Mark Your Calendar For Aug.17, TRIL To Report Data In Q4, FLML Launches Akova

(RTTNews) - Endo International plc (ENDP) has decided to withdraw its supplemental New Drug Application relating to specific abuse deterrent labeling for OPANA ER.

OPANA ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. The sNDA for OPANA ER includes studies designed to evaluate the abuse deterrence of the formulation.

The drug garnered sales of $175.8 million in 2015, down 11% compared to 2014. In the six months ended June 30, 2016, OPANA ER fetched $83.2 million in sales compared to $89.9 million in the comparable period last year.

ENDP closed Friday's trading 5.08% higher at $24.18. In after-hours, the stock was down 0.33% to $24.10.

Flamel Technologies (FLML) has launched Akova, which was recently approved by the FDA, to address clinically important hypotension in surgical settings.

During the intraoperative period, anesthesia can lead to hypotension, or a significant drop in blood pressure, and is associated with complications like stroke and myocardial infarction.

The company estimates the market volume of Akovaz to be somewhere in the range of seven million vials per year when factoring in sales to repackaging companies.

FLML closed Friday's trading at $13.27, up 2.08%.

Portola Pharmaceuticals Inc. (PTLA) will get to know the FDA decision on its investigational drug Andexanet alfa, which is specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors, on August 17, 2016.

Factor Xa inhibitors are anticoagulants used to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. One of the major complications of treatment with Factor Xa inhibitors is bleeding, and currently, there is no antidote or reversal agent approved for use against Factor Xa inhibitors.

Portola has licensed the development and commercial rights to Andexanet alfa in Japan to Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) while retaining full commercial rights to the antidote outside of Japan.

Andexanet alfa, if approved, has the long-term potential to address a total worldwide market in excess of $2.0 billion, according to the company.

PTLA closed Friday's trading at $27.61, up 4.07%.

Trillium Therapeutics Inc. (TRIL)(TR.TO) is all set to report data from a phase I study of its lead drug candidate, TTI-621, in relapsed or refractory hematologic malignancies, in the fourth quarter of 2016.

TRIL closed Friday's trading at $10.29, up 2.39%.