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    • ENEMA;RECTAL - 4GM/60ML
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    Top drugs and pharmaceutical companies of 2019 by revenues

    Top drugs and pharmaceutical companies of 2019 by revenues

    Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

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    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
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    J&J’s diabetes drug reduces heart risk at the cost of toes; Google’s AI eye doctor initiative

    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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    #Phispers by PHARMACOMPASS
    15 Jun 2017
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    Dr. Reddy’s expansion plans for API production

    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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    #Phispers by PHARMACOMPASS
    03 Apr 2015
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