Our focus is always on maximizing the
value of your asset to the market.
Maximizing Revenue for Orphan 505b2 Drug
Situation: During a time of FDA-driven market change, a client planned to launch an orphan 505B2 into the Cystic Fibrosis market. The market annual growth rate was limited to approximately 1000 new patient starts and, optimistically, approximately 2,500 therapeutic switches. Switching was driven largely by the lack of symptomatic control in this complex patient population. The revenue from the target population was approximately $35M below expectations. The phase III program had been completed and the NDA submitted to the FDA.
Insight: The client’s clinical program omitted a key population also requiring symptomatic control and within anticipated labeling. This population tended to be prescribed inexpensive low-dose products, some of which the client manufactured for other suppliers, but all of which were being discontinued due to FDA requirements.
Strategy: We evaluated the market opportunity and preemptively re-positioned the company’s approach to target the broader market opportunity of CF & GI businesses. To maintain market share during a time of transition and to increase revenue, we re-launched a generic product the company manufactured while the branded product was still pending approval.
Results: The company was able to use the currently marketed generic product, which had to be removed from the market once the new brand was approved, to transition patients and capture immediate business with an authorized generic of the new brand at launch. Within Year One alone, this company achieved 72 million in net revenue.
Competitive Assessment for New Product Entering Established Market
Situation: New Perspectives was asked to assess a product acquisition opportunity for a new product entering the well-established airway clearance market.
Insight: The new product, a hand-held device placed on 6 locations on the chest cavity, differed slightly in form from the market leader, a vest worn by the patient. The new product had demonstrated therapeutic distinction in one controlled study, but the market leader’s effectiveness was demonstrated in numerous controlled studies. The market leader’s cost to patients, therefore, was reimbursed by insurance companies for up to $15,000 annually, whereas the new product was only reimbursed for up to $500.
Strategy: Our competitive assessment demonstrated the reimbursement challenge for the new device would need to be addressed before the company could expect significant market uptake of the new product.
Due Diligence on Previous Strategy and Fresh Relicensing Approach
Situation: An EU specialty pharma company hired New Perspectives to conduct due diligence on a previous licensee’s strategic approach, including implementation and sales performance. Insight: After extensive investigation, we determined that the licensee had not optimized the product opportunity. For example, neither a strategic nor a tactical plan had been drafted and executed by the licensee in an effort to guide the organization.
Strategy: New Perspectives conducted an opportunity assessment to identify potential customer insights which, when addressed, could improve business results. We created a strategic plan, including a new creative campaign, to support re-licensing or sale of the asset.
Results: The redefined product opportunity and launch strategy enabled the company to reacquire the product and re-license it to an organization that was able to optimize the potential of the asset.
Transnational Pharmaceutical Company Forms U.S. Subsidiary and Launches First Product with Launch Perspectives® Blueprint
Situation: An EU specialty pharma company with an active NDA application before the FDA (which included an REMS program) was seeking to either sell the company, license the product or launch its first product with a U.S.-based subsidiary.
Insight: Regardless of the ultimate path chosen by the parent company, continued commercialization and launch preparations added significant value to the asset and the organization by reducing time to market post- approval. Management did not have the bandwidth to focus on U.S. commercialization while seeking a licensee or buyer. Using our proprietary tool- Launch Perspectives® Blueprint -New Perspectives outlined the path to launch, the relevant interdependencies and the requirements for a start-up commercial organization. We focused on developing the launch strategy and organization required for a U.S. launch, implementing every detail.
Strategy: We developed and implemented a strategic plan to allow for the initiation of phased commercial operations, including staffing, based on milestone achievement and status of deal negotiations.
Results: The company commercialized and launched the product in the U.S. with a CSO partner. Only one U.S. employee was hired prior to FDA approval. (The first U.S. employee was hired at the end of May, the product was FDA approved in the beginning of July, and the sales team launched in September.) New Perspectives provided center-of-excellence experts to progress through the launch implementation.