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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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    Teva sues ex-exec romantically involved with Apotex’s CEO; Pfizer bids adieu to Brazil

    Teva sues ex-exec romantically involved with Apotex’s CEO; Pfizer bids adieu to Brazil's Teuto

    This week, Phispers brings you two tales of alleged misuse of information involving former employees of Teva and AstraZeneca. Latin America is presenting more challenges for pharma MNCs, especially with Brazil under recession. Meanwhile, FDA is investing US$ 500 million under the Cures Act, passed by the Obama Administration in December last year. And Eli Lilly has won a long-drawn patent dispute against Actavis over its cancer best-seller. Teva sues ex-exec romantically involved with Apotex’s CEO   Last week, Teva filed a lawsuit against its ex-employee Barinder Sandhu who was Senior Director, Regulatory Affairs, US Generics at Teva USA, until her termination in October, 2016. Also named in the lawsuit is Jeremy Desai, who is President and CEO of Teva’s direct competitor — Apotex, a Canada-headquartered drug firm. Teva has claimed that Sandhu breached her confidentiality agreement by sharing trade secrets and other confidential information to benefit Apotex’s own competitive product development.  According to the lawsuit, Sandhu “emailed Teva USA documents containing trade secrets and other confidential information, many specifically marked ‘Confidential’, to Desai at his Apotex email account.” She also allegedly sent information to her personal email account, in violation of Teva USA’s policies, used USB flash drives on her work-issued computer laptop and used a cloud-based drive to share “hundreds of Teva USA documents”. The information shared by Sandhu relates to a project whose identity has been concealed in the lawsuit as ‘Product X’. Teva claims that Desai and/or Apotex used the “misappropriated information to gain a competitive advantage over Teva USA”. According to the complaint, Apotex employees openly discussed Teva USA’s trade secrets and other confidential information related to ‘Product X’ and participated in roundtable discussions in an effort to advance Apotex’s potential market position of its competing generic product. The lawsuit mentions that in the summer of 2016, Teva USA learned through a former Apotex employee that Sandhu had provided Desai with a copy of highly confidential correspondence from the FDA to Teva USA known as a Complete Response Letter (“CRL”).  This letter from the FDA provided comment on an application for ‘Product X’, which was circulated amongst Apotex employees. After accusing former protege of info misuse, is AstraZeneca’s CEO leaving to take the top job at Teva?   There was more news last week, pertaining to the potential misuse of confidential information — AstraZeneca accused former executive Luke Miels of misusing confidential information and documents to win the top pharma job at GlaxoSmithKline. According to court documents obtained by the Times, Miels alleged that Pascal Soriot, AstraZeneca CEO and Miels’ former mentor, took Miels' decision to resign and join GSK very personally and “sought to threaten and punish” him by enforcing a 12-month notice period. AstraZeneca, on the other hand, alleged that Miels, who was paid US$ 1.67 million (£1.3 million) last year, “had access to information that was confidential beyond his 12-month notice period” that would damage Astra if it was obtained by a competitor. Miels’ lawyers responded by stating that AstraZeneca was in no position to complain about him using AstraZeneca’s documents in his job negotiations since AstraZeneca had shared  confidential information with Soriot before he left Roche to become Astra’s CEO. The story may take another unexpected twist as Israeli news reports say that AstraZeneca CEO Pascal Soriot has agreed to take the top job at Teva. Soriot is expected to earn twice as much as Teva’s previous CEO and receive a bonus upon signing the contract, estimated at about $20 million. Pfizer bows out with sale of Teuto in Brazil   Not long ago, Brazil was one of the hottest emerging markets for drugs, and big pharma were lining up to cash in on this opportunity. Today, Brazil is in the midst of a historic recession that has dampened drug demand. Back in 2010, when the going was good, Pfizer had struck a US$ 240 million deal for a 40 percent stake in the Brazilian generic drug firm — Laboratório Teuto Brasileiro. But the joint venture never really took off. And recently, Pfizer has accepted a payment of 1 Brazilian Real — or US$ 0.30 — to relinquish its stake to the heirs of Laboratório Teuto’s founder. For nearly a year, Pfizer had been trying to offload Teuto. A spokesperson for Pfizer said: “Since 2010, both companies have worked together to improve access to medicines in Brazil.” However, Pfizer arrived at this decision as a result of a “desire to focus resources on ensuring the success of its existing portfolio and pipeline.” Pfizer’s exit follows challenging acquisition experiences by Sanofi and Teva in Latin America. Eli Lilly wins patent dispute against Actavis over its best-selling cancer drug   Last week, Eli Lilly won a long-drawn patent dispute with Actavis after the UK Supreme Court ruled that the generic drugmaker's versions of Lilly's top-selling cancer drug — Alimta — directly infringes on certain Lilly patents in Britain, France, Italy and Spain. The generic version of Alimta (pemetrexed) is now owned by Teva, after it bought Allergan's generic business — Actavis — in August last year. Alimta is Lilly's top-selling oncology treatment. It generated sales of US$ 2.3 billion last year. This decision reportedly applies to about US$ 300 million worth of annual sales. Merck’s purchase of Sigma Aldrich under EU scanner   The European Commission has raised objections to the purchase of Sigma Aldrich by German drugmaker Merck. In a Statement of Objections sent out to Merck and Sigma-Aldrich, the Commission alleged that these companies breached EU merger rules. The companies could face a fine equivalent to 1 percent of the combined firm’s annual revenue, the Commission said. According to the Commission, when Merck and Sigma-Aldrich disclosed their merger plan in 2015 they did not share details of a project “with relevance for certain laboratory chemicals at the core of the Commission’s analysis.” The Commission said the project was being developed by one of the parts of the Sigma business that was acquired by Honeywell in October 2015. The technology developed as a result of the project was subsequently licensed to Honeywell, the Commission added. “Honeywell now has the technology it should have received with the divested business. However, this happened with a delay of almost one year and only because the Commission was subsequently made aware of the issue by a third party,” the Commission said. FDA to invest US$ 500 million innovation fund under Cures Act   Last week, the FDA laid out its plans of investing the US$ 500 million innovation fund earmarked in the 21st Century Cures Act, passed last year under the Obama Administration. The fund will be spent from this year, until 2025, and is subject to annual appropriations from the US Congress. Scott Gottlieb, FDA’s Commissioner, in a blog post, said the agency’s plans for investing the innovation fund are steps that will both improve public health (by facilitating biomedical innovation) and reduce drug costs (by cutting the burden of unnecessary regulation). FDA’s plans for the innovation fund include allocating US$ 25.8 million to advance patient-focused drug development, and US$ 95.3 million to regulatory science initiatives, including qualification of drug development tools such as biomarkers. It also plans to streamline the regulation of targeted drugs for rare diseases, and to award grants to advance continuous manufacturing technology. The largest expenditure from the innovation fund — US$ 168.2 million — is earmarked for FDA’s initiatives designed to improve the collection of evidence about safety and efficacy. “FDA’s headway in pursuing the opportunities enabled by Cures illustrates the agency’s enthusiasm and commitment to the law—both its letter and its spirit,” Gottlieb said in his blog. Did Gilead use Chinese API claiming it came from an approved South Korean manufacturer?   The United States Court of Appeals for the Ninth Circuit reversed a federal judge’s 2015 ruling in the Gilead Sciences’ case. The US drugmaker is back in court to defend accusations that it made false statements about complying with federal regulations on HIV drugs. There were allegations that Gilead had netted billions of dollars in government purchases, and that it had fired a whistleblower — a senior employee who spoke against the company’s illicit conduct. The ex-employees claim that Gilead used a company called Synthetics China to produce unapproved emtricitabine, at unregistered facilities, to save money. For almost one and a half years, beginning in 2007, Gilead imported emtricitabine API from Synthetics China to use in its finished drugs, claiming that the API had come from its approved South Korean manufacturer. Emtricitabine is used by Gilead to produce several HIV drugs, such as Atripla, Emtriva and Truvada. The Ninth Circuit three-judge appeals panel held that former Gilead employees Jeff and Sherilyn Campie had adequately pleaded that Gilead’s conduct opened it to liability under the False Claims Act (FCA). In 2008 and 2009, the government paid more than US$ 5 billion for the HIV drugs, the court held.  

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    #Phispers by PHARMACOMPASS
    13 Jul 2017
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    After beef, India may ban gelatin capsules; GSK, Gilead’s HIV race heats up

    After beef, India may ban gelatin capsules; GSK, Gilead’s HIV race heats up

    This week in Phispers, we bring you the latest twists in the GSK-Gilead rivalry over HIV drugs. India, which recently banned beef nationwide, plans to now replace gelatin with cellulose-based capsules. A lawsuit in the US says Mylan may have overcharged the government US$ 1.27 billion in the form of rebates on EpiPens. And, there is an update on the opioid crisis. Read on. After beef, India mulls banning animal-based gelatin capsules   As India deals with the aftermath of the controversial cattle trade ban, the Health Ministry is reviewing a proposal to replace gelatin capsules with cellulose-based capsules which are of plant origin and are “safe for use” as compared to animal-based gelatin capsules. Various stakeholders, NGOs and consumers have 21 days to weigh the pros and cons of this proposal and respond. India’s ministry of health and family welfare constituted an expert committee on March 20 this year to address all technical issues pertaining to replacement of gelatin capsules with cellulose-based capsules for encapsulation of drugs. The Indian government's ban on the trade of cattle for slaughter threatens US$ 4 billion in annual beef exports and millions of jobs if the government does not revoke it. Indian meat traders, under the aegis of the Qureshi Action Committee and other trade and industry associations, plan to petition India's Supreme Court to get the government order revoked. As Pfizer hikes price of 91 drugs, Maryland enacts law to curb generic drug price gouging   Last week, we had shared our list of drugs with ‘no patents and no competition’.  While our list provides tremendous opportunities for generic companies in the short-term, we also warned that the FDA’s continued focus on accelerating review of these drugs will require companies to rely on strategies less opportunistic than price gouging, to drive their future business growth. On October 1, 2017 Maryland will become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers. The Bill was passed by the Maryland General Assembly on April 20, 2017. On May 26, Maryland Governor Larry Hogan sent a letter to the Speaker of the House stating that he would allow the bill to become law without his signature. The move coincides with Pfizer hiking the price of 91 drugs by an average of 20 percent so far this year in the United States. This includes price hikes for its erectile dysfunction treatment, Viagra, and its pain drug, Lyrica, on June 1. There are two essential provisions of the Maryland Bill. First, it prohibits a generic drug manufacturer or wholesale distributor from engaging in price gouging in the sale of an “essential off-patent or generic drug.” Second, the Bill authorizes the Maryland Medical Assistance Program (MMAP) to notify the Maryland Attorney General of a price increase when the Wholesale Acquisition Cost (WAC) of a prescription drug increases by at least 50 percent from the WAC within the preceding one-year period. Or, when the price paid by MMAP would increase by at least 50 percent from the WAC within the preceding one year period and the WAC for either a 30-day supply or a full course of treatment exceeds US$ 80. Mylan may have received US$ 1.27 billion more in rebate for EpiPens   In the US, Senate Judiciary Committee Chairman Charles Grassley released a Medicaid investigator's report which highlighted that Mylan’s EpiPen may have received US$ 1.27 billion more from the rebate program from 2006 through 2016 than what the company was entitled to receive. The amount is nearly three times a proposed settlement that the company had announced in October 2016. Earlier, Mylan had said it would return US $465 million to the government as part of settlement negotiations with the Department of Justice (DOJ). Talks with the DOJ continue. Senator Grassley has been involved in a long exchange with Mylan questioning the significant price-hikes which the company had implemented over the years. The EpiPen auto-injector, used to treat allergic reactions, cost US$ 57 a shot when Mylan purchased it in 2007. However, a series of price increases has raised the cost to more than US$ 600 for a pair of EpiPens. Before the price hike controversy hit Mylan, the Epipen generated more than US$ 1 billion in sales and contributed about 40 percent to Mylan’s overall profits. GSK, Gilead’s HIV contest heats up, as GSK goes for priority review   Two of the top 10 fastest growing drugs in 2016 were those used to treat HIV. GlaxoSmithKline’s Triumeq (abacavir, dolutegravir, lamivudine) and Gilead’s Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), both generated a sales growth in excess of US$ 1 billion. For a long time, Gilead dominated the HIV market. But GSK fought back recently. In an effort to stay ahead in the game, GSK used a priority review voucher, for which it paid US$ 130 million, to shave four months off its application approval process. ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc and Shionogi Limited as its shareholders, announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the first HIV maintenance regimen single-tablet, which comprises of only two medicines. The two-drug regimen contains dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant, Janssen Sciences Ireland UC). However, don’t count Gilead out. In four late-stage studies, the US company's new drug bictegravir was found to be as effective as GSK's established dolutegravir, which has been the cornerstone of the British group's growing HIV business in recent years. This year, Gilead plans to apply for regulatory approval to sell its combination of bictegravir and emtricitabine/tenofovir alafenamide (FTC/TAF), with a submission in the US in the second quarter and in Europe in the third quarter. If Gilead uses a priority voucher at the US FDA, it could launch in the US market in the first quarter of 2018, industry analysts said. Mallinckrodt explores divestment of its generics business   Mallinckrodt Plc plans to sell off its generic drug unit in a deal that could fetch the company around US$ 2 billion. The move would also help the specialty pharmaceutical maker shift towards higher-margin branded drugs. Mallinckrodt's generics unit has seen its sales plummeting, in part because some of its products include opiate-based pain killers, which have fallen out of favor with doctors due to their addictive potential. The divestment would complete the company’s gradual shift away from its original focus on generic drugs and nuclear imaging towards branded specialty pharmaceuticals, which now make up for bulk of its revenues. Between 2015 and 2016, Mallinckrodt's generic drug sales declined around 18 percent, to just over US$ 1 billion. During the same period, sales of branded specialty drugs increased by around US$ 2.3 billion. The England-based Mallinckrodt has reportedly hired investment bank Credit Suisse Group AG to run a sale process for the unit. Canadian researchers trace the origins of the opioid crisis, as Ohio sues drug makers   Last week, the state of Ohio in the US sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a skyrocketing drug addiction epidemic. Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the US Centers for Disease Control and Prevention. Canadian researchers have traced the origins of the current opioid crisis to a letter published in the New England Journal of Medicine (NEJM) in 1980, which stated that opioids were not addictive. The original letter titled ‘Addiction Rare in Patients Treated with Narcotics’, was just a paragraph long. The lone evidence the letter cited was an anecdote that out of 11,882 hospitalized patients treated with narcotics, only four patients with no history of addiction became addicted. The journal's prestige helped fuel this misguided belief. The letter was cited over 600 times, usually to argue that opioids were not addictive. Last week, the NEJM published an unusual warning for readers about the 1980 letter. The editor's note on the original letter in the NEJM reads, "For reasons of public health, readers should be aware that this letter has been 'heavily and uncritically cited' as evidence that addiction is rare with opioid therapy." The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc".    

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    #Phispers by PHARMACOMPASS
    08 Jun 2017
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