Lupin receives UK marketing authorisation for Luforbec® 100/6 pMDI, first branded generic alternative to Fostair® to treat Asthma & COPD

Lupin receives UK marketing authorisation for Luforbec® 100/6 pMDI, first branded generic alternative to Fostair® to treat Asthma & COPD

Slough, UK, June 14, 2021:  Lupin Healthcare, the UK-based wholly owned subsidiary of Lupin Limited (Lupin) today announced that it has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Luforbec (beclometasone/formoterol) 100/6 dose pressurised metered dose inhaler (pMDI), the first branded generic of Fostair®, which has the potential to offer significant cost savings for the NHS.¹

Luforbec is indicated for the treatment of adult asthma and for the symptomatic treatment of chronic obstructive pulmonary disease (COPD) (FEV1 <50% predicted normal*).² Luforbec has the same licensed indications as Fostair® 100/6 pMDI.^2,3 It also has the same active ingredients, an extra fine formulation, and similar device characteristics to Fostair® 100/6 pMDI.^2,3,4

In the 12 months to February 2021, the NHS spent over £179 million on Fostair® 100/6 pMDI and the availability of Luforbec offers significant savings potential for the NHS, upon launch.⁵

Commenting on the development, Thierry Volle, President - EMEA, Lupin Limited said, “The approval of Luforbec is a pivotal milestone for the UK and a welcome step for Lupin as we draw on our strong expertise in respiratory research and development and expand our respiratory portfolio. We are proud to support healthcare providers and patients by continuing to invest in specialised treatments for chronic diseases.”

‘‘We are very proud to receive the first marketing authorisation for generic Fostair® in the UK. We believe this will be the first of many future Lupin respiratory licenses in the UK and it builds on our heritage of delivering high quality medicines and value to the NHS and patients.” said Ben Ellis, General Manager – Lupin Healthcare UK.

Respiratory diseases affect one in five people. It is the third biggest cause of death in the UK and is a clinical priority for the NHS.⁶ In the UK, around 5.4 million people are currently receiving treatment for asthma, which is equivalent to one in every 12 adults.⁷ An estimated 1.2 million people are also living with COPD and this number is only set to increase.⁸ Asthma and COPD place a heavy cost burden on the NHS, estimated at £3 billion and £1.9 billion per year, respectively.⁶

About Luforbec 100/6 pMDI²

Luforbec is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA)) is appropriate. This includes patients not adequately controlled with ICS and ‘as needed’ inhaled short-acting beta2-agonist or patients already adequately controlled on both ICS and LABA. Luforbec is indicated for symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

* Spirometry is a test used to measure the ability of a person to inhale and exhale air respective to time. Forced expiratory volume (FEV) is one of the main results of spirometry and is the amount of air an individual can forcefully exhale in seconds. The subscript refers to the number of seconds of the measurement's duration.⁹

About Lupin UK

Lupin Healthcare is a subsidiary of the global pharmaceutical company Lupin Limited which has a presence in over 100 countries and is the 3rd largest pharmaceutical company in the USA by prescriptions.¹⁰ Lupin’s heritage lies in generic medicines and delivering quality medicines and value to patients and healthcare providers. Lupin has a resilient supply chain with excellent supply history as well as having tried and tested continuity plans in place. Entrepreneurial spirit, external focus and pipeline strength elevate Lupin Healthcare from a standard generics company to a more specialist organisation, partnering with the NHS to deliver value in the anti-retroviral, oral contraceptives, neuroscience and respiratory space. In January 2019 Lupin launched its first medicines in neuromuscular conditions and it is one of the largest providers of HIV medications to the NHS offering £218,000,000 direct savings to the NHS in HIV medicines alone.¹¹

www.lupinhealthcare.co.uk/

For further information please contact:

1 NHS BSA. Drug Tariff. https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff Accessed June 2021.

2 Luforbec 100/6 pMDI. Summary of Product Characteristics (SPC). Lupin Healthcare UK Limited

3 Fostair 100/6 pMDI. Summary of Product Characteristics (SPC). Chiesi Ltd. https://www.medicines.org.uk/emc/medicine/21006#gref Accessed June 2021

4 Lupin Healthcare Limited. Data on File. UK-LUF-2104-00004

5 General Practice Prescribing Data. March 2020 – February 2021. This public sector information is licensed under the Open Government Licence v3.0. http://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/. The NHS Business Services Authority (BSA) is the provider of the England data. NHS Wales Shared Partnerships Services is the provider of the Wales data. The Business Services Organisation is the provider of the Northern Ireland data. Public Health Scotland is the provider of the Scotland data

6 NHS. Respiratory Disease. https://www.england.nhs.uk/ourwork/clinical-policy/respiratory-disease/. Accessed June 2021.

7 Asthma UK. Understanding Asthma. https://www.asthma.org.uk/advice/understanding-asthma/what-is-asthma/. Accessed June 2021

8 British Lung Foundation. Our COPD research. https://www.blf.org.uk/research/our-impact/our-copd-research. Accessed June 2021.

9 David S, Edwards CW. Forced Expiratory Volume. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK540970/. Accessed June 2021.

10 IQVIA MAT Dec 2020 https://www.lupin.com/portfolio/lupin-quarter-iii-fy2021-results. Accessed June 2021.

11 Lupin Healthcare Limited. Data on File. LUP-CORP-002