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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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29 Apr 2020

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Zhejiang Hisun’s FDA import alert; a new chapter in the fight against data integrity

A few months ago, PharmaCompass covered the Health Canada request to quarantine drugs linked to leading Chinese drug maker, Zhejiang Hisun Pharma (Hisun) due to data integrity concerns.The “interim precautionary measure” was taken “in light of recent findings from a trusted regulatory partner that raised concerns about the reliability of the laboratory data generated at this site”.Last week, the trusted regulatory partner – i.e. the United States Food and Drug Administration (FDA) – announced it had placed Zhejiang Hisun Pharma on its import alert list. Regulators unite against data integrity violations International regulatory agencies are collaborating with each other at an unprecedented pace. Health Canada’s decision to quarantine drugs from Hisun almost three months before FDA’s official action indicates an extremely low level of tolerance for companies that fail to maintain data integrity. Health Canada has also taken similar action against companies who have recently failed European inspections (e.g. India’s Polydrug Laboratories and China’s Jinan Jinda Pharmaceutical Chemistry). Polydrug Laboratories was also included in the most recent FDA Import Alert list indicating a growing impatience in international regulatory agencies against non-compliant firms. Last week, Brazilian Health Surveillance Agency (ANVISA) announced suspending import of all APIs from India’s Parabolic Drugs. ANVISA’s resolution was driven by Parabolic’s failure of a European Good Manufacturing Practices (GMP) inspection in July this year Hisun’s importance in the pharmaceutical supply chainThe FDA decision to ban almost all products coming from the Hisun facilities into the United States is going to create significant disruption in the pharmaceutical supply chain, given the colossal scale of Hisun Pharma’s operations.Zhejiang Hisun Pharma qualifies as one of the most prominent active pharmaceutical ingredients (API) manufacturers in the business, with more than 93 Drug Master Files submitted with the FDA, four approved finished products listed in the FDA Orange Book and 35 Certificates of Suitability issued by the European Directorate of Quality Medicine,.Hisun’s core operations in Taizhou city cover a very large area and are divided into three parts (the Yantou campus; Waisha Campus; and East Factory) which are separated by public roads. The Taizhou site employs approximately 4,000 people and focuses on fermentation-based anti-infectives, cardiovascular products (e.g. statins) along with synthetic anti-cancer products. Hisun’s branded generic player ambitions Two years ago, Hisun’s ambitions to transform itself from an API maker to a branded generic company were announced through the launch of Hisun-Pfizer Pharmaceutical Co., a joint venture with Pfizer where Hisun has a controlling stake of 51 percent while Pfizer has the balance 49 percent.With a vision to become “a widely respected international pharmaceutical company,” Hisun exports more than “80 percent of its API products” to more than 30 nations and regions. Hisun will not disappear post the import banHowever, Hisun’s importance in the supply chain is demonstrated by the number of exemptions which the FDA had to make in order to ensure that there are no drug shortages created as an outcome of the import alert. Fourteen products have been excluded from the import alert. Bleomycin, Capreomycin, Daunorubicin Citrate Liposomal, Doxorubicin Hydrochloride, Mitomycin, Tazobactam, Granisetron, Cladribine, Cyclophosphamide finished form and API, Cytarabine, Floxuridine, Fludarabine, Ivermectin and Adenosine will still be allowed entry into the United States from the Hisun plant. Our viewLast month we analyzed if “speedy action by European agencies suggest revival of API production in the West” and suggested that the era where companies were securing their supply of APIs by looking for low-cost players in Asia appears to be waning away.With a major Chinese player like Hisun now running into severe compliance problems and the number of alternatives available being quite limited, we foresee a significant shift in the pharmaceutical supply chain.

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17 Sep 2015

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Mylan’s great Indian misadventure

News about Mylan N.V.’s US $ 1.6 billion cash acquisition of Agila Specialties Private Limited, a developer, manufacturer and marketer of high-quality generic injectable products, from India’s Strides Arcolab is giving us a sense of déjà vu. Will this turn out to be a misadventure similar to what Daiichi Sankyo experienced with Ranbaxy? The Ranbaxy sagaJapanese drug maker Daiichi Sankyo says it got “burned” in its June 2008, US $ 4.6 billion acquisition for a controlling stake of India’s largest pharma company at that time, Ranbaxy. An FDA inspection of Ranbaxy’s facility in 2006 uncovered serious data falsification issues that made Ranbaxy eventually plead guilty in 2013 and agree to pay US $ 500 million to the US government to resolve false claims allegations, current Good Manufacturing Practices (cGMP) violations and making false statements to the FDA. Finally, Daiichi sold its stake to India’s Sun Pharmaceuticals, hoping that Sun Pharma will have better luck fixing Ranbaxy. Immediate trouble for MylanMylan announced its acquisition in February 2013 to pick up nine injectable plants which belonged to Agila. However, troubles started within four months. In June 2013, an FDA inspection found problems in the manufacturing operations at a plant in Bangalore, and issued a warning letter. Mylan continued with their acquisition and the deal closed in December 2013.Since then the problems have only got worse.On August 6, 2015 Mylan received another warning Letter, which indicates that the problems have now expanded to two other plants. The Bangalore plant (cited in 2013) was not able to address the concerns of the FDA inspectors and has also been included in the recent warning letter. Recurrent violationsConcerns found at Mylan’s operations are not as severe as the blatant data falsification found at Ranbaxy (read: Dirty Medicine by Katherine Eban for details). However, Mylan failed to address an observation made in 2013, at the Bangalore facility, which required it to “follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.”As the manufacturing operations of injectable products requires a high degree of assurance that sterility will be maintained. Mylan’s continued use of “non-integral and non-sterile gloves” in manufacturing was another concern which found mention in both the warning letters.Compliant operations are expected to thoroughly investigate drug products or components used in their manufacturing, which fail quality standards. The 2013 warning letter mentioned there was a failure to conduct thorough investigations into “non-integral gloves found” was not only a concern but a “repeat observation from 02/2011”.In the recent warning letter, the failure to conduct thorough investigations on other issues has been highlighted as well. Mylan failed to investigate the exact cause which made injection solutions change color or cause adverse reactions and hence the FDA concluded that “several violations are recurrent and long-standing”. The impact of the FDA warningMylan’s press release in response to the FDA warning letter said “this Agency action has no material impact on Mylan's business or its previously announced full year earnings guidance.” However, the FDA warning letter states that in March and April 2015, Mylan “voluntarily recalled seven “for Injection” lots of Gemcitabine 200 mg/vial, Gemcitabine 2g, Gemcitabine 1g, Carboplatin 10 mg/mL, Methotrexate 25 mg/mL, and Cytarabine 20 mg/mL.” “In June, 2015, you expanded your recall to an additional eight lots of Gemcitabine and Methotrexate. However, other lots released into distribution may have been compromised by this manufacturing issue,” the FDA warning letter added. Fixing injectable non-compliances is a monumental challengeOf late, turning around compliance problems at injectable manufacturing operations has been a big challenge for pharmaceutical companies. Companies like German giant Boehringer Ingelheim’s continued struggle with their US-based Ben Venue facility finally ended with them giving up and selling the facility to Jordan-based Hikma Pharmaceuticals. Immediately after Hikma announced the acquisition, their plans to move part of the production from Ben Venue to their facility in Portugal suffered a setback as their Portuguese operations received a warning letter. Hospira, the world’s leading provider of injectable drugs was recently acquired by Pfizer for US $ 17 billion. Hospira has been struggling to get warning letters lifted which have been issued to their injectable production in Italy, India and Australia. Hospira was able to resolve FDA’s concerns for their Rocky Mountain facility in the United States but it took them “five years and hundreds of millions of dollars in investments” Our viewThe problems being faced at Mylan are different to those that Daiichi Sankyo inherited in their Ranbaxy acquisition. However, the turnaround challenge is equally daunting since getting injectable manufacturing operations to comply with the current regulatory expectations is becoming increasingly difficult. If Mylan wants to achieve its objective to “create a global injectables leader” – which doubles its injectables production from around 350 million units to around 650 million units by 2016 – there is undoubtedly a lot of hard work that lies ahead for the Dutch (or are they American?) pharma major.

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27 Aug 2015

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