Market Place
US, Indian governments reviewing dependence on China for drugs; FDA finds “recurrent failures” at Dr Reddy’s
This week, Phispers brings more updates on the novel coronavirus, which officially got named as COVID-19.
With the world taking stock of COVID-19, researchers at the University of Toronto say the epidemic started one month prior to what has been commonly reported.
In the US, senators called on the FDA to ensure safety of the drugs and medical devices being imported from China, in view of the rising numbers of infections and deaths due to COVID-19.
The FDA posted the Form 483s issued to Dr Reddy’s and Lupin’s API manufacturing sites which revealed an emerging pattern of problems being uncovered by the inspectors.
There was more bad news on Alzheimer’s as Roche and Eli Lilly announced that their experimental drugs failed to meet endpoints.
And in the US, a former senior executive of Taro Pharmaceuticals was indicted in a generic price fixing scandal.
Senators call
on FDA to ensure
safety of Chinese drug imports; India monitoring API supplies
In view of the rising numbers of infections and deaths due to the COVID-19 outbreak in China, US Senators Marco Runio and Chris Murphy called on the US Food and Drug Administration (FDA) Commissioner Stephen Hahn to ensure the safety of the drugs and medical devices being imported from China.
In a letter to Hahn, the senators point out that the US imported more than US$ 12 billion in food, drugs and medical devices from China in 2018 and that China is one of the largest producers of APIs.
“While the Centers for Disease Control and Prevention (CDC) stated it’s unlikely the 2019-nCoV will spread to the United States from these products, we are concerned that the pandemic could impact the FDA’s ability to monitor compliance with good manufacturing standards and the ability for Chinese manufacturers to maintain supplies to meet demand in the United States and the growing demands in China,” the senators write.
They also ask Hahn whether the FDA has the resources to ensure the 2019-nCoV outbreak does not impact the US supply of food, drugs and devices.
The senators further ask the commissioner how many FDA personnel are still in China to conduct inspections, as the US has ordered nonessential personnel to leave the country, and whether the outbreak has affected the agency’s inspection schedule.
Some FDA staff have already left the country and are back in the US. The senators also asked the FDA chief what steps the agency has taken to ensure there are no shortages of drugs or devices due to manufacturing disruptions in China stemming from the outbreak.
Meanwhile, a report said the prolongation of coronavirus outbreak in China could hit Indian pharma sector. China accounted for 67.56 per cent of total imports of bulk drugs and drug intermediates in 2018-19 at US$ 2.4 billion. “The situation is being closely monitored by all companies. The government is seized of the issue and all are working in an integrated way to deal with the situation.” Indian Pharmaceutical Alliance (IPA) Secretary General Sudarshan Jain said.
Indian pharma firms are closely monitoring the 2019-nCov outbreak in China since it could impact the supply of APIs in the country, if the situation in China does not improve soon.
India has a high dependence on fermentation-based APIs/intermediates namely antibiotics and vitamins. A Sanofi India spokesperson said: “It is too soon to predict any impact that the coronavirus outbreak might have. We are closely monitoring the situation to ensure we have no discontinuity in supply.”
A report published in The Economic Times said a high-level committee constituted by the Department of Pharmaceuticals (DoP) is contemplating restrictions on the exports of some crucial antibiotics and vitamins in light of the coronavirus outbreak. This comes as traders have been raising the prices of some bulk drugs for pharmaceutical companies amid the prolonged shutdown in China.
FDA finds “recurrent failures” at Dr Reddy’s, concerns at Lupin’s API site
The FDA posted the Form 483s issued to Dr Reddy’s and Lupin’s API manufacturing sites which revealed an emerging pattern of problems being uncovered by FDA inspectors.
During inspections conducted in January 2020, the investigators raised concerns over shortcomings in the process validation studies performed at both firms.
At Dr Reddy’s, the firm rejected out-of-specification (OOS) results related to residual solvents. Inadequate investigations led to the firm continuing “to have recurrent failures” in process validation and commercial batches without having a scientifically justifiable root cause. The FDA also questioned the firm’s cleaning processes for equipment as they were not found to be adequately established and validated.
At Lupin’s facility, the FDA found inadequate control and monitoring over critical process parameters during process validation studies. The firm also failed to investigate unexplained discrepancies in exhibit batches and the FDA investigator also questioned the firm’s analytical reference standard management and sampling practices.
Lupin also failed to convince the inspector that the changes to the master batch records are recorded and approved by the QA and that there hasn’t been an unauthorized change to the master batch record.
Sun subsidiary
Taro’s executive indicted in generic price
fixing scandal
In the US, a federal grand jury returned an indictment against a former senior executive for his role in conspiracies to fix prices, rig bids, and allocate customers for generic drugs, and for making a false statement to federal agents who were investigating those conspiracies. The person — Ara Aprahamian — was the former sales and marketing executive of Taro Pharmaceutical Industries. Indian drugmaker Sun Pharmaceuticals had acquired the Israeli pharma company in 2010.
Aprahamian was indicted for participating in two conspiracies to fix generic drug prices between 2013 and 2015. He is also charged with lying to an FBI agent when he denied that he had spoken to a competitor about pricing.
Drug pricing has become a hot topic of late, amid reports that some drugs, including some that have been on the markets for decades, have seen their prices increase sharply.
According to the indictment, the defendant and his co-conspirators agreed to increase prices and allocate customers for numerous drugs, including, but not limited to, medications used to treat and manage arthritis, seizures, pain, various skin conditions, and blood clots.
Bob Gage, a lawyer for Aprahamian, said: “We have absolute confidence that once all the facts are brought to light Mr. Aprahamian will be proven innocent.”
In latest Alzheimer’s setback, Lilly, Roche’s drugs fail endpoints
There was more bad news on finding a remedy to Alzheimer’s Disease, which has already seen more than 100 failures. This week, Roche and Eli Lilly announced that their experimental drugs failed to halt gene-driven Alzheimer's disease.
In a press statement, Genentech, a member of the Roche Group announced that gantenerumab did not meet its primary endpoint in people who have an autosomal dominant Alzheimer’s disease (ADAD), which accounts for less than 1 percent of all cases of the disease.
The study of Roche’s gantenerumab and Eli Lilly’s solanezumab was spearheaded by Washington University in St. Louis. It focused on ADAD, which is caused by gene mutations that follow generations of families. Those afflicted often develop Alzheimer’s disease before the age of 60 and have a 50 percent chance of passing the mutation on.
Like many other Alzheimer’s drug prospects, gantenerumab and solanezumab are designed to neutralize beta-amyloid plaques seen as a driver behind brain cell death.
As death toll rises to over 1,100, Wuhan virus gets official name — COVID-19
PharmaCompass has been bringing you comprehensive coverage of the novel coronavirus (2019-nCoV), which has killed over 1,100 people and infected over 45,000 people worldwide, with a vast majority of the cases being reported in mainland China. The World Health Organization (WHO) has officially named the disease caused by the coronavirus as COVID-19.
“COVID-19 stands for coronavirus disease in 2019,” said Soumya Swaminathan, chief scientist at the WHO, Switzerland. The virus is named by an international group of virologists.
Two other diseases caused by coronaviruses were given names describing the clinical manifestations: SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome).
Meanwhile, researchers at the University of Toronto said the epidemic started one month prior to what has been commonly reported. The researchers have used a new disease-transmission model to determine this.
Using open access data that are updated daily, the model replicates epidemiological scenarios and allows researchers to test narratives about the outbreak that originated in Wuhan (China), including the notion that it started in December.
“You can’t get up to that level of cases if the epidemic started in December even if you pushed the reproduction really high,” said David Fisman, a professor in the Dalla Lana School of Public Health and one of the model’s creators.
“It had to be earlier, which raises some interesting questions about how this emerged,” Fisman added. The plausible start date, according to Fisman, seems to be mid-November.
On February 9, the WHO said no new countries reported cases of 2019-nCoV in the past 24 hours. In Canada, renowned epidemiologist Bruce Aylward will be leading a team of WHO experts in China to study the outbreak of the novel coronavirus. Aylward arrived in China on February 10 to lay the groundwork for the larger international team tasked with learning more about the virus.
Aylward and his team will be looking to the origin of the virus and the severity of the disease. Aylward is a veteran of past infectious disease outbreaks.
Possibility of several undetected cases in US: Former commissioner of the FDA Scott Gottlieb said for every person who traveled into the US infected with the new coronavirus, and who was successfully diagnosed and quarantined, there maybe three more who arrived undetected. “It was only toward the end of January that we started to even look for sick travelers,” Gottlieb said.
Citing the example of Singapore that has as many travelers arriving from China as the US (around 3 million a year), Gottlieb said: “It’s understandable that small outbreaks might become evident in that small and dense island nation of 5.7 million before they can be spotted in the US.”
“The risk to any American remains low, but that could quickly change. It will be critical that we identify small outbreaks early, in order to prevent larger spread. There are policy steps that we can take now to reduce these viral threats, and precautions that Americans can take to lower their individual risk,” Gottlieb added.
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