Crossject Reports Positive Results From Bioequivalence Study With Needle Free ZENEO® Methrotrexate

CHENÔVE, France, November 24, 2014 /PRNewswire/ —

  • The needle-free injection with ZENEO® Methrotrexate produces similar blood levels to the current injectable formulation
  • Study data an important milestone in the development of CROSSJECT’s portfolio of ZENEO® needle-free products

CROSSJECT (ISIN: FR0011716265; Mnémo: ALCJ), the creator of ZENEO®, a needle free injection system, announces the similarity between the ZENEO® Methotrexate needle-free injection system and the current injectable formulation. ZENEO® Methotrexate has met its objectives in a key bioequivalence study, enabling CROSSJECT to show the clinical effectiveness of its innovating product, also called “needle free injection”.

This clinical study, also called a bioequivalence study, is the only one needed to confirm the effectiveness and the safety of the product, with a view to complete the filing of the marketing authorization (MA) application for ZENEO® Methotrexate in Europe. Moreover, CROSSJECT’S clinical development plan for ZENEO® Methotrexate has received approval from the ANSM and the FDA.

ZENEO® Methotrexate, an innovative needle-free and subcutaneous auto-injection device, has been developed principally for the treatment of rheumatoid polyarthritis, a chronic inflammatory disease which can lead to deformities and deterioration of joints. Methotrexate is already registered in the form of pre-filled syringes.

The single center bioequivalence study was conducted on 52 subjects. The results demonstrate the similarity between ZENEO® needle-free administration and current needle injection systems, as the principal objectives of the study were achieved. ZENEO® delivered the desired dose of methotrexate (25 mg).

The success of this study has allowed CROSSJECT to confirm ZENEO®’s potential to offer better treatment compliance compared to current injection systems. It also promises to be better tolerated when compared to oral formulations of methotrexate.

ZENEO® Methotrexate already has a commercialization partner in France. These results should help accelerate current negotiations with potential European and international commercialization partners for this promising product.

Patrick Alexandre, President and founder of CROSSJECT, stated:“We are very pleased with the positive results of this study, which confirm the effectiveness and reliability of our ZENEO® device. These results represent an important landmark in the development of our needle-free ZENEO® device and make us more optimistic about our ability to successfully execute our strategy and build value from our portfolio of exciting supergeneric products.”

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About Crossject – http://www.crossject.com

Crossject is using its world-leading needle-free injection system, ZENEO™ to develop an attractive pipeline of high value SUPERGENERICS or New Therapeutics Entities. These needle-free products, which are based on well-known injectable drugs (chemicals & biologics), are designed to enhance patient safety, compliance and comfort.

Crossject’s needle-free, pre-filled, single-use ZENEO ™ injection systems are unique in that they can be tailored to deliver drugs intra-dermally, subcutaneously and intramuscularly. This means that ZENEO™ can allow a wide range of drugs and vaccines for a broad range on indications to be developed and approved in a very short period of time. Outside its own portfolio of SUPERGENERICS, Crossject anticipates partnering ZENEO with other pharma/biotech looking to improve the life cycle management of their key drugs or biologics.

CROSSJECT is listed on Alternext Paris (Mnemo : ALCJ, ISIN : FR0011716265)


Patrick Alexandre / Timothée Muller


Citigate Dewe Rogerson
Laurence Bault /Lucie Larguier
+33(0)1-53-32-84-78 / 84-75

SOURCE Crossject

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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