Trinity Partners Reveals Findings on FDA-Approved Novel Drug Performance

Trinity Partners, a leading global life sciences consulting firm, today announced the findings of its second annual Trinity Drug Index which assessed all novel drugs approved by the FDA in 2014. The index ranks drug performance against three categories: commercial success, therapeutic value and R&D complexity, assigning each drug a score in those three areas as well as an overall composite score.

Top findings of this year’s Trinity Drug Index include:

· Immuno-oncology agent Keytruda was the best performing drug approved in 2014, followed by Harvoni and Opdivo.

· To be successful, mass-market, primary care products had to demonstrate at least moderate therapeutic innovation coupled with substantial marketing power.

· While several orphan drugs achieved high commercial scores, others (mainly, “ultra-orphans”) were not able to reap the success expected based on their therapeutic value.

· Of products acquired during the regulatory review process or after FDA approval (Esbriet, Northera, Dalvance, Sivextro, and Zerbaxa), all but Esbriet underperformed commercially.

· Anti-infective agents did not perform well commercially despite average to above average therapeutic scores.

“Most of the top performers are innovative specialty drugs targeting multiple niche indications with high unmet needs,” said John Corcoran, Founder and President, Trinity Partners. “With increasing competition and tighter payer and regulatory controls, it’s critical that companies prioritize their investment to ensure an optimal return.”

To shed light on why products over- or under-perform commercially relative to their therapeutic value, the index authors included three case studies. These include a look at Keytruda and Opdivo (overperformers), Zerbaxa (underperformer), and Vimizim and Zykadia (underperformers).

“Even with the unique challenges presented by certain markets, success can be achieved in all therapeutic areas,” said Neal Dunn, Partner, Trinity Partners. “The key to executing a winning clinical and commercial strategy is to clearly and effectively demonstrate the value of novel agents.”

To view the full index, click HERE

Trinity Partners Launches New Whitepaper to Assess Value in Ultra-Orphan Markets

Trinity Partners, a leading global life sciences consulting firm, today announced, at the NORD Rare Disease and Orphan Products Breakthrough Summit in Washington, D.C., a new whitepaper titled ‘Assessing Value in Ultra-Orphan Markets’.

In the last five to 10 years, the concentration on orphan development has exploded. From acquisitions to creation of separate rare disease units, pharma companies of all sizes have an increased focus on the orphan market. Yet, while rare diseases have the attention of the industry and the incentives continue to be strong, finding success in the orphan market is not easy. This new whitepaper outlines the crucial clinical and commercial attributes that drive success for ultra-orphan, non-oncology products.

Key insights include:

    • Potential products (to acquire or for portfolio planning) must first be assessed on several different commercial and clinical criteria specific to ultra-orphan markets.
    • Success in the ultra-orphan market does not follow one formula. Soliris (Alexion) and KUVAN (BioMarin) are two assets that score high with regard to clinical and commercial opportunity, yet followed very different paths to success.
    • The complexities surrounding success in the ultra-orphan market will continue to grow as competition rises alongside increased payer and pricing sensitivity.

“There are more than 7,000 rare diseases with only 500 approved treatments, which is a clear indicator of a large unmet need and opportunity for success in the orphan market space,” said Herman Sanchez, Partner, Trinity Partners, and lead author of the report. “However, being aware that there is a large market opportunity and truly realizing that opportunity are very different things. Our whitepaper outlines key insights and findings based on our deep commercialization experience in the market, providing companies with a proven roadmap to recognize the critical metrics that determine success and the efforts needed to achieve them.”

Trinity Partners, headquartered in Waltham, MA, with additional offices in San Francisco, New York City and Princeton, New Jersey, has extensive experience in orphan and ultra-orphan markets globally including NA, EUMEA, LATAM and APAC. The firm has more than 150 employees and has worked with six of the top 12 global pharmaceutical companies and 12 of the top 20 specialty and biopharmaceutical companies.

“The industry is driving to more targeted therapies, including new and exciting gene therapies, and many of them could become success stories with the right considerations. We’ve worked with many companies in the U.S. and around the globe on their commercialization strategies and are excited to share key learnings in our new whitepaper,” added Neal Dunn, Partner, Trinity Partners and co-author of the whitepaper.

NORD’s Rare Diseases and Orphan Products Breakthrough Summit is the largest and most meaningful multi-stakeholder event of its kind – featuring more than 20 speakers from the FDA, participation from over 80 patient organizations and the Pharma/Biotech industry’s foremost experts in orphan product innovation, investment and commercialization.

To read the full whitepaper and access all key insights, click here.

Trinity Partners Identifies Value Proposition of Most Expensive Drugs Approved by the FDA from 2014-2016

Trinity Partners today, in tandem with the 22nd Annual International ISPOR Meeting, announced the results of a whitepaper titled, “What We Value: The Proposition Behind the Price.” The authors analyze the costliest drugs to the healthcare system approved by the FDA from 2014-2016 in order to understand the interaction between value and price.  In this industry analysis, Trinity reveals the factors that appear to allow some drugs a higher price point than others and addresses key questions including: What do the most expensive drug launches in the recent past reveal about what our society values? What does the market seem to be willing to pay for?

Download the whitepaper here: http://bit.ly/2qQyKso

Trinity Partners Identifies Hallmarks of Successful US Biopharma M&As

Trinity Partners today, in concert with the 35th Annual JP Morgan Healthcare Conference, has announced the findings of a white paper exploring the strategic decisions that successfully position a company for a maximized M&A exit. By examining the past ten years of biopharma M&A activity, Trinity has developed a framework that summaries the optimal path for private companies, taking into consideration major factors that inform valuations including financials, R&D portfolio, licensing opportunities, partnerships and more.

 

Download the whitepaper HERE

Trinity Partners Unveils Findings of Its Inaugural Drug Index

Trinity Partners announced today the findings of its first annual ‘Trinity Drug Index,’ a comprehensive research-based report which assessed 22 novel drugs approved by the FDA in 2013. The Index rates drug performance as measured by a retrospective look at commercial success relative to therapeutic value and R&D complexity, assigning each drug a score in those three areas as well as an overall composite score.

Top findings of this year’s Trinity Drug Index include:

  • Sovaldi, which treats Hepatitis C, received the highest ranking with an overall score of 4.4 out of 5
  • Most of the top performers were specialty drugs
  • Drugs for primary care markets such as COPD and diabetes tend to show weaker differentiation and limited commercial performance, exacerbated by significant R&D expense
  • Commercial underperformance given significant therapeutic value is rare, and could be due to a rapidly changing competitive environment
  • Well-executed business strategy may boost commercial performance of drugs that are not vastly superior therapeutically
  • Moving forward, it will be more critical than ever to demonstrate a product’s value vis-à-vis existing competition

If you would like to read the full whitepaper, it is available for free on the Trinity Partners website HERE.