Hospira (NYSE: HSP) is a global specialty pharmaceutical and medication delivery company that is focused on products that improve the safety and efficacy of patient care in the acute care setting. Hospira is a global leader in manufacturing specialty injectable pharmaceuticals and medication delivery systems that deliver drugs and intravenous fluids. Hospira is also a leading provider of contract manufacturing services to pharmaceutical and biotechnology companies for formulation development and filling and finishing of injectable pharmaceuticals. Hospira's U.S. product line is based on five categories: Specialty Injectable Pharmaceuticals, Medication Delivery Systems, Injectable Pharmaceutical Contract Manufacturing, Sales to Abbott, and Other. Other includes sales to non-hospital customers and sales of critical care products. Specialty Injectable Pharmaceuticals and Medication Delivery Systems generate the majority of Hospira's base revenue. Hospitals, alternate site clinics, home healthcare providers, and long-term care facilities use Hospira's broad portfolio of products. Hospira is benefiting from healthcare legislation in the U.S. which allows pharmaceutical manufacturers to produce generic versions of biotech drugs. However, Hospira is struggling with a large backorder volume and shortages of chemicals from suppliers.
Hospira has benefited from strong U.S. sales of docetaxel and gemcitabine, two major oncolytic pharmaceuticals. Hospira has also recently decreased its backorder volume and increased manufacturing efficiency from the Project Fuel optimization initiatives. However, a joint-venture arrangement related to the production of docetaxel and higher research and development expenses associated with new product development programs have weighed on the company's earnings.
The Affordable Care Act, signed into law in 2010, authorizes the Food and Drug Administration to approve "biosimilar" forms of brand-name biotech drugs. Biosimilars have been unavailable in the U.S. because they were not part of the 1984 landmark Hatch-Waxman law, which allowed for cheaper generic drugs from chemically derived products.
Biotech drugs are some of the most expensive medications. The new health law requires extensive clinical trials before biosimilar drugs are approved. In Europe, patients enjoy savings of 20-30% on biosimilar drugs over the brand-name alternative. Hospira sells Retacrit, a biogeneric version of Epogen, in Europe to patients with renal dysfunction who have anemia. Hospira has begun a clinical trial of its biosimilar version of Epogen in 20 U.S. hemodialysis centers. Hospira will benefit from the new biosimilar market opportunity in the U.S.
Some cancer drugs have been in short supply in recent months. Hospira is one of two major suppliers in Canada of a drug that is made abroad and is in short supply. The one that appears to have the most sensitivity is carboplatin, used mainly when solid tumours have been diagnosed. Reasons for the shortage include shortages of the active pharmaceutical ingredient and operational issues in some plants. When Hospira is unable to fill its orders of certain cancer drugs, hospitals turn to other pharmaceutical companies.
The use of generic pharmaceuticals is subject to variations in the structure of health care systems and government policies regarding the use of generic products and pricing, which all lead to differing levels of customer acceptance. There are different policies and levels of generic penetration in each country, causing the competition for generic pharmaceuticals to differ widely.