IHS Global Insight Perspective | |
Significance | The collaboration with the University of Wisconsin's non-profit unit is related to human embryonic stem-cell technology. The deal will allow Pfizer to expand its R&D base, particularly for regenerative medicine. |
Implications | The attack on Lyrica's intellectual property, on the other hand, is a setback for Pfizer, and means the total number of generic challengers rises to six. The product is one of the fastest-growing products for Pfizer. |
Outlook | The two developments highlight the increasing pressure on Big Pharma firms in terms of sustaining growth prospects. Pfizer will be severely tested over its intellectual property rights on Lyrica in the ensuing years as the litigation gathers pace. |
Pfizer Alliance with U.S. University
U.S. pharma major Pfizer has entered into a licensing arrangement with the University of Wisconsin relating to the latter's stem-cell technology. The deal involves the university's private non-profit organisation, the Wisconsin Alumni Research Foundation, which will license its human embryonic stem (hES) cell patents to Pfizer providing the pharma giant with rights to use the technology for development of drugs. The pharma major has said it will implement a three-pronged strategy for the use of the technology—drug discovery research, improvement in the safety of new treatments, and support in its move towards cell therapy. Stem-cell technology will be an addition to the Pfizer's recently formed division, Pfizer Regenerative Medicine Research Unit.
Lyrica Patent
Separately, the firm is facing some challenges to its patent for the neurodegenerative drug Lyrica. The pharma major has been on the offensive recently, filing patent-infringement lawsuits against Indian firms Sun Pharma, Wockhardt, and Lupin. The product is indicated as a treatment for neuropathic pain associated with diabetic peripheral neuropathy, fibromyalgia, and as adjunctive therapy for adult patients with partial onset seizures. BusinessStandard.com reported that the firm filed lawsuits at the District Court of Delaware against the three Indian firms. According to the Orange Book, Lyrica's patent expires between 8 October 2013 and 30 December 2018. The source also noted that the lawsuit alleges three patent infringements by Lupin and one each by the other two Indian firms.
Outlook and Implications
The two developments signal Big Pharma's strengths and vulnerabilities in relation to the changing dynamics of the global pharmaceutical space. The agreement with the University of Wisconsin provides Pfizer with a valuable addition to its research arsenal, primarily as a tool for progressing its regenerative medicine development. The licence allows Pfizer to have access to information and materials, particularly cell lines to explore new ranges of therapies. It is significant to note here that the Wisconsin Alumni Research Foundation (WARF) also has an agreement with Geron Corporation for hES. The organisation received endorsement from the U.S. Patent Trademark Organisation (USPTO) on two of its hES patents (see United States: 12 March 2008: USPTO Upholds Two Human Embryonic Stem Cell Patents).
On the Lyrica patent front, the infringement lawsuit was triggered by Abbreviated New Drug Applications (ANDAs) from the three Indian firms that contained Paragraph IV certification. The lawsuit is primarily to block final approval of the ANDAs that would allow for the introduction of generic versions of the drug in the U.S. market. Pfizer is expected to strongly defend its intellectual property as the drug is one of the top performers in terms of growth for the firm, garnering sales of over US$2.5 billion in 2008. The latest lawsuit will add to the three other challenges to the product by generic firms Teva Pharma (Israel), Sandoz (Switzerland; part of Novartis), and Actavis (Iceland). Lyrica is clearly under increasing threat from generic competition, and the initiation of litigation allows some breathing space for Pfizer as it ensures a 30-month stay on marketing of the generic version or until a decision by the courts has been reached, whichever is earlier.
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