IBJNews

Endocyte pulls trigger on European drug submission

Back to TopCommentsE-mailPrintBookmark and Share

Endocyte Inc. will submit its ovarian cancer drug EC145 for European market approval in the third quarter of this year after the European Commission granted it orphan drug status, the company announced Tuesday.

The submission means West Lafayette-based Endocyte could have its first commercial product as early as 2013.

It has been nearly a year since European regulators first indicated to Endocyte that they would be willing to consider EC145 for market approval as an “orphan drug,” which meant they would accept a submission based only on results of a Phase 2 clinical trial, rather than waiting for the results of a larger and longer Phase 3 human trial.

European regulators were willing to grant this “orphan drug” status to EC145 because large numbers of women have ovarian cancers that do not respond to typical chemotherapy treatments. And there has been no new drug approved to treat ovarian cancer in 10 years.

“Targeting patients with a high unmet medical need is a prerequisite to pursuing this regulatory path and, by any measure, these patients fit that definition,” said Endocyte CEO Ron Ellis in a prepared statement.

The European Commission also granted orphan status to an imaging agent Endocyte has developed, called EC20, which lights up ovarian tumors in women that have a genetic variation that makes them bond hungrily to folate.

That’s important because Endocyte’s drug, EC145, is a combination of a very powerful chemotherapy agent and folate, so that it enters cancerous cells but does not enter healthy cells. That allows EC145 to be more deadly to cancer, without serious side effects, than patients can tolerate with traditional chemotherapy agents.

Women with tumors most open to folate, known as FR++, have shown the best response to EC145. In fact, Endocyte released new data Tuesday from its Phase 2 clinical trial, which showed that women with FR++ tumors showed a 62-percent decrease in risk of progression of their cancer and a 52-percent improvement in overall survival rates, when compared with women receiving chemotherapy alone.

An announcement in December that EC145, when applied to women with all types of ovrian cancer, actually led to worse overall survival, sent Endocyte’s shares plunging.

Investors were also worried then because a shortage of Doxil, an ovarian cancer drug given in combination with EC145, had forced Endocyte to stop enrolling patients in its Phase 3 clinical trial. That halt violated one of the prerequisities for Euopean approval of EC145, which sparked fears that EC145 would be significantly delayed before reaching market.

The Doxil shortage issue was solved earlier this month when the U.S. Food and Drug Administration allowed imports of the drug from Europe.

“After discussions with EU health authorities about Phase 3 trial plans and updated clinical data, including an updated overall survival analysis, we are pleased to move forward with these applications,” Ellis said.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. The east side does have potential...and I have always thought Washington Scare should become an outlet mall. Anyone remember how popular Eastgate was? Well, Indy has no outlet malls, we have to go to Edinburgh for the deep discounts and I don't understand why. Jim is right. We need a few good eastsiders interested in actually making some noise and trying to change the commerce, culture and stereotypes of the East side. Irvington is very progressive and making great strides, why can't the far east side ride on their coat tails to make some changes?

  2. Boston.com has an article from 2010 where they talk about how Interactions moved to Massachusetts in the year prior. http://www.boston.com/business/technology/innoeco/2010/07/interactions_banks_63_million.html The article includes a link back to that Inside Indiana Business press release I linked to earlier, snarkily noting, "Guess this 2006 plan to create 200-plus new jobs in Indiana didn't exactly work out."

  3. I live on the east side and I have read all your comments. a local paper just did an article on Washington square mall with just as many comments and concerns. I am not sure if they are still around, but there was an east side coalition with good intentions to do good things on the east side. And there is a facebook post that called my eastside indy with many old members of the eastside who voice concerns about the east side of the city. We need to come together and not just complain and moan, but come up with actual concrete solutions, because what Dal said is very very true- the eastside could be a goldmine in the right hands. But if anyone is going damn, and change things, it is us eastside residents

  4. Please go back re-read your economics text book and the fine print on the February 2014 CBO report. A minimum wage increase has never resulted in a net job loss...

  5. The GOP at the Statehouse is more interested in PR to keep their majority, than using it to get anything good actually done. The State continues its downward spiral.

ADVERTISEMENT