UK marketing authorisations for IOPIDINE® (apraclonidine) fully transferred to Essential Pharma as change in UK NICE guidelines for glaucoma treatment expected to lead to increase in patients’ need for product

UK marketing authorisations for IOPIDINE® (apraclonidine) fully transferred to Essential Pharma as change in UK NICE guidelines for glaucoma treatment expected to lead to increase in patients’ need for product

Recent change in NICE guidelines indicating laser surgery as first line therapy for glaucoma is expected to increase need for IOPIDINE to control or prevent post-surgical elevations in intraocular pressure

Continuation of global marketing authorisation transfer from Novartis for this important product

Zug, Switzerland & Egham, UK – 15 December 2022 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically well-established pharmaceutical products across key therapeutic areas, announces that it has completed the transfer of the UK marketing authorisations for IOPIDINE® (apraclonidine) in both available concentrations, IOPIDINE® 0.5% and 1%, following its acquisition of the product from Novartis in December 2021.

IOPIDINE® is a short-term adjunctive therapy for patients with chronic glaucoma to prevent or control intraocular pressure*,1 including after selective laser therapy, a form of laser eye surgery now recommended as the initial treatment for open angle glaucoma.2

A recent change in regulations by the UK’s National Institute for Health and Care Excellence (NICE), which placed laser surgery as first line therapy for glaucoma, means that IOPIDINE®, especially IOPIDINE® 1% which is indicated to control or prevent post-surgical elevations in intraocular pressure that occur in patients after selective laser therapy (SLT), will continue to be an important treatment for glaucoma patients that require additional intraocular pressure reduction.2

The acquisition of this long-established therapy sold across more than 20 global markets including several countries in the EU plus Canada, Australia and Japan, is in line with Essential Pharma’s commitment to ensure the sustainable supply of essential specialty medicines to patients. The acquisition also demonstrates Essential Pharma’s strong integration capabilities for newly acquired products and underlines the group’s strategy to be a trusted partner to regional and global pharma companies looking to streamline their portfolios across international markets.

Steen Vangsgaard, CEO of Essential Pharma, commented: “We are delighted to have completed the MA transfer, enabling us to ensure the continued supply of IOPIDINE® and fulfilling a vital need for patients, as has been demonstrated by the change in recent NICE guidelines. We are also pleased that Novartis chose us as a trusted partner for its divestment, further underlining Essential Pharma’s expertise and commitment to ensuring long-term, structured supply of established medicines.”

Gus Gazzard, Professor of Ophthalmology (Glaucoma Studies) UCL & Director of Surgery at Moorfields, commented: “Based on a 3-year scientific study, we compared the treatment of glaucoma using continuous daily eye drops with initial selective laser therapy. This study has shown that SLT has favourable cost-effectiveness versus treatment with daily eye drops.3 Followed by a public consultation finalised in 2021, NICE decided to change the guidelines to recommend SLT as a first line therapy for all open angle glaucoma, which is expected to contribute to meaningful savings to the NHS over the coming years.” 2

In the UK, chronic open angle glaucoma (COAG) affects around 2% of people aged over 40 and can rise to almost 10% in people aged over 75. Ocular hypertension (OHT) affects 3-5% of people in the UK over 40 years of age and occurs when pressure inside the eye is higher than normal, which can cause glaucoma. According to latest NICE guidelines which were updated in 2022, SLT is now recommended as a first line option to treat glaucoma and ocular hypertension allowing patients to quickly receive effective treatment to improve their quality of life.2

1.   IOPIDINE® Summary of Product Characteristics. Available from https://www.medicines.org.uk/emc/product/839/smpc. Accessed December 2022

2.   NICE, Press Release 26 January 2022. Selective laser therapy recommended to treat glaucoma and ocular hypertension. Available from https://www.nice.org.uk/news/article/selective-laser-therapy-recommended-to-treat-glaucoma-and-ocular-hypertension#:~:text=News,Selective%20laser%20therapy%20recommended%20to%20treat%20glaucoma%20and%20ocular%20hypertension,(Wednesday%2C%2026%20January). Accessed December 2022

3.   Gazzard G, Konstantakopoulou E, Garway-Heath D, et al. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial, Lancet. 2019 Apr 13;393(10180):1505-1516. (https://pubmed.ncbi.nlm.nih.gov/30862377/. Accessed December 2022)

About Essential Pharma

Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to well-established, “at risk” products essential to patients across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving patients access to medicines that otherwise may not be available.

Essential Pharma operates globally, supplying a portfolio of over 150 essential medicines across multiple therapeutic areas. Essential Pharma’s growth strategy is based around identifying and acquiring mature, at-risk products from larger pharmaceutical groups looking to streamline their product portfolios.

Essential Pharma is a trusted partner to multiple pharma companies of all sizes with a proven history of integrating assets, managing complex technology and product transfers while ensuring continual and sustainable supply to patients.

Essential Pharma maintains strong relationships with partners at multiple manufacturing sites across Europe and the US in order to ensure the continuing manufacture of its products to the highest regulatory standards.

Essential Pharma’s growth strategy is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long term sustainable growth, including healthcare.

For more information, please visit essentialpharmagroup.com

CONTACTS

Essential Pharma

Steen Vangsgaard, CEO

Tel: +44(0)1784 477 167

Email: info@essentialpharmaceuticals.com

Consilium Strategic Communications

Mary-Jane Elliott / Tracy Cheung / Matthew Cole

Tel: +44 (0) 20 3709 5700

Email: Essentialpharma@consilium-comms.com

GlobeNewswire Distribution ID 1000772445

UK marketing authorisations for IOPIDINE® (apraclonidine) fully transferred to Essential Pharma as change in UK NICE guidelines for glaucoma treatment expected to lead to increase in patients’ need for product

UK marketing authorisations for IOPIDINE® (apraclonidine) fully transferred to Essential Pharma as change in UK NICE guidelines for glaucoma treatment expected to lead to increase in patients’ need for product

Recent change in NICE guidelines indicating laser surgery as first line therapy for glaucoma is expected to increase need for IOPIDINE to control or prevent post-surgical elevations in intraocular pressure

Continuation of global marketing authorisation transfer from Novartis for this important product

Zug, Switzerland & Egham, UK – 15 December 2022 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically well-established pharmaceutical products across key therapeutic areas, announces that it has completed the transfer of the UK marketing authorisations for IOPIDINE® (apraclonidine) in both available concentrations, IOPIDINE® 0.5% and 1%, following its acquisition of the product from Novartis in December 2021.

IOPIDINE® is a short-term adjunctive therapy for patients with chronic glaucoma to prevent or control intraocular pressure*,1 including after selective laser therapy, a form of laser eye surgery now recommended as the initial treatment for open angle glaucoma.2

A recent change in regulations by the UK’s National Institute for Health and Care Excellence (NICE), which placed laser surgery as first line therapy for glaucoma, means that IOPIDINE®, especially IOPIDINE® 1% which is indicated to control or prevent post-surgical elevations in intraocular pressure that occur in patients after selective laser therapy (SLT), will continue to be an important treatment for glaucoma patients that require additional intraocular pressure reduction.2

The acquisition of this long-established therapy sold across more than 20 global markets including several countries in the EU plus Canada, Australia and Japan, is in line with Essential Pharma’s commitment to ensure the sustainable supply of essential specialty medicines to patients. The acquisition also demonstrates Essential Pharma’s strong integration capabilities for newly acquired products and underlines the group’s strategy to be a trusted partner to regional and global pharma companies looking to streamline their portfolios across international markets.

Steen Vangsgaard, CEO of Essential Pharma, commented: “We are delighted to have completed the MA transfer, enabling us to ensure the continued supply of IOPIDINE® and fulfilling a vital need for patients, as has been demonstrated by the change in recent NICE guidelines. We are also pleased that Novartis chose us as a trusted partner for its divestment, further underlining Essential Pharma’s expertise and commitment to ensuring long-term, structured supply of established medicines.”

Gus Gazzard, Professor of Ophthalmology (Glaucoma Studies) UCL & Director of Surgery at Moorfields, commented: “Based on a 3-year scientific study, we compared the treatment of glaucoma using continuous daily eye drops with initial selective laser therapy. This study has shown that SLT has favourable cost-effectiveness versus treatment with daily eye drops.3 Followed by a public consultation finalised in 2021, NICE decided to change the guidelines to recommend SLT as a first line therapy for all open angle glaucoma, which is expected to contribute to meaningful savings to the NHS over the coming years.” 2

In the UK, chronic open angle glaucoma (COAG) affects around 2% of people aged over 40 and can rise to almost 10% in people aged over 75. Ocular hypertension (OHT) affects 3-5% of people in the UK over 40 years of age and occurs when pressure inside the eye is higher than normal, which can cause glaucoma. According to latest NICE guidelines which were updated in 2022, SLT is now recommended as a first line option to treat glaucoma and ocular hypertension allowing patients to quickly receive effective treatment to improve their quality of life.2

1.   IOPIDINE® Summary of Product Characteristics. Available from https://www.medicines.org.uk/emc/product/839/smpc. Accessed December 2022

2.   NICE, Press Release 26 January 2022. Selective laser therapy recommended to treat glaucoma and ocular hypertension. Available from https://www.nice.org.uk/news/article/selective-laser-therapy-recommended-to-treat-glaucoma-and-ocular-hypertension#:~:text=News,Selective%20laser%20therapy%20recommended%20to%20treat%20glaucoma%20and%20ocular%20hypertension,(Wednesday%2C%2026%20January). Accessed December 2022

3.   Gazzard G, Konstantakopoulou E, Garway-Heath D, et al. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial, Lancet. 2019 Apr 13;393(10180):1505-1516. (https://pubmed.ncbi.nlm.nih.gov/30862377/. Accessed December 2022)

About Essential Pharma

Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to well-established, “at risk” products essential to patients across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving patients access to medicines that otherwise may not be available.

Essential Pharma operates globally, supplying a portfolio of over 150 essential medicines across multiple therapeutic areas. Essential Pharma’s growth strategy is based around identifying and acquiring mature, at-risk products from larger pharmaceutical groups looking to streamline their product portfolios.

Essential Pharma is a trusted partner to multiple pharma companies of all sizes with a proven history of integrating assets, managing complex technology and product transfers while ensuring continual and sustainable supply to patients.

Essential Pharma maintains strong relationships with partners at multiple manufacturing sites across Europe and the US in order to ensure the continuing manufacture of its products to the highest regulatory standards.

Essential Pharma’s growth strategy is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long term sustainable growth, including healthcare.

For more information, please visit essentialpharmagroup.com

CONTACTS

Essential Pharma

Steen Vangsgaard, CEO

Tel: +44(0)1784 477 167

Email: info@essentialpharmaceuticals.com

Consilium Strategic Communications

Mary-Jane Elliott / Tracy Cheung / Matthew Cole

Tel: +44 (0) 20 3709 5700

Email: Essentialpharma@consilium-comms.com

GlobeNewswire Distribution ID 1000772445