Budesonide
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)   

Impressions: 54653

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

#PharmaFlow by PHARMACOMPASS
29 Apr 2020
Trump tells FDA to fund itself fully through industry fees; Astra’s CEO dumps Teva offer
This week, Phispers brings you lots of regulatory news from the US, where the Trump administration has instructed FDA to fund itself entirely through industry fees; and the agency’s chief has pledged to accelerate generic reviews through two new policies. This was yet another bad week for Teva, as it faced charges in Europe, lost a patent battle in the US to Takeda, and AstraZeneca’s CEO reportedly tossed away an offer to head it. Plus, there is news on AstraZeneca’s investment in China and Novartis’ CAR-T cell therapy for cancer. Teva’s woes continue: Faces EC charges; loses patent battle; and Soriot drops offer   Teva’s troubles continued unabated. First, Pascal Soriot, the chief executive of AstraZeneca, who was rumored to be the next head of the Israeli drugmaker, decided not to leave AstraZeneca. He is reportedly forgoing an offer of a US$ 20 million bonus, and a chance to reorganize Teva, the world’s largest generic drug company. Last week, the UK-based drug firm confirmed that Soriot would be presenting AstraZeneca’s second-quarter earnings, on July 27. Rumors of Soriot’s likely appointment were floated by an Israeli financial website. Teva is likely to announce the name of its new CEO within a month, Chaim Hurvitz, a member of Teva’s founding family, said. Second, the European Commission (EC) charged Teva of doing an illegal deal with Cephalon to delay selling a cheaper generic version of Cephalon’s sleep disorder drug. In the past, the EU regulator has charged scores of other companies as well, including Denmark’s Lundbeck, USA’s Johnson & Johnson and France’s Servier. According to the regulator, the pay-for-delay deals cost European consumers billions of euros. Third, the Israeli pharma biggie lost a patent battle in the US appeals court to Takeda Pharmaceutical. The court said a patent on Takeda's cancer treatment — Velcade — is valid, pushing back the date when generic drug makers, including Teva and Mylan, will be allowed to launch lower-cost versions of the drug in the US. AZ invests US$ 79 million in Australia to cater to China’s demand for asthma drug   Air pollution is choking people in the big cities of China, raising demand for AstraZeneca’s asthma medicine — Pulmicort respules. As a result, the British pharmaceutical giant announced an investment of US$ 79.27 million (AUD $100 million)  last week at its Sydney site which manufactures the treatment.  The announcement was made in London on July 13, at a meeting between AstraZeneca CEO Pascal Soriot and Australia’s Prime Minister Malcolm Turnbull. AstraZeneca will add three production lines to the existing eight at its Sydney site, each with a capacity to produce over 70 million units of Pulmicort respules in a year. The company will bolster exports from the site to over US$ 1.9 billion (AUD 2.4 billion) in the next four years, with a further goal of doubling respules production to 1 billion by 2025. “The demand for this asthma product, particularly for children in China, is immense and we see that trend continuing,” Mark Morgan, manufacturing director of AstraZeneca Australia, said. Although labor costs are lower in China, the manufacturing technology “is difficult to replicate,” Morgan added. Over 50 percent of Pulmicort’s worldwide sales come from China. And its demand increased by 18 percent — from US$ 485 million in 2015 to US$ 570 million in 2016. White House tells FDA to fund itself via industry fees; FDA scouts for top talent   In the US last week, the House of Representatives passed the bill that reauthorizes US Food and Drug Administration (FDA) to levy user fees. Soon after that, the White House reiterated its earlier call to amend the agreements so that the FDA is entirely funded by the medical products industries. In a statement, the White House said: “The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs… In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.” Last week’s statement said President Trump is “concerned with certain other provisions in the bill, such as those providing additional market exclusivity to manufacturers, which could make exclusivity unpredictable and decrease competition.” Meanwhile, the FDA Commissioner Scott Gottlieb is embarking on a talent hunt to recruit new staffers for the Prescription Drug User Fee Act (PDUFA)-related positions in the drugs and biologics programs. “To take on this new effort, we’re establishing a dedicated group of full-time staff with the responsibility to ensure that we reliably and predictably identify, recruit, and efficiently hire the scientific personnel the Agency needs,” Gottlieb said in his blog. Novartis’ CAR-T cell therapy unanimously recommended for approval by FDA   The US FDA’s advisory committee has unanimously (10:0) recommended Novartis’ CAR-T cell therapy — CTL019 (tisagenlecleucel) — for approval to treat pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). CAR-T is short for chimeric antigen receptor T cell (CAR-T) therapy. In the US, ALL is the most common childhood cancer. This therapy is an immunotherapy approach to treat cancer, also considered the “fifth pillar” (after surgery, chemotherapy, radiation and targeted therapies like imatinib and trastuzumab) of cancer treatment. This approach, called adoptive cell transfer (ACT), uses engineered immune cells to generate remarkable responses in patients with advanced cancer. In several early stage trials, when ACT was tested in patients with advanced ALL (with few treatment options left before these patients), many reported a complete disappearance of the cancer. And these patients remained cancer free for extended periods. Therefore, Novartis’ CTL019 assumes tremendous importance. Meanwhile, the FDA advisory committee also unanimously recommended Biocon/Mylan’s and Amgen’s biosimilars for approval. The two recommendations imply a double whammy for Roche, with its drugs Avastin and Herceptin poised to get impacted by these biosimilars. The FDA’s Oncologic Drugs Advisory Committee (ODOC) voted 16-0 in favor of Milan’s proposed Herceptin biosimilar to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease. The ODOC also voted 17-0 to recommend FDA approval for Amgen’s ABP 215, an Avastin biosimilar, in each of the approved indications for the reference medication. The uses include metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma. Concord Biotech faces GMP concerns; FDA warning letters to firms in India, Italy   Ahmedabad-based Concord Biotech, a research and development-driven biotech firm that makes fermentation-based APIs, was placed on Health Canada’s Inspection Tracker due to “general GMP observations” shared by a regulatory partner. While no details of the observations were divulged, Health Canada did not mention any data integrity concerns and is “continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner).” The FDA also issued a warning letter to Tubilux Pharma SpA in Italy over concerns arising from an inspection conducted in December 2016. The investigators raised concerns over turbulent airflow on an aseptic processing line which “poses a significant contamination hazard” to the product. Limitations in Tubilux’s “current equipment and process design” also posed “a significant hazard” in the aseptic processing operation. The warning letter also highlights that some of the products manufactured at Tubilux were not tested for particulates prior to release. During the inspection, FDA “observed repeated instances of high particle count alarms during production”. Tubilux specializes in manufacturing various types of products used in ophthalmic applications. A September 2016, FDA inspection at Vista Pharmaceuticals in India highlighted concerns over the sale of isoxsuprine hydrochloride USP, 20 mg tablets, by the firm. Although isoxsuprine hydrochloride is sold in the US, the drug is not approved in the Orange Book. The firm had also not validated the manufacturing process for isoxsuprine hydrochloride USP, 20 mg tablets. The warning letter also mentions that during the walk through of the firm’s manufacturing areas, FDA investigators observed that the equipment was in a state of disrepair. “Specifically, our investigators saw holes and corrosion in three pieces of equipment,” the letter noted. FDA chief pledges to accelerate generic reviews through two new policies   This week, the US FDA Commissioner, Scott Gottlieb, made an announcement that by the end of 2017, the American drug regulator will issue two new documents to improve the review process for generic drugs. These documents are meant to streamline the submission and review of abbreviated new drug applications (ANDAs) under the FDA’s drug competition action plan. The first document is a planned internal manual of policies and procedures (MAPP) — titled “Good ANDA Assessment Practices”. It will look to reduce “unnecessary” and “duplicative” procedures from FDA’s reviews to make them more efficient. However, the document will not alter any of the review goals the FDA agreed to as part of the negotiations to reauthorize the GDUFA. For applications that aren’t approved, MAPP will instruct reviewers to detail what needs to be fixed in the complete response letter (CRL), and provide follow up with sponsors over phone if the reasons in the letter are unclear, Gottlieb said. The second document will be a guidance on “Good ANDA Submission Practices”. It will be added to the Center for Drug Evaluation and Research’s ‘to-do list’ for the year, which already includes 13 other new and revised draft guidances for generic drugs. According to Gottlieb, this guidance will detail common issues found in ANDA submissions and give sponsors advice on how to avoid those issues before submitting an application.  

Impressions: 3431

https://www.pharmacompass.com/radio-compass-blog/trump-tells-fda-to-fund-itself-fully-through-industry-fees-astra-s-ceo-dumps-teva-offer

#PharmaFlow by PHARMACOMPASS
20 Jul 2017
GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal
This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics.   GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field.  Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs.  FDA continues to race ahead with generic approvals  The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark  In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements.  Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million..  The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement. 

Impressions: 2749

https://www.pharmacompass.com/radio-compass-blog/gsk-google-form-first-bioelectronics-firm-11-generic-companies-benefit-from-the-teva-allergan-deal

#PharmaFlow by PHARMACOMPASS
04 Aug 2016
Who has the biggest one? Sales of the top pharma products by revenue.
We always knew math was fuzzy, but never imagined addition could get so complicated.  A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best selling products along with the top therapy areas. The list, based on data published by IMS Health, caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical companies.  As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics. Which pharmaceutical company is the largest? Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company.  Should divisions like diagnostics, animal health, vaccines, consumer health be counted when determining the size of a pharmaceutical company? FiercePharma, in their analysis, used the total revenue of all divisions of the organizations to determine the largest organization; in their case it is Johnson & Johnson. IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest company. As currency exchange rate fluctuations have their own, big role, in determining the size of organizations, we believed it would be best to share the revenues, as presented, so that you can draw your own conclusions. Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports)  Big Pharma IMS Rank IMS Sales (US $Mn) Fierce Pharma Rank Fierce Pharma Sales (US $Mn) Group Sales based on the Annual Report (Currency as reported, Mn)    Novartis 1 51,307 2 57,996 USD 57,996 Pfizer 2 44,929 4 49,605 USD 49,605 Sanofi 3 40,037 5 43,070 Euro 33,770 Roche 4 37,607 3 49,866 CHF 49,866 Merck & Co 5 36,550 6 42,237 USD 42,237 Johnson & Johnson 6 36,422 1 74,331 USD 74,331 AstraZeneca 7 33,313 8 26,095 USD 26,095 Glaxo SmithKline 8 31,470 7 37,960 GBP 23,006 Teva 9 26,001 11 20,272 USD 20,272 Gilead Sciences 10 23,673 10 24,474 USD 24,890 Amgen 11 20,473 12 20,063 USD 20,063 Lilly 12 19,909 14 19,615 USD 19,615 AbbVie 13 19,049 13 19,960 USD 19,960 Bayer 14 18,347 9 25,470 Euro 42,239 Bristol-Myers Squibb Not in Top 20 15 15,879 USD 15,879 NB: Mn is million Click here to access and download all the 2014 data (Excel version available) for FREE! Since each group has multiple divisions, we further split the sales for you to brainstorm: Table 2/ Sales comparison of the different divisions of top pharmaceutical companies in 2014 (Annual Reports in Mn)  Big Pharma Pharma Division Vaccine Division Generics Consumer Health Other Divisions Medical Devices/ Diagnostics Division Animal Health Division Divestures/ Other adjustments Novartis USD 31,791   Sandoz USD 9,562   Alcon USD 10,827     USD 5,816 Pfizer USD 45,708     USD 3,446 USD 451       Sanofi Euro 22,578 Euro 3,974 Euro 1,805 Euro 3,337     Euro 2,076   Roche CHF 38,969         CHF 10,897     Merck & Co USD 30,740 USD 5,302     USD 6,195       Johnson & Johnson USD 32,313     USD 14,496   USD 27,522     AstraZeneca USD 26,095               Glaxo SmithKline GBP 18,670     GBP 4,336         Teva USD 10,458   USD 9,814           Gilead Sciences USD 24,474             USD 416 Amgen USD 19,327       USD 736       Lilly USD 16,481       USD 788   USD 2,346   AbbVie USD 19,960               Bayer Euro 12,052     Euro 7,923       Euro 22,264 Bristol-Myers Squibb USD 15,879               Click here to access and download all the 2014 data (Excel version available) for FREE! Not sure that it adds any extra clarity on what should define a global pharmaceutical company… Since the various divisions make companies complicated to assess, what about product sales? The good news is that we have a winner!  Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason. Unfortunately, things stopped making sense the moment we reached the number-two product on the IMS list. Lantus®, Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%.   So unless the Euro/Dollar exchange rate moves back towards the 1.5 range, there seems to be a serious difference in the way the product sales are calculated by companies and by IMS.    Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications! Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports) Products IMS Rank IMS Sales (US $Mn) Annual Reports Sales (US $Mn) Pharma Compass Rank Big Pharma Currency Annual Reports Sales in Mn Marketing Partner Marketing Partner Annual Report Sales (US $Mn) Humira® 1 11,844 12,543 1 Abbvie USD 12,543     Lantus® 2 10,331 7,676 5 Sanofi Euro 6,344     Sovaldi® 3 9,375 10,283 2 Gilead Sciences USD 10,283     Abilify® 4 9,285 7,556 6 Bristol Myers-Squibb USD 2,020 Otsuka 5,536 Enbrel®   5 8,707 8,538 4 Amgen USD 4,688 Pfizer 3,850 Seretide® 6 8,652 6,589 8 GSK GBP 4,229     Crestor® 7 8,473 5,512 11 AstraZeneca USD 5,512     Remicade®   8 8,097 9,880 3 Johnson & Johnson USD 6,868 Merck & Co. 2,372 Mitsubishi Tanabe 640 Nexium® 9 7,681 3,655 19 AstraZeneca USD 3,655     Mabthera®   10 6,552 6,936 7 Roche CHF 5,603 Roche 1,305 Avastin®   11 6,070 6,449 9 Roche CHF 6,417     Lyrica® 12 6,002 5,168 12 Pfizer USD 5,168     Herceptin®   13 5,564 6,306 10 Roche CHF 6,275     Spiriva® 14 5,483 3,917 17 Boehringer Euro 3,237     Januvia® 15 4,991 3,931 16 Merck & Co. USD 3,931     Copaxone® 16 4,788 4,237 14 Teva USD 4,237     Novorapid® 17 4,718 2,835 20 Novo Nordisk DKK 17,449     Neulasta® 18 4,627 4,596 13 Amgen USD 4,596     Symbicort® 19 4,535 3,801 18 AstraZeneca USD 3,801     Lucentis®   20 4,437 4,152 15 Novartis USD 2,441 Roche 1,711 Click here to access and download all the 2014 data (Excel version available) for FREE! It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view. Our take: With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing upon and others, which may not be worthwhile to pursue. While the assessment of pharmaceutical sales is far more complicated than what we had originally imaged, the focus of Big Pharma on small molecules is on Hepatitis C drugs (Sofosbuvir,­ Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments. Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports) Products Big Pharma Sales (US $Mn) 2013 Sales (US $Mn) 2014 Growth (%) Ibrutinib Pharmacyclics, Inc (now AbbVie) 14 492 3414% Dasatinib Bristol-Myers Squibb 1280 1493 17% Trametinib GSK 10 68 580% Nilotinib Novartis 1266 1529 21% Ruxolitinib Novartis 163 279 71% Ceritinib Novartis Not launched 31   Sunitinib Maleate Pfizer 1204 1174 -2% Crizotinib Pfizer 282 438 55% Axitinib Pfizer 319 410 29% Tofacitinib Citrate Pfizer 114 308 170% Click here to access and download all the 2014 data (Excel version available) for FREE! However, Big Pharma is now all about biologics. IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”.  The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis). Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!  

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https://www.pharmacompass.com/radio-compass-blog/who-has-the-biggest-one-sales-of-the-top-pharma-products-by-revenue

#PharmaFlow by PHARMACOMPASS
23 Apr 2015