Technology Prepares for Commercial Launch

The U.S. owner of needle-free injection technology invented in Cambridge is preparing for the commercial launch of the technology into a multi billion dollar market, over six years after the company that initially developed it lapsed into bankruptcy.

The DosePro technology – originally called Intraject – has received investment of well over a quarter of a billion dollars during its lengthy formative period, but San Diego, CA-based Zogenix, which bought it in 2006, has marked itself out as the company with the ability to make it pay.

The technology, first developed by failed Cambridge medical device specialist Weston Medical as long ago as 1994, has been earmarked for a US launch in January 2010 by new owners, Zogenix.

The product is being used in conjunction with the drug sumatripan and has been approved by US medicines regulator the Food and Drug Administration as a needle-free delivery system to treat acute migraine and cluster headache.

SUMAVEL DosePro is set to become the world’s first subcutaneous needle-free delivery system for the treatment of migraine.

The technology could also be making its debut on UK shores within the next two years after the European licensee for the technology, German firm Desitin Pharmaceuticals, filed for European regulatory approval of SUMAVEL DosePro in October.

Zogenix has pumped “a significant portion” of the $150m in private equity it has raised to date into the product, adding to the estimated $150m that was invested in it by Weston Medical and then Hayward, California-based Aradigm, which bought it in May 2003.

Although the outlay on the development of DosePro is considerable, the sums that have changed hands on the two occasions that the technology has been sold are less eye-watering.

Aradigm paid Weston Medical $2m for the intellectual property and other assets, while Zogenix paid $4m upfront for global rights to the technology, agreeing to a further milestone payment as well as royalties on product sales.

Aradigm divested the product as part of a strategic refocus around pulmonary drug delivery. The market for triptans, the class of drugs to which sumatripan belongs, is estimated to be worth $3.3bn in the US.

Zogenix has managed to gain regulatory approval for the technology in just three years, no mean feat given the lack of progress in the previous 12 and also the regulatory framework for a drug/device combination product. Such products are subject to the full drug New Drug Application process in the US, and the equivalent in Europe.

Catherine O’Connor, who is senior director, commercial communications at Zogenix, outlined the company’s achievements: “In the past three years since acquiring the DosePro technology from Aradigm, Zogenix has improved the delivery system, conducted bioequivalence and ease of use studies, submitted the new drug application with the FDA, developed full commercial plans including marketing strategy, programs, materials and PR, hired a sales force, entered a co-promotion agreement with Astellas US Pharma and are producing SUMAVEL DosePro at commercial scale. We also out-licensed the European rights to Desitin.”

Pain and CNS specialist, Zogenix recently announced a $20m dollar extension of its Series B funding round – bringing the total raised in the round to $71m – as it prepares for a launch of the product early next month. The company said  much of the proceeds would be used to build up stocks of the product ahead of launch and to expand its team.

Weston Medical, which floated in London in May 2000, employed as many as 150 at its height, seeing its market cap reach £355m. It fell from grace after a series of technical glitches and missed milestones lost it the confidence of investors. Licensees and partners included Roche, Abbott Laboratories and GlaxoSmithKline.

The company was working to a 2003 launch date when design problems first became public in September 2002.

Christopher Samler, the company's CEO went on to co-found venture capital firm, Iceni Capital.

But as Weston Medical’s contribution to the technology fades into the mists of time, Zogenix has earned itself the right to look beyond the market launch of Sumavel DosePro to the next opportunities that it might present.

O’Connor said: “The immediate plans are to ensure a successful launch of SUMAVEL DosePro in the US. The successful launch of our first product is essential to becoming a fully commercial operation and for providing additional revenue to develop and acquire pharmaceutical products (whether using DosePro technology or not) to our portfolio. Beyond that, we believe there are other products that would have potential application using the DosePro delivery system that would benefit patients in a variety of disease states. 

“We plan to explore those applications ourselves as well as outlicense the technology to other pharmaceutical companies who would like to create drug/technology combination pharmaceutical products.

“We are exploring the application of DosePro technology with other injectable compounds including protein, peptide and small molecule formulations.  Our company focus is to remain in the CNS and pain therapeutic arena; however, other companies may outlicense the technology for use in other therapeutic areas.”