Crossject still on course for launch of first 'supergeneric' next year
The French company is focused on the development of what it calls 'supergenerics', making use of its delivery platform to turn elderly, established drugs with no patent protection into vibrant new brands.
Heading its pipeline of seven supergenerics is a formulation of methotrexate (MTX) delivered using Crossject's Zeneo needle-free injector, a device which makes use of a miniaturised gas propellant technology normally encountered in airbags.
Liquid formulations of drugs are propelled at enormous velocities by the injector, penetrating the skin and collecting in the tissues below. Crossject says that with fine tuning, the approach can be adapted to deliver both small- and large-molecule drugs and vaccines, and also deposit the payload intradermally, subcutaneously or intramuscularly, as desired.
The company has just achieved a couple of significant objectives on its path to commercialisation its Zeneo platform, according to analysts at Edison, who expect the firm to start generating revenues from sales before the end of 2017.
Firstly, it has agreed a manufacturing partnership with French contact manufacturing organisation (CMO) Cenexi, which will take charge of the filling and assembly of Zeneo MTX and subsequent products.
This change in manufacturing will delay the expected marketing approvals and launch of Zeneo MTX from the first- to second-half of next year, notes Edison in a new research report.
However, owever, H"Crossject's management believes the deal will improve its ability to ramp-up production to meet expected demand and reduce capital expenses by shifting industrial investment responsibility to Cenexi," it adds. The company has previously announced its intention to build an 1,800 m2 lab and GMP production facility near Dijon.
In the meantime, Crossject has completed a successful bioequivalence study for Zeneo MTX and expects to file for marketing authorisation in Europe later this year.
It also has a clear path to market in China after signing a supply agreement for Zeneo MTX with Xi'an Xintong Pharmaceutical Research, which the company has estimated could be worth €360m over the next 10 years, and has also licensed the drug to Sayre Therapeutics for distribution in India, Sri Lanka, Bangladesh and Nepal.
At the moment, Crossject's valuation of around €44.6m "appears to be modest given the breadth and depth of the pipeline, advanced stage of clinical development and the market opportunity for the Zeneo system," according to Edison.
In the near-term, Crossject sees considerable potential for its second product, a Zeneo formulation of adrenaline/epinephrine that is intended as an alternative to needle-based auto-injectors such as Meda's EpiPen, which are carried by millions of people around the world.
The company has already signed an unnamed commercial partner for the product, which is billed as an easy-to-use and safer alternative to adrenaline auto-injectors.
A 2014 study by the University of Texas showed that fewer than 20% of patients used this form of auto-injector correctly. And last year, a European Medicines Agency (EMA) review concluded there were considerable issues with these devices, including a tendency to deliver drug to the skin rather than muscle if patients lack effective training.
The EMA review was prompted by a Medicine and Healthcare products Regulatory Authority (MHRA) investigation into the death of a teenager from a nut allergy despite her using an auto-injector.
Crossject maintains that its formulation eliminates dosing errors and could provide cost savings by keeping patients suffering from an allergic reaction out of the emergency room.
Other Zeneo-delivered drugs in Crossject's pipeline include sumatriptan for migraines, epilepsy drug midazolam, apomorphine for Parkinson's disease and naloxone for opioid overdose.
