By Tamara Mathias
(Reuters) – Agile Therapeutics Inc’s shares sank 75 percent on Friday after the drug developer said it expects to pursue what could be a prolonged appeal against health regulators’ issues over its chief experimental product, a contraceptive patch.
The U.S. Food and Drug Administration (FDA) had already declined to approve Twirla, Agile’s stick-on contraceptive, on two occasions, and Agile said the agency still had “significant concerns” about the adhesion properties of the patch.
“In light of the feedback from the FDA, we also are re-evaluating our business plan to identify ways to extend our ability to fund the company’s operations,” Agile Chief Executive Officer Al Altomari said in a statement.
In an April 16 meeting with the Princeton, New Jersey-based company, the FDA proposed that Agile should reformulate certain properties of Twirla and carry out a new study.
The agency also suggested that an independent advisory committee assess the drug.
Twirla, which contains a combination of female hormones, is designed to be applied once weekly for three weeks, but the FDA says the patches tend to fall off and, as a result, may not deliver the amount of hormones necessary for effective birth control.
Altomari said Agile “flat-out” disagreed with the FDA’s assessment, and that it expects to escalate the matter and pursue a dispute resolution process with the agency.
Agile has enough cash to fund the appeal if it put other business activities on hold, he added.
Agile had $28.3 million in cash as of March 31.
“Enough is enough. We need to go upstairs. We need a fresh set of eyes on this … patches don’t jump off women’s bodies in the middle of the process,” Altomari said on a conference call with analysts.
Agile expects each step in the appeals process to take about 60 days, and while it hopes for a resolution by the end of the year, the company did not give a more specific timeline.
“Bottom line, this is a challenging update and the stock will clearly be weak today reflecting what is now greater uncertainty on path forward,” said Randall Stanicky, analyst at RBC Capital Markets.
Agile’s stock was last down 76 percent after hitting a record low of 58 cents on Friday morning.
(Reporting by Tamara Mathias in Bengaluru; Editing by Arun Koyyur and Sai Sachin Ravikumar)
