Actavis plc (ACT) confirmed that the U.S. Court of Appeals for the Second Circuit has granted the company’s motion to expedite its appeal of a lower court ruling in Dec 2014, whereby Actavis was required to continue distribution of Namenda immediate-release (IR) tablets. The company had asked the court to hear the case on an accelerated basis so that a final decision is reached by Feb 16, 2015.
However, the court refused to grant a stay on the lower court ruling, while the appeal is still ongoing.
The news should somewhat relieve Actavis. In order to reduce the impact of genericization, Actavis had launched Namenda extended release (XR), a higher-dose and once-daily formulation of Namenda IR. Actavis was looking to shift IR patients to the new XR regimen ahead of generic entry. The company had earlier planned to stop selling Namenda IR from Jan 2015.
We remind investors that in Sep 2014, the Office of the Attorney General of the State of New York had filed a lawsuit accusing the company of attempting to prevent or delay generic competition for Namenda IR based on its commercial plans for Namenda XR. Namenda IR, approved for the treatment of moderate-to-severe dementia of the Alzheimer’s type, is expected to face generic competition starting Jul 2015.
Separately, Actavis announced that the FDA has acknowledged receipt of the company's New Drug Application (NDA) resubmission for its pipeline candidate cariprazine. Actavis is evaluating cariprazin, an atypical antipsychotic, for the treatment of patients with schizophrenia and manic or mixed episodes associated with bipolar I disorder in collaboration with Hungary-based Gedeon Richter Plc.
We remind investors that the FDA had issued a Complete Response Letter to Actavis in Nov 2013 in response to its NDA submitted in 2012. The agency had then asked for additional clinical trial data on the candidate in order to better define the optimal dosing regimen, maintain the demonstrated efficacy and minimize the potential for the development of adverse events generally associated with this class of drug.
Resubmission of the NDA includes additional data required by the FDA and a response by the FDA is expected by the second quarter of 2015.
Actavis currently carries a Zacks Rank #2 (Buy). Other favorably-ranked stocks in the health care sector include Mylan (MYL), Progenics Pharmaceuticals, Inc. (PGNX) and Supernus Pharmaceuticals, Inc. (SUPN). While Progenics carries a Zacks Rank #1 (Strong Buy), the other two carry the same Zacks Rank as Actavis.
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