Pfizer's generic move
KALAMAZOO — A $100 million investment into a new production line by Pfizer aims to put Kalamazoo at the center of generic injectable medicines.
Pfizer is taking what was once a shrinking proportion of its product portfolio and turning it into growth, said David Simmons, president and general manager of the company’s established products division. Pfizer’s Established Products Business Unit focuses on the production of medicines that have lost or are close to losing patent exclusivity, and account for $10 billion in annual sales.
Simmons spoke to MiBiz from Pfizer’s New York headquarters, and said the company is well positioned to grab market share in the off-patent pharmaceutical industry.
“The strategic value we bring to this business is our broad product portfolio, our capabilities in reformulation and low-cost manufacturing,” Simmons said. “These position us to become one of the world’s top pharmaceutical players in the off-patent marketplace.”
Pfizer expects the global market for off-patent products to grow from $270 billion in 2006 to more than over $500 billion in 2011. Simmons said the worldwide off-patent marketplace suffers from quality and supply reliability issues, leaving space in the market for Pfizer to grow.
“With our broad established products portfolio and capabilities in low-cost manufacturing, Pfizer is in an ideal position to supply high quality medicines at an affordable price,” Simmons said. “In the past, off-patent products were a shrinking part of Pfizer’s business. With our Established Products Business Unit, we’re well on our way to turning that around.”Simmons said Pfizer’s pursuit of global partners is paying dividends, with more than 200 licensed medicines being brought into the established products portfolio. Agreements with highly regarded Indian generics companies Aurobindo Pharma Ltd. and Claris Lifesciences Ltd. give Pfizer access to more than 60 medicines available in 70 different countries, and 100 medicines available in North America, Europe, Australia and New Zealand.
In January, Pfizer announced that it would commercialize off-patent sterile injectable and oral products in the United States through licensing agreements with Strides and Onco Laboratories Ltd. and Onco Therapies Ltd., two joint ventures between Strides and Aspen, South Africa.
“We aim to provide underserved patients and payers in all parts of the world with affordable medicines characterized by Pfizer’s reputation for quality, safety and innovation,” Simmons said.
In late 2009, the company invested $100 million into the construction of Aseptic Processing North (APN), a new sterile injectable manufacturing area in Pfizer’s main Portage manufacturing facility. The line is designed specifically for the manufacture of freeze-dried, or lyophilized, products.
The first product to come off the line will be the anti-inflammatory steroid Solu-Cortef, used to treat a number of conditions, including severe allergic reactions. The facility is awaiting U.S. Food and Drug Administration approval for the production of Dynastat, a non-narcotic, post-surgical pain reliever for European markets; Bacatracin, an antiobiotic; and SoluMedrol, another anti-inflammatory medicine that recently celebrated its 50th birthday.
Kalamazoo and the 120 employees at the Portage facility are at the center of Pfizer’s injectable medicine production, accounting for approximately 60 percent of the injectable products that are marketed in the U.S., explained Janet Zlomek, director of drug products operations for Pfizer Global Manufacturing Kalamazoo.
The line is largely automated, and the equipment’s design allows quick changeover from one medicine to another with clean-in-place and sterilize-in-place technology to reduce downtime, allowing for flexibility in lot sizes, ranging from pilot scale to large commercial scale.
“Kalamazoo produces a large portfolio of injectable products for global markets. We support hospital sales in the United States, along with other responsibilities, so it is advantageous to have a manufacturing location in the Midwest,” Zlomek said. “We have established extensive experience in the design, construction, and operation of aseptic and lyophilization facilities. This facility went from design concept to full qualification in approximately three years. It was designed with flexibility and efficiency in mind.”
Due to the expertise in injectable medicine production, the APN facility came online quickly and makes the Kalamazoo manufacturing site valuable to Pfizer’s generics business, said Simmons.
“When Pfizer announced the formation of its business-unit structure in 2008, which included Established Products, one of our strengths was the fact that Kalamazoo already manufactured a large number of off-patent medicines, does so with excellence, and continually focuses on new approaches to remain competitive in terms of quality, productivity and cost,” Simmons said. “Kalamazoo has some world-class, highly differentiated capabilities and a quality pedigree that is in a league all its own.”
