Vectura Group plc (LSE:VEC) ("Vectura", "the Group"), an industry-leading inhaled airways disease focused business, reports that Novartis announced today that it has signed a licensing agreement with Sunovion Pharmaceuticals Inc., (MARLBOROUGH, Mass, "Sunovion"), for the US commercial rights to its three treatments for chronic obstructive pulmonary disease ("COPD"), Utibron(TM) Neohaler® (indacaterol/glycopyrrolate) inhalation powder, Seebri(TM) Neohaler® (glycopyrrolate) inhalation powder, and Arcapta® Neohaler® (indacaterol) inhalation powder.
This license is specific to the US and has no implications outside this market. Novartis will continue to manufacture these medicines for Sunovion. Novartis will also continue to commercialise Ultibro® Breezhaler® (indacaterol/glycopyrronium), Seebri® Breezhaler® (glycopyrronium) and Onbrez® Breezhaler® (indacaterol) to COPD patients outside of the US.
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.
James Ward-Lilley, CEO of Vectura, commented:
"We are pleased that Novartis has signed this licensing agreement with Sunovion to bring Seebri and Utibron to the US market. We are confident that with its established US respiratory focus and commercialisation expertise Sunovion will be a strong partner. The launch of these products in 2017 will give doctors new treatment options for their COPD patients. We look forward to the successful US commercialisation of these products and the further contribution they will make to the substantial existing recurring and growing royalty stream we receive from Novartis as reported in our recent interim results."
This announcement includes inside information
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| Vectura Group plc | +44 (0)1249 667700 |
| Andrew Derodra - Chief Financial Officer Fleur Wood, Director - Communications Elizabeth Knowles - Director Investor Relations and Analysis | |
| Consilium Strategic Communications | +44 (0)20 3709 5700 |
| Mary-Jane Elliott / Sue Stuart / | vectura@consilium-comms.com |
| Jessica Hodgson | |
About Vectura
Vectura, a FTSE250 company listed on the London Stock Exchange (LSE:VEC), is an industry-leading inhaled airways disease focused business with proprietary formulation and devices across DPI, pMDI and smart nebulisation platforms. With our extensive range of technologies, capabilities and collaborations, we believe we can become a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. In June 2016 Vectura completed a merger with Skyepharma PLC.
Vectura has seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Chiesi, Almirall, Janssen, and Tianjin KingYork.
For further information, please visit Vectura's website at www.vectura.com.
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(TM) 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.gov2,3.
Outside the US, the dose and regimen of indacaterol/glycopyrronium is different than in the US. It is available as a once-daily formulation, marketed as Ultibro® Breezhaler® 110/50 mcg, and is available as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD4. 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(TM) 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, the dose and regimen of glycopyrronium is different than 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 emphysema7. It is not approved for the treatment of asthma. Outside the US, it is marketed as Onbrez® Breezhaler® (indacaterol) 150 mcg and 300 mcg8.
About the Novartis US COPD portfolio
The Novartis US COPD portfolio includes Utibron Neohaler, Seebri Neohaler and Arcapta Neohaler, which are all indicated as maintenance treatments for COPD patients and use transparent capsules to help with dose confirmation.
About Sunovion
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion's vision is to lead the way to a healthier world. The Company's spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, the Company has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Sunovion's track record of discovery, development and commercialisation of important therapies has included Brovana® (arformoterol tartrate), Latuda® (lurasidone HCI), and most recently Aptiom® (eslicarbazepine acetate).
Sunovion's COPD portfolio includes Brovana® (arformoterol tartrate), an FDA approved twice-daily nebulised long-acting beta agonist (LABA), and SUN-101/eFlow® (glycopyrrolate), an investigational nebulised long-acting muscarinic antagonist (LAMA), for which Sunovion submitted a New Drug Application (NDA) to the FDA in July 2016.
Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, Ontario are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the Company's web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.
About COPD
Chronic obstructive pulmonary disease (COPD) affects an estimated 27 million people in America9, claiming the lives of 143,489 Americans in 201210. It is progressive (usually gets worse over time), and can be a life-threatening disease11,12. COPD makes it difficult to breathe, with symptoms that can have an impact on health-related quality of life11,12.
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
References
1. Utibron Neohaler US Product Information. Available at: www.pharma.us.novartis.com/product/pi/pdf/utibron.pdf [Accessed November 7, 2016]
2. Clinicaltrials.gov. Efficacy and Safety Study of QVA149 in COPD Patients. NCT02487446. Available at: https://clinicaltrials.gov/ct2/show/NCT02487446?term=indacaterol+AND+Umeclidinium%2FVilanterol&rank=4 [Accessed 11 November 2016].
3. Clinicaltrials.gov. Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients. NCT02487498. Available at: https://clinicaltrials.gov/ct2/show/NCT02487498?term=indacaterol+AND+Umeclidinium%2FVilanterol&rank=2 [Accessed 11 November 2016].
4. Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf [Accessed November 7, 2016]
5. Seebri Neohaler US Product Information. Available at: www.pharma.us.novartis.com/product/pi/pdf/seebri.pdf [Accessed November 7, 2016]
6. Seebri Breezhaler EU Summary of Product Characteristics. [Online] Revised 02-Oct-2015. Available at: http://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+44mcg/ [Accessed November 7 2016].
7. Arcapta Neohaler US Product Information. Available at: https://www.pharma.us.novartis.com/product/pi/pdf/arcapta.pdf [Accessed November 7, 2016]
8. Onbrez Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001114/WC500053732.pdf [Accessed November 7, 2016]
9. National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. Bethesda, Maryland: U.S Department of Health and Human Services, NIH, NHLBI. February 2012.
10. National Vital Statistics Report (NVSR): Deaths: Final Data for 2012. Available at: http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf [Accessed November 7, 2016].
11. Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed November 7, 2016].
12. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed November 16 2016].