Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

By Dan Stanton

- Last updated on GMT

Related tags: Pharmaceutical drug, Pharmacology

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex
Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax vaccine using its solid-dose injector – welcome to our needle-free drug delivery round-up.

Injex Pharma’s INJEX30 drug delivery device is a standalone needle-less product for the administration of injectables such as insulin, though Dr. Dirk Kautz - SVP Research & Business Development at Injex - told in-Pharmatechnologist.com that currently the company “is looking for cooperation partners in the pharmaceutical industry regarding combination products involving prefilled ampoules.”

His words come following news of the successful accreditation by China’s Food and Drug Administration (CFDA – formerly known as the SFDA) of the INJEX30 device following a long-awaited approval process.

“China is a very important market for INJEX Pharma,”​ said Dr. Dirk Kautz, SVP Research & Business Development at Injex, speaking with in-Pharmatechnologist.com, “especially with regards to diabetes.”

According to figures from the International Diabetes Federation ‘Diabetes Atlas’ 2012​, over 92m people in China has diabetes (either type I or II), almost four times that of the USA and thus this market was important for Injex to enter.

The INJEX30 is an independent delivery device for administering liquid medications suitable for jet injection without the use of a needle. Instead a fine stream of medication is propelled through a small hole at the end of a disposable ampule.

The device has had European authorisation since 2000 and is also allowed to be marketed in the US and Canada.

Glide Pharma Awarded ‘Solid-Dose’ Contract by Pfenex

Glide Pharma - who recently received a £14m ($21m) investment​ to bring its Solid-Dose Injector (SDI) to market - has been selected by Pfenex to develop a solid formulation containing the recombinant Protective Antigen (rPA) from Bacillus anthracis expressed in Pfenex Expression Technology.

Furthermore, the drug will be manufactured to be suitable for delivery using the SDI technology – a combination of a disposable drug cassette and a reusable applicator which delivers a solid dose formulation under the skin using a spring-powered actuator.

Bertrand Liang, CEO of Pfenex said in a statement: “[Glide’s] novel formulation and delivery technology allows us to expand our anthrax vaccine program.”

Such systems belongs to part of a number of needle-less products being used for medications which need to be administered on a regular basis, and thus offer more comfort and convenience to users.

Demand in innovative and alternative delivery systems such as insulin pens, auto-injectors and solid-dose injectors has also led recent investments and regulatory approval from a host of companies including SHL​, Merck Serono​, and Biogen​. 

Related topics: Drug Delivery, Delivery technologies

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