In Phispers this week, two drugmakers emerging from bankruptcy — Mallinckrodt and Endo — are merging in order to leverage their US manufacturing facilities, and make good use of Trump’s protective tariffs. The merger deal has been valued at US$ 6.7 billion.In other deals, AstraZeneca is acquiring Belgian biotech EsoBiotec for up to US$ 1 billion. The drugmaker has also inked a US$ 1.35 billion deal with Alteogen to develop subcutaneous formulations of its oncology drugs. Roche has signed a multi-year oncology deal with Oxford BioTherapeutic to develop first-in-class antibody-based treatments for cancer. And Otsuka’s Taiho Pharmaceutical has agreed to acquire its proprietary antibody-drug conjugate (ADC) partner Araris for a total consideration of up to US$ 1.1 billion.In divestment news, Pfizer has completely exited its investment in Haleon by selling its entire 7.3 percent stake for approximately US$ 3.24 billion.Hilary Perkins, the newly appointed Chief Counsel of the US Food and Drug Administration (FDA), has resigned just two days into her role following criticism from Republican Senator Josh Hawley over her previous defense of the FDA’s position on the abortion pill mifepristone.All drug manufacturers that were chosen for Medicare price
negotiations under Inflation Reduction Act (IRA) have agreed to participate in
the second round.And in news from clinical trials, Orca Bio’s investigational cell therapy, Orca-T, has shown remarkable results in a pivotal late-stage clinical trial on blood cancer patients.Mallinckrodt, Endo announce US$ 6.7 bn merger to capitalize on Trump’s tariffsMallinckrodt and Endo, both pharmaceutical companies that recently emerged from bankruptcy due to opioid litigations in
the US, have announced a merger valued at US$ 6.7 billion. This strategic move is expected to create a diversified pharmaceuticals leader with a strong US manufacturing base.The new entity will be listed on the New York Stock Exchange and
will focus on branded drugs. It will have extensive US manufacturing
facilities. Mallinckrodt CEO Siggi Olafsson noted that this domestic production
capacity positions the company to benefit from US tariffs on imported goods.Pfizer sells entire stake in Haleon for US$ 3.24 bn: Pfizer has sold its entire 7.3 percent stake in Haleon, the British consumer
healthcare company known for brands like Sensodyne, Panadol, and Advil, for approximately £ 2.5 billion (US$ 3.24 billion). The shares were sold to institutional investors and Haleon.Astra acquires EsoBiotec for up to US$ 1 bn, inks US$ 1.35 bn deal with AlteogenAstraZeneca has signed a definitive deal to acquire Belgian cell therapy
biotech EsoBiotec for up to US$ 1 billion. The deal includes an upfront payment of US$
425 million plus an additional US$ 575 million in milestone-based contingent payments.EsoBiotec’s ENaBL platform is an innovative approach that could shorten treatment timelines from weeks to minutes and significantly reduce manufacturing costs, thus expanding patient access.AstraZeneca has also inked a deal with Alteogen that could be worth up to US$ 1.35 billion, aiming to develop
subcutaneous (SC) formulations
of its oncology drugs. SC formulations are generally
more convenient for patients, offering faster administration and potentially
improved adherence compared to traditional intravenous (IV) infusions.Taiho buys out ADC partner
Araris: Otsuka’s Taiho Pharmaceutical has agreed to acquire ADC partner Araris for a total consideration of up to US$
1.1 billion. The Japanese drugmaker will
make an upfront payment of US$
400 million.Orca Bio’s cell therapy drubs standard of care in phase 3, blood cancer trialOrca Bio’s investigational cell therapy, Orca-T, has demonstrated remarkable results in a pivotal late-stage clinical trial on patients with various
types of blood cancers, including acute myeloid leukemia (AML), acute
lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), and
mixed-phenotype acute leukemia (MPAL). The trial revealed that 78 percent of patients
receiving Orca-T survived without moderate-to-severe chronic graft-versus-host
disease (cGvHD) at the one-year mark, compared to 38 percent in the standard
allogeneic hematopoietic stem cell transplant (alloHSCT) group. Overall
survival rates were also notably higher in the Orca-T group.Roche signs multi-year
oncology deal with Oxford Bio, bets US$ 1 bn in biobucksClinical stage oncology company Oxford BioTherapeutics (OBT) has entered into a multi-year collaboration with Roche to discover
novel, potentially first-in-class antibody-based treatments for cancer. OBT will receive up to US$ 36 million in upfront payments from Roche, with an option to receive over US$ 1 billion in milestone payments, along with product royalties on net sales. Under the terms of the agreement, targets will be identified via OBT’s OGAP-Verify discovery platform.Meanwhile, according to a Reuters report, Roche is abandoning global diverse workforce
targets while Novartis is ending its use of diverse panels for US hiring, in
order to avoid penalties under recent US executive orders.All selected drugmakers agree
to second round of Medicare price talks under IRAAll drug manufacturers, including Denmark’s Novo Nordisk and Israel’s Teva Pharmaceuticals, have now agreed to participate in the second round of Medicare price negotiations. Under the IRA, the Centers for Medicare & Medicaid Services (CMS) is set to send initial maximum fair price proposals for the 15 selected drugs, used by 5.3 million Medicare beneficiaries from November 2023 through October 2024.The proposals, which must be accepted or countered within 30 days, are expected by June 1, with further meetings potentially extending the process until November 1. The list includes high-cost drugs like Novo’s Ozempic, Wegovy, and Rybelsus (all semaglutide), as well as Merck’s Janumet (sitagliptin/metformin) and AstraZeneca’s Calquence (acalabrutinib), among others. CMS’ initiative follows last year’s negotiations that achieved list price reductions of between 38 percent and 79 percent on 10 drugs.Top FDA lawyer quits two days
into role after being accused of being pro-abortionHilary
Perkins, who was recently appointed as Chief Counsel for the FDA, has resigned just two
days into her role. Her resignation followed criticism from Republican Senator
Josh Hawley, who labeled her as pro-abortion and supportive of vaccine
mandates. Perkins had previously defended the FDA’s position on the abortion pill mifepristone during her tenure at the
Department of Justice under the Biden administration. In her LinkedIn post, she stated that her past work had become “an unnecessary distraction from advancing the Administration’s priorities.”
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