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Novavax’s Covid vaccine shows 96 percent efficacy; GSK-Merck’s US$ 4.2 billion cancer drug flops again
This week, Phispers brings you news on Novavax’s Covid-19 vaccine that has proven to be 96 percent effective in preventing the disease caused by the original strain of the virus in a late-stage trial conducted in the UK. The jab was 86 percent effective in protecting against the UK variant and 55 percent effective against the South African mutation of the virus.
After showing positive data in January, Eli Lilly’s Alzheimer’s drug — donanemab — has shown some downsides in the full-data from the phase 2 clinical trial. It has shown a slight win on one disease scale but has got undermined by a failure on a more widely used measure of Alzheimer’s disease.
Gilead and Merck announced an agreement to jointly develop the combination of two experimental medicines that they have so far been researching separately, in the hope to provide a meaningful treatment option to patients with HIV.
ANI Pharmaceuticals has agreed to buy niche generics drugmaker Novitium for US$ 210 million, in a bid to expand both its generic drug and CDMO businesses.
And GSK and Merck’s oncology drug bintrafusp alfa faced yet another setback, as it failed in second-line treatment of patients with locally advanced or metastatic biliary tract cancer.
Novavax boasts of 96% efficacy; protects against severe Covid-19 disease
American drugmaker Novavax Inc’s Covid-19 vaccine has proven to be 96 percent effective in preventing cases caused by the original variant of the novel coronavirus in a late-stage trial conducted in the United Kingdom. These efficacy results take the vaccine a step closer to regulatory approval.
According to the company, there were no cases of severe illness or deaths among those who got the vaccine. This is also a sign the vaccine could stop the worse effects of new variants that have cropped up. The jab was 86 percent effective in protecting against the more contagious UK variant of the virus. Based on data from infections of both versions of the coronavirus, the combined efficacy rate stood at 90 percent.
However, things didn’t look as good when it came to the more contagious and widely circulating South African variant of the coronavirus. In a smaller trial conducted in South Africa, where volunteers were primarily exposed to this newer variant, the Novavax vaccine was 55 percent effective. This finding is based on people without HIV. The vaccine still fully prevented severe illness. Novavax’s Chief Medical Officer, Filip Dubovsky said the performance in the African country suggests there may still be a case for using it in areas where the South African variant is dominant.
Novavax hopes to use this data to submit for regulatory authorization in various countries. However, it is not sure when it will seek emergency use authorization in the US, or if regulators will require it to complete an ongoing trial in the United States. Dubovsky said Novavax is planning to file for EUA from UK regulators sometime soon.
Novavax is also developing new formulations of this vaccine to protect against emerging variants. The company plans to initiate clinical testing of these shots in the second quarter of this year.
Lilly’s Alzheimer’s drug shows mixed results; its bowel disease treatment succeeds in late-stage trial
In January this year, we had carried news that Eli Lilly’s Alzheimer’s drug — donanemab — had shown positive result in a small, two-year study. Donanemab is an investigational antibody that targets a modified form of beta amyloid. The trial, known as Phase 2 Trailblazer ALZ study, was conducted on patients with early symptoms of Alzheimer’s disease.
However, this week, there is news that full data from its phase 2 clinical trial is a mixed bag, with a slight win on one disease scale but was undermined by a failure on a more widely used measure of Alzheimer’s disease.
Full data from the 257-subject clinical trial, published in The New England Journal of Medicine, show patients on donanemab experienced a 6.86 decline in scores on the Integrated Alzheimer’s Disease Rating Scale (iADRS). Scores in the placebo group fell 10.06. Lower iADRS scores indicate greater cognitive and functional impairment.
In Phase 2, Lilly found donanemab had no statistically significant effect on CDR-SB over placebo. The results, therefore, are a mixed bag. While it succeeds on iADRS, failure on the well-understood CDR-SB complicates efforts to understand what the apparent effects of donanemab mean in practical terms for patients.
Eli Lilly understands that more testing is needed to validate the drug’s benefit, and is running a second, 500-subject phase 2 clinical trial that uses change in CDR-SB as the primary goal, with iADRS serving as a secondary endpoint.
Lilly’s bowel disease treatment: There was more news from Eli Lilly this week. The drugmaker said its experimental treatment for an inflammatory bowel disease succeeded in a late-stage trial. According to a Reuters news report, the 12-week study was testing the efficacy and safety of mirikizumab in patients with moderate to severe ulcerative colitis, a chronic inflammatory disease of the colon that leads to ulcers causing abdominal pain, bloody stools and incontinence. Mirikizumab met the main goal of reducing colon inflammation and frequency of stools in patients compared to placebo.
Gilead, Merck agree to pair two of their experimental HIV drugs for better treatment options
Gilead and Merck & Co have announced an agreement to jointly develop the combination of two experimental medicines that they have so far been researching separately. This way, the two drugmakers hope to provide a long-lasting and meaningful treatment option to patients with HIV.
Both the drugs being developed by the two drugmakers are in late-stage development. The two-drug regimen will bring together Gilead’s lenacapavir (a capsid inhibitor) and Merck's islatravir (a nucleoside reverse transcriptase translocation inhibitor).
While daily, single-tablet regimens are already available for patients with HIV, “options that would allow for less frequent oral dosing, or infrequent injections rather than daily dosing, have the potential to address preference considerations, as well as issues associated with adherence and privacy,” the two companies said.
According to Gilead and Merck, both lenacapavir and islatravir have demonstrated activity at low dosages in clinical testing, which supports investigating them together as long-acting oral and injectable formulations. The first clinical studies of the oral combination are slated to begin in the second half of this year. Gilead’s CEO, Daniel O’Day has said a product could be approved as early as 2025. The partners indicated they may also explore other formulations down the line.
Under the agreement, while Gilead will bear 60 percent of the development and commercialization costs, Merck will supply the other 40 percent across the oral and injectable formulation programs. The companies will also split marketing responsibilities, and share global product revenues equally until certain tiers are hit.
ANI Pharma to buy niche generics maker Novitium for US$ 210 million
American drugmaker ANI Pharmaceuticals has agreed to buy niche generics maker Novitium Pharma for US$ 210 million, and the deal is expected to close in the second half of 2021. Novitium Pharma is a privately held, New Jersey-based drug company with development, manufacturing, and commercialization capabilities.
ANI Pharma will purchase Novitium at a price of US$ 163.5 million upfront, including US$ 89.5 million in cash plus US$ 74 million in equity. The deal also features potential future cash payments of up to US$ 46.5 million, the company said.
With this deal, ANI Pharma has hit two birds with one stone — this buyout will bolster ANI’s portfolio of generic drugs, while also growing its CDMO business. Over the last decade or so, ANI Pharmaceuticals has been steadily growing its generics business, and has also been working on expanding its CDMO business.
ANI will take over operations at Novitium’s 50,000-square-foot manufacturing plant in East Windsor, New Jersey, where the latter is in the midst of a 20,000-square-foot expansion. The upgrade will add another 18 manufacturing suites to the 27 currently running there, the companies said. Novitium’s East Windsor site also houses eight clinical suites for R&D. Novitium will fold nine existing customers into ANI’s own CDMO business.
GSK, German Merck’s US$ 4.2 billion oncology drug flops yet again
Two months after GlaxoSmithKline and Merck KGaA’s oncology drug bintrafusp alfa failed to beat Merck’s blockbuster Keytruda in certain lung cancers, the drug now has to contend with yet another disappointment. The drug failed in second-line patients with locally advanced or metastatic biliary tract cancer.
Back in 2019, GSK had signed a US$ 4.2 billion deal with Merck KGaA and the drug bintrafusp alfa — a bifunctional fusion protein immunotherapy — was at the center of this deal. It had failed a mid-stage test that the two companies had undertaken to treat 159 second-line patients with locally advanced or metastatic biliary tract cancer (BTC).
An independent review showed it had an objective response rate (ORR) of just 10.1 percent , with efficacy hitting below a predefined threshold. However, Merck is not giving up just yet. An ongoing phase 2/3 study of bintrafusp alfa with chemo as a first-line treatment for BTC “is assessing a different hypothesis than the second-line monotherapy study,” according to a statement.
Despite the second-line flop, Merck says it saw single-agent activity in a tough area. Even though it had a small ORR, this was better than what others had achieved.
Despite Merck’s optimism, the consecutive flops have raised major issues for GSK, which is struggling to fulfill its R&D chief Hal Barron’s vision of making oncology the big new focus area in its pipeline. GSK had paid US$ 360 million upfront more than two years ago to team up with Merck on bintrafusp alfa.
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