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Pfizer’s ulcerative colitis drug bags FDA nod; Novo to buy BP med for US$ 1.3 billion
This week’s Phispers has news on several drug approvals — the US Food and Drug Administration (FDA) approved Pfizer’s Velsipity for adults with ulcerative colitis, granted expanded approval to Merck’s Keytruda for early-stage lung cancer, and approved UCB’s plaque psoriasis treatment. Ardelyx’s Xphozah, a drug that treats high phosphate levels in patients with chronic kidney disease (CKD), was also approved by the agency.
In deals, Novo Nordisk acquired ocedurenone, an experimental (oral) treatment for uncontrolled hypertension with potential applications in cardiovascular and kidney disease, from KBP Biosciences for US$ 1.3 billion. Thermo Fisher said it will acquire proteomics solutions provider Olink Holding for up to US$ 3.1 billion. And Gilead Sciences entered into a 12-year partnership with biotech firm Assembly Biosciences to advance research and development of novel antiviral therapies.
Pfizer has significantly lowered its full-year revenue forecast for 2023, and has also announced cost-cutting measures such as layoffs and expense cuts that will help save US$ 3.5 billion.
In regulatory news, FDA has issued Form 483 to Panacea Biotec’s Baddi facility in India with nine observations. The agency has also issued a Form 483 with six observations to Samsung Biologics’ manufacturing plant in Korea.
Pfizer’s ulcerative colitis drug — Velsipity — receives FDA approval
FDA has approved Pfizer’s drug, Velsipity (etrasimod) to treat adults with moderate to severe ulcerative colitis, an inflammatory bowel disease. The decision was based on data from a late-stage study that showed a reduction in disease symptoms for patients who took the drug, when compared to a placebo. Pfizer had acquired Velsipity as the key asset in its US$ 6.7 billion buyout of Arena Pharmaceuticals last year. Pfizer has initiated worldwide regulatory filing for the drug, with market authorization anticipated by European Medicines Agency (EMA) in early 2024.
Cuts revenue forecast, plans cost cuts: Pfizer has significantly reduced its full-year revenue forecast, owing to lower-than-expected sales of its Covid-19 products. The drug behemoth has revised its 2023 revenue expectations to a range of US$ 58 billion to US$ 61 billion, a substantial reduction from its previous forecast of US$ 67 billion to US$ 70 billion. The company also plans to save US$ 3.5 billion through job cuts and cost reductions.
Merck’s Keytruda bags FDA nod in sixth non-small cell lung cancer indication
Merck’s blockbuster oncology med Keytruda has received FDA approval to treat patients with resectable non-small cell lung cancer (NSCLC), an earlier stage lung cancer. It is to be used in combination with platinum-containing chemotherapy as a neoadjuvant treatment (a treatment given before the main therapy), and then continued as a single agent adjuvant treatment after surgery. With this approval, Keytruda now has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
UCB secures FDA nod for its plaque psoriasis treatment: UCB’s treatment for plaque psoriasis— Bimzelx (bimekizumab) — has obtained FDA approval. Bimekizumab is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F), a company statement said. UCB expects to rake in €4 billion (US$ 4.2 billion) from global peak sales of Bimzelx.
FDA approves Ardelyx’s kidney disease-related drug: FDA has approved Ardelyx’s drug Xphozah (tenapanor) making it the first and only phosphate absorption inhibitor to treat high phosphate levels in patients with chronic kidney disease (CKD). The company plans to make the drug available in the United States in November. FDA had declined to approve Xphozah in 2021, citing unclear treatment benefits.
Novo to buy hypertension med from KBP Biosciences for US$ 1.3 billion
Novo Nordisk has acquired ocedurenone, an oral treatment in late-stage trial, for uncontrolled hypertension with potential applications in cardiovascular and kidney disease, from KBP Biosciences for up to US$ 1.3 billion. This deal is aligned with Novo’s strategic focus on expanding from its “core in diabetes into other serious chronic diseases, including through novel drug modalities,” Novo said in a statement.
The Danish drugmaker anticipates sales growth for the year to be in the range of 32 and 38 percent, up from its earlier estimate of 27 to 33 percent.
Meanwhile, the drug regulator in Europe has warned about pre-filled pens falsely labelled as Novo Nordisk’s Ozempic (a popular diabetes drug) at wholesalers in the European Union and the UK.
Thermo Fisher to buy Olink for US$ 3.1 billion: Thermo Fisher Scientific will acquire proteomics solutions provider Olink Holding for US$ 3.1 billion. Olink provides a platform of products and services that are deployed across major pharma companies and leading clinical and academic institutions to deepen the understanding of real-time human biology.
Gilead inks deal with Assembly Bio: Gilead Sciences has entered into a 12-year partnership with biotech firm Assembly Biosciences. The collaboration is aimed at advancing the research and development of novel antiviral therapies, with an initial focus in Assembly Bio’s established areas of herpesviruses, hepatitis B virus and hepatitis D virus. Gilead is paying US$ 100 million upfront to gain rights to Assembly Bio’s current and future programs.
Lilly’s experimental bowel disease drug shows promise in late-stage study
Eli Lilly’s experimental drug, mirikizumab, successfully achieved the primary goals in a late-stage trial evaluating its effectiveness as a treatment for individuals with moderate to severe Crohn’s disease, a condition characterized by inflammation in the digestive tract. Lilly plans to file for approval next year.
Meanwhile, AstraZeneca’s experimental drug datopotamab deruxtecan posted disappointing results in a late-stage lung cancer trial, which led to a four percent drop in its shares.
FDA issues Form 483 to Panacea Biotec, Samsung Biologics
FDA has issued a Form 483 with nine inspectional observations to Panacea Biotec’s subsidiary, Panacea Biotec Pharma Limited. The Form 483 was issued post inspection of its biologics plant in Baddi (India) from October 3 to 12. The nine observations, according to the company, pertained to “improvements in existing procedures and are addressable”.
The agency also issued a Form 483 with six inspectional observations to Samsung Biologics’ manufacturing facility in Korea after conducting inspections from August 21 to 25, August 28 to 31 and on September 1. The six observations were related to deficiencies in manufacturing processes, FDA said.
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