Current Report Filing (8-k)
08 Janeiro 2015 - 12:01PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
January 5, 2015
Date of Report (Date of Earliest Event Reported)
HOSPIRA, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
1-31946 |
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20-0504497 |
(Commission File Number) |
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(I.R.S. Employer Identification No.) |
275 N. Field Drive
Lake Forest, Illinois 60045
(Address of Principal Executive Offices, including Zip Code)
Registrants Telephone Number, Including Area Code: (224) 212-2000
Not Applicable
(Former Name or Former Address, If Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
On January 8, 2015, Hospira, Inc. distributed the attached press release regarding Hospiras devices, including information regarding notification on January 5, 2015, from the U.S. Food and Drug Administration (FDA) that the FDA had lifted an import alert that previously prohibited U.S. importation of infusion pump devices manufactured in Hospiras Costa Rica device manufacturing facility.
* * * *
This Current Report may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including projections of certain measures of Hospiras results of operations; projections of certain charges, expenses, and cash flow; and other statements regarding Hospiras goals, plans and strategy. Hospira cautions that these forward-looking statements are subject to risks and uncertainties, including adequate and sustained progress on Hospiras quality initiatives, continuous improvement activities, and device strategy that may cause actual results to differ materially from those indicated in the forward-looking statements. Factors that may affect Hospiras operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings Forward-Looking Statements, Risk Factors, and Managements Discussion and Analysis of Financial Condition and Results of Operations in Hospiras latest Annual Report on Form 10-K, and as updated by Hospiras Reports on Form 10-Q, filed with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which apply only as of the date of this Current Report. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments, other than as required by law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description of Exhibit |
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99.1 |
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Press Release regarding Hospiras devices, dated January 8, 2015 |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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HOSPIRA, INC. |
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Date: January 8, 2015 |
/s/ Royce Bedward |
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By: |
Royce Bedward |
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Its: |
Senior Vice President, General Counsel and Secretary |
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EXHIBIT INDEX
Exhibit No. |
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Exhibit |
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99.1 |
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Press Release regarding Hospiras devices, dated January 8, 2015 |
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Exhibit 99.1
For Immediate Release
HOSPIRA ANNOUNCES SIGNIFICANT PROGESS ON
GLOBAL DEVICE STRATEGY
Quality systems, significant investment credited for import alert lift
LAKE FOREST, Ill., Jan. 8, 2015 Hospira, Inc. (NYSE: HSP), the worlds leading provider of injectable drugs and infusion technologies, today unveiled significant progress on its global device strategy. The global device strategy, initiated in 2013, establishes a streamlined and modernized device portfolio to address customer needs and to position the company for future innovation and growth, all while supporting continued advancement of device remediation, including quality improvement efforts. Progress announced today includes the lifting of the import alert on the companys portfolio of infusion devices by the U.S. Food and Drug Administration (FDA), the introduction of next-generation pumps and details on future technology development.
On January 5, the FDA notified Hospira that it lifted the import alert that previously prohibited U.S. importation of infusion pump devices manufactured in Hospiras Costa Rica device manufacturing facility, including Hospiras Plum A+ and LifeCare PCA infusion pumps. Hospira is now able to sell these infusion devices to new and existing customers without medical necessity certificates, and will resume the importation of these devices into the United States immediately.
Globally, we know our customers depend upon Hospiras products and we are pleased to be returning these devices to the market. We strive to continuously improve the performance of our products and meet the expectations of both customers and regulatory agencies. This is an important milestone in that process, said David J. Endicott, president, Hospira Medical Devices. In 2015, we expect that our continued efforts to streamline and modernize our portfolio will result in a number of key product launches, with Hospira ultimately providing the most advanced and intuitive pumps in the industry.
Progress in Hospiras global device strategy is reflected in the following areas:
· Quality systems: Hospiras investments continue to strengthen its global device quality systems and promote continuous improvement to better meet evolving regulatory standards.
· New Product Launches: In 2015, Hospira expects to offer its customers new next-generation pump technology, including:
· SapphirePlusTM Hospiras partner Q Core Medical recently received FDA clearance on this Hospira MedNetTM-ready general-infusion device, which features unique patented technology, innovative design, wireless capability and an intuitive touch screen to help improve the safety and efficiency of I.V. medication administration.
· Plum 360TM Hospira is awaiting FDA clearance on this new infusion system, which builds on its unique air management and concurrent delivery features, while expanding its drug library and wireless capability.
· Hospira MedNet 6.1 The latest update to the Hospira MedNet safety software enables MedNet to operate with all Hospira pump platforms, building on its leadership position in I.V. Clinical Integration and helping hospitals improve I.V. administration productivity and prevent medication errors.
The anticipated launches of these new pumps in 2015, along with ongoing efforts to replace and retire past technologies, are critical in bringing Hospira customers the most advanced medication management systems.
· Future technology: Hospira and partner Q Core Medical recently enhanced their collaboration to develop a next-generation platform of pumps, building on both the Sapphire and Plum cassette technologies. The partnership continues to strengthen and supplement Hospiras own research and development efforts. Together, Hospira and Q Core will launch a full spectrum of pumps, including general infusion, PCA, syringe and ambulatory devices that build on the intuitive design of Sapphire and leverage the proven Hospira MedNet software.
The development of next generation Plum and Sapphire platforms continues to demonstrate Hospiras long-term commitment to the I.V. infusion market and is a critical part of the companys strategy to build future growth.
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About Hospira
Hospira, Inc. is the worlds leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.
Private Securities Litigation Reform Act of 1995
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospiras goals, plans and strategy related to Hospiras global devices. Hospira cautions that these forward-looking statements are subject to risks and uncertainties, including adequate and sustained progress on the companys quality initiatives and device strategy that may cause actual results to differ materially from those indicated in the forward-looking statements. Other factors that may affect Hospiras operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations in Hospiras latest Annual Report on Form 10-K and subsequent Forms 10-Q, filed with the U.S. Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments, except as required by law.
Contacts:
Media Lindsey Negaard (224) 212-2656 |
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Tareta Adams (224) 212-2535 |
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Financial Community Karen King (224) 212-2711 |
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Ruth Venning (224) 212-2774 |
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