In this example Iclusig needed to identify how to amplify the need and articulate the differentiation to be successful with their product launch.
This is the third blog in the five blog series:创建成功发布的框架. IQVIA analyzed launches globally to identify common launch challenges and pitfalls. Four launch archetypes were identified, "science sells“，“市场塑造”，“”，谁受益" and "强调差异”，每个都有非常具体的关键成功因素。
The "market shaping" archetype is defined by a drug with low unmet need in the market and high product differentiation, the critical success factors for these types of product launch are:
- Disease/MOA awareness pre-launch
- Amplify unmet needs
- Aggressive positioning
- 广告系列/数据以建立优势。
Additional challenges for emerging biopharma include:
- Need for highly experienced and strategic commercial resources.
In this blog we are using the following as an example of a “market shaping” archetype.
Market shaping: Launching Iclusig into the Chronic Myeloid Leukemia (CML) indication
Ariad Pharmaceuticals' Iclusig (ponatinib) received accelerated approval for use in Chronic Myeloid Leukemia (CML) in 2012 from the Food and Drug Administration.
Iclusig was the fifth tyrosine kinase inhibitor into this indication. The drug also received a narrow indication in CML: Adult patients with CML that is resistant to or intolerant to previous TKI therapy and treatment of adult patients with T315I-positive CML. The T315I mutation develops in around 20% of the ALL population, and results in a worse prognosis. This additional niche indication provided the team with the differentiation point it needed.
但是，认为未满足的需求很低，因为CML中使用了四个TKI，即Gleevec，Sprycel，Tasigna和Bosulif在第一和第二行CML中使用。具有合理的功效和安全结果。同样，在发布时对T315i突变进行测试并不常见。
Creating the market need
即使T315i突变使结果恶化，但很少有医生对此进行测试，也没有看到需要改变患者的情况。ARIAD推出了一个品牌网站，cmlrisks.com, using the image of a butterfly made from snakes – "more threatening than it appears" – to suggest that treatment failure due to resistance puts patients' lives unnecessarily at risk.
该网站及其信息强调了与阻力突变相关的风险，以及需要尽早检测抵抗力故障。它还鼓励医生进行检查，以了解合规性，药物相互作用和突变。
该小组使用强大的临床证据来支持其消息传递，这表明2 TKI失败后CML患者的生存可能性如何减少。
To get more insight into the “market shaping” archetype visit: A framework for successful biopharma launches for therecorded webinar, supported by a slide presentation.
More about the Authors:
- William McClellan
卓越中心负责人，卓越发射
威廉（William）是卓越制药领域的专家，拥有超过20年的经验。他在IQVIA领导着美国卓越启动中心，他专注于发射准备，跟踪和绩效诊断，利用患者数据（例如预测性建模以及定量和定性研究）。
Contributor:
- Maneesh Gupta
iqvia品牌与商业策略高级校长
Maneesh is a Senior Principal with Consulting Services at IQVIA. He focuses on launch, brand, and commercial strategy. He has been helping organizations excel at launches and become more customer centric for over 20 years. His papers on these topics have been published in several industry journals.