Three drugs enter human trials to treat Covid-19; FDA anticipates drug supply disruptions
This week, Phispers brings you more updates on the novel coronavirus which has so far taken over 2,000 lives.
Three existing drugs that have shown promise in inhibiting Covid-19 in vitro have entered human trials in China.
The FDA said it is bracing for drug and medical supply shortages in the US due to the outbreak.
Meanwhile, Indian drugmaker Wockhardt sold a plant in India and 62 brands to Dr Reddy’s for US$ 260 million.
Several explosions took place at an API manufacturing unit situated in Newburyport, Massachusetts.
After a former executive of Taro Pharmaceutical pleaded guilty in a drug price fixing case in the US, a former executive of Sandoz followed suit.
And a joint US-Indian operation stopped shipments of illicit, unapproved drugs to the US.
Covid-19 update:
Three drugs show promise, as China actively holds clinical trials
The novel coronavirus (Covid-19) has infected over 75,000 persons, with over 1,000 cases outside mainland China. The virus has now killed over 2,000 people, with only six of the deaths taking place outside mainland China. Covid-19 cases have now been detected in 28 countries.
However, in the fight against the novel coronavirus, there have been some encouraging developments in medical research. Scientists have been working around the clock, running clinical trials on potential treatments and researching on a vaccine for Covid-19.
According to a report published in Nature, China has more than 80 running or pending clinical trials on potential treatments for Covid-19. That list has new drugs along with thousand-year-old traditional therapies in a public registry of China’s clinical trials. And the list is growing every day.
So far, there is no known cure for Covid-19. However, three existing drugs that showed promise in inhibiting the novel coronavirus in vitro have entered human trials in China, and early results show that some patients are seeing noticeable improvement.
The three drugs are anti-malaria drug chloroquine, anti-flu drug favipiravir, and experimental drug remdesivir. These three drugs were selected from 100 other drugs after they demonstrated great promise when used in experiments on infected cells in a controlled lab environment.
China is also testing different types of vaccines against the novel coronavirus, and some, including a recombinant protein vaccine, have entered animal trials. However, since the novel coronavirus is a new pathogen, researching the vaccine and ensuring its efficacy will take time.
The types of vaccines Chinese scientists are testing include an inactivated vaccine, an mRNA vaccine, a recombinant vaccine, a DNA vaccine and others.
Meanwhile, the World Health Organization (WHO) has said Chinese scientists are testing two antiviral drugs against the new coronavirus and preliminary clinical trial results are weeks away.
FDA anticipates drug supply disruptions: In a statement, the FDA said it is bracing for drug and medical supply shortages in the US as the Covid-19 outbreak from China continues to spread globally. The agency said it has contacted hundreds of drug and device-makers. So far, there have been no disruptions in the supply chain. But FDA said it will take all available measures if disruptions appear.
The FDA has also halted all plant inspections in China. It said it can rely on facilities’ compliance history and other information to determine whether drugs are safe for import or not.
A Reuters report said the world could face a shortage of antibiotics if the drug industry’s supply problems posed by Covid-19 cannot be resolved soon. EU Chamber of Commerce President Joerg Wuttke told a roundtable in Beijing that the synchronization of supplies in China was being hampered by the outbreak.
India mulls ban on export of 12 drugs: India plans to ban export of 12 essential drugs in wake of the Covid-19 outbreak. An eight-member expert committee constituted by the government to assess availability of medicines in the country has suggested imposing export restrictions on 12 drugs including antibiotics like chloramphenicol, neomycin, metronidazole, azithromycin, clindamycin; vitamin B1, B2 and B6; as well as hormones like progesterone used during pregnancy and in menstrual problems.
Beijing imposes 14-day self-quarantine: Beijing is imposing a 14-day self-quarantine on all those returning to the city, and will punish those who refuse to quarantine themselves or follow official rules on containing Covid-19.
Meanwhile, the outbreak is also impacting drugmakers. AstraZeneca has forecast a likely slowdown in revenue growth this year, assuming a hit from Covid-19 lasting up to a few months. However, it said there had been limited disruption to its operations so far.
Wockhardt sells plant,
62 brands to Dr Reddy’s for
US$ 260 million
Indian drugmaker Wockhardt, which has seen its financial fortunes plummet over the last several years due to FDA-related manufacturing issues, has decided to sell a plant and portfolio of products to Dr Reddy’s Laboratories for around US$ 258.7 million (INR 18.5 billion).
The drugmaker will sell the plant in Baddi (in the state of Himachal Pradesh, India) along with a portfolio of 62 products and transfer all employees and operations to Dr Reddy’s.
The business comprises of a portfolio of 62 brands in multiple therapy areas such as respiratory, neurology, vasomotor symptoms, dermatology, pain and vaccines, which would be transferred to Dr Reddy’s along with related sales and marketing teams and the plant in Baddi with all plant employees.
In a filing today, Wockhardt said the business being offloaded includes some of its branded operations in India, as well as in Nepal, Bhutan, Sri Lanka and the Maldives. It said the business had sales of about US$ 53 million (INR 3.77 billion) for the nine months that ended December 31, 2019. That amounted to about 15 percent of its consolidated revenues for the three quarters.
The divestment is being done to improve the cash flows of Wockhardt. After the sale, slated to be completed in May, Wockhardt will still maintain a significant amount of its Indian business, as well as operations in the US and UK. It will also continue to have a number of bulk drug and formulation plants, several of which have also faced FDA’s flak.
G V Prasad, co-chairman and managing director of Dr Reddy’s said: “India is an important market for us and this acquisition will help in considerably scaling-up our domestic business.”
Meanwhile, Wockhardt had withdrawn an abbreviated new drug application (ANDA) for phenytoin sodium capsules, 100 mg (extended). In all, the FDA is withdrawing approval of 28 ANDAs. The applicants notified the FDA that the drug products were no longer marketed and requested that the approval of the applications be withdrawn, a statement said.
Several explosions take place at API manufacturing plant in
US
On February 13, there were several explosions at a chemical plant in Newburyport, Massachusetts. The explosions left a 5-by-8-foot hole in the roof of PCI Synthesis, a CDMO. The building had to be evacuated, though no one was injured at the drug manufacturing facility.
Newburyport’s deputy fire chief Stephen Bradbury said firefighters responded to a fire alarm call at about 4:30 am. While investigating, the firefighters heard three explosions take place in another room. Bradbury said there were a total of six explosions, and all were contained to one area.
A state hazardous materials team arrived and the firefighters evacuated three businesses adjacent to PCI Synthesis. The cause of the explosions is still under investigation.
Soon after the explosions, PCI Synthesis’ parent company, Seqens, tweeted, “We’re working diligently with local authorities after reports of an explosion at our Newburyport facility. All employees on site were safely evacuated; no injuries reported. We will provide more information when we learn more. Thanks to police and fire for their quick response.”
The plant operates 24 hours a day. Fewer than 10 employees were working at the time of the initial explosions and they left the building safely, a press release said. PCI Synthesis reopened for business on February 14.
After Taro, former
Sandoz executive pleads guilty for role in price fixing
Last week, we had carried news of Ara Aprahamian, former sales and marketing executive of Taro Pharmaceutical Industries, being indicted in the US for his role in conspiracies to fix prices, rig bids, and allocate customers for generic drugs.
Soon after Aprahamian’s indictment, a former executive of Novartis unit Sandoz — Hector Armando Kellum — pleaded guilty for his role in a conspiracy to fix prices and rig bids for generic drugs.
According to a statement issued by the US Department of Justice (DOJ), from at least March 2013 until at least June 2015, Kellum conspired to fix prices, rig bids, and allocate customers for generic drugs.
The conspiracy affected products including, but not limited to, clobetasol and nystatin triamcinolone cream.
The DOJ said Kellum had pleaded guilty to working to fix the prices of clobetasol, used to treat eczema and psoriasis, and nystatin triamcinolone cream, an anti-fungal drug that also has a corticosteroid.
The government said one of Kellum’s alleged co-conspirators was Aprahamian of Taro.
Kellum is the fourth executive to be charged in this investigation, and the third to plead guilty. To date, two companies have also been charged. The corporate charges were resolved by deferred prosecution agreement.
A joint US-Indian
operation stops shipments of illicit, unapproved drugs
This week, the FDA announced it has stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place last month.
This was the FDA’s first bilateral enforcement operation along with the government of India. Christened ‘Operation Broadsword’, the operation targeted packages entering the US through an International Mail Facility (IMF) from January 28 to 30.
During Operation Broadsword, investigators from both the governments examined over 800 shipments, which identified approximately 50 different FDA-regulated products, including medications intended to treat and/or mitigate serious diseases, such as various forms of cancer and HIV. Many of the shipments, which included opioid drugs products, had been transshipped through third-party countries to conceal their point of origin and avoid detection.
“Health risks are further compounded when products are sent through such third-party countries, which undermines protections afforded via regulated pharmaceutical supply chains,” an FDA statement said.
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