Key Developments: Actavis PLC (ACT)

ACT on New York Consolidated

217.65USD
11 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Actavis plc confirms generic Diclegis patent challenge
4:25pm EDT 

Actavis plc:Confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release tablets, 10 mg/10 mg.ANDA product is a generic version of Duchesnay Inc.'s Diclegis, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.  Full Article

Impax Laboratories acquires two products from Actavis
Wednesday, 2 Jul 2014 04:05pm EDT 

Impax Laboratories Inc:Acquires from Actavis plc two generic products for cash consideration pursuant to a purchase agreement and a supply agreement.Financial terms of the agreement were not disclosed.  Full Article

Actavis plc completes acquisition of Furiex Pharmaceuticals Inc
Wednesday, 2 Jul 2014 08:46am EDT 

Actavis plc:Completes acquisition of Furiex Pharmaceuticals, Inc. in all-cash transaction valued at about $1.1 bln, and up to about $360 mln in Contingent Value Right that may be payable based on status of eluxadoline, Furiex's lead product, as controlled drug following approval.Says in connection with close of Furiex acquisition, Actavis further announced that it has closed the transaction related to the sale of Furiex's royalties on alogliptin and Priligy to Royalty Pharma for about $415 mln.  Full Article

Actavis plc appoints CEO and President
Tuesday, 1 Jul 2014 09:00am EDT 

Actavis plc:Appointed Brenton L. Saunders as CEO and President.  Full Article

Actavis plc completes Forest Laboratories acquisition
Tuesday, 1 Jul 2014 08:20am EDT 

Actavis plc:Completed acquisition of Forest Laboratories, Inc. in cash and equity transaction currently valued at about $28 bln.Combination creates one of specialty pharmaceutical companies, with annual revenues of more than $15 bln anticipated for 2015.  Full Article

Actavis plc gives FY 2015 revenue guidance in line with analysts' estimates
Tuesday, 1 Jul 2014 08:20am EDT 

Actavis plc:Anticipates annual revenues of more than $15 billion for FY 2015.FY 2015 revenue of $15.57 billion - Thomson Reuters I/B/E/S.  Full Article

Actavis plc Confirms Generic Zubsolv patent challenge
Monday, 30 Jun 2014 07:30am EDT 

Actavis plc:Confirms that it has filed an Abbreviated New Drug Application (ANDA) with U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base.Actavis' ANDA product is generic version of Orexo's Zubsolv, which is partial opioid agonist indicated for maintenance treatment of opioid dependence.Orexo AB and Orexo US, Inc. filed suit against Actavis on June 26, in U.S. District Court for District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents.Lawsuit was filed under provisions of Hatch-Waxman Act, resulting in stay of final FDA approval of Actavis' ANDA for up to 30 months from the date plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner.Based on available information, Actavis believes it may be a first applicant to file an ANDA for the generic version of Zubsolv and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.  Full Article

Actavis plc prices $3.7 bln of senior unsecured notes
Tuesday, 10 Jun 2014 05:19pm EDT 

Actavis plc:Says that its indirect subsidiary, Actavis Funding SCS, priced a private debt offering of $500 million of 1.300 pct senior unsecured notes due 2017, $500 million of 2.450 pct senior unsecured notes due 2019, $1.2 billion of 3.850 pct senior unsecured notes due 2024.Says $1.5 billion of 4.850 pct senior unsecured notes due 2044, for a total offering of $3.7 billion in aggregate principal amount.Actavis intends to use the net proceeds from the offering along with borrowings under its indirect subsidiary Actavis Capital and for for general corporate purposes.  Full Article

Actavis plc announces offering of senior unsecured notes
Tuesday, 10 Jun 2014 08:48am EDT 

Actavis plc:Announced that its indirect subsidiary, Actavis Funding SCS, is privately offering three, five, ten and thirty year senior unsecured notes.Intends to use the net proceeds from the offering, along with borrowings under its indirect subsidiary Actavis Capital S.a r.l.'s new senior unsecured term loan facilities, other financings and cash on hand.  Full Article

Actavis plc Finalizes agreement related to Asacol HD patent challenge litigation
Monday, 9 Jun 2014 05:54pm EDT 

Actavis plc:Finalizes its previously announced agreement with Zydus Pharmaceuticals USA Inc. to settle all outstanding patent litigation related to Zydus' generic version of Asacol HD (mesalamine) delayed-release tablets.Terms of agreement are unchanged from those disclosed by the companies in Dec. 2013.Under terms of agreement, Actavis will grant Zydus an exclusive license to market its generic Asacol HD beginning on Nov. 15, 2015, or earlier.Under certain circumstances, following receipt by Zydus of final approval from U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic AsacolHD.Alternatively, if Zydus does not gain FDA approval of its generic Asacol HD by July 1, 2016, Zydus will be permitted to launch an authorized generic version of Actavis' product beginning on July 1, 2016.Other terms of settlement were not disclosed.  Full Article

U.S. allows Actavis Plc's purchase of Forest Labs with conditions

WASHINGTON - Generic drugmaker Actavis Plc has won U.S. approval to buy specialty pharmaceuticals company Forest Laboratories on condition it sell or relinquish the rights to four generic medicines, the Federal Trade Commission said on Monday.

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