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GlaxoSmithKline (GSK) has had a bad week: a failed phase 3 clinical trial of the two-functional immunotherapy bintrafusp alfa first-line treatment for lung cancer, and another promising oncology drug, anti-PD-1 therapy dostarlimab, unexpectedly delayed screening.
but some pharmaceutical analysts worry that these problems may be more than a short-term flash in the pan.
even questioned GSK's trading capabilities and questioned the company's outlook.
Porges, an analyst at SVB Leerink, even said GSK's five-year roadmap may be in jeopardy.
last week's J.P. Morgan medical conference, GSK's chief scientific officer, Dr. Hal Barron, presented a roadmap: a commitment to launch more than a decade of potentially heavy-duty drugs by 2026, including bintrafusp alfa and dostarlimab.
SK's outlook for the future is attractive, these continued disappointments are becoming a major concern for GSK's medium- and long-term prospects," Mr. Porgeges said in a note to investors.
three years ago, Emma Walmsley, GSK's chief executive, initiated major changes, including a consumer joint venture with Pfizer, which is being spinned off into a separate company, and increased investment in its pharmaceutical portfolio.
investment is a 300 million euro, $4.6 billion deal with Merck in 2019 to develop bintrafusp alfa.
The drug is a pioneering dual-functional immunotherapy that combines the TGF-β trap and anti-PF-L1 mechanism in a fusion protein, with the aim of binding common local blocking of two immunosuppressive pathways, while targeting these two pathways to control tumor growth through potential recovery and enhancement of the anti-tumor response.
, the drug is being developed to treat a variety of incurable types of tumors.
recently, the key phase 3 of bintrafusp alfa's treatment of lung cancer INTR@PID failed the Lung 037 study.
the study is evaluating patients with highly expressed stage IV non-small cell lung cancer (NSCLC) in the first-line treatment of bintrafusp alfa, in direct comparison with the Mercadon anti-PD-1 therapy Keytruda.
independent monitoring committee, after reviewing all the data, told GSK and Merck that the study was unlikely to reach the common primary endpoint of progress-free lifetime (PFS) and recommended that the trials be discontinued.
based on this recommendation, the two sides decided to terminate the study.
Porges noted in the report that trials of bintrafusp alfa for bile tube and cervical cancer are still ongoing, but the recent disappointment of a small trial in MSI's high tumor casts doubt on the future of the drug.
although the history of the 'New GlaxoSmithKline' is not long, so far the company's capital allocation process and results have not inspired confidence.
, on the other hand, had hoped that the FDA would be able to review another near-term cancer drug, dostarlimab, by the end of last year.
the company said earlier this week that coVID-19 travel restrictions prevented FDA inspections of drug factories and that no inspections had been scheduled.
company still expects the FDA to approve dostarimab for the treatment of microsatellite high instability (MSI-H) endometrial cancer, and a decision will be made in the first half of this year.
vaccine is another key growth area for GSK, with 16 vaccines under development.
but there are some minor problems.
sales of Shingrix, the company's much-watched shingles vaccine, fell 25 percent in the third quarter of last year as people delayed vaccinations because of a blockade of the COVID-19 pandemic.
of all GSK businesses, vaccine sales fell the most.
analysts at Credit Suisse predict Shingrix will face another obstacle in the short term: the U.S. Centers for Disease Control (CDC) has issued guidance recommending that coVID-19 vaccines should not be used with other vaccines.
a report to investors, Credit Suisse said it would "significantly limit" Shingrix's sales in the first half of 2021.
note that Evaluate Pharma, a pharmaceutical market research organization, recently released a list of the biggest winners and losers in the stock market in the 2020 COVID-19 outbreak.
, GSK was the top TOP loser among the big pharmaceutical companies, with stock prices down 25 percent in 2020 and a market value loss of $24.9 billion.