BMS to buy Mirati for up to US$ 5.8 billion; GSK inks US$ 3 billion Shingrix deal with Zhifei

By PharmaCompass

2023-10-12

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In this week’s Phispers, we bring you news on Bristol Myers Squibb’s US$ 5.8 billion acquisition of Mirati that will strengthen its oncology pipeline. In other deals, Chinese drugmaker Zhifei has secured exclusive distribution rights in China for GSK’s top-selling shingles vaccine, Shingrix, in a deal worth £2.5 billion (US$ 3.05 billion). And Japan’s Kyowa Kirin is set to buy Orchard Therapeutics, a Britain-based biopharmaceutical firm, for US$ 477.6 million to advance the development of new drugs.

In approvals, the US Food and Drug Administration (FDA) has approved Novartis’ intravenous Cosentyx (secukinumab) for the treatment of rheumatic diseases. And in a late-stage trial, Merck’s Keytruda has demonstrated gains in patients with non-small cell lung cancer (NSCLC).

In regulatory news, Alnylam Pharmaceuticals has abandoned an expanded use application for its heart-disease drug Onpattro for the treatment of a potentially fatal heart muscle disease after it was rejected by FDA.

The agency has also issued warning letters to two online sellers, instructing them to discontinue the sale of unapproved versions of semaglutide and tirzepatide, the active ingredient (API) found in Novo’s weight-loss drug Wegovy. A study published in the JAMA medical journal suggests Wegovy may pose a higher risk of pancreatitis, intestinal blockage, and stomach paralysis.

Meanwhile, Bayer has opened its first cell therapy launch facility in Berkeley, California, aimed at providing cell therapies to a global patient population.

BMS to acquire Mirati for up to US$ 5.8 billion for its promising oncology pipeline

Bristol-Myers Squibb has agreed to acquire Mirati Therapeutics, a drugmaker specializing in cancer drugs, in a deal valued at up to US$ 5.8 billion. The acquisition will give BMS access to Mirati’s lung cancer drug Krazati (adagrasib) and several promising clinical assets that complement BMS’ oncology pipeline. Krazati received accelerated FDA approval for the treatment of adult patients with KRAS-mutated non-small cell lung cancer (NSCLC) in 2022.

GSK signs US$ 3 billion shingles vaccine deal with Zhifei: China’s leading vaccines company, Zhifei, has secured exclusive distribution rights to GSK’s top-selling shingles vaccine Shingrix in China in a deal worth £2.5 billion (US$ 3.05 billion). Shingrix is GSK’s top-selling drug, and Zhifei plans to double its sales to over £4 billion (US$ 4.88 billion) by 2026.

AbbVie to buy Mitokinin for US$ 655 million: AbbVie is acquiring biotech company Mitokinin for an upfront payment of US$ 110 million to develop a potential first-in-class treatment for Parkinson’s disease (PD). It will pay US$ 545 million if Mitokinin achieves various milestones spelt out in the deal.

Kyowa Kirin to acquire Orchard Therapeutics: Japanese drugmaker Kyowa Kirin is set to purchase Orchard Therapeutics, a Britain-based biopharmaceutical firm, for US$ 477.6 million to advance the development of new drugs.

Bayer opens first cell therapy launch facility in California

Bayer has inaugurated its first cell therapy launch facility in Berkeley, California, aimed at providing cell therapies to a global patient population. Bayer has invested US$ 250 million in the 100,000 square feet facility that will supply materials needed for late-stage clinical trials.

FDA okays Novartis’ intravenous Cosentyx for treating rheumatic diseases

FDA has approved Novartis’ intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The IV formulation of Cosentyx offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring.

Merck posts positive data for Keytruda in NSCLC: Merck has reported positive late-stage trial results for its cancer therapy, Keytruda. In this trial, Keytruda is the first to demonstrate improved overall survival when used as a neo-adjuvant and adjuvant treatment, compared to pre-operative chemotherapy, for patients with non-small cell lung cancer (NSCLC).

FDA warns online vendors to stop selling unapproved weight-loss drugs

FDA has issued warning letters to two online sellers, instructing them to discontinue the sale of unapproved versions of semaglutide and tirzepatide, the APIs found in popular medications such as Novo’s weight-loss drug Wegovy and Eli Lilly’s diabetes med Mounjaro. In the letters addressed to Semaspace and Gorilla Healing, FDA has emphasized that the only approved semaglutide products are Ozempic and Rybelsus, while tirzepatide is only approved for the treatment of diabetes. The agency said these vendors were in violation of the US law as they were selling these drugs without confirming that customers had prescriptions from licensed healthcare professionals. Meanwhile, Germany’s federal drug regulator has urged pharmacies and drug distributors to be vigilant after wholesale batches of counterfeit versions of Ozempic were found in the country.

Wegovy shows higher stomach complications in study: A study published in the JAMA medical journal suggests that medications in the same category as Novo Nordisk’s popular weight-loss treatment Wegovy may pose a higher risk of pancreatitis, intestinal blockage, and stomach paralysis when compared to an older obesity drug, Contrave by Orexigen Therapeutics. The drugs within this category, known as GLP-1 inhibitors, include semaglutide (active ingredient in Wegovy, Ozempic, and Rybelsus) and liraglutide (active ingredient in Saxenda, and Victoza).

Novo halts Ozempic kidney trial after early gains: Novo Nordisk has announced its decision to stop the trial evaluating Ozempic to treat kidney failure in diabetes patients. The decision follows a recommendation of an independent committee that said the results from an interim analysis have met certain pre-specified criteria for stopping the trial early for efficacy.

Alnylam abandons heart-disease drug’s expanded use plea after FDA rejection

FDA has issued a complete response letter (CRL) to Alnylam Pharmaceuticals’ supplemental New Drug Application (sNDA) for Onpattro (patisiran) for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis, a potentially fatal disease of the heart muscle. The agency said Onpattro didn't lead to significant improvements in patients with the condition. Post the CRL, Alnylam has said it will no longer pursue an expanded indication for patisiran in the US.

FDA issues Form 483 to Spectrum Lab with 14 observations: FDA has issued a Form 483 to American API maker Spectrum Labs with 14 observations that range from issues such as dirty packing rooms to incomplete lab control records. The Form 483 was issued after the agency carried out inspections at three facilities of Spectrum in New Brunswick, New Jersey, earlier this year. Overall, FDA has carried out seven inspections across the three sites of Spectrum.

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MARKET INTEL by PharmaCompass

BMS to acquire Mirati for up to US$ 5.8 billion for its promising oncology pipeline

Bayer opens first cell therapy launch facility in California

FDA okays Novartis’ intravenous Cosentyx for treating rheumatic diseases

FDA warns online vendors to stop selling unapproved weight-loss drugs

Alnylam abandons heart-disease drug’s expanded use plea after FDA rejection