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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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FDA haunted by problems at Chinese plant; Sun Pharma gets entangled in price gouging furor

Phispers brings you the latest in global pharma news, such as how the drug price hike uproar in the US is affecting Sun Pharma, how the UN may adopt a resolution on fighting the menace of antibiotic resistance and how bioelectronics is working towards improving diabetes care. And there is more on Zhejiang Hisun, Novartis and GSK. Import alert on Zhejiang Hisun continues to haunt the FDAA little over a month ago, Bloomberg highlighted the challenges of banning China’s Zhejiang Hisun. This week, the FDA had to exempt even more products to ensure supply sustainability in the United States. In addition to the 14 drugs which were exempted when the initial import alert was announced, Sulbactam Sodium and Mesna have now been excluded from the import alert list.The FDA had issued an indefinite ban on the Zhejiang Hisun factory. Yet, in order to avoid possible shortages of drugs, the FDA allowed the plant to continue to export 15 ingredients for use in finished drugs in the US, including nine key cancer medicine components. In the US, more than 80 percent of drug ingredients are produced overseas, in mainly China and India. The FDA has stepped up inspections in order to check quality. However, it relies on pharmaceutical companies to ensure the ingredients are up to the US standards. Sun Pharma’s unit gets summoned for price gouging in the USThe ripples of the ongoing uproar in the US over high drug prices can be felt in India. Last week, the US Department sent grand jury subpoenas to Sun Pharmaceutical Industries’ unit – Taro Pharmaceuticals. In a statement to the Securities Exchange Commission, Taro said two of its commercial executives in its US unit were summoned by the antitrust division of the Department of Justice (DOJ). The DOJ sought “communications with competitors and others” regarding the sale of generic drugs. Taro contributed US $ 230 million to Sun Pharma’s US $ 375 million revenue from the US last year.According to a news report, Taro has received notice for raising the price on clobetasol – a steroid that is sold as a topical ointment, cream, and gel – substantially between July 2011 and June 2014. The price of 15 grams of 0.05 percent topical ointment increased from US $5.75 to US $124.36 during the period, according to Truven Health Analytics. UN General Assembly to take up antibiotic resistance next weekNext week, we will know whether combatting the menace of antibiotic resistance will become an international priority or not. The United Nations will open its two-week long General Assembly in New York next week, where it will debate issues of global importance. On September 21, the assembly will host a “high-level meeting” on the threat of resistant bacteria. The assembly will showcase presentations from representatives of governments and non-profit and academic organizations. The same day, the UN is expected to adopt its first-ever resolution on the importance of combating antibiotic resistance, and perhaps also some sort of a commitment to action.According to estimates, antibiotic resistance kills 700,000 people around the globe each year, with 23,000 people dying each year in the US and 25,000 in Europe. After Novartis and GSK, Google now ties up with Sanofi This week, there was some big news in the field of bioelectronics, a novel field of medicine that is focused on fighting diseases by targeting electrical signals in the body. Sanofi and Verily (the life sciences unit of Google parent Alphabet) announced they would invest about US $ 500 million in a joint venture combining devices with services to improve diabetes care.The deal with the French drug maker Sanofi comes after British drug maker GlaxoSmithKline (GSK) and Verily created a new bioelectronics company. Verily is also working on the development of a smart contact lens in partnership with Swiss drug maker Novartis that has an embedded glucose sensor to help monitor diabetes. These partnerships are examples of growing ties between the pharma and tech sectors.There was more positive news from Sanofi. Last week, it received positive data from a Phase III study of their diabetes drug sotagliflozin. Considered the next-gen improvement on the SGLT2 (sodium/glucose cotransporter 2) inhibitors, investigators say that two doses of sotagliflozin were able to reduce A1C levels by 0.43 percent and 0.49 percent in patients with type 1 diabetes. GSK sells anesthetic drugs to South Africa’s Aspen for US $ 370 millionAs part of its drive to focus on core therapy areas, British drug maker GlaxoSmithKline is selling its portfolio of anesthetic drugs to South Africa's Aspen Pharmacare for around US $ 372 million (GBP 280 million).On Monday, the two companies announced that Aspen would pay GBP 180 million (US $ 238 million) for the products Ultiva, Nimbex, Tracrium, Mivacron and Anectinein, and an additional GBP 100 million (US $ 132 million) in milestone payments. The two firms have a long history of working together. GSK has already sold the US and Canadian rights to these drugs. The company earned around GBP 35 million (US $ 46 million) from the anaesthetics in the first half of 2016. Novartis finds ECA support in its battle over ban on toxic chemicalNovartis recently received significant support from the European Chemicals Agency in its battle over diglyme – a toxic chemical that Novartis used for making an ingredient found in two medicines.Last month, the ECA decided to support a Novartis request for a seven-year exemption from a pending ban on diglyme. The chemical is used to make indacaterol, an ingredient in treatments for chronic obstructive pulmonary disorder. The ban goes into effect in August 2017.A final decision, however, will be made by the European Commission. And, it is unclear when the decision will be made. However, a leading environment group – ChemSec -- has urged ECA to support the ban. ChemSec had insisted the ban should be upheld due to “socio-economic” costs associated with continued use of the chemical, as well as negative consequences for companies that produce potential alternatives.

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15 Sep 2016

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FDA haunted by problems at Chinese plant; Sun Pharma gets entangled in price gouging furor

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