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Actelion Receives FDA Approval of Tracleer (bosentan) for Use in Pediatric Patients with Pulmonary Arterial Hypertension

SOUTH SAN FRANCISCO, Calif, September 6, 2017 – Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has approved a new 32 mg tablet for oral suspension for Tracleer (bosentan) for use in pediatric patients aged three years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. With this approval, Tracleer becomes the first FDA-approved medicine for pediatric PAH patients in the United States. PAH is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected person.

Tracleer is an orally active endothelin receptor antagonist (ERA) for the treatment of patients with PAH (WHO Group 1). This approval covers a new 32 mg dosage of Tracleer, which features a scored tablet. The tablet can be dispersed in a teaspoon of water before oral administration. The lower dosage and score lines on the tablets are designed to allow physicians to vary the prescribed dose by the weight of the patient.

“Actelion has focused on the needs of the PAH community since Tracleer, our first treatment for PAH, was approved in 2001,” said Gary Palmer, M.D., MBA, senior vice president, Medical, Actelion Pharmaceuticals US, Inc. “We’re pleased our portfolio of treatments continues to grow and pediatric PAH patients will now have an FDA-approved treatment option available.”

Actelion expects to make the 32 mg dosage option of Tracleer available by the fourth quarter of 2017. The existing 62.5 and 125 mg dosages for adult use will remain available.

About Endothelin Receptor Antagonists (ERAs)

Tracleer is an oral ERA, which is a medication that helps PAH patients by blocking the effects of the extra endothelin their bodies produce. Endothelin is a naturally occurring chemical in the body and is involved in blood flow.[1]

However, patients with PAH have levels of endothelin that are higher than normal. Researchers have found that too much endothelin can cause blood vessels to tighten. It is more difficult for blood to flow through tightened blood vessels, and this can affect how well the heart works. 1,[2],[3]

Pulmonary Arterial Hypertension (PAH)

PAH is high blood pressure in the arteries of the lungs. It's a serious condition that can make it difficult for blood to flow through the lungs, which can force an affected individual’s heart to work harder.[4]

PAH is a chronic and progressive disease. This means that over time, PAH will get worse.[4] PAH is a rare disease and not all causes are known.[4] While PAH can affect people at any age, the average patient is diagnosed in their late 40s. And although anyone can develop PAH, it affects almost four times as many women as men.[5]

PAH involves a change in the levels of several natural chemicals in the blood. Over time, this can cause the arteries in the lungs to become thick and stiff,[6] which can make it difficult for blood to flow. As a result, the heart must work harder to pump blood from the right side of the heart through the arteries of the lungs.[4]

About Actelion Ltd

In June 2017, Actelion became part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Actelion's medicines have helped to expand and strengthen Janssen's portfolio with leading, differentiated in-market medicines and promising late-stage compounds. Janssen has added Pulmonary Hypertension as a therapeutic area of focus to maintain the leadership position Actelion has built in the PAH disease area.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and availability of TRACLEER® (bosentan). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Actelion Ltd, Actelion Pharmaceuticals US, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References

[1] TRACLEER® (bosentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc.
[2] McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension. J Am Coll Cardiol. 2009;53:1573-1619.
[3] Goraca A. New views on the role of endothelin. Endocr Regul.2002;36:161-167.
[4] Pulido T, Adzerikho I, Channick RN, et al. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013;369(9):809-818. doi:10.1056/NEJMoa1213917.
[5] Hayes GB. How do I really know I’ve got PH? In: Hayes GB. Pulmonary Hypertension: A Patient’s Survival Guide. 5th ed. Silver Spring, MD: Pulmonary Hypertension Association; 2012:chap 1.
[6] Frost AE, Badesch DB, Barst RJ, et al. The changing picture of patients with pulmonary arterial hypertension in the United States: how REVEAL differs from historic and non-US Contemporary Registries. Chest. 2011;139(1):128-137. doi:10.1378/chest.10-0075.

Source: Actelion Pharmaceuticals US, Inc.

Posted: September 2017

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