SLS Europe and Bilthoven Biologicals receive positive CHMP Opinion for SIILTIBCY – a novel Tuberculosis Skin Test in Europe

SLS Europe and Bilthoven Biologicals receive positive CHMP Opinion for SIILTIBCY^® – a novel Tuberculosis Skin Test in Europe

• SIILTIBCY^® is poised to be the first skin test in Europe that accurately detects TB, regardless of BCG vaccination status
• EMA has given a positive recommendation, with a final decision on marketing approval expected by the end of 2024.
• Recommendation is based on comprehensive manufacturing and clinical data showing the accuracy and safety of SIILTIBCY^®
• SIILTIBCY^® will be ready for shipment to EU Member States immediately following authorization by the European Commission
• This collaboration marks a significant milestone for the Cyrus Poonawalla Group of companies - SLS Europe, Bilthoven Biologicals, and Serum Institute of India - to deliver innovative solutions for Tuberculosis infections

Bilthoven (The Netherlands) – Hannover (Germany), October, 23, 2024 – Serum Life Science Europe GmbH (SLS Europe), a pharmaceutical development company and Bilthoven Biologicals (BBio), a vaccine manufacturer, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending authorisation of SIILTIBCY^®, the diagnostic test for tuberculosis (TB) infection in adults and children aged 28 days or older.

The European Commission (EC) will review the CHMP recommendation, with a final decision anticipated in the fourth quarter of 2024. SIILTIBCY^®, already marketed in India as Cy-Tb, is manufactured by Serum Institute of India to ensure supply readiness in Europe and globally. Following the EC decision, the diagnostic test will be available to applicable EU Member States. SLS Europe will be the Marketing Authorization Holder, while BBio will import, release, and market SIILTIBCY^®.

The positive CHMP opinion is based on a comprehensive review of manufacturing, development and clinical trial data supporting the accuracy and safety of SIILTIBCY^®. This assessment is informed by results from three pivotal Phase 3 clinical trials involving over 2,500 participants across Europe and Africa, which demonstrated the test's effectiveness for diagnosing TB. Trial findings were published in reputable medical journals, including The Lancet Respiratory Medicine.

Adar Poonawalla, CEO of Serum Institute of India, remarked, "The positive CHMP opinion for SIILTIBCY^® is a watershed moment in our fight against tuberculosis. This skin test, developed through years of research, addresses a critical gap in TB diagnostics by providing accurate results regardless of BCG vaccination status. As we prepare to introduce SIILTIBCY^® to the European market, we're offering a powerful new tool that could support global eradication efforts. This milestone underscores our commitment to developing innovative, affordable solutions for pressing global health challenges.”

“The EMA’s positive opinion for SIILTIBCY^® represents a crucial advancement in the fight against TB,” said Leander Grode, Managing Director of SLS Europe. “By strengthening diagnostic capabilities, we are taking significant strides toward supporting public health initiatives and aligning with global efforts to eradicate TB.”

“Traditional TB skin tests often produce false-positive results in BCG-vaccinated individuals due to cross-reactivity. By providing a reliable and precise diagnostic test, we are empowering healthcare professionals to make better-informed decisions, contain the costs of diagnosis and ultimately save more lives,” said Jurgen Kwik, Chief Executive Officer of BBio. “We welcome the positive opinion for SIILTIBCY^® and are working towards making the diagnostic available across Europe.”

The expected approval of SIILTIBCY^® signifies the first collaboration for European product introductions between sister companies SLS Europe, BBio, and Serum Institute of India which are part of the Cyrus Poonawalla Group. In this partnership, SLS Europe will serve as the Marketing Authorization Holder, overseeing regulatory compliance and product safety. BBio will import, release, and market SIILTIBCY^® across the EU Member States. The Serum Institute of India, the world’s largest vaccine manufacturer by doses produced and sold globally, has been responsible for manufacturing SIILTIBCY^® to ensure supply readiness both in Europe and worldwide.

About TB

An estimated 2 billion people worldwide are infected with TB and annually 9 million people fall ill with the disease. Although Europe is considered a low incidence region, with over 170,000 TB cases annually, the huge reservoir of TB infection in the world stresses the importance of targeted testing. Targeted testing is one pillar in WHOs End TB Strategy to further lower the incidence of TB.

About SIILTIBCY^®

SIILTIBCY^® is a skin test, indicated in the EU and European Economic Area countries for diagnosing TB infection, in adults and children aged 28 days or older. SIILTIBCY^® should be used in combination with risk assessment, radiography, and other medical and diagnostic evaluations. The first-in-class ESAT-6 and CFP-10 containing skin test was designed to provide high specificity in a field-friendly format.

About SLS Europe

SLS Europe is a pharmaceutical consulting and development company based in Hannover, Germany. Established in 2002, SLS Europe provides strategic expertise in pharmaceutical development, clinical trial management, and regulatory affairs, specializing in guiding biotechnology and pharmaceutical companies through the European and global regulatory landscape. The company supports product development from R&D to commercialization, collaborating with partners to bring innovative products to both European and global markets.

As the Marketing Authorization Holder, SLS Europe ensures regulatory compliance and oversees the safety and efficacy of its products throughout their lifecycle. SLS Europe is part of the Cyrus Poonawalla Group, enhancing its capacity in the pharmaceutical sector.

About BBio

BBio is a Netherlands-based end-to-end vaccine manufacturer of viral and bacterial vaccines, with its facilities in Bilthoven - Utrecht Science Park Bilthoven. A carve-out of the former Netherlands Vaccine Institute, it was acquired by Serum Institute of India in 2012 and today employs a little under 500 people. 

The company has a long-standing track record in supplying vaccines to European markets and works with global health partners such as UNICEF, PAHO, and WHO & /GAVI. With the manufacturing of polio vaccines, BBio is key contributor to the worldwide program for polio eradication. BBio is part of the EU funded pandemic preparedness program, having ever-warm vaccine manufacturing facilities. Together with SII, BBio offers its unmatched end-to-end vaccine capabilities to vaccine developers and innovators, making affordable vaccines and therapies available worldwide.

About Serum Institute of India

Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SII's multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.

Founded in 1966, SII's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosil,' the world's most affordable PCV, 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second malaria vaccine to be authorized for use in children in malaria-endemic regions. Moreover, SII has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.

To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide.

Contact:      
Bilthoven Biologicals B.V.     
Teunie Westera       
+31 30 800 464 0       
teunie.westera@bbio.nl      

Serum Life Science Europe GmbH     
Dr. Leander Grode       
+49 511 169 908 0       
bd@sls-eu.com

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