HELSINKI: Ascelia Pharma AB announced that the US Patent Office (USPTO) has issued a new patent covering a second-generation formulation of lead drug candidate Mangoral, currently in the pivotal Phase 3 study SPARKLE.

The new patent further improves the unique value proposition of the Mangoral franchise and provides patent protection until year 2040 in the US.

The opportunity to improve the Mangoral product and add patent protection rights add significant value to Ascelia Pharma’s Mangoral franchise. With the new patent, the protection rights are further strengthened until year 2040 in the US.

The new patent covers an effervescent tablet formulation of Mangoral, which makes it even easier for patients and health care professionals to use Mangoral. Plans for market authorization and launch of the 2nd generation Mangoral are under development.

“We are very pleased to have granted the patent for an improved formulation of Mangoral. This will further benefit the target patient population for Mangoral and demonstrates our long-term commitment to provide better imaging solutions for a patient population with poor alternatives today. The new US patent will add significant value and is a result of our successful life cycle management work and our focus on developing novel and better medicinal products for patients in need,” said Magnus Corfitzen, CEO of Ascelia Pharma.

Mangoral (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function.

These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Mangoral, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study.

The Orphan Drug Designation in the US provides a minimum of 7 years of exclusivity after its marketing authorization. In the EU, a new product is granted 10 years of exclusivity after EMA marketing authorization.

Ascelia Pharma is a biotech company focused on orphan oncology treatments. It develops and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway.

The company has two drug candidates – Mangoral and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). www.ascelia.com