Development of new Foscavir® product presentation

For immediate release

05 May 2016

CLINIGEN GROUP PLC 

Clinigen develops new Foscavir® (foscarnet sodium) product presentation

Revitalisation of Foscavir® continues with new 250ml bag presentation 

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has developed with Medisol and acquired from them the exclusive global rights to a 250ml bag form of foscarnet sodium, to continue the revitalisation of Foscavir®, in line with Group strategy.

The rights to the new bag presentation were acquired for an upfront payment to cover development costs followed by milestone payments over three years related to gaining marketing authorisations in key markets.

Clinigen has been supplying Foscavir to hospitals in 250ml glass bottles since its acquisition of the product from AstraZeneca in 2010. As stated at the HY results, it has been the Group's strategic intention to further diversify the presentation of Foscavir to provide hospital pharmacists with more options to meet their needs.

The development and acquisition of Medisol's presentation of foscarnet sodium, in 250 ml plastic (polyolefin) bags will give the Group a 'ready to use' option to offer its customers. Clinigen will now own all the intellectual property related to this bag presentation of foscarnet.

David Moran, Managing Director, Clinigen Specialty Pharmaceuticals, said:

"This product development is part of our ongoing strategy to differentiate Foscavir and extend its product life. By offering a new bag presentation, we are responding to our customers' requirements and strengthening our position in the foscarnet market. The bag presentation, using a different API and finished product manufacturer, gives us both security of supply and a choice of product, enhancing our market offering.

"Foscavir remains a highly effective CMV treatment in clinical practice. We will continue to invest in its development, offering continued benefits to patients and healthcare practitioners worldwide."

Peter George, CEO of Clinigen said:

"This further strengthens our portfolio and represents our commitment to revitalising our existing products in parallel to finding new products to add to our growing Specialty Pharma portfolio. Foscavir is a key product for the Group and our success with the product has helped secure this exclusive development agreement for the bag form of Foscavir with Medisol.

"Over the medium to long term, we believe the bag option will become the preference for hospitals worldwide due to its ease of use. We will commence the roll-out in Europe over the next 12 months before launching the product in other geographies including the US, Japan and LATAM."

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About Foscavir® (foscarnet sodium)

Foscavir® is licensed for the treatment of cytomegalovirus (CMV) retinitis in HIV patients, and acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.

The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.

The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programs for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).

Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital commercial products.

For more information, please visit www.clinigengroup.com

About Medisol

Medisol is a company specialising in the development of injectable niche pharmaceutical products and related Intellectual property rights. The company was founded in Lyon, France in 2011 by Alain BOTELLA, Managing Director and Gil CHEVALIER, President.