Amgen launches direct-to-patient program to sell cholesterol drug at 60% discount

 Amgen launched a direct-to-patient program Oct. 6 to offer its cholesterol medication Repatha at a reduced price.

The AmgenNow program will provide Repatha for $239 per month — nearly 60% below the current U.S. list price — to all eligible patients, including those who are uninsured or prefer to pay out of pocket, according to an Oct. 6 news release. Program participants will not be subject to step therapy or prior authorization requirements.

The new price is the lowest among economically developed countries, the release said, and it supports the Trump administration’s effort to lower U.S. drug costs. The company plans to make AmgenNow accessible through TrumpRx, a federal website set to launch in early 2026 that will connect consumers with discounted medications. 

Several drugmakers — including Pfizer, Eli Lilly, Novo Nordisk and Novartis — have launched or announced similar direct-to-consumer programs in recent months, particularly for chronic conditions, like obesity and high cholesterol. These efforts follow federal pressure on pharmaceutical companies to match lower prices found in other high-income countries.

https://www.beckershospitalreview.com/pharmacy/amgen-launches-direct-to-patient-program-to-sell-cholesterol-drug-at-60-discount/

Adnoc Offers Concessions to End EU Probe of $13.7 Billion Covestro Deal

 Abu Dhabi’s state oil group offered concessions to the European Union’s competition regulator in a bid to end its probe of the company’s $13.7 billion bid for German plastics maker Covestro.

A spokesperson for the European Commission said Monday that the companies filed remedies to the regulator as part of its investigation but didn’t disclose what they were. An update on the commission website shows the concessions were filed on Thursday.

“Following thorough engagement with the European Commission, we have submitted a robust and proportionate package of proposed commitments,” a spokesperson for XRG, the energy investment arm of Abu Dhabi National Oil Company, said. “They represent our disciplined approach as a long-term investor and underscore the strength of this transaction, and we are confident this will lead to timely clearance.”

XRG is set to be home to Covestro once the deal is closed.

The commission—the EU’s executive arm—had paused its probe in September and suspended its original Dec. 2 deadline to make a decision, saying it was waiting for more information about the transaction. Adnoc criticized the regulator at the time, calling its probe “disproportionate and invasive.”

The commission started investigating Adnoc’s Covestro deal in July under an EU law designed to tackle market distortions caused by companies with heavy subsidizing from non-EU governments. The deal is also being looked at by Germany under rules governing foreign direct investments.

Adnoc announced its bid for Covestro last year—valuing the company at around 11.7 billion euros ($13.74 billion)—in a move that would position the company as a more fully integrated energy group akin to U.S. majors like Exxon Mobil.

https://www.msn.com/en-us/money/companies/adnoc-offers-concessions-to-end-eu-probe-of-13-7-billion-covestro-deal/ar-AA1NWdMK

French armed forces min exits government

 French Armed Forces and Veterans Affairs Minister Bruno Le Maire announced on Monday that he has offered his resignation from the government, less than a day after being appointed, which President Emmanuel Macron accepted.

Writing on X, Le Maire described his decision to join now-former Prime Minister Sebastien Lecornu's government as patriotic but noted that it has led to "incomprehensible, false, and disproportionate reactions in some quarters." "No individual situation must block the proper functioning of the country and our institutions," he wrote. "I hope that this decision will allow discussions to resume with a view to forming a new government, which France needs."

The day before, Lecornu presented the names of his ministers. However, after less than a day, Lecornu announced his resignation, citing disagreements between the members of his government from different parties.

https://breakingthenews.net/Article/Le-Maire-exits-French-government/64932304

Russia warns UK planning attack on vessel in Europe

 Russia's Foreign Intelligence Service (SVR) warned that the United Kingdom is planning to stage a "provocation" involving an attack on a "civilian foreign vessel in a European port," as reported by Tass on Monday.

"The group's members have already arrived in the UK for sabotage training. After the terrorists are 'discovered,' they plan to announce that they were acting on 'Moscow's orders,'" the agency said. Furthermore, the SVR stated the Ukrainian militants would carry Chinese-made underwater equipment, which would later be used as evidence of Beijing's support for Russia's war in Ukraine.

The SVR stated that "London's rapid slide to the margins of world history" spurned British intelligence services to try and pit the "world's largest players against each other," while noting such attempts would fail.

https://breakingthenews.net/Article/Russia-warns-UK-planning-attack-on-vessel-in-Europe/64930206

AstraZeneca-Daiichi delayed TNBC readout for Datroway delivers survival benefit

 AstraZeneca and Daiichi Sankyo pushed back the readout of their trial of Datroway in triple-negative breast cancer (TNBC) patients ineligible for frontline immunotherapies, but the result has been worth the wait.

The results of the TROPION-Breast02 trial of the TROP2-targeting antibody-drug conjugate (ADC) were originally due to be reported last year, but are now available, and reveal statistically significant improvements in both overall survival (OS) and progression-free survival (PFS).

According to AZ and Daiichi, Datroway (datopotamab deruxtecan) is the first and only therapy to significantly improve OS compared to chemotherapy in this patient population, who can't be treated with standard PD-1/PD-L1 inhibitor immunotherapies.

That is far from a niche population, as it is estimated that around 70% of patients with metastatic TNBC are not eligible for this type of immunotherapy, because their tumours test negative for the PD-L1 biomarker, for example.

"We expect today's results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options," said AZ's head of oncology and haematology R&D, Susan Galbraith.

Gilead's rival TROP2 ADC Trodelvy (sacituzumab govitecan) already has positive PFS data in this setting from the ASCENT-03 study, but so far has not demonstrated an OS benefit. Meanwhile, BioNTech is also testing its PD-L1xVEGF bispecific pumitamig, with and without chemo, in a similar population in the ROSETTA Breast-01 trial.

Gilead has said it hopes to position Trodelvy as a "backbone treatment" for all patients across first-line metastatic TNBC, based on ASCENT-03 and the accompanying ASCENT-04 study, which tested the drug alongside MSD's PD-1 inhibitor Keytruda (pembrolizumab) in previously untreated, PD-L1-positive metastatic TNBC.

AZ and Daiichi are also running the TROPION-Breast05 study in PD-1/PD-L1-eligible advanced TNBC patients, with or without AZ's PD-L1 inhibitor Imfinzi (durvalumab), as well as TROPION-Breast04 and TROPION-Breast03 in neoadjuvant and post-neoadjuvant treatment of earlier-stage TNBC.

Datroway is already FDA-approved for previously treated metastatic HR-positive, HER2-negative breast cancer and for previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC).

Daiichi originated Datroway and has exclusive ownership of the drug in Japan, but licensed co-development rights in other markets to AZ in 2020 for $1 billion upfront, plus up to $5 billion in regulatory and sales milestones. AZ has previously pinned a $5 billion peak sales target on the ADC.

https://pharmaphorum.com/news/delayed-tnbc-readout-datroway-delivers-survival-benefit

Oculis takes second eye disease therapy into pivotal trials

 Swiss biotech Oculis is poised to start registration trials for privosegtor, its drug candidate for neuro-ophthalmic diseases, in the wake of encouraging phase 2 data.

The Zug-based company said privosegtor (OCS-05) will start two trials (PIONEER-1 and 2) in acute optic neuritis (AON) later this year and early in 2026, and a third (PIONEER-3) in non-arteritic anterior ischemic optic neuropathy (NAION) shortly before the end of next year.

The decision to move the drug into late-stage development follows encouraging phase 2 results in the ACUITY study of serum-glucocorticoid kinase (SGK-2) activator privosegtor in AON, a rare disease characterised by sudden inflammation of the optic nerve. The condition causes temporary vision loss and pain with eye movement and often is a warning sign for multiple sclerosis.

NAION, meanwhile, is a relatively rare sight-threatening disorder that, nevertheless, is the second-leading cause of optic nerve blindness after glaucoma. It has hit the headlines of late after a patient sued Novo Nordisk, claiming that his NAION was caused by the company's GLP-1 diabetes therapy Ozempic (semaglutide).

Privosegtor is Oculis' second ophthalmic drug to start a pivotal trials programme after OCS-01, a topical anti-TNF drug in an eyedrop formulation, which is in a pair of phase 3 trials in patients with diabetic macular oedema (DME), with results due in the second quarter of 2026 and regulatory filings scheduled for the latter half of the year.

PIONEER-1 and PIONEER-2, will look at privosegtor treatment after the onset of AON in patients with and without MS, with the primary endpoint low-contrast visual acuity (LCVA) at three months. At the moment, corticosteroids are used to treat the condition but there are no approved neuroprotective therapies to protect or restore vision.

PIONEER-3 will enrol patients with acute-onset NAION, another disease that has no medical or surgical treatment shown to improve patients' prognosis.

All three trial protocols have been agreed with the FDA in end-of-phase 2 discussions, according to Oculis, which reckons it has enough cash on hand – around $182 million – to take privosegtor through the PIONEER programme and fund operations to mid 2027 without dipping into a recently announced loan facility with venture capital group BlackRock.

"The positive FDA meeting marks a significant milestone for our rapidly advancing neuroprotection candidate," commented the company's chief executive, Riad Sharif. "With this milestone and the upcoming top-line results from DIAMOND phase 3 DME programme, Oculis is now in a strong position with multiple pivotal studies, targeting multi-billion-dollar markets."

Other potential indications for privosegtor include geographic atrophy, neuropathic keratitis, and glaucoma.

https://pharmaphorum.com/news/oculis-takes-second-eye-disease-therapy-pivotal-trials

Chiesi, Arbor Weave $2.1B Rare Disease Pact

 

The centerpiece of the collaboration is the gene editor ABO-101, being developed for primary hyperoxaluria type 1, a rare disease that leads to severe kidney stones.

Italy’s Chiesi Group is growing out its rare disease portfolio with a global, multitarget research partnership with California-based Arbor Biotechnologies in a deal that could reach beyond $2.1 billion.

Chiesi will send Arbor $115 million in upfront and near-term payments, with up to $2 billion in development, regulatory and commercial milestones on the line, the company announced Monday. In return, the pharma will gain exclusive rights to Arbor’s gene editor ABO-101, being developed for primary hyperoxaluria type 1 (PH-1), an ultra-rare genetic disease of the liver.

For its investment, Chiesi will also gain access to Arbor’s proprietary technologies for developing knockout and reverse transcriptase (RT) editing therapies.

Aside from the upfront and milestone commitments, Arbor will also be eligible to receive low double-digit tiered royalties on sales of products that reach the market.

In a statement Monday, Giacomo Chiesi, executive vice president of Chiesi Global Rare Diseases, called the Arbor agreement “a transformative moment” for both the company and the broader rare disease community. The companies, he added, will look “beyond current approaches and [will explore] the potential of gene editing” to provide “more comprehensive therapeutic options” for patients with rare diseases.

Arbor has already initiated the Phase I/II redePHine study of ABO-101, which is currently enrolling with a target of 23 participants. The trial has a primary completion date of March 2029. Under Monday’s deal, Arbor and Chiesi will collaborate on redePHine.

PH-1 is the most common type of primary hyperoxaluria, a genetic disorder that leads to severe forms of kidney stones. The disease is caused by a mutation in the AGXT gene, triggering a liver enzyme deficiency that results in the buildup of oxalate crystals in the kidney and other organs. Primary hyperoxaluria afflicts less than 3 patients per 1 million people, and PH-1 accounts for around 80% of these cases.

Aside from kidney stones, patients with PH-1 develop kidney damage and end-stage kidney disease. The only cure for PH-1 is a dual liver and kidney transplant, according to Monday’s release.

Designed as a one-time treatment, Arbor’s ABO-101 targets the HAO1 gene in the liver to suppress the production of oxalates, in turn preventing the toxic buildup that is the hallmark of PH-1.

https://www.biospace.com/business/chiesi-arbor-weave-2-1b-rare-disease-pact