Pharmaceutical Technologist - July 2008 - (Page 15)

Generics expected period. It is based on the patent filing date, and was introduced by regulators to compensate big pharma companies for the marketing time ‘lost’ during the regulatory review process. Patent term restoration and supplementary protection can delay market entry for generics companies, which need to be aware of any such provisions when formulating their launch plans. When generics companies attempt to enter the US market ahead of patent expiry, certified ANDA applications will likely be challenged by big pharma companies, which usually undertake patent litigation to defend the validity of existing patents. Generics companies must be prepared (and able) to fight any such costly litigation when pursuing ANDAs. On the other hand, generics companies can challenge unreasonable ring fencing of patents. High-profile cases include challenges by Ranbaxy Laboratories (India) on Pfizer’s (NY, USA) anticholesterol drug, Lipitor and GlaxoSmithKline’s (UK) antibiotic, Ceftin; and challenges by Dr Reddy’s Laboratories (India) on Eli Lilly’s (IN, USA) antidepressant, Prozac. More recently, rather than entering litigation proceedings, some generics companies have entered into strategic deals with Big Pharma to sell blockbuster drugs when they go off patent. One example is Dr Reddy’s who, in 2006, entered into a deal with Merck (NJ, USA) for the launch of generic versions of the blockbuster drugs Zocor and Proscar, providing the company with 180-day market exclusivity for the generic versions. Additional complexity for generic companies in overcoming patent barriers lies in the fact that outstanding patent terms often vary between the US and Europe, and within Europe on a country-by-country basis. players have strong networks linked into the buying community. There are several ways generics companies can overcome this and a favoured route is to partner with an established player in the target market. This offers the emerging market player a relatively rapid and low-risk option to market entry compared with establishing and developing a proprietary sales force; for example, the joint venture between Mayne Pharma (Australia) and Zydus Cadila (India), and the copromotion agreement between Lupin Pharmaceuticals (India) and Cornerstone Biopharma (NC, USA). These deals provided the emerging market companies with manufacturing, marketing and US promotion capabilities. Alternative options include the acquisition of established companies complementary to the generics company portfolio based in the target territory, as illustrated in Table 1. barriers and developing the strategies to overcome these is of value to both companies and potential investors. PT References 1. World Generic Market Report, (Espicom, UK, December 2006). 2. World Generic Market Report, (Espicom, UK, December 2007). 3. G.J. Buehler, “Office of Generic Drugs Update” (2006). www.fda.gov 4. Improving Access to Generic Drugs (FDA, USA, June 2003). 5. U.V. Venkataram, Office of Generic Drugs, “Review and Approval of ANDAs CMC Issues” (2007). www.fda.gov 6. European Generic Medicines Association, “Generic Medicines, Data Exclusivity and Patents” (2007). www.egagenerics.com Elizabeth Hill is Head of Transaction Support for Cambridge Consultants Ltd (UK). Conclusion The potential rewards of success for generic pharmaceuticals companies in regulated markets are tempered by the need to overcome regulatory, intellectual property and marketing hurdles to achieve marketing authorization and market access. An understanding of the potential Table 1 Illustrative acquisitions by emerging market companies.2 Emerging market company Acquired company (year) Transaction value (million) Sun Pharmaceutical Industries Ltd Able Laboratories Assets, US (2005) Valeant Facilities, Hungary & US (2005) Taro Pharmaceutical Industries, Israel (2007) $23.15 Unavailable $454 £9 €480 $324 Unavailable Unavailable $11 $150 $265 $52 Dr Reddy’s Laboratories Ltd BMS Laboratories and Meridian Healthcare, UK (2002) Betapharm, Germany (2006) Ranbaxy Laboratories Ltd Terapia, Romania (2006) Ethimed NV, Belgium (2006) Allen SpA, Italy (2006) Marketing barriers With the belief that the regulatory and intellectual property barriers outlined can be surmounted, generics manufacturers must establish a route to market before they can commence sales. This can be challenging, especially in markets where existing Wockhardt Ltd Esparma GmbH, Germany (2004) Pinewood Labs Ltd, Ireland (2006) Negma Laboratories, France (2007) Morton Grove, US (2007) www.ptemagazine.com 15 http://www.fda.gov http://www.fda.gov http://www.egagenerics.com http://www.ptemagazine.com

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Pharmaceutical Technologist - July 2008 Contents Industry Highlights Morpheus Market Watch Overcoming the Barriers The Tide of Change Eight Steps to Improved Water Efficiency Q&A

Pharmaceutical Technologist - July 2008

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