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Corporate Presentation RIGEL PHARMACEUTICALS, INC. 1180 Veterans Boulevard South San Francisco, CA 94080 www.rigel.com November 2019

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Page 1: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Corporate Presentation

RIGEL PHARMACEUTICALS, INC.

1180 Veterans Boulevard

South San Francisco, CA 94080

www.rigel.com

November 2019

Page 2: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Forward-Looking Statement

These slides contain forward-looking statements, including statements relating to Rigel’s growth and

partnership strategy into additional markets and indications for fostamatinib disodium hexahydrate, the

potential for fostamatinib in ITP to obtain approval in the EU by the end of 2019, the utility of fostamatinib

in other indications, including warm autoimmune hemolytic anemia, its strategy for TAVALISSE ®

(fostamatinib disodium hexahydrate) tablets for the treatment of adult patients with chronic immune

thrombocytopenia who have had an insufficient response to a previous treatment in the US, its clinical

trials, the sufficiency of Rigel’s cash, cash equivalents, short-term investments and the timing of its current

cash runway.

Any statements contained in these slides that are not statements of historical fact may be deemed to be

forward-looking statements. Words such as "anticipates," "plans," "intends," "expects" and similar

expressions are intended to identify these forward-looking statements. These forward-looking statements

are based on Rigel's current expectations and involve risks and uncertainties.

There are a number of important factors that could cause Rigel's results to differ materially from those

indicated by these forward-looking statements, including risks associated with the timing and success of

clinical trials and other risks detailed in Rigel's SEC reports, including its Quarterly Report on Form 10-Q for

the quarter ended September 30, 2019. Rigel expressly disclaims any obligation or undertaking to update

the forward-looking statements discussed in this presentation.

2 Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.2

Page 3: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

3

$107.5 million in cash at end of 3Q

$60 million debt facility in place

Grow TAVALISSE®

sales in the U.S.Capture value in global

ITP market

Capitalize on

Opportunity in Warm

Antibody AIHA2

Expand Development

Pipeline

Strong Financial Position

$1 billion market1 $800 million market1Indication with no

FDA-approved therapy

Developing commercially

attractive molecules

• Fostamatinib (SYK) expected

exclusivity to 2031

• IRAK1/4 inhibitor advancing in

clinic

• RIP1 inhibitor entered first-in-human

• Received positive opinion for

fostamatinib MAA from CHMP

• Potential European launch in 2020

• Ph 3 initiated in Japanese patients

• Canada & Israel newest markets

• Increased net product sales by

15% QoQ and 141% YoY

• +50% persistency rate at month 4

• Phase 3 enrollment ramping

• Potentially first FDA-approved

product for wAIHA

• Substantial synergies with ITP

business

1Company’s internal estimate based on 2018 sales of ITP therapies used for steroid-refractory patients.2Investigational compound in this indication and has not been submitted for FDA review.Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Executing on Key Value Drivers

Page 4: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Growing in the U.S. and creating access in markets globally

$1BU.S.

$400M

ROW

$400M

Europe

$1.8 billion global ITP market1

1 Company’s internal estimate based on 2018 sales of ITP therapies used for steroid-refractory patients.4

Bringing a Novel Therapy to ITP Patients Worldwide

Page 5: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Chronic ITP

5

Chronic immune thrombocytopenia (ITP) is a rare autoimmune disease characterized by a low platelet count1

Symptoms:

• Severe bleeding episodes

• Bruising

• Fatigue – diminished quality of life

• In severe cases - mucocutaneous/cerebral

hemhorrage2, which can result in death

1 Cines DB, et al. N Engl J Med. 2002, 2 Lee MS, et al. Neurology. 1998, 5Picozzi VJ, et al. Am J Med. 1980

Page 6: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

6

TAVALISSE: A Differentiated Product

Only available treatment that addresses underlying pathophysiology1

• MOA inhibits the spleen tyrosine kinase (SYK) pathway to

prevent the actual destruction of platelets2

Treatment options (after steroids) include3:

• Stimulating platelet production

• Depleting B cells to slow platelet destruction

• Surgically removing spleen to reduce production of

platelet-destroying antibodiesTAVALISSE

x

1 TAVALISSE [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; April 2018. 2 Podolanczuk A, et al. Blood. 2009;113:3154-3160. 3 Ghanima W, et al. Blood. 2012;120(5):960-969 1980 Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Page 7: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Multiple Entry Points

7

68,300 U.S. Adult cITP Patients*

Addressable Market

(Options Post-steroids)18,700

14,100

35,500

“Watchful Waiting”

Steroids

Rituximab TPO (Oral) TPO (SQ) Splenectomy Cytotoxics Immunosuppressants Other

Heterogeneity of Therapy (Post-steroids)*

*Pre-TAVALISSE launch Sources: Quantitative Physician Research, April 2017, n = 150; Symphony Health, PatientSource®, 7 years ending November 2016. Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Cycling between treatment optionsCycling on and off treatment

Page 8: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (cITP) who have had an

insufficient response to a previous treatment.

Select Important Safety Information

Adverse Reactions

• Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea,

dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

• Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased,

respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.8

Page 9: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

9

Growing TAVALISSE Utilization in the U.S.

$11.7M net product sales revenue: +15% QoQ; +141% YoY

• Highlight compelling value drivers: differentiated MOA, efficacy, suitable for chronic use

• Continued education about TAVALISSE, leverage physician experience through peer-to-peer education

Adult ITP Market1

$800M

ROW

$1BU.S.

1 Company’s internal estimate based on 2018 sales of ITP therapies used for steroid-refractory patients.Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

+50% Persistency Rate – Refill Rate at 4 Months

• Advancement into earlier lines of therapy

• Supporting optimal dosing and AE management

Page 10: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

10

Shift in Treatment Approach to Targeted Therapy

TPO-RA, thrombopoietin receptor agonist. 1. Ghanima W, et al. Blood. 2012;120(5):960-969. 2. Kistangari G, McCrae KR. Hematol Oncol Clin North Am. 2013;27(3):495-520. 3. WinRho® SDF [package insert]. Berwyn, PA: Aptevo BioTherapeutics, LLC; August 2016. 4. Mizutani H, et al. Blood. 1992;79(4):942-947. 5. Stasi R, et al. Blood. 2001;98(4):952-957. 6. TAVALISSE™ [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; April 2018. 7. NPLATE® [package insert]. Thousand Oaks, CA: Amgen, Inc.; October 2017. 8. PROMACTA® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals; May 2018. Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Limit Platelet Destruction

Stimulate Platelet Production

Targeted (Disease Mechanism)

TPO-RAs7,8

Systemic (Immune Suppression)

Splenectomy1

Intravenous

immunoglobulin2,3

Corticosteroids4

RituximabTAVALISSE6

1916

1981

2001

2007

1950

2018

Page 11: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

11

Treatment Options Not Optimal for All1

Lines of Therapy Received- IVIg and low dose prednisone

- IVIg and pulse dexamethasone

- Eltrombopag

- IVIg and pulse dexamethasone

- Rituximab weekly x 4 infusions

61-year-old female

• Initially diagnosed with ITP in 2014

• Initial presentation; bruising and epistaxis

Reported side effects- Anxiety (IVIg, low dose prednisone, pulse dexamethasome)

- Weight gain (IVIg, low dose prednisone)

- Thrombocytosis without thrombosis (eltrombopag)

- Intolerant to dexamethasone

- Highly fluctuating and inconsistent platelet counts throughout treatment (2k to >400K)

Patient prescribed TAVALISSE…

1 Select case studies – individual results may varyPlease see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Page 12: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

12

Proper Management Leads to Patient Success1

0

50

100

150

200

250

300

Platelet counts while taking TAVALISSE100 mg BID

Dose increased

150 mg BID

Dose decreased

100 mg BID

• Grade 1 diarrhea (4 bowel

movements on loperamide) and

HTN exacerbation

• Lisinopril and losartan doses were

adjusted due to HTN exacerbation

Pla

tele

t C

ou

nt

(x 1

09/L

)

Week 1 Week 8 Week 13 Week 17 Week 19 Week 20 Week 29Week 2 Week 3 Week 5 Week 7 Week 9 Week 11 Week 22 Week 25 Week 27

1 Select case studies – individual results may varyPlease see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Page 13: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

• Ensure physicians and patients understand novel MOA and safety profile

• Support optimal dosing and AE management for greater chance of patient success and long-term treatment

• Leverage physician experience with peer-to-peer education

• Provide market access and support for patients

• Communicate efficacy outcomes with earlier line data to expand utilization in these patient segments

13

Ongoing Execution to Drive Utilization

Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Page 14: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

14

Capturing Value of Global ITP Markets

$1BU.S.

Europe

• Received positive opinion for fostamatinib MAA from CHMP

‒ European Commission (EC) decision ~70 days later

• If approved, Rigel receives $20M milestone payment from

Grifols

• Germany likely first market to launch 2020

Japan/Asia

• Initiated Phase 3 clinical trial in Japanese patients; NDA

submission anticipated in 4Q21/1Q22

Canada/Israel

• New Drug Submission (NDS) filed in Canada for fostamatinib

in adult chronic ITP

Provide access to fostamatinib in $800M ex-U.S. market

Adult ITP Market1

$800M

Ex-U.S.

1 Company’s internal estimate based on 2018 sales of ITP therapies used for steroid-refractory patients.

Page 15: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

15

Warm AIHA

• Warm autoimmune hemolytic anemia (wAIHA) is a rare autoimmune disorder characterized by the body’s destruction of its own healthy red blood cells

• ~40,000 adult wAIHA patients in the U.S.1

Symptoms:

• Difficulty breathing, dizziness, and fatigue

• Enlargement of spleen

• More severe cases can lead to heart palpitations and

heart failure

1 Symphony Health, PatientSource®, 7 years ending November 2016.

Page 16: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

16

• Targeting over 100+ sites in 22 countries for efficient enrollment

• Potentially first-to-market based on anticipated timeline

⎻ Mid-2020: Complete enrollment

⎻ Mid-2021: Topline results

• Projected to be ~$1 billion market in the

U.S.2, and currently no FDA-approved

therapy

• Only molecule currently in a Phase 3 trial

for wAIHA

• Synergies with ITP enable a highly

accretive market opportunity

⎻ Same targeted physicians

⎻ Same mechanism of action

⎻ Established commercial infrastructure

Phase 3 Enrollment Strategy

Capitalize on Opportunity in Warm Antibody AIHA (wAIHA)1

1Investigational compound in this indication and has not been submitted for FDA review. 2DelveInsight Research “Warm Autoimmune Hemolytic Anemia [wAIHA] – Market Insight, Epidemiology, and Market Forecast”.

Page 17: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

17

Expand Development Pipeline

Continuing to generate and capitalize on novel discoveries

• Exploring immune system for targets that play a role in broad range of indications

• Use cell-based assays which more closely represent actual conditions of the targets in human disease

• Include multiple molecules per program

• Maximize asset value through optionality in development approach

• Large or small markets

• Company-sponsored, co-development with pharma partner, out-license

• Domestic versus global markets

3 Clinical Programs Ongoing

4 pathway inhibitors out-licensed and in development

SYK IRAK 1/4 RIP1

JAK JAK

AXL MDM2

Page 18: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Three Development Programs with Broad Potential

18

SYK RIP1IRAK1/4

Page 19: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

19

SYK

Page 20: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

20

SYKIRAK 1/4

1Investigational compound in this indication and has not been submitted for FDA review.

Page 21: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

21

SYK

RIP1

IRAK 1/4

*Rigel Internal Data

1Investigational compound in this indication and has not been submitted for FDA review.

Page 22: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

22

SYK

RIP1

IRAK 1/4

*Rigel Internal Data

Psoriasis

AML ITP

AIHA CLL

GvHD

LupusInflammatory Bowel Disease Gouty Arthritis

Psoriatic Arthritis Multiple Sclerosis

Alzheimer’s

DermatomyositisRheumatoid Arthritis

1Investigational compound in this indication and has not been submitted for FDA review.

Page 23: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

23

IRAK1/4 Inhibitor Program

Developing novel MOA that inhibits IRAK1/4 pathways –first to target both

Phase 1 Study Results of R835

• Showed to be tolerated in healthy subjects

• Encouraging PK characteristics

• Linear, dose-proportional exposure

• No food effect

• Quick attainment to steady-state

• Long half-life

• In LPS Challenge Proof-of-Mechanism (PoM)

study, showed inhibition of cytokine production

1 R835 is an investigational compound not approved by the FDA. * Rigel Internal Data

Page 24: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

24

RIP1 Inhibitor Program

Recently entered Phase 1 with R5521, RIP1 Inhibitor

• Receptor-interacting protein-1 kinase

(RIP1) is a key driver of necroptosis, a type

of regulated cell death

⎻ Triggers inflammation in response to

molecules from the ruptured cells

⎻ Progresses to tissue damage in inflammatory

and neurodegenerative diseases

• Multiple lead chemical series of CNS-

penetrant RIP1 inhibitors identified

⎻ Select candidate in 2020 for clinical studies

1 R552 is an investigational compound not approved by the FDA.

Page 25: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

3Q ’19 Product Sales Analysis

25

• Q3 ‘19 gross product sales of $14.4M

• Q3 ‘19 gross-to-net adjustment of $2.7M or

~18.5% of gross product sales

1.8

4.9

7.38.1

10.2

11.7

-

2

4

6

8

10

12

14

Q2 '18 Q3 '18 Q4 '18 Q1 '19 Q2 '19 Q3 '19

LTD Net Product sales ($M)

• 1,355 total bottles shipped and total

5,438 bottles shipped LTD

• 1,291 bottes shipped to patients &

clinicals and 64 bottles remaining in

distribution channel

• 500 total bottles remained in

distribution channels at September 30,

2019

• $11.7M net product sales in Q3 '19 and

$44.0M in net product sales in the first 5

quarters of launch

Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Page 26: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

Q3 2019 Financial Results(In thousands, except for per share amounts)

26

• $9.1M in contract revenues from payments related to collaborations

• Total costs and expenses increased due R&D costs as site enlistment and patient enrollment ramp in Phase 3 pivotal trial of TAVALISSE in patients with warm AIHA1

• Secured $60 million credit facility with Midcap Financial

• Initial tranche of $10 million was received at closing in September

• Cash & short-term investment balance totaled $107.5M as of September 30, 2019

2019 2018 2019 2018

Revenues

Product sales, net 11,716$ 4,865$ 29,943$ 6,652$

Contract revenues from collaborations 9,141 — 13,945 —

Total revenues 20,857 4,865 43,888 6,652

Costs and expenses:

Cost of product sales 310 69 728 99

Research and development 14,463 11,097 38,638 33,136

Selling, general and administrat ive 18,121 18,069 56,276 48,632

Total costs and expenses 32,894 29,235 95,642 81,867

Loss from operations  ( 12,037 ) ( 24,370 ) ( 51,754 ) ( 75,215 )

Interest income  555 604 2,068 1,507

Net loss ( 11,490 ) ( 23,766 ) ( 49,694 ) ( 73,708 )

Net loss per share, basic & diluted ( 0.07 )$ ( 0.14 )$ ( 0.30 )$ ( 0.47 )$

167,609 166,464 167,326 158,456

Weighted-avg shares used in computing net loss

per share, basic & diluted

3 Months Ended September 30, 9 Months Ended September 30,

1Investigational compound in this indication and has not been submitted for FDA review. Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Page 27: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

27

$107.5 million in cash at end of 3Q

$60 million debt facility in place

Grow TAVALISSE

sales in the U.S.

Capture value in global

ITP market

Capitalize on

Opportunity in Warm

Antibody AIHA2

Expand Development

Pipeline

Strong Financial Position

$1 billion market1 $800 million market1Indication with no

FDA-approved therapy

Developing commercially attractive

molecules

1Company’s internal estimate based on 2018 sales of ITP therapies used for steroid-refractory patients.2Investigational compound in this indication and has not been submitted for FDA review.Please see slides 28 & 29 for Important Safety Information. Please visit www.TAVALISSE.com for full prescribing information.

Executing on Key Value Drivers

Page 28: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

28

Indication

TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with

chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information

Warnings and Precautions

• Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.

• Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.

• Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.

• Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.

• TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

TAVALISSE® (fostamatinib disodium hexahydrate) Tablets Indication and Important Safety Information

Page 29: Corporate Presentation - Jefferies...These slides contain forward-looking statements, including statements relating to Rigel’s growth and partnership strategy into additional markets

29

Drug Interactions

• Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.

• It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.

• Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.

• Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

• Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

• Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

Please see http://www.tavalisse.com/ for full Prescribing Information

To report side effects of prescription drugs to the FDA, visit http://www.fda.gov/medwatchor call 1-800-FDA-1088 (1-800-332-1088)

TAVA_ITP-19116

TAVALISSE (fostamatinib disodium hexahydrate) Tablets Important Safety Information (cont’d)