MAIA Pharmaceuticals Announces the Tentative Approval by the FDA of its NDA for Sincalide for Injection

PRINCETON, N.J., Feb. 28, 2018 /PRNewswire/ -- MAIA Pharmaceuticals, Inc., a Princeton, NJ based specialty pharmaceutical company, announces the Tentative Approval of its Sincalide for Injection NDA by the U.S. Food and Drug Administration (FDA).

As of 2013, there were over 648,000 patients¹ where KINEVAC^®2 was used to stimulate gallbladder contraction. Until now, KINEVAC^® was the only drug approved by FDA for stimulation of gallbladder contraction and other indications. Over the past 5 years, KINEVAC^® has often been unavailable to patients and prescribers, causing it to be repeatedly listed on the FDA Drug Shortage List.

MAIA’s Sincalide for Injection is a new and innovative formulation of sincalide that addresses the recurrent shortages of KINEVAC^® as well as KINEVAC^®‘s shelf-life issues. Recognizing the shortages of KINEVAC and the unmet medical need, the FDA granted “Priority Review” to MAIA’s NDA.

“We are pleased to have received this Tentative Approval for Sincalide for Injection. This is a huge step towards getting patients access to a drug that has been plagued by recurrent supply issues for many years forcing practitioners to rely on less than desirable alternatives to address their need which include using preparations from compounding pharmacies or alternate therapies, which are not approved by the FDA. We hope to restore a consistent supply of a stable product, for which there is a clear unmet and public health need,” said Dr. Srikanth Sundaram, President and CSO of MAIA.

“With the FDA’s tentative approval of MAIA’s NDA, the only issue precluding MAIA from supplying sincalide to heath care practitioners and patients who desperately need it is the ongoing patent litigation with Bracco Diagnostics Inc., which we are confident will be resolved in MAIA’s favor,” said Bikram Malik, Operations, MAIA.

“Tentative approval” means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. The tentative approval will be eligible for conversion to a final approval subject to the resolution of the current patent litigation between MAIA and Bracco Diagnostics Inc.

Indications
Sincalide for Injection is indicated in adults to:

• stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals;
• stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology;
• accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract.

About MAIA Pharmaceuticals, Inc.
MAIA is a Princeton, NJ based specialty pharmaceutical company focused on developing and bringing to market injectable products where there are unaddressed patient and/or practitioner needs.

¹ Based upon Bracco Diagnostics public statements
² KINEVAC^® is a registered trademark of Bracco Diagnostics Inc.

Contact: Bikram Malik, 1-973-296-8084, bmalik@maiapharma.com

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SOURCE MAIA Pharmaceuticals, Inc.