Eli Lilly and Company is set to launch Cymbalta into the depression and stress urinary incontinence markets in mid-2003. Datamonitor analyzes whether the company most synonymous with the antidepressant market can become a key player again and challenge the position of established compounds such as Wyeth's Effexor.
The Market Brief "Duloxetine - The Next Blockbuster Antidepressant?" evaluates the current data for Cymbalta (duloxetine) in both depression and stress urinary incontinence and examines the drug in comparison to key rivals, such as Wyeth's
Effexor. The Brief also considers the co-marketing agreements Lilly
has signed with players such as Boehringer Ingelheim
Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNaRI) antidepressant currently in the final stages of the approval process for the treatment of major depressive disorder (MDD) and stress urinary incontinence (SUI). Developed by Eli Lilly, Cymbalta, is expected to reach the major US and European markets from mid-2003 onwards.
Lilly is already well positioned in the psychiatry market through the commercial success of its two major products over the last 15 years: namely its groundbreaking selective serotonin re-uptake inhibitor (SSRI) Prozac (fluoxetine) and Zyprexa (olanzapine), its market leader in the antipsychotic arena, and the highest grossing CNS product in 2002 with global sales of $3.6 billion.
Lilly's position in the CNS arena will however, not guarantee the success of Cymbalta. With the antidepressant market becoming increasingly competitive drug companies are having to identify progressively more niche positions in which to launch their products.
Organon has targeted Remeron (mirtazapine) at sleeping disorders and GlaxoSmithKline
has aimed Wellbutrin SR (bupropion) at sexual symptoms. Datamonitor expects that Lilly will follow suit and target the treatment of painful symptoms associated with depression as the platform on which Cymbalta will be launched.
Effexor in the way
The key competitor for Cymbalta will be Wyeth's Effexor, a drug that is firmly established in the global antidepressant market having generated revenues of $2.1 billion in 2002. Once Cymbalta reaches the market, it will be the first serious competition that Effexor has faced within its own class.
Consequently, Wyeth has already begun to try to raise the barriers to entry by focusing on the areas that Cymbalta is expected to target. For example, in December 2002, Wyeth published data from eight double-blind depression trials and five double-blind generalized anxiety disorder (GAD) trials, which outlined the efficacy of venlafaxine in the treatment of the physical symptoms of these disorders. In the cases of depression, the drug was claimed to be superior to not just placebo but also members of the SSRI class.
Wyeth holds a key advantage in being able to emphasize the shear depth of clinical data available for Effexor, which is far greater than for Cymbalta. Wyeth can also point to the millions of patients who have already been successfully treated with Effexor.
In order for Lilly to successfully compete against Effexor, it is imperative that the company launches a once-daily version of Cymbalta for the depression market. Physicians are unlikely to switch patients from a once-daily version of Effexor to a multi-regimen version Cymbalta, as patient compliance will be a major issue. Effexor only began to show dramatic increases in its prescription levels following the launch of an extended-release version, with Cymbalta likely to face a similar situation.
Aside from launching into major depression and SUI, Eli Lilly will probably look to move the drug into other markets over the course of its lifecycle, such as anxiety disorders and neuropathic pain. Over the last 15 years, the traditional lifecycle management model of antidepressant medicines has changed. Increasingly, companies are looking at markets outside of depression to drive sales of their drugs, particularly in the latter stages of their patent life.
Lilly, through the marketing of Prozac, was instrumental in this development and it now means that any manufacturer launching antidepressant products must develop strategies to move into other markets in order to remain competitive.
The crossover of symptoms between anxiety and depression, coupled with the fact that 50% of patients treated for depression also suffer from a comorbid anxiety disorder, makes anxiety an obvious target for antidepressant manufacturers.
Although products such as Effexor and Organon's Remeron are used off-label for neuropathic pain, it is not an area that has been heavily targeted by antidepressant manufacturers. However, the revenue success of Pfizer's Neurontin (gabapentin) has outlined the commercial opportunity that exists in this market.
Over the last few years, the use of antidepressants in anxiety has helped ensure the global antidepressant market is now valued at over $14 billion. Whilst there is now increased competition in this field there is nevertheless, significant opportunities for antidepressant manufacturers to target secondary disorders.
By consistently emphasizing Cymbalta's efficacy in the treatment of pain related symptoms in depression Eli Lilly has focused on an area that has yet to be seriously targeted by other pharmaceutical companies. Significantly, Wyeth is also yet to position the market-leading Effexor as a treatment for this indication.
Cymbalta's commercial prospects have also been improved by the various licensing agreements arranged by Lilly, with other pharmaceutical manufacturers. In Boehringer Ingelheim, for example, Lilly has partnered with a company that is experienced well-established in the urology market, an area where Lilly has a limited presence.
With such alliances in place Cymbalta has the potential to shape the SUI market, due to the lack of licensed products in this area. With the drug expected to receive US marketing approval by the fourth quarter of this year Eli Lilly will also be hoping that Cymbalta can have an impact on the depression market as a whole.