End-of-life care

How to determine the right strategy for mature brands

By Tim Arendt, Fahti Khosrow-Shahi, and Seb Morisot

Tim Arendt is VP, Fahti Khosrow-Shahi is managing director, and Seb Morisot is engagement manager, Campbell Alliance.

Based on current trends, soon 90 percent of products dispensed will be for a generic. As a result, companies are more aggressively managing their product life cycles. Life cycle planning requires a coordinated effort with respect to understanding the market dynamics, the future trends in markets, and the clinical profile of the brand and where it can be optimized. With a wide range of generic defense strategies and tactics available, however, it can be challenging to decide which tactics make the most sense for a given brand.

Due to the long lead times of product development and the long FDA approval cycle, a life cycle optimization plan should begin immediately upon or prior to approval of the new chemical entity. If a brand is within 24 months of impending patent expiry, it is probably too late to implement all of the options available. The options examined in this article are primarily based on small molecule strategy, versus biosimilars, which have their own set of considerations.

Potential strategies

Large companies like Allergan with its Botox brand, emerging companies like Otonomy with ciprofloxacin, and startups like Evoke Pharmaceuticals with its intranasal formulation of metoclopramide have successfully managed the life cycle of their products. The companies like these that succeed utilize a range of different strategies.

Harvest mode/pricing optimization
Harvest mode/pricing optimization is aggressive pricing 24 months prior to patent expiration followed by letting the product go generic at a higher price point with the understanding of retaining less than 5 percent market share.

Authorized generic
Authorized generics allow the branded company to maintain its sales volume but at a lower price. The price erosion is going to depend on the number of generics in the market. The authorized generic option does not preclude pricing optimization and keeping the legacy product on the market.

Line extensions and indications in pediatrics
For any brand, a pediatrics indication should be explored as it provides an additional six months of exclusivity. Companies should also aggressively pursue line extensions and other indications that may offer additional patent protection and utilization of a brand. Formulation and dose changes are key to this strategy.

Enhanced reformulations
Enhanced reformulations, especially in the pain space, can provide superior product for the patient, i.e., abuse deterrent technologies. Abuse deterrent technologies can lead to some relief in the marketplace, as FDA has shown a tendency to pull products that do not have it.

Patent mining
Patent mining should occur long before the patent expiration. A patent specialist should examine use patents, manufacturing patents, and any other intellectual property associated with the brand, its use, or the manufacturing technologies employed in the development of the product. Sometimes a use patent may have been pulled that the company may not have been aware of. This strategy allows the company to identify the gaps in their patents and establish a plan for plugging those holes.

Regulatory enforcement
If companies invest in the clinical and legal development of their products, they should have every right to protect those agents from assault on their patents. When companies have a firm position on their patent and it is being challenged by a generic developer, they should always explore a Citizens Petition route so that the FDA fully understands the effects associated with approving a generic to the reference product. The regulatory pathways for approval of a generic should be explored in detail, such as the case with dermatologics (with the exception of topical steroids) and biosimilars.

Determining the right path forward

Developing a generic defense strategy should be the result of a multi-faceted approach comprising analogue analyses, competitive and regulatory/technical assessments, and stakeholder research.

Identify opportunities
The first step is to identify the opportunities available to mount a generic defense, including all the potential “levers” and supporting strategies. A repository of generic defense strategies and tactics can be assembled for the brand, supported by the analyses of analogs.

To determine where to focus efforts in developing case studies, look at all brands that have recently lost exclusivity for which data are available and sort the brands according to sales performance before and after loss of exclusivity. To facilitate a strong comparison across brands, sales data can be filtered in pre- vs. post-loss-of-exclusivity revenue in order to determine the extent of generic erosion. All relevant products within a branded franchise (e.g., different formulations of a same product) should be taken into consideration to measure the impact of generic entry.

Companies should then conduct an analysis to identify assets that were significantly affected by the entry of a generic (greater than 50 percent decrease in sales in the first year following generic entry), moderately impacted by generics (zero percent to 50 percent erosion), or resisted generic entry (no erosion). Based on this analysis, it is then possible to filter for potential for the brand.

Companies should next analyze the levers used for assets that resisted generic erosion to generate a menu of generic defense levers to be subsequently filtered for applicability to the brand. They should also examine the environment in which the successful assets evolved in the wake of generic competition.

Identify market events
The next step is to identify all of the potential market events that can impact the brand. Scenarios and expected timelines should be defined, along with the triggering events (internal and external, including state-by-state generic substitution status) and the estimated timeline for potential scenarios.

Distinct scenarios can be characterized based on relative timing of events and their associated probabilities, as well as their impact to the brand business. A timeline can then be devised in order to help understand the potential impact to the brand based on internal and competitive events. Companies should then identify potential scenarios for the relative timing of the generic launches and examine factors to determine the likelihood of any of the given scenarios: manufacturing capability, FDA guidance track record, ANDA submission, two-plus-year ANDA approval timeline.

It will then be possible to evaluate the impact, including barriers and drivers for the brand.

Determine the “if this, then this” generic defense strategy
The final step is to generate strategies and tactics for the brand. The case study analyses and research conducted above will help develop a list of core tactics available to the company to protect the brand business.

Core strategies and tactics can be prioritized according to three parameters: market risk, execution risk, and impact. Execution risk indicates the feasibility of strategies and tactics. Market risk indicates potential for risk due to factors affecting the overall market. Impact indicates potential effect of strategies and tactics on generic protection.

Based on the identified strategies and tactics, it is then necessary to evaluate implementation requirements and build the generic defense playbook based on immediate imperatives and event-contingent imperatives. Depending on the culture and reporting structure of the organization, execution can be challenging. This is particularly true in a highly siloed organization.

Companies require a comprehensive and executable plan for each one of their promoted products. Once the plan is established, routine updates in the normal business planning cycle are needed to ensure the life cycle plan is optimized and executed. Plans need to be updated on an annual basis, based on changes in the market, regulatory environment, and payer landscape.