Key Developments: Actavis PLC (ACT)

ACT on New York Consolidated

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30 Jan 2015
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Latest Key Developments (Source: Significant Developments)

Actavis PLC to acquire Auden Mckenzie for 306 mln pounds
Monday, 26 Jan 2015 07:30am EST 

Actavis PLC:Says along with the owners of Auden Mckenzie Holdings Ltd reached a definitive agreement, under which Actavis will acquire Auden Mckenzie for about 306 mln pounds in cash, plus a two-year royalty on a percentage of gross profits of one of Auden Mckenzie's products.Auden Mckenzie will be acquired on a debt free basis, and the transaction will exclude Auden Mckenzie's real estate portfolio.Latham & Watkins is serving as legal counsel to Actavis.Morgan Lewis is serving as legal counsel to Auden Mckenzie.Roger Davies of Redpharma is serving as an adviser to Auden Mckenzie.  Full Article

Richter and Actavis PLC announce positive phase III results for cariprazine in prevention of relapse in patients with schizophrenia
Tuesday, 20 Jan 2015 02:00am EST 

Gedeon Richter Plc and Actavis plc:Says positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia.  Full Article

Actavis plc and Gedeon Richter announces FDA receipt of NDA resubmission for Cariprazine
Tuesday, 6 Jan 2015 02:00am EST 

Actavis plc:The company and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2receptor partial agonist with preferential binding to D3receptors.The Prescription Drug User Fee Act (PDUFA) date is expected to be in the second quarter of 2015.  Full Article

Richter Gedeon Vegyeszeti Gyar Nyrt and Actavis PLC announce FDA receipt of NDA resubmission for Cariprazine
Monday, 5 Jan 2015 07:00pm EST 

Richter Gedeon Vegyeszeti Gyar Nyrt:Announces that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis PLC's New Drug Application (NDA) resubmission for its atypical antipsychotic, cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.Says the Prescription Drug User Fee Act (PDUFA) date is expected to be in the second quarter of 2015.  Full Article

Actavis plc's XYDALBA (dalbavancin) receives CHMP Positive Opinion
Friday, 19 Dec 2014 04:15pm EST 

Actavis plc:Says the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted Actavis' subsidiary Durata Therapeutics International, B.V., a positive opinion for XYDALBA (dalbavancin).XYDALBA (dalbavancin) used for treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.  Full Article

Actavis plc will appeal injunction requiring continued distribution of NAMENDA IR
Monday, 15 Dec 2014 03:11pm EST 

Actavis plc:Confirms that it is filing an emergency appeal to the U.S. Court of Appeals for the Second Circuit seeking to immediately overturn a lower court ruling requiring company to continue distribution of NAMENDA(memantine HCl) immediate-release tablets.On Monday, Dec. 15, Judge Robert Sweet of the United States District Court for the Southern District of New York (New York City) issued a preliminary injunction requiring Actavis to continue distribution of NAMENDA immediate-release tablets.On Dec. 11, company first confirmed the Court's intention to issue the injunction.  Full Article

Actavis plc announces FDA acceptance of sNDA for SAPHRIS (asenapine) for treatment of Bipolar I disorder in pediatric patients
Thursday, 13 Nov 2014 08:00am EST 

Actavis plc:Says U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' Supplemental New Drug Application (sNDA) for SAPHRIS.For acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age.Actavis' sNDA for SAPHRIS has been granted priority review status by FDA.Expects Prescription Drug User Fee Act (PDUFA) date to be in Q1 2015.Says sNDA submission for asenapine is based on results of 3-week monotherapy trial in 403 pediatric patients (10 to 17 years of age), of whom 302 received asenapine.  Full Article

Actavis plc names Maria Teresa Hilado Chief Financial Officer
Monday, 10 Nov 2014 04:15pm EST 

Actavis plc:Announces that Maria Teresa (Tessa) Hilado will join the company, effective Dec. 8, as Chief Financial Officer.  Full Article

Actavis announces planned retirement of R. Todd Joyce in early 2015
Wednesday, 5 Nov 2014 06:45am EST 

Actavis PLC:Says Chief Financial Officer R. Todd Joyce will retire from Actavis in early 2015.To ensure a smooth transition, the company said Joyce will continue as the company's CFO until a successor is named.Actavis has engaged a leading executive search firm to identify successor.  Full Article

Actavis plc raises H2 2014 outlook; raises FY 2014 EPS outlook
Wednesday, 5 Nov 2014 06:30am EST 

Actavis plc:Now expects H2 2014 total net revenue to be about $7.4 bln.H2 2014 non-GAAP earnings per share of between $6.60 and $6.70.Now expects FY 2014 non-GAAP earnings per share of between $13.51 to $13.61.Q3 2014 revenue of $3.6 bln and EPS of $3.10 - Thomson Reuters I/B/E/S.Q4 2014 revenue of $3.7 bln and EPS of $3.36 - Thomson Reuters I/B/E/S.FY 2014 revenue of $12.56 bln - Thomson Reuters I/B/E/S.  Full Article

CORRECTED-BRIEF-Actavis to buy Auden Mckenzie for 306 mln pounds

Jan 26 - Jan 26 - Actavis PLC : * To acquire auden mckenzie for 306 mln gbp * Says Auden Mckenzie will be acquired on a debt free basis, and the transaction will exclude auden mckenzie's real estate portfolio * Deal includes two-year royalty on a percentage of gross profits of one of auden mckenzie's products * Says deal mmediately accretive to Actavis non-GAAP earnings * Says deal adds about 175 marketed products; pipeline of about 40 products * Says "acquisition will

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