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US, UK okay Lilly’s Mounjaro for weight loss; FTC questions over 100 Orange Book patents
The US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have approved Eli Lilly’s Mounjaro (tirzepatide) for weight management. It will be sold under the brand name Zepbound for this indication.
FDA has also approved Takeda’s Fruzaqla (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer who have previously undergone treatment. And Phathom Pharma’s Voquezna (vonoprazan) has been approved by the agency for treating erosive gastroesophageal reflux disease (GERD).
The US Federal Trade Commission (FTC) has challenged over 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine auto-injectors, and other drug products as improperly or inaccurately listed in FDA’s Orange Book.
In deals, Bristol Myers Squibb has acquired Orum Therapeutics’ experimental treatment for acute myeloid leukemia, a type of blood cancer. Atara Biotherapeutics has expanded its global partnership with Pierre Fabre Laboratories to commercialize its T-cell therapy for a rare form of blood cancer.
BioNTech has revised its 2023 revenue projection, reducing it by approximately € 1 billion (US$ 1.1 billion) due to decreased demand for Cominarty, its Covid-19 vaccine developed along with Pfizer. Sage Therapeutics and Biogen have set the price of their oral postpartum depression (PPD) pill, Zurzuvae, at US$ 15,900 for a complete 14-day treatment course.
US, UK approve Lilly’s Mounjaro for weight management; to be sold as Zepbound
Drug regulators in the United States and United Kingdom have approved Eli Lilly's Mounjaro for weight management. It has been christened Zepbound (tirzepatide) for this indication. The drug will pose strong competition to Novo Nordisk’s Wegovy.
Mounjaro has been available in the market as a cure for type 2 diabetes since 2022. Zepbound will be available in the US market later this month.
These two drugs are the best for weight loss so far and will compete in a market that's expected to reach US$ 100 billion by the end of the decade. According to Lilly, Zepbound will list at a price of US$ 1,059.87 for a month’s supply, compared to a list price of US$ 1,349 for Novo’s Wegovy.
Novo to discontinue Levemir insulin in US: Novo Nordisk will discontinue its long-acting insulin Levemir in the US, due to manufacturing constraints, reduced patient access and availability of alternatives. The company said supply disruptions would start in mid-January, followed by discontinuation of the Levemir injection pen in April and of Levemir vials by 2024-end.
FDA okays Takeda’s Fruzaqla for previously-treated metastatic colorectal cancer
FDA has approved Japanese drugmaker Takeda’s Fruzaqla (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer who have been previously treated. The approval was received under priority review more than 20 days ahead of the scheduled PDUFA date of November 30, 2023. The approval of Fruzaqla is based on data from two large phase 3 trials.
Approves Phathom’s Voquezna for erosive GERD: Phathom Pharma’s Voquezna (vonoprazan) has obtained FDA approval for treating erosive GERD and relieving associated heartburn in adults, marking the first significant innovation in the US erosive GERD market to gain FDA approval in over 30 years. Voquezna successfully achieved the primary and important secondary goals in the crucial late-stage trial, comparing Voquezna to a standard proton pump inhibitor (PPI). FDA has also approved a reformulated version of Voquezna to treat H. pylori infection. The company will make the drug available in the US by the year-end.
FTC challenges over 100 Orange Book patents; letters sent to 10 drugmakers
In the US, the Federal Trade Commission (FTC) has challenged over 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” popularly known as the “Orange Book.”
The Orange Book identifies drugs and products that the FDA has deemed safe and effective. FTC has notified FDA that it disputes the accuracy or relevance of the listed information for these patents. The drugmakers have been given 30 days to either withdraw or amend their patent listings or ‘certify under penalty of perjury’ that the patents are proper.
The commission has sent letters to 10 companies that include AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty (part of Viatris), and subsidiaries of GSK and Teva. Medications like AbbVie’s Restasis and Viatris’ EpiPen autoinjector are part of the targeted drugs. In the letter addressed to Teva, the FTC has said it was challenging 35 patents related to its inhalers.
Pfizer lays off staff, BioNTech cuts 2023 revenue target due to lower Covid sales
BioNTech has revised its 2023 revenue projection, reducing it by approximately € 1 billion (US$ 1.1 billion) due to decreased demand for Comirnaty, its Covid-19 vaccine developed along with Pfizer. The biotech adjusted its full-year Covid-19 vaccine revenue forecast to around € 4 billion (US$ 4.28 billion), down from the previously anticipated € 5 billion (US$ 5.35 billion), in sharp contrast to the sales of € 17.2 billion (US$ 18.4 billion) reported last year.
Meanwhile, Pfizer has announced 100 job cuts at its Irish plant in Newbridge, Kildare. The affected employees were involved in producing Pfizer’s Covid-19 antiviral, Paxlovid. The company has also downsized about 200 positions at its Kalamazoo, Michigan site after evaluating the demand for Comirnaty and Paxlovid.
BMS acquires Orum’s blood cancer treatment: Bristol Myers Squibb has acquired Orum Therapeutics’ experimental treatment for acute myeloid leukemia, a type of blood cancer, for a total deal value of US$ 180 million.
Atara expands T-cell partnership with Pierre Fabre: Atara Biotherapeutics has expanded its global partnership with Pierre Fabre Laboratories for US$ 30 million upfront and up to US$ 640 million in milestone payments to commercialize its T-cell therapy tabelecleucel (or Ebvallo) for a rare form of blood cancer.
Meanwhile, Sage Therapeutics and Biogen have set the price of their oral postpartum depression (PPD) pill, Zurzuvae, at US$ 15,900 for a complete 14-day treatment course.
Combo therapy for GI cancers: Gilead Sciences and Arcus Biosciences have shared promising mid-stage study outcomes for their upper gastrointestinal cancer therapy. The preliminary analysis of domvanalimab, along with zimberelimab and chemotherapy, demonstrated positive overall response rates and encouraging six-month progression-free survival rates.
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