||The examples and perspective in this article may not represent a worldwide view of the subject. (December 2010)|
|Traded as||NYSE: HSP|
|Founded||Lake Forest, Illinois (May 3, 2004)|
|Headquarters||Lake Forest, Illinois, United States|
|F. Michael (Mike) Ball, CEO; John C. Staley, Chairman of the Board of Directors|
|Products||Generic acute-care and oncology injectables, integrated infusion therapy, medication management systems|
|Revenue||$4.1 billion (2011)|
Hospira, Inc. is an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois. It has approximately 15,000 employees. Hospira is the world's largest producer of generic injectable pharmaceuticals, manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management systems. Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. It was formerly the hospital products division of Abbott Laboratories. On September 3, 2015, Hospira was acquired by Pfizer.
Worldwide sales in 2011 were approximately $4.1 billion.
In January 2004, Abbott announced it was spinning off its hospital products division.
Hospira's name was picked by employee vote. The name is derived from the words hospital, spirit, inspire and the Latin word "spero," which means "hope." Hospira became an independent company on Monday, May 3, 2004, with 14,000 employees, 14 manufacturing sites and an estimated $2.5 billion in annual sales. 
In 2007, Hospira purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $2.1 billion. The deal expanded Hospira's international reach and its presence in the oncology market.
More recent acquisitions by Hospira include biotechnology business from Pliva-Croatia in 2009, the generic injectable pharmaceuticals business of Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company, for approximately $400 million, announced in late 2009 and completed in 2010; Javelin Pharmaceuticals, Inc., maker of post-operative pain management drug Dyloject, for approximately $145 million, in 2010; and TheraDoc, a clinical informatics company that develops hospital surveillance systems, in 2009.
In 2011, Hospira's board chose Mike Ball, formerly president of Allergan, as Hospira's new CEO. Ball became CEO in March 2011. Hospira named John Staley its non-executive chairman with the retirement of former executive chairman Christopher Begley in January 2012. Begley had announced his retirement as Hospira's chief executive in August 2010, but had remained as executive chairman.
Some of the key products produced by Hospira:
- Precedex (dexmedetomidine hydrochloride injection)
- GemStar SP
- Hospira MedNet software
- LifeCare PCA
- Plum A+
- ADD-Vantage System
- Carpuject Syringe System
- iSecure Syringes
- Biosimilars: Hospira received marketing approval from the European Commission in December 2007 for its biosimilar drug, Retacrit. Retacrit is an erythropoietin, or EPO, for the treatment of anemia associated with chronic renal failure and chemotherapy. The European Union has developed a regulatory pathway to approve biosimilars in Europe, but a comparable U.S. Food and Drug Administration (FDA) clearance system does not yet exist. Hospira launched Retacrit in Europe in early 2008 and today sells the product in all major European markets. In 2010, Hospira received approval and launched in Europe its second biosimilar, Nivestim, a generic filgrastim for the prevention of febrile neutropenia. Hospira also received approval for Nivestim in Australia in 2010, and launched the product in Australia in 2011. To date, Hospira is the only United States-based company selling biosimilars in Europe. Hospira announced in 2010 the start of a U.S. trial for biosimilar EPO.
- Hextend: Manufactured and distributed by Hospira under license from BioTime (NYSE MKT: BTX), a biotechnology company helmed by CEO Michael D. West, PhD.
- Hospira MedNet: Hospira MedNet is a customizable system that helps hospitals define medication dose limits and track intravenous drug deliveries to help prevent errors.
- Precedex: Precedex (dexmedetomidine hydrochloride) is Hospira's proprietary I.V. sedative, and is a relatively selective alpha-2-adrenoceptor agonist. In the United States, it is approved for continuous I.V. sedation of initially intubated and mechanically ventilated patients in the intensive care setting for use up to 24 hours. Precedex has shown promise as a sedative agent for ICU patients and may decrease the occurrence of a combined end point of delirium and coma. In 2010, Hospira received approval in Japan for long-term use (greater than 24 hours) of Precedex.
- Plum A+: The Plum A+ is an infusion system that administers intravenous (I.V.) medications, fluids and solutions to patients. It is designed to reduce the risk of infusion-related medical errors through both the innovative cassette technology and Drug safety software called MedNet.
- VisIV: VisIV is an intravenous (I.V.) solution bag free of polyvinyl chloride (PVC) materials that can damage the environment and of the so-called plastic "overwrap" that covers the IV bag during shipping to prevent moisture evaporation and keep the medication concentrated.
Sodium thiopental production
Sodium thiopental is an anesthetic discovered by Abbott Laboratories in the 1930s. Hospira manufactured the drug after splitting off from Abbott under the brand name Pentothal. The WHO considers it an essential drug. However, it is also used as part of the lethal injection protocol in many US states. Though Hospira has supplied these states with the drug, it has said, "we do not support the use of any of our products in capital punishment procedures."
|Wikinews has related news: Final US manufacturer ceases production of lethal injection drug; executions delayed|
On January 21, 2011, the company announced that it would stop producing sodium thiopental. Hospira had recently moved production of the drug from a plant in North Carolina to a plant in Liscate, Italy. However, the Italian government threatened to bar its export unless Hospira monitored the entire supply chain all the way to the end user in order to ensure it was only used for medical purposes. The Italian constitution bans the use of capital punishment. Company officials determined there was no way it could prevent sodium thiopental from being used in executions, and did not want to expose their employees to liability.
Legislation and litigation
Oxaliplatin: In August 2009, Hospira introduced a generic version of Sanofi-Aventis SA's (SNY) colon-cancer drug known generically as oxaliplatin and by the brand name Eloxatin, in the United States. In April 2010, Hospira announced a legal settlement with Sanofi-Aventis. Under the settlement terms, Hospira agreed to stop selling oxaliplatin injection in the United States by June 30, 2010, and can relaunch the product in the United States on Aug. 9, 2012.
Biosimilars: In 2010, the U.S. Congress passed legislation that would allow the marketing of biosimilar drugs in the United States. The legislation would allow 12 years of data exclusivity for brand-name biologics. Some consumer groups, like AARP, oppose this provision, saying it would cause lack of access to the promise of such drugs.
Hospira's competitors in specialty injectable pharmaceuticals include Fresenius AG, Baxter International Inc., Bedford Laboratories, Mylan, Sandoz, Teva Pharmaceuticals as well as divisions of several multinational pharmaceutical companies. Its competitors in medication management systems include Baxter, B. Braun Melsungen AG, CareFusion and Fresenius Medical Care AG.
Infusion pump system firmware vulnerability disclosures
In 2014-2015 two security researchers independently identified what were described as severe defects in Hospira's PCA system firmware, the software controlling various of their drug infusion equipment (CVE-2015-3459 and further advisory ICSA-15-125-01B). Numerous remote exploit vulnerabilities were found, in what was believed to be the first FDA safety advisory of its kind. This was followed in July 2015 by a second FDA recommendation that hospitals discontinue use of the affected pumps entirely. The devices, extent of their flaws, and implications, were widely discussed.
The issues were first publicly disclosed by 0XTech ("Hextech") Security on 28 April 2015, when security specialist Jeremy Richards described the PCA3 drug infusion pump, used medically in life-critical systems, as "literally the least secure IP enabled device I’ve ever touched in my life", and "not only susceptible to attack, it is so poorly programmed it can be rendered a useless brick with a single typo (thankfully I have two, making recovery possible)". The firmware issues, affecting a range of pumps, were publicly described by two analysts, including Richards, in 2015 as enabling unauthorized and potentially fatal dose modification by wireless, forged drug library updates to the infusion pump, unauthenticated remote shell access for the root (superuser) access, use of identical and easily decrypted hard-wired user passwords, wireless and FTP credentials and identical private encryption keys and certificates across different device lines, as well as "a slew of outdated software (>100 different vulnerabilities)". A public communication was released by the FDA on 13 May 2015. Some of these were later described in detail in an advisory dated 10 June 2015 by the DHS's Cyber Emergency Response Team, whose assessment stated that all but one of the known issues could be exploited remotely, only a low skill level was needed to exploit all but two of the issues, and exploits to achieve some of the issues are publicly available; however no instance of an actual exploit was known. Richards stated that "The only thing I needed to get in was an interest in the pump".
On 8 June 2015 a second security researcher, Billy Rios, broke silence to state that he had non-publicly reported such vulnerabilities in their pumps (which he needed medically) to the manufacturer and FDA almost a year prior to Richards' public post, in May 2014, and drawn Hospira's attention to the further risk that other pumps might have identical issues. He stated that around November 2014 he "received notification that Hospira was 'not interested in verifying that other pumps are vulnerable'." Hospira's "lack of transparency" and failure to release a patch for "even one vulnerability" after many months, resulted in Rios independently purchasing various other Hospira pump models, and a finding that the vulnerabilities existing on the PCA3 and PCA5 models confirmed by the FDA had also existed on the Plum A+, PCA Lifecare, the older Symbiq model which might still be in use, as well as suspected but not yet verified to exist on the Plum A+3, Plum 360, Sapphire and Sapphire Plus pump models. As all devices use the same software and hard-wired security, any person who gained physical access to a vulnerable model could acquire unauthorized access to, and modify the functioning of, any other such model they are near. The FDA's advice (prior to recommending discontinuation) was that hospitals scrutinize the files in the pumps to confirm no tampering had occurred, and undertake a risk assessment to decide whether to continue wireless use, switch to wired-only use, or disable and remove networked access to the pumps entirely. Rios stated that given widespread coverage and identical software on these pumps, it was "impossible to believe that Hospira was unaware that the PCA3 issues also affected other pumps in their product lines". By June 10, 2015, the Lifecare PCA system had been updated (named version 7) to mitigate the known issues and the updated version was being reviewed by the FDA prior to release.
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