Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
Amgen is getting into golf. Having acquired a clutch of sporting sponsorships in the Horizon Therapeutics acquisition, the big biotech has decided to keep the marketing relationship with the Irish Open and other deals going under its own brand. Dublin-headquartered Horizon, which was led by a man once described as “an avid golfer”, was a regular sponsor of sporting events, particularly golf in Ireland. In 2022, the company inked a six-year deal worth $15.5 million to be the title sponsor of the Irish Open. The deal was part of a roster of sponsorships that continued to grow even as Amgen worked to close its $27.8 billion takeover of the company. Now, Amgen has confirmed the commitment to Irish golf will outlive Horizon. Starting next year, the formerly Horizon-sponsored tournament will be rebranded as the Amgen Irish Open. The professional Irish golfers Shane Lowry, Pádraig Harrington, Séamus Power and Brendan Lawlor ...
Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based company has a library of multimodal and longitudinal data along with the accompanying biospecimens, Culmination Bio’s CEO Lincoln Nadauld told Pharmaceutical Technology. The data for Culmination’s library consists of de-identified HIPPA-compliant data from Intermountain Health. This allows the company to “identify specific patient cohorts and proactively or prospective rapidly recruit them”, which can accelerate drug discovery and clinical trial recruitment. Nadauld said that having biospecimens is instrumental in validating diagnostic devices, adding: “An example would be a liquid biopsy company validating their novel technology in the liquid biopsy space, for cancer. They often need fresh samples from patients with defined diseases, and we can deliver not only the biospecimens but the accompanying multimodal data that ...
Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
AUS Food and Drug Administration (FDA’s) Oncology Advisory Committee (AdCom) has raised questions about the upcoming decision to grant traditional approval of Amgen’s high-profile KRAS G12C inhibitor Lumakras (sotorasib). Lumakras was granted accelerated approval in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who had received at least one prior systemic therapy. This approval was based on the CodeBreaK 200 trial (NCT04303780) of sotorasib versus docetaxel. Lumakras generated $285m in sales last year worldwide, according to Amgen’s 2022 annual report to shareholders. The latest AdCom questioned the reliability of the data In the briefing document released by the FDA from the meeting, several features of the Codebreak trial were listed that were inconsistent with a sufficient well-controlled trial. The main issue noted was that too many patients were allowed to swap between the treatment and control arms ...
By Tristan Manalac Pictured: Amgen’s office in Massachusetts/iStock, hapabapa The FDA’s Oncologic Drugs Advisory Committee on Thursday voted against Amgen, which is seeking to convert the accelerated approval of its oral G12C KRAS inhibitor Lumakras (sotorasib) to full approval in non-small cell lung cancer. In a 10-2 vote, the panel of external experts found that Amgen’s progression-free survival (PFS) data from the Phase III confirmatory CodeBreaK 200 study could not be reliably interpreted. In particular, the adcomm noted the high number of study dropouts, the small sample size and potentially biased behavior of the trial’s investigators. “No one expects a perfect [randomized controlled trial] but what we hope for is a small number of issues in trial conduct and an effect large enough to withstand the uncertainties caused by those issues,” committee member Mark Conaway, professor at the Division of Translational Research and Applied Statistics at the University of Virginia ...
Acquisition includes company’s inflammatory disease medicines. Image Credit: Adobe Stock Images/SciePro Amgen revealed in a company press release that it has officially finished its purchase of Horizon Therapeutics for an approximate value of $27.8 billion. According to the company, the acquisition includes: • Alignment with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases. • Strengthening of Amgen’s leading inflammation portfolio by adding first-in-class, early-in-lifecycle medicines such as Tepezza (teprotumumab-trbw), Krystexxa (pegloticase) and Uplizna (inebilizumab-cdon), which treat rare inflammatory diseases. • Leveraging of Amgen’s world-class capabilities in biologics research and development, process development and manufacturing, as well as Amgen’s presence in more than 100 countries around the world. • Generating robust cash flow to support capital allocation priorities, including ongoing investment in innovation while sustaining a commitment to an investment grade credit rating. • Acceleration of revenue growth; expected to be ...
Amgen and Horizon Therapeutics have reached a consent order agreement with the Federal Trade Commission (FTC) to resolve an ongoing administrative lawsuit. This sets the stage for Amgen to proceed with the last steps in finalising the acquisition of Horizon. In December last year, Amgen reached an agreement to acquire the complete issued and to-be-issued ordinary share capital of Horizon Therapeutics for $116.50 (€107.82) per share in cash or nearly $27.8bn on a fully diluted basis. As a result of the agreement, Amgen and Horizon anticipate submitting joint proposals to dismiss the preliminary injunction motion and lift the temporary restraining order (TRO) in the US District Court for the Northern District of Illinois. In May this year, the FTC took legal action in federal court to prevent the transaction, arguing that it would allow Amgen to leverage rebates from its successful drugs to exert influence over insurance companies and pharmacy ...
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