design, delay and deals

The following key points come from a recently published article in PM360, a resource for pharma marketers. It highlights the range and complexity of considerations during product development which ultimately influence both the likelihood of product licensing and the potential value of the deal. The last point, which I have highlighted, seems to me to be the current issue responsible for delay, which the company was flagging in last week’s update. Recent clinical testing has thrown up new potential indications for the TPM/oxycodone patch. That means that an indication launch sequence now has to be evaluated, which will take a bit more time. It has to be done because it matters - and it matters a lot. It stands to not only influence the design of next stage trials, it potentially influences just how much POH can get for its licence deal.

Following the key points is a brief update on major pharma licensing deals undertaken in Q2 this year, which may be of interest.

When It Comes to Licensing Deals, It’s All About Market Access

• Although essential, clinical success and regulatory approval are no longer sufficient to guarantee marketplace success. Probability, timing and sustainability of market access are also crucial to assessing licensing.

• Pre-Phase III assets present potential benefits to prospective buyers, namely the opportunity to shape the clinical development plan to optimize the value proposition and pricing and reimbursement potential.

• Payers are interested in innovation only when it translates into increased value, such as improving patient outcomes and reducing treatment costs. Ensuring the innovation translates into payer value is an important consideration when optimizing the development of a novel asset.

• Alignment between clinical achievements and market access considerations is critical for success. Designing clinical trials must take into account the impact of certain decisions on the asset’s pricing and market access potential. Clinical trial inclusion criteria often become the reimbursement eligibility criteria imposed by payers.

• Active trial comparators and head-to-head data against the standard of care at launch will likely be required. Comparator selection establishes pricing potential. Therefore, one must evaluate not only whether the comparator will be the standard of care at the time of launch but also whether it will retain its branded price or lose exclusivity prior to the new asset’s launch.

• Determining the appropriate launch sequence for multiple indications is essential to optimizing market access and price potential. Typically, price cannot be renegotiated upward. Therefore, the ability to first launch the asset in the indication with the highest potential price is critical to maximize value; the ability to do so must be evaluated.(1)



This week, a list of licensing/R&D collaborative deals undertaken by top-tier pharmaceutical manufacturers during Q2 of this year was released.

A total of 36 deals were struck. Most were early-stage deals, one was for a Phase 3 asset, two were for Phase 1 assets and six involved Phase 2 assets.

Based on the deals in Q2 for which financial details were disclosed, the average total value was $375 million. The average upfront payment paid in Q2 was $71 million, with subsequent milestone payments standing at an average of $336 million. (2)


(1) http://www.pm360online.com/when-it-comes-to-licensing-deals-its-all-about-market-access/

(2) http://www.firstwordpharma.com/node/1126827?tsid=28#axzz2aQAWMJ6K