NeuClone Announces First Human Dose of Stelara (Ustekinumab) Biosimilar Candidate in Phase I Clinical Trial
[caption id="attachment_9277" align="aligncenter" width="732"] Press Release[/caption]
SYDNEY, AUSTRALIA, October 17, 2019 ? NeuClone, a clinical-stage biopharmaceutical
company exclusively focused on developing high-quality biosimilar products, today
announced it has commenced dosing of Stelara? (ustekinumab) biosimilar candidate,
NeuLara, in a Phase I clinical trial.
The single-dose, double-blind, randomised, three-arm study is being conducted across
multiple Australian sites in over 200 healthy volunteers. The primary objective is to
demonstrate equivalent pharmacokinetics (PK) and secondary objective is to demonstrate
equivalent safety of NeuLara to US- and EU-sourced Stelara?.
NeuLara is the second biosimilar from NeuClone?s pipeline to enter clinical development and
is developed in partnership with Serum Institute of India.
?Following several years establishing NeuClone as a leading biosimilar company, NeuLara?s
entry into clinical development demonstrates our ability to advance multiple biosimilar
products that will provide greater access to affordable, life-changing medicines, globally.?
stated Dr Noelle Sunstrom, CEO and Founder of NeuClone.
The NeuLara Phase I clinical trial is being conducted under the Australian Therapeutic
Goods Administration (TGA) Clinical Trial Notification (CTN) scheme. This pathway offers a
streamlined approach and data output is supported by global regulatory agencies such as
the EMA and U.S. FDA.
Prior to initiating the trial, NeuLara was subjected to extensive preclinical testing to confirm
structural and functional similarity in comparison to the reference product Stelara?. Testing
included positive PK and safety results from a non-clinical primate study, as well as
comprehensive physicochemical analysis of Stelara? and NeuLara, including X-ray
crystallography.
NeuLara is being developed as a biosimilar candidate of ustekinumab, an antibody targeting
interleukin-12 and -23, approved under the brand name Stelara? to treat patients with plaque
psoriasis, psoriatic arthritis, Crohn?s disease and ulcerative colitis.
In 2018, Johnson & Johnson reported Stelara? global sales of USD 5.2 billion.
1
EvaluatePharma (2019) predicts this figure will increase over the coming years, reaching
USD 7.8 billion in 2024.
2
NeuClone representatives are attending the upcoming 2019 BIO-Europe conference in
Hamburg from 11-13th November and look forward to discussing biosimilar development and
commercialisation opportunities with potential partners.
About NeuClone
NeuClone is a clinical-stage biosimilar company focused exclusively on developing a
pipeline of biosimilar monoclonal antibodies. Six biosimilar products have been disclosed in
NeuClone's pipeline that reference Herceptin?, Stelara?, Synagis?, Prolia?/XGEVA?,
Perjeta? and Humira?. NeuClone develops biosimilar products using its proprietary
NeuMAX? platform that facilitates low-cost manufacture of biologics, while enabling the
highest product quality. NeuClone is led by a highly experienced team with state of-the-art
integrated facilities based in Sydney, Australia. For more information, please visit
www.neuclone.com.
About the NeuClone and Serum Institute Partnership
NeuClone and Serum Institute have partnered to develop multiple biosimilars for global
registration in accordance with the most stringent regulatory standards. Serum Institute is
well known in the vaccine industry as the world?s largest vaccine manufacturer by number of
doses produced and sold globally (over 1.6 billion annually). NeuClone and Serum Institute
have a strategic and commercial vision to replicate Serum Institute?s vaccine success with
biosimilars ? making them available at sufficient volume, quality and price to deliver globally.
Under the partnership, NeuClone is responsible for initial biosimilar development, analytical
characterisation and biosimilarity confirmation. Serum Institute is responsible for clinical and
commercial manufacture. In September 2019, Serum Institute inaugurated their new $450
million biologics facility located in Manjri, India. The two million square foot facility will include
commercial scale biosimilar manufacture and is designed for global regulatory compliance
including US and European agencies.
Company Contact
John Oksinski
Global Head of Business Development
j.oksinski@neuclone.com
Tel: +61 2 9209 4020
Media Contact
Mark Button
mark@markbutton.info
Tel: +1 408 310 2168
References
1 Johnson & Johnson. Johnson & Johnson Reports 2018 Fourth-Quarter Results. 22 Jan
2019.
2 EvaluatePharma. Word Preview 2019, Outlook to 2024. 12th Edition. June 2019.
Stelara? is a registered trademark of Johnson & Johnson.
Herceptin? is a registered trademark of Genentech Inc.
Prolia? and XGEVA? are registered trademarks of Amgen Inc.
Synagis? is a registered trademark of MedImmune Inc.
Perjeta? is a registered trademark of Genentech Inc.
Humira? is a registered trademark of AbbVie Inc.