GSK Cuts Flu and Pneumonia Vaccines After Disappointing Data
Buried deep in GlaxoSmithKline’s quarterly report was an announcement that the global pharma giant cut the development of two vaccine programs – one for strep pneumonia and the other for a universal flu vaccine.
In its announcement, GSK said the decision to cut the two programs were made following an analysis of available research results, including interim data from an ongoing Phase I study of the flu vaccine. GSK said it remains committed to further research in flu including pursuing other approaches.
During a call with analysts, Roger Connor, president of global vaccines at GSK, stressed that the removal was not a cause for alarm, particularly as the company’s shingles vaccine continues to generate significant revenue. Connor said the two candidates that were scrapped were not priority vaccine candidates for GSK. The universal flu assets, which was a partnered asset in Phase I and II, was stopped following an interim data analysis.
“Just to emphasize, we’re still very much committed to flu development, and we are looking at the early stages of our pipeline looking at alternative approaches in the universal flu space. Just for your information, the other asset that we stopped was a next-generation option for prevention of pneumococcal disease. We are looking at new technologies there, again, not viable to go forward. Again, these are not priority assets for us and really allow us to stay focused on our priority assets in our pipeline,” Connor said, according to transcripts of the call.
Connor went on to point to GSK’s RSV portfolio, which he said he was excited about. The company currently has three different vaccines in development for RSV, he said. Connor said that as he looks at the RSV vaccines, he sees “a real potential for first and best-in-class vaccines within that portfolio.” RSV is the most common cause of viral pneumonia in young children, which is the leading cause of death in children under the age of five worldwide. In the United States, RSV is the leading cause of hospitalization of infants, with an estimated number of annual cases of about 76,000.
Connor noted that the RSV vaccine candidates for older adults and maternal use have both received a Fast Track designation from the U.S. Food and Drug Administration. The older adult RSV vaccine uses the same adjuvant system as Shingrix, the company’s shingles vaccine, which generated $465 million in the first quarter.
GSK Chief Executive Officer Emma Walmsley said the company has seen strong growth in several of its products, most notably in vaccines with Shingrix.
“Strengthening our pipeline is critical to our long-term success and we’ve made good progress here too,” Walmsley said.
During the call with analysts, Walmsley said the pointed to the changes she brought to GSK when she assumed the helm two years ago, particularly in the areas of oncology. She said the company is generating data to support three upcoming oncology filings: BCMA in multiple myeloma; Zejula in the first-line maintenance therapy of ovarian cancer; and for dostarlimab in endometrial cancer. Additionally, Walmsley pointed to the fact that GSK closed its deals with Merck KGaA, Darmstadt, Germany and Tesaro in the quarter, which strengthens the company’s oncology pipeline. GSK and Merck will collaborate on the development and potential commercialization of M7824, an immunotherapy for difficult to treat cancers. In December GSK plunked down $5.1 billion for Tesaro Oncology, which brought Zejula, an oral, once-daily PARP inhibitor used as maintenance treatment for ovarian cancer, under its umbrella. Zejula has become a cornerstone of GSK’s oncology. The PARP inhibitor is approved in 35 countries globally. Luke Miels, Merck’s president of global pharmaceuticals, said during the call that PARPs remain an important option for ovarian cancer patients. Miel said the company continues to believe that the class is underappreciated. He noted there are several options for how PARP inhibitors can help additional patients, including those who are HRD-positive.
“We have made a strong start to 2019, which is an important year of execution for GSK,” Walmsley said.
BioSpace source:
https://www.biospace.com/article/gsk-cuts-flu-and-pneumonia-vaccines-following-disappointing-data
