Latest news with #Daiichi
Yahoo
4 days ago
- Business
- Yahoo
At ASCO, Enhertu cements growing role in stomach cancer care
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. AstraZeneca and Daiichi Sankyo's targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly prescribed, two-drug regimen involving chemotherapy. The finding, detailed Saturday at the American Society of Clinical Oncology's annual meeting, gives physicians a clearer choice for when patients' disease progresses after initial treatment. Data from the trial should also shore up AstraZeneca and Daiichi's market position. Enhertu already won Food and Drug Administration approval for gastric cancer that's positive for a protein called HER2 following first-line treatment with Herceptin, an older HER2-targeting medicine. A so-called antibody-drug conjugate, Enhertu combines the active agent in Herceptin with a chemotherapy toxin, delivering a more potent drug dose directly to HER2-expressing tumor cells than can be administered otherwise. It is one of six blockbuster cancer drugs sold by AstraZeneca and the fastest growing one, with more than $3 billion in 2024 revenue. Cyramza, an Eli Lilly drug, is FDA-approved for gastric cancer that progresses following chemo. Small trials have suggested that, with Herceptin and chemo or just chemo, Cyramza can improve response rates and survival in people whose disease progressed on Herceptin. It is part of the standard second-line regimen Enhertu was tested against. In AstraZeneca and Daiichi's trial, called Destiny-Gastric04, investigators randomized nearly 500 people with HER2-positive cancer who had progressed on Herceptin to receive either Enhertu or Cyramza plus a chemotherapy drug called paclitaxel. The trial measured overall survival as its main goal, with progression-free survival and response rates secondary endpoints. Results showed that Enhertu reduced the risk of death by 30%, extending median survival by 3.3 months to reach 14.7 months, compared to 11.4 months for the Cyramza-chemo combination. The antibody-drug conjugate also reduced the risk of progression by 26%, delaying relapse or death by 1.1 months when compared to Cyramza and chemo. Among Enhertu-treated patients, 44% had their tumors shrink or disappear, significantly more than the 29% of people given Cyramza and chemo. 'This study is practice-validating in the U.S., given [Enhertu's] existing inclusion in guidelines and current use in the second-line setting,' Pamela Kunz, a Yale University specialist in gastrointestinal cancer, said in a press conference ahead of the ASCO meeting. 'It will be practice-changing in many countries outside of the U.S., and will really position [Enhertu] as a preferred second-line treatment.' The trial's findings only apply to HER2-positive patients, which account for as much as one-sixth of the roughly 30,000 new cases of stomach cancer each year. Nearly all trial participants experienced side effects from treatment, although a slightly higher 93% of people who received Enhertu reported side effects compared with 91% on Cyramza. Similar numbers, around half in each group, had side effects judged to be severe or worse. Nearly 14% given Enhertu experienced inflammation or scarring of lung tissue, a known side effect of the drug that previously prompted the FDA to put a 'black box' warning on its label. Kunz said the incidence of lung damage should prompt doctors to 'take note' and 'think about patient selection and consider patient comorbidities' before prescribing Enhertu. With Enhertu's place in the second-line setting now established, AstraZeneca and Daiichi are working to expand its use further by testing it in newly diagnosed people with inoperable HER2-positive tumors. The Destiny-Gastric05 trial is studying it in combination with Merck & Co.'s immunotherapy Keytruda and chemo head-to-head against the FDA-approved regimen of Herceptin, Keytruda and chemo. Results may not be available for three years, however.
Time of India
6 days ago
- Business
- Time of India
Fortis Open Offer: Daiichi Sankyo's 'misleading' statements continue to damage interests, says NTK
IHH Healthcare 's Singapore-headquartered indirect subsidiary Northern TK Venture Pte Ltd (NTK) on Thursday said Daiichi Sankyo's "misleading statements" concerning the Fortis Healthcare open offer continue to damage NTK's interests. Earlier this month, NTK had applied with the Tokyo District Court to amend its ongoing damages claim against Daiichi Sankyo, increasing it by almost tenfold to JPY 200 billion (approximately Rs 11,800 crore or USD 1.38 billion). The damages claim relates to IHH's open offer for Fortis Healthcare Ltd and Daiichi's actions that have obstructed its completion. Following this, Daiichi claimed in a statement on May 22 that the suspension of the public tender offer for Fortis Healthcare was under the instructions of the Supreme Court of India during enforcement procedures based on an arbitration ruling. Daiichi had said that NTK's claims that it interfered with the latter's open offer are without any merit, and are not sustainable. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Moose Approaches Girl At Bus Stop In Gabes - Watch What Happens Happy in Shape Undo "Since the case is pending at the Tokyo District Court, NTK will refrain from correcting inaccuracies in the statement, but NTK will continue to present the correct facts and pursue its claims before the Tokyo District Court to obtain reliefs, including recovery of damages from Daiichi Sankyo," IHH said in a media advisory on Thursday. NTK reiterated its earlier statement that its claims against Daiichi Sankyo are tort claims premised on Daiichi Sankyo's unlawful interference with NTK's trade or business, conspiracy of Daiichi Sankyo and other persons, malicious falsehood, and defamation, each under the applicable substantive laws. Live Events "This lawsuit pertains to NTK's claim at the Tokyo District Court for damages, among others, arising from alleged obstruction by Daiichi Sankyo of NTK's efforts to complete its open offers to acquire shares in Fortis Healthcare Limited and its step-down subsidiary, Fortis Malar Hospitals Limited," NTK had said in a media advisory earlier. According to NTK, while IHH was declared the successful bidder in a bid process run by FHL, it received preferential allotment of shares by FHL, triggering an Open Offer. While NTK attempted to execute the Open Offer, Daiichi Sankyo unfairly obstructed the execution of the Open Offer and prevented the completion of the acquisition, resulting in significant losses to NTK. As per NTK, Daiichi Sankyo obtained an ex parte interim status quo order from the Supreme Court of India without notifying IHH and NTK that it was seeking such an order against them. NTK said in its media advisory that the open offer for FHL could not progress due to Daiichi's actions. Daiichi Sankyo has been in dispute with the erstwhile promoters of Ranbaxy Limited (Malvinder Singh and Shivinder Singh) for recovering money from the damage caused by the acquisition of Ranbaxy Laboratories. While Daiichi Sankyo has instituted proceedings in the Delhi High Court and the Supreme Court against the Singh Brothers, IHH and NTK have stated that they have no connection with the duo. As per NTK, Daiichi Sankyo has speculated that the Singh Brothers were somehow connected to IHH. IHH has transformed Fortis into India's leading healthcare company with a network of 28 hospitals and 400 labs.
Yahoo
6 days ago
- Business
- Yahoo
Merck, Daiichi pull approval application for ADC in lung cancer
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Merck & Co. and Daiichi Sankyo have withdrawn an approval application in the U.S. for a lung cancer drug at the center of a multibillion-dollar alliance the companies formed two years ago. In a short statement Thursday, the companies said they've pulled a Food and Drug Administration submission for an experimental therapy known as patritumab deruxtecan. Merck and Daiichi had been seeking an 'accelerated' approval of the drug in people whose non-small cell lung cancer has a mutation in a gene called EGFR and, last September, reported that it meaningfully delayed tumor progression compared to chemotherapy in a Phase 2 trial. However, Merck and Daiichi have also found that their drug didn't extend survival, the gold standard for a cancer drug. That finding, as well as subsequent discussions with the FDA, led the companies to withdraw their application, according to their statement. The companies will present study results at the American Society of Oncology Meeting on Sunday. This outcome is a 'reminder of how challenging it can be to treat these patients with EGFR-mutated non-small cell lung cancer in the second and later line settings,' said Eliav Barr, the chief medical officer of Merck Research Laboratories, in the statement. Merck currently draws the bulk of its revenue from the cancer immunotherapy Keytruda, which in recent years became the world's top-selling drug. But Keytruda is poised to lose patent protection later this decade, and Merck has been facing increasing skepticism from analysts and investors about its plans to offset those future losses and grow. The company's share price has fallen nearly 40% over the last 12 months. One area of research Merck has looked to is antibody-drug conjugates, a type of targeted cancer medicine seen as a potential way to replace traditional chemotherapies. The company formed a pair of alliances with China-based drugmaker Kelun Biotech in 2022 and, a year later, sprung for a collaboration with Daiichi that could potentially be worth as much as $22 billion. In aligning with Daiichi, Merck may have been spurred on by the success AstraZeneca has had with a similar type of ADC-focused partnership. A 2019 deal between Daiichi and AstraZeneca yielded Enhertu, an ADC that's cleared for use in several cancers and is now a blockbuster medicine. Merck partnered with Daiichi a month after the Japanese company reported Phase 2 data underlying an accelerated approval application for patritumab deruxtecan. But the companies have faced setbacks since. U.S. regulators rejected their ADC last June due to findings at a manufacturing plant. Now, after pulling their application, Merck and Daiichi are searching for a new path forward. The companies are 'conducting further biomarker analyses' to better identify lung cancer patients who might benefit from treatment, said Ken Takeshita, Daiichi's global head of R&D, in the statement. 'We remain confident in the broad development of [our drug],' which includes trials across 15 types of cancer, he added.
Time of India
21-05-2025
- Business
- Time of India
IHH Group seeks damages of Rs 11,800 crore from Daiichi
New Delhi: Malaysia's IHH Healthcare is seeking JPY 200 billion (Rs 11,800 crore) in damages from Japan's Daiichi Sankyo for blocking its bid for control of Indian hospital operator Fortis. IHH's Singapore-based indirect subsidiary Northern TK Ventures (NTK) has approached the Tokyo District Court seeking to amend its ongoing damages against Daiichi Sankyo, increasing the claim by almost tenfold to JYP 200 billion (about Rs 11,800 crore or USD 1.38 billion) from previous JYP 20 billion. NTK had in October 2023 filed a claim alleging that the Japanese drugmaker caused losses to the company by preventing it from proceeding with open offers to buy a stake in the Indian hospital chain in 2018, it said in a media advisory. "In the petition to increase claim, NTK has sought, amongst others, to amend the amount of the damages claimed from the initial amount of JPY 20 billion to Rs 10,930 crore for losses arising from NTK's tortious claim (other than defamation) against Daiichi Sankyo; JPY 5 million for losses arising from NTK's defamation claim against Daiichi Sankyo; and the accrued interest on the damages claimed," IHH said. The lawsuit pertains to NTK's claim at the Tokyo District Court for damages, among others, arising from alleged obstruction by Daiichi Sankyo of NTK's efforts to complete its open offers to acquire shares in Fortis Healthcare Limited and its step-down subsidiary, Fortis Malar Hospitals Ltd. IHH, Asia's largest healthcare operator, had bought a 31 per cent interest in the Indian firm through NTK, but later paused its open offer to buy an additional 26 per cent after the Japanese company filed a contempt plea against Fortis' founders. According to NTK, while IHH was declared the successful bidder in a bid process run by FHL, it received preferential allotment of shares by FHL, triggering an open offer. While NTK attempted to execute the open offer, Daiichi Sankyo unfairly obstructed the execution of the open offer and prevented the completion of the acquisition, resulting in significant losses to NTK. As per NTK, Daiichi Sankyo obtained an ex parte interim status quo order from the Supreme Court of India without notifying IHH and NTK that it was seeking such an order against them. NTK said in its media advisory that the open offer for FHL could not progress due to Daiichi's actions. Daiichi Sankyo has been in dispute with the erstwhile promoters of Ranbaxy Limited (Malvinder Singh and Shivinder Singh) for recovering money from the damage caused by the acquisition of Ranbaxy Laboratories. While Daiichi Sankyo has instituted proceedings in the Delhi High Court and the Supreme Court against the Singh brothers, IHH and NTK have stated that they have no connection with the duo. As per NTK, Daiichi Sankyo has speculated that the Singh brothers were somehow connected to IHH. IHH has transformed Fortis into India's leading healthcare company with a network of 28 hospitals and 400 labs.>
Time of India
22-04-2025
- Business
- Time of India
Shivinder Mohan Singh moves NCLT, files plea for personal insolvency
New Delhi: Former Fortis Healthcare promoter Shivinder Mohan Singh has moved a plea before the National Company Law Tribunal for personal insolvency , stating that his liabilities far exceed his assets. Singh has filed the plea under Section 94 of the Insolvency and Bankruptcy Code (IBC) before the Delhi-based bench of the insolvency tribunal, according to lawyers associated with the matter. The plea was listed before a two-member bench comprising Mahendra Khandelwal and Subrata Kumar Dash on Monday, which briefly heard the matter. The bench has now posted the matter on May 20 for the next hearing. Section 94 of the IBC allows a debtor to apply to the NCLT to initiate the insolvency resolution process. The debtor may apply either by himself, or jointly with Partners, or through a Resolution Professional to the NCLT for initiating an Insolvency Resolution Process under Section by submitting an application. Debt-ridden Shivinder Mohan Singh faces over Rs 3,500 crore recovery in an arbitration from the Japanese drug maker Daiichi Sankyo . In his plea, Singh has submitted that his liabilities now far exceed the value of available assets. Most of his assets have either been attached or disposed of at significantly reduced value, primarily due to ongoing litigation and enforcement proceedings related to the Daiichi dispute, as well as financial mismanagement within RHC Holding Pvt. Ltd., where he was a corporate guarantor. A Singapore-based arbitral tribunal on April 29, 2016, awarded Rs 3,500 crore in favour of the Japanese firm, directing the Singh brothers to pay. Later, Daiichi Sankyo moved the Delhi High Court for its enforcement. The Delhi High Court on January 31, 2018, upheld the Rs 3,500 crore arbitral award passed in favour of Daiichi and paved the way for the enforcement of the 2016 tribunal award against the brothers who had sold their shares in Ranbaxy to Daiichi in 2008 for Rs 9,576.1 crore. Sun Pharmaceuticals Ltd had later acquired Ranbaxy from Daiichi.
