Pharmadax Inc. Announces Seroquel XR® Patent Challenge Settlement

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Pharmadax Inc. has entered into a licensing agreement with AstraZeneca Pharmaceuticals concerning its generic version of Seroquel XR® (quetiapine fumarate extended-release) tablets

Pharmadax Inc., a pharmaceutical company based in New Taipei City, Taiwan, and its subsidiary Pharmadax USA, Inc., based in Irvine, California, today announced that they have entered a license agreement with AstraZeneca Pharmaceuticals LP and AstraZeneca UK Limited and have agreed to settle all outstanding patent litigations concerning Pharmadax’s abbreviated new drug application ("ANDA") relating to commercialization in the United States of a generic version of the AstraZeneca drug product, Seroquel XR® (quetiapine fumarate extended-release) tablets.

Pursuant to the settlement, AstraZeneca and Pharmadax will file a proposed Consent Judgment in the United States District Court for the District of New Jersey to conclude the litigation, subject to other regulatory review. The settlement provides, in part, that Pharmadax is permitted to launch its generic versions of the 50, 150, 200, 300 and 400 mg strengths of Seroquel XR®, on November 1, 2016, or earlier in certain circumstances, subject to prior U.S. Food and Drug Administration ("FDA") approval of Pharmadax’s ANDA for those strengths. All other terms of the settlement are confidential.

Pharmadax’s actual launch may also be subject to a six month statutory delay relating to a prior filer of a generic equivalent of the branded product.

Yipin Huang, Chairman of Pharmadax Inc., stated: “We are pleased to negotiate a settlement to end this litigation with AstraZeneca. The agreement provides Pharmadax with a license to bring a generic Seroquel XR® product to the market in advance of the expiry of AstraZeneca’s Orange Book-listed patent and removes the expenses and uncertainty inherent in patent litigation.”

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Margaret Choy