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WHO halts HCQ trials for Covid; Merck vs Merck: ‘Mercky’ saga continues; Akorn files for bankruptcy
This week, Phispers brings you updates on clinical trials for Covid-19 treatments and vaccines.
While the WHO halted trials of HCQ for the novel coronavirus due to safety concerns, clinical data on remdesivir suggested that the drug is superior to any other standard treatment being given to Covid-19 patients.
The first remdesivir generic was launched in Bangladesh, and India approved applications of Cipla and Hetero Labs to manufacture and sell remdesivir.
In vaccine development, China’s CanSino Biologics reported positive early data, and British drugmaker AstraZeneca received a US$ 1.2 billion commitment from the US government for its efforts to develop a vaccine.
The US has also pledged to buy at least 300 million doses of any vaccine that clears all tests by October.
Merck is also joining the race for a Covid-19 vaccine.
In non-Covid news, Sanofi is selling most of its long-held stake in American drugmaker Regeneron to create a war chest that will help it focus on reshaping its drug pipeline.
After losing to Merck US in 2016, Merck of Germany won a case against Merck US for the latter’s use of the name “Merck” in the UK. And after facing a series of problems, American drugmaker Akorn filed for bankruptcy.
WHO halts trials of HCQ for Covid after large study shows increased risk of death
After news of a study of over 96,000 Covid-19 patients published in The Lancet last week, there is word on malaria drug hydroxychloroquine (HCQ) from the World Health Organization (WHO). The agency has temporarily halted trials of HCQ as a possible treatment for coronavirus due to safety fears.
In the study, published in The Lancet, nearly 15,000 out of the 96,000 Covid-19 patients were given HCQ or a related form chloroquine, either alone or along with an antibiotic. The study found that these patients were more likely to die in hospital and develop heart rhythm complications than other Covid patients in a comparison group.
The study said: “We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for Covid-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of Covid-19.”
HCQ was part of WHO’s international clinical trial named ‘Solidarity’ announced in March to help find an effective treatment for Covid-19. Over 100 countries are participating in The Solidarity Trial, which compares four treatment options against standard of care, to assess their relative effectiveness in treating Covid-19. The drugs are — remdesivir, HCQ, lopinavir with ritonavir; and lopinavir with ritonavir plus Interferon beta-1a (a drug used to treat multiple sclerosis).
The WHO said this week that trials in the HCQ arm in several countries are being “temporarily” suspended as a precaution. And until there is sufficient evidence, WHO has cautioned physicians and medical associations against recommending or administering these unproven treatments to patients with Covid-19. It has also raised concerns over reports of individuals self-medicating themselves with HCQ and chloroquine and causing themselves serious harm.
The US President Donald Trump has repeatedly promoted the drug. He even called HCQ a game-changer and had said last week that he has been taking the drug to ward off the virus.
On March 28, the US Food and Drug Administration (FDA) had granted emergency use authorization (EUA) to HCQ and chloroquine products to treat Covid-19, based on thin evidence of their efficacy.
Mandeep Mehra, one of the authors of the study published in The Lancet said the research shows that the FDA should withdraw that authorization.
Covid vaccine update: China’s CanSino reports positive early data; Astra gets funding from US
After Moderna, there is news that China’s CanSino Biologics has reported positive data from its Phase I trial for a vaccine for Covid-19. In an article published in The Lancet, CanSino Biologics published data supporting its safety in patients.
Samples of blood from a group of 108 vaccinated adults showed both neutralizing antibodies and T-cell responses against the novel coronavirus in most of those tested. Whether the vaccine protects against Covid-19 infection or not can only be confirmed through further studies.
Healthy adult volunteers in Wuhan, China, received a single intramuscular injection of either a low, middle or high dose of the vaccine. There were no serious adverse events. The most common adverse reactions were fever, fatigue, headache and muscle pain. Like Moderna, CanSino is moving its vaccine candidate into Phase II. The mid-stage trial is underway in Wuhan.
A day prior to when the Phase I data was published, CanSino had struck a deal with Canada’s Precision NanoSystems for the development of an mRNA lipid nanoparticle vaccine against Covid-19.
Over 100 vaccine candidates against SARS-CoV-2 are in development, with about 12 in human testing designed to mainly evaluate safety.
Astra’s Covid vaccine gets US$ 1.2 billion pledge: The US government has pledged to commit up to US$ 1.2 billion to AstraZeneca for its efforts to develop a vaccine for Covid-19. It has also pledged to obtain at least 300 million doses of any vaccine that passes all the tests by October.
This way, the US has secured almost a third of the first 1 billion doses planned for AstraZeneca’s experimental Covid-19 vaccine, as the world struggles to look for treatments and get their economies back to work.
As part of the deal with the Biomedical Advanced Research and Development Authority (BARDA), AstraZeneca will begin late-stage clinical trials this summer with roughly 30,000 people in the US. The British drugmaker is developing the vaccine along with the Oxford University.
In a statement, Health and Human Services Secretary Alex Azar called the contract a “major milestone” in Operation Warp Speed, a program launched by the Trump administration to accelerate Covid-19 medical products to the American public.
The agreement between the US government and the British drugmaker came days after the UK government pledged US$ 79 million to AstraZeneca and indicated the deal will provide access to 30 million doses in September. AstraZeneca has said it has arranged enough production capacity to make 400 million doses by fall this year.
Sanofi to sell US$ 13 billion Regeneron stake; create war chest for new drug pipeline
French drugmaker Sanofi SA is selling most of its long-held stake in Regeneron Pharmaceuticals Inc. This is likely to give Sanofi a war chest of around US$ 13 billion to help the drugmaker reshape its drug pipeline as it plans to focus more on rare diseases and oncology drugs.
American drugmaker Regeneron said it had agreed to repurchase approximately US$ 5 billion of its shares directly from Sanofi. The French drugmaker had bought the stake in early 2013.
Sanofi has been disengaging itself from Regeneron for more than a year now. Last year, Sanofi and Regeneron had unveiled plans to restructure their longstanding partnership. And now, the French drugmaker has plans to unload about 22.8 million Regeneron shares, a stake sale that could bring in around US$ 13 billion. The proceeds are likely to be used for dealmaking, say news reports.
The partnership between the two companies “has been one of the most productive in the industry,” Paul Hudson, CEO of Sanofi, said in a statement. While Sanofi “remains committed” to their partnership, Hudson said the “proceeds from this transaction will help further” Sanofi’s ability to execute its “strategy to drive innovation and growth.”
Though it intends to sell its equity investment, Sanofi also said the move would not change the ongoing collaboration between the two groups.
Remdesivir update: Clinical trial data published; first generic launched in Bangladesh
On May 22, the New England Journal of Medicine (NEJM) published a study on the preliminary findings of the clinical trials undertaken by the National Institute of Allergy and Infectious Diseases (NIAID) on Gilead’s remdesivir, which is being considered as a potential treatment for Covid-19.
The study suggests that the drug is superior to any other standard treatment currently being given to coronavirus patients as it has shown improvement in recovery time.
According to a post on NEJM’s Twitter handle, in this double-blind, randomized control trial in 1063 adults hospitalized with Covid-19, a 10-day course of intravenous remdesivir was found to be superior to placebo in shortening the time to recovery. The estimates of mortality at 14 days were 7.1 percent in the remdesivir group and 11.9 percent in the placebo group.
Last month, NIAID had said in a statement that patients who had received the drug had a 31 percent faster recovery time than those who did not and were able to leave the hospital on day 11 as compared to standard 15-day discharge time. Following this, on May 1, the US Food and Drug Administration had given emergency use authorization to the Gilead drug.
Post the emergency approval to remdesivir, India has approved applications of Cipla Ltd and Hetero Labs to manufacture and sell remdesivir. This way, India has waived the requirement for undertaking local clinical trials, in a move to get Indian patients faster access to the drug.
The drugmakers will be required to conduct Phase-IV (post treatment) trials in India to help identify any unforeseen side effects on patients, a report published in The Economic Times said.
Earlier this month, five generic drugmakers Cipla Limited, Ferozsons Laboratories, Hetero Labs Limited, Jubilant Lifesciences and Mylan had signed non-exclusive voluntary licensing agreements with Gilead Life Sciences, the patent holder of remdesivir.
Meanwhile, Bangladesh-based Beximco Pharmaceuticals has launched generic remdesivir for the treatment of Covid-19. This is the world’s first generic remdesivir. The company is donating remdesivir to the Bangladesh government for supply to the government hospitals. The medicine will be given free of cost at these hospitals.
Avigan trial continues despite negative reports: In April, a subsidiary of Japanese company Fujifilm — Fujifilm Holdings Corp — had launched a Phase II clinical trial of its influenza drug Avigan (favipiravir) to treat Covid-19 patients. Avigan, a drug that was approved in Japan in 2014, specifically targets RNA polymerase required for influenza virus replication.
The drug has not shown apparent efficacy in treating Covid-19 in clinical trials so far. Japan’s Prime Minister Shinzo Abe had said he was hoping for the approval of Avigan by the end of May.
While medical experts have voiced concerns about rushing to approve the drug, the lead researcher in the Avigan trial for coronavirus has said it’s too early to make a call on whether it works or not, He has also shrugged off negative reports about the interim results, saying patients are still being enrolled. The final results of the trial for the antiviral are expected around July.
‘Mercky’ saga continues: Merck KGaA wins case against US-headquartered MSD
Back in January 2016, we had reported on how, the two Mercks — Merck of Germany and Merck of the US and Canada — had accused each other of violating the Coexistence Agreement drafted in 1955 (and revised in 1970). The two companies had fought over their Facebook page. Around the same time, the German Merck — Merck KGaA — had also objected to the US company’s use of the name “Merck” in the UK. In 2016, Merck KGaA had lost that case.
But last week, on appeal, a London judge ruled that the US-headquartered Merck Sharp & Dohme (MSD) violated the trademark rights of Merck KGaA enshrined in their decades-old co-existence agreement over their shared nomenclature. And that the US corporation had infringed on Merck KGaA’s copyright numerous times. The judge reviewed 16 instances brought forth by Merck KGaA.
Merck enters race for Covid vaccine: US-headquartered Merck has also joined the race for the Covid-19 vaccine. In fact, the company has a three-pronged strategy for getting into Covid vaccine. First, it is buying Vienna-based biotech —Themis — for an undisclosed amount. Themis is developing an experimental Covid-19 vaccine based on a measles vaccine that could go into human trials soon. Through this acquisition, the American drugmaker will be picking up a vaccine that’s been based on discovery work undertaken at the Institut Pasteur, a French non-profit private foundation named after Louis Pasteur.
Second, it has entered into a collaboration on another vaccine with the nonprofit International AIDS Vaccine Initiative (IAVI). This deal is for the development of a vaccine related to Merck’s existing Ebola vaccine that could enter human studies later this year.
And third, it has inked a deal with Ridgeback Biotherapeutics, and is licensing an experimental antiviral drug from the Miami-based biotech focused on orphan and infectious diseases.
“We are committed to making a contribution to the eradication of Covid-19,” Roger Perlmutter, who heads Merck Research Laboratories, said.
Manufacturing problems, data-integrity issues drive Akorn to bankruptcy
Akorn, which has seen a series of problems over the last few years, has filed its Chapter 11 petition in the Delaware bankruptcy court. Some weeks back, the specialty drugmaker had said it has given up on finding itself a buyer amidst the broader uncertainty due to the Covid-19 pandemic.
The Illinois-based company listed as much as US$ 10 billion of debt and US$ 10 billion of assets in its Chapter 11 petition.
Akorn said it has reached an agreement with lenders representing more than 75 percent of its secured debt. The lenders will collectively make an initial, stalking horse bid for the sale of its business. The lenders will provide additional liquidity to fund business operations during this process, the company said.
In April 2018, Fresenius had walked away from a US$ 4 billion takeover of Akorn, citing an investigation wherein Akorn had materially breached the FDA’s data integrity requirements.
Akorn then got sued by its shareholders for concealing data integrity problems that caused them to lose money when the truth went public. In August 2019, Akorn put the issue to rest by settling with its shareholders.
Akorn has received several FDA warning letters over the last year or so. It received warning letters for its Somerset (New Jersey) manufacturing facility in June 2019, and for its Decatur (Illinois) facility in January 2019. Then in February 2019, the company’s Amityville (New York) facility was hit with another warning letter.
The company generated net sales of US$ 682 million last year, which were down 2 percent from the US$ 694 million generated in 2018.
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