Novartis Halts Development of GT005, a $1.5 Billion Gene Therapy for Geographic Atrophy

Sep 12, 2023 19:11 CST Updated 19:11

Novartis

Drug Development and Manufacturing

September 11,According to investment institution reports, Novartis has stopped itsMid-term clinical trial of GT005 pipeline (this is aRelated to Dry Eye SyndromeGeographic Atrophy (GA)Gene Therapy).

This may also have accelerated Novartis' divestment process of its ophthalmology business pipeline.

Poor Clinical Data? Novartis Fails to Open the Blind Box

GT005 is a product that Novartis acquired in 2021 for approximately $1.5 billion.Gyroscope TherapeuticsAnd the pipeline obtained.

In December 2021, Novartis announced the acquisitionBritish Ophthalmic Gene Therapy Company Gyroscope TherapeuticsNovartis will pay an upfront payment of $800 million and potential additional milestone payments of up to $700 million.

*** Prior to the completion of the acquisition, Gyroscope Therapeutics will continue to operate as an independent company.

In hindsight, this acquisition can be considered a failure; Novartis will no longer pay subsequent milestone payments.

Geographic Atrophy (GA)Geographic atrophy (GA) is the advanced form of dry age-related macular degeneration (AMD), which can lead to progressive and irreversible vision loss. Currently, there are no approved treatments for GA, making it one of the most challenging unmet needs in retinal diseases.

GT005 is designed as an AAV2-based gene therapy administered via subretinal delivery for the treatment of GA secondary to AMD. As of late 2021, a Phase 1/2 clinical trial and two Phase 2 clinical trials are underway; additionally, GT005 has received Fast Track designation from the U.S. FDA.

Following the initial benefit-risk assessment of the HORIZON Phase 2 program by the latest independent clinical data monitoring committee, the development of GT005 in GA will be terminated.The committee believes that the overall clinical data does not support the continued implementation of the project.。

Acquisitions and License-ins in the pharmaceutical field are like opening blind boxes; even if a pipeline seems promising in all aspects, its success cannot be guaranteed until it achieves commercialization—whether it turns out to be a pearl or a stone remains uncertain until the end.

In July 2023, disappointing clinical data also led to Novartis selling off two more assets. These included the anti-TIGIT checkpoint inhibitor, developed in collaboration with BeiGene for non-small cell lung cancer. Additionally, due to "lack of efficacy" in Phase II trials, Novartis also dropped its obesity drug MBL949, which was under development.MBL949 works through the GFD-15 pathway, and Novartis CEO Vas Narasimhan has previously promoted it as having a "unique mechanism of action."”

Divestment of ophthalmology business,

Focus on Five Core Areas

Although the poor clinical data was the driving force behind this decision, it might also be a move by Novartis to follow the trend.

Last November, there were initial reports that Novartis was undergoing a restructuring, including global layoffs of 8,000 employees and the sale of certain assets, such as its respiratory and ophthalmology divisions, to raise funds for investment in other drugs.

According to the Novartis official website, it has 21 ophthalmic products.

By the end of 2022,Novartis has transferred the exclusive commercialization rights of five ophthalmic products approved by the U.S. FDA in the United States to Harrow Health, an eye care pharmaceutical company.

July 2023,Novartis announced a cooperation agreement with Bausch+Lomb, under which it will divest Xiidra, an approved dry eye disease drug, SAF312 (libvatrep), a chronic ocular surface pain drug in development, the usage rights of the AcuStream delivery device, and OJL332, a second-generation TRPV1 antagonist in preclinical development stage, to Bausch+Lomb. The total value of the cooperation is$2.5 billion, including $1.75 billion in upfront cash and an additional $750 million in milestone payments.

Informed sources revealed that Novartis is seeking potential buyers for some of its ophthalmology assets.

On July 6, Shreeram Aradhye, President of Global Drug Development and Chief Medical Officer of Novartis, told reporters that as the company decided to focus on innovative drugs, one aspect was identifying core therapeutic areas, namelyThe five major fields of cardiovascular, immunology, neuroscience, solid tumors, and hematology; on the other hand, the company has also made trade-offs,The R&D of anterior segment diseases in respiratory and ophthalmology is no longer a key focus area for Novartis.The company hopes to focus its resources and manpower as much as possible on core therapeutic areas, specifically those therapeutic fields where Novartis excels the most and has the strongest capabilities.

· END ·

--Video Dynamics--

▲ Brain-Computer Interface + AI, Allowing Paralyzed and Speech-Impaired Patients to "Speak" Again

--Featured Recommendations--