Rezurock demonstrates strong efficacy with durable ORR across all organs and FFS, along with meaningful improvements in various endpoints and QoL, as supported by clinical trials and RWE across diverse markets.1

black

Clinical Trial (ROCKstar* 36-month follow-up)2-4

<ul>
 <li>74%: overall response rate (ORR) at 36 months</li>
 <li>Subgroups Best ORR
 <ul>
 <li>75%: Severe cGVHD patients</li>
 <li>72%: Prior ibrutinib cGVHD patients</li>
 <li>69%: Prior ruxolitinib cGVHD patients</li>
 </ul></li>
 <li>Organ-specific complete response:</li>
</ul>

<ul>
 <li>Failure free survival (FFS)&nbsp;</li>
</ul>

<ul>
 <li>86%:&nbsp;Overall survival (OS) at 24months</li>
</ul>

<ul>
 <li>69.9 weeks/16 months: Median duration of response (DoR)</li>
</ul>

<ul>
 <li>68% of the responders experienced clinically meanigful improvement in the Lee Symptom Scale (LSS)</li>
</ul>

*All the results are presented for the 200 mg once daily dosage (N=77)
&nbsp; &nbsp;

<ul>
 <li>44.2% improvement in ORR at 6 months (ref 4): (space) 39% of patients receiving Rezurock (LOT- episodes = 113) achieved a response (space) 27% of those receiving BAT (LOT-episodes = 245) achieved a response</li>
 <li>28% improvement in FFS at 1 year(ref 4): 61.2% of patients treated with Rezurock (LOT-episodes = 113) remained failure-free 47.8% of those on BAT (LOT-episodes = 245) remained failure-free</li>
</ul>

Belumosudil showcased promising efficacy and safety results with no new safety signals identified. This was consistently demonstrated across various country cohorts:

France: In patients receiving at least two prior lines of therapy (N=68).

Germany and Switzerland: In heavily pretreated patients (N=33).7

Canada: In patients with a history of extensive treatment (N=35).

Spain: In patients receiving at least two prior lines of therapy (N=63).10

Abbreviations
ORR:&nbsp;Overall response rate;&nbsp;FFS:&nbsp;Failure-free survival;&nbsp;QoL:&nbsp;&nbsp;Quality of life;&nbsp;RWE:&nbsp;Real-world evidence;&nbsp;GI :&nbsp;Gastrointestinal;&nbsp;n:&nbsp;Sample size;&nbsp;DoR:&nbsp;Duration of response;&nbsp;LOT: Line of therapy;&nbsp;BAT:&nbsp;Best available therapies;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease.

References

Rezurock Efficacy

PAYOR

OUT-OF-TAXONOMY

Rezurock is a cost-effective treatment when compared to the available treatments against 3L cGVHD,with a coverage resulting in a neutral/limited incremental budget impact.1

Cost-effectiveness Analysis2,4

<ul>
 <li>At a WTP of&nbsp;£30,000&nbsp;per QALY gained, Belumosudil demonstrated a&nbsp;significant clinical benefit&nbsp;versus BATs with an incremental gain of:&nbsp;0.854&nbsp;QALYs</li>
 <li>Belumosudil is cost-effective vs. BAT in patients aged&nbsp;12&nbsp;years and older&nbsp;with cGVHD who received&nbsp;at least two prior lines of systemic therapy.</li>
</ul>

Budget-impact Analysis3

<ul>
 <li>Costs savings associated with the&nbsp;management of AEs&nbsp;(e.g., neutropenia and thrombocytopenia) in 2026 are projected to be&nbsp;≈$108.4M</li>
 <li>Costs savings associated with&nbsp;healthcare resources utilization&nbsp;(e.g., emergency room visits, ICU stays) in 2026 are projected to be&nbsp;≈$65.1M</li>
</ul>

Belumosudil allows for the offset of healthcare system costs compared with BAT, resulting in a $128.8M cost savings from a national US payer perspective

Abbreviations
3L:&nbsp;Third line;&nbsp;WTP:&nbsp;Willingness-to-pay;&nbsp;AE:&nbsp;Adverse event;&nbsp;RWE:&nbsp;Real-world evidence;&nbsp;ICU:&nbsp;Intensive Care Unit;&nbsp;LOT: Line of therapy;&nbsp;BAT:&nbsp;Best available therapies;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease;&nbsp;US:&nbsp;United States.

Rezurock Economic Value

<h2>What is TTP?</h2>
Thrombotic thrombocytopenic purpura (TTP)— A rare, life-threatening medical emergency
TTP is a rare, life-threatening thrombotic microangiopathy (TMA). There are approximately 3 cases per million people.1,2 
 The name thrombotic thrombocytopenic purpura describes the 3 main characteristics of the disease.

Thrombotic:&nbsp;characterized by the formation of microthrombi (blood clots) within a blood vessel, which clog the vessel and prevent blood circulation.

Thrombocytopenic:&nbsp;a lower-than-normal platelet count due to the consumption of platelets during microthrombi formation, which causes occlusion of microvasculature.

Purpura:&nbsp;spots of variable size on the skin or in the mucous membranes, due to small hemorrhages; they can be dark red and as small as a pinhead (petechiae) or purplish and 2 to 3 cm in diameter (ecchymosis).

<h2>Types of TTP</h2>

Acquired TTP3,4
<ul>
 <li>aTTP, also known as immune-mediated thrombotic thrombocytopenic purpura (iTTP)</li>
 <li>The most common form of TTP; approximately 95% of TTP cases are aTTP</li>
 <li>Caused by&nbsp;autoantibody inhibition of ADAMTS13&nbsp;activity.</li>
</ul>
ADAMTS13=a disintegrin and metalloproteinase with thrombospondin type 1 motif, 13.

Hereditary TTP4,5
<ul>
 <li>Also known as congenital TTP, inherited TTP, familial TTP, or Upshaw–Schulman syndrome</li>
 <li>Very rare form of TTP; mainly detected in children</li>
 <li>Caused by&nbsp;mutations in the ADAMTS13 gene</li>
</ul>

<h2>Primary aTTP vs secondary aTTP2,6,7</h2>

Primary aTTP
<ul>
 <li>Primary aTTP refers to acquired autoimmune TTP for which there is no obvious underlying/precipitating cause/disease</li>
 <li>Primary aTTP accounts for the majority of cases of TTP</li>
</ul>

Secondary aTTP
<ul>
 <li>Secondary aTTP refers to acquired autoimmune TTP for which a defined underlying disorder or trigger can be identified, including connective tissue disease (eg, systemic lupus erythematosus), HIV infection, cytomegalovirus infection, and/or a specific precipitating factor (eg, pregnancy or drugs)</li>
 <li>Treatment of the underlying disorder and/or removal of the underlying precipitant may be required, as well as standard TTP therapy</li>
</ul>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(241, 135, 0);">
 TTP causes systemic microthrombi and consequent thrombocytopenia, hemolytic anemia, and organ ischemia. These symptoms—coupled with TTP’s rarity—can cause confusion with other TMAs, making TTP a challenge to diagnose.8-10</td>
 </tr>
 </tbody>
</table>

<h2>Signs and symptoms of aTTP include1,7-10</h2>

Petechiae, purpura, bruising (skin)

Headache, confusion, seizures, coma 
 (neurological)

Abdominal pain, diarrhea 
 (gastrointestinal)

Suspect aTTP?

<h2 style="text-align: center;">The incidence of TTP is 2 to 6 per million individuals4</h2>

Rare diseases defined as

cases per million&nbsp;11

Ultra-rare diseases defined as

cases per million&nbsp;12

<h2 style="text-align: center;">aTTP primarily affects young, healthy adults13,14</h2>

years of age on average

of people affected are women

higher aTTP incidence 
 in the Black population

<h2 style="text-align: center;">If left untreated, TTP is rapidly fatal8,15-17</h2>

acute mortality rate16,17

of TTP deaths occur within 24 hours of presentation8

<h3 style="text-align: center;">Even with plasma exchange therapy (PEX), mortality risk persists15,16,18</h3>

Up to

acute mortality associated with episodes of aTTP&nbsp;16,18

&nbsp;&nbsp;

median time from diagnosis to death 16,18 in acute phase of TTP in patients treated with PEX15,18

<h2>The burden of thrombotic thrombocytopenic purpura (TTP)</h2>
Short- and long-term implications threaten patients with aTTP
<h3>Short-term implications</h3>

Mortality
<ul>
 <li>Untreated, aTTP has an acute mortality rate of up to&nbsp;90%1-3</li>
 <li>Approximately 55% to 80% of deaths among patients with aTTP occur within&nbsp;2 weeks of diagnosis4-6</li>
 <li>Significantly higher rates of in-hospital mortality have also been reported in patients with&nbsp;TTP and CV complications(19.7% vs 4.1%)7</li>
</ul>

Health-related quality of life
<ul>
 <li>Rates of depression (10% to 73%) are considerably higher&nbsp;in patients following an episode of TTP, compared with both healthy individuals and reference populations8-12</li>
</ul>

Morbidity
<ul>
 <li>Most common complications&nbsp;in patients hospitalized with TTP&nbsp;are CV complications&nbsp;(25%), such as stroke (10%), heart failure (8%), and acute coronary syndrome (6%)7</li>
</ul>

Economic burden
<ul>
 <li>Short-term treatment of acute thromboembolism such as stroke, acute MI, or TIA&nbsp;requires multiple healthcare resources, including hospitalization with diagnostic tests (eg, CT scans), administration of thrombolytic and/or other drugs, admittance to intensive care/critical care unit, and/or ongoing specialist nursing care (eg, physiotherapy, speech therapy)13-15</li>
</ul>

An increased time at risk of microvascular thrombosis can lead to irreversible organ damage to the heart, brain, and kidneys16

<h3>Long-term implications</h3>

Mortality
<ul>
 <li>23-fold increase in mortality&nbsp;was observed in patients who did not reach a platelet recovery rate of 5 × 109/L per day by day 3 of PEX17</li>
 <li>Inability to normalize platelet count over 7 days of PEX was associated with a&nbsp;significantly increased risk of death18</li>
</ul>

Health-related quality of life
<ul>
 <li>Long-term outcomes are driven by the consequences of platelet aggregation, leading to&nbsp;systemic microvascular thrombosis7,19</li>
</ul>

Morbidity
<ul>
 <li>Recovery following an acute episode of aTTP is not a resolution of symptoms but the beginning of a long-term morbidity burden:&nbsp;hypertension, stroke, and depression requiring pharmacological treatment were significantly greater for TTP survivors&nbsp;versus the age- and sex-matched US population8,9,20</li>
</ul>

Economic burden
<ul>
 <li>Other long-term consequences that have been reported include&nbsp;neurocognitive impairment, depression, hypertension, headaches, and SLE;&nbsp;all require healthcare resources on an ongoing basis11,20</li>
</ul>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(241, 135, 0); text-align: center;">Long-term morbidity leads to suboptimal health-related quality of life, in both mental (anxiety, depression) and physical functioning, and potentially reduces life expectancy8-20</td>
 </tr>
 </tbody>
</table>

Abbreviations

<h2>The pathophysiology of thrombotic thrombocytopenic purpura (TTP)</h2>
<h3>TTP is characterized by potentially fatal systemic microthrombi1,2</h3>
TTP is caused by severely decreased activity of the ADAMTS13&nbsp;enzyme. ADAMTS13 is the protease that cleaves von Willebrand factor (vWF). In patients with acquired TTP (aTTP), this deficiency is immune mediated.1
Decreased ADAMTS13 activity leads to an accumulation of ultra-large von Willebrand factor (ULvWF) multimers, which spontaneously bind to platelets and induce aggregation. This results in dangerous microthrombi that drive severe thrombocytopenia, microangiopathic hemolytic anemia, and organ ischemia.2
ADAMTS13=a disintegrin and metalloproteinase with thrombospondin type 1 motif, 13.
<h4>TTP pathophysiology</h4>
An in-depth exploration of the causes of TTP and the severe consequences of the disease.

TTP is a life-threatening thrombotic microangiopathy (TMA) that requires quick diagnosis and urgent treatment.&nbsp;1,2

ACQUIRED-THROMBOTIC-THROMBOCYTOPENIA-PURPURA-ATTP

RARE-BLOOD-DISORDERS

Understanding TTP

<h2>What is the pathophysiology of aTTP?</h2>
<h3>3 Key mechanisms drive the pathophysiology of aTTP2</h3>

Auto antibody formation 
 Autoantibodies to ADAMTS13 inhibit its activity or enhance clearance of the enzyme.

ADAMTS13 deficiency causes&nbsp;uncleaved ULvWF 
 ADAMTS13 (the enzyme responsible for cleaving vWF in the blood-clotting process) is deficient, leaving platelet-hyperadhesive ULvWF strands intact to circulate without being cleaved.

Microthrombi formation 
 ULvWF accumulates and spontaneously binds to platelets, forming microthrombi.

<h3>Normal Physiology2,3</h3>

<h3>Thrombotic Thrombocytopenic Purpura2,3</h3>

Adapted from Joly B et al.&nbsp;Blood&nbsp;2017 and Saad J &amp; Schoenberger L 2018.

<h2>Formation of microthrombi causes2</h2>

<h4>Severe thrombocytopenia</h4>
(often platelets &lt;30 × 109/L)

<h4>Microangiopathic hemolytic anemia 
 (MAHA)</h4>
characterized by the presence of schistocytes in blood smear

<h4>Organ ischemia</h4>
(lesions can occur in any organ, but they most frequently affect the heart, brain, gastrointestinal tract, and kidney)

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="text-align: center; background-color: rgb(241, 135, 0);">Platelet aggregation leads to microthrombi formation, which can have fatal consequences.1,2</td>
 </tr>
 </tbody>
</table>

<h2>Signs and symptoms of aTTP</h2>
The symptoms of aTTP are driven by microthrombi, which are unpredictable and potentially fatal1,2
Microthrombi can have serious acute and chronic consequences in TTP—putting patients at risk for devastating effects and death without urgent treatment.

<h3 style="text-align: center;">Microthrombi can occur in any organ with microvessels, but the most commonly affected are3</h3>

Tissue and organ damage resulting from ischemia leads to increased levels of lactate dehydrogenase (LDH), troponins (heart), and creatinine (kidney).¹,⁴

<h2>Expert Opinion About aTTP</h2>

<h2>Signs and symptoms of acquired thrombotic thrombocytopenic purpura (aTTP) include1,4,5</h2>

of TTP episodes result in ischemia due to platelet aggregation in the microcirculation of the brain.3

<h2>The consequences of microthrombi can be severe, with TTP potentially resulting in acute thromboembolic events such as1,2,4</h2>

<h4>&nbsp;</h4>
<h4>Arterial thrombosis</h4>

<h2>Consequences can also be long term</h2>

TTP is a life-threatening thrombotic microangiopathy (TMA) that requires quick diagnosis and urgent treatment. 1,2

<h2 style="text-align: center;">3rd leading cause of death globally1 
 6th leading cause of death in the US2</h2>

DALY, disability-adjusted life year; QALY, quality-adjusted life year. 
 1. World Health Organization. The top 10 causes of death. Accessed May 2, 2023. https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death. 2. American Lung Association. COPD Trends Brief: Mortality. 
 Accessed April 10, 2023. https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-mortality. 3. Centers for Disease Control and Prevention. COPD. Accessed April 10, 2023. https://www.cdc.gov/dotw/copd/ 
 Index.html#:~:text=COPD%20affects%20more%20than%2015,smoke%20and%20other%20air%20pollutants. 4. World Health Organization. Global health estimates: Leading causes of DALYs. Accessed April 17, 2023. https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/global-health-estimates-leading-causes-of-dalys. 5. Zafari Z, et al. Chest. 2021;159(4):1400-1410.

<h2 style="text-align: center;">Persistent symptoms of COPD can impose substantial limitation on physical activity and contribute to worsening shortness of breath and poor HRQoL1</h2>

<h2 style="text-align: center;">Symptoms of COPD are associated with:</h2>

HRQoL, health-related quality of life. 
 1. Miravitlles M, Ribera A. Respir Res. 2017;18:67. 2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2023. 
 Accessed March 16, 2023. https://goldcopd.org/wp-content/uploads/2022/12/GOLD-2023-ver-1.1-2Dec2022_WMV.pdf. 3. Jones PW, et al. Prim Care Respir J. 2012;21(3):329-336. 4. Kessler R, et al. Eur Respir J. 2011;37(2):264-272. 
 5. Jones SE, et al. J Thorac Dis. 2018;10(Suppl 12):S1390-S1399. 6. Miravitlles M, et al. Respir Res. 2014;15(1):122.

<h2 style="text-align: center;">Acute exacerbations 
 of COPD</h2>

HRQoL, health-related quality of life. 
 *Patients (mean age=75.4 years) with a first severe exacerbation of COPD requiring hospitalization (N=73,106). 
 †Patients aged ≥35 years (N=126,013) with 252,756 index COPD-related hospitalizations. 
 1. Seemungal TA, et al. Am J Respir Critical Care Med. 1998;157(5 Pt 1):1418-1422. 2. Jones SE, et al. J Thorac Dis. 2018;10(Suppl 12):S1390-S1399. 3. Kessler R, et al. Chest. 2006;130 (1):133-142. 4. Suissa S, et al. Thorax. 2012;67(11):957-963. 5. Gershon AS, et al. PLoS One. 2019;14(5):e0216741. 6. Guarascio AJ, et al. Clinicoecon Outcomes Res. 2013;5:235-245. 7. Wacker ME, et al. Int J Chron Obstruct Pulmon Dis. 2017;12:3437-3448.

CHRONIC-OBSTRUCTIVE-PULMONARY-DISEASE-(COPD)

RESPIRATORY

(COPD): Disease Burden and Heterogeneity

CHRONIC-RHINOSINUSITIS-WITH-NASAL-POLYPS-CRSWNP

You can imagine more than 90% of CRSwNP patients losses their ability's of smell

Smell is mediated by Olfactory Sensory Neurons in the olfactory epithelium. Horizontal Basal Stem Cells regenerate these Olfactory Sensory Neurons, maintaining the sense of smell.

“Smell—we call it the Cinderella of the senses"

In dealing with the severe burden of CRS with nasal polyps, patients can get used to their reduced sense of smell. What would it mean to bring it back? Watch as an expert explains the impact the sense of smell has on quality of life and what biologics can do to restore patients’ lost smell.
Restoring the sense of smell is key to improving quality of life for patients with CRS with nasal polyps. For patients experiencing significant smell loss, biologic therapy can help restore the sense of smell.1,2

What can biologic treatment do for patients with CRS with nasal polyps?

When Claus Bachert, M.D., Ph.D., says “the patient is king,” what does that mean for his approach to treating CRS with nasal polyps? Watch as the editor of The Journal of Allergy and Clinical Immunology explains what access to biologics like Dupixent means for his patients and his practice.
Easier access to biologics like Dupixent would allow more patients to receive treatment that targets the underlying source of CRS with nasal polyps.1-3

Rethink your Nasal Polyps. Type 2 Inflammation a Nasal Polyp mystery

Most of us enjoying the ability to breath and smell, but CRS patients that simple joy is missing.

OTHER-RARE-DISEASE-TOPICS

RARE-DISEASE

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