Pharma Focus Asia

Novartis out-licenses three COPD products in the US

Thursday, December 22, 2016

Novartis announced that it has signed a licensing agreement with Sunovion Pharmaceuticals Inc. (Sunovion) for the US commercial rights to its three treatments for chronic obstructive pulmonary disease (COPD),  Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder, Seebri™ Neohaler® (glycopyrrolate) inhalation powder, and Arcapta® Neohaler® (indacaterol) inhalation powder.

This deal is specific to the US only and has no implications outside this market. Novartis will continue to manufacture these medicines for Sunovion. Novartis will also continue to bring Ultibro® Breezhaler® (indacaterol/glycopyrronium), Seebri® Breezhaler® (glycopyrronium) and Onbrez® Breezhaler® (indacaterol) to patients living with COPD outside of the US.

"Given the evolving market dynamics, we believe these products will have the greatest impact in the US when commercialized by a company with an established presence in the COPD field," said Fabrice Chouraqui, President of Novartis Pharmaceuticals Corporation. "Novartis will continue to focus on areas in the US where we have strong capabilities and leadership, and can bring the greatest value to physicians and patients."

Outside the US, Novartis' indacaterol/glycopyrronium formulation Ultibro Breezhaler 110/50 mcg administered once-daily is the leading therapy in sales in its class. In all markets other than the US, Novartis has a full respiratory presence and portfolio and is committed to building category leadership and meeting the evolving needs of patients living with respiratory diseases including asthma and COPD. The COPD portfolio remains a global priority for Novartis.

In the US, Novartis remains committed to improving care across respiratory diseases including asthma and cystic fibrosis and, through its pipeline, anticipates expanding its respiratory portfolio.

About Utibron Neohaler
Utibron Neohaler (indacaterol/glycopyrrolate) 27.5/15.6 mcg is a twice-daily fixed dose combination of long-acting beta2-adrenergic agonist (LABA) and long-acting muscarinic antagonist (LAMA). In the US, Utibron Neohaler is a prescription medicine approved as a long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema1. It is not approved for the relief of acute bronchospasm or the treatment of asthma.

Utibron Neohaler was approved in October 2015 in the US with a dose of indacaterol/glycopyrrolate 27.5/15.6 mcg administered twice-daily, which is different from the product marketed outside the US. Recent new data from two head-to-head studies showed Utibron Neohaler provided clinically meaningful and comparable bronchodilation to GSK's Anoro™ Ellipta® in US patients with COPD. However, the primary endpoint in terms of 24-hour lung function improvement (FEV1 AUC0-24h) was not met statistically. A full evaluation of this new data is ongoing and will be communicated in due course. The primary objectives of the two head-to-head studies were to demonstrate that Utibron Neohaler was non-inferior to Anoro Ellipta in terms of improving lung function over a 24-hour period (FEV1 AUC0-24h), after 12 weeks of treatment, more information on the trial design can be found at: Clinicaltrials.gov.

Outside the US, Utibron Neohaler is not available. Outside the US, the dose and regimen of indacaterol/glycopyrronium is different than the dose and regimen in the US. It is available as a once-daily formulation of indacaterol/glycopyrronium, marketed as Ultibro® Breezhaler® 110/50 mcg, and is available as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD2. Once-daily Ultibro Breezhaler is currently approved for use in over 90 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

About Seebri™ Neohaler®
Seebri Neohaler (glycopyrrolate) 15.6 mcg is a twice-daily LAMA bronchodilator. In the US, Seebri Neohaler is a prescription medicine approved as a long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema5. It is not approved for the treatment of asthma.

Outside the US, Seebri Neohaler is not available. Outside the US, the dose and regimen of glycopyrronium is different than the dose and regimen in the US. It is available as a once-daily formulation of glycopyrronium, marketed as Seebri® Breezhaler® 50 mcg, and is available as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD6. Once-daily Seebri Breezhaler is approved for use in over 90 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.

About Arcapta® Neohaler®
Arcapta Neohaler (indacaterol) 75 mcg, is a once-daily LABA bronchodilator. It is a prescription medicine approved in the US as long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is not approved for the treatment of asthma. Outside the US, it is marketed as Onbrez® Breezhaler® (indacaterol) 150 mcg and 300 mcg

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