Generic pharma manufacturers are in a fierce competition with one another – margins are extraordinarily tight to turn around drugs in short timeframes at low costs, all while appealing to the masses. As a result, generic firms are being forced to optimize their resources and reduce costs wherever possible. But, is there another way for generic players to differentiate themselves?
Yes – and one of the focuses should be on enhancing existing products through new formulations and drug technologies to improve delivery and/or reduce safety concerns.
For example, many patients that have central nervous system diseases, such as Parkinson’s and Huntington’s, often lose control of their motor skills, which makes swallowing pills a major issue. Perhaps a non-pill, transmucosal buccal film or lozenge could help. This is just one of many opportunities for further exploration.
How can this process add value to generic firms?
Generic firms can utilize the 505(b)(2) application to develop these products. The FDA gives products with new formulations and/or delivery mechanisms marketing exclusivities of 3, 5 or 7 years. The length of time depends on the nature and class of the drug. This pathway typically has lower clinical trial risk since applications use existing reference drugs with known safety profiles and efficacy endpoints. Also, time to market and costs are often reduced since fewer clinical trials are necessary to collect data (Source: The Food and Drug Law Institute - 505(b)(2)).
This unique application presents an alternative revenue source to targeting drugs off patent for generic production.
Are generic firms already playing in this area?
Yes - top global generic pharma firms are investing in this area.
For example, Teva Pharmaceuticals is one of the first to develop a commercialization platform based on improving existing molecules through new delivery mechanisms, a term they have coined: “New Therapeutic Entities (NTEs)”. Teva has invested in 4 classes of NTEs in 2013 alone:
- Abuse deterrent opioids for the management of Pain
- Long-acting injectable for Schizophrenia patients
- Fixed dose combination of two drugs for Glaucoma
- Direct release of GI drug for Crohn’s Disease (Source: Teva website).
Although the idea of repurposing or reformulating a molecule is not a new concept, it has grown in popularity over the past few years and will continue to grow in the years to come.
So, where can we begin? How precisely can we develop product reformulation ideas?
First, a culture of ideation and innovation must be encouraged throughout the organization. The pharma manufacturer should align their strategic corporate objectives with this concept of reformulation development to ensure the right resources (e.g., molecules, technologies, and people) and processes are in place.
Then, key ideation principles should be identified and communicated to the team to allow for unfiltered, creative thinking around reformulating. Some principles may include:
- Be open and receptive to all ideas
- De-emphasize reimbursement/pricing concerns related to the idea as it will be discussed further downstream in the evaluation process
- Elicit support from a cross-functional team consisting of R&D, Medical/Clinical, Manufacturing, Regulatory, Legal, and Commercial/Marketing, among others.
We recommend a four-step approach to reformulation ideation (Figure 1)
1. Prioritize disease state focus areas to make ideation manageable
2. Educate stakeholders through training sessions to allow for an understanding of opportunities for improvement (e.g., better patient quality of life, reduction of major side effects, and/or more convenient delivery mechanism) and key delivery technologies available for use
3. Collect, revise and optimize reformulation ideas for further evaluation through online surveys and/or in-person working sessions
4. Conduct validation sessions to further evaluate the ideas and begin the more in-depth due diligence assessments, eventually leading to commercialization go/no-go decisions
Now, how can Capgemini Consulting help?
Capgemini Consulting has extensive experience in driving innovation within life sciences companies. We have an established framework and approach to facilitate productive ideation, with experience across various therapeutic areas such as Pain, Central Nervous System, and Oncology.
Further, we have worked with numerous clients (small and large, generic and branded focused, US and global) to optimize their product portfolios and focus their attention to their most valuable and profitable programs.
We welcome conversations with your team and look forward to partnering in the future. Please feel free to reach out to David Auerbach, Will Rose, and Kelly Wagner at any time.
Capgemini Consulting North America – Life Sciences
David Auerbach – Senior Consultant – CC NA Life Sciences
Special thanks to Rohan Maru, Will Rose, and Kelly Wagner for their support in this initiative.
Capgemini Consulting Life Sciences Blog Editors: Joe Medel and Jeremy Golan