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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.

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02 Apr 2020

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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.

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04 Mar 2020

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Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

This week, the biggest news in the world of pharmaceuticals was the termination of the Pfizer-Allergan mega-merger due to new measures taken by the US government. Post that, Allergan signed a US $ 3 billion licensing deal with UK’s Heptares for a portfolio of neurological drugs. But a lot more happened last week – for instance, Pfizer and Celltrion won approval for a biosimilar of J&J’s Remicade, GSK said it wants to make it easier for manufacturers in least-developed countries to make its drugs and Valeant terminated the salesforce for its female libido pill. Pharmaceutical Whispers (Phispers) brings you the latest news from across the world. Pfizer-Allergan terminate merger; Allergan signs licensing deal with HeptaresOn Monday, the US Treasury announced new measures to curb tax-inversion deals. The measures seemed to specifically target the Pfizer-Allergan US $ 160 billion mega deal. And, by Wednesday, the US government had achieved its desired objective – Pfizer and Allergan announced their decision to mutually terminate the deal. Allergan, which is run from New Jersey but has a legal domicile in Dublin, last year agreed to merge with Pfizer. This mega-merger would have moved the Pfizer headquarters from New York to Dublin, saving the pharma behemoth billions of dollars in taxes. As per news reports, Pfizer will need to pay a US $ 400 million fee to Allergan for expenses relating to the deal. Though the US Treasury decision and the termination of the Pfizer-Allergan deal represents a victory for President Barack Obama, whose administration proposed tougher rules aimed at curbing tax inversions, Allergan is not wasting time. Just hours after Allergan backed away from the US $ 160 billion-merger with Pfizer, the company bounced back with a US $ 3.3 billion licensing deal for global rights to a portfolio of drugs for neurological disorders from the UK's Heptares. The deal sends a clear signal that Allergan CEO Brent Saunders plans to barrel ahead with new pacts to bolster the company's pipeline. Pfizer, Celltrion win approval for biosimilar of J&J’s RemicadeNot all news this week was negative for Pfizer as the FDA approved Celltrion’s biosimilar application of Johnson & Johnson’s Remicade. The product will be co-marketed by Pfizer in the United States, a relationship Pfizer accessed through its acquisition of Hospira last year. Celltrion’s application is only the second biosimilar approved by the FDA. However, unlike generic medicines, biosimilars which have been currently approved are not interchangeable with the reference drug. The European Medicines Agency also issued a positive opinion to the Bioepis copy of Remicade. Samsung Bioepis, a joint venture between a unit of the Samsung group and Biogen, has become a force in the biosimilar drugs industry. In fact, South Korea too is emerging as a hub for biosimilar production. Last week, Bioepis filed a lawsuit against AbbVie Inc., makers of the world’s best-selling rheumatoid arthritis drug – Humira – which generated sales of US $ 14 billion last year. In 2015, Johnson & Johnson’s Remicade sales were US $ 6.5 billion. Glaxo not to patent drugs in poorer countriesIn an unusual step, GlaxoSmithKline said it wants to make it easier for manufacturers in the world's 48 least-developed countries to copy its medicines. The company said it would not file patents in these countries in the hope that by removing the fear of patent litigation and by allowing independent companies to make and sell versions of its drugs in those areas, it would widen public access to these drugs. In countries classified as lower middle income countries by GSK, it will continue to file patents, but will grant licenses to generic manufacturers in exchange for a “small royalty”. Gilead has adopted a similar model, of granting generic licensing agreements in developing countries, for its blockbuster Hepatitis C treatment, Sovaldi. The end of the female Viagra?Valeant Pharmaceutical, still reeling from all its accounting and price-gouging problems, has terminated the sales force for the female libido pill that it acquired last year for US $ 1 billion. The drug – Addyi (flibanserin) – failed to gain traction in its first six months on the market. Valeant’s stock has plunged 90 percent since its peak in August last year. Valeant plans to relaunch its sales effort for Addyi with an internal team it will build in the coming months, says a Bloomberg news report. In the meantime, the drug will still be available. Along with the 140 contract workers that make up the Addyi sales force, Valeant is firing about 140 employees across its dermatology, gastrointestinal and women’s health divisions, with dermatology taking the biggest hit. Valeant has about 22,000 employees. Alkem, Rusan and Anuh Pharma – data-integrity issues raise its ugly head yet again in India Inspection at Alkem: In July 2015, the European Union banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences. And this year, another laboratory is under the lens of EU regulators.A routine inspection by the European Medicines Agency in March 2015 of the Department of Bioequivalence of Alkem Laboratories, a major generic drugs manufacturer in India, raised concerns regarding study data used to support the marketing authorization applications of some drugs in the EU. Rusan Pharma back in news: In an inspection conducted in 2010 at Rusan Pharma’s facility in Gandhidham (India), the UK’s Medicines and Healthcare Regulatory Agency (MHRA) uncovered “evidence of fraudulent presentation of data” and determined that the site did not comply with Good Manufacturing Practices (GMPs). The same year, another unit of Rusan, located in Ankleshwar (India), did not meet GMP compliance standards during an inspection conducted by Romania’s National Agency for Medicines and Medical Devices. This week, Rusan was back in news. In January 2016, re-inspection by UK’s MHRA of the Gandhidham site found the Pharmaceutical Quality System “not operating in an adequate manner”. In addition, the inspection report mentions “there was not adequate evidence that the root causes of critical data integrity issues raised at the last inspection had been addressed.” Non-compliant sourcing of drugs by Anuh Pharma: The French Health Agency’s inspection at Anuh Pharma’s facility in Boisar (India) revealed the firm was sourcing commonly used Azithromycin from a non-EU GMP compliant source (Hebei Dongfeng Pharmaceutical Company Limited, China), micronizing the product and then directly exporting it to Europe under the manufacturer name, Anuh Pharma. In addition, several documents were found within a pile of rubble which included an original batch repacking record. A large number of active substances were manufactured at the site, such as chloramphenicol, chloramphenicol palmitate, erythromycin, erythromycin ethylsuccinate, roxithromycin, ciprofloxacin HCl etc. Catalent’s compliance problems delay OPKO’s new drug launchWith more than 40 manufacturing facilities around the world, Catalent is a preferred manufacturing partner for several major pharmaceutical companies across the world. OPKO Health, Inc., one of Catalent’s customers submitted its application for RAYALDEE® (calcifediol) to the FDA. In the complete response letter (CRL) issued to the company, the FDA indicated observations of deficiencies at Catalent’s St. Petersberg, Florida, facility as a result of an FDA field inspection initiated on March 14, 2016, and had held up the new drug approval. According to a news report, OPKO revealed the deficiencies occurred at Catalent’s primary softgel development and manufacturing at St Petersburg, Florida, which was hit with a Form 483 being issued on March 25. Meanwhile, Catalent began production of essential drugs at its French plant, which had been suspended by France’s health regulator in November last year due to occurrence of out-of-place capsules in several product batches. Safety warnings for new age diabetes drugs -- saxagliptin and alogliptin Last year, the FDA had issued safety warnings on new age diabetes drugs called SLGT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) and PharmaCompass had asked the question, “Diabetes: Which new drug is the safest?”. At the time Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was not the case for other products in the same categrory such as AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin). This week the FDA issued a safety warning on Onglyza® (saxagliptin) and Nesina® (alogliptin) as the evaluation of two clinical trials determined that more patients who received saxagliptin or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo. Blockbuster drug approval expected soon for non-alcoholic fatty liver The FDA reviewed the application of Intercept Pharmaceuticals Inc's liver drug, Obeticholic Acid (OCA) and did not raise any major red flags indicating a high likelihood that it will get approved. While the drug is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease, late-stage studies are underway on the same drug to treat non-alcoholic steatohepatitis (NASH), which has no approved treatment. Obeticholic acid (OCA) is listed as one of the top 10 possible blockbuster drugs by FierceBiotech with an expected sales in 2020 of US $ 1.6 billion. Gilead is also actively building its liver disease pipeline and this week, the company paid US $ 400 million upfront to acquire an early-stage pipeline of liver disease drugs from privately held Nimbus Therapeutics. Heart-disease science turns over its headScience is supposed to be simple – for instance, LDL is bad cholesterol and HDL is good cholesterol. If a drug lowers the bad cholesterol and increases the good one, the risk of heart disease should reduce significantly. Specialists were stunned by the results of a study of 12,000 patients, announced on Sunday at the American College of Cardiology’s annual meeting: “There was no benefit from taking the drug, Evacetrapib.” The drug’s maker, Eli Lilly, stopped the study in October, citing futility, but it was not until Sunday’s meeting that cardiologists first saw the data behind that decision. As per the study, participants taking the drug saw their LDL levels fall to an average of 55 milligrams per deciliter from 84. Their HDL levels rose to an average of 104 mg per deciliter from 46. Yet 256 participants had heart attacks, compared with 255 patients in the group who were taking a placebo. Ninety-two patients taking the drug had a stroke, compared with 95 in the placebo group. And 434 people taking the drug died from cardiovascular disease, such as a heart attack or a stroke, compared with 444 participants who were taking a placebo.

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Chinese industrial activity revival at 98.6 percent, officials assure of API supplies

COVID-19: India restricts drug exports amid rising prices of essential bulk drugs; FDA announces first drug shortage

Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

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