Sinclair Pharma Regulatory News (SPH)

Ellansé® Approved for Sale in Brazil

Second generation collagen stimulator approved by ANVISA

Launch anticipated within weeks

London, 16 January 2018 Sinclair Pharma plc (AIM:SPH.L) ("Sinclair" or the "Group"), the international aesthetics company, is pleased to announce that it has received regulatory approval of Ellansé® by ANVISA in Brazil.

Brazil is the one of the leading aesthetic dermatology markets with around 1.3 million* injectable procedures estimated to have taken place in 2017.

Ellansé is the first of a new class of pre-mixed bioresorbable collagen stimulating fillers. The 'L' and 'E' formulations are the longest acting, non-permanent products available, and with all four formulations ('S', 'M', 'L', 'E') approved at the outset, Sinclair will offer Tunable Longevity™ providing up to 4 years clinical benefit.

In anticipation of this approval and ahead of launch, Sinclair had created an Ellansé Brazil Advisory Board comprising some of the most influential plastic surgeons and dermatologists in that market. Chaired by Dr Reinaldo Tovo and Dr Antonio Graziosi, this group of key opinion leaders is already educating the clinician community throughout Brazil and more widely in Latin America.

Dr Antonio Graziosi - "Ellansé is a new class of dermal fillers that brings duration, with the benefit of collagen stimulation and volume, to our patients. It's an amazing alternative for me and for Brazilian clinicians."

Dr Reinaldo Tovo - "The use of fillers that can also safely biostimulate the production of one's own collagen is a new concept that is revolutionising treatments. This new polycaprolactone filler can produce an effect, which lasts four years, creating positive results for doctors and patients."

In anticipation of approval early in 2018, Sinclair invested in multiple pre-launch activities including physician training during H2 2017. Today's news means that the product can now be 'soft launched' immediately, ahead of our planned full launch at the end of Q1. A busy calendar of educational, promotional and training events is scheduled for 2018, including our first LATAM World Experts' Meeting in Rio de Janeiro in June. Over 1,000 dermatologists and plastic surgeons are expected to attend this two day Sinclair only event.

Sinclair's Brazilian affiliate has already delivered very strong sales traction for Silhouette Soft® and more recently Perfectha®. This affiliate is Sinclair's largest by revenue and headcount, with coverage across all the major cities and a commercial team comprising 42 sales representatives. Silhouette Soft sales in Brazil are already the highest in any territory where it is approved. Perfectha was brought in-house early last year, but due to regulatory reasons could only be relaunched by Sinclair in Q4 2017. The launch has so far been highly successful and the product already looks set to surpass its previous market share.

Chris Spooner, CEO, commented: "This is a great start to the year and builds on the commercial momentum from 2017. Pre-marketing and product training activities in Brazil have already generated widespread interest in Ellansé, aided by a new Advisory Board comprising top plastic surgeons and dermatologists, renowned throughout the world as well as South America. Sinclair has a very busy programme of launch and training events including our first LATAM 'WEM', and I am confident in our Brazilian team's ability to rapidly convert this investment into strong sales growth. More broadly, Ellansé in-market sales growth exceeded 30% in Q4 2017 and aided by this approval and strong trends in several other markets, we expect this growth rate to accelerate through 2018."

*Millenium Research

Ends

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About Ellansé®

Ellansé is a tailor-made bioresorbable collagen stimulator. Ellansé works by not only correcting the wrinkles and folds in the skin, but also by stimulating the body's own collagen for a long-lasting, natural result. It is fully resorbed by the body over time. Ellansé is different to other dermal fillers which are commercially available, offering a unique combination of total and predictable bio-resorbability for its entire range. Only administered by trained physicians, Ellansé offers a personalised treatment option with a sustained duration of 12 months (Ellansé-S) up to 4 years (Ellansé-E).

See www.ellanse.com

About Sinclair Pharma plc - www.sinclairpharma.com 

Sinclair Pharma plc is an international company operating in the fast growth, high gross margin, global aesthetics market. Sinclair has built a strong portfolio of differentiated, complementary aesthetics technologies, which are experiencing significant growth, targeting unmet clinical needs for effective, high quality, longer duration, natural looking and minimally-invasive treatments. Against the background of a dynamic market growth rate, Sinclair is planning multiple new launches and line extensions over the next few years, notably in China and the USA. The Group has an established sales and marketing presence in the leading EU markets, Brazil and South Korea, and a network of international distributors including the US.

"Safe Harbor" Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward‐looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward‐looking statements due to a variety of factors.