Aflibercept

Despite a 108% increase in sales from its blockbuster macular degeneration drug Vabysmo, Roche saw a 6% slide in revenue in the first quarter, credited largely to a decrease in sales of COVID products. It’s been eight months since Regeneron secured approval for a high-dose version of its powerhouse macular degeneration treatment Eylea in the U.S. So how much impact has souped-up Eylea had on the upward trajectory of Roche’s Vabysmo, which was approved 19 months earlier as a longer-acting challenger? Not much, according to sales figures released by Roche on Wednesday morning. In the first quarter of 2024, Vabysmo racked up revenue of 847 million Swiss francs ($927 million), which was up 108% year over year and demolished the analyst consensus of 750 million Swiss francs. It also was a huge leap sequentially from sales of 594 Swiss francs in the fourth quarter of last year. Regeneron and Bayer have yet to report their first-quarter results. Bayer got high-dose Eylea approved in EU in early January. In February, Regeneron reported that Eylea U.S. sales fell from $6.3 billion in 2022 to $5.9 billion in 2023, with high-dose Eylea accounting for $166 million in sales over the last four months of the year. Back then, Regeneron also said that it didn’t expect to see a sales surge for Eylea HD in the first quarter because its permanent J-code would not kick in until April 1. J-codes are part of an identifying system that allows pharmacies, hospitals and physicians to bill for medications, and getting it can be an important step for drug reimbursement.  In a conference call on Wednesday, Roche’s pharma CEO Teresa Graham said the company has not seen any sales impact on Vabysmo since the start of this month. Roche pointed to a network meta-analysis comparing results from seven trials of Vabysmo and Eylea which included more than 5,000 patients and concluded that Vabysmo produced more reduction in central subfield thickness in both age-related macular degeneration (AMD) and diabetic macular edema (DME). “This analysis adds to the growing body of evidence that Vabysmo’s unique [mechanism of action] leads to the superior anatomical outcomes in the drying of eyes, supporting Vabysmo is the preferred choice for first-line treatment in AMD and DME,” Graham said. Graham added that real-world data studies that included more than 50,000 Vabysmo patients will validate Vabysmo’s credentials as “a standard of care,” in AMD and DME. The company will present those results next week in Seattle at the Association for Research in Vision and Ophthalmology conference. Vabysmo continued to grow its market share in the U.S. to 25% in AMD and 18% in DME, which is an increase of 3 percentage points from the previous quarter in both indications, Roche said. Additionally, Vabysmo also has already grabbed an 8% share of the retinal vein occlusion market since the FDA signed off on the label expansion in October of last year. Roche added that more than 40% of Vabysmo patients are new to eye treatments, compared to a 10% figure for treatment-naïve patients in the first quarter of last year. The company is targeting Q3 to re-launch wet AMD treatment Susvimo. The medicine approved for use in Susvimo is a customized formulation of ranibizumab, but at a different concentration than what is used for eye injections with Lucentis (ranibizumab injection). Additionally, in the second half of this year, Roche hopes to file for diabetic macular edema and diabetic retinopathy as new indications for Susvimo which was originally approved in October of 2021 but recalled by the company a year later because of a leakage issue. Overall, for the first quarter, Roche reported sales of 14.4 billion Swiss francs ($15.8 billion), which was a 6% decline from revenue of 15.3 billion Swiss francs ($16.8 billion) in the first quarter of 2023 and a 2% drop sequentially. Roche blamed the declines on the loss of revenue from its COVID-19 products but CEO Thomas Schinecker said that those effects will end in the second quarter, setting the company up for a return to revenue growth. Excluding COVID products, Roche’s sales were up 7% in the quarter, supporting the company’s guidance to mid-single-digit growth in 2024, which the company confirmed on Wednesday. Roche’s top product, multiple sclerosis treatment Ocreuvus, rang up sales of 1.66 billion Swiss francs ($1.82 billion) in the quarter,  good for 8% growth year over year. With an approval expected for its injectable version of Ocrevus, Roche expects a blockbuster-sized bump in sales, “upwards of the $2 billion range,” Graham said. Making major sales gains in the period were blood cancer treatment Polivy, which was up 70% year-over-year to 387 million Swiss francs ($424 million) and breast cancer drug Phesgo, which increased sales 81% to 249 million Swiss francs ($273 million). Polivy was approved in 2019 and Phesgo made the grade in 2020.

SOUTH SAN FRANCISCO, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that the ongoing Phase 2b ASPIRE study of UBX1325 has been extended from 24 to 36 weeks to assess potentially greater durability compared to aflibercept. In addition, the study is being upsized from 40 to 50 patients to increase the statistical power. The ASPIRE study is designed to evaluate the safety, efficacy, and long-term durability of UBX1325 as a monotherapy compared head-to-head to aflibercept in patients with diabetic macular edema (DME). “We previously demonstrated significant improvement in vision with extended durability in patients treated with UBX1325 in the BEHOLD proof-of-concept study and look forward to extending those findings in the current ASPIRE study,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “As the only treatment candidate in clinical development for DME that targets senescent cells, UBX1325 leverages a novel mechanism of action that could provide sustained improvements in visual acuity and lessen the treatment burden compared to current standard of care. We see UBX1325 as an emerging, potentially paradigm-shifting therapeutic approach in DME.” As a result of extending the study, UNITY expects to disclose topline results from the ASPIRE study in two data readouts: 24-week primary endpoint data in the first quarter of 2025, and 36-week long-term extension data in the second quarter of 2025. The Company continues to believe that current cash, cash equivalents and marketable securities are sufficient to fund operations into the third quarter of 2025. ASPIRE is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active DME who are not achieving optimal benefit from standard of care. The study is expected to enroll about 50 subjects who will be randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months after randomization. There will be no scheduled treatments in either arm between 24 and 36 weeks to allow direct comparison of durability of effect between the two treatment arms. The primary efficacy endpoint is non-inferiority to aflibercept as assessed by mean change from baseline in Best Corrected Visual Acuity (BCVA) to week 24. Secondary endpoints include change in BCVA from baseline over time, Central Subfield Thickness (CST) change from baseline over time, and proportion of participants who do not require anti-VEGF rescue, all through week 36. Additional information about ASPIRE (NCT06011798) can be found here. About UBX1325UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the BCL-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean BCVA through 48 weeks compared to sham treatment. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease. About UNITYUNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME and other ophthalmologic diseases, the expected timing of enrollment and results of the clinical trials in UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements, including risks of delay or disruption of enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see UNITY’s most recent Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on April 15, 2024, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission. Media ContactInizio Evoke CommsKatherine SmithKatherine.Smith@inizioevoke.com Investor ContactLifeSci Advisors, LLCJoyce Allairejallaire@lifesciadvisors.com