Trinity issued a paper on asset valuation that explores the common methodologies for the valuation of pharma and biotech assets and highlights key considerations for capturing asset-specific nuances and accurately reflecting value. Read it here: http://bit.ly/2NIyTu4
Leading global life sciences consulting firm Trinity Partners today released a new whitepaper analyzing the oncology clinical trial pipeline to determine the extent to which basket trials are being utilized and, in particular, how many are likely to be registrational studies resulting in tissue-agnostic indications.
Historically, basket trials have been used to explore multiple tumor types in one trial in order to prioritize the ones with the greatest response for further research. However, with Keytruda’s MSI-H and dMMR approval, basket trials have now become a viable registrational strategy to pursue a tissue-agnostic indication. Key findings from the whitepaper include:
- Only 2 trials appear to clearly be pursuing a tissue-agnostic regulatory filing; there are no basket trials currently in Phase III.
- Although many of the trials identified are not clearly linked to a planned regulatory filing for a tissue-agnostic indication, the authors expect that the results of these trials, if positive in the broad indication, could lead to future registrational trials in the next 1-3 years.
- Across the 37 basket trials identified for analysis, 16+ types of biomarkers or genetic mutations are currently being studied. This broad scope verifies the growing trend of tumor-agnostic research across oncologic agents, regardless of biomarker studied.
“In the near term, pending the results of these trials, interest in tissue-agnostic basket trial development is likely to grow, especially as next-generation genomic sequencing continues to become more widespread in oncology,” said Jillian Godfrey Scaife, principal at Trinity Partners. “Whether the number of tissue-agnostic indication approvals will ever be substantial enough to drive a significant shift in treatment approaches remains an open question.”
“With this research, we sought to better understand whether and when there will be a tipping point in the oncology treatment paradigm,” added Vivian DeWoskin, engagement manager. “The growing pool of mid-phase/exploratory tissue-agnostic trials suggests we could be headed in that direction, leading to many long-term implications on the clinical application, commercialization and development of targeted oncolytics in the next several years.”
Trinity works with more than 100 clients annually, including 18 of the top 25 global biopharmaceutical companies and dozens of leading medical device and diagnostic companies. Trinity has over 150 professionals on staff that focus solely on the life sciences industry.
To view the full whitepaper, click here.
Key findings from the report, which seeks to reveal opportunities to accelerate biosimilar adoption, include the following:
- Biosimilar pricing to date has not offered the sharp discounts payers expect, after accounting for contract discounts and nuances such as the “rebate trap”;
- Biologic innovators have taken legal and promotional actions that derail biosimilar commercial success;
- Providers are not fully comfortable with biosimilars and are interested in seeing more clinical and real-world data; if biosimilars were to attain interchangeability status, this gap in clinical comfort could be minimized
The report, conducted in partnership with Schlesinger Associates, is supported by findings from qualitative market research with medical directors at payer organizations in the United States. The findings are based on historical trends, current market dynamics, and future market access expectations in biosimilars.
“Biosimilar access still lags behind traditional small molecule markets, but there is so much potential for long-term cost savings for payer plans and the U.S. healthcare system as a whole,” said Neal Dunn, Partner, Trinity Partners. “Once interchangeability is achieved, other barriers such as clinical confidence and litigation will fall into place.”
“Each country’s commercial and regulatory landscape is nuanced based on laws, pay structures, and culture, which creates unique environments for market access,” said John Corcoran, Founder and President, Trinity Partners. “Our in-depth knowledge of the U.S. market provides us with unique insights that allow us to optimally navigate those channels to achieve market access as quickly as possible, thus providing treatments to patients who need them the most.”
To view the full research report, click here.
About Trinity Partners
Trinity Partners is a trusted life sciences strategy consulting firm that takes a personalized approach to working with pharmaceutical, biotech, medical device, and diagnostic clients worldwide to create evidence-based solutions that drive business strategy and impact bottom lines. To learn more about Trinity Partners, click here.
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, 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 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 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 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.
Check out Ryan P Million’s take on drug pricing in the US oncology market and download the full white paper here, http://bit.ly/1U3iNrh