QuoteAfter seven years of development and regulatory wrangling, a Shockoe Slip-based drug device maker has moved a big step closer to getting its flagship product to market.

But a huge obstacle still looms.

Intelliject announced Monday that it received tentative approval from the FDA for its lead product, a credit card-size device that allows patients to inject themselves with an epinephrine drug. Epinephrine is used to combat severe allergic reactions, and typically people with bee or peanut allergies carry it with them in case of an emergency.

Standing in Intelliject's way is a legal battle in Delaware against a pharmaceutical giant. The FDA won't grant the final approval until Intelliject resolves a lawsuit filed by King Pharmaceuticals that claims Intelliject's product infringes on its patent for its own popular epinephrine device.

The tentative approval means Intelliject can almost taste the end of the road for the long-awaited development of its e-cue product. The company had previously been calling it the EpiCard.

This phase of the approval process also means that drug giant Sanofi-aventis, which ponied up $230 million for commercialization licensing rights, would finally be able to sell Intelliject's product.

But with a trial not scheduled to take place until early next year in federal court in Delaware, Intelliject must play the waiting game.

"We feel very good about our case," said Neil Hughes, Intelliject's vice president of marketing.

Intelliject is being represented by a number of lawyers from several firms from Delaware and Chicago, including McDonnell Boehnen Hulbert & Berghoff and the Bayard Firm. The company has changed attorneys during the course of the suit.

Hughes would not say whether Sanofi was also footing the bill for lawsuit.

Hughes said changing the new name — e-cue —is the FDA-approved brand name for the product.

"EpiCard was used internally and with potential partners," said Hughes. "It was more of a working name."

King Pharmaceuticals' product, which it says Intelliject is infringing upon, is called the EpiPen.

Changing the name of the product has nothing to do with the patent suit, said Ronn Gunn, Intelliject's vice president of drug development and regulatory affairs.

The company's tentative approval came after a 10-month, first-phase review process. That's considered speedy in the drug regulatory world.

The time from submission to tentative approval is typically 20 months, Gunn said.

Headquartered in the Turning Basin building in Shockoe Slip, Intelliject has 15 local employees. In all, about 100 people across the country are working on the e-cue product.

Despite the ongoing legal battle, the company is celebrating the tentative FDA approval.

"This is a huge milestone," Hughes said. "We're enjoying it, but we have a lot to still to do."

Michael Schwartz is a BizSense reporter. Please send news tips to Michael@richmondbizsense.com.

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Success, for them, will be when their auto-injector is in the hands of people, like themselves, at risk of severe allergic reactions, Eric Edwards said. That is at least a year or more down the road.
"With this partnership, Intelliject is responsible for finishing the development of the product through [Food. and Drug Administration] approval," Eric Edwards explained. "It's a late-stage product. We will be filing our new drug application with the FDA [in. 2010]. . . . Within the next couple of years this product should be on the market."

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The FDA has tentatively approved the e-cue™ for emergency treatment of allergic reactions including anaphylaxis. Tentative approval means that the product review is complete and the submission met the FDA's requirements to be approved. The FDA reserves final approval of the product, however, until all exclusivity or patent challenges have been resolved, specifically the current patent litigation brought against Intelliject by King Pharmaceuticals, Inc. (King) and Meridian Medical Technologies, Inc. (Meridian). Pfizer Inc., the world's largest pharmaceutical company, according to published data, owns King and Meridian. Final FDA approval is required before a product can be marketed in the United States.