Innovation in Women's Health & Prostate Cancer - J.P. Morgan Healthcare Conference
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Innovation in Women’s Health & Prostate Cancer J.P. Morgan Healthcare Conference January 2020
Forward-Looking Statements This presentation contains forward-looking statements, including without limitation, statements related to: Myovant’s focus on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases; Myovant’s ability to advance the clinical development of relugolix through the LIBERTY, SPIRIT and HERO clinical trials and MVT-602 through its clinical trials; the timing and success of Myovant’s regulatory filings and potential approvals; Myovant’s business strategies, financial condition and trends, competitive position, potential growth opportunities, the effects of competition and expectations or probabilities for success. Forward-looking statements can be identified by “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. Myovant cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks relating to those discussed in the section titled “Risk Factors” set forth in Part I, Item 1A of Myovant’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission, or the SEC, on May 24, 2019, and other filings that Myovant makes with the SEC from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for its management to predict all risk factors, nor can Myovant assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, Myovant undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. 2
Improve the lives of millions of women and men,
many impacted by diseases during their most
productive years of life.
3
A Unique Investment Opportunity
2019 Positive Phase 3 Data:
• Uterine Fibroids
~$400M
• Prostate Cancer Cash and committed funding
2020 Endometriosis:
• Phase 3 Data RIGHTS
Wholly-owned U.S. and EU
Uterine Fibroids: rights for all indications
• 1-Year Data
• NDA Submission
• MAA Submission
Prostate Cancer:
• NDA Submission
• Castration Resistance-Free
Survival Data
4
Myovant’s Late-Stage Pipeline
PHASE 1 PHASE 2 PHASE 3 ANTICIPATED MILESTONES
Relugolix
COMBINATION THERAPY • NDA Submission (April 2020)
Symptoms of • MAA Submission (Q1 2020)
Uterine Fibroids • 1-Year Extension Data (Q1 2020)
COMBINATION THERAPY
• Phase 3 Data
Symptoms of
(SPIRIT 2 Q1 2020; SPIRIT 1 Q2 2020)
Endometriosis
MONOTHERAPY • NDA Submission (Q2 2020)
Advanced • Castration Resistance-Free Survival
Prostate Cancer Data (Q3 2020)
MVT-602 kisspeptin agonist
Female Infertility
as Part of Assisted • Phase 2 Development
Reproduction
MAA = Marketing Authorisation Application for European Medicines Agency
5 Relugolix Combination Therapy = relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mg
GnRH Pathway
Shared Across Women's Health and Prostate Cancer
KISSPEPTIN
Brain
KISS1R
GNRH Hypothalamus
production Estrogen drives
GNRH uterine fibroids and
Pituitary endometriosis
FSH & LH
GNRH production
receptor
Testosterone drives
prostate cancer
Definition: Follicle-Stimulating Hormone (FSH); Luteinizing Hormone (LH)
6
Relugolix Mechanism of Action
RELUGOLIX
Brain
Estrogen
GNRH RECEPTOR
Hypothalamus
ANTAGONIST Estrogen drives
GNRH
uterine fibroids and
Pituitary endometriosis
RELUGOLIX
GNRH Reduced FSH & Testosterone
receptor LH production
Testosterone drives
prostate cancer
Definition: Follicle-Stimulating Hormone (FSH); Luteinizing Hormone (LH)
7
One Pill, Once A Day
Two Distinct Therapeutic Candidates
WOMEN’S HEALTH PROSTATE CANCER
Relugolix 40 mg Relugolix 120 mg
+ estradiol 1.0 mg (following single 360 mg loading dose)
+ norethindrone acetate 0.5 mg
RELUGOLIX RELUGOLIX
COMBINATION TABLET MONOTHERAPY TABLET
Designed for the treatment of Designed with the potential to be the
women with symptomatic uterine first and only oral androgen
fibroids or endometriosis as an deprivation therapy for men with
alternative to surgery or other advanced prostate cancer.
invasive procedures.
8 *Relugolix is an investigational drug that has not been FDA approved for use
Relugolix for Women’s Health 9
~5M women
with symptoms
in U.S.
Millions of
Women
In Need of Better
Medicines for >$34B
~250,000
Uterine Fibroids hysterectomies per year
each year
in U.S. annual societal
cost
Stewart. NEJM. 2015; Stewart. Lancet. 2001
Majoribanks et al. Cochrane Database Syst. Rev. 2006. Cardozo et al. Am J Obstet Gynecol. 2012;
Wright et al. Obstet Gynecol. 2013; Cohen et al. Obstet Gynecol. 2017.
10Uterine Fibroids: A Common, Debilitating Disease
EFFECTS
Heavy Bleeding Anemia Pelvic Pain Urinary Pregnancy
Symptoms Complications
Stewart. NEJM. 2015; Stewart. Lancet. 2001.
11~6M women
with symptoms
in U.S.
Millions of
Women
In Need of Better
Medicines for >$70B
~100,000
Endometriosis hysterectomies per year
each year
in U.S. annual societal
cost
Bulletti et al. J Assist Reprod Genet. 2010; Quaas et al. Fertil Steril. 2015;
Simoens et al. Human Reproduction. 2012; Wright et al. Obstet Gynecol. 2013;
Cohen et al. Obstet Gynecol. 2017.
12Endometriosis: A Common, Debilitating Disease
EFFECTS
Pelvic Pain Painful Infertility Fatigue Bowel
Intercourse Symptoms
Bulun. 2019. NEJM. 2009; Vercillini et al. Nature Reviews Endocrinology. 2014.
13Despite the significant burden of uterine fibroids
and endometriosis, women do not have the options
they deserve and need.
14Contraceptives
INCOMPLETE
SYMPTOM RELIEF
• Blood loss
• Pain
• Anemia
GnRH Antagonist
Monotherapy
Low Dose
A Clearly Defined
Gap in Treatment
in Uterine
Fibroids and
Endometriosis
GnRH Antagonists TREATMENT-INDUCED
Monotherapy
High Dose SIDE EFFECTS
• Bone loss
GnRH Agonists • Hot flashes
15Relugolix
Combination
Vision INCOMPLETE
SYMPTOM RELIEF
Intentionally
Designed to Fill • Blood loss
• Pain
Treatment Gap
• Anemia
RELUGOLIX COMBINATION TABLET VISION
• Reduction in blood loss & pain
• Well-tolerated with bone health maintained
• One pill, once a day
TREATMENT-INDUCED
SIDE EFFECTS
*Relugolix is an investigational drug • Bone loss
that has not been FDA approved for
use; these are aspirational statements
• Hot flashes
16Relugolix Combination Tablet Vision: One Dose, Two Diseases
RELUGOLIX COMBINATION TABLET* OTHER
BID BID*
ENDOMETRIOSIS
QD 200 mg 200 mg E2/N
150 mg
OR + OR +
One pill, once a day 200 mg 200 mg
BID* BID*
8 mm
300 mg 300 mg E2/N
FIBROIDS
UTERINE
+ OR +
300 mg 300 mg
Pills and tablets to scale (except 300 mg; size is unknown) *In late-stage clinical development
E2/N = estradiol and norethindrone acetate
17 *Relugolix is an investigational drug that has not been FDA approved for useLIBERTY Development Program: Long-Term Data
6 months 1 Year 2 Years
LIBERTY 1 & 2 OPEN LABEL RANDOMIZED
(PHASE 3) EXTENSION WITHDRAWAL
Placebo Placebo
Retreatment with
R Relugolix Combination Therapy Relugolix Combination Therapy R Relugolix Combination
Relugolix Combination
Relugolix
12 weeks
Therapy 28 WEEKS Relugolix Combination Therapy
12 weeks
DOUBLE BLIND TREATMENT: DOUBLE BLIND TREATMENT:
24 WEEKS 52 WEEKS
Data Available in
✓ Positive Phase 3 Data
Q1 2020 Data Forthcoming
18 Relugolix Combination Therapy = relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mg84.3% Reduction in
1
Menstrual Blood Loss
2 Reduction in Pain
Relugolix
Combination: 3
Bone Mineral Density
Comparable to Placebo
LIBERTY Clinical
Data Insights Well-Tolerated with
4 Adverse Event Rates
Comparable to Placebo
*Relugolix is an investigational drug
that has not been FDA approved for use 5 One Dose, Once a Day
19Reduction in Menstrual Blood Loss Volume with
Relugolix Combination Therapy
Placebo Relugolix Combination Therapy
AT WEEK 24 OVER TREATMENT PERIOD
0 20.0
-15.1
Change from Baseline (%)
Change from Baseline (%)
-20
-23.2 0.0
L2
Mean Percent
-20.0
L1
-40
-84.3 -84.3 †
-40.0
-60
-60.0 L2
-80 -80.0
L1
-100 P < 0.0001 P < 0.0001 -100.0
Baseline W4 W8 W12 W16 W20 W24
LIBERTY 1 LIBERTY 2 Weeks
†A patient with MBL volume of 2710.3 mL at Week 4 was excluded from the analysis.
Data Presented at American Society for Reproductive Medicine (ASRM), October, 2019. L1 = LIBERTY 1; L2 = LIBERTY 2
20 Relugolix Combination Therapy = relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mgBone Health Maintained Across LIBERTY Studies
(Lumbar Spine)
1 1–
0– Placebo
Mean Percentage Change
0
(95% CI) from Baseline
-1 -1 – Relugolix
-2 -2 – Combination
-3 -3 – Therapy
-4 -4 –
-5 -5 –
-6 -6 –
-7 -7 –
-8 -8 –
Baseline Week 12 Week 24
21 Relugolix Combination Therapy = relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mgBone Mineral Density Distribution Comparable
to Placebo in LIBERTY
Distribution of Change in Bone Mineral Density at Week 24 (Lumbar Spine)
L1: Placebo
More Common
L2: Placebo
L1: Relugolix Combination Therapy
L2: Relugolix Combination Therapy
Distribution
Less Common
-5% 0% 5%
Percent Change from Baseline (%)
22 Relugolix Combination Therapy = relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mgEndometriosis Phase 3 Results in Q1 and Q2 2020
CO-PRIMARY ENDPOINTS
Reduction in dysmenorrhea (painful periods) and non-menstrual pelvic pain as assessed using the
Symptoms of Endometriosis Scale (a daily questionnaire for the assessment of endometriosis-
associated pain) scored using the Numerical Rating Scale
6 months 2 Years
Placebo
Endometriosis- Extension Study
Primary
Associated Pain R Relugolix Combination Therapy
Endpoint
Relugolix
N = ~600 Combination Therapy
Relugolix
Relugolix
12 weeks Combination Therapy WEEK 24 WEEK 104
12 weeks
DOUBLE-BLIND TREATMENT: 24 WEEKS
23 Relugolix Combination Therapy = relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mgRelugolix for Advanced Prostate Cancer The First and Only Oral GnRH Receptor Antagonist in Development for Prostate Cancer 24
>200,000
men
Prostate
treated
with ADT
Cancer
each year
the 2nd Most
Common Cancer
Affecting Men 30% men ~3M men
Androgen Deprivation with prostate
Therapy (ADT) is the diagnosed with
cancer have
Foundational Treatment cardiovascular prostate cancer
disease alive in the U.S.
National Cancer Institute; PharmaPoint Prostate Cancer 2017;
Litwin et al. JAMA, 2017; Sartor et al. NEJM, 2018. Datamonitor Prostate Cancer Forecast 2018. SEER 21 Database;
American College of Surgeons National Cancer Database; Albertsen et al. Eur Urol. 2014.
25Relugolix Has Potential to Benefit Broad Spectrum of
Men with Advanced Prostate Cancer
2018 Prevalence of GnRH-Treated Prostate Cancer Patients
Current Standard of Care
Biochemical Recurrence
with Higher Risk Factors ~40K
Injectable
Locally Advanced ~90K Clinical Flare
Weeks to reduce
Metastatic ~80K PSA; Months for
testosterone
recovery
0 10 20 30 40 50 60 70 80 90 100
SEER 21 Database; American College of Surgeons National Cancer Database; Clinton. Expert Opinion on Pharmacotherapy, 2017.
26 *Relugolix is an investigational drug that has not been FDA approved for use; these are aspirational statementsHERO: Phase 3 Study Design in Advanced Prostate Cancer
Relugolix
360 mg loading dose on Day 1,
120 mg tablet once daily
Men with N = 624 Primary Endpoint: Secondary Endpoint:
Advanced
Prostate Cancer R Testosterone Castration Resistance-Free
Suppression Survival
N = 934 Leuprolide acetate
Injection every 3 months WEEK 48
N = 310
Data Available in
✓ Positive Phase 3 Data Q3 2020
27Testosterone Suppression
1
Without Clinical Flare
The Relugolix 2
Testosterone Recovery
Within 90 Days
Difference:
HERO Clinical 50% Fewer Major Adverse
Data Insights 3 Cardiovascular Events as
Compared to Leuprolide
*Relugolix is an investigational drug
4 One Pill, Once A Day
that has not been FDA approved for use
28Achieved U.S. Primary Endpoint
95% CI (94.9%, 97.9%)
100
90
80
Response Rate (%)
96.7% of men
60
responded to treatment
96.7 Sustained testosterone suppression
40 to castrate levels (< 50 ng/dl) with
lower bound of 95% CI > 90%
20
0
Relugolix
Category 1
CI = Confidence Interval
29Relugolix Achieved Faster Onset & Recovery than Leuprolide
700
Relugolix
600 Leuprolide
Mean Testosterone Levels (ng/dL)
Testosterone Recovery
500 Subpopulation (N = 184)
400
Normal
300 280
ng/dL
200
Castrate
100
50
ng/dL
0
0 4 15 29 2
57 3
85 4
113 10
309 11
337 12
367 13
397 14
427
Days Months
END OF TREATMENT
30Launch Readiness
Hiring of Commercial and Medical Affairs Teams
Advisory Boards and KOL Engagement
Presentations and Publications
Brand Strategies and Tactics
Building Commercial Operations and Medical Affairs Infrastructure
31Focused and Efficient Field Team
WOMEN’S PROSTATE
HEALTH CANCER
Millions of women with uterine Men with prostate cancer
fibroids and endometriosis are primarily treated by
are treated primarily by ~18K Urologists and
~36K OB/GYNs in the U.S. Oncologists in the U.S.
Rayburn, The American College of Obstetricians and Gynecologists, 2017; American Urological Association; Kirkwood et al. J Oncol Pract. 2013.
32 *Relugolix is an investigational drug that has not been FDA approved for useA Unique Investment Opportunity
2019 Positive Phase 3 Data:
• Uterine Fibroids
~$400M
• Prostate Cancer Cash and committed funding
2020 Endometriosis:
• Phase 3 Data RIGHTS
Wholly-owned U.S. and EU
Uterine Fibroids: rights for all indications
• 1-Year Data
• NDA Submission
• MAA Submission
Prostate Cancer:
• NDA Submission
• Castration Resistance-Free
Survival Data
33Thank You! Contact Email: investors@myovant.com
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