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China’s energy crunch threatens pharma supply chains

This week, PharmaCompass looks at the energy crunch in China and its likely fallout on the global pharmaceutical supply chains. Till not so long ago, there was an adage — ‘when America sneezes, the world catches a cold’. These days, the same holds true of China, which is today the world’s second largest economy. It is also the largest exporter of goods in the world, supplying consumer electronics, cars, textiles, chemicals and a plethora of other goods to several countries across the world. The country is striving to emerge as the world’s next superpower by dethroning the US. The pandemic has shown us that the interconnectedness of supply chains can lead to widespread shortages and interruptions in production across the world. Today, China is in the midst of a serious energy crunch. The blackouts may be limited to China, but their impact will be felt along the global supply chains for all products, including pharmaceuticals. Chinese Generic Drug Facilities Registered with the USFDA (Free Excel Available) Curbs on power usage The energy crunch in China is triggered by factors such as a shortage of coal supplies, tougher emissions standards and strong demand from manufacturers and industry. These factors have led to widespread curbs on the usage of electricity. China is the world’s top-most consumer of electricity. As the world’s top producer of carbon dioxide and other polluting gases, China’s ability to cut emissions is seen as critical in the global fight against climate change. The country has said it aims to bring carbon emissions to a peak by 2030 and to net zero by 2060. Recently, the country banned cryptocurrency mining, a highly energy-intensive activity that has stoked a surge in illicit coal extraction. According to the country’s main planning agency, the National Development and Reform Commission (NDRC), only 10 out of 30 mainland Chinese regions achieved their energy reduction targets in the first six months of 2021. To make matters worse, Beijing is contending with an ongoing trade dispute with Australia, the world’s second-largest coal exporter, which has greatly curbed coal shipments to China. “The electricity shortages in China are worsening, and widening geographically. It’s getting so bad Beijing is now asking some food processors (like soybean crushing plants) to shut down,” Bloomberg’s chief energy correspondent said on Twitter. Chinese Generic Drug Facilities Registered with the USFDA (Free Excel Available) Factories halts production Since mid-August, 20 provinces have implemented power cuts, including the manufacturing hubs of Guangdong, Zhejiang and Jiangsu, putting pressure on companies’ earnings. The impact on industries is broad and includes power-intensive sectors like aluminum smelting, steel-making, cement manufacturing and fertilizer production. According to Reuters, China’s factory activity unexpectedly shrank in September due to wider curbs on electricity use and elevated input prices. According to data from the National Bureau of Statistics, the official manufacturing Purchasing Manager's Index (PMI) was at 49.6 in September as against 50.1 in August, slipping into contraction for the first time since February 2020. According to Morgan Stanley, about 7 percent of aluminum production capacity has been suspended and 29 percent of cement production has been affected by the power crunch. Paper and glass could be the next industries to face supply disruptions, they said. Numerous factories have halted production, including many supplying Apple and Tesla. Some shops in the northeast are relying on candles, while malls are closing early to save energy. China is already grappling with curbs on the property and tech sectors, and there are concerns around the future of its cash-strapped real estate giant — Evergrande. As a result, Goldman Sachs and Nomura have revised downwards their projections for China’s economic growth. For Q3, Goldman’s new growth forecasts has shrunk to 0 percent quarter-on-quarter (4.8 percent year-on-year). Nomura has cut its Q3 and Q4 China GDP growth forecasts to 4.7 percent and 3.0 percent, respectively, from 5.1 percent and 4.4 percent previously, and its full-year forecast to 7.7 percent (from 8.2 percent). Chinese Generic Drug Facilities Registered with the USFDA (Free Excel Available) Pharma supply chain concerns According to Fitch Ratings, China is the world’s largest exporter of active pharmaceutical ingredients (APIs) exporter and its two largest export destinations — India and the US — accounted for 16.8 percent and 12.5 percent of China’s total API export value, respectively, in 2019. Over the last few years, both India and the US have been concerned about their high dependence on China for APIs and other drug inputs. Back in December 2019, Chuck Schumer (who is currently the Senate majority leader) had expressed serious concern over the grave national security and public health risks posed by the United States’ growing reliance on China for production of a wide range of life-saving drugs used by the US military and hospitals across the country. Schumer had requested the Government Accountability Office (GAO) to investigate the capability of the US to manufacture finished drug products and APIs. India too has repeatedly expressed concerns over its huge dependence on China for APIs — nearly 70 percent of the country’s APIs are imported from China with dependence as high as 90 percent for certain life-saving drugs. This year, in February, the Indian government had rolled out the Production Linked Incentive (PLI) scheme for drugs and had chosen 11 pharmaceutical companies to make key starting materials, drug intermediates and APIs to reduce its dependence on Chinese imports. Since then, India has levied anti-dumping duties on various chemicals and APIs being imported from China. In March, India had imposed anti-dumping duty on the antibacterial drug — ciprofloxacin hydrochloride and in August an anti-dumping probe was initiated against a chemical (ATS-8) used to produce the commonly used cholesterol lowering drug atorvastatin. And just this month, India recommended the imposition of anti-dumping duty on vitamin C being imported from China. Chinese Generic Drug Facilities Registered with the USFDA (Free Excel Available) Our view PharmaCompass’ database on generic drug manufacturers registered with US Food and Drug Administration (FDA) tells us that there are 155 generic facilities in China that supply generic drugs to the US. Out of this, over half, or 80 facilities are situated in the three provinces of Jiangsu, Zhejiang and Guangdong that are worst hit by the power crunch. Given this, the energy crunch in China definitely poses a risk to the global supply chains for drugs and APIs. The PharmaCompass compilation does not include many Chinese companies that manufacture key intermediates that are used by companies around the world to produce APIs. In October-end, Glasgow (Scotland) would host the 26th United Nations Climate Change Conference (COP26). According to news reports, none of the largest greenhouse gas emitting countries are on track to meet their climate goals. In this scenario, coupled with rising instances of extreme weather conditions and fears of more pandemics in the future, the power crunch in China might just be another reason after Covid-19 for countries to rework their pharma supply chains. Given the volatilities and uncertainties, nations have realized they need to reduce their dependence on countries like China and India in order to keep their economic growth engine moving. Chinese Generic Drug Facilities Registered with the USFDA (Free Excel Available)

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29 Sep 2021

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Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

In less than three weeks, Donald Trump will assume office as the President of the United States. He has mentioned that he wants Medicare (a national social insurance program) to directly negotiate the price it pays for prescription drugs. Medicare provides health insurance to Americans aged 65 or more, who have worked and paid into the system through the payroll tax. It also provides health insurance to younger people with some disabilities or end-stage renal disease and amyotrophic lateral sclerosis. In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people. As we flag off the New Year, PharmaCompass provides insights into drug prices and prescription patterns in the US in order to help professionals make informed decisions. We believe that the cost of medicines in the US, which have been a subject of much public outcry and discussions in the recent years, will continue to be scrutinized during 2017. Medicare data for 2014 Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers who collectively prescribed approximately US $121 billion worth of prescription drugs paid for under this program. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed (including original prescriptions and any refills), and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers). The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not include information in cases where 10 or fewer prescriptions were dispensed. Top Ten Drugs by Cost, 2014 [Most expensive for Medicare] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Sofosbuvir 109,543 33,028 7,323 $3,106,589,192 Esomeprazole Magnesium 7,537,736 1,405,570 286,927 $2,660,052,054 Rosuvastatin Calcium 9,072,799 1,752,423 266,499 $2,543,475,142 Aripiprazole 2,963,457 405,048 130,933 $2,526,731,476 Fluticasone/Salmeterol 6,093,354 1,420,515 281,775 $2,276,060,161 Tiotropium Bromide 5,852,258 1,211,919 253,277 $2,158,219,163 Lantus Solostar (Insulin Glargine) 4,441,782 972,882 224,710 $2,016,728,436 Sitagliptin Phosphate 4,495,964 789,828 190,741 $1,775,094,282 Lantus (Insulin Glargine) 4,284,173 787,077 223,502 $1,725,391,907 Lenalidomide 178,373 27,142 9,337 $1,671,610,362 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Average Cost Per Claim Adagen 13 $1,224,835 $94,218 Elaprase 100 $6,560,225 $65,602 Cinryze 1,820 194 196 $96,155,785 $52,833 Carbaglu 60 $2,901,115 $48,352 Naglazyme 129 $6,189,045 $47,977 Berinert 538 73 68 $25,685,311 $47,742 Firazyr 1,568 269 232 $70,948,143 $45,248 H.P. Acthar 9,611 2,932 1,621 $391,189,653 $40,702 Procysbi 314 41 47 $12,542,911 $39,946 Folotyn 15 $598,210 $39,881 Top Ten Drugs by Claims, 2014 [Most Commonly Used by Patients] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Lisinopril 38,278,860 7,454,940 464,747 $281,614,340 Levothyroxine Sodium 37,711,869 6,245,507 416,518 $631,855,415 Amlodipine Besylate 36,344,166 6,750,062 451,350 $303,779,661 Simvastatin 34,092,548 6,768,159 387,651 $346,677,118 Hydrocodone-Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Omeprazole 33,032,770 6,707,964 475,122 $529,050,385 Atorvastatin Calcium 32,603,055 6,740,061 419,327 $747,635,818 Furosemide 27,133,430 5,176,582 456,047 $135,710,772 Metformin HCl 23,475,787 4,509,978 364,273 $203,948,989 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Prescribers, 2014 [Most Popular with Doctors] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Hydrocodone/Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Ciprofloxacin HCl 7,253,018 4,926,835 568,201 $46,728,353 Amoxicillin 6,298,980 4,384,899 557,614 $31,193,739 Cephalexin 5,040,219 3,529,303 557,048 $36,987,401 Azithromycin 7,339,954 5,274,010 544,625 $70,699,119 Prednisone 11,032,986 4,505,821 536,108 $86,537,932 Tramadol HCl 14,250,227 4,272,724 515,816 $125,343,514 Sulfamethoxazole /Trimethoprim 4,833,758 3,090,944 500,790 $29,231,511 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 Amoxicillin/Potassium Clav 3,551,452 2,710,244 478,361 $61,713,432 The findings from CMS data The CY 2014 data represented a 17 percent increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services. Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail drugs and US $ 128 billion (28.1 percent) was for non-retail drugs. The drug pricing process in the US is complex and reflects the influence of numerous factors, including manufacturer list prices, confidential negotiated discounts and rebates, insurance plan benefit designs, and patient choices. An IMS study found that across 12 therapy classes widely used in Medicare Part D, medicine costs to plans and patients in Medicare Part D are 35 percent below list prices. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! While the CMS does not currently have an established formulary, Part D drug coverage excludes drugs not approved by the US Food and Drug Administration, those prescribed for off-label use, drugs not available by prescription for purchase in the US, and drugs for which payments would be available under Parts A or B of Medicare. Part D coverage excludes drugs or classes of drugs excluded from Medicaid coverage, such as: Drugs used for anorexia, weight loss, or weight gain Drugs used to promote fertility Drugs used for erectile dysfunction Drugs used for cosmetic purposes (hair growth, etc.) Drugs used for the symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee Our view The Medicare program is designed such that the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do under other programs. For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D. If Trump administration kick starts direct negotiations on Medicare drug prices with drug companies, 2017 will surely turn out to be a year for the pharmaceutical industry to remember. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!

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05 Jan 2017

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GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics. GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field. Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs. FDA continues to race ahead with generic approvals The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements. Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million.. The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement.

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04 Aug 2016

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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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07 Apr 2016

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Antibiotic resistant superbugs: deadlier than cancer and closer to you than you think

The global war on superbugs, bacteria that grow resistant to drugs, infect humans and defy conventional medicines, just opened another battlefront when antibiotic contamination was found in rivers in China, which wasn’t a result of the factories that produce the antibiotics. The situation in China can easily be replicated in other countries in the world and in turn, could totally impact you. Latest situation in ChinaIn the first ever comprehensive study done in China, at the Guanzhou Institute of Geochemistry, rivers around densely populated regions were found to be contaminated with antibiotics at alarmingly high levels. China the largest producer and user of antibiotics in the world, measured environmental concentrations (MECs) of ciprofloxacin, norfloxacin, ofloxacin, and norfloxacin at levels up to 7560 ng/L compared with Italy (9 ng/L), USA (up to 120 ng/L) and Germany (20 ng/L). Seven antibiotics were found to have concentrations of over 1,000 nanograms per liter in the environment, a level of extremely serious concern. Bacterial resistance rates in hospitals (i.e. superbugs) are found to be directly correlated to the environemental concentrations levels and usage of antibiotics. The Haihe River and the Pearl Rivers, which flow through major Chinese citites of Beijing, Tianjing, Shenzhen and Guangzhou, were found to be the most severely antibiotic-polluted water basins. China’s Pearl River Delta, has overtaken Tokyo to become the world’s largest urban area in both size and population. The report, focused on 36 frequently detected antibiotics in China and their environmental impact. The total usage for the 36 selected chemicals was 92,700 tons in 2013 with approximately 54,000 tons of antibiotics excreted by human and animals, almost all of which, entered the environement. It is estimated that half of all antibiotics in China are consumed by animal livestock. Farmers overuse and abuse of antibiotics, by adding them directly to animals’ feed to promote growth. A key contributor to the environmental contamination problem is that up to 75 percent of antibiotics, fed to animals get excreted into the environment without any waste treatment. What are the Chinese doing about it?While, China has no established limits for the allowable level of antibiotics in the environment, there is a strong sense of urgency to address the problem. As part of the initiatives taken, the Chinese Academy of Sciences has drawn up an Antibiotic Intensity Map of all the country's 58 river basins to monitor the levels of antibiotics at all times. In addition, the Chinese government is taking necessary measures against facilities, which are polluting the environment to ensure compliance. Measures taken need to be watched closely as China is the antibiotic supplier to most countries in the world. As the Chinese crackdown occurs on factories polluting the environment, European regulators have been suspending imports from Chinese factories for GMP compliance concerns (Zhuhai United is the latest to get a non-compliance report). Antibiotics resistance will overtake cancer in number of deaths by 2050Globally all countries, including China are aware that antibiotics resistance is a global healthcare challenge that will overtake cancer in number of deaths by 2050 and cost the world economy almost $100 trillion. Not only will antibiotic resistance become the leading cause of deaths by 2050, 90% of the 10 million deaths are expected to occur in Asia and Africa. Deaths by comparison for cancer are estimated to be 8.3 million, diabetes 1.5 million, diarrhea 1.4 million and road accidents 1.2 million. Countries like South Africa, where the government is battling a drug shortage crisis, is an outcome of the situation in China as there is unavailability of commonly prescribed antibiotics. The use of antibiotics, has become integral to the global medical and food systems. However, the concerns over the resistance to antibiotics has been declared a “national security priority” by the White House while the WHO calls it a serious, worldwide threat to public health. The Chinese study, has added a new dimension to this global war, where contamination of antibiotics in the water we drink has been highlighted. Contamination caused by human and animal excrement more than the factories producing the antibiotics. Since humans and animals consume antibiotics globally and there is a carry over of these antibiotics into the environment, it is worth questioning if the water we drink is being controlled for antibiotic levels? After all, the harm caused by passive smoking has created smoke-free laws, would it be completely ridiculous to discuss antibiotics-free environment legislation?

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25 Jun 2015

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Haunted: Teva’s $1.2 billion ‘pay-for-delay’ penalty; which companies will get hit next?

Teva Pharmaceutical Industries, Ltd., which acquired Cephalon in 2012, will make a total payment of $1.2 billion as part of a ‘pay-for-delay’ settlement reached with the Federal Trade Commission (FTC) last week. What exactly did Cephalon, for which Teva paid $6.8 billion, do so wrong? Isn’t ‘pay-for-delay’ common practice in the pharmaceutical industry? First of all what is a pay-for-delay? ‘Pay for delay’ or reverse payment patent settlements, are agreements where the brand name drug manufacturer compensates generics, not to market the generic product for a specific period of time. These settlements allow the brand manufacturers to extend their patent monopolies and according to an FTC study, these deals cost consumers and taxpayers $3.5 billion in higher drug costs every year. What exactly happens and why is it a big deal now? Cephalon allegedly paid four generic drug companies (Teva, Ranbaxy Pharmaceuticals, Mylan Pharmaceuticals, and Barr Laboratories), over $300 million in total. In return the generics agreed to drop their patent challenges and forgo marketing of their generic versions of Cephalon’s blockbuster sleep-disorder drug Provigil, for six years, until April 2012. An extended monopoly for Provigil, in the absence of generic competition, was “$4 billion in sales that no one expected”, the CEO of Cephalon reportedly said when the deal was struck. While in Europe, regulators have been going after pay-for-delay cases for years, it was only as recently as 2013, in FTC v. Actavis, that the U.S. Supreme Court made clear that reverse payment patent settlements are subject to the same antitrust rules that govern general U.S. business conduct. The payment made by Teva will compensate purchasers, including drug wholesalers, pharmacies, and insurers, who overpaid because of Cephalon’s illegal conduct, is the first positive outcome for the FTC after the Supreme Court ruling. How common are ‘pay-for-delay’ settlements? Based on data provided by the FTC, for the past few years, more than 100 settlements are reached annually between brand and generic pharmaceutical companies. Over 30% of these settlements have the potential of being ‘pay-for-delay’ agreements. Table// Potential pay-for-delay settlements reached between brand and generic companies: Financial Year 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Final Settlements: between brand and generic companies 14 11 28 33 66 68 113 156 140 145 Involving First Generic Filing 8 5 11 16 29 32 49 54 43 41 Potential Pay-for-Delay: Involving First Generic Filing 2 9 11 13 15 26 18 23 13 Settlements 3 14 14 16 19 31 28 40 29 How severe are the penalties for ‘pay-for-delay’ settlements in Europe? The European Commission has fined Johnson & Johnson (J&J) just under 10.8 million euros and Novartis 5.49 million euros, after discovering a ‘pay-for-delay’ deal on the painkiller Duragesic (fentanyl). The amount pales in comparison to the whopping €428m fine on Servier and several other companies (Niche/ Unichem; Matrix, which is now part of Mylan; Teva; Krka and Lupin) for conspiring to delay generics of the widely-used blood pressure drug Coversyl/ Aceon (perindopril). In yet another settlement, agreements which operated in 2002 and 2003 between the Danish originator Lundbeck, and other generic companies, resulted in Euro 146 million in fines. What should we expect in the future? Based on an FTC presentation made in September 2014, they highlighted 19 Cases to Watch, which has them targeting almost every major brand and generic pharmaceutical company. However, with the complexities involved, this list is continuously evolving: The cases (by name of the brand product) Actos, Adderall, Aggrenox, AndroGel, Cipro, Effexor, K-Dur, Lamictal, Lidoderm, Lipitor, Loestrin, Nexium, Niaspan, Opana, Provigil, Skelaxin, Solodyn, Wellbutrin.The brand companies involvedAbbvie, Abbott, AstraZeneca, Bayer, Besins, Biovail, Boehringer, Cephalon, Endo, GlaxoSmithKline, King, Medicis, Pfizer, Shire, Schering, Takeda, Warner Chilcott, Wyeth.The generic companies Actavis , Barr, Duramed, Dr. Reddy’s, HMR, Impax, Lupin, Mutual, Mylan, Par, Perrigo, Ranbaxy, Rugby, Sandoz, Teva, Upsher Smith. Our view: Pharmaceutical companies, lawyers and the FTC will be busy for the coming few years, since there are a series of suits, which will be challenging settlements reached between brand and generic pharmaceutical companies. While patents provide temporary monopolies to promote innovation, brand drug manufacturers will need to resort to more innovative ways of sustaining their profits. Click here and learn about the different strategies adopted in the United States to block generics?

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04 Jun 2015

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Dr. Reddy’s expansion plans for API production

Unrelated to the inspection of the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment, Forests & Climate Change to expand their drug and intermediate manufacturing at three locations. All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were Existing Capacity Planned Capacity Anticipated Investment CTO I 14.7 TPM 45.5 TPM Rs 30 crores CTO II 21.9 TPM 68.9 TPM Rs 45 crores CTO - III 4.45 TPM 28.1 TPM Rs 12 crores *$1 million is approximately about Rs 6.2 crores & TPM is tons per month In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below). Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business. Table Dr. Reddys production plans at various facilities Product Name Planned Capacity (TPM) Facility Location Alendronate Sodium Trihydrate 6.67 CTO - III Alfuzosin 2.33 CTO - I Altretamine 0.03 CTO - I Amlodipine Besylate 33.33 CTO - II Amlodipine Besylate 133.33 CTO - III Amlodipine Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2) 100 CTO - II Amlodipine Maleate 30 CTO - III Amsacrine 0.07 CTO - I Anastrazole 0.83 CTO - II Aprepitant 3.33 CTO - III Aripiprazole 0.33 CTO - II Atomoxetine 1.67 CTO - III Atorvastatin 375.83 CTO - II Azacitidine 0.67 CTO - I Bicalutamide 0.03 CTO - II Bivalirudin 0.03 CTO - II Bivalirudin Trifluoro Acetate 0.03 CTO - I Bortezomib 0.03 CTO - I Cabazitaxel 0.02 CTO - I Candesartan cilexetil 6.67 CTO - II Cetirizine Hydrochloride 66.67 CTO - I Cetirizine 16.67 CTO - II Ciprofloxacin 176.67 CTO - II Ciprofloxacin HCl 533.33 CTO - II Ciprofloxacin Lactate 33.33 CTO - II Clopidogrel Bisulfate 500 CTO - I Clopidogrel Premix 166.67 CTO - II Diluted Everolimus 5% (Everolimus) 0.33 CTO - II Disodium Pamidronate 0.33 CTO - III Docetaxel 1.9 CTO - I Dutasteride 3.33 CTO - II Esomeprazole magnesium 66.67 CTO - III Ezetimibe 3.33 CTO - II Fexofenadine Hydrochloride 500 CTO - I Finasteride 10 CTO - II Fluoxetine 110 CTO - I Fondaparinux Sodium 0.33 CTO - II Galantamine 0.03 CTO - II Gemcitabine 13.33 CTO - I Glimepiride 13.33 CTO - II Imatinib 0.17 CTO - I Irinotecan 0.33 CTO - I Ketorolac 66.67 CTO - II Lacidipine 5 CTO - III Lamotrigine 33.33 CTO - I Lansoprozole 8.33 CTO - III Letrozole 0.03 CTO - II Levocetrizine Di HCl 10 CTO - III Levofloxacin 200 CTO - II Lomustine 1.33 CTO - I Losartan Postassium 150 CTO - I Meloxicam 0.03 CTO - I Memantine HCl 3.33 CTO - II Mesalamine 0.03 CTO - II Metoprolol Succinate 266.67 CTO - II Moxifloxacin 116.67 CTO - II Norfloxacin 0.03 CTO - I Omeprazole 133.33 CTO - III Omeprazole Magnesium 50 CTO - III Omeprazole Sodium 10 CTO - III Omerprazole Form B 33.33 CTO - III Paclitaxel 0.33 CTO - I Pantoprazole Sodium 100 CTO - III paroxetine HCl 0.03 CTO - II Pemetrexed 0.67 CTO - I Rabeprazole Sodium 83.33 CTO - III Raloxifene 33.33 CTO - II Ramipril 100 CTO - III Repaglinide 6.67 CTO - II Rivastigmine 6.67 CTO - II Risperidone 13.33 CTO - I Rivastigmine 6.667 CTO - I Rizatriptan Benzoate 1.33 CTO - II Rocuronium Bromide 0.03 CTO - II Ropinrole HCl 1.83 CTO - III Rosiglitazone 3.33 CTO - II Sparfloxacin 3.33 CTO - I Tacrolimus 5 CTO - II Tadalafil 3.33 CTO - II Telmisartan 100 CTO - II Temozolamide 0.03 CTO - I Terbinafine HCl 133.33 CTO - III Tizanidine HCl 16.67 CTO - III Topotecan 0.07 CTO - I valganciclovir 0.03 CTO - I Vardenafil 3.33 CTO - II Voriconazole 8.33 CTO - III Ziprasidone Hydrochloride 100 CTO - I Zoledronic acid 0.33 CTO - III Zolmitriptan 0.83 CTO - I Zonisamide 0.03 CTO - II

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03 Apr 2015

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Find PharmaFlow Article for Ciprofloxacin Hydrochloride

Ciprofloxacin Hydrochloride

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

51 API Suppliers

23 USDMF

18 CEP/COS

3 JDMF

11 EU WC

20 KDMF

21 NDC API

19 Listed Suppliers

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

DOSSIERs // Finished Dosage Formulations

218 Dossiers

93 FDA Orange Book

37 Europe

35 Canada

2 South Africa

51 Listed Dossiers

DRUG PRODUCT COMPOSITION

SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% BASE

OINTMENT;OPHTHALMIC - EQ 0.3% BASE

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

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89 Fillers, Diluents & Binders

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