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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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    https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
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    India leads DMF submissions to the FDA during Q4 of 2016 and Q1 of 2017

    India leads DMF submissions to the FDA during Q4 of 2016 and Q1 of 2017

    A review of the Drug Master Files (DMFs) submitted to the United States Food and Drug Administration (FDA) from October 2016 to March 2017 (the fourth quarter of 2016 and the first quarter of 2017) indicates an extremely robust pharmaceutical industry in India. However, the filing make one question an article we had carried earlier this month on the end of India’s pharma honeymoon. India filed more than half the DMFs submitted   Indian companies filed more than half (176) of the 345 DMFs submitted with the FDA. China (60) came a distant second, followed by the United States (40). While DMF submissions were made from 26 other countries, the activity levels seen were a far cry from what was seen in India and China.  In our past compilation for the second and third quarters of 2016, Macleods Pharmaceuticals (14 DMFs) had pipped MSN Laboratories (13 DMFs) to become the leading filer from India. However, in the recent review period, MSN bounced back with 41 DMF submissions, compared to six for Macleod. Leading Indian pharmaceutical majors such as Aurobindo, Sun Pharma, Amneal, Mylan’s India operations, Hetero, Cipla and Jubilant had six or more filings each. Ajinomoto’s North American operations filed 11 DMFs for various amino acids and led the submissions for products manufactured in the United States.  Tianjin Weijie Pharmaceutical led the pack from China, with eight DMF submissions.   Over the review period, a total of 345 submissions were made to the FDA, almost similar to the 379 DMFs filed during the second and third quarters of 2016. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! The next FTF challenges  Since APIs form the building blocks of finished formulations, DMF submissions give a sneak preview into the next possible first-to-file (FTF) generic challenges to patented drugs.  In December 2016, Indian drug major Sun Pharmaceutical Industries announced it will acquire a branded oncology product, Odomzo, from Novartis for an upfront payment of US$ 175 million. A little over three months after the announcement, MSN Labs filed the first DMF for Odomzo’s active pharmaceutical ingredient (API), sonidegib phosphate. Odomzo was approved by the FDA in July 2015 and is indicated for the treatment of adult patients with locally advanced basal cell carcinoma. While patents for Novartis’ drugs Tafinlar and Mekinist are not scheduled to expire until 2029, Novartis should prepare for a generic competitor as DMFs were filed for the APIs used in both drugs by MSN Labs. The drugs had combined sales in 2016 of US$ 672 million. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! In addition, MSN Labs also filed the first DMF for nintedanib esylate, the API used in Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment, Ofev, and for cabozatinib (S)-malate, the API used by Exelixis for its kidney cancer treatment — Cabometyx. While in most cases MSN’s DMF is the first one to get filed, in the case of Helsinn’s Akynzeo, which is used to prevent chemotherapy-induced nausea and vomiting, Apicore US also filed a DMF along with MSN. Although sales forecasts for Bayer’s pulmonary arterial hypertension treatment — Adempas (riociguat) — were lowered as the drug did not get the expected sales start and planned label expansions did not materialize, this did not stop MSN Labs from filing the first DMF for this product as well. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Another drug which is struggling to meet analyst expectations is Novartis’ Entresto. Once considered “one of the most important products in the company's history” with an expectation to reach US$ 10 billion in peak sales, the drug generated sales of only US$ 170 million in 2016. Regardless, Mylan filed the first DMF for the API.  Another drug where MSN Labs did not file the first DMF was for AstraZeneca’s ovarian cancer treatment, Lynparza (olaparib). Alp Pharm Beijing submitted the DMF for the drug which generated US$ 218 million in sales in 2016 and a figure Bernstein Research analyst Timothy Anderson forecasts will grow to US$ 684 million by 2020. The onslaught on Novartis’ portfolio is not limited to only patented products as Lamprene, a product which has been on the market since 1986, and not had any generic competitor, had Zhejiang Huahai file a DMF indicating a generic competitor maybe on the horizon soon. Mylan’s Sotradecol has been the only injectable form of sodium tetradecyl sulfate on the market since 2004. That monopoly may end soon as the FDA completed the review of a DMF filed for the API early this year. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Most actively filed products — vortioxetine hydrobromide and dolutegravir sodium  The most actively filed DMFs, with seven filings each, were those for Takeda’s depression drug Trintellix (vortioxetine hydrobromide) and GSK’s HIV treatment dolutegravir sodium. Johnson & Johnson’s diabetes treatment Invokana (canagliflozin), which recently demonstrated that it decreased the risk of heart attacks and strokes, while increasing the risk of amputation, particularly of toes, had six new DMFs filed. There were also six new DMFs filed for apremilast, five for darunavir and four each for dapagliflozin and rivaroxaban. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Filings for new drugs under development  Helsinn is moving ahead with the filing of anamorelin hydrochloride, as it filed DMFs for the API and the 100 mg tablets, a product which was welcomed enthusiastically by oncology experts as it raised hopes to be a drug for cancer cachexia, the extreme wasting seen at the end stages of the disease. But those hopes were recently dashed, as a review of the clinical data by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) found only "marginal" effects and recommended that the product be refused marketing authorization in Europe. Now it remains to be seen what the FDA’s verdict on this drug will be.  Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! AB Science’s Masitinib has been in the news recently as an EMA committee announced the drug, developed for a range of cancers, could not be approved due to “serious failings” in the way clinical studies were conducted.  However, this did not stop Excella GmbH from filing its second DMF for the API. Multiple sclerosis treatment dimethyl fumarate (Biogen’s Tecfidera) generated sales of US$ 3.97 billion in 2016 and is projected to achieve US$ 5.56 billion by 2020.  While there are now 28 DMFs filed for dimethyl fumarate, in March this year Alkermes announced the initiation of a new phase 3 study of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis. It remains to be seen when Alkermes’ product will get approved. However, MSN Labs followed Honour Labs to file the second DMF for this product. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! A new submission for deslorelin acetate (an injectable gonadotropin releasing hormone super-agonist) indicates there maybe a new drug development underway for this age-old peptide as currently there are no approved drugs in the US. A similar situation seems to exist for taurolidine, an antimicrobial that seeks to prevent infections in catheters. Vasudha Pharma’s filing of cisapride monohydrate comes as a surprise. The product, which was launched by Janssen for increased motility of the gastrointestinal tract, was later withdrawn from the US market due to concerns of fatalities linked to cardiac arrhythmias. The product, however, continues to be exported from India to countries like Switzerland, Thailand, Mexico, China and Canada. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Our view  The last quarter of 2016 and the first quarter of 2017 clearly demonstrate an API industry in India and China, which is extremely active with new product development, regardless of disappointing financial results posted by major pharma companies and growing concerns over regulatory non-compliances. Given the market headwinds and increased compliance expectations, it remains to be seen how many of these DMFs filed actually result in drugs reaching the market. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!  

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    https://www.pharmacompass.com/radio-compass-blog/india-leads-dmf-submissions-to-the-fda-during-q4-of-2016-and-q1-of-2017

    #PharmaFlow by PHARMACOMPASS
    22 Jun 2017
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