Oseltamivir Phosphate
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: 54752

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

#PharmaFlow by PHARMACOMPASS
29 Apr 2020
World looks for effective treatment to coronavirus, as drugmakers, regulators race ahead to find vaccines, cure
Now that the World Health Organization (WHO) has declared the new coronavirus (2019-nCoV) as a public health emergency of international concern, some of the biopharma industry’s biggest names are taking important steps to combat the disease. The death toll from the coronavirus outbreak is rising each day. As many as 563 people have died in China, and the virus has now spread to nearly 30 countries across the world, including Japan, Thailand, Singapore, Hong Kong, South Korea, Australia, Malaysia, Germany, India and the US. In fact, infectious disease specialists and scientists say the new coronavirus may be more contagious than what the current data suggests. The virus has spread from about 300 people on January 21 to over 28,000 people across the world. The numbers may be even higher as there is limited testing capacity. “The rapid acceleration of cases is of concern,” Dr. Mike Ryan, executive director of the WHO’s emergencies program said last week. Health authorities all over the world are trying to contain the outbreak. In the US, nearly 200 Americans were placed under quarantine at a US air base in California after being evacuated from Wuhan, China. Under the new restrictions, US citizens who have traveled to China within the last 14 days will be directed to one of the 11 airports designated for screening. The FDA is halting travel of all its employees to China and recalling its inspectors from the country. Shortage of face masks, body suits   The fear of the fast spreading coronavirus has led to an acute shortage of face masks in Asia, the US and the UK. Manufacturers are increasing production to meet surging demand. In fact, China is the source of most of the world’s masks and respirators. However, today it is using more masks than it ever has. As a result, fewer masks and respirators will be available to the countries that have been importing them from China. In fact, former FDA commissioner Scott Gottlieb tweeted that China is witnessing a shortage of protective body suits. “Since much of supply chain for masks, gowns, gloves is through China; we should prepare for potential of stretched supply chains and increased demand here in US in event of outbreaks or epidemic spread in America,” Gottlieb tweeted quoting a Bernstein analysis Meanwhile, India has banned the export of personal protection equipment such as masks and clothing amid the global coronavirus outbreak. In Hong Kong, which has been struggling with a shortage of face masks, toilet rolls became unavailable in some supermarkets. Social media posts showed empty shelves and shoppers lining up to buy rolls. Success of flu, HIV drugs on coronavirus: Though there is no formal cure discovered to treat the virus, the treatment protocol established in China and confirmed by physicians in Thailand shows that a combination of Lopanvir and Ritonavir, old generation drugs used to treat HIV, along with flu medication Oseltamivir, has worked on patients. Thai doctors have seen success of such a treatment. “This is not the cure, but the patient’s condition has vastly improved. From testing positive for 10 days under our care, after applying this combination of medicine the test result became negative within 48 hours,” Dr. Kriangska Atipornwanich, a lung specialist at Rajavithi Hospital in Bangkok said. Thailand has recorded 19 cases of coronavirus. Of the Thai patients, eight have recovered and gone home while 11 are still under treatment in hospitals. Meanwhile, Indian drug companies say they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus. Rise in screening tests: Roche has developed a test that can tell whether or not someone has the 2019-nCoV infection within a couple of hours. Roche’s coronavirus test hasn’t been approved for marketing as yet. Co-Diagnostics Inc has also said that the initial verification of its screening test designed to identify the presence of the coronavirus was successful. Healthcare company Novacyt has also launched a new molecular test for the Wuhan coronavirus. The company said its Primerdesign coronavirus test could detect the 2019 strain of the virus, adding it believed this would differentiate it from other current tests which it said were less specific. New coronavirus projects   There are multiple drugmakers and diagnostics companies making noise about their coronavirus projects. Here are some noteworthy projects: Gilead’s remdesivir: Gilead’s experimental anti-viral treatment — remdesivir — has shown some positive results as a patient in the US with worsening symptoms of a confirmed 2019-nCoV infection has been treated with the drug. Remdesivir appeared effective as a throat swab was tested negative for the virus just a few days after receiving the infusion. Incidentally, Gilead is developing remdesivir to combat the Ebola virus, not 2019-nCoV. Success from a single patient is great news, but the company needs more evidence to prove its case. Gilead is also expediting laboratory testing of remdesivir against samples of the new coronavirus. Last week, Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said his agency was working with Gilead to test remdesivir. Gilead is also working with Chinese authorities to begin a controlled, randomized study. However, such a study is bound to take months. Meanwhile, China has kick-started a clinical trial to speedily test remdesivir for 2019-nCoV. In fact, the virology institute in Wuhan has applied for a patent on this experimental Gilead drug. Scientists have found remdesivir and chloroquine, an 80-year-old malaria drug, to be highly effective in laboratory settings to thwart the novel coronavirus. However, the two drugs’ efficacies on humans required further clinical tests, the institute said. Remdesivir will also be tested by a medical team from Beijing-based China-Japan Friendship Hospital for efficacy in treating the deadly new strain of coronavirus. Gilead said the drug was shown to be active in animals with Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which are closely related to the current virus. Moderna, J&J, GSK work on vaccines: Moderna, a Massachusetts-headquartered biotechnology firm, is developing a vaccine to prevent the coronavirus from spreading. Though there isn’t any accomplishment as yet, the Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund the manufacturing of a 2019-nCoV vaccine that uses the company’s proprietary messenger RNA (mRNA) platform. Last week, Johnson & Johnson also said it would begin work on developing a vaccine for the virus. GlaxoSmithKline and CEPI also said they would work to accelerate the creation of a vaccine. The goal is then to provide many vaccine doses rapidly, a statement said. The project will rely on GSK’s adjuvant system, designed to enhance the body’s immune response and create a stronger and longer lasting protection against infection. However, developing a preventive and confirming that it is safe and useful in humans could take 12 to 18 months Regulators, WHO prepare for new cures   The European Medicines Agency (EMA), US Food and Drug Administration (FDA) and the WHO have taken various precautions and are preparing themselves for new medicines, vaccines and in-vitro diagnostics (IVDs). FDA has issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the “presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals who meet CDC criteria for 2019-nCoV testing.” To date, this test has been limited to use at CDC laboratories, but FDA said today’s authorization allows the use of the test at any CDC-qualified lab nationwide. Similarly, EMA said it is ready to support drug developers with all available regulatory tools (i.e., scientific advice, the PRIME scheme, the accelerated assessment and conditional marketing authorization) to advance and expedite the development of ways to fight and prevent the spread of this virus. WHO says ‘no effective treatment’ yet   The WHO has played down reports that talk of effective drugs that could treat the new coronavirus. Television reports in China have pointed to an effective drug for the virus. And Britain’s Sky News said researchers had made a “significant breakthrough” in developing a vaccine. WHO spokesman Tarik Jasarevic said: “There are no known effective therapeutics against this 2019-nCoV (virus) and the WHO recommends enrollment into a randomized controlled trial to test efficacy and safety.” “Even at the accelerated pace enabled by new technologies, the earliest that scientists hope to be able to start initial human trials of a new coronavirus vaccine is by June this year,” a Reuters news report said. Our view   According to the WHO website, there have been multiple disease outbreaks over the last 20 years, including diseases like dengue, avian flu, zika virus, SARS, MERS and many others. Till date, most of these diseases don’t have a cure or a vaccine. These diseases are being treated by various antiviral drugs, and the treatments are largely symptomatic. “The process of developing and testing drugs or vaccines against a new pathogen normally takes many years and is often fraught with pitfalls and failures,” a Reuters report said.Most of the viruses are mutating at a fast pace, creating newer strains each year. Scientists are concerned that the 2019-nCoV has mutated to adapt to its new human hosts far more quickly than SARS. Data on the virus is changing by the day, and some infectious disease specialists say it will take weeks before they can see just how contagious it is. Scientists believe the virus is more contagious than what the current data suggests.Clearly then, this is a race between a fast-spreading and fast-mutating virus and the skills of the biopharmaceutical industry to contain its spread. This time though, the pharmaceutical industry is showing a lot of urgency in finding a vaccine as well as a cure. 

Impressions: 2136

https://www.pharmacompass.com/radio-compass-blog/world-looks-for-effective-treatment-to-coronavirus-as-drugmakers-regulators-race-ahead-to-find-vaccines-cure

#PharmaFlow by PHARMACOMPASS
06 Feb 2020
Sales Forecast of FDA’s Novel Drugs Approvals in 2018
The year 2018 was a landmark year for the US Food and Drug Administration (FDA) as the agency approved a record number of novel drugs. FDA approved 62 novel drugs in 2018, out of which 34 were orphan drugs. FDA’s Center for Drug Evaluation & Research (CDER) approved 59 drugs while the other three were approved by the Center for Biologics Evaluation and Research (CBER). In a speech towards the end of the year, FDA Commissioner Scott Gottlieb said: “Far more important than the overall quantity of approvals however is the quality of the new drugs”. He went on to add that some “of [the] previous records were set in years when there were a lot of drugs that critics bemoaned were me-too medicines,” or novel chemical entities that addressed the same common, therapeutic targets. In 2018, FDA reversed three earlier drug rejections, approved the first cannabis-based drug, allowed the first ever RNA interference drug to market and gave the green light to Loxo Oncology/Bayer’s Vitrakvi (larotrectinib) which became the second anti-cancer drug (after Merck’s Keytruda) to bag an approval that treats cancer based on a biomarker across different types of tumors rather than the location in the body where the tumor originated. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Gilead’s Biktarvy tops our list for sales potential   PharmaCompass compiled the peak sales estimates of the new drugs approved in 2018 and in our compilation, Gilead’s antiretroviral treatment for HIV — Biktarvy — topped the charts with an estimated sales potential of almost US$ 5.3 billion followed by Vertex’s cystic fibrosis drug Symdeko that is expected to bring in US$ 2.75 billion. Alexion’s Ultomiris, Abbvie’s Orilissa, Novartis’ Lutathera and J&J’s Erleada are all expected to bring in more than US$ 2 billion for their companies at their peaks.  Although Loxo’s cancer drug, with an estimated US$ 860 million in peak sales, did not make it to the list of top 15 drugs in 2018 by sales potential, the company got purchased by Eli Lilly earlier this month for US$ 8 billion. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Pfizer won four approvals, Shire won three   For 2018, Pfizer led the approvals with four drugs that got the green light, followed by Shire with three drugs. Companies like AstraZeneca, Array Biopharma, Alynlam and Paratek Pharmaceuticals each won two drug approvals. Merck also had two approvals which were in cooperation with other companies. Amgen, Teva and Eli Lilly got their CGRP inhibitors for migraine prevention approved within a few months of each other. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 First cannabis-based drug bagged approval   Last year, FDA also approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome.  CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. And Epidiolex is the first marijuana-based drug to be approved in the US for epilepsy. It is produced by GW Pharmaceuticals. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 CBD does not cause intoxication. It is one of the hundreds of molecules found in marijuana and has been cited by scientists as a potential treatment for mental health issues. 2018 saw the launch of one-dose flu cure from Shionogi   In March 2018, Shionogi & Co Ltd.’s Xofluza — a pathbreaking drug that cures flu with just one dose — was approved in Japan. The drug is a treatment for influenza A and influenza B.  In October, the US Food and Drug Administration (FDA) also approved Xofluza (baloxavir marboxil). Xofluza is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 The single dose feature gives Xofluza an edge over other neuraminidase inhibitors like Tamiflu and Relenza. For example, Tamiflu typically requires two doses each day for five days. Therefore, there are nine more doses of Tamiflu required, as compared to the single-dose Xofluza. Shionogi aims to double the global market for flu treatment with Xofluza. “While the global market of flu drug is said to be about US$ 1 billion to US$ 1.5 billion, we want to expand it to around US$ 3 billion,” Shionogi CEO Isao Teshirogi said last year. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Though the FDA approval for Xofluza has been granted to Shionogi, Genentech (a member of the Roche Group which marketed Tamiflu, which is now a generic) will be marketing the medication in the US. Industry gets far lower returns from its drug launches   Gottlieb used Twitter to promote the progress of FDA’s review cycle. “In 2018, CDER met its PDUFA goal for 100 percent of the novel drugs approved – 95 percent of which on the first cycle – reflecting our efficiency in getting new therapies to patients quickly,” he tweeted. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 A ‘cycle’ is the time from when CDER accepts an application for a new drug until the agency decides whether to approve it or not. However, the record number of approvals doesn’t present the complete picture for the pharmaceutical industry. A study published in December by Deloitte highlighted that the industry is getting far lower average returns from its drug launches than ever before. While the costs to bring a drug to market have almost doubled in eight years to over US$ 2 billion, peak sales forecasts have halved to a little over US$ 400 million, the study said. Drug discovery reviews in the scientific publication Nature reached a similar conclusion. “Projected peak annual sales for new therapeutic drugs (NTDs) approved in 2018 total US$ 45 billion — lower than 2017’s US$ 58 billion — and the value of the average peak sales per product has continued to trend down to only US$ 720 million per drug in 2018, the lowest figure in almost a decade,” the publication said. “The decline is driven both by fewer blockbusters at the top end, as well as a proliferation of very small products at the bottom end. We believe the underlying driver of both these trends — more approvals but smaller markets per approval — is better understanding of biology fostering precision medicine,” it added. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Our view   After suffering brutal losses towards the end of 2018, wherein biotech was among the US stock market’s most oversold sectors and saw a decline of nearly 10 percent, this year the biotech sector has got off to the best start since 2012. Drug companies are continuing to innovate more targeted therapies, and Chinese companies are investing in developing new drugs. While the industry expects to see a lot more mergers and acquisitions in 2019, where smaller biotech companies get acquired by major pharmaceutical corporations, it is unlikely that the general trend of companies bagging more approvals for targeted therapies with a smaller peak sales potential is going to reverse anytime soon.  Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018  

Impressions: 7059

https://www.pharmacompass.com/radio-compass-blog/sales-forecast-of-fda-s-novel-drugs-approvals-in-2018

#PharmaFlow by PHARMACOMPASS
17 Jan 2019