Key Developments: Baxter International Inc (BAX.N)

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Latest Key Developments (Source: Significant Developments)

Baxter International Inc to divest Vero Cell
Monday, 15 Dec 2014 09:00am EST 

Baxter International Inc:Entered into a definitive agreement to sell its Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics Inc.Financial details were not disclosed.  Full Article

Baxter International Inc announces filing of Form 10 registration statement in connection with planned Spin off of Biopharmaceuticals Business
Wednesday, 10 Dec 2014 05:15pm EST 

Baxter International Inc:Says the filing of an initial Form 10 Registration Statement with the U.S. Securities and Exchange Commission (SEC) in connection with the company's previously announced plan to spin off its biopharmaceutical business.Filing is an important step in creating two premier global healthcare companies: Baxter International Inc., which will focus on lifesaving medical products; and Baxalta Incorporated, which will focus on developing and marketing innovative biopharmaceuticals.Form 10 filing outlines Baxter's intent to spin off at least 80 percent of the outstanding common stock of Baxalta through a tax-free distribution to Baxter shareholders, with Baxter retaining the remaining shares.The retained equity stake by Baxter of up to 20 percent of Baxalta's shares provides additional flexibility in the capital structures of the two new companies and enhanced value for shareholders.Baxter plans to dispose of the Baxalta common stock in a disciplined manner over a period of time not to exceed five years.  Full Article

Baxter declares quarterly dividend
Tuesday, 11 Nov 2014 09:05am EST 

Baxter International Inc:Declares a quarterly dividend of $0.52 per common share.Payable on Jan. 2, 2015 to shareholders of record as of Dec. 5.  Full Article

Baxter International's investigational 20 pct Subcutaneous Immunoglobulin Treatment meets efficacy and tolerability endpoints in phase 2/3 Study
Thursday, 30 Oct 2014 09:00am EDT 

Baxter International Inc:Presents the results of Phase 2/3 study of its investigational 20 pct concentration subcutaneous immunoglobulin treatment for primary immunodeficiencies (PI) during the biennial congress of the European Society for Immunodeficiencies, held in Prague.Phase 2/3 study evaluated the efficacy, safety, tolerability and pharmacokinetics (PK) of IGSC 20 percent in European patients at least two years old with PI.Total of 48 study participants received IGSC 16 percent or IVIG 10 percent for three months, followed by weekly doses of IGSC 20 percent for up to 12 months (median of two sites per infusion).Study met its primary endpoint that measured the rate of validated acute serious bacterial infections, or VASBIs.  Full Article

Baxter International Inc launches HYQVIA in US for Adult Patients with Primary Immunodeficiency
Monday, 20 Oct 2014 09:00am EDT 

Baxter International Inc:Launch and first shipments of HYQVIA [Immune Globulin Infusion 10 pct (Human) with Recombinant Human Hyaluronidase], Baxter's subcutaneous immunoglobulin treatment for adult patients with primary immunodeficiency (PI) in US.Treatment was approved by U.S. Food and Drug Administration (FDA) in Sept. of this year.  Full Article

Baxter International Inc gives Q4 2014 outlook in line with analysts' estimates; raises FY 2014 sales outlook and lowers EPS outlook
Thursday, 16 Oct 2014 07:00am EDT 

Baxter International Inc:Expects Q4 2014 sales growth of about 3 pct excluding the impact of foreign currency.Expects Q4 2014 sales to be flat to 2013 levels.Expects Q4 2014 earnings, before special items, of $1.30 to $1.33 per diluted share.Expects FY 2014 sales growth of 11 to 12 pct, before the impact of foreign exchange.Expects FY 2014 earnings, before special items, of $4.86 to $4.89 per diluted share.Says Q4 2014 earnings guidance excludes of about $0.07 per diluted share of projected intangible asset amortization expense.Says FY 2014 earnings guidance excludes $1.03 per diluted share of special items comprising $0.96 per diluted share of items recorded year to date.Q4 2014 revenues of $4.38 bln and EPS of $1.41 - Thomson Reuters I/B/E/S.FY 2014 revenues of $16.82 bln and EPS of $5.16 - Thomson Reuters I/B/E/S.  Full Article

Kamada Ltd announces second extension of strategic agreement with Baxter International Inc
Monday, 29 Sep 2014 06:30am EDT 

Kamada Ltd:Says the second extension to supply Glassia to Baxter in its strategic agreement with the biopharmaceutical business of Baxter International Inc.Supply of Glassia to Baxter has been extended through 2017 and that the transition to royalty payments for Glassia produced by Baxter is not expected to begin before 2018.Until that time, Kamada will continue to produce Glassia for distribution by Baxter.Kamada is confident in its ability to support the increased demand from Baxter throughout the term of the amended agreement.  Full Article

Baxter International Inc and Merrimack Pharmaceuticals enter into exclusive Ex-U.S. licensing agreement and plans to submit New Drug Application for MM-398 with FDA
Wednesday, 24 Sep 2014 07:00am EDT 

Baxter International Inc:Says an exclusive license and collaboration agreement for the development and commercialization of MM-398 (nanoliposomal irinotecan injection), also known as nal-IRI.Through the agreement, Baxter gains exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan, and Merrimack retains commercialization rights in the United States; the rights in Taiwan are held separately.MM-398 is an investigational drug candidate for which Merrimack is preparing a New Drug Application in the United States for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.Under the terms of agreement, Merrimack receives a $100 mln upfront payment from Baxter.U.S. Food and Drug Administration (FDA) and European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer.Merrimack is planning to submit a New Drug Application for MM-398 with the FDA in 2014.Baxter expects to submit for regulatory approvals outside of the United States beginning in 2015.  Full Article

Baxter announces Baxalta as the name of new global biopharmaceutical company
Wednesday, 10 Sep 2014 04:30pm EDT 

Baxter International Inc:Announces that Baxalta Incorporated will be the name of the new, publicly traded biopharmaceutical company that is expected to launch in mid-2015.Says upon completion of the separation, Baxalta plans to trade on the New York Stock Exchange under the symbol BXLT.Says Baxter International will continue trading on the NYSE under the symbol BAX.Says as previously announced, the corporate headquarters of both companies will be located in northern Illinois.  Full Article

Baxter International Inc announces positive top-line results from Its phase 3 study of BAX 855, extended half-life recombinant FVIII for hemophilia a patients
Thursday, 21 Aug 2014 09:00am EDT 

Baxter International Inc:Announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].Met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older.Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm.BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions.  Full Article

BRIEF-Co don AG reaches milestone for EU-wide approval

* Reaches milestone for EU-wide approval: successful patient recruitment for phase III clinical trial Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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