Ozempic Maker's Plight Shows Managing Markets Counts Too
For years, Novo had a relatively quiet life as one member of an insulin oligopoly alongside US peer Eli Lilly & Co. and France's Sanofi SA. While it wasn't a completely smooth ride — 2016 was dire — Novo has never seen operational and strategic challenges on the scale it's now facing. In developing Ozempic for diabetes and its sibling Wegovy for weight loss, the company suddenly found itself riding a tiger.
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Yahoo
11 minutes ago
- Yahoo
Knight Therapeutics and Incyte Amend Supply and Distribution Agreement to Add Retifanlimab and Axatilimab in Latin America
MONTREAL, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has expanded its existing relationship and amended its agreement with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), for the exclusive rights to distribute retifanlimab (sold as ZYNYZ® in the United States and Europe) and axatilimab (sold as NIKTIMVO™ in the United States) in Latin America. Under the terms of the amended agreement Incyte will be responsible for the development, manufacture and supply to Knight of retifanlimab and axatilimab, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America. Knight and Incyte had entered into an exclusive supply and distribution agreement for MINVUVI® (tafasitamab) and PEMAZYRE® (pemigatinib) in Latin America in September 2021. Retifanlimab is approved in the United States and Europe for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.1 Based on epidemiological data from two Brazilian registries, there are an estimated 550 – 1,250 new cases of MCC each year across Brazil, Mexico, Colombia and Argentina.2 Retifanlimab is also approved by the U.S. Food and Drug Administration (FDA) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).1 In addition, the FDA approved retifanlimab as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.1 While epidemiological data for SCAC in LATAM is limited, there are approximately 2,700 – 4,000 new cases of SCAC each year in Brazil, Mexico, Colombia and Argentina.3 Axatilimab received FDA approval in August 2024 for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.4 Chronic GVHD is a serious complication of allogeneic stem cell transplantation in which the donor's immune cells attack the recipient's tissues, potentially affecting multiple organs such as the skin, liver, lungs, and gastrointestinal tract. There are approximately 1400 – 1800 reported allogeneic transplants in Brazil every year.5 'We are thrilled to expand our partnership with Incyte and for the opportunity to bring two innovative biologic products to the LATAM region,' said Samira Sakhia, President and CEO of Knight Therapeutics. 'These therapies are highly complementary to our existing portfolio and will significantly strengthen our presence in oncology and hematology, reinforcing our commitment to delivering transformative treatments to patients across Latin America.' 'As a partner, Knight, has an extensive track record of successful collaborations as well as strong distribution capabilities in Latin America,' said Lee Heeson, Executive Vice President and Head of Incyte International. 'We look forward to continuing to work together and to expanding our existing partnership for tafasitamab and pemigatinib to include retifanlimab and axatilimab so that eligible patients in the region can access our innovative medicines.' About Retifanlimab ZYNYZ® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.1 ZYNYZ® is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 ZYNYZ® is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. ZYNYZ® is a registered trademark of Incyte. About Axatilimab NIKTIMVO™ (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg .4 In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in cGVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD; a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids which are expected to initiate by year end. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). NIKTIMVO™ is a trademark of Incyte. All other trademarks are the property of their respective owners. References Incyte Corporation. ZYNYZ (retifanlimab-dlwr) injection, for intravenous use: Full prescribing information. Retrieved July 24, 2025, from Melo, Andreia C de, and Luiz C Santos Thuler. 'Trends in the Incidence and Morbidity of Merkel Cell Carcinoma in Brazil.' Future Oncology 17, no. 22 (May 7, 2021): 2857–65. Mignozzi, Silvia, Claudia Santucci, Matteo Malvezzi, Fabio Levi, Carlo La Vecchia, and Eva Negri. 'Global Trends in Anal Cancer Incidence and Mortality.' European Journal of Cancer Prevention 33, no. 2 (November 27, 2023): 77–86. Incyte Corporation. NIKTIMVO (axatilimab-csfr) injection, for intravenous use: Full prescribing information. Retrieved July 24, 2025, from Associação Brasileira De Transplante De Órgãos. 'Registro Brasileiro de Transplantes.'XXV No. 3. About Knight Therapeutics Inc. Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at or Forward-Looking Statements This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. Investor Contact: Knight Therapeutics Inc. Samira Sakhia Arvind Utchanah President & Chief Executive Officer Chief Financial Officer T: 514.484.4483 T. +598.2626.2344 F: 514.481.4116 Email: IR@ Email: IR@ Website: Website:
New York Times
11 minutes ago
- New York Times
RB Leipzig receive improved offer from Newcastle United for Benjamin Sesko
Red Bull Leipzig have received an improved offer from Newcastle United to sign Benjamin Sesko. An opening bid worth €75million plus €5million in add-ons was deemed insufficient by Leipzig, leading Newcastle to raise that to at least €80m. Sesko is also wanted by Manchester United, but a proposal has yet to arrive from Old Trafford and the figures they have indicated a willingness to pay are lower than those of Newcastle at present. Advertisement That leaves the St James's Park side in a strong position as things stand, after a day of positive talks held by their co-owner Jamie Reuben with Leipzig and the 22-year-old striker. Nothing is agreed yet and there is currently no guarantee of the outcome, which could still be Sesko staying if Leipzig do not accept a deal. The Slovenia international's preference will be crucial — however Leipzig have no intention of settling for a fee below their expectations to grant that, meaning both suitors must reach the required level in order to close the transfer. Newcastle have a long-standing interest in the 22-year-old forward and The Athletic reported on July 24 that the Premier League club were considering a move for him in the event that Alexander Isak leaves the club. The Sweden international wants to leave St James' Park this summer and has been training at his former club, Real Sociedad, while Eddie Howe's squad are on a pre-season tour of Asia. Liverpool had a formal £110m bid for Isak rejected on Friday, as revealed by The Athletic, but the Premier League champions retain a strong interest in the forward, having initially expressed an interest in doing a deal in the region of £120m last month. Sesko has been the subject of interest from several clubs this summer after scoring 21 goals in all competitions for Leipzig last season. Manchester United are also interested in signing the Slovenian and are prioritising him if they are to sign another striker this summer. Arsenal had been monitoring Sesko before they completed the €63.5million (plus €10m) signing of Viktor Gyokeres. Chelsea had admired Sesko for several years but opted to sign Liam Delap and Joao Pedro this summer. Sesko signed a new contract with Leipzig last year which runs through to 2029, with his deal expected to include a gentleman's agreement allowing him to leave for the right project. He has recorded 39 goals and eight assists in 87 appearances for the German club since signing of RB Salzburg in 2023, with both clubs owned by the Red Bull GmbH conglomerate. The striker has also scored 16 goals in 41 appearances for Slovenia, and represented his country at last year's European Championships. Analysis by German football writer Seb Stafford-Bloor Reasonably well, but it was not the season he needed to produce to assuage the doubts. While his overall level of performance improved in the broader sense, with Sesko becoming more connected with the rest of the Leipzig side, his goalscoring numbers were down. He scored one fewer Bundesliga goal (13) in 2024-25 than he did the year before, despite playing almost an extra 900 minutes. He was never able to replicate that seven-game streak from the previous year, either, meaning that it felt underwhelming as a result, despite some eye-catching goals (particularly against Bayern Munich at the Red Bull Arena). Advertisement But Leipzig had a bad season. They sacked Marco Rose in March, limped to their lowest finish since being promoted to the Bundesliga in 2016 and only won one game of their eight Champions League games. That's valuable context. Nevertheless, consistency was still an issue for Sesko and the gap between his best performances and his worst, which is a historic criticism, remains too wide.
Yahoo
41 minutes ago
- Yahoo
W. R. Berkley Corporation Names Wayne Ashley President of Berkley Re UK Limited
GREENWICH, Conn., August 04, 2025--(BUSINESS WIRE)--W. R. Berkley Corporation (NYSE: WRB) today announced the appointment of Wayne Ashley as president of Berkley Re UK Limited effective October 2025. Clare Himmer will continue as Berkley Re UK's chief executive officer with the expectation that Mr. Ashley will succeed her as CEO upon her retirement at the end of 2025. W. Robert Berkley, Jr., president and chief executive officer of W. R. Berkley Corporation, commented on the appointment, "Clare's leadership at Berkley Re UK has been instrumental in continuing to build a strong presence across the U.K. and European reinsurance markets. Her contributions have left a lasting positive impact, and we are deeply appreciative of all she has achieved on behalf of the Company. We're pleased that Clare will remain an integral part of our organization through the transition—her insight, experience, and guidance continue to be a tremendous asset to the entire group. We are excited to welcome Wayne to the BRUK team. With a strong background and proven industry track record, Wayne is well-positioned to play a pivotal role in propelling the company forward. His addition marks an exciting chapter in our ongoing growth, and we warmly welcome him to Berkley." Mr. Ashley has over 30 years of experience in the international reinsurance market. He most recently led the London division of a leading multi-line global reinsurer, where he was responsible for the overall management and development of international property and casualty reinsurance business outside of North America and Bermuda. Clare Himmer, who joined Berkley Re UK in 2021, has had a successful 33-year career in the property and casualty reinsurance industry. She will continue to lead the organization through the transition and will remain a valuable resource for both the Berkley Re UK team and W. R. Berkley Corporation. For further info about products and services available from Berkley Re UK Limited, visit Founded in 1967, W. R. Berkley Corporation is an insurance holding company that is among the largest commercial lines writers in the United States and operates worldwide in two segments of the property casualty insurance business: Insurance and Reinsurance & Monoline Excess. For further information about W. R. Berkley Corporation, please visit View source version on Contacts Karen A. HorvathVice President - External Financial Communications(203) 629-3000
