According to the companies, the divested assets will include Xiidra and SAF312, a potential therapy for chronic ocular surface pain. The deal is expected to close later this year.
Novartis announced today it has signed an agreement to divest ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up to $2.5 billion, including $1.75 billion in upfront cash, plus additional milestone payments.
Bausch + Lomb will acquire Xiidra (liftegrast ophthalmic solution 5%) in a deal that will bolster its foothold in the dry eye disease (DED) space.1
According to a news release, Bausch + Lomb acquired the non-steroid eye drop, which was specifically approved to treat the signs and symptoms of DED via inflammation management. Under the agreement, Bausch + Lomb will also acquire SAF312 (libvatrep), an investigative therapy for chronic ocular surface pain; AcuStream, a delivery device in dry eye indications; and OJL332, a second generation TRPV1 antagonist in pre-clinical development, from Novartis for $2.5 billion.2
This acquisition was strategic, as Bausch + Lomb looks to fill out its dry eye portfolio, which currently features a slew of eye and contact lens drops and the newly FDA-approved Miebo (perfluorohexyloctane ophthalmic solution). Miebo is the first and only water-free drop to target tear evaporation to relieve signs and symptoms of DED. Both Xiidra and Miebo target signs and symptoms of dry eye, but each targets distinct elements of the DED cycle, making the therapies complementary to Bausch + Lomb’s portfolio.
“This acquisition is a prime example of our strategy in action, as it provides needed scale for the company and transforms our pharmaceuticals business by making us a leader in ocular surface diseases,” Brent Saunders, chairman and CEO, Bausch + Lomb, said in a press release.
“The deal is also expected to accelerate margin expansion through a larger mix of pharmaceutical products in our portfolio, provide strong and immediate earnings accretion and presents a clear path to deleverage, making it financially compelling.”
Under the agreement, Bausch + Lomb acquires Xiidra, libvatrep, AcuStream, and OJL332 from Novartis for up to $2.5 billion. The Board of Directors of each respective company approved the transaction of $1.75 billion in cash upfront with milestone obligations up to $750 million for meeting sales thresholds and pipeline commercialization. Bausch + Lomb is supported by JP Morgan, who will finance the $1.75 billion purchase price with new debt prior to closing. The transaction is expected to close by the end of 2023.
Ronny Gal, chief strategy and growth officer of Novartis, said in a news release the transaction will enhance our focus on prioritized innovative medicines to alleviate society’s greatest disease burdens, achieve the greatest patient impact and drive the company's growth strategy.
"Our ongoing portfolio refinement enables us to best deploy our scientific expertise and resources towards priority programs and therapeutic areas, while remaining open to opportunistic development for additional high impact conditions leveraging our advanced technology platforms," Gal said in the statement. "We believe that Bausch + Lomb has the capabilities, scale and commitment to continue the work of Novartis in delivering and developing much needed therapies for patients suffering from dry eye and related conditions.”
Closing is anticipated in the second half of 2023 subject to customary conditions.
Novartis will continue its R&D efforts in addressing retinal diseases via platforms including gene therapy and optogenetics.
Dry eye disease (DED) is one of the most common ocular surface disorders,3 affecting approximately 38 million people in the United States and approximately 739 million people worldwide.4 Research has shown a higher prevalence of DED in the US over the past 10 years, including in younger adult populations (ages 18 to 34), largely due to lifestyle changes and more time spent on digital screens.5
Marguerite McDonald, MD, FACS, OCLI Vision, Oceanside, New York, noted in a news release dry eye disease is multifactorial and can stem from varying root causes, which means differing treatment options are needed.
“With the acquisition of Xiidra and recent approval of Miebo, Bausch + Lomb enhances its approach to different facets of dry eye and is well positioned to ensure both medicines reach as many patients as possible," she said in the release.
Over the next five years, the United States’s prescription DED field is expected to grow at a double-digit compounded annual growth rate.6 Xiidra is patented through 2033, and generated approximately $487 million in sales in 2022.
1. Bausch + Lomb will acquire XIIDRA. www.bausch.com. June 30, 2023. Accessed June 30, 2023. https://www.bausch.com/news/releases/?id=163
2. Novartis signs agreement to divest “front of eye” ophthalmology assets in line with focused strategy. Press release. Novartis.com. June 30, 2023. Accessed June 30, 2023. https://www.novartis.com/news/media-releases/novartis-signs-agreement-divest-front-eye-ophthalmology-assets-line-focused-strategy
3. National Eye Institute. Dry Eye. Last updated April 8, 2022. Accessed May 2, 2023. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye
4. Downs P. 2020 Dry Eye Products Market Report: A Global Analysis for 2019 to 2025. Market Scope; 2020.
5. Modern technology and a multi-screen lifestyle viewed as important factors in rising prevalence of dry eye disease. News release. PR Newswire; October 17, 2016. Accessed October 4, 2022. https://www.multivu.com/players/English/7893551-shire-dry-eye-disease-awareness/
6. U.S. dry-eye size including aqueous supplements, secretagogues, corticosteroids, LFA-1 antagonists, calcineurin inhibitors across anti-inflammatory and non-anti-inflammatory drug classes. Source: DRG (12/2022); Expert interviews; Analyst reports.