Intarcia loses some of its sparkle with FDA rejection
- Intarcia Therapeutics, Inc. revealed Wednesday the Food and Drug Administration has rejected its type 2 diabetes drug-device combo ITCA 650, sending the Boston-based company a complete response letter (CRL).
- The privately-held biotech said it does not expect to have to conduct any further clinical trials or any "long-lead time chemistry, manufacturing and controls activities" to fulfill the requirements laid out in the agency's rejection letter.
- Intarcia said it has clear and constructive advice to deal with the manufacturing issues in the CRL, but gave no further details.
Dubbed a biotech "unicorn" due to its lofty valuation, Intarcia has a strong cash position, raising over $600 million through September in a private equity financing. The well-funded company has said publicly it is unlikely to seek an initial public offering prior to commercialization of its lead product for fear of leaving value on the table. Past investments have put the company's value as high as $5 billion.
The company has been developing a drug-device combo that uses a decades-old diabetes drug in an implant. The device is inserted under the skin through a non-invasive procedure, providing diabetics with months of consistent drug therapy.
"Real-world outcomes data consistently demonstrate that the majority of patients living with type 2 diabetes struggle to adhere to chronic pills and injections," said Intarcia Chairman, CEO and President Kurt Graves in a statement. "Diabetes remains a devastating public health crisis that is still spiraling out of control because of poor control and poor adherence issues."
ITCA 650 uses the drug exenatide, which is a GLP-1 agonist first approved as Byetta in 2005. A long-acting weekly version of the drug was later approved under the name Bydureon.
While Byetta was a first-in-class drug, the GLP-1 class has expanded rapidly and is now widely used as an add-on to insulin in patients with type 2 diabetes. Some of these drugs have even shown the ability to reduce the risk of cardiovascular death in large cardiovascular outcomes trials.
Intarcia is banking on physicians being comfortable with the use of ITCA 650 because of their long relationship with Byetta and Bydureon.
The company hopes that, by providing a more consistent means of administration for the drug, they can improve patient compliance (and outcomes), while bringing in blockbuster sales.
Complete response letters are not publicly disclosed by the FDA, meaning it is up to the company to reveal what such a rejection might entail — there is no way to check how transparent companies are about a letter's contents.
Intarcia’s statement indicates the company intends to resolve the issue quickly. Yet, the company did not give any timeline around when it plans to refile.
- Intarcia Therapeutics Press release
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