Crossject - Prefilled single-use needle-free injection devices

Crossject technology is the outcome of R&D cooperation initiated and developed with industrial partners, each a European leader in its field. This new and highly innovative therapeutic solution offers answers to the main public health issues posed by the use of needles.

There is strong demand for needle-free injection technology. Zeneo, the Crossject range of needle-free injectors, offers answers to many major unresolved public health issues:

  • needle phobia - Zeneo helps approximately 10% of the patients overcome their fear of needles so they can take their medical treatment
  • accidental contamination (needle-stick injury) of healthcare staff and patients' entourage becomes a thing of the past
  • emergency situations - in many conditions, such as allergies or asthma attacks, rapid intervention is crucial; Zeneo provides an instant, simple to deliver, remedy
  • patient quality of life - Zeneo is a self-administered device that reduces the social stigma associated with chronic injectable treatments, making them more acceptable to patients and considerably improving their quality of life
  • poor compliance - according to the WHO, poor compliance with chronic treatments is a global problem affecting 50% of patients; Zeneo improves compliance considerably.

The Zeneo range of needle-free injectors covers a broad spectrum of drug delivery techniques, including intradermal, subcutaneous and intramuscular. Of all the various methods of drug delivery, injectables represent a fast-growing share of the market, worth $10bn. Additionally, over half the products in early clinical development, particularly those developed through biotechnology, are administered using this method. This creates an extraordinary market opportunity for single-use, needle-free injectors, which clearly enjoy the greatest growth potential.

Rheumatoid arthritis/auto-immune diseases

Rheumatoid arthritis is a degenerative disease affecting the joints, which gradually become deformed and painful. Patients require lengthy chronic treatment, involving frequent injections administered at home.

With the loss of dexterity that rheumatoid arthritis can cause, self-injecting a dose of anti-tumour necrosis factor can be a daunting challenge. Zeneo improves the treatment offered to patients suffering from this disease by making self-injection much easier, safer and more reliable. The injector is prefilled, so the patient can inject the right dosage.

When it comes to injectables, anything that makes the injection more comfortable (less frequent or less invasive) for the patient is also an obvious aid to ensuring better treatment compliance.

Zeneo business model and strategy

Zeneo is an ideal platform for pharmaceutical companies. Combining the injector with conventional or biotech drugs provides real added value, whether the drug concerned is in development, coming to market, already on the market or in generic form. At every stage, the difference lies in Zeneo's stand-out differentiation and its ability to improve the medical service rendered. The Zeneo business model is based on two approaches:

  • selling operating licences to pharmaceutical companies to expand their drug catalogue - the devices are customised in accordance with specific requests; Crossject has already entered agreements with several international pharmaceutical firms, including GSK
  • selling distribution licences for turnkey product/services combining device and drug via internal development to obtain marketing approval for off-patent drugs.

Innovative platform with many applications

The Zeneo is made up of three distinct subassemblies: an actuator, a pharmaceutical subassembly and a nozzle. The actuator generates sufficient pressure to inject the drug to the required depth beneath the skin, without the use of a needle. But the real innovation is the platform's extraordinary ability to adapt to different pharmaceutical applications:

  • the intensity of the gas generator and the nozzle can be adapted to ensure the proper penetration and optimal distribution of the drug in the target tissue
  • the pharmaceutical subassembly can be aseptically filled on standard high-throughput syringe filling lines.

To date, Crossject has filed 26 patent family applications and holds over 370 patents granted worldwide.

Needle-free injectors evolve

There is now much more interest in needle-free technologies, as more sophisticated solutions reach the market. Manufacturers hope that customers will take a long-term view of costs, as there is value behind the higher purchase price of needle-free injectors.

There has been a long-standing interest among the medical community to develop needle-free devices for delivering drugs through the skin. Indeed, workable solutions are nothing new, but it seems the technology has recently taken a major step forward, opening the possibility of its widespread use.

Greater awareness of the importance of infection control, especially in the USA and Europe, has led to a greater need for single-use devices. Previously, this meant modified traditional syringes, but now there is a needle-free alternative. 'Needle-free technologies were first created at the beginning of the last century, and multi-use devices were used for vaccinations in the army and in the third world,' explains Bruno Besse, director of medical affairs for Crossject SA. 'Now, we have developed small, single use devices. Big, expensive devices have now been miniaturised.'

Crossject designs and develops drug delivery solutions for the pharmaceutical industry. Its single-use, needle-free technology relies on its unique gas generator technology, which uses energetic materials similar to an airbag to produce a pressure customised to the chosen drug and the required depth of delivery through the skin.

For the patient, this technology offers many advantages, of which the most significant is the absence of a needle. Needlephobia, according to the American Psychiatric Association, affects around 10 per cent of the population. Beyond those
people, there are also many who may not qualify as phobic, but who might avoid vaccination or be less compliant with selfinjection therapies due to a strong aversion to needles.

'Needlephobia is not uncommon, and there are others who just don't feel comfortable with needles,' says Besse. 'Selfinjection can be hard, so our device has been designed by ergonomists to not resemble a syringe with a needle. 'There is a lot of interest from the point of view of patient care and the use of self-injection for more than just diabetes. So, there is more focus on a small device that is simple to use for self-therapy.'

For health workers and hospitals, the Crossject solution has additional benefits. For instance, it features a detachable nozzle, which allows the drug-filled glass cylinder to be removed. These glass vials can be quickly and easily filled using standard

Better long-term value

Tests on this latest evolution of needle-free technology show it to be at least as effective as traditional syringes in terms of volume of drug delivered. Furthermore, it exhibited improved diffusion and more reliable depth of penetration. As well as
improving safety and protecting against infection, needle-free devices for single-use could also offer cost benefits in the longterm. More reliable penetration, for example, could mean more efficient use of drugs.

'Overall, cost would be the same or maybe lower. To inject the same volume of drug, you don't need to fill the device as much - you can save around 8 per cent in volume of vaccines. With expensive drugs, this can be important. Then you have to discount the human cost of people not complying with self-injection therapy,' explains Besse.

Developers like Crossject are already looking to produce smaller devices, which might enable intradermal injection. Though this is normally time-consuming to perform, and there are few drugs designed for this method of delivery, it could be the preferred mechanism for delivery administering gene-vaccines or bio-tech drugs. It is also a method that requires around 20 per cent of the volume of the drug compared to IM or subcutaneous injection and so promises further cost efficiencies.

Despite the test results, doubts nevertheless linger among some leading pharmacists. 'There is a lot of interest, but people are sceptical because of the failure of one of our competitors a few years ago,' notes Besse. 'But, they also see that the delivery technology, which is not a medical device, but has a patent that could cover the drug, like a pre-filled pen. This can prolong the lifecycle of an existing drug, as well as providing a differentiator in the market for new drugs.' There is little doubt that the technology is ready, but it needs the mindset of the industry to accept it.

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The gas and nozzle can be adapted to ensure accurate drug delivery.
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