As we return from
our one-week break due to the CPhI Worldwide, we find our double-dose Phispers
edition to be filled with several large deals and key approvals by the US Food
and Drug Administration (FDA).Pfizer and Novo Nordisk intensified their multi-billion-dollar bidding war for American biotech Metsera, the developer of next-generation obesity drugs. Kimberly-Clark announced one of the largest consumer health mergers in history with a US$ 48.7 billion acquisition of Kenvue, Johnson & Johnson’s former consumer
health unit. In other deals, Novartis agreed to buy RNA-drug developer Avidity
Biosciences for US$ 12 billion, and Roche signed two licensing agreements worth
more than US$ 3 billion for brain and respiratory therapies.Eli Lilly pledged
over US$ 4 billion to expand manufacturing capacity in Europe and Puerto Rico.
FDA approved Lynkuet, Bayer’s non-hormonal therapy for menopause-related hot flashes. It also
approved UCB’s first treatment for an ultra-rare mitochondrial disorder. However,
the agency rejected Biohaven’s drug for a rare neurodegenerative disorder.Clinical setbacks
continued to hit the gene therapy space as Sarepta and Intellia reported major
trial failures. And Harmony Biosciences paused the development of its
cannabidiol gel for a genetic condition after the drug failed a late-stage
trial.Meanwhile, George
Tidmarsh, FDA’s drug center chief, resigned amid a misconduct probe, adding to the
existing leadership turmoil at the agency.Pfizer, Novo Nordisk escalate bidding war for
obesity drug developer MetseraPfizer and Novo Nordisk have intensified their battle to acquire American biotech Metsera, a developer of obesity drugs. The fight escalated as both companies submitted higher bids, with Novo raising its offer
to US$ 10 billion, which Metsera has deemed superior, and Pfizer increasing its
own bid to US$ 8.1 billion from the original offer of US$ 7.3 billion. Pfizer
has filed lawsuits against Metsera, its board, and Novo Nordisk, alleging that Metsera
breached its earlier merger agreement and accused Novo of structuring its bid to block Pfizer’s entry into the
fast-growing obesity market. A Delaware judge has, so far, declined to
intervene but scheduled another hearing to review the bidding process.Kimberly-Clark to buy Kenvue in US$ 48.7 bn deal;
Novartis to acquire Avidity for about US$ 12 bnKimberly-Clark has said it is acquiring Johnson & Johnson’s
former consumer health unit, Kenvue, in a cash-and-stock deal valued at US$ 48.7 billion. The merger will create
a global consumer health giant with expected annual revenue of about US$ 32
billion and a portfolio of 10 billion-dollar brands, including Tylenol (acetaminophen), Neutrogena, Aveeno and Listerine.Novartis to acquire Avidity: Swiss drugmaker Novartis has announced the acquisition of US-based Avidity Biosciences for about US$ 12 billion in cash to expand its treatments for rare muscle disorders. Avidity, based in San Diego, is developing
RNA-based drugs that target the root cause of severe muscle diseases such as
Duchenne muscular dystrophy. As part of the deal, Avidity will spin off its
early-stage cardiology drug programs into a new publicly-traded company called
SpinCo.Roche pledges over US$ 3 bn in two licensing
deals for brain, respiratory drugsRoche has announced two major licensing agreements worth a total of over US$ 3 billion. First, the Swiss drugmaker signed a research and licensing deal with US biotech Manifold
Bio worth over US$ 2 billion to develop new methods for delivering drugs to the brain, building on
its 15 years of work in brain drug delivery. Second, Roche entered a deal worth
more than US$ 1 billion with Shanghai-based Qyuns Therapeutics for global rights to QX031N, a bispecific antibody in development to
treat asthma and chronic obstructive pulmonary disease (COPD).Eli Lilly to invest US$ 4.2 bn in Europe, Puerto
Rico to expand manufacturingEli Lilly will invest US$ 3 billion to build an oral medicines manufacturing site in Katwijk, the Netherlands, thereby boosting capacity for its
experimental GLP-1 pill, orforglipron, and creating 500 jobs. The company will also spend over US$ 1.2 billion to expand its Puerto Rico facility, supporting production of heart disease, diabetes, cancer and immune disorder drugs.FDA drug center chief resigns: George Tidmarsh stepped down from the post of head, FDA drug center, after federal officials began
reviewing serious concerns about his personal conduct. The move followed a lawsuit by Aurinia Pharmaceuticals, which accused Tidmarsh of using his FDA role to
pursue a personal vendetta against its board chair, Kevin Tang.FDA approves Bayer’s non-hormonal med to treat menopause-related hot
flashesFDA has approved Bayer’s Lynkuet (elinzanetant), the first-of-its-kind oral non-hormonal drug to treat moderate to severe hot flashes and night sweats experienced by
menopausal women. The approval is based on late-stage studies showing a rapid and sustained reduction in
these symptoms.Okays UCB’s treatment for rare disorder: FDA has approved UCB’s Kygevvi
(doxecitine and doxribtimine), marking the first treatment for thymidine kinase 2 deficiency (TK2d), one of the world’s rarest mitochondrial diseases. TK2d is caused by a genetic defect that
prevents cells from repairing mitochondrial DNA, leading to progressive muscle
weakness and, in many cases, respiratory failure.Sarepta’s muscular dystrophy drug fails late-stage trial; FDA rejects Biohaven’s drugSarepta Therapeutics said its late-stage trial of two gene-targeted therapies, casimersen and golodirsen, for
Duchenne muscular dystrophy failed to meet the main goal of improving patients’ ability to climb stairs. Following the announcement, Sarepta’s shares fell
over 37 percent in extended trading.FDA rejects Biohaven’s rare disorder drug: FDA has rejected Biohaven’s
application for Vyglxia (troriluzole), an oral small-molecule drug for spinocerebellar ataxia (SCA), citing bias and design flaws in the company’s real-world, evidence-based submission. SCA is a rare
neurodegenerative disorder that impairs coordination and balance and currently
has no approved treatments.Harmony pauses cannabidiol gel program: Harmony Biosciences has paused development of its cannabidiol gel, ZYN002, after the treatment failed a late-stage trial in fragile X syndrome, a genetic condition that causes
developmental and intellectual disabilities. The company said it will review
the full results of the study before deciding whether to continue testing the
drug in another genetic disorder. Harmony picked up ZYN002 last year through
its acquisition of US-based Zynerba Pharmaceuticals.FDA pauses Intellia’s late-stage trials: FDA has paused two phase 3 studies of Intellia Therapeutics’ experimental gene-editing therapy after a patient developed serious liver problems. The treatment, known as nexiguran ziclumeran, was being tested for transthyretin amyloidosis, a rare disease that damages the heart and nerves.
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