Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP...

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COMPANY PROFILE

Transcript of Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP...

Page 1: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

COMPANY PROFILE

Page 2: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

O u r m i s s i o n i s t o i m p r o v e p a t i e n t s ’ l i v e s

b y i d e n t i f y i n g , d e v e l o p i n g , a n d

c o m m e r c i a l i z i n g m e a n i n g f u l p r o d u c t s t h a t

a d d r e s s u n m e t m e d i c a l n e e d s .

Page 3: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

W h o We A r e

Where there’s a will, there’s a way. Patients are our will.

Jazz Pharmaceuticals plc is an international biopharmaceutical company focused

on improving patients’ lives by identif ying , developing , and commercializing

meaningful produc ts that address unmet medical needs .

We have a diverse portfol io of products and product candidates, with a focus in theareas of sleep and hematology/oncology. We also support commercial products inother therapeutic areas where we can meaningfully address serious medical needs.

As part of our unwavering commitment to improve patients’ l ives, we are continuingto expand our commercial product portfol io and our research and developmentpipeline in therapeutic areas that can leverage our unique expertise. We do thisthrough a growth strategy of growing sales of the existing medicines in our portfol io;acquiring commercial products or product candidates that are in late-stagedevelopment; and pursuing focused development of our pipeline of differentiatedtherapies.

Page 4: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

We have a strong patient-focused culture at Jazz Pharmaceuticals that our

employees believe in and pursue ever y day. It is clearly identified through our

mission , vision and core values .

Each member of our team makes integral contr ibutions and is working toward a common goal to improve patients' lives.

Everything we do at Jazz Pharmaceuticals is focused on three things:• Putting patients f irst• Being a great place to work• Living our core values — integrity, collaboration, passion, pursuit of excellence

and innovation

O u r C u l t u r e

Page 5: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

We have a diverse por tfolio of produc ts in our therapeutic areas of focus:

sleep and hematology/oncology.

We also suppor t commercial products in therapeutic areas where we can meaningfully address serious medical needs. For complete prescribing information and a BOXED Warning for Xyrem ®, Prialt®, FazaС lo® and Versacloz®, please visit JazzPharmaceuticals.com.

Xyrem ® (sodium oxybate) oral solution Erwinaze ® (asparaginase Erwinia chrysanthemi) for injectionPrialt® (ziconotide) intrathecal infusion FazaClo ® (clozapine) LD and HD orally disintegrating clozapine tabletsVersacloz ® (clozapine) oral suspension

For a list of products available outside the US, please visit JazzPharmaceuticals.com.

P r o d u c t s

Page 6: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

Re s e a r c h a n d D e v e l o p m e n t

SLEEP HEMATOLOGY/ONCOLOGY

XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416

Pediatric Narcolepsy1

EDS in Narcolepsy

EDS in OSA Narcolepsy VOD2

SteroidRefractory

aGvHD

AcuteLymphoblastic

Leukemia

ST

AT

US

At Jazz Pharmaceuticals, we strive to identify and develop new, meaningfulproducts that fill significant unmet medical needs of patients. We are activelyexpanding global R&D capabilities and advancing our clinical pipeline intherapeutic areas that leverage our expertise.

Our research and development program currently includes clinical developmentprograms in the areas of sleep and hematology/oncology for new productcandidates, l ine extensions for existing products and the generation of additionalclinical data for existing products.

Phase 3 trial initiated in

2Q15

Phase 3 trial initiated in

2Q15

Phase 1 completed

1Q15, further evaluation warranted

FDA Priority Review granted

PDUFA date of March 31, 2016

Development discontinued

based on Phase 3 data analysis

Patient enrollmentin pivotal

Phase 2 study suspended in

1Q153

Phase 3 trial initiated in

3Q14

1 Evaluating in children and adolescents who have narcolepsy with cataplexy.2 Hepatic veno-occlusive disease (VOD) with evidence of multi-organ dysfunction following hematopoietic stem cell transplantation.3 Jazz Pharmaceuticals voluntarily suspended patient enrollment based on the occurrence of hypersensitivity-like reactions following the administration of JZP-416 in some treated patients. The company is in the process of collecting and evaluating the available data and plans to conduct additional research and analysis prior to determining whether to resume the study and determining next steps regarding the development of JZP-416. EDS = Excessive Daytime Sleepiness, OSA = Obstructive Sleep Apnea, aGvHD = acute Graft vs Host Disease, NDA = New Drug Application

Page 7: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

Bruce C. Cozadd Chairman and Chief Executive Of f icer

Russell J. Cox Executive Vice President and Chief Operating Of f icer

Suzanne Sawochka Hooper Executive Vice President and General Counsel

Heather McGaughey Senior Vice President, Human Resources

Iain McGill Senior Vice President, Jazz Pharmaceuticals Europe and Rest of World

Robert McKague Senior Vice Presidentand Chief Compliance Of f icer

Michael P. Miller Senior Vice President, US Commercial

Karen Smith, M.D., Ph.D. Global Head of Research and Development and Chief Medical Of f icer

Paul Treacy Senior Vice President, Technical Operations

Matthew Young Executive Vice President and Chief Financial Of f icer

Our leadership team has a proven track record of successfully developing and

commercializing therapeutics and creating patient programs that result in better

patient care.

At the same time, they’ve demonstrated their ability to drive shareholder value and built Jazz Pharmaceuticals into an employer of choice. The following individuals comprise Jazz Pharmaceuticals’ Executive Committee. See JazzPharmaceuticals.com for biographies and a listing of the company’s Board of Directors.

O u rL e a d e r s h i p

Page 8: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

O u r P h i l a n t h r o p i c Re s p o n s i b i l i t y

At Jazz Pharmaceuticals, we view our corporate giving as an opportunity for us to

help improve patients’ l ives by fill ing unmet needs, to demonstrate our commitment

to the communities we serve by building powerful collaborations, and to make an

impact through meaningful investments in organizations, initiatives and causes that

reflect our mission, values, and strategic focus.

Jazz is committed to support ing programs through educational grants, sponsorships andresearch that benefits patients and the scienti f ic or medical community. These supportedprograms are healthcare-related and consistent with Jazz Pharmaceuticals’ therapeuticsareas of focus. We are also committed to being an exemplary corporate cit izen andcontributing to the well-being of the communit ies in which we l ive and work.

Funding Areas of Focus Include: • Healthcare-related charitable support • Philanthropic charitable support• Independent medical education

Page 9: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

20 03 Jazz Pharmaceuticals founded

20 03/20 04 Management team assembled/capital raised

20 05 Acquired Orphan Medical and its product, Xyrem®

20 07 Launch of Luvox CR®

2012 Merger with Azur Pharma, which changed Jazz Pharmaceuticals in manyways, including providing new global headquarters in Dublin, Ireland,brining in new employees and new members of our management team andexpanding our product offerings by bringing Prialt® into the company

2012 Acquired EUSA Pharma, which extended our product offeringsto include Erwinaze® /Erwinase® and helped us establish our Europeancommercial infrastructure

2013 License agreement with Concer t Pharmaceuticals for the r ights to JZP-386

2014 Broke ground on manufacturing facility in Ireland

2014 Acquired r ights to JZP-110 from Aerial BioPharma

2014 Acquired Gentium, which added Def itelio® (def ibrotide) to our product por t folio; European commercial launch of Def itelio

2014 Acquired r ights to def ibrotide in the Americas from Sigma-Tau Pharma

O u rH i s t o r y

2015 JZP-110 Phase 3 clinical program initiated

Page 10: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

W h a t ’s i n O u r N a m e?

The name "Jazz Pharmaceuticals" was inspired by the talented jazz musicians who

come together — each a musical specialist with an individual style — to make music

in concert that is greater than the sum of its parts. Each talented member of our team,

working collaboratively, comes together to contribute to a common goal: improving

patients’ lives.

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Headquar tered in Dublin , Ireland , we have over 880 employees working

collaboratively across multiple o� ces in the US and EU to reach patients in the

numerous countries in which our produc ts are available.

We have operations in the following locations:

Dublin, IrelandOxford, EnglandLyon, FranceMunich, GermanyPalo Alto, California, USAPhiladelphia, Pennsylvania, USAVilla Guardia, Italy

O u r G l o b a l Re a c h

Jazz Direct MarketPartner Market

Page 12: Company Profile Oscar13Nov - Jazz Pharmaceuticals · PDF fileResearch and Develop ment SLEEP HEMATOLOGY/ONCOLOGY XYREM JZP-110 JZP-386 Defibrotide Leukotac JZP-416 Pediatric Narcolepsy1

For more information about Jazz Pharmaceuticals,please visit JazzPharmaceuticals.com.