Johnson & Johnson : Janssen to Highlight Depth of Prostate Cancer and Solid Tumor Portfolios with Multiple Data Presentations at ESMO 2019

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Janssen to Highlight Depth of Prostate Cancer and Solid Tumor Portfolios with Multiple

Data Presentations at ESMO 2019

• Second interim analysis from the Phase 3 SPARTAN study reporting updated overall survival results in patients with non-metastaticcastration-resistant prostate cancer treated with ERLEADA® (apalutamide)
• Patient-reportedoutcomes from the Phase 3 TITAN study evaluating ERLEADA® in patients with metastatic castration-sensitive prostate cancer
• Interim analysis from the Phase 2 GALAHAD study evaluating niraparib in the treatment of patients with metastatic castration-resistant prostate cancer and biallelic DNA-repair gene defects, featured as late-breaking abstract

RARITAN, N.J., September 17, 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple data presentations from its prostate cancer and solid tumor portfolios will be featured at the European Society for Medical Oncology (ESMO) Annual Congress 2019, taking place September 27 to October 1 in Barcelona, Spain. Among Janssen's 12 accepted abstracts are an oral presentation reporting updated overall survival results from the ERLEADA® (apalutamide) Phase 3 SPARTAN study in patients with non-metastatic castration- resistant prostate cancer (nmCRPC); patient-reported outcomes from the ERLEADA® Phase 3 TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC), demonstrating preservation of overall health-related quality of life; and a late-breaking interim

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analysis from the Phase 2 GALAHAD study evaluating niraparib in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD).

"Janssen is focused on addressing areas of unmet need in both prostate cancer and solid tumors, and this year's ESMO Annual Congress provides an opportunity to share these important study results for both approved and investigational therapies," said Mark Wildgust, Ph.D., Vice President, Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "In particular, we look forward to presenting new data for ERLEADA® and niraparib, which reinforce our continued commitment to improve outcomes for patients diagnosed with prostate cancer across the disease spectrum."

Company-sponsored abstracts to be presented at the meeting include:

Abstract No.	Title	Date/Time
ERLEADA® (apalutamide)
	Oral Presentation
Abstract #843O	Apalutamide and Overall Survival in Patients with	Friday, September 27
	Nonmetastatic Castration-Resistant Prostate	2:39 PM - 2:51 PM
	Cancer (nmCRPC): Updated Results from the	CET
	Phase 3 SPARTAN Study
	Poster Presentations
Abstract #851PD	Patient-Reported Outcomes (PROs) From TITAN: A	Monday, September
	Phase 3, Randomized, Double-Blind Study of	30
	Apalutamide Versus Placebo	12:00 PM CET
	Added to Androgen Deprivation Therapy in
	Patients with Metastatic Castration-Sensitive
	Prostate Cancer (mCSPC)
Abstract #883P	Androgen Receptor Aberrations in Patients with	Monday, September
	Metastatic Castration-Sensitive Prostate Cancer	30
	(mCSPC) Treated with Apalutamide Plus Androgen	12:00 PM CET
	Deprivation Therapy in TITAN
Abstract #900TiP	A Phase 2 randomized, open-label study	Monday, September
	comparing salvage radiotherapy in combination	30
	with 6 months of androgen-deprivation therapy	12:00 PM CET
	with LHRH agonist or antagonist versus anti-
	androgen therapy with apalutamide in patients
	with biochemical progression after radical
	prostatectomy
Niraparib
	Poster Presentations
Abstract #LBA50	Pre-specified interim analysis of GALAHAD: A	Sunday, September
	Phase 2 study of niraparib in patients with	29
	metastatic castration-resistant prostate cancer	8:30 AM CET
	(mCRPC) and biallelic DNA-repair gene defects
Abstract #897TiP	A Phase 3 randomized, placebo-controlled, double-	Monday, September
	blind study of niraparib plus abiraterone acetate	30
	and prednisone versus abiraterone acetate	12:00 PM CET
	2

	and prednisone in patients with metastatic
	prostate cancer (NCT03748641)
Abstract #1412P	Analytical performance of the Resolution-HRD	Monday, September
	plasma assay used to identify mCRPC patients	30
	with biallelic disruption of DNA repair genes for	12:00 PM CET
	treatment with niraparib
ZYTIGA® (abiraterone acetate)
	Poster Presentation
Abstract #95P	Evaluation of markers associated with efficacy of	Monday, September
	abiraterone acetate plus prednisone in patients	30
	with castration-sensitive prostate cancer (mCSPC)	12:00 PM CET
	from the LATITUDE study
BALVERSA™ (erdafitinib)
	Poster Presentations
Abstract #925P	Analysis of response to prior therapies and	Monday, September
	therapies after treatment with erdafitinib in	30
	fibroblast growth factor receptor (FGFR)-positive	12:00 PM CET
	patients with metastatic urothelial carcinoma
Abstract #926P	Erdafitinib versus available therapies in advanced	Monday, September
	urothelial cancer: A matching adjusted indirect	30
	comparison	12:00 PM CET
Abstract #932P	Hyperphosphatemia due to Erdafitinib (a Pan-FGFR	Monday, September
	Inhibitor) and Antitumor Activity Among Patients	30
	with Advanced Urothelial Carcinoma	12:00 PM CET
Solid Tumor Portfolio
	Poster Presentation
Abstract #488P	Correlation of Progression Free Survival-2 and	Saturday, September
	Overall Survival in Solid Tumors	28
		2:00 PM CET

About ERLEADA® (apalutamide)

ERLEADA® (apalutamide) is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC.1 It became the first treatment to receive FDA approval for nmCRPC on February 14, 2018.1 ERLEADA® was also approved for the treatment of nmCRPC by the European Commission on January 12, 2019. ERLEADA® is being studied in five Phase 3 registrational clinical trials. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer include apalutamide as a treatment option for patients with non-metastatic (M0) CRPC with a category 1 recommendation for those with a PSA doubling time ≤10 months*.2 Similarly, the American Urological Association (AUA) Guidelines for Castration- Resistant Prostate Cancer (CRPC) recommend clinicians offer apalutamide (ERLEADA®) with continued androgen deprivation therapy (ADT) as one of the treatment options for patients with nmCRPC at high risk for developing metastatic disease. (Standard; Evidence Level Grade A)**.3 ERLEADA® is taken orally, once daily, with or without food.1

*Referenced from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed September 5, 2019. To view the most recent and complete version of the

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NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way

**Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.

**Evidence Level: A designation indicating the certainty of the results as high, moderate, or low (A, B, or C, respectively) based on AUA nomenclature and methodology.

About Niraparib

Niraparib is an orally-administered selective poly ADP ribose polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer. In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc., for exclusive rights to niraparib in prostate cancer. In the U.S., niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.4 Niraparib is currently marketed as ZEJULA® by TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer. Please refer to the full Prescribing Information available at https://www.zejula.com/prescribing-information.

About ZYTIGA® (abiraterone acetate)

ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), approved by the U.S. FDA on April 28, 2011and by the European Commission on September 7, 2011. Additionally, ZYTIGA® was approved for the treatment of high-risk metastatic castration-sensitive prostate cancer (mCSPC) by the European Commission on November 20, 2017and by the U.S. FDA on February 8, 2018. Since its first approval in the U.S. in 2011, ZYTIGA® has been approved in combination with prednisone or prednisolone, in more than 100 countries. More than 500,000 patients worldwide have been prescribed ZYTIGA®.

About BALVERSATM (erdafitinib)

BALVERSA™ (erdafitinib) is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.5 In

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2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize BALVERSA™. This indication was approved by the U.S. FDA on April 12, 2019under an accelerated approval based on tumor response rate. Patients may be suitable for BALVERSA based on an FDA-approved companion diagnostic. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.5

For more information about BALVERSA™, visit www.BALVERSA.com.

ERLEADA™ IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Pregnancy - ERLEADA™ (apalutamide) can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS

Falls and Fractures - In a randomized study (SPARTAN), falls and fractures occurred in 16% and 12% of patients treated with ERLEADA™ compared to 9% and 7% treated with placebo, respectively. Falls were not associated with loss of consciousness or seizure. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone targeted agents.

Seizure - In a randomized study (SPARTAN), 2 patients (0.2%) treated with ERLEADA™ experienced a seizure. Permanently discontinue ERLEADA™ in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA™. Advise patients of the risk of developing a seizure while receiving ERLEADA™ and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

ADVERSE REACTIONS

Adverse Reactions - The most common adverse reactions (≥10%) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, decreased appetite, fracture, and peripheral edema.

Laboratory Abnormalities - All Grades (Grade 3-4)

• Hematology - anemia ERLEADA™ 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA™ 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA™ 41% (2%),

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