Pfizer has terminated one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates as the race heats up to market the first oral weight loss drug. The loss of lotiglipron means Pfizer will rest its hopes on its other candidate danuglipron to take on Novo Nordisk and Eli Lilly for the first marketed weight loss pill. The market responded accordingly to Pfizer’s announcement about shelving the program, with shares in the company opening 3% lower on Monday morning compared to pre-announcement market close (23 June). The decision to scrap lotiglipron was due to elevated levels of transaminases seen in two Phase I studies and a currently ongoing Phase II study. Pfizer said no liver-related symptoms or side effects were observed and added that the increase in transaminase levels has not been seen in any of its danuglipron trials. Pfizer has already published results for danuglipron in the Journal of the American ...
Samsung Biologics has announced a strategic collaboration with Pfizer for the long-term commercial manufacturing of the latter’s multi-product biosimilars portfolio. Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more capacity for manufacturing for the biosimilars portfolio. The portfolio will cover inflammation, oncology and immunology. Samsung will use its new facility, Plant 4, for the products manufacturing. Samsung Biologics president and CEO John Rim said: “We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with ...
South Korea’s Samsung Biologics has captured a $411 million contract to manufacture biosimilars for pharma giant Pfizer.Under the deal, Samsung has pledged “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.” The company described the deal as a “long-term” arrangement. Pfizer’s biosimilar portfolio features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen. The Samsung partnership will likely also include production of Pfizer’s biosimilar to AbbVie’s Humira, The Korea Herald reports, citing industry experts. AbbVie recorded $21.24 billion in sales of Humira last year. Amgen is already marketing a Humira copycat, but Pfizer and many other players are set to enter the market this year. In a financial filing, Samsung Biologics put the value of the Pfizer deal at $411 million, making it the biggest of its nature for the company and ...
David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
By Tristan Manalac Pictured: Scales of justice/Kanizphoto, iStock Tuesday, New York-based Promosome filed separate lawsuits against Moderna and Pfizer, accusing both companies of violating patent protections related to mRNA technology, according to a report by Reuters. In the filings submitted to the Southern District Court of California, Promosome claims that in 2009 company-affiliated scientists “discovered a method for increasing protein expression by making small changes to the mRNA that could affect the amount of protein produced without altering the amino acid sequence encoded by the mRNA.” This method is protected by U.S. Patent No. 8,853,179, also known as the ’179 Patent. Promosome scientists, including Nobel laureate Gerald Edelman, gave the company exclusive license to the ’179 Patent. Promosome eventually disclosed the protected technology to Moderna—which ultimately declined to license it—and to Katalin Karikó, who served as senior vice president and top mRNA scientist at BioNTech at the time of the ...
Pfizer has announced positive phase 3 results supporting the safety and efficacy of its investigational antibiotic combination, aztreonam-avibactam (ATM-AVI), in treating serious infections caused by multi-drug resistant, gram-negative bacteria. Declared by the World Health Organization as one of the top ten threats to global health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases. Pfizer’s late-stage programme included a study which compared ATM-AVI and metronidazole with two older antibiotics – meropenem and colistin – for the treatment of complicated intra-abdominal infections, hospital-acquired pneumonia and ventilator-associated pneumonia. For patients with complicated intra-abdominal infections, the cure rate was 76.4% in the ATM-AVI plus metronidazole treatment group, versus 74% in the meropenem and colistin cohort. Additionally, for patients with hospital-acquired pneumonia and ventilator‐associated pneumonia, the cure rate ...
About a month after GSK won the world’s first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should ACIP members put their support behind the vaccine. The FDA approved Abrysvo based on data from a phase 3 trial called RENOIR, which enrolled about 37,000 participants. In the study, the vaccine achieved 66.7% protection against RSV-associated lower ...
Alnylam Pharmaceuticals isn’t letting up with its COVID-19 vaccine patent allegations. Late last week, the company filed its third set of lawsuits against the two largest manufacturers of coronavirus vaccines. Once again, RNA specialist Alnylam is accusing Pfizer and Moderna of violating its lipid particle delivery technology with their lucrative COVID-19 vaccines. Specifically, Alnylam claims that Pfizer stepped on four of its patents and that Moderna infringed three. With the lawsuits, it’s seeking a “reasonable royalty” for the alleged damages. The new suits come after Alnylam originally sued the two last March, arguing that it invented the delivery tech utilized by the vaccines more than a decade ago. Then, in July, the biotech followed up with new claims. Earlier this month, Moderna hit back against the claims in a set of countersuits, alleging that Alnylam “baselessly seeks to profit” from its inventions. Moderna pointed out that the company “based its ...
With demand plummeting for COVID-19 vaccinations, the EU has cut a deal with Pfizer and BioNTech to alter their contract, reducing purchases of the companies’ Comirnaty vaccine by roughly 35%, EU sources told Bloomberg. The companies provided little information on the adjusted contract, calling it a “rephrasing of delivery doses annually through 2026,” in a release. “The agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States,” the companies wrote. “The EC [European Commission] will maintain access to future adapted COVID-19 vaccines and the ability to donate doses.” Some member states opted out of the deal, according to a statement from the EU. Meanwhile, the world’s other premier producer of COVID-19 vaccines, Moderna, is looking to advance sales of its mRNA shot in China, as it has established a unit called Moderna Biotech Ltd. in Shanghai, Reuters reports. Moderna CEO Stephane Bancel visited Shanghai last month, according ...
Nicole DeFeudis Editor The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.” The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third. Some member states have opted out of the amendment, and “will continue to be bound by current contractual obligations,” the Commission said. The news comes weeks after the World Health Organization ended its three-year global health emergency for Covid-19, while warning that “the virus is ...
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