Emma Walmsley, chief executive officer of GlaxoSmithKline, is predicting a good year for her company, with the potential of six regulatory approvals in the United States.
Emma Walmsley, chief executive officer of GlaxoSmithKline, is predicting a good year for her company, with the potential of six regulatory approvals in the United States.
Walmsley made the prediction Monday at the J.P. Morgan Healthcare Conference during an interview with CNBC’s Jim Cramer. Walmsley, who has helped turn GlaxoSmithKline around over the past few years with an intense focus on pharmaceuticals, told Cramer on his Mad Money show that GSK has three priorities – innovation, performance and trust.
“I am pleased with the progress and the momentum that we’ve been able to make over the past couple of years,” she said, as she touted positive data for patients on a number of programs, including those gained with the $5.1 billion acquisition of Tesaro Oncology in late 2018. She also pointed to some positive data in multiple myeloma, as well as the two-drug regimens for HIV that GSK subsidiary ViiV Healthcare has been developing.
That Tesaro acquisition has begun to show dividends. In October, Zejula, the PARP inhibitor at the center of the deal, was approved for a new indication. The FDA expanded Zejula’s (niraparib) approved treatments to include previously treated patients with advanced ovarian, fallopian tube, or primary peritoneal cancer patients. Zejula was initially approved by the FDA in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
With all the positive data, Walmsley said she hopes that the clinical strengths of these drugs will lead to at least six approvals over this year. In December, the company submitted a Biologics License Application to the U.S. Food and Drug Administration for belantamab mafodotin in multiple myeloma, following positive Phase III results. As BioSpace reported, if the GSK drug is approved, it will go head-to-head against Johnson & Johnson and Genmab’s Darzalex, which in December showed that it decreased the risk of death or cancer getting worse by 37% in multiple myeloma patients.
The company is also looking at potential approval of a treatment for Hypereosinophilic Syndrome (HES), a rare group of inflammatory disorders. In November, GSK’s Nucala posted positive results in a Phase III trial. The drug demonstrated a statistically significant result with 50% fewer patients experiencing a HES flare, defined as a worsening of symptoms or eosinophil threshold requiring an escalation in therapy when added to standard of care and compared to placebo. GSK said the results mark Nucala as the first treatment to demonstrate a reduction in flares for this rare disease. Nucala, which targets the IL-5 pathway, was initially approved in 2015 by the FDA to treat patients age 12 years and older with severe asthma with an eosinophilic phenotype.
In HIV, ViiV, which is also partly owned by Pfizer and Shionogi Limited, has been driving forward in its research. However, in December the company saw a setback in its combination treatment of cabotegravir and rilpivirine for HIV-1 infection in virologically suppressed adults. The FDA issued a Complete Response Letter, raising concerns over “Chemistry Manufacturing and Controls.” GSK said it will work closely with the FDA to determine the appropriate next steps for this New Drug Application. ViiV won FDA approval for its first two-drug regimen, Juluca, in 2017.
The company, Walmsley told Cramer, has been “building confidence” in its ability to execute innovation. The company, Walmsley said, is “accelerating investment” in its research and development capabilities, but did not provide specifics as to how much money. In 2018, R&D head Hal Barron laid out the framework for the company’s long-term strategy that included a focus on oncology, the immune system and genetics.
