Market Place
Trump admin wants to pull global supply chains out of China; FDA okays remdesivir for emergency use
This week, Phispers has news on remdesivir, Gilead’s investigational antiviral drug.
The USFDA has issued an emergency use authorization for the drug for treatment of Covid-19.
Gilead has said it plans to produce one million Remdesivir courses by December this year.
It is working with international partners to expand production.
Moderna has announced a 10-year strategic tie-up with Lonza for large-scale manufacturing of its mRNA vaccine against the novel coronavirus.
Generic antacid — famotidine — which is undergoing clinical trials for treating Covid-19 patients is facing shortages as consumers in the US are hoarding the drug.
The removal of ranitidine (another drug that reduces stomach acid) due to the presence of cancer-causing impurity NDMA has worsened famotidine’s shortage.
The University of California has identified 69 existing drugs and compounds that have a potential to treat Covid-19.
The Trump Administration in the US is creating an alliance of trusted partners to pull global supply chains out of China.
Alexion bought Portola for US$ 1.4 billion.
And, the mega-merger of AbbVie and Allergan moved a step closer with the FTC and an Irish court approving the deal.
Trump administration wants to pull global supply chains out of China
It’s becoming a heady mix of politics and the pandemic. With the US Presidential elections due on November 3, the US President Donald Trump has stepped up his attacks on China. For long, he has pledged to bring manufacturing back from overseas.
The economic destruction and the US coronavirus death toll are driving this push to move US production and supply chain dependency away from China.
Trump has said repeatedly that he could put new tariffs on top of the up to 25 percent tax on US$ 370 billion in Chinese goods currently in place. According to United Nations data, China overtook the US as the world’s top manufacturing country in 2010, and was responsible for 28 percent of global output in 2018.
Covid-19 has woken up regulators and world leaders on how much the world depends on China. Janet Woodcock, director of the US Food and Drug Administration’s Center for Drug Evaluation and Research, told a House of Representatives subcommittee on health in October that the number of facilities in China supplying active pharmaceutical ingredients (APIs) had more than doubled since 2010 to 13 percent of all those serving the US market.
Both the US and Europe are looking to rebalance their drug supply chain. In December, a delegation of the European Fine Chemicals Group (EFCG), an association representing API manufacturers, informed EC commissioners about measures needed to support the repatriation of pharmaceutical chemical production from China back to Europe.
The US is pushing to create an alliance of “trusted partners” dubbed the “Economic Prosperity Network.” The US government is working with Australia, India, Japan, New Zealand, South Korea and Vietnam to “move the global economy forward,” US Secretary of State Mike Pompeo said last week. Many American companies have invested heavily in China and also rely on China’s 1.4 billion population for the sales of their products.
FDA okays remdesivir for emergency use; Gilead to make one million treatment
courses by Dec
On May 1, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Gilead Sciences’ investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed Covid-19 in adults and children hospitalized with severe disease.
Severe disease is defined as patients with low blood oxygen levels, or those who need oxygen therapy or more intensive breathing support such as a mechanical ventilator.
The EUA comes two days after the National Institutes of Health’s clinical trial showed remdesivir accelerated recovery against Covid-19. Preliminary results from this study were announced last week.
The NIH study suggested a potential survival benefit associated with remdesivir, as patients taking the drug had a lower mortality rate than patients in the placebo arm (8 percent versus 11.6 percent), though the result was not statistically significant.
The issuance of an EUA is different from an FDA approval. “In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency,” an FDA statement said.
While this was happening, there were reports that the remdesivir study conducted by the National Institute of Allergy and Infectious Diseases had changed the main goal (original endpoint) just weeks before. Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, tweeted a screenshot of a record of the change on the US government’s online registry of clinical trials. However, as of now, the NIAID’s comments on the issue appear to imply that it isn’t contentious.
Meanwhile, on April 30, the European Medicines Agency (EMA) said it has started a “rolling review” of remdesivir. Under its rolling review procedure, EMA says the Committee for Medicinal Products for Human Use (CHMP) rapporteurs are assigned to the drug during its development to review data as it becomes available.
“While the overall review timeline for remdesivir cannot be anticipated at this moment, it is expected that this procedure will allow EMA to complete its assessment significantly earlier compared with a regular evaluation procedure,” EMA said, noting that several rolling review cycles may be carried out as data is generated.
EMA cautions that it is “too early to draw any conclusions regarding the benefit-risk balance of the medicine,” and notes that it has not yet evaluated the full study results.
Gilead to produce one million Remdesivir courses by December: Gilead has said it will work with international partners to expand production of remdesivir.
The company said it still expects to have more than one million remdesivir treatment courses manufactured by December, “with plans to be able to produce several million treatment courses in 2021.” The company expects to produce more than 140,000 rounds of its 10-day treatment regimen by the end of May.
Moderna announces 10-year strategic tie-up with Lonza
for manufacturing vaccines
Moderna Inc, a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Lonza Ltd have announced a 10-year strategic collaboration agreement to enable large-scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future.
On April 27, 2020, Moderna had announced it submitted an Investigational New Drug (IND) application to the FDA for Phase 2 and late stage studies of mRNA-1273 if supported by safety data from the Phase 1 study. Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020.
Under the terms of the agreement, the two companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza US in July 2020.
The goal of the collaboration is to enable manufacturing of up to 1 billion doses per year. “What Lonza provides us is a 10x scale-up from Norwood alone,” Moderna CEO Stéphane Bancel told Endpoints.
The collaboration leverages Lonza’s worldwide expertise in technology transfer and manufacturing.
A portion of the funding for the establishment of manufacturing operations at Lonza US is covered by Moderna’s contract with Biomedical Advanced Research and Development Authority (BARDA). The company received US$ 483 million from BARDA to accelerate the development of this vaccine.
Being
studied for Covid-19, famotidine faces shortages; ranitidine removal worsens it
Famotidine, a generic pill used to treat ulcers, acid reflux and heartburn has been added to FDA’s list of drug shortages.
On April 26, it was reported that in a clinical trial, critically ill Covid-19 patients at Northwell Health in the New York City area were receiving nine times the heartburn dose. Interim results from 391 patients could be known in “a few weeks,” according to a hospital researcher. Days later, the Washington Post reported that people had started “hoarding” the medicine.
Drugmakers including Teva Pharmaceutical Industries, Carlsbad Technology and Aurobindo Pharma have reported increased demand for famotidine, sold as Pepcid in branded form.
The famotidine shortage comes a month after FDA had requested removal of ranitidine as it had found levels of cancer-causing impurity N-nitrosodimethylamine (NDMA) in the drug increase over time. And when stored at higher room temperatures, it may result in consumer exposure to unacceptable levels of this impurity.
Late last month, the European Medicines Agency’s human medicines committee (CHMP) had also recommended the suspension of all ranitidine medicines in the EU due to the presence of low levels of NDMA.
Northwell kept the famotidine study under wraps to secure a research stockpile before other hospitals, or even the federal government, started buying it. “If we talked about this to the wrong people or too soon, the drug supply would be gone,” Kevin Tracey, a former neurosurgeon in charge of the hospital system’s research said.
As of last week, 187 Covid-19 patients in critical status, including many on ventilators, have been enrolled in the trial, which aims for a total of 1174 people.
Drugs being tested to treat Covid-19: All across the world, researchers and manufacturers are moving potential therapeutics into clinical trials at a rapid pace. Several large trials are examining potential Covid-19 therapeutic options in different treatment arms.
The World Health Organization has launched their own trial — Solidarity — evaluating various treatment candidates for Covid-19. More than 70 countries have joined the trial. Plasma and stem cells from patients who have recovered from Covid-19 are also being investigated.
Meanwhile, 69 existing drugs and compounds have been identified that have a potential to treat Covid-19.
In an article published in MarketWatch, Nevan Krogan, a professor and director of the Quantitative Biosciences Institute and senior investigator at the Gladstone Institutes at the University of California, San Francisco wrote: “Our multidisciplinary team of researchers at the University of California, San Francisco, called the QCRG, identified 69 existing drugs and compounds with potential to treat Covid-19. A month ago, we began shipping boxes of these drugs off to Institut Pasteur in Paris and Mount Sinai in New York to see if they do in fact fight the coronavirus.”
But there is a caveat — these are preliminary findings and have not been tested in people. “No one should go out and buy these drugs,” Krogan said.
Alexion buys rival Portola; FTC, Irish High Court clear AbbVie-Allergan deal
This week, drugmaker Alexion Pharmaceuticals Inc announced US$ 1.4 billion deal to buy rival Portola Pharmaceuticals Inc in order to gain access to a treatment for reversing the effects of blood thinners.
With this deal, Alexion gets Portola’s Factor Xa inhibitor reversal agent — Andexxa — that will mark a change in focus for Alexion. Andexxa was approved in the United States in 2018 and had brought in sales of US$ 111.5 million in 2019. The treatment reverses the effects of drugs Eliquis and Xarelto in cases of life-threatening or uncontrolled bleeding.
At present, Alexion’s treatment portfolio consists of drugs targeting the C5 protein, which makes up part of the immune system that can sometimes attack the body’s own healthy cells.
“The acquisition of Portola represents an important next step in our strategy to diversify beyond C5. Andexxa is a strategic fit with our existing portfolio of transformative medicines and is well-aligned with our demonstrated expertise in hematology, neurology and critical care,” said Alexion CEO Ludwig Hantson.
Alexion has been striving to maintain its leadership in treating certain rare blood disorders and has embarked on a string of acquisitions to boost its pipeline of rare disease drugs.
Last year, Alexion agreed to buy Achillion Pharmaceuticals Inc for US$ 930 million to gain access to its rare blood disorder treatments. Before that, it had bought Sweden’s Wilson Therapeutics for US$ 855 million and followed that up with the purchase of Syntimmune for a total value of up to US$ 1.2 billion.
AbbVie-Allergan merger: After waiting for nearly a year, AbbVie and Allergan finally bagged the approval of the Federal Trade Commission (FTC) in the US for their US$ 63 billion merger. And on Wednesday, the Irish High Court also cleared the merger.
The FTC approval came nearly two months after the deal passed scrutiny by the European regulator. According to a press statement issued by Allergan, the Irish High Court’s decision is subject to administrative obligations that are expected to be complete on May 8.
The delay happened due to pushback from consumer groups and tight scrutiny by regulators. As part of the agreement, AbbVie and Allergan will offload Allergan's late-stage gastrointestinal candidate brazikumab to AstraZeneca as well as two pancreatic replacement enzymes — Zenpep and Viokace — to Nestlé.
Once cleared, the merger will create the fourth-largest drugmaker in the world.
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