BofAML-Pomalyst is off to a strong start (31% prescribed since launch) and projected use trends are | CELG Message Board Posts

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Msg  177145 of 191966  at  4/23/2013 10:12:28 AM  by

Rob Cos

The following message was updated on 4/23/2013 10:14:42 AM.

Strong Buy

BofAML-Pomalyst is off to a strong start (31% prescribed since launch) and projected use trends are slightly accelerated compared to Kyprolis adoption patterns

  

BofA Merrill Lynch

 

Biotechnology

1Q check on hem/onc drug launches

􀂄 Conclusions from quarterly hem/onc survey

As part of our quarterly hem/onc survey series, we are publishing results from a

survey of 75 hem/oncology community practices conducted in early April to gauge

the latest adoption trends for key biotech drugs in the myeloma landscape (CELG,

Takeda, ONXX), myeloproliferative disorders (INCY), rare disorders (ALXN), and

CML (ARIA). We are increasing our ONXX sales estimates based on our survey

results; there is potential upside to estimates for CELG. Feedback on ALXN, ARIA

and INCY is consistent with steady sales growth.

ALXN: aHUS uptake positive, education still required

Our survey points to continued growth for Soliris in both PNH and aHUS as new

patients are identified. Physician knowledge about how to best use Soliris in

aHUS is limited however, underscored by the finding that 75% of physicians

believe their aHUS patients require only intermittent therapy despite bad

outcomes with treatment discontinuation in this setting.

ARIA: initial experience and long term view positive

Iclusig is preferentially used in Sprycel/ Tasigna failures, although Iclusig is

starting to see some traction in Gleevec failures as well. Iclusig penetration

remains modest, but >70% of physicians view tolerability as comparable to other

TKIs. Physicians preferentially expect to use Iclusig broadly in resistant CML (as

opposed to reserving for T315I only), and the majority envision Iclusig moving into

earlier lines of therapy over time (not true for PFE’s Bosulif).

 

CELG: Pomalyst uptake likely comparable to Kyprolis

CELG's Pomalyst is off to a strong start (31% prescribed since launch) and projected use trends are slightly accelerated compared to Kyprolis adoption patterns. In the near term, Pomalyst is expected to be used primarily in the salvage setting, consistent with newly launched drugs in this space.

 

INCY: increasing traction, education needed on titration

Jakafi adoption is steadily increasing (85% have prescribed). >80% of physicians

believe that Jakafi has at least a possible survival benefit, with approximately half

of these physicians wanting additional data. Among those convinced Jakafi has a

survival benefit, physicians plan to modestly increase Jakafi prescribing. Our

survey did not find any changes in dose titration to manage hem toxicity.

ONXX: Kyprolis not impacted by Pomalyst launch

Our survey predicts continued Q/Q Kyprolis growth with increased use in earlier

lines of therapy. >80% of physicians indicated that Pomalyst approval has had no

impact on their use of Kyprolis, and the majority of physicians use Kyprolis before

Pomalyst. Kyprolis cardiac/pulmonary safety is viewed comparably to Velcade.

Industry Overview

 

Quarterly hem/onc survey findings:

ALXN: Soliris to continue to grow from

new patient adds, more education

required on how to use Soliris in aHUS

ARIA: initial Iclusig impressions positive

on safety and efficacy, use to steadily

increase

CELG: no major changes in Revlimid use,

initial demand for Pomalyst strong

INCY: expect continued steady increases

in Jakafi use; survival data gaining

traction, more mature data should drive

further increases in use

ONXX: Kyprolis trends point to continued

growth despite Pomalyst launch, infusion

schedule remains biggest complaint,

Background on the survey

􀂄 All 75 physicians were board certified in hematology oncology and have an

average of 879 patients under care. Our survey covers a total of 66K patients

under care.

􀂄 Of disease types that we polled, multiple myeloma was the most frequent

(5%), followed by CML, polycythemia vera, and myelofibrosis. As expected

PNH and aHUS patients represent ultra rare conditions (<1% of practices).

􀂄 This is the fifth in our quarterly series of hem/onc surveys. In order to monitor

trends closely, we aim to have a high proportion of the same physicians from

quarter to quarter.

􀂄 Overall, our surveys underscore that physicians project more optimistic use

of new drugs than what they actually prescribe. When comparing surveys,

observe the downward trend of projected use vs. actual.

 

Multiple myeloma: CELG’s Revlimid and

Pomalyst, Takeda’s Velcade, ONXX’s Kyprolis

Revlimid expansion plateaued, Kyprolis is on the map

We asked physicians about current and future anticipated Revlimid, Velcade and

Kyprolis use as 1) induction therapy ahead of transplant; 2) maintenance therapy

following transplant; and 3) initial therapy in patients ineligible for transplant:

􀂄 Revlimid penetration remains high in the post transplant maintenance setting:

65% for Revlimid alone and 70% overall when accounting for a modest amount

of combo use with Velcade or Kyprolis. Physicians predict no real expansion in

Revlimid use over the next 12 months in this setting, and penetration is not

meaningfully different from our December and September surveys.

􀂄 The survey also indicates that 13% of patients do not receive any myeloma

drugs in the maintenance setting, consistent with our December survey.

􀂄 Revlimid penetration in newly diagnosed transplant ineligible patients is 64%,

with 27% (absolute) of use in combination with Velcade or Kyprolis. No

expansion in Revlimid use is expected in this setting over the next 12

months.

􀂄 Kyprolis use in the front line and maintenance settings is limited (2% alone

and 4-6% in combo with Revlimid), but is expected to increase modestly to 6-

10% in total over the next 12 months, primarily at the expense of Velcade.

W

 

Kyprolis adoption projected to increase

􀂄 Following the late July 2012 FDA approval of Kyprolis, 73% of physicians

had prescribed Kyprolis by late March, up from 62% in December and 37% in

our Sept survey. 88% physicians project they will have used Kyprolis by year

end 2013.

􀂄 Our survey points to 1.5x more new patients starts in 1Q13 vs. 4Q12 (139 vs.

91), with strong continued increases in new starts over the next nine months

(250 pts anticipated in 4Q13). However, increases in 2Q13 new starts are

expected to be relatively modest relative to1Q13 (+7%). A more reliable

indicator of demand, projected demand from current users, similarly shows

flat 2Q starts. Current users project ~23% growth in new starts in each of 3Q

and 4Q.

􀂄 Physicians in our survey anticipate an average of 2.6, 3.3 and 3.8 patients

per practice in the next three quarters.

 

Kyprolis moving into earlier lines of therapy

Almost two thirds of Kyprolis use is in patients who have received at least three

prior therapies (64%), with the remainder primarily in patients with 1-2 prior

therapies (33%). This use in earlier lines of therapy represents an increase from

26% in our December survey. Projected use in patients receiving 1-2 prior

therapies is expected to grow modestly over the next 12 months. We expect

ASPIRE data to meaningfully increase share in this population (est. 4Q13

topline).

Kyprolis administration patterns: mostly on label

We asked physicians a series of questions on Kyprolis administration and found

that the majority of current use is according to the label. However, some

physicians are already using Kyprolis off label, consistent with the feedback we

received in our prior surveys. Key points include:

􀂄 23% of Kyprolis use is weekly (vs. Labeled 2x/week = 77%), which is an

increase from 15% in our December survey. We expect weekly use to

increase, especially following important dosing data available possibly at

ASH 2013.

􀂄 87% of use is at the labeled 27mg/m2 dose (vs. >27mg/m2 dose = 13%),

consistent with our December survey.

􀂄 A quarter of Kyprolis use is in combination with another myeloma drug,

typically dexamethasone. Combination use should make the overall regimen

more effective, and therefore has the potential to increase duration of

therapy.

Kyprolis better vs. Velcade on tolerability despite subQ

We asked physicians how they rate their experience with Kyprolis relative to

Velcade on several factors including infusion schedule, cardiac/pulmonary

toxicity, peripheral neuropathy, reimbursement, and response to therapy. We

think the comparable scores on safety are particularly noteworthy given the FDA's

attention to Kyprolis on cardiac/pulmonary safety. Infusion schedule remains a

negative for Kyprolis, which we expect to be alleviated with weekly dosing data.

Peripheral neuropathy remains a big positive for Kyprolis; this is noteworthy

considering the majority of the market has switched to subQ Velcade, which is

associated with lower rates of severe peripheral neuropathy.

Dyspnea a concern, but not limiting uptake

We asked physicians how dyspnea associated with Kyprolis impacts their outlook

for use in their practices. Only a small minority of physicians indicated that they

are significantly concerned with the side effect and would not expand their use

(no physicians plan to reduce use). Almost 90% of physicians plan to increase

use of Kyprolis, although 65% did indicate their concern with the potential side

effect. Approximately a quarter of respondents indicated that this will not impact

their usage negatively at all.

Pomalyst off to a strong start

􀂄 Following its recent approval in February, 31% of physicians had already prescribed CELG's Pomalyst by the end of March. By the end of 2Q13, two thirds (67%) of physicians expect to prescribe Pomalyst to at least one patient, and 85% plan to prescribe it by the end of 2013. This trend in projected use is similar to, but slightly accelerated compared to Kyprolis adoption patterns (73% after three quarters on the market).

􀂄 Overall, physicians anticipate the split of Kyprolis and Pomalyst new patient starts at 55%/45%, respectively, at the end of 2013 (similar ratios in each upcoming Q of 2013). Current prescribers of Pomalyst do not project a significantly different usage pattern, though are closer to parity in use (52%/48%).

􀂄 New patient starts for both drugs are expected to increase Q/Q in the next nine months.

Pomalyst use further back in treatment

Physicians anticipate that most of Pomalyst use will be in patients with at least three prior lines of therapy (70%), with an even higher weighting in this setting from physicians who have actually prescribed Pomalyst (81%). This feedback is consistent with Pomalyst's more recent market entry (physicians tend to place the

newest drugs as last line of therapy). We expect Pomalyst to make its way into earlier lines of therapy after physicians gain more experience.

 

Minimal impact of Pomalyst on Kyprolis so far

We asked physicians how recent FDA approval of CELG’s Pomalyst might impact their use of Kyprolis relative to the last 6 months. The vast majority of respondents (84%) indicated that Pomalyst approval has had no impact on their use of Kyprolis. This feedback is in direct contrast to our December survey, in which nearly half of physicians projected a decrease in their Kyprolis use in early 2013 when Pomalyst was expected to become available.

􀂄 Slightly less than a third of physicians expect to use Pomalyst before prescribing Kyprolis. The majority of physicians anticipate Pomalyst use after Kyprolis (58%) or expect to use the drugs in combination (11%). Interestingly, these responses are almost identical for the 25% of physicians who have used both drugs. These sentiments are generally consistent with our December survey, although then a slightly higher percentage of physicians (37%) had predicted Pomalyst use ahead of Kyprolis.

 

􀂄 64% of physicians expect to use Pomalyst ahead of Thalomid, which is an increase from 59% in our December survey. We remind investors that Thalomid is currently being pushed further down the line of therapies and CELG had already pulled any marketing support for the drug before its launch of Pomalyst.

 

Myelofibrosis: INCY’s Jakafi

Steadily increasing Jakafi adoption

􀂄 85% of physicians in our survey have prescribed Jakafi to new patients in the

last 9 months. In our prior surveys, 74% of physicians had Jakafi experience

in December and 68% in September, showing incremental market expansion

driven by new prescribers.

􀂄 The average number of new patients started in 1Q13 increased to 1.7,

consistent with INCY’s expectation of 1-2 patients per physician; the average

number in 4Q12 and 3Q12 was 1.4 and 1.1 respectively.

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22 April 2013

9

􀂄 Our survey projects a decline in new patient starts in 2Q13 vs.1Q13 (1.5 vs.

1.7). That said, we are cautious to call it a real indicator of demand for the

quarter because in the series of our surveys over the past year, we have

noticed that, more often than not, physicians projected no increase or decline

in new starts for any upcoming quarter (see Kyprolis and Jakafi), suggesting

a survey artifact. New patient starts are projected to increase in each

subsequent quarter by 20-30% (3Q13 and 4Q13). We maintain our quarterly

estimates for Jakafi where we model steady Q/Q new patient starts

consistent with management’s expectation for continued steady demand.

􀂄 Analyzing the subset of current prescribers, new patient starts are similarly

expected to decline slightly in 2Q13, and then pick up in 3Q13 and 4Q13.

􀂄 Overall penetration into current/future prescribers practices is expected to

increase from 28% in 1Q13 to 68% by the end of 2013.

Chart 13: Jakafi reported and projected new patient starts

0

50

100

150

200

4Q11 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13

Jun-12 Sep-12 Dec-12 Mar-13

Source: BofAML Global Research.

Chart 14: Jakafi penetration of MF practice, reported and projected

0%

20%

40%

60%

80%

4Q11 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13

Jun-12 Sep-12 Dec-12 Mar-13

Source: BofAML Global Research.

Titration concept – continued education needed

Thrombocytopenia and anemia are the two key side effects that lead to Jakafi

discontinuations. INCY indicated that it is focused on educating physicians on

titration strategies to prevent dropouts. We asked physicians what their typical

response has been to one or the other side effect in the past 6 months and what

they expect it to be in the next 6 months to get a sense for the impact of INCY’s

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10

educational campaign. Approximately half of physicians typically interrupt dosing

and restart at a lower dose, the rest are split fairly evenly among discontinuing

treatment, introducing transfusions or just unsure. Interestingly, physicians do not

expect their strategy to change in a significant way in the next 6 months. Also, the

responses are similar for thrombocytopenia and anemia, whereas INCY noted

previously that it feels that there is a much better understanding of

thrombocytopenia, with anemia remaining its educational focus area. Results

from the survey do not provide a strong consensus view on how to handle these

side effects, but it points to the need for further education by the company.

Chart 15: Physicians’ response to thrombocytopenia in the past/next 6 months

0%

20%

40%

60%

Discontinue treatment Interrupt dosing,

restart at lower dose

Maintain dose,

administer red cell

transfusion

Unsure

past 6 months next 6 months

Source: BofAML Global Research

Chart 16: Physicians’ response to anemia in the past/next 6 months

0%

10%

20%

30%

40%

50%

Discontinue treatment Interrupt dosing,

restart at lower dose

Maintain dose,

administer red cell

transfusion

Unsure

past 6 months next 6 months

Source: BofAML Global Research

Discontinuation trends similar to prior surveys

Discontinuations early in the launch have been an issue that dampened the Jakafi

sales outlook. Dropouts were primarily attributed to lack of response and disease

progression (~25%), similar to our prior surveys. Only 14% of physicians reported

hematologic toxicity and 11% reported non hematologic toxicity as the main

reasons for Jakafi discontinuations.

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11

Chart 17: Reasons for Jakafi discontinuations

0%

5%

10%

15%

20%

25%

30%

Lack of

response

Hem tox Non-hem tox Disease

progression

Other* N/A - I hav e not

had any Jakafi

discontinuations.

* Other attributed to non compliance and move to transplant.

Source: BofAML Global Research

Survival benefit data – positive impact longer term

We asked physicians for their view on the most recent survival data for Jakafi,

presented at the American Society of Hematology 2012 meeting. We also asked

if the survival data would impact physicians’ use of Jakafi in 2013 relative to 2012.

Our overall conclusions are similar to the ones from the December survey: 1) an

inflection point is unlikely in the near term, but sales should track higher; 2) it may

be well into 2014 before we observe a noticeable shift in attitude towards these

data; 3) more data will be important to solidify a survival benefit in physicians’

minds.

􀂄 Only a minority of physicians (11%) are outright unconvinced by the survival

benefit and another 7% are unfamiliar with the data.

􀂄 17% of physicians believe that Jakafi has a convincing survival benefit in

intermediate and high risk MF patients.

􀂄 A quarter of physicians believe that Jakafi has a survival benefit high risk MF

patients only.

􀂄 40% of physicians are on the fence and would like more mature data.

􀂄 Encouragingly, half of physicians expect the data will lead them to modestly

increase the use of Jakafi in 2013 vs. 2012.

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Chart 18: View on the most recent survival data for Jakafi

0%

10%

20%

30%

40%

50%

Unconv incing

benefit

Possible benefit,

need more

mature data

Conv incing,

believ e that

Jakafi imparts

surv iv al benefit,

but only for high

risk MF

Conv incing,

believ e that

Jakafi imparts

surv iv al benefit

to intermediate

and high risk MF

Unfamiliar w ith

data

Source: BofAML Global Research.

Chronic myeloid leukemia (CML)

No surprises in front line CML dynamics

We asked physicians about their current and anticipated CML prescribing habits

across lines of therapy. Key findings include:

􀂄 Novartis’ Gleevec remains the number one prescribed drug in newly

diagnosed CML with 43% share, consistent with our December survey. Over

the next 12 months, physicians expect to marginally decrease their usage of

Gleevec (38%) in favor of newer drugs, primarily Iclusig.

􀂄 Sprycel and Tasigna split almost the entire remaining frontline market, with

Sprycel capturing a touch more share (28% Sprycel vs. 25% Tasigna),

although our December survey showed Tasigna with a slight edge. This

suggests lack of any strong preference for one over the other. We note that

these trends are consistent with IMS data that also shows roughly equal

prescription volumes for both Sprycel and Tasigna.

Chart 19: Impact of survival data on 2013 use vs. 2012 use

0%

10%

20%

30%

40%

50%

60%

Significantly

increase

use

Modestly

increase

use

No impact Modestly

decrease

use

Significantly

decrease

use

Unfamiliar

with data

Source: BofAML Global Research.

Chart 20: Impact of survival data on 2013 use vs. 2012 for physicians

who indicated they are convinced by the data

0%

10%

20%

30%

40%

50%

60%

70%

Significantly

increase

use

Modestly

increase

use

No impact Modestly

decrease

use

Significantly

decrease

use

Unfamiliar

with data

Source: BofAML Global Research.

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Chart 21: Prescription trends in the newly diagnosed CML market

0%

10%

20%

30%

40%

50%

Current In 12 months

Gleev ec Spry cel Tasigna Bosulif Iclusig

Source: BofAML Global Research.

Sprycel/Tasigna tie in Gleevec failures, room for new drugs

Physicians indicated that 18% of their CML patients covered in our survey fail

Gleevec frontline therapy and require a new therapy annually. We asked

physicians about their current and future prescribing habits in the second and

third line treatment settings:

􀂄 Sprycel appears to be the preferred option in Gleevec failures (47% share),

followed by Tasigna with 41% market share. However, as with response

trends in the frontline setting, our December survey indicated the opposite

share relationship, though with a similarly small margin between the two; this

further highlights the relative parity in use between both drugs. Together,

second generation TKIs capture 89% of the second line CML market, which

is consistent with our December survey.

􀂄 In the next 12 months, Sprycel and Tasigna are expected to lose some share

to newly approved drugs, Bosulif and Iclusig (11% today to 22% in 12

months). We expect physicians to continue to prefer second generation

TKIs in Gleevec failures given the long experience physicians have with

those drugs.

Chart 22: Prescription trends in Gleevec failures

0%

10%

20%

30%

40%

50%

Current In 12 months

Spry cel Tasigna Bosulif Iclusig

Source: BofAML Global Research

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Salvage setting: Iclusig gaining share

􀂄 Currently, only 35% of Sprycel/Tasigna failures are being prescribed the

other drug (Tasigna/Sprycel). This is a notable decrease from 50% in our

December survey. Physicians predict further declines in market share of

these two drugs in this setting (28% share in the next 12 months), primarily in

favor of Iclusig.

􀂄 Iclusig holds 30% of the salvage market and appears to have gained share

faster than our December survey predicted. Share gains over the next 12

months are expected to slow and physicians project Iclusig use in 36% of

patients in this setting.

􀂄 Noteworthy is that while PFE’s Bosulif currently holds a quarter of the

salvage market, physicians do not project increased Bosulif gains in the next

12 months. Nonetheless, this trend is worth watching considering Bosulif

market share is not meaningfully different from Iclusig's.

􀂄 Gleevec share is 11% in the salvage setting, and expected to stay flat over

the next 12 months.

Chart 23: Prescription trends in Sprycel/Tasigna failures

0%

10%

20%

30%

40%

Current In 12 months

Spricel/Tasigna switch from prior Gleev ec Bosulif Iclusig

Source: BofAML Global Research.

Still early days for Iclusig and Bosulif

To date, only 31% and 24% of physicians in our survey have prescribed Iclusig

and Bosulif, respectively. These physicians have prescribed Iclusig and Bosulif to

4% and 3% of their patients, respectively, suggesting physicians have limited

experience with either drug. Use is expected to steadily increase, with physicians

projecting Iclusig and Bosulif use in 7% and 5% of their patients, respectively.

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15

Chart 24: % of physicians that have prescribed Iclusig/Bosulif to date

0%

5%

10%

15%

20%

25%

30%

35%

Iclusig Bosulif

Source: BofAML Global Research.

Chart 25: % of patients that have been prescribed Iclusig/Bosulif

0%

1%

2%

3%

4%

5%

Iclusig Bosulif

Source: BofAML Global Research.

Chart 26: % of patients expected to be prescribed Iclusig

0%

1%

2%

3%

4%

5%

6%

7%

Apr - Jun '13 Jul - Sep '13 Oct - Dec '13

Source: BofAML Global Research.

Chart 27: % of patients expected to be prescribed Bosulif

0%

1%

2%

3%

4%

5%

6%

7%

Apr - Jun '13 Jul - Sep '13 Oct - Dec '13

Source: BofAML Global Research.

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16

Initial Iclusig/Bosulif impressions

We asked physicians what best describes their view of Iclusig and Bosulif. Almost

half (48%) of physicians plan to use Iclusig broadly in 2nd gen TKI resistant

patients. Nearly one third of physicians plan to reserve Iclusig for patients with the

T315I mutation, but notably 15% answered the same for Bosulif, indicating a

limited knowledge base about Bosulif's resistance profile and/or suggesting

continued confusion between the two drugs. We did find it noteworthy that 44% of

physicians were unsure about how to use Bosulif, nearly double that of Iclusig.

Chart 28: Physician view of scope of treatment for Iclusig and Bosulif

0%

10%

20%

30%

40%

50%

60%

I anticipate using this in

broad Spry cel/Tasigna

resistant CML patients.

I w ill reserv e use for T315I

patients.

Not sure

Iclusig Bosulif

Source: BofAML Global Research.

Iclusig and Bosulif tolerability comparable to other TKIs

We polled physicians regarding the tolerability profile of Iclusig and Bosulif

relative to other TKIs (Gleevec, Sprycel and Tasigna). 73% and 78% of

physicians who have used Iclusig and Bosulif, respectively, believe that both

drugs have tolerability profiles that are at least as comparable to, or better than,

the other TKIs, which is a positive signal for future uptake of both drugs.

􀂄 Half of responding physicians indicated that they believe that the tolerability

profiles of both Iclusig and Bosulif are comparable to the other TKIs.

􀂄 Approximately the same percentage of physicians believe that both the

newest drugs have superior tolerability profiles to the other TKIs, though

Bosulif has a slight edge over Iclusig (28% vs. 23%).

􀂄 6-10% of physicians are not yet familiar enough with both drugs to

characterize tolerability as yet.

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Chart 29: Tolerability profile relative to other TKIs (Gleevec, Sprycel and Tasigna)

0%

10%

20%

30%

40%

50%

60%

Better tolerated Comparable Less w ell tolerated Not enough

ex perience to know

Iclusig Bosulif

Source: BofAML Global Research.

Iclusig more likely to move up lines of therapy than Bosulif

We asked physicians how they envisioned using Iclusig and Bosulif in the future,

after more clinical data is available and with more experience using these drugs.

Iclusig is clearly differentiated here, with 60% of physicians indicating that they

expect Iclusig to move up from the salvage setting vs. 40% of physicians

indicating the same for Bosulif. This is the most meaningful point of difference

between the two drugs as of now, with significant implications for future market

potential of both. With the caveat that ~25-30% of physicians still don’t have

enough experience to gauge future use:

􀂄 Almost a quarter of physicians (23%) believe that Iclusig has the potential to

be the best frontline therapy for CML. Only 12% of physicians believe the

same is true for Bosulif.

􀂄 37% of physicians believe that Iclusig is likely to move up the lines of therapy

short of being a frontline option; 28% of physicians believe the same is true

for Bosulif.

􀂄 15% of physicians believe that Iclusig is likely to remain a salvage therapy,

while almost twice the number of physicians believe the same is true for

Bosulif (28%).

Chart 30: Potential of Iclusig and Bosulif with more clinical data and experience

0%

10%

20%

30%

40%

Has the potential to

be the best front line

TKI for CML.

Will likely mov e into

earlier lines of CML

therapy but unlikely

to be front-line.

Will likely alway s be

a salv age treatment.

Not sure

Iclusig Bosulif

Source: BofAML Global Research.

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Rare disease: ALXN’s Soliris in PNH &

aHUS

PNH remains growth area for Soliris

According to our latest survey, physicians have 28% of their PNH patients on

ALXN’s Soliris. 65% of physicians have at least one PNH patient, and 80% of

physicians with a PNH patient are using Soliris. Physicians expect to increase

Soliris use in PNH to 38% of patients over the next twelve months, suggesting

continued potential for Soliris to grow in 2013.

Chart 31: % of patients on Soliris for PNH and aHUS

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Mar '12 Jun '12 Sep '12 Dec '12 Mar '13 Sep '12

+ 12

mos

Dec '12

+ 12

mos

Mar '13

+ 12

mos

Current 12 months later

PNH aHUS

Source: BofAML Global Research.

aHUS uptake positive, but more education required

Physicians have a weighted average of 16% of their aHUS patients on ALXN’s

Soliris, only half of what we noted in our last survey in December (32%), and

consistent with the prior survey in June (17%). However, physicians anticipate

increasing Soliris use to 43% in the next 12 months. We note that the results are

driven by extremely small patient numbers, so we caution against over

interpreting responses quantitatively, but the trends point towards continued

Soliris adoption in aHUS. Nearly half of physicians report having a patient with

aHUS. We expect this number to grow over time as physicians learn how to

better diagnose aHUS.

We asked physicians that have treated patients with Soliris for aHUS (21% of all

docs in our survey) some specific questions around their use of the drug. All

questions were binary, requiring either “Agree” or “Disagree” responses:

􀂄 Almost 90% of physicians agree that first time aHUS patients treated with

Soliris are in the hospital.

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Biotechnology

22 April 2013

19

􀂄 Less than half of physicians (44%) believe that the occurrence of diarrhea at

presentation of TMA symptoms rules out the use of Soliris. We are not

surprised there is confusion on this point, and believe a STEC-HUS label for

Soliris will help physicians prescribe Soliris even in the presence of diarrhea.

􀂄 Physicians are generally split (56% agree/44% disagree) on whether aHUS

can be diagnosed on the basis of platelet count metrics, avoiding an

ADMS13 test. This further highlights, in our view, confusion around the actual

diagnosis of aHUS which is the primary gating factor in the use of Soliris by

physicians.

􀂄 The vast majority (75%) of physicians believe their aHUS patients require

only intermittent Soliris therapy vs. chronic treatment. We were most

surprised by this finding considering the extremely bad outcomes in aHUS

patients who have discontinued Soliris treatment by physicians who thought

that intermittent therapy would be sufficient treatment.



 
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