Key Developments: Actavis PLC (ACT)

ACT on New York Consolidated

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29 May 2015
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Latest Key Developments (Source: Significant Developments)

Eli Lilly and Co loses Alimta drug patent case in Germany to Actavis - Reuters
Friday, 6 Mar 2015 09:39am EST 

Eli Lilly and Co:Has lost a patent case in Germany over its Alimta lung cancer drug to generic producer Actavis, hitting the company's future sales hopes for the medicine - Reuters.The German appeal court ruled that Actavis would not infringe patents held by Lilly if it marketed an alternative salt form of the drug, known generically as pemetrexed, once the compound patent expires in Dec 2015.The ruling contradicts a previous verdict by a lower court in Germany and Lilly's general counsel, Michael Harrington, said the company would fight the decision.  Full Article

Actavis PLC announces pricing of public offering of senior notes
Tuesday, 3 Mar 2015 08:20pm EST 

Actavis PLC:Announced that it has priced an offering of $21 billion aggregate principal amount of senior unsecured notes in 10 tranches in a registered public offering to be issued by its indirect wholly-owned subsidiary, Actavis Funding SCS, and guaranteed by certain of its other subsidiaries.The net proceeds from the offering of the Notes will be about $20.8 billion.Intends to use the net proceeds from the offering of the Notes, together with the proceeds from its offerings of its Ordinary Shares and 5.500 pct. Mandatory Convertible Preferred Shares, Series A and additional debt financing, including borrowings under unsecured term loan facilities.And an unsecured cash bridge loan facility, to finance a portion of the cash portion of the merger consideration for its previously announced acquisition of Allergan, Inc.Expects to use the net proceeds from the offering of the Notes, together with cash on hand, to redeem the Notes.J.P. Morgan, Mizuho Securities and Wells Fargo Securities are the joint book-running managers of the offering of the Notes.  Full Article

AstraZeneca PLC announces acquisition of rights to Actavis PLC portfolio
Tuesday, 3 Mar 2015 02:05am EST 

AstraZeneca PLC:Says that it has completed the transaction to acquire rights to Actavis' branded respiratory business in US and Canada.Says strategic transaction strengthens AstraZeneca's respiratory franchise globally and builds on acquisition of Almirall's respiratory portfolio in 2014 by extending company's development and commercialisation rights into US for both Tudorza Pressair and Duaklir Genuair.Says on completion of acquisition, AstraZeneca is paying Actavis $600 mln of initial consideration and agreed to pay low single digit royalties above a certain revenue threshold.AstraZeneca has also paid Actavis an additional $100 mln for a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between AstraZeneca and Actavis.  Full Article

Actavis PLC receives approval from European Commission for XYDALBA (dalbavancin)
Monday, 2 Mar 2015 08:30am EST 

Actavis PLC:Says European Commission has granted it's subsidiary Durata Therapeutics International B.V., marketing authorization for XYDALBA (dalbavancin) for treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.Says XYDALBA is first and only once-weekly IV antibiotic approved for treatment of ABSSSI with two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.  Full Article

Actavis PLC and Medicines360 announce FDA approval of LILETTA to prevent pregnancy for up to three years
Friday, 27 Feb 2015 08:00am EST 

Actavis PLC and Medicines360:Says approval of LILETTA (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration (FDA) for use by women to prevent pregnancy for up to three years.LILETTA is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.  Full Article

Actavis Plc receives US FDA approval for avycaz
Wednesday, 25 Feb 2015 05:21pm EST 

Actavis Plc:Says received US Food and Drug Administration (FDA) approval for avycaz for treatment of adult patients with complicated intra-abdominal infections and complicated urinary tract infections.Treatment addresses serious infections in patients with no or limited alternative treatment options.  Full Article

Actavis PLC announces pricing of public offerings of ordinary shares and mandatory convertible preferred shares
Wednesday, 25 Feb 2015 08:00am EST 

Actavis PLC:Has priced its concurrent offerings of 13,194,445 ordinary shares at $288.00 per share and 4,600,000 5.500 pct mandatory convertible preferred shares, Series A, at $1,000.00 per share, each being offered in a separate registered public offering.The net proceeds from the Ordinary Shares offering and the Mandatory Convertible Preferred Shares offering will be about $3.7 billion and $4.5 billion, respectively.J.P. Morgan, Mizuho Securities, Wells Fargo Securities, Morgan Stanley, Barclays and Citigroup are the joint book-running managers on the Ordinary Shares and Mandatory Convertible Preferred Shares offerings.  Full Article

Actavis PLC confirms generic uceris patent challenge
Tuesday, 24 Feb 2015 04:05pm EST 

Actavis PLC:Confirms that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Budesonide Extended-release Tablets, 9 mg.Actavis' ANDA product is a generic version of Salix Pharmaceuticals' Uceris, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.  Full Article

Actavis PLC receives final approval for generic version of Subutex
Friday, 20 Feb 2015 08:45am EST 

Actavis PLC:Receives final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (Buprenorphine 2 mg and 8 mg sublingual tablets).Actavis intends to begin shipping its product shortly.  Full Article

Actavis PLC proposes public offerings of ordinary shares
Thursday, 19 Feb 2015 07:38am EST 

Actavis PLC:Commences concurrent offerings totaling $8.4 bln, comprising $4.2 bln of ordinary shares and $4.2 bln of mandatory convertible preferred shares, Series A, each in a separate registered public offering, subject to market and other conditions.Intends to use the net proceeds, together with additional debt financing to finance the cash consideration for its previously announced acquisition of Allergan Inc and certain related transactions and financing expenses.J.P. Morgan, Mizuho Securities, Wells Fargo Securities, Morgan Stanley, Barclays and Citigroup are the joint book-running managers on the Ordinary Shares and Mandatory Convertible Preferred Stock offerings.  Full Article

FDA approves Actavis, Valeant drugs for irritable bowel syndrome

WASHINGTON - U.S. health regulators approved new irritable bowel syndrome drugs from Actavis Plc and Valeant Pharmaceuticals International Inc on Wednesday, validating big investments both companies made to acquire the products.

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