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J&J’s diabetes drug reduces heart risk at the cost of toes; Google’s AI eye doctor initiative

This week in Phispers, we bring you news on J&J’s Invokana, a drug that reduces heart risk while increasing the risk of amputation of toes. There is news from Google, which is tying up with India’s Aravind Eye Care System for its artificial intelligence eye doctor initiative. And WHO takes a step towards reducing antibiotic resistance by grouping antibiotics into ‘Access’, ‘Watch’ and ‘Reserve’. Manufacturing errors trigger drug recalls by Lupin and Dr. Reddy’s in the US Earlier this month, we carried an article on the end of India’s pharma honeymoon. News this week from Lupin and Cipla added another dimension to the problem as manufacturing errors triggered drug recalls in the United States. Lupin voluntarily recalled a lot of its birth control pills — Mibelas 24 Fe — in the US. A market complaint indicated a packaging error, making the lot number and expiration date no longer visible. This product is an oral contraceptive for women. As a result of the packaging error, the FDA says the first four days of the birth control packet have four non-hormonal placebo tablets as opposed to the active tablets. This may place the user at risk for contraceptive failure and unintended pregnancy. Similarly, Dr. Reddy’s had to recall hundreds of thousands of cartons of a popular acne medicine — Zenatane — manufactured by Cipla’s plant in Pune. According to FDA enforcement reports, Dr. Reddy’s is recalling 190 lots, consisting of 778,279 cartons of its Zenatane brand isotretinoin capsules, in four dose sizes. The voluntary Class II recall was initiated in late May after the products failed dissolution testing. During this period of turmoil, the Indian company which is generating a lot of positive press is Cadila Healthcare. Cadila’s US division Zydus Pharmaceuticals’ subsidiary Nesher Pharmaceuticals has received final FDA approval to market Nystatin Topical Powder, an anti-fungal antibiotic used to treat skin infections caused by yeast. There is more good news from Zydus Cadila. After years of patent battles, the FDA has approved Zydus Cadila’s generic version of Shire’s ulcerative colitis drug Lialda. This came as a rude shock to Shire investors who had believed the US$ 800 million drug was safe for a few more years. However, there is a chance that instead of a flood of generics, the Zydus' generic may be the only competition for Lialda for sometime. Zydus Cadilla has indicated that its version will have a six-month exclusivity. J&J’s diabetes drug saves heart at the cost of toes; Sanofi’s insulin slashes hypoglycemia risks for seniors Would you like to sacrifice your toes to save yourself from a heart attack? Well, a diabetes drug made by Johnson & Johnson (J&J), does just that. The drug — Invokana — decreases the risk of heart attacks and strokes, while increasing the risk of amputation, particularly of toes. According to the results of the 10,142-patient study, funded by J&J, for every three heart attacks, strokes, or cardiovascular deaths prevented by Invokana, there were two amputations, 71 percent of them of toes or the lower foot. While this is a setback to J&J, its rivals — Eli Lilly and Boehringer Ingelheim — who make a similar drug called Jardiance, may be cheering the findings of this study, performed on sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs prevent the kidney from absorbing sugar from the blood. But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” Harlan Krumholz of Yale University said. Another study examining an at-risk population of seniors who had switched to basal insulin found Sanofi’s Toujeo to outdo its peers at cutting the risk of hypoglycemia in older patients. During a six-month follow-up, the study found that amongst the ‘at-risk’ seniors, those taking Toujeo were 57 percent less likely to experience hypoglycemia than those who switched to competing insulins—such as Novo Nordisk’s Tresiba and Levemir, and Toujeo’s predecessor, Lantus. Google ties up with Indian hospital chain for artificial intelligence eye doctor initiative Google will soon begin work on a grand experiment that would use machines to widen access of healthcare. If successful, this initiative will protect millions of diabetes patients from an eye disease that leads to blindness. Last year, researchers at Google had said they had trained image recognition algorithms to detect signs of diabetic retinopathy roughly as accurately as human experts. Left untreated, diabetic retinopathy causes blindness. The software examines photos of a patient’s retina to spot tiny aneurisms that would help detect early stages of the disease. Google is working with the Aravind Eye Care System in India, a network of eye hospitals, in order to integrate this technology. “This kind of blindness is completely preventable, but because people can’t get screened, half suffer vision loss before they’re detected,” Lily Peng, a product manager with the Google Brain AI research group, said. “One of the promises of this technology is being able to make healthcare more accessible.” There are more than 400 million people worldwide with diabetes, including 70 million in India. FDA tells Endo to pull out its opioid pain medication, as Gottlieb attacks addiction Last week, the US FDA asked drugmaker Endo Pharmaceuticals to remove its powerful opioid pain medication — Opana ER — from the market, due to “the public health consequences of abuse”. “We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” he added. Opioid overdoses killed 33,000 Americans in 2015, with half of those involving a prescription opioid. Opana ER, which is oxymorphone hydrochloride, is used to manage severe pain. The FDA approved it for this use in 2006. The drug is about twice as powerful as OxyContin, another often abused opioid. In 2012, Endo reformulated the drug to make it more resistant to physical and chemical tampering. While the drug met the standards for approval, FDA says Endo never showed that the reformulation would reduce abuse. Amgen loses bid to delay Novartis’ biosimilar; FDA rejects Coherus’ biosimilar for Neulasta Amgen lost a case in the Supreme Court of the United States that sought to delay biosimilars of its rivals. Amgen had argued that its biosimilar rivals should be forced to delay their 180-day marketing notices until the FDA had made up its mind on the marketing application. However, on Monday, the Supreme Court took a decision by determining that the law never imposed a two-tier timing system for these notices. Therefore “the applicant may provide notice either before or after receiving FDA approval.” This has proven to be a clear win for Sandoz — the generic unit of Novartis that is fielding an array of copycat biologics. The group is launching a copy of Amgen’s Neupogen. And in the process, Sandoz has unleashed a fresh wave of biosimilars hitting the US market. However, Amgen won somewhere else — the FDA rejected Coherus Biosciences’ application for a biosimilar of Amgen’s blockbuster Neulasta (a drug that fights infections in cancer patients). This action effectively delays any rival until 2018, at the earliest. The FDA's response comes as Amgen gears up for biosimilar competition for Neulasta, which generated about US$ 4.6 billion in sales last year. The FDA requested Coherus for a re-analysis of certain data and asked the drug developer for more manufacturing information. WHO updates list of essential medicines; groups antibiotics into three categories Last week, the World Health Organization (WHO) released its Essential Medicines List (EML), with a new advice on which antibiotics to use for common infections and which to preserve for serious circumstances. Amongst the additions to the WHO Model list of essential medicines for 2017 are medicines for HIV, hepatitis C, tuberculosis and leukaemia. The EML is used by many countries to increase access to medicines. The updated list has added 30 drugs for adults and 25 for children, and specifies new uses for 9 already-listed products. In all, it contains 433 drugs deemed essential to address the most important public health needs. This time, WHO has grouped antibiotics into three categories – ACCESS, WATCH and RESERVE – with recommendations on when each category should be used. Initially, the new categories apply only to antibiotics used to treat 21 of the most common general infections. If found useful, it could be broadened in future versions of the EML to apply to drugs to treat other infections. Antibiotics in the ACCESS group must be available at all times as treatments for a wide range of common infections. It includes drugs like amoxicillin, an antibiotic used to treat infections such as pneumonia. The WATCH group includes antibiotics that are recommended as first- or second-choice treatments for a small number of infections. For example, the use of ciprofloxacin, used to treat cystitis (a type of urinary tract infection) and upper respiratory tract infections (such as bacterial sinusitis and bacterial bronchitis), should be dramatically reduced to avoid further development of resistance. The third group, RESERVE, includes antibiotics that should be considered as last resorts, such as colistin and some cephalosporins. These must be used only in the most severe circumstances when all other alternatives have failed.

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15 Jun 2017

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Phispers: Another Heparin scandal in China, GSK may have a new CEO, Female libido pill problems

Pharmaceutical Whispers (Phispers) this week cover another major heparin scandal emanating from China, GSK may have a new CEO in 2017, the pharma world reducing dependence on China for antibiotics, regulatory moves to accelerate drug approvals in the US and China and a lot more. Chinese heparin producer fails European inspection Last week, heparin producer Dongying Tianyong in China failed a European Directorate for the Quality of Medicines (EDQM) inspection. Heparin is a substance widely used as an injectable anticoagulant and as an intermediate. Results obtained from suppliers of crude heparin appeared to be manipulated and the quality system was identified as very weak and deficient, and not in compliance with the EU GMPs. The inspection was conducted in December while the summary report was posted February 25, 2016. Back in 2008, major recalls of heparin were announced by the US Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China, causing 81 deaths. The FDA had also indicated the contamination may have been deliberate and had identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. The contaminant – oversulfated chondroitin sulfate – cost US $ 9 a pound compared with US $ 900 a pound for heparin, creating one of the biggest pharmaceutical quality scandals in history. Dongying Tianyong also manufactures Enoxaparin Sodium, an active pharmaceutical ingredient (API) produced from heparin, for which a ‘recall of product’ has been considered and the company’s regulatory filing has been suspended. Is there going to be a repeat of the scrutiny on heparin manufacturers in China once again? World’s antibiotic supply chain will not rely completely on ChinaIn July 2015, Novartis announced it is shutting down three of its plants, one of which produced the antibiotic intermediate 7-ACA (7-aminocephalosporanic acid) – the core chemical structure (building block) for producing a whole host of cephalosporin antibiotics. At the time, PharmaCompass had expressed concern that the Novartis’ plant shut down has created an urgency to find alternatives to Chinese APIs, since the global supply of 7-ACA would be dependent on China in view of the announced closure. However, the global imbalance will not occur any time soon as International Chemical Investors Group (ICIG) announced the acquisition of Novartis’, Frankfurt-Höchst-based site which produces 7-ACA. With this acquisition, CordenPharma Group (the pharma platform of ICIG) will become one of the major suppliers of 7-ACA to customers worldwide. Expect accelerated drug approvals in China and the USThe China Food and Drug Administration (CFDA) said in a statement it would accelerate the approval of drugs. For pharmaceutical firms, the approval of drugs has been a headache for long and they complain it takes too long to get drugs to market.The newly appointed FDA commissioner, Dr. Robert Califf, mentioned that accelerated generic drug approvals will be high on his list of priorities. In addition, policy leaders in the United States have suggested speedy reviews of generic drugs that lack competition. This is one of the two specific actions aimed at reducing generic drug shortages more rapidly and price gouging. The other action suggested by the policy leaders is to give the FDA permission to clear a generic product based on an equivalent approval from a foreign country. Mylan breathes a sigh of relief, Teva’s Epipen launch “significantly delayed”While on the topic of accelerated approvals, Mylan breathed a sigh of relief as their billion-dollar allergy-reaction injector, Epipen will not see Teva as a competitor until at least 2017. Teva’s launch has been “significantly delayed” as the FDA found “major deficiencies” in its application. Epipen contributed 13% to Mylan’s global revenues last year. Libido pill problems greet Valeant CEO on return from leaveOne of the pharmaceutical industry’s poster boys for high prescription drug prices – Valeant Pharmaceuticals’ CEO Michael Pearson – returned to work after a nine-week medical leave owing to pneumonia. Valeant is known to acquire medicines and then hike the prices.While Valeant’s business practices have been under close scrutiny and its shares are trading at the lowest level in two and a half years, now bad news is emerging about Addyi, the female libido pill Valeant acquired in 2015. A Dutch study found that, Addyi “gives limited gain in sex” and the benefits were slightly “more modest than those submitted to the F.D.A. during the approval process”. Not the kind of issue Pearson would have liked to deal with after returning to work post illness. GSK may have a new CEO in 2017GlaxoSmithKline’s chairman Sir Philip Hampton is believed to have instructed recruiters Egon Zehnder to identify a replacement for GSK CEO, Sir Andrew Witty. Some of the drug giant’s biggest investors have been demanding a split of GSK since they believe the sum of GSK’s parts is worth more than the current stock market value. It remains to be seen if Witty’s successor will be an internal or an external person. To keep him from leaving, IMS Health pays Its CEO more than IBM IMS Health Holdings paid its Chief Executive Officer Ari Bousbib US $ 34.8 million in 2015 to prevent him from leaving to a bigger rival of the data-services firm. In comparison, Accenture paid CEO Pierre Nanterme US $ 15.9 million for 2014. And IBM gave Ginni Rometty US $ 19.3 million. Both Accenture and IBM also provide data services to healthcare clients and have market valuations more than seven times IMS Health’s US $ 8.5 billion. Gilead’s sofosbuvir battles on patents and prices continue in IndiaGilead’s Hepatitis C treatment – Sofosbuvir – has been one of the most spectacular drug launches in pharmaceutical history. Sold as Sovaldi (sofosbuvir) and Harvoni (combination of sofosbuvir and lepidasvir), it generated 2015 sales of over US $ 19 billion. However, with the price in the United States at almost US $ 1,000 per pill and as little as US $ 4.29 per pill in India, Gilead made headlines again as the Indian Patent Office began hearings to determine whether Gilead Sciences “deserves a patent” for sofosbuvir.For those interested in this topic, a detailed report on the “Patent Situation of Key Products for the Treatment of Hepatitis C” is available on the World Health Organization (WHO) website. Otsuka’s innovative TB drug under fire for high priceOne of the first new tuberculosis (TB) drugs in decades made by Japanese drug maker Otsuka Pharmaceutical got slammed this week for a ‘ridiculously high’ price tag. While Otsuka is charging US $ 1,700 for a six-month course of treatment, delamanid, which is known commercially as Deltyba, must be taken with other medicines, which make the complete regimen cost anywhere from US $ 1,000 to US $ 4,500 in developing countries. Unlike Gilead’s problems with Sofosbuvir, this drug won’t be available in India anytime soon as Otsuka still has not applied for regulatory approvals. Deal-making round-up: AstraZeneca, Pfizer, Baxalta, Sanofi, AbbVie and Boehringer’s Astra Zeneca’s US $ 4 billion buy of Acerta got endorsed by the award of special “orphan” status to the key drug, acalabrutinib. However, the amount pales in comparison to the US $ 35 billion Pfizer is expected to avoid in taxes through its Allergan merger.The European Medicines Agency had recommended acalabrutinib as an orphan product for chronic lymphocytic leukaemia or small lymphocytic lymphoma, mantle cell lymphoma and lymphoplasmacytic lymphoma.Cancer deal-making remained in focus as Baxalta and Precision Biosciences announced a partnership to develop allogeneic chimeric antigen receptor T cell (CAR-T) therapies. The collaboration could generate up to US $ 1.7 billion for Precision Bioscience. However, another multi-billion oncology deal is being anticipated between AbbVie and Boehringer and should be announced soon.While deals are being announced, Sanofi’s divesture of its European generic unit, planned to begin this quarter, may get delayed. France’s largest drug maker needs more time to determine which assets should be included in the sale. However, it seems like all roads lead to China – AstraZeneca divested rights to two ageing heart drugs for US $ 500 million to China Medical System Holdings. China Medical will pay AstraZeneca US $ 310 million for a licence to sell Plendil (a blood pressure pill) in China. It will also pay AstraZeneca US $ 190 million for the global rights of Imdur (a drug for angina treatment) outside of the US.

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03 Mar 2016

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Novartis’ plant shut down creates urgency to find alternatives to Chinese APIs

With Novartis shutting two plants in Germany and one in India by 2016-end, the global reliance on China for bulk drugs has increased even further, raising serious concerns over safety, supplies and national security. Which plants? Last week, Novartis announced it will be shutting three plants of its generic business – Sandoz – by the end of 2016. The first plant is in India and the other two are located in Germany, in Gerlingen and Frankfurt. Frankfurt, manufacturer of a key antibiotic intermediateThe Frankfurt plant is where Sandoz manufactures 7-ACA (7-aminocephalosporanic acid), the core chemical structure (building block) for producing a whole host of cephalosporin antibiotics. The reason given for closure -- prices of the cephalosporin active pharmaceutical ingredients (APIs) and intermediates have collapsed as Asian competitors have dumped excess capacity on the market. The shutdown of the Frankfurt facility means that the global reliance on China for APIs, used to produce antibiotics (such as cephalosporin) and especially 7-ACA, will increase only further. Chinese APIs are already a security threat for India India produces a third of the world's medicines, mostly in the form of generic drugs. However, according to an Oct 2014 report by a Boston Consulting Group (BCG) and Confederation of Indian Industry (CII), more than 90 percent of the key raw materials (intermediates and APIs) that go into making at least 15-odd essential drugs come from China.The drugs listed include the most commonly used painkiller such as paracetamol, aspirin; antibiotics such as amoxicillin and ampicillin, cephalexin, cefaclor, ciprofloxacin, ofloxacin, levofloxacin; first line diabetes drug metformin; and antacid ranitidine. There are no domestic producers left for many drugs such as penicillin-G, and its derivative 6-aminopenicillanic acid, or 6-APA.Since India is still receiving a large quantity of 7-ACA from Germany (confirmed by the import statistics available on the PharmaCompass database), 7-ACA and its derivatives were not mentioned in this report.As per news reports, the Indian government is now worried about over-dependence on imports from China. "Any deterioration in relationship with China can potentially result in severe shortages in the supply of essential drugs to the country. Additionally, China could easily increase prices of some of these drugs where it enjoys virtual monopoly," said Bart Janssens, partner, BCG, in a news report published in The Economic Times. Recognizing the national healthcare security challenge facing India, the Department of Pharmaceuticals (DoP) has decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients.’ As part of this initiative, the Indian government intends to build cluster parks to boost India’s self-reliance on Chinese imports. Quality, environmental concerns over Chinese AntibioticsChinese supplies of 7-ACA have been plagued with multiple issues in the past. In 2012, for instance, several Chinese drug companies were accused of manufacturing 7-ACA using contaminated ‘gutter oil’, instead of more expensive soybean oil. Gutter oil is reprocessed oil manufactured from waste oil and animal fat collected from restaurants’ fryers, drains, grease traps and slaughterhouses. Chinese restaurants can get through a lot of cooking oil and this waste oil fuels a highly profitable gutter oil black market as there are few other outlets, such as biofuel production, for this by-product.Similarly, antibiotic pollution in the rivers of China is a serious cause of concern for the Chinese. Our previous analysis, “Antibiotic resistant superbugs: deadlier than cancer and closer to you than you think” provides a detailed overview regarding the challenge being faced. However, with growing focus on antibiotic pollution in China, a shutdown of factories failing pollution norms would be a severe setback for the global antibiotic supply chain. In addition to these challenges, quality concerns have been raised during international regulatory inspections of some of the leading antibiotic producers in China, like Zhuhai United and North China Pharmaceutical Company. South African stock outs of essential drugs a global concernThe outcomes of these challenges are already being felt in countries such as South Africa which are facing an acute shortage of critical drugs. According to a report published in Groundup, drug shortages in South Africa’s health facilities have become a crisis. The story mentioned the situation in a hospital (Stanger Hospital) in Ilembe District KwaZulu Natal, where 200 products were out of stock. These included various doses of morphine, some antibiotics and antiretrovirals, especially paediatric ones, used to treat HIV. “About a hundred patients per week are going without ranitidine which prevents stomach ulcers. Several Ilembe facilities are even out of stock of paracetamol tablets,” the Groundup report said. There are multiple reasons for the drug stock outs. However, unprofitability because old, off-patent products are being sold by manufacturers at prices very close to the cost of production has played a major role. Firms are abandoning such products and seeking higher return alternatives. In addition, due to quality failures suppliers are unable to provide lifesaving medications to the South African population. Our ViewThe problems of stock outs and quality concerns in South Africa can easily expand across the world and can’t be addressed until the global pharmaceutical industry reduces its reliance on China for bulk drugs and intermediates. It remains to be seen if the threat to the global supply chain will make Novartis reconsider its decision or drive a national government to buy the Frankfurt facility.

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30 Jul 2015

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Serious GMP Problems uncovered at Lupin (ANVISA) & Zydus Cadila (USFDA)

The Indian pharmaceutical industry cannot seem to shake off its difficult performance trend during international regulatory inspections. Generic majors Lupin and Zydus Cadila are the latest in the list of companies, who have had serious GMP deficiencies uncovered during recent inspections.How much will this impact the industry? Update on Dr Reddy’s Srikakulam observations In one of our recent assessments, we had analyzed why “Dr. Reddy’s largest API facility maybe the next to get banned from exporting to the United States”. Quality Executive Partners Inc, a boutique consultancy firm, which specializes in providing executive level talent, recently posted the redacted Form 483 issued to Dr. Reddy’s.The observations listed on the form, highlight concerns, which had not previously been reported. Dr. Reddy’s not only failed to mention the presence of an analytical laboratory, which was “only discovered” later, they deleted analytical raw data and the inspectors found many original documents in the company’s waste area.Multiple instances where samples were failing specifications and reported as passing have also been cited. Serious concerns at Zydus CadilaQuality Executive Partners Inc, also posted the redacted Form 483 issued to Cadila Healthcare’s Zyfine unit (also known as Zydus Cadila), which was inspected by the U.S. FDA in December 2014. The facility, located in Ahmedabad, India, had a series of glaring data-integrity observations, which ranged from:Records were not made readily available during the inspection; the Vice President, Corporate QA stated that the requested document was located at an employee’s home.During the FDA walk through the inspectors found five original and rewritten records, which were falsified.Inspectors found rough notebooks in the scrap yard as well as the engineering and QA offices.Documents were signed and dated by individuals who were not present at the site.Reprocessing was performed without review and approval of the quality unit.Batch records were not reviewed by production and QA personnel before release.Washing and toilet facilities lacked soap.Could this inspection be the reason Zydus appointed a new President of Corporate Quality in December? Lupin’s Brazilian dreams hit a bumpLupin’s Latin America expansion plans hit a bump recently, when the Brazilian Health Agency (ANVISA) suspended imports of certain products from their Mandideep plant due to GMP concerns found, during an ANVISA inspection. It was less than two weeks ago, when Lupin announced their first major Brazilian foray, an acquisition of Medquimica Industria Farmaceutica S.A. for an estimated $100 million. The Brazilian pharmaceutical market, the sixth largest in the world and growing at a compounded rate of 17% is part of Lupin’s Latin America strategy, which also had them acquire Mexico’s Laboratorios Grin last year.While the ANVISA resolution does not list in detail the problems found, ANVISA has recommended the suspension of import of all beta-lactam cephalosporins, and all drugs which have been produced with these products from the Mandideep plant.Lupin’s 2014 annual report states that the cephalosporin business contributed 47% of the revenues to their API portfolio.Since Brazil’s ANVISA and Mexico’s regulatory agency, COFEPRIS (Federal Commission for the Protection against Sanitary Risk), share a high level of mutual cooperation (e.g. outcome of certain inspections by one authority are recognized by the other), the impact of the Mandideep inspection on Lupin’s Latin American dreams remains to be seen. Our view:Failure in international regulatory inspections is continuously tarnishing India’s reputation as a producer of high quality, low cost medicines. Especially as lots of these concerns can be avoided so easily (see our previous compilation of 'Where companies who fail EDQM inspections go wrong.') However, while bad news travels fast, India still maintains a more than 90% success rate in international regulatory inspections. In order to preserve the 'Made in India' image, Indian companies need to avoid what is easily avoidable and continuously communicate and broadcast their inspection successes.

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28 May 2015

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