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Chinese industrial activity revival at 98.6 percent, officials assure of API supplies
While the world feels the heat of the Covid-19 pandemic with the global pharmaceutical supply chain getting impacted, normalcy is returning to China. According to new reports, the production of drugs and APIs in China is also returning to normal. In a press conference held by top Chinese officials this week, the country’s ministers highlighted that as of March 28, the average operating rate of industrial enterprises across China had reached 98.6 percent and the production of some key vitamin, antibiotic and analgesic raw material drug companies had returned to normal with yields of major products reaching above 80 percent.  Officials had paid heed to resumption of production   The officials highlighted that during the critical period of epidemic prevention and control, the Chinese government had paid close attention to the resumption of production of API companies. After receiving reports that some companies in Hubei had not resumed work, which would impact the supply chains of products like metronidazole, ibuprofen, and taurine, the authorities urgently coordinated with the relevant departments of Hubei, other provinces, cities and counties to carry out key scheduling for some API manufacturers and actively organized employees to return to work. However, despite these initiatives, due to the impact of the epidemic, wherein some enterprises had stopped production and subsequently faced challenges with logistics and transportation difficulties, there was a shortfall in supply. The export volume of APIs did decrease this year compared with the same period last year and the officials estimated that most products witnessed a drop of about 10 to 20 percent, and in some cases the decline of individual varieties had reached 30 percent. Repeated communications between the officials and these companies revealed that the main contributor to the decline in exports was sea freight, as international shipping had greatly reduced, and transportation costs have also increased. Although international transportation has become a bottleneck for the supply of some APIs, the press conference highlighted that the output of other APIs had exceeded the level of the same period last year. China to meet global demand for chloroquine   The officials made a special mention of medications like chloroquine phosphate which have received significant attention as a potential treatment of the novel coronavirus. After chloroquine phosphate was identified as a potentially effective treatment, the government worked with the two major API manufacturers in China to organize the companies to meet international demand. For example, Chongqing Kangle Pharmaceuticals exported 4.9 tons of chloroquine APIs within five days. This news from China is encouraging to the global supply chain as following the rising interest in a chloroquine analog — Hydroxychloroquine (HCQ) — the Indian government issued a directive which prohibits the export of HCQ API and formulations made from HCQ. The directive did, however, offer exemptions to exports from special economic zones/export-oriented units and in cases where export is made to fulfill an export obligation under any advance license issued on or before the date of the notification. Last week, Hungary, which is also one of the world’s largest exporters of HCQ, also banned the commercial export of the ingredient and the United Kingdom (UK) banned the export of finished formulations of HCQ as part of a list of 135 medicines posted that cannot be exported from the UK because they were needed for the UK patients. In early March, the Indian government had also restricted the exports of 13 APIs along with some of their finished formulations. The list included paracetamol tinidazole metronidazole acyclovir vitamin B1 vitamin B6 vitamin B12 progesterone chloramphenicol and neomycin. However, a recent report published in The Economic Times highlighted that out of 13 drugs whose exports were restricted, the government is likely to lift the ban on the following five APIs — paracetamol, tinidazole, metronidazole, ornidazole and azithromycin. There were also reports of significant pressure from the US on the Indian government for products like paracetamol and the officials expect the ban to be lifted in the coming days. The Chinese officials further went on to provide assurances that the supply of chloroquine phosphate can be increased in accordance with international market demand and that China’s Ministry of Industry and Information Technology will also organize the implementation of monitoring and production scheduling of key products, coordinate and solve the export transportation difficulties encountered by enterprises and strengthen communication.  Our view   The press conference highlighted that China attaches great importance to the safety of the global pharmaceutical industry supply chain and President Xi Jinping had promised at the G20 summit of member states on March 26 that China will increase its efforts to supply APIs to the international community.  The Chinese government is working earnestly to implement the commitment to maintain the production of API manufacturers and ensure the safety and stability of global industrial chain supply, the statement emerging out of the press conference said. Given the global pharmaceutical supply chain’s overwhelming dependence on China, the nation’s return to normalcy is a positive sign for countries across the world. For the time being, the pandemic has only increased the world’s dependence on China. All countries that want to reduce their reliance on China will take time not just to build capacities, but also to emerge out of the Covid-19 crisis.  

Impressions: 1610

https://www.pharmacompass.com/radio-compass-blog/chinese-industrial-activity-revival-at-98-6-percent-officials-assure-of-api-supplies

#Phispers by PHARMACOMPASS
02 Apr 2020
COVID-19: India restricts drug exports amid rising prices of essential bulk drugs; FDA announces first drug shortage
Now that it has been established that the novel coronavirus is going to globally impact the drug supply chain, it becomes imperative to analyze the extent of the impact. Since the outbreak of the novel coronavirus — COVID-19 — in December, PharmaCompass has been constantly reaching out to manufacturers around the world to assess the current state of the drug supply chain. This week, we share our preliminary analysis based on the feedback we have received from drug manufacturers around the world. Drug shortages are for real   Last week, the US Food and Drug Administration (FDA) announced the first human drug shortage as a result of the coronavirus outbreak. In addition, the FDA announced it was tracking 20 drugs that could face shortages. Some generic drugmakers are predicting shortages as early as in June or July, due to the novel coronavirus. The FDA did not disclose the name of the drug in shortage or the 20 drugs it is tracking, as this is considered ‘confidential commercial information’.  In India, a committee constituted by the country’s Department of Pharmaceuticals started monitoring the availability of 58 active pharmaceutical ingredients (APIs) to take preventive measures against illegal hoarding and black-marketing in the country. According to a report published in The Economic Times, after reviewing the list of drugs, 34 were found to have no alternatives which include critical and essential drugs like potassium clavulanate, ceftriaxone sodium sterile, piperacillin tazobactam, meropenem, vancomycin, gentamycin and ciprofloxacin. This was immediately followed by the Indian government restricting the exports of 13 APIs along with some of their finished formulations. The list includes paracetamol, tinidazole, metronidazole, acyclovir, vitamin B1, vitamin B6, vitamin B12, progesterone, chloramphenicol and neomycin. For most of the products on this list, India is a net importer, as there is little domestic manufacturing of these APIs. COVID-19 is also likely to impact bottomlines. Leading generic drugmaker Mylan said it expects the coronavirus outbreak to impact its financial results while some of the largest drugmakers — including AstraZeneca, Merck and Pfizer — have said that the coronavirus outbreak could affect their supplies or sales. Paracetamol affected; prices double in less regulated markets   The decline in industrial activity in China is certainly taking its toll, as drugs which are on the World Health Organization’s Model list of Essential Medicines are beginning to face significant price increases in the wake of disruption of key starting raw materials for bulk drugs.  The export restriction out of India on commonly used analgesic, Paracetamol — sold under the brand names such as Tylenol (in the US), Panadol (in the UK), Dafalgan (France) and Crocin (India) — is not surprising as the API has witnessed almost doubling of prices in less regulated markets because exports of its key building block para-amino phenol (PAP) have dramatically reduced from China.  While there are only a few manufacturers who produce paracetamol without being dependent on Chinese PAP, a few major manufacturers in India depend almost completely on Chinese PAP for their paracetamol production and usually only keep three to four months of inventory. By the end of February, their inventory stockpiles had halved and in the event of a continued supply disruption, their entire inventory pipeline is likely to dry out. In addition, Chinese paracetamol manufacturers, who export a significant amount of their bulk ingredient production globally, including to India, are also currently unable to export. This is beginning to create the potential of panic among sourcing executives across the world. Several antibiotics also in danger of acute shortages   While paracetamol was listed on the API watch list circulated by India’s Department of Pharmaceuticals, our survey has revealed that other products on the list like ciprofloxacin, amoxicillin and azithromycin are also facing severe raw material shortages. As a result, the prices of these bulk drugs have also increased sharply. In a statement to The Economic Times, leading Indian generic manufacturer Mankind Pharma’s chairman and managing director said amoxicillin is the most commonly used API to manufacture antibiotics and the company has invested Rs 1 billion (US$ 14 million) in placing irregular orders with vendors to try and address the potential shortage that is expected. He went on to say that if the situation continues until April, there will be an acute shortage. In a statement to the US House of Representatives last October, Janet Woodcock, the FDA’s Director of Center of Drug Evaluation and Research, said the FDA has determined that there are three WHO Essential Medicines whose API manufacturers are based only in China. The three medicines are: capreomycin, streptomycin (both indicated to treat Mycobacterium tuberculosis) and sulfadiazine (used to treat chancroid and trachoma). Streptomycin is also on the watch list published by India’s Department of Pharmaceuticals along with commonly used anti-hypertensives like losartan, valsartan, telmisartan and olmesartan and diabetes treatment metformin. Intermediates becoming a problem for generic drugmakers   PharmaCompass’ discussions have also revealed that in many cases while API manufacturing factories in China have returned to work, there are disruptions in the availability of raw materials and/or logistics at sea ports and airports which have led to unavailability of supplies.  While the FDA has a list of the number of API facilities in China which are in a position to supply to the United States, Woodcock said in her statement that the FDA “cannot determine with any precision the volume of API that China is actually producing, or the volume of APIs manufactured in China that is entering the US market.” This visibility reduces drastically when one has to assess the dependence of each API manufacturer around the world on China for intermediates. Our discussions have revealed that it is these intermediates which are becoming a problem for most API manufacturers, even those based in India. It was worth highlighting that a manufacturing process change at an intermediate stage of commonly used blood pressure medicine valsartan resulted in the recall of millions of pills as it was found to contain a cancer causing impurity above acceptable levels. Similarly, in 2008, the adulteration of heparin in China, which killed 81 people and left 785 severely injured, was an outcome of the subcontracting of precursor chemicals of Heparin. Our view   The over-dependence on China for key starting materials has been the subject of discussion ever since we launched PharmaCompass. Rosemary Gibson explored this subject in detail in her book China Rx: Exposing the Risks of America’s Dependence on China for Medicine. The restrictions imposed on industrial activity and transportation in China in the first two months of this year has resulted in NASA’s satellite images showing a decline in pollution levels over China. While China works towards getting its industrial and transportation engine up and running to 2019 levels, the outbreak has spread to other countries which will further increase the demand for drugs to fight the virus.  This is a time when the pharmaceutical industry needs to act responsibly and make decisions which are in the best interests of patients globally. Sharing information is one such step — it will allow for drug stockpiles and inventories that exist to be re-distributed to areas which need them most. For, in the event of an urgent need, drugs will become available to those who are most in need.  

Impressions: 8151

https://www.pharmacompass.com/radio-compass-blog/covid-19-india-restricts-drug-exports-amid-rising-prices-of-essential-bulk-drugs-fda-announces-first-drug-shortage

#Phispers by PHARMACOMPASS
04 Mar 2020
China shuts plants of major antibiotic producers to fight pollution; more troubles for Teva
This week, Phispers has lots on generics. While the global leader Teva has more troubles at hand, generic players in the US face fresh lawsuits, and Sanofi plans to sell its European generic unit. There is also talk of Novartis buying America’s generic-drugs maker Amneal. In other news, oncologists find problem with clinical trials, and China shuts plants to curb pollution  Teva braces declining sales, lawsuits and closure of its Mexico plant There is more bad news from Israel’s Teva Pharmaceutical Industries. First, its Rimsa plant in Mexico is said to be shut, and a lot of employees have been (reportedly) laid off. As per a news report, it’s difficult to make the Rimsa plant operational anytime soon. Teva had invested US $ 2.3 billion in the facility. There are reports that the company may make a write-down on its investment in Rimsa. In September, the global leader in generics had claimed that the Espinosa brothers, who had controlled Rimsa until its sale to Teva, had deceived the regulatory authorities and patients for years and sold defective and illegal drugs. Teva’s troubles don’t end there. The company is also setting aside US $ 520 million in its bid to settle allegations of paying bribes in Russia, Mexico and Ukraine. In its latest earnings report released Tuesday, Teva noted that “advanced discussions” are under way with the federal courts in the US to resolve the incidents, which took place between 2007 and 2013. Teva has completed 12 acquisitions worth US $ 46 billion in the last four years. Teva’s blockbuster Copaxone, which brings in 19 percent of its overall sales, has lost several patent challenges in the US and is likely to face generic competition early next year, putting more than US $ 4 billion in sales at risk. Even without a generic competitor, sales declined 2.2 percent year-on-year in the third quarter this year.   To control pollution, north China industrial hub curbs drug production If you live in Delhi, and are coping with the hazardous pollution levels, here’s something that will interest you. A wide-ranging ban has been imposed in a northern Chinese industrial hub on production at drug plants, steel mills and other businesses. This is a last-ditch attempt by the government of Shijiazhuang city to meet this year’s pollution control target — to reduce the levels of PM 2.5 (fine particles that pose a risk to human health) by 10 percent. Shijiazhuang is the capital of the northern Hebei province, which reported economic growth of 6.8 percent in the first three quarters of this year. Last week, the government of Shijiazhuang city said for the remaining 45 days of the year, it will curb output at thermal power plants, halt all production at industries such as steel and cement, and limit manufacturing of pharmaceuticals, chemicals and even furniture. In 2014, President Xi Jinping had responded to public outrage over high smog levels. As a result, local officials are trying hard to strike a balance between pollution control and economic growth. Shijiazhuang is home to major active pharmaceutical ingredient (API) producers such as North China Pharmaceutical, CSPC Zhongnuo Pharmaceutical, CSPC Ouyi Pharmaceutical and many others. These companies are critical to the global antibiotic supply chain as they provide the building blocks for antibiotic manufacturing, such as 6-APA and 7-ACA, along with commonly used antibiotics such as Penicillin, Amoxicillin, Amipicillin and Azithromycin.  PharmaCompass has been routinely covering the Chinese bulk drug industry and its impact on the environment. In April this year, PharmaCompass had reported how school children in China were wearing gas masks due to pollution concerns. And prior to that, we had carried an article on how dependent the world has become on bulk drugs from China.  More trouble for generic drug-makers in the US as unions file lawsuits In a fresh salvo at the generic drug industry, a union representing sergeants of the New York Police Department is attempting to hit some companies with civil penalties. The generic industry is already facing charges from a two-year US Justice Department antitrust probe. The union has filed two lawsuits against two groups of drug-makers, which includes Novartis AG’s generic drug unit, Ireland-based Perrigo Co., India’s Wockhardt and Taro Pharmaceutical Industries (Israeli subsidiary of India’s Sun Pharma). The union has alleged that the companies colluded to raise prices of two dermatological creams by as much as 1,000 percent since 2013. Besides this, at least four other unions have filed lawsuits of their own, with two of them adding Actavis Inc., acquired in August by Teva, to the list of defendants. All the unions manage health benefits for their members. The unions say they overpaid for the drugs due to the price collusion. They point to data that the drug-makers took price hikes on certain medicines by nearly the same amounts within months of each other. A lawyer for the New York sergeants’ union said he expects a judge will call a conference in December to decide if the cases can be combined.  Novartis may buy generic drug-maker Amneal for US $ 8 billion Swiss healthcare major Novartis AG is in talks to acquire American generic-drugs maker Amneal Pharmaceuticals. Through this acquisition, Novartis plans to strengthen its Sandoz business. According to Bloomberg, Novartis and Amneal may reach an agreement soon. Amneal makes the antiviral acyclovir (to treat herpes) and gabapentin (for epilepsy and pain). The acquisition could cost Novartis around US $ 8 billion. Amneal is a family-owned business led by co-founders Chintu and Chirag Patel and has operations in North America, Australia, Europe and Asia. Its portfolio of generic treatments includes around 115 approved molecules in the US.  Sanofi to sell off European generic drug unit French drug maker Sanofi confirmed it has decided to sell off its generic drug unit in Europe. The decision will affect two manufacturing plants in the Czech Republic and Romania. Sanofi CEO Olivier Brandicourt recently informed investors that the company has “made a definitive decision to initiate a carve-out process and divest the generics portfolio in Europe.” The move is part of the company’s 2020 strategic roadmap. He, however, did not provide details. Sanofi had acquired Zentiva, a Czech generic business, in 2008 for US $ 2.6 billion. And Sanofi’s generic business is centered around this acquisition. The business is particularly strong in the Czech Republic, Romania and Turkey. On Monday, Zentiva Romania informed the Bucharest Stock Exchange that its majority shareholder Sanofi has decided to sell its Romanian generic drug plant as part of a major divestment plan of its EU generic drugs business. A company spokesperson said the planned scope of the divestment is the generics business “related to Europe,” so it excludes Russia, the Commonwealth of Independent States (CIS) and Turkey. And it includes the two “dedicated manufacturing sites producing and distributing generics for the European market,” one in Prague (Czech Republic), and the other in Bucharest (Romania).  Former Valeant executives arrested for fraud Last week, two former executives of Valeant Pharmaceuticals — Gary Tanner and Andrew Davenport, who had been the CEO of Philidor — were arrested on charges of running a fraud scheme that swindled millions of dollars out of Valeant. The fraud was allegedly conducted with the help of a mail-order pharmacy, that is now defunct. According to Preet Bharara, US Attorney for the Southern District of New York, the arrests were part of an ongoing probe of the scheme. The criminal complaint alleges that Tanner and Davenport conspired to enrich themselves with Valeant funds. The two helped Valeant set up Philidor in early 2013, which was primarily a vehicle to market and distribute Valeant drugs. According to the complaint, Tanner focused on building Philidor’s business, resisted his superiors’ directives to line up other distributors for Valeant’s products and ultimately received a US $10 million kickback from Davenport. The complaint alleges that in 2014, the two orchestrated Valeant’s agreement to buy an option to purchase Philidor, which cost Valeant at least US $ 133 million. More than US $ 40 million of that went to shell companies controlled by Davenport. One such shell company — called ‘End Game LP — gave a kickback of US $10 million to Tanner.  Homeopathy products in the US may carry caveats soon In a report on homeopathic advertising, the Federal Trade Commission (FTC) in the US said that homeopathic drugs should “be held to the same truth-in-advertising standards as other products claiming health benefits.” Only the US Food and Drug Administration (FDA) can prevent homeopathic marketers from selling their products. The FTC has no teeth in the matter. But very soon, homeopathic products could include statements such as ‘there is no scientific evidence backing homeopathic health claims’ and ‘homeopathic claims are based only on theories from the 1700s that are not accepted by modern medical experts.’ However, this may not affect sales of homeopathic products. There are claims that such statements could backfire because homeopaths and those who believe in homoeopathy don’t trust modern medicine. They could also believe that if homeopathy has been around for that long, it must work. This is not the first-time homeopathic medicines would carry caveats. In 1988, the FDA had struck a deal where it agreed that homeopaths could be self-regulating, if they include a disclaimer that their claims haven’t been evaluated by the FDA.  In February this year, PharmaCompass had carried a news nugget on Professor Paul Glasziou, a leading academic in evidence-based medicine at Bond University, who had declared homeopathy as a “therapeutic dead-end” after a systematic review concluded the controversial treatment was no more effective than placebo drugs.   Cancer clinical trials exaggerate benefits of new drugs, say oncologists Two cancer physicians argue that large clinical trials — required for approval of new cancer drugs in the US — often overstate the effectiveness of the treatment in the real world. During cancer clinical trials, some volunteers take the experimental drug, while others receive standard care with existing drugs. The groups are then compared to see if their tumors have shrunk, how long it takes for the tumors to return, and how long do the patients survive. This way, the trial sees whether the experimental drug is safe and effective and can be sold to patients in the US. The process is based on the premise that trials give an accurate indication of safety and efficacy among cancer patients in general, and not only those who are eligible for and selected for the trial. The trouble is, participants in clinical trials are unlike the overall cancer population, point out oncologists Dr. Sham Mailankody of Memorial Sloan Kettering Cancer Center and Dr. Vinay Prasad of the Oregon Health and Science University in JAMA Oncology. They’re younger, healthier, wealthier, better plugged in to the healthcare system, and better educated. According to these oncologists, if cancer patients are similar in age, socio-economic status, have presence of other (similar) illnesses, and other characteristics as those in a clinical trial, they might do as well. But for everyone else, the trial results probably promise more than the drug can deliver.    

Impressions: 4461

https://www.pharmacompass.com/radio-compass-blog/china-shuts-plants-of-major-antibiotic-producers-to-fight-pollution-more-troubles-for-teva

#Phispers by PHARMACOMPASS
24 Nov 2016
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