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8-K - FORM 8-K - QUESTCOR PHARMACEUTICALS INC | d367854d8k.htm |
EX-99.3 - TRANSCRIPT OF CONFERENCE CALL - QUESTCOR PHARMACEUTICALS INC | d367854dex993.htm |
EX-99.1 - PRESS RELEASE - QUESTCOR PHARMACEUTICALS INC | d367854dex991.htm |
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NASDAQ:
QCOR
NASDAQ:
QCOR
June 14, 2012
Investor Update
Rheumatology
June 14, 2012
Investor Update
Rheumatology
Exhibit 99.2 |
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Safe Harbor Statement
Note: Except for the historical information contained herein, this press release contains
forward-looking statements that have been made pursuant to the Private Securities
Litigation Reform Act of 1995. These statements relate to future events or our future
financial performance. In some cases, you can identify forward-looking statements by terminology such as "believes,"
"continue," "could," "estimates," "expects," "growth,"
"may," "plans," "potential," "should," "substantial" or "will" or the
negative of such terms and other comparable terminology. These statements are only predictions.
Actual events or results may differ materially. Factors that could cause or contribute to
such differences include, but are not limited to, the following: Our reliance on Acthar
for substantially all of our net sales and profits; Reductions in vials used per prescription resulting from
changes in treatment regimens by physicians or patient compliance with physician
recommendations; The complex nature of our manufacturing process and the potential for
supply disruptions or other business disruptions; The lack of patent protection for
Acthar; and the possible FDA approval and market introduction of competitive products; Our ability to continue to generate
revenue from sales of Acthar to treat on-label indications associated with NS, and our
ability to develop other therapeutic uses for Acthar; Research and development risks,
including risks associated with Questcor's work in the area of NS and potential work in
the area of Rheumatology, and our reliance on third-parties to conduct research and development and the ability of
research and development to generate successful results; Our ability to comply with federal and
state regulations, including regulations relating to pharmaceutical sales and marketing
practices; Regulatory changes or other policy actions by governmental authorities and
other third parties in connection with U.S. health care reform or efforts to reduce federal and
state government deficits; Our ability to receive high reimbursement levels from third party
payers; An increase in the proportion of our Acthar unit sales comprised of
Medicaid-eligible patients and government entities; Our ability to estimate reserves
required for Acthar used by government entities and Medicaid-eligible patients and the impact that unforeseen
invoicing of historical Medicaid prescriptions may have upon our results; Our ability to
effectively manage our growth, including the expansion of our sales force, and our
reliance on key personnel; The impact to our business caused by economic conditions; Our
ability to protect our proprietary rights; The risk of product liability lawsuits; Unforeseen business interruptions and
security breaches; Volatility in Questcor's monthly and quarterly Acthar shipments, estimated
channel inventory and end-user demand, as well as volatility in our stock price; and
Other risks discussed in Questcor's annual report on Form 10-K for the year ended
December 31, 2011 as filed with the Securities and Exchange Commission, or SEC, on February 22, 2012, and other
documents filed with the SEC.
The risk factors and other information contained in these documents should be considered in
evaluating Questcor's prospects and future financial performance.
|
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Acthar Has Multiple Approved , On-Label
Rheumatology-Related Indications
Note: This presentation is intended for investors; not healthcare
providers. The full Acthar PI is available at
http://www.acthar.com/files/Acthar-PI.pfd.
Rheumatology-Related Indications in Acthar PI
As adjunctive therapy for short-term administration (to
tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis, Rheumatoid arthritis, including juvenile
rheumatoid arthritis (selected cases may require low-dose
maintenance therapy), Ankylosing spondylitis.
During an exacerbation or as maintenance therapy in
selected cases of: systemic lupus erythematosus, systemic
dermatomyositis (polymyositis). |
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Rheumatology: Estimated Patient Populations*
Indication
Total Estimated
US Population
Estimated Target
Acthar Population
Dermatomyositis/Polymyositis
66K
~26K
Systemic Lupus Erythematosus
250K
~50K-100K
Rheumatoid Arthritis
1.3M
~50K
Psoriatic Arthritis
500K
~40K
Juvenile Rheumatoid Arthritis
300K
-
Ankylosing Spondylitis
500K
-
*Questcor estimates |
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Dermatomyositis (DM) and Polymyositis (PM)
Disease State Overview and Brief Summary of
Treatment Experience with Acthar
Todd Levine, M.D.
Phoenix Neurological Associates
Director of the ALS Clinic and Co-Director of Neurophysiology at Banner Good
Samaritan Medical Center
Assistant Professor of Neurology at the University of Arizona
Member of The Myositis Association Medical Advisory Board
Dermatomyositis (DM) and Polymyositis (PM)
Dermatomyositis (DM) and Polymyositis (PM)
Disease State Overview and Brief Summary of
Disease State Overview and Brief Summary of
Treatment Experience with Acthar
Treatment Experience with Acthar
Todd Levine, M.D.
Todd Levine, M.D.
Phoenix Neurological Associates
Phoenix Neurological Associates
Director of the ALS Clinic and Co-Director of Neurophysiology at Banner Good
Director of the ALS Clinic and Co-Director of Neurophysiology at Banner Good
Samaritan Medical Center
Samaritan Medical Center
Assistant Professor of Neurology at the University of Arizona
Assistant Professor of Neurology at the University of Arizona
Member of The Myositis Association Medical Advisory Board
Member of The Myositis Association Medical Advisory Board |
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Dermatomyositis and Polymyositis: Serious
Autoimmune Disorders
Rare neuromuscular conditions; high unmet need
Both involve autoimmune inflammatory myopathies
(inflammation of muscle)
DM also characterized by skin manifestations
Treated by both Rheumatologists and Neurologists
Begins as insidious proximal muscle weakness that grows in
severity and can involve other organs, including lungs
Muscle weakness can progress to where patients require ambulation assistance,
such as a walker or wheelchair
Can cause sustained disability, diminished QoL, even death
Rare neuromuscular conditions; high unmet need
Both involve autoimmune inflammatory myopathies
(inflammation of muscle)
DM also characterized by skin manifestations
Treated by both Rheumatologists and Neurologists
Begins as insidious proximal muscle weakness that grows in
severity and can involve other organs, including lungs
Muscle weakness can progress to where patients require ambulation assistance,
such as a walker or wheelchair
Can cause sustained disability, diminished QoL, even death |
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DM/PM Patients Underserved By Current
Therapies
Current treatments include steroids, immunosuppressants,
IVIG, rituximab
Only Acthar and steroids are FDA-approved in the treatment of DM/PM
Many patients do not respond to, or are unable to tolerate,
corticosteroids and immunosuppressant therapy
IVIG and Rituxan are used off-label to treat resistant cases
There are no studies comparing any two therapies in DM/PM
Current treatments include steroids, immunosuppressants,
IVIG, rituximab
Only Acthar and steroids are FDA-approved in the treatment of DM/PM
Many patients do not respond to, or are unable to tolerate,
corticosteroids and immunosuppressant therapy
IVIG and Rituxan are used off-label to treat resistant cases
There are no studies comparing any two therapies in DM/PM |
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Report of 5 cases of refractory DM and PM treated with Acthar
recently published in Drug Development, Design and Therapy
All patients had been unresponsive and/or unable to tolerate a
variety of current therapies used to treat DM and PM
All had biopsy-confirmed DM or PM
Concomitant therapies were kept stable for 60 days prior to Acthar administration
Manual muscle strength testing (MMT) was performed at baseline and 3 months
Patients were dosed with 80U of Acthar 1-2 times per week for a
period of 12 weeks or more
4 patients were dosed 2x per week and 1 patient was dosed 1x per
week
2 patients have remained on therapy beyond 12 weeks: 1 for 8 months and another
for 4 months; both are on ongoing Acthar therapy
Report of 5 cases of refractory DM and PM treated with Acthar
recently published in Drug Development, Design and Therapy
All patients had been unresponsive and/or unable to tolerate a
variety of current therapies used to treat DM and PM
All had biopsy-confirmed DM or PM
Concomitant therapies were kept stable for 60 days prior to Acthar administration
Manual muscle strength testing (MMT) was performed at baseline and 3 months
Patients were dosed with 80U of Acthar 1-2 times per week for a
period of 12 weeks or more
4 patients were dosed 2x per week and 1 patient was dosed 1x per
week
2 patients have remained on therapy beyond 12 weeks: 1 for 8 months and another
for 4 months; both are on ongoing Acthar therapy
Acthar Treatment in DM and PM:
Patient Types and Dosing |
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All patients experienced clinically significant improvement
Muscle strength improved in all 5 patients
Skin manifestations improved in all 3 DM patients
All patients reported improvements with daily living activities
3
patients
who
previously
required
assisted
ambulation
were
able
to
ambulate
independently
1 patient who was previously unable to work was able to return to work
No significant Acthar side effects observed in these patients
Positive insurance coverage on this initial cohort of patients
All patients experienced clinically significant improvement
Muscle strength improved in all 5 patients
Skin manifestations improved in all 3 DM patients
All patients reported improvements with daily living activities
3
patients
who
previously
required
assisted
ambulation
were
able
to
ambulate
independently
1 patient who was previously unable to work was able to return to work
No significant Acthar side effects observed in these patients
Positive insurance coverage on this initial cohort of patients
Acthar Treatment in DM and PM:
Overall Observed Results (n=5)
Note: Since this is a small case series of only 5 patients, it may
not be fully representative of efficacy or safety in the DM/PM
population. |
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Treatment history after Dx included prednisone,
mycophenolate, azathioprine, IVIG, cyclosporine, and
methotrexate
Began treating patient in 2004
Positive response to rituximab, cyclosporine, and IVIG
Maintained on IVIG and cyclosporine until a relapse in 2006
Patient then showed brief improvement with azathioprine,
cyclosporine, IVIG
In 2007, patients strength worsened and an MRI scan of the patients legs showed
active inflammation
Patient was rechallenged with rituximab but did not show any improvement
Treatment history after Dx included prednisone,
mycophenolate, azathioprine, IVIG, cyclosporine, and
methotrexate
Began treating patient in 2004
Positive response to rituximab, cyclosporine, and IVIG
Maintained on IVIG and cyclosporine until a relapse in 2006
Patient then showed brief improvement with azathioprine,
cyclosporine, IVIG
In 2007, patients strength worsened and an MRI scan of the patients legs showed
active inflammation
Patient was rechallenged with rituximab but did not show any improvement
DM Patient Example: History |
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Patient received Acthar 80 U 2x/wk for 12 weeks (no titration)
Concomitant medication: IVIG 2 gm/kg/mo and azathioprine 200 mg/day
Patient tolerated Acthar treatment well with no significant side
effects
Positive response to Acthar treatment
Muscle enzymes returned to normal (800
100)
MMT strength improved from 3/5 to 4+/5 in upper extremity muscle
groups, her
iliopsoas from 3/5 to 4/5, and quadriceps from 3-/5 to 4+/5
Patient received Acthar 80 U 2x/wk for 12 weeks (no titration)
Concomitant medication: IVIG 2 gm/kg/mo and azathioprine 200 mg/day
Patient tolerated Acthar treatment well with no significant side
effects
Positive response to Acthar treatment
Muscle enzymes returned to normal (800
100)
MMT strength improved from 3/5 to 4+/5 in upper extremity muscle
groups, her
iliopsoas from 3/5 to 4/5, and quadriceps from 3-/5 to 4+/5
DM Patient Example: Initial Acthar Treatment |
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~6 months after completing Acthar treatment the patient
experienced increased weakness in proximal leg muscles (3+/5)
Patient then given tacrolimus for 6 months with no results
Patient then began a second course of treatment with Acthar
Dosed 80 U 1x per week
Patient noted the treatment response was not as good as previous
treatment with
Acthar 80 units 2x per week
Dosing changed to 2x per week and patient noted improvement
Leg muscles improved to 4+/5
No adverse events reported
Returned to work and is ambulating independently
Has continued on Acthar for 8 months
~6 months after completing Acthar treatment the patient
experienced increased weakness in proximal leg muscles (3+/5)
Patient then given tacrolimus for 6 months with no results
Patient then began a second course of treatment with Acthar
Dosed 80 U 1x per week
Patient noted the treatment response was not as good as previous
treatment with
Acthar 80 units 2x per week
Dosing changed to 2x per week and patient noted improvement
Leg muscles improved to 4+/5
No adverse events reported
Returned to work and is ambulating independently
Has continued on Acthar for 8 months
DM Patient Example: Follow-Up Acthar Treatment |
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DM/PM Commercial Opportunity
Steve Cartt
Chief Operating Officer
DM/PM Commercial Opportunity
Steve Cartt
Chief Operating Officer |
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DM/PM Represents Significant Commercial
Opportunity Due to High Unmet Need
~66,000 DM/PM patients in the US, based upon key
epidemiological study which found a prevalence rate of 21.5
cases per 100,000 population (Bernatsky 2009)
Estimate supported by Questcor survey of treating physicians (N=192)
Approximately 26,000 are target Acthar patients
~40% of patients experience active disease, significant side effects or both with
current therapies (Questcor survey, N=192)
Typical dosing regimen of 80U 2x per week for 12 weeks
5 vials of Acthar required for this typical
regimen
Some patients require a longer treatment regimen
~66,000 DM/PM patients in the US, based upon key
epidemiological study which found a prevalence rate of 21.5
cases per 100,000 population (Bernatsky 2009)
Estimate supported by Questcor survey of treating physicians (N=192)
Approximately 26,000 are target Acthar patients
~40% of patients experience active disease, significant side effects or both with
current therapies (Questcor survey, N=192)
Typical dosing regimen of 80U 2x per week for 12 weeks
5 vials of Acthar required for this typical
regimen
Some patients require a longer treatment regimen |
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Questcor Rheumatology Plans
Pilot rheumatology selling effort beginning mid-July
National Sales Director and manager positions (2) have been filled, with
hiring/training of 12 experienced Rheum reps in progress
Initial promotional effort focused on DM/PM
Potential to expand Rheumatology Sales Force following pilot
Potential roll-out of DM/PM selling effort by current
Neurology Sales Force to about 1,000 neurologists specializing
in neuromuscular disease
Initiate patient registry of Acthar experience in DM/PM
Gather clinical data in SLE, RA, PsA
Pilot rheumatology selling effort beginning mid-July
National Sales Director and manager positions (2) have been filled, with
hiring/training of 12 experienced Rheum reps in progress
Initial promotional effort focused on DM/PM
Potential to expand Rheumatology Sales Force following pilot
Potential roll-out of DM/PM selling effort by current
Neurology Sales Force to about 1,000 neurologists specializing
in neuromuscular disease
Initiate patient registry of Acthar experience in DM/PM
Gather clinical data in SLE, RA, PsA |
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Rheumatology: Estimated Patient Populations*
Indication
Total Estimated
US Population
Estimated Target
Acthar Population
Dermatomyositis/Polymyositis
66K
~26K
Systemic Lupus Erythematosus
250K
~50K-100K
Rheumatoid Arthritis
1.3M
~50K
Psoriatic Arthritis
500K
~40K
Juvenile Rheumatoid Arthritis
300K
-
Ankylosing Spondylitis
500K
-
*Questcor estimates |
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NASDAQ:
QCOR
NASDAQ:
QCOR
June 14, 2012
Investor Update
Rheumatology
June 14, 2012
Investor Update
Rheumatology |