
generate a weak immune response in some recipients. In the heart failure trial there was a donor specific antibody response in 6 of the treated patients, or 13% of that group, but four lost
their antibodies in less than one month. There was no effect on therapeutic outcomes from the antibodies, and no clinical-signs or symptoms related to such antibodies. We understand that in
repeat dosing work in non-human primates there had been no immune response issues observed in terms of its impact on therapeutic effectiveness. We conclude from all this that immune
response is not an issue with MPCs.
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3. Mesoblast (MSB) 31 January 2012
Animal data points to solid clinical
prospects in Type II diabetes
Today’s announcement follows on from favourable animal data in Type II diabetes which
Mesoblast announced on 10 November, and follow-up data announced on 12 January:
• The company’s investigators took 17 non-human primates with dietary-induced Type II
diabetes, gave them a single dose of MPCs (0.1, 0.3, 1 or 2 million cells), and then
2
measured the effect on glucose metabolism over a twelve week period . Three of the
17 monkeys were used as controls;
• The change from baseline in fasting blood glucose for the treated subjects versus
placebo for each dose level was statistically significant at two, four, six and eight weeks
(p<0.001), with the control group showing no significant changes in their high levels of
fasting blood glucose;
• At the highest doses of 1 million and 2 million cells, the change in fasting blood glucose
at eight weeks from baseline was statistically significant (p<0.05) at eight weeks and
3
remained so at 12 weeks .
• There was a correlation between fasting blood glucose and C-Reactive Protein (CRP),
a marker of inflammation that is frequently used as an indicator of cardiovascular
health. Also, there was a demonstrated dose response for CRP, with the higher doses
seeing a statistically significant drop in CRP as opposed to the lower doses (p<0.05)
We see six reasons why this data is important for the prospects of MPCs as a
therapy for Type II diabetes:
1) The data was from a good animal model. Old world non-human primates have proved
4
viable animal models for studying Type II diabetes for many years . We understand
Mesoblast’s data were generated using a colony of outbred cynomolgus monkeys, that
is, ‘long-tailed macaques’ or ‘crab-eating macaques’ native to Southeast Asia (Macaca
fascicularis). For this monkey there is a particularly robust body of science on its
5
usefulness as a diabetes model , since the monkey gets the same kind of diabetes as
6
humans when fed a high-sugar, high-fat diet , making it an ideal setting in which to
study diabetes therapies. Also, the complete gene sequence of the monkey has
7
recently become available thanks to Roche researchers .
2) The statistical significance of the data was impressive. Obviously a greater number of
The 2011 non-human
primate study results control subjects would be desirable in order to show statistical significance in terms of
had high statistical treatment versus control. However the low p values versus baseline suggest that the
significance effect on fasting plasma glucose and CRP was real, particularly since the number of
test subjects was so small.
3) The favourable effect at twelve weeks was important. Cynomolgus monkeys have a life
8
span of around 30 years in captivity , so, roughly speaking, twelve weeks worth of
data in this monkey can be considered the equivalent of around 32 weeks in a human.
Given that diabetes drugs are considered effective in people if they can reduce HbA1c
below 7% at the 24-26 week point, we think the statistically significant effect at eight
weeks on fasting blood glucose is highly relevant to any upcoming human trials.
2
The eight-week data were presented in November 2011.
3
Reported January 2012.
4
See ILAR J. 2006;47(3):259-71 and ILAR J. 2006;47(3):186-98.
5
See, for example, J Med Primatol. 1988;17(6):319-32; Lab Anim Sci. 1993 Feb;43(1):73-7; Vet Pathol. 1996 Sep;33(5):479-85; and Toxicol Pathol. 2001 Jan-Feb;29(1):142-8.
6
See J Med Primatol. 2011 Oct;40(5):335-41
7
See Genome Res. 2011 Oct;21(10):1746-56. Epub 2011 Aug 23.
8
Source: Wisconsin National Primate Research Center, University of Wisconsin-Madison.
Page 3

4. Mesoblast (MSB) 31 January 2012
4) The drop in fasting blood glucose at the high dose could be a proxy for glycemic
control. At eight weeks the 2 million cell dose group had dropped fasting blood glucose
9
by 44 mg/dl , to 110 mg/dl (assuming the controls in Mesoblast’s trial at 154 mg/dl
represents an adequate baseline). That this was favourable is suggested by fasting
10
blood glucose of 100-125 being considered only ‘pre-diabetes’ in humans . Now
compare the performance of MPCs in the current study to the diabetes drug Byetta,
where a 10 mcg twice-daily injection of Byetta as a monotherapy at 24 weeks was only
11
able to bring fasting blood glucose down by 19 mg/dl, from 155 mg/dl to 136 mg/dl .
This, drop however, was good enough to reduce HbA1c levels in Byetta’s patients
from 7.8% to 6.9%, thereby restoring glycemic control. This suggests the potential for
MPCs to be seriously competitive with existing diabetes drugs.
5) MPCs are cardioprotective. As the data released to date on MPCs in heart failure
would suggest, MPCs have a favourable cardiovascular profile. Mesoblast has now
demonstrated this through the data on C-Reactive Protein (CRP). CRP is often used in
evaluating heart disease risk because the white blood cells associated with
inflammation invade artery walls and release damaging chemicals, leading to plaque
12 13
formation . In this study CRP came down from levels >3 mg/L , generally considered
14
‘high risk’ , to the low point of the range considered ‘medium risk’ (1.0–3.0 mg/L) and
15
remained so throughout the entire 12 week study period . We think the CRP data
provides good confirmatory evidence not only of the ability of MPCs to turn down an
16
inflammatory response but also of the favourable cardiovascular profile of stem cells
as a potential diabetes therapy. This is important given how cardiovascular issues
knocked down GSK’s former blockbuster diabetes drug Avandia over the 2007-2010
period.
6) The non-human primate data builds on mouse data which Mesoblast generated two
MPCs may be able to
rebuild damaged years ago. In December 2009 Mesoblast reported the results of a study of MPCs in a
17
pancreatic tissue mouse model of diabetes . A 35-subject experiment saw single-dose injections of
MPCs boost pancreatic islet cells two-fold in the treated mice compared to the controls
18
(p=0.0012), with the ratio of beta-to-alpha islet cells 29% higher (p=0.005) , blood
glucose levels down 35% (p=0.012) and blood insulin levels up 34% (p=0.04). This
indicated that MPCs could potentially regenerate pancreatic islet beta cells in Type II
diabetics. Mesoblast hasn’t reported data on pancreatic histology with regard to the
non-human primate study because the monkeys hadn’t been sacrificed at the time the
data was generated, however there is the potential, given the other data that is
available, for regeneration to have happened.
A diabetes application for MPCs would potentially dwarf all the others. As we note
below, there is currently a US$34bn global market for insulin and diabetes drugs, growing
strongly thanks to high and rising diabetes prevalence. MPCs, if successful in humans as a
diabetes therapy, would have certain key advantages that would make it a contender for
leadership of this market.
9
Milligrams per decilitre. A decilitre is one-tenth of a litre.
10
Source: American Diabetes Association. Healthy blood glucose is under 100.
11
This was for 10 mcg twice-daily Byetta as a monotherapy at 24 weeks (source: Eli Lilly, Byetta prescribing information, Table 5).
12
Data from the Physicians Health Study of 18,000 apparently healthy doctors found that elevated levels of CRP were associated with a threefold increase in the risk of heart attack (see
Circulation. 2002 Jun 4;105(22):2595-9). Meanwhile in the ~28,000 apparently healthy women in the Harvard Women's Health Study, CRP was more accurate than cholesterol levels in
predicting heart problems (see N Engl J Med. 2002 Nov 14;347(20):1557-65). In recent years CRP has come to be regarded as diagnostic of Metabolic Syndrome (see Circulation.
2003;107:391-397).
13
Milligrams per litre.
14
See Circulation. 2003 Jan 28;107(3):499-511.
15
At 0.3, 1 or 2 million MPC/kg.
16
We noted in our 27 September 2011 comprehensive update note on Mesoblast (see page 47 of that note) that Mesenchymal Stem Cells had demonstrated ability in terms of
immunomodulation, and we assume that MPCs are similarly well placed.
17
Presumably mice in which the pancreas had been partially destroyed by the chemotherapy drug streptozotocin. See Lab Anim (NY). 2009 Feb;38(2):55-60.
18
Islet cells are so-called because when looking at the cells through a microscope, they look like islands floating in the pancreas. Beta cells are the islet cells that actually produce the insulin
which lowers blood glucose. Alpha cells produce glucagon, which increases blood glucose. A higher ratio of beta cells to alpha cells means less blood glucose.
Page 4

5. Mesoblast (MSB) 31 January 2012
8% of the world’s adult population has
diabetes
The International Diabetes Federation has recently released a new estimate of 366 million
19
adults living with diabetes globally , which would represent around 8% of the adult
population aged 20-79.
Figure 1 – High income countries with significant diabetes Figure 2 – Diabetes patient populations grew strongly between
populations 2007 and 2010 but the worst is yet to come
Current 600
Diabetics Diabetics adult Growth rate
Country now (million) 2030 (million) prevalence 2011-2030 (pa)
500
United States 23.7 29.6 10.9% 1.1%
Japan 10.7 10.2 11.2% -0.3% 400
Million patients
Germany 5.0 5.6 8.0% 0.5%
Low income
Italy 3.6 4.2 7.8% 0.9% 300
Middle income
France 3.2 3.9 7.3% 0.9%
High income
Korea, South 3.2 4.3 8.8% 1.5%
200
United Kingdom 3.1 3.6 6.8% 0.9%
100
Spain 2.8 3.9 8.1% 1.6%
Saudi Arabia 2.8 5.5 16.2% 3.5% 0
Canada 2.7 3.7 10.8% 1.5% 2007 2011 2030
SOURCE: INTERNATIONAL DIABETES FEDERATION, BELL POTTER SECURITIES SOURCE: INTERNATIONAL DIABETES FEDERATION, CIA WORLD FACTBOOK, BELL POTTER SECURITIES
Global diabetes prevalence has been rising rapidly
20
At least 8% of the Type II Diabetes has been described as a ‘public health emergency in slow motion’ as
world’s adult the increase in Western-style diet and lack of exercise drives increased prevalence globally
population had year after year. International Diabetes Federation data from the last five editions of that
diabetes in 2011 21
organisation’s Diabetes Atlas suggests that prevalence among adults aged 20-79 has
increased from 4.6% in 2000 to 8.3% in 2011. Patient numbers over that time may have
grown 8.2% pa, from 166 million to 366 million, with the current figure from IDF and recent
22
similar estimates published in The Lancet taking account of new data suggesting that
23
prevalence has previously been underestimated .
24
• The emergence of diabetes has been most noticeable in high income countries
where, using IDF data, we estimate that prevalence has risen from 8.6% to 9.5% of 20-
79 year olds in just four years, from 2007 to 2011.
• The world’s largest diabetes populations are those of India and China, with,
There are over 150 25
million diabetics in respectively, 61.3 million (8.3% of the adult population) and 90.0 million (9.3%)
India and China estimated to be diabetics. We expect that rapidly rising incomes in these countries will
alone ensure higher levels of medical expenditure directed to diabetes in the near future.
• The problem is expected to get worse. The IDF has projected a 2.2% pa increase in
diabetes patients numbers over the two decades to 2030, which would increase global
prevalence by around 1.6% of the population aged 20-79, to 9.9%. This kind of growth
19
See Diabetes "massive challenge" as cases hit 366 million by Ben Hirschler, Reuters, 13/9/2011.
20
See Increase in diabetes: ‘A public health emergency in slow motion’ by Kim Janssen, Chicago Sun-Times, 16/9/2011.
21
See www.diabetesatlas.com.
22
See Lancet. 2011 Jul 9;378(9786):99.
23
The 5th Edition of the Diabetes Atlas, which contains these new estimates, has recently been published online.
24
That is, GDP per capita greater than US$20,000. Between 2007 and 2010 the prevalence of diabetes in middle-income countries (GDP per capita $10,000-20,000) rose from 7.5% to
10.1% of 20-79 year olds, while over the same period low income countries increased prevalence from 5.0% to 7.6% of 20-79 year olds.
25
Formerly IDF had estimated 43.2 million patients or 4.5% of the adult population, with numbers derived in part from Diabetologia 2003; 46: 1190-8. In March 2010 the IDF suggested that its
figures probably underestimated diabetes in China by half.
Page 5

6. Mesoblast (MSB) 31 January 2012
will see the number of diabetics in high and middle income countries rise by two to
three times population growth.
Figure 3 – India and China’s diabetes prevalence has been
Figure 4 – 8% of adults in EU member countries are diabetic
growing strongly
14%
10%
Prevalence of diabetes in 20-79 year-olds
12%
9%
Estimated percentage of population
8% 10%
aged 20-79 with diabetes
7% 8%
6%
6%
5% India
4% China 4%
3% 2%
2%
0%
Cyprus
Slovenia
Belgium
Sweden
Latvia
Bulgaria
Lithuania
Greece
Slovakia
Portugal
France
Luxembourg
Poland
Austria
Finland
Spain
Germany
Denmark
Hungary
Czech Republic
Netherlands
Ireland
United Kingdom
Malta
Romania
Estonia
Italy
1%
0%
2000 2003 2007 2011
SOURCE: IDF SOURCE: IDF
There have been two major beneficiaries of this increased need – the insulin suppliers, and
the producers of pills that help boost pancreatic output of insulin. Together they have
created the world’s fourth largest drug class, worth US$34bn pa, and growing 15% pa in
local currency terms.
Figure 5 – The global market for anti-diabetes medications is now Figure 6 – The anti-diabetes drug class has been growing 15% pa
worth US$34bn in local currency terms and 13% in US dollar terms
40 RoW spending 14.0%
40
US spending 13.5%
35
USDbn global sales of anti-diabetes agents
35 13.0%
30 Local currency sales growth
30 (RHS) 12.5%
USDbn in sales
25 25
12.0%
20 Pills 20 11.5%
15 Insulin 11.0%
15
10 10.5%
10
5 10.0%
5
0 9.5%
2006 2007 2008 2009 2010 0 9.0%
2006 2007 2008 2009 2010
SOURCE: IMS HEALTH, BELL POTTER SECURITIES SOURCE: IMS HEALTH
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7. Mesoblast (MSB) 31 January 2012
Insulin is now a ~US$14bn business
26
The global insulin Around 27% of American diabetics currently use insulin as part of their therapy , while
market is growing possibly close to half of all diabetics become insulin-dependent within six years of
27
7% pa in volume diagnosis . Since diabetes is a chronic disease, this means many years of insulin usage
28
terms by patients . With patient numbers increasing so rapidly the global market for insulin, now
worth around US$14-15bn pa, is increasing at a 7% pa rate in volume terms and 17% pa in
value terms:
• The last five years has seen the rise of long-acting and ultra-short acting insulin
29
analogues, which improve the effectiveness of insulin therapy by providing adequate
30
basal and bolus insulin . We think these insulins are the main reason deaths from
31
diabetes are going down in the US and elsewhere . The cost for this, however, has
been 7-8% pa inflation in the price of insulin as the mix has shifted;
• We believe that the percentage of diabetics on insulin has increased by perhaps 2% of
the patient population over the last five years, driven in part by a trend towards earlier
32
initiation of insulin treatment .
The insulin market is completely dominated by three giant players:
• America’s Eli Lilly, whose Humalog short-acting insulin enjoyed US$2bn in 2010 sales;
• The French company Sanofi-Aventis best known for Lantus long acting insulin, which
33 th 34
did US$4.6bn in 2010 sales and was the world’s 15 most prescribed drug in 2010 .
35
• Denmark’s Novo-Nordisk , whose lead products are Levemir (a long acting insulin,
US$1.2bn in global sales in 2010) and NovoRapid / Novolog (ultra-short acting insulin
36
products with US$2.2bn in global sales in 2010) .
Figure 7 – Less people are dying from diabetes thanks to better Figure 8 – The insulin market has been growing at 17% pa as
insulin products patients switch to longer-acting products
76,000 16
75,000 14
Worldwide sales (USDbn)
US deaths from diabetes
74,000 12
10 Short acting, intemediate
73,000
and mixed
72,000 8 Ultra-short acting
71,000 6
Long-acting
70,000 4
69,000 2
68,000 0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2005 2006 2007 2008 2009 2010
SOURCE: CDC SOURCE: NOVO NORDISK, SANOFI-AVENTIS, ELI LILLY
26
Source: CDC, 2008 estimates. Remarkably, around 16% of American diabetics take no medications at all.
27
This was a finding of the United Kingdom Prospective Diabetes Study, where 44% of subjects on the class of diabetes drug called sulphonylureas had failed within six years. See Diabet
Med. 1998 Apr;15(4):297-303..
28
Generally Type II diabetics have the same life expectancy as the general population - see PLoS One. 2009 Aug 28;4(8):e6817. In the US average age at diagnosis is around 46 – see Ann
Fam Med. 2005 Jan-Feb;3(1):60-3 - and US life expectancy is around 78. This potentially means up to three decades of insulin usage.
29
See Arch Intern Med. 2008;168(19):2088-2094.
30
Basal insulin being the base levels required to keep blood glucose stable between meals and overnight, and bolus insulin being the extra insulin needed to cope with sudden glucose intake
at mealtimes. In the last fifteen years the insulin market has segmented, with the short-acting insulins like Humalog (insulin lispro) emerging to provide the bolus solution, and two long-acting
insulins - insulin detemir (Levemir) and insulin glargine (Lantus) – leading the basal insulin space.
31
In recent years diabetes has slipped to No 7, from No 6 previously, in the list of America’s most common causes of death.
32
See Cleve Clin J Med. 2004 May;71(5):385-6, 391-2, 394 passim.
33
It also sells Apidra, its ultra short acting insulin product that enjoyed US$200m in 2010 sales.
34
Source: IMS Health.
35
Bagsværd, Denmark, OMX: NOVO B, www.novonordisk.com.
36
The company is currently seeking US approval for Deglugec, a long acting insulin that would compete with Lantus.
Page 7