Latest news with #Vabysmo
Otago Daily Times
3 days ago
- Health
- Otago Daily Times
Attitude to eye health criticised
A multinational pharmaceutical company has stooped to "punching down" on New Zealand's disabled community while promoting its vision loss treatment, a Dunedin advocate says. Market research by the New Zealand arm of Roche, a Swiss multinational holding healthcare company, was released last week and said while most people understood the importance of vision, public awareness of specific eye conditions, symptoms and how to prevent vision loss remained low. "New Zealanders overwhelmingly value their vision above all other senses according to recent market research, with participants saying they'd be willing to lose 5.6 years of perfect health, rather than live a decade without sight," the company's media release began. In New Zealand, Roche distributes Vabysmo, a medicine approved by MedSafe to treat age-related macular degeneration, the leading cause of blindness in the country. Blind and low vision advocate and Dunedin resident Julie Woods, who is also known as "That Blind Woman", said it "distresses" her the company was comparing hypothetical trade-offs between life expectancy and vision loss. "That just shows how afraid people are of vision loss," she said. "You can live a perfectly good life without vision, but you can't without your health." She said preserving eye health was "obviously" a great cause. "But it doesn't give organisations the right to push their own product and put down [or punch] down a community of people." Ms Woods said Roche's approach spoke to a medical model of disability which was: "we can't fix you, therefore you're broken". "Whereas the social model of disability says that we are disabled by the barriers that society creates, and we're not broken and we're not less than." She said Roche's use of New Zealanders' fears of not seeing loved ones' faces or recognising facial expressions, body language and social cues was "bull...." and was emotive toward sighted people. A Roche spokesperson said the market research was based on a similar study conducted in the United Kingdom and the company sought guidance from professionals within the eye community, including a patient advocacy group. "Their advice advocated for raising awareness about the importance of eye health and regular eye examinations to prevent irreversible, yet preventable, vision loss," the spokesperson said. "The intent of the campaign was to raise awareness of the importance of eye health and preventable vision loss, encouraging individuals to get their eyes tested or seek help if they are experiencing symptoms." The spokesperson said Roche respected Ms Woods' opinion and acknowledged her advocacy for the blind and low vision community in New Zealand.
Yahoo
7 days ago
- Business
- Yahoo
Regeneron Pharmaceuticals, Inc. (REGN): A Bull Case Theory
We came across a bullish thesis on Regeneron Pharmaceuticals, Inc. (REGN) on Notes From The Beauty Contest's Substack. In this article, we will summarize the bulls' thesis on REGN. Regeneron Pharmaceuticals, Inc. (REGN)'s share was trading at $605.39 as of 29th May. REGN's trailing and forward P/E were 15.39 and 17.39 respectively according to Yahoo Finance. A scientist in a lab conducting research on cell-based therapeutics and biotechnology. Regeneron's latest earnings report was notably weak, with a 3.7% revenue decline and a 14% EPS drop, surprising given the company's history of exceeding market expectations. The primary driver was a steep 26% year-over-year decline in the U.S. Eylea franchise, particularly a 39% drop in 2mg Eylea sales. This was partly due to a co-pay assistance funding gap, which forced many Medicare patients to switch to cheaper alternatives like compounded Avastin, impacting both Regeneron and rival Roche's Vabysmo. Regeneron, having contributed over $400 million last year to charitable foundations supporting co-pay assistance, is now seeking to share this burden, proposing a matching donation program to encourage broader industry support. Another setback was the FDA's Complete Response Letter delaying approval of the Eylea-HD pre-filled syringe, a key product needed to compete with Vabysmo. The delay stemmed from third-party component issues rather than drug efficacy, and management believes resolution could be near. Margins also contracted, with gross margin falling from 89% to 85% due to unspecified inventory write-offs, possibly related to older Eylea 2mg or even leftover REGEN-COV stock. However, the margin pressure appears more tied to one-offs and increased R&D spending than structural issues. On a more positive note, Regeneron's pipeline is broadening meaningfully. Itepekimab, an IL-33 antibody, shows promise as a major respiratory asset with pivotal COPD data upcoming and expanded trials underway. The growing RNAi pipeline, now at nine siRNAs through its Alnylam collaboration, signals Regeneron's potential evolution beyond antibodies into a broader genetic medicine powerhouse. Regeneron Pharmaceuticals, Inc. (REGN) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 66 hedge fund portfolios held REGN at the end of the first quarter which was 68 in the previous quarter. While we acknowledge the potential of LYFT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
Genentech to onshore US manufacturing amid rising drug pricing tensions
Genentech (San Francisco, CA) has announced an investment exceeding $700m to establish its first East Coast manufacturing facility in Holly Springs, North Carolina. This expansive 700,000ft² facility is set to create over 1,500 construction jobs and more than 400 permanent manufacturing positions, marking a substantial economic boost for the region. The company shared that it might increase the investment based on future US policy and business needs. Currently, the facility is expected to support the metabolic medicines portfolio manufacture of Genentech and its parent company Roche (Basel, Switzerland). The announcement of the manufacturing investment follows a positive Q1 2025 earnings call from Roche on 24 April 2025, where the company reported an 8% increase in sales for the pharmaceuticals division due to strong demand for key blockbusters such as Phesego, Vabysmo, Xolair, Xofluza, and Hemlibra. These five drugs generated a total of $4.3bn in Q1 2025 – an increase from Q1 2024. The development of the North Carolina manufacturing facility aligns with Roche's plans to invest $50bn in pharmaceuticals and diagnostics in the US over the next five years, including new and expanding manufacturing facilities in Indiana, Pennsylvania, Massachusetts, and California, as shared in Roche's Q1 2025 earnings call. Genentech's latest manufacturing expansion is one among the many investments into US-based manufacturing operations to counter international tariffs, national security concerns, rising tensions with China, and other executive orders enacted during the first 100 days of Trump's second term that impact the pharmaceutical industry. As the administration pushes for a return to US manufacturing, outsourcing agreements with domestic manufacturers are increasing. Although the total number of Q1 contract service agreements has decreased year-on-year in the past five years, there has been a 10% increase in the number of US-based contract service agreements in Q1 2025 compared to Q1 2024, according to GlobalData's Deals Database (Figure 1). However, the Trump administration's executive order "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients', announced on 12 May 2025, prompted Roche to state that its $50bn manufacturing investment could be 'reassessed' due to potential fluctuations in the 'current policy environment'. The executive order, which aims to lower US drug prices by aligning them to the lowest prices paid in other developed nations, has created debate among pharmaceutical companies and stakeholders. Stephen Ubl, PhRMA president, argues that the "most-favored-nation plan" will '[jeopardise] the hundreds of billions [their] member companies are planning to invest in America'. During the Financial Times' US Pharma and Biotech Summit, Calley Means, a key member of HHS Secretary Robert F Kennedy, Jr's team, challenged Roche to retract their investment following the company's response to the 'most-favored-nation plan'. However, Roche reaffirmed that they are not pulling their investment. "[The company] still intend[s] to invest $50bn in pharmaceutical R&D and manufacturing and diagnostics in the US," the Roche representative shared. "Genentech to onshore US manufacturing amid rising drug pricing tensions" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
Bayer's Eylea set for longer treatment intervals to challenge Roche's Vabysmo
Bayer's retinal disease treatment Eylea (aflibercept) is set for an extended treatment interval, a label extension that could give the drug an advantage over rival Roche's Vabysmo (faricimab). A committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion that would allow 8mg of Eylea to be injected in intervals of up to six months. Shares in the German big pharma company rose 1% at market open on 23 May following the announcement. Bayer's market cap is $21.5bn. Although Eylea is approved in four indications in Europe, the label extension will only be eligible for two conditions, notably neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DME). The European Commission will now mull over CHMP's opinion with a decision 'expected within the next weeks', according to Bayer, which licensed the rights to the drug outside the US from manufacturer Regeneron in 2012. Despite Eylea reaching the market first, Roche has eroded a stake of Bayer's market share with its bispecific antibody Vabysmo. Similar to Eylea, Vabysmo is approved for a range of retinal diseases but has higher uptake due to the longer intervals between injections. Vabysmo generated $4.3bn in sales in 2024, becoming one of Roche's top-selling drugs. Whilst Eylea and Eylea 8mg – the latter known as Eylea HD in the US – reached combined sales of $9.5bn in 2024, year-over-year growth was lower than Vabysmo. Regeneron and Bayer are also having to contend with a market influx of biosimilars. Therefore, an extended treatment interval could be a major step for Bayer in maintaining its market share. The positive judgment by the committee was based on positive three-year results from open-label extension studies of the pivotal clinical trials PULSAR (NCT04423718) and PHOTON (NCT04429503) in nAMD and DME, respectively. Eylea 8mg demonstrated that it could maintain visual and anatomic improvements at dosing intervals of six months. Across both studies, 24% of patients in nAMD and 28% of patients in DME had a last assigned dosing gap of six months at the end of the three years. The long-term data did not show any new safety signals, and the rates of ocular treatment-emergent adverse events (AEs) were similar across patients switching from 2mg to 8mg of Eylea. Eylea works by inhibiting vascular endothelial growth factor (VEGF), which prevents abnormal blood vessel growth. With the label extension, Eylea 8mg would be the only anti-VEGF approved for a treatment interval of six months. Roche's Vabysmo became the first bispecific antibody approved for the eye. It acts by neutralising angiopoietin-2 (Ang-2) and VEGF-A. Bayer's global product strategy and commercialisation executive vice-president Christine Roth said: 'Following approval of the European Commission, extended treatment intervals with Eylea 8mg of up to six months can significantly reduce the frequency of injections and visits to the clinic for patients. 'These extended intervals, combined with the unique product profile of Eylea 8mg, position it to become a new standard of care for retinal diseases.' "Bayer's Eylea set for longer treatment intervals to challenge Roche's Vabysmo" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
23-05-2025
- Health
- Yahoo
Bayer wins EU watchdog's endorsement for longer Eylea treatment intervals
(Reuters) -German drugmaker Bayer on Friday won an endorsement by the European Medicines Agency to extend the intervals between shots of its anti-blindness treatment Eylea, giving it a potential edge over Roche's rival treatment Vabysmo. Bayer said in a statement the European Medicines Agency recommended that eye drug Eylea, at a high dose of 8 mg, can be injected at intervals of up to six months to treat wet age-related macular degeneration and diabetic macular oedema. Bayer shares were up 2.5% at 0717 GMT, surpassing a gain of 0.7% in the Stoxx Europe 600 Health Care index. Eylea, an injection against the leading causes of blindness among the elderly, is currently approved in the EU for treatment intervals of up to five months. Bayer has developed it jointly with Regeneron. Vabysmo, a major driver of revenue growth for Switzerland's Roche, is cleared to be given at intervals of up to four months. The EU commission has the final say on drug approval but it typically follows the medicines agency's opinions. Bayer said that decision is expected within the next few weeks.
