A delay in the regulatory approval process for Neoprobe Corp.’s (OTCBB:NEOP) cancer drug could have the effect of helping the company increase the drug’s price once it’s commercialized.
Neoprobe said in a statement Wednesday that the U.S. Food and Drug Administration had requested additional data to be included in the New Drug Application (NDA) for the company’s Lymphoseek drug, which is is a tracing agent that identifies cancerous lymph nodes in patients with breast cancer and melanoma.
While that request for additional data could delay the approval process, it also could have a positive ramification for the company, Neoprobe officials said in a conference call with investors Thursday morning. That is, the additional data could help Neoprobe establish that Lymphoseek is superior enough to competing products that it could command a higher per-dose price than what the company had initially targeted, CEO David Bupp said.
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The company had originally planned on a per-dose U.S. price of about $225. That compares to an average price of about $450 for the existing drug coupled with the procedure to identify cancerous lymph nodes — the use of “vital blue dye” with a colloid, according to Bupp.
Bupp wouldn’t provide specifics on what the new Lymphoseek price might be, but offered a hint. “At this point in time, it’d be premature to talk about pricing,” he said. “We have the opportunity to begin looking at premium pricing and come out of the box with a price that would approach the combined pricing,” which is a reference to the $450 amount.
Neoprobe said in August it planned to file its NDA in the fourth quarter of this year. However, as a result of the FDA’s request for additional safety data, the first quarter of 2011 now looks more likely, according to Wednesday’s statement from the company. The FDA must approve an NDA before a company can begin legally selling the associated drug in the United States.
The delay stems from an FDA request concerning an ongoing Phase 3 safety study of Lymphoseek. The FDA has now requested that Neoprobe include data from the safety study in its “primary” NDA. Neoprobe had previously planned on including the study data as a “major amendment” to the application, based on guidance from a March meeting with the regulatory agency.
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Neoprobe also used the call to provide investors with an update of its RIGScan product, a gamma detection and tracing agent system that enables surgeons to locate tumor tissue during surgery. The technology offers the potential of more thorough cancer removal, as well as preservation of non-cancerous tissue.
The plan is to submit to the FDA by the end of the fourth quarter a document that describes the design of a Phase 3 trial of RIGScan. Assuming the regulatory agency approves the trial design, Neoprobe is looking to begin conducting the study during the second half of 2011, Bupp said.
