We are Applying our Experience to Our Current Clients

• Asten was retained by a specialty pharmaceutical company seeking to determine the optimal development path and appropriate licensing terms for a development-stage molecule with potential in multiple indications and therapeutic areas.  

Asten leveraged their proprietary R&D benchmarking methodology to collect and analyze historical drug development data for over 1900 clinical programs of interest from 1994-2008.  R&D benchmarking data were combined with licensing and market metrics to prioritize 23 high-interest indications, according to their strategic and clinical attractiveness in the context of the company’s overall strategy.

 

• R&D metrics included: probability of successful Phase II to Phase III transition, time in phase and historical licensing activity for each indication
• Additional metrics for target markets included (among several others): size, competitive environment, unmet need, complexity of clinical trials and reimbursement landscape
• In-depth analysis was performed on top indications to pair historical Phase II success rates with mechanisms most relevant to the development candidate. Asten conducted a detailed analysis matching mechanism and development stage to probability of success analysis to assist strategic decision-making

Asten also reviewed relevant comparable deals to determine the appropriate license structure and terms and to develop a framework for valuation.  Over 1,200 deals were filtered for the appropriate criteria.   Of these, 28 were selected for in-depth analysis and used as the basis for recommending the optimal license structure and creating a sample term sheet for potential deal negotiations.

• Worked with a specialty pharmaceutical company to estimate the potential value of a development-stage drug for three orphan indications, including two rare genetic diseases.  Interviewed treating physicians to determine unmet needs in current standard of care for each disease state as well as potential uptake of the development-stage product
  • Developed novel method for estimating incidence of disease for which reliable estimates were unavailable (manuscript currently in preparation with academic collaborators) 
  • Created flexible model of disease estimating potential revenues in high low and base cases
  • Estimated impact of single vs. multiple indication launches on pricing

• Asten worked with a Canadian biotechnology company to help them understand the potential value of a development-stage enabling technology.  Asten interviewed area-specific opinion leaders, identified relevant strengths and weaknesses of the technology and estimated the value to potential licensing partners.  This work helped define an appropriate range of deal terms based on the stage of the product and historical deals

  • Performed analysis of licensing terms of comparable technologies

  • Created sample term sheet to aid in negotiations of licensing terms

  • Supported business development activities in preparation for licensing discussions   

• Supported the licensing efforts of a European specialty pharmaceutical company by creating a revenue model of a development-stage women’s health product. For this project, Asten leveraged existing qualitative and quantitative market research conducted by the company.  Modeled the effect of multiple market scenarios in the potential of the product

• Worked in partnership with a health care management consultancy to evaluate the slow uptake of a marketed product for a major worldwide pharmaceutical company. Interviewed over 20 clinicians, key opinion leaders and payers to understand the perception of the product in the marketplace and drivers of use. This work identified the key limitations of use and potential upside drivers to inform further quantitative and qualitative studies. Examples of analysis included:

  • Comparative analysis of product from clinical, scientific and pharmacological perspective, relative to other currently marketed products
  • Evaluation of perceptions of the product by both high and low users of the product
  • Evaluation of current marketing strategies and identification of gaps informed by interviews with physicians and thought leaders
  • Identification and quantification of key drivers for future increased market share
  • Broad quantification of potential upside for the product based on key variables
  • Analysis of payer hurdles/issues in reimbursement for this product  

• Retained by a private specialty pharmaceutical company to evaluate the competitive positioning of a late-stage development product with respect to the strategic path chosen by management.  The results of this analysis are included in a board presentation geared to explaining and clarifying the clinical path being championed by management and the consequent rationale behind the revenue projections.  Asten provided scientific and commercial rationale for the decision based on comparative literature, discussions with opinion leaders and analysis of IMS sales data. Examples of analysis included:

  • Comparison of development product to current standard of care in the context of ease of use and pharmacodynamics
  • Analysis of differentiating factors between the product and standard of care for management and investors
  • Characterization of trends in the development and use of the two agents based on review of products currently in clinical trials and analysis of sales and prescription audit

• Asten worked with a specialty pharmaceutical company to determine the commercial potential of a reformulation of a currently approved product for a new indication. The project consisted of a review of market research, the pharmacokinetic profile of the product, clinical development pipelines, currently marketed products and revenues in the therapeutic area. Key highlights of the project included:
  • Interviews with opinion leaders revealed that the phamacokinetic profile of the product was crucial to defining appropriate market segments 
  • A market model was created reflecting uptake in the appropriate market segments and projecting the value of the product in two potential market scenarios.  The flexible nature of the model permits additional scenario testing.
  • Asten prepared a presentation outlining the competitive positioning of the product in the proposed indication relative to other agents both in the clinical development pipeline and on the market
  • This presentation was offered to the board to inform strategic decisions on the future of this program

• Retained by an early stage diagnostic imaging company to help assess the projected utilization of their product by health care practitioners upon market entry and value the current asset. Asten performed interviews with thought leaders, a survey of practicing physicians and performed a thorough review of the scientific, clinical and commercial landscapes. Following the collection of data, Asten created market models with inputs on a flexible dashboard based on the results of analysis.  This analysis is currently being used by the company to aid in fundraising efforts and partnering discussions

• Worked with a startup biopharma with a unique funding mechanism to create a therapeutic area prioritization matrix to guide initial product acquisitions.  Asten created a high-level therapeutic area model to justify business plan rationale to investors. We then worked with the CEO of the company to refine his message and prepared documents for presentation to potential investors. Asten continues to work with this group to prioritize individual products for acquisition once the therapeutic focus has been established

• Valued platform technology across four therapeutic areas for midsize biotech company in licensing discussions with a global pharmaceutical company. Validated counter-proposal with significantly higher milestone and royalty payments than originally offered.  To support the assumptions of the proposal, Asten created interactive, flexible market models for forecasting the potential value of pipeline assets for biotech company. Asten then identified strengths and weaknesses of proposed term sheet and preliminary license agreement for biotech company in anticipation of deal with a major pharmaceutical company and made suggestions around retention of maximum IP value and best deal terms for near-term and future revenue generation