#Ziritaxestat

[sandlerresearch]

Idiopathic Pulmonary Fibrosis - Opportunity Analysis and Forecasts to 2029 (Event Driven Update) published on

https://www.sandlerresearch.org/idiopathic-pulmonary-fibrosis-opportunity-analysis-and-forecasts-to-2029-event-driven-update.html

Idiopathic Pulmonary Fibrosis - Opportunity Analysis and Forecasts to 2029 (Event Driven Update)

Idiopathic Pulmonary Fibrosis – Opportunity Analysis and Forecasts to 2029 (Event Driven Update)

Summary

Idiopathic pulmonary fibrosis (IPF) is the most common subtype of idiopathic interstitial pneumonias (IIPs), which belong to a group of rare diseases termed interstitial lung diseases (ILDs). Idiopathic pulmonary fibrosis (IPF) is a new and rapidly-establishing market, which, before 2011 was non-existent, with no approved pharmaceutical treatments for the chronic, debilitating disease, which has an abysmal prognosis. However, the last decade has seen a period of explosive growth in the IPF market following the entry of two pharmacological small molecule treatments; Roche’s Esbriet and Boehringer Ingelheim’s Ofev. The landscape will continue to evolve and the increasing uptake of current therapies and approval of new products will be the primary drivers of growth over the forecast period.

The catalyst for this event-driven update is the discontinuation of GLPG-1690 by Gilead/Galapagos for development in all indications, including IPF and Systemic Sclerosis (SSc) in Q1 2021. Due to IPF’s high clinical unmet needs, the discontinuation of GLPG-1690 represents a major setback in the disease space, since ziritaxestat was expected to be the first late-state pipeline product to launch for IPF in the next several years. The next earliest pipeline agent set to launch is pamrevlumab in 2024.

Key Highlights

– The greatest drivers of growth in the global IPF market include the launch of six new pipeline therapies during the forecast period and an increasing diagnosed prevalence in many 7MM countries. – The main barriers to growth in the IPF market include low diagnostic and treatment rates and the patent expiries of both Ofev and Esbriet in all markets. – The late-stage pipeline products are completely distinct mechanisms of action both from each other and the available marketed therapies. – The most important unmet needs in the IPF market are improved drug safety and efficacy and improvement in patient quality of life.

KEY QUESTIONS ANSWERED

– Which unmet needs are limiting the treatment of IPF in the 7MM? – What strategies can the pharmaceutical industry employ to increase treatment rates for IPF? How should these strategies differ across different geographical markets? – What effect will the launch of generics have on the sales of branded agents? – What are the main R&D trends in the IPF market and which companies are leading the way? Are there major differences in the mechanisms of action used by therapies in late-stage versus early-stage clinical development? – What was the impact of the COVID-19 pandemic on the IPF treatment, clinical trial conduct, and looking forward?

Scope

– Overview of IPF including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines. – Topline IPF market revenue, annual cost of therapy, and major pipeline product sales in the forecast period. – Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting IPF therapeutics sales in the 7MM. – Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs. – Analysis of the current and future market competition in the global IPF therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to – – Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines. – Develop business strategies by understanding the trends shaping and driving the global IPF therapeutics market. – Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global IPF market in the future. – Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. – Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. – Track drug sales in the global IPF therapeutics market from 2019-2029. – Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

#Pharmaceutical

[pharmaphorumuk]

Gilead/Galapagos alliance hit again as IPF drug is binned

Gilead and Galapagos’ much-trumpeted R&D alliance has suffered another setback with the abandonment of ziritaxestat after a late-stage failure in idiopathic pulmonary fibrosis (IPF). 

Ziritaxestat (GLPG1690) – a first-in-class autotaxin inhibitor – was the flagship asset in the $5.11 billion partnership signed by the two companies in 2019, and has been advanced into the phase 3 ISABELA programme on the strength of encouraging results in a small, phase 2 study.

Now, on the advice of the trial’s data monitoring committee, two ISABELA trials and all other development activities for ziritaxestat have been terminated after it was decided that continuing would be futile.

That includes the mid-stage NOVESA study in diffuse cutaneous systemic sclerosis, despite preliminary positive data reported last year, which could point to a safety issue rather than a lack of efficacy in IPF.

Gilead chief executive Daniel O’Day was lauded for the wide-ranging agreement with Galapagos when it was announced, with analysts at Jefferies saying it provided options on a big slice of the latter’s pipeline without the expense and challenges of a full takeover.

Fast forward to now, however, and that hefty upfront spend – $3.95 billion in cash plus a $1.1 billion equity investment – and the once-shiny deal is starting to look a little tarnished.

Late last year, the partners abandoned plans to seek US approval of JAK inhibitor Jyseleca (filgotinib) in the US after the drug was turned down by the FDA. Although that drug wasn’t specifically covered by the alliance, Gilead and Galapagos’ longstanding collaboration on its development was a big part of its foundation.

After ziritaxestat, the duo’s next most advanced project is GLPG1972, an ADAMTS-5 blocker in phase 2b for osteoarthritis that is partnered with Servier outside the US. However, that study also failed to deliver a win when it read out last October.

Finally, in December Gilead and Galapagos reported results with follow-up IPF candidate GLPG1205, a GPR84 antagonist, which backed further development of the drug. The data but showed less of an effect on lung symptoms than ziritaxestat in its mid-stage trial, however, so it remains a high-risk programme.

“We are extremely disappointed by this news,” said Onno van de Stolpe, CEO of Galapagos.

“Despite this setback, we remain committed to leveraging our novel target research engine and strong cash balance to discover potential therapies for IPF and fibrosis,” he added.

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from https://pharmaphorum.com/news/gilead-galapagos-alliance-hit-again-as-ipf-drug-is-binned/