Lung Cancer: Eli Lilly’s Affinitac to challenge th

Lung cancer is one of the most prevalent forms of cancer to afflict both men and women, accounting for nearly 15% of all cancer cases. The size of the lung cancer market - estimated at $1.6bn in 2002 - can help make or break a drug. Datamonitor examines the potential impact of Eli Lilly’s Affinitac on the current treatment leaders and the lung cancer market as a whole. In Strategic Perspectives: Lung Cancer Datamonitor considers the current drug regimens used in first- and second-line therapy for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) in the seven major markets. In addition, Datamonitor assesses the commercial potential of key pipeline drugs in the classes of cytotoxics, angiogenesis inhibitors, gene therapies and vaccines, and forecasts their sales to 2010. The cytotoxics, including platinum agents and taxanes, form the mainstay of lung cancer treatment in major markets. Despite patent expiries that have already occurred or are impending, the overall value of the cytotoxics market is forecast to remain stable to 2010, due to the introduction of novel products. AstraZeneca's Iressa was expected to be a blockbuster force in the lung cancer market. However, its highly-publicized problem with side-effects has given Eli Lilly's Affinitac the opportunity to take the position of key market driver for lung cancer. Cytotoxics still lead Cytotoxics, mainly platinum-based regimens, represent the majority of lung cancer treatments. However, there has been no significant improvement in terms of survival in the last 20 years from existing drugs. With such a high level of unmet need, the disease has attracted a high level of R&D interest from pharmaceutical and biotechnology companies. Bristol-Myers Squibb (BMS) is a dominant force in the US lung cancer market by virtue of having Paraplatin (carboplatin), Platinol (cisplatin) and Taxol (paclitaxel) in its portfolio. Its influence could have been expected to have waned due to the loss of patent protection for Platinol and Taxol in the US. However its aggressive marketing tactics have convinced physicians to switch from cisplatin to more expensive carboplatin. In addition, Datamonitor’s primary research identified that physicians believe carboplatin to be better tolerated than cisplatin. Intense competition In Europe, where the healthcare systems are more cost-sensitive, cheaper cisplatin is preferred over carboplatin despite the higher toxicity of cisplatin. As the US healthcare system is the least cost-conscious, the low price point of cisplatin alone is unlikely to persuade physicians to switch to the drug, and BMS, which has recently suffered a number of setbacks elsewhere in the oncology market, is expected to continue to market carboplatin heavily until its patent expiry in 2004. BMS’ Taxol (paclitaxel) is expected to face stiff competition from Aventis’ Taxotere (docetaxel) as one of the key components of first-line platinum-based regimen for NSCLC in Europe in the short term. However, this battle is likely to be short-lived, as Taxol’s patent expires in 2003 and both taxanes’ will be usurped by cheaper paclitaxel generics. Aventis is likely to aggressively market Taxotere in Europe to increase the uptake during the short period that taxane prices remain protected. Datamonitor expects the increased revenue from Taxotere to be significant during this period. However, in the cost-sensitive European markets, Datamonitor expects generic paclitaxel to flood the European markets from the end of 2003. Unless Taxotere shows superior efficacy or tolerability over paclitaxel, it is difficult to envisage Taxotere significantly increasing sales after paclitaxel generics enter into the market. Gene therapy to have a say Datamonitor does not believe that Aventis would risk conducting head-to-head studies comparing Taxotere with paclitaxel in the event that paclitaxel is shown to be more efficacious. Therefore, Aventis is likely to rely on heavy marketing of Taxotere in order to maintain its prescription rate in Europe after Taxol’s patent expiry. The market leaders held by BMS and Aventis will also face the challenge of Eli Lilly’s Affinitac. Despite the skepticism toward gene therapy, Datamonitor expects Affinitac to be one of the main driving forces in the more aggressive lung cancer markets to 2010, on the grounds of its efficacy, tolerability and synergy with mainstream agents. A significant proportion of physicians interviewed by Datamonitor believe that gene therapy has potential in lung cancer treatment. Nearly two-thirds of physicians indicated that gene therapy is expected to have a low side-effect profile and be better tolerated than conventional chemotherapy. Datamonitor believes that Affinitac, formerly known as ISIS 3521, is the gene therapy with the highest commercial potential, based on currently available data. Affinitac in combination with cisplatin and Gemzar appears well-tolerated by patients with a variety of solid tumors, and to exhibit up to a 59% response rate, with 51% of patients achieving stable disease, with efficacy even in previously treated, relapsed and refractory patients. Still work to be done In August 2001, Eli Lilly and Isis entered into a strategic alliance that includes the global commercial license of Isis' antisense cancer compounds including Affinitac. The deal is considered to be worth more than $300m. Together Lilly’s resources and Isis’ expertise in antisense gene therapy should ensure a significant uptake of Affinitac if launched. However, the companies need to raise the profile of Affinitac among physicians. According to Datamonitor research, only 30% of physicians interviewed believed that Affinitac has significant potential as a gene therapy, and physicians were unimpressed with gene therapies overall. Lilly will therefore need to target and educate physicians at the earliest opportunity to begin building support for Affinitac. Lilly is promoting the use of Affinitac in combination with the already established Gemzar, another Lilly product. Successful clinical trials here should provide a smoother passage into the lung cancer market for Affinitac. Based on the currently available data, Datamonitor predicts sales of $773m in lung cancer by 2010 for Affinitac, making it the driving force in the lung cancer market, which is expected to grow from $1.6bn in 2002 to nearly $4.6bn in 2010. One thing is certain - commercial success in this highly competitive sector will depend more than ever on an understanding of the dynamics of the market, and access to the latest, most reliable analysis of changing market conditions and events. If you found this week's Expert View useful, you may be interested in Datamonitor's reports, all available from http://www.datamonitor.com/healthcare

· Strategic Perspectives : Lung Cancer - Cytotoxics Holding Steady While Innovatives Find a Niche priced $6,400

· Drugs of Tomorrow: Cancer Overview - The Synergistic Advance - Innovatives Complement Traditional Chemotherapies priced $6,100

Drugs of Tomorrow

· Treatment Algorithms 2001: Lung Cancer - Waiting for Innovation priced $6,100

Treatment Algorithms 2001 For a free Datamonitor healthcare report please click here.