After 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 [email protected].
After 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 [email protected].
Good news. Also, For all you Epi-pen patients: there is now a generic available–ask your pharmacy to carry it. Epi-pens are expensive and must be replaced biannually even if not used.
There is NO generic version of EpiPen. The products are completely different. The only thing that is the same is the epinephrine INSIDE the device. If you make the mistake of assuming that EpiPen and the generic product are the same, it could be a fatal mistake. You must be trained on how to use both products and there are no training materials available to physicians or patients or pharmacist for the generic product. If you are trained on EpiPen and then have an emergency, your inability to operate the device could petentially be fatal. Please do not make this… Read more »
You have to watch the dates on your EpiPen when your pharmacist gives it to you. i once got one that would expire in 1 month! It is always different so watch carefully. They use up what they have on hand if you don’t speak up.