Varenicline
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
Phispers: Novartis may sell Roche stake; Perrigo’s CEO to head Valeant
This week’s pharma news capsule – Phispers (Pharmaceutical Whispers) – updates us on smoking cessation pills, WHO alert on Bangalore’s Semler Research, Valeant’s new CEO and more.Novartis plans to sell Roche stake and fuel its M&A machine Novartis is in talks with banks to sell its US $ 14 billion stake in rival Roche. Once struck, the sale will provide the Basel-headquartered Novartis cash for new deals. Between 2001 and 2003, Novartis had built up its one-third stake in Roche's voting stock under former chairman and CEO Daniel Vasella, as a basis for a possible merger that never happened. Since Vasella's departure in 2013, there has been speculation that Novartis would sell its holding. The divestment makes sense for current Novartis CEO Joe Jimenez, who is under pressure to improve growth after disappointments with the company’s eye care unit Alcon and new heart drug Entresto. After FDA action, WHO issues notice of concern to Bangalore-based CRO Semler Just days after the FDA alerted an untold number of drug makers that marketing applications containing clinical trial data prepared by Semler Research Center would have to be repeated, due to data integrity concerns, the World Health Organization (WHO) issued the company a notice of concern. Investigators concluded that, “Manipulation of at least five studies over an extended period of time indicates this is a common practice; WHO is of the impression that to execute this type of manipulation several staff members on various levels within the organization have to be collaborating and coordinating.”The findings have questioned studies performed on WHO pre-qualified products for Mylan Laboratories, Micro Labs Ltd, Lupin Ltd, Strides Shasun Ltd as well as others which are currently under evaluation.   Valent ropes in Perrigo’s Joseph Papa to be its next CEOValeant Pharmaceuticals International has taken on Joseph Papa (aged 60) from its rival Dublin-based Perrigo to be its chairman and chief executive and work on rebuilding investor confidence in Valeant, after last year’s price-gouging episodes and the more recent accounting troubles. The announcement came after weeks of talks with Papa. The news led to tumbling of Perrigo shares by 18 percent on Monday. Some months back, Papa had helped Perrigo beat back a hostile bid from Mylan. Nonetheless, Papa leaves behind a business which is struggling business to meet the commitments made while fending off the Mylan bid.  Setback for DMD patients as FDA panel votes against Sarepta’s drugOn Monday, the FDA advisory panel in the US voted that a drug from Sarepta Therapeutics was not effective in treating Duchenne muscular dystrophy (DMD) – a rare and fatal muscle-wasting disease. While the FDA staff took dim view of the Sarepta trial data, the day-long session saw emotional pleas from dozens of parents and their children, some of whom appeared in wheelchairs, to describe how the Sarepta drug, called eteplirsen, could impact their lives. While the FDA usually follows the advisory panel’s recommendation, the final decision on whether or not to approve eteplirsen will be taken on May 26.   Smoking-cessation pills have no suicide risk, says studySeven years after American regulators slapped the strictest ‘black box’ warnings on two popular smoking-cessation medicines – Pfizer’s Chantix and GlaxoSmithKline’s Zyban – a large international study found these pills did not appear to increase the risk of suicidal behavior. The study had been order by the US Food and Drug Administration (FDA), and both Pfizer and GSK are hopeful that the regulator will remove warnings put on these prescription drugs. The warnings about serious psychiatric side effects, such as “changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions” in some patients scared off both doctors and smokers wanting to quit. Meanwhile, experts say both Chantix and Zyban are safe — far safer than smoking, which kills about 440,000 Americans each year. Drug makers may lose case in the US over patent reviewsA case in the US could end up with serious implications for drug pricing. In the Supreme Court this week, there were signs that the pharmaceutical industry could end up on the losing side of the case – which focuses on Obama administration’s rules for a new process to review patents.Drug makers, supporting the plaintiffs, are urging the court to change that process, which at present makes it easier to invalidate the patents that are crucial to their business. But the plaintiffs seemed to be at a disadvantage before the court. 

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https://www.pharmacompass.com/radio-compass-blog/phispers-novartis-may-sell-roche-stake-perrigo-s-ceo-to-head-valeant

#PharmaFlow by PHARMACOMPASS
28 Apr 2016
A prescription for mobile pharma apps!
 The pharmaceutical industry, which spends more on marketing than research, has a dismal track record when it comes down to developing mobile applications. However, the Johnson & Johnson Official 7 Minute Workout app may finally have turned the tables and given Big Pharma a fighting chance before Apple, Google and Samsung takeover digital health.   Johnson & Johnson Official 7 Minute Workout and the app marketJ&J Official 7 Minute Workout application recently announced a partnership with U.S. pharmacy chain Walgreens’ Balance Rewards for healthy choices program. Since Walgreens’ previous collaborations has been primarily with technology companies, like Jawbone, Fitbit, iHealth etc. how is Big Pharma going to finally get back in the mobile app development game?Johnson & Johnson’s app, with more than 1.3 million downloads, has a significantly higher popularity when compared with the 6.6 million downloads in the past 7 years, for apps from all leading pharma companies combined. Based on a research report published last year, pharmaceutical companies developed more than 40,000 apps, however downloads and usage weren’t at par with apps from other industries.  Two primary reasons cited for the limited success of pharma apps have been that the “app portfolio is not globally available” and apps are “built around core products of the pharma companies and not around actual market demand”.J&J’s focus on fitness and that too in 7 minutes, has clearly found a global market demand, which is different to those buying their baby shampoo. Actually, the app not only made Men’s Fitness list of top 10 fitness apps for 2014, it also topped the internal J&J blog for the most read stories last year. We tried it too and while we may not participate in any upcoming triathlon, we definitely are addicted! It’s convenient to do and provides the high impact energy exercise needed without consuming a lot of time.   Which other Pharma apps have become popular?Other apps, which topped the popularity charts are Sanofi’s GoMeals (a nutrition database can tell you what's in your meal before you pick up your fork) and Janssen’s Care4Today (providing the tools to take your medication on time). They also meet the same criteria as J&J’s workout app of being global in design and not focusing on any specific product.The focus on mobile health is becoming the “next big thing” for Apple, Google and Samsung. Apple has introduced, through its Apple HealthKit feature, capabilities to not only monitor health metrics but also change the way clinical trials will be performed in the future. Announcements made at the recent Apple WorldWide Developers Conference (WWDC) in June, also introduced capabilities where HealthKit can now measure women’s menstruation cycles, the skin’s UV exposure as well the body’s water hydration levels. What will the Pharma app market look like soon?Ernst & Young assessed that “social media channels will generate significant health care data — from 50 petabytes today to 25,000 petabytes by 2020”; a petabyte is a million gigabytes (GB)! However, before app developers let their creativity run wild, there are regulations, which need to be complied with since apps can get classified as medical devices. The FDA has published guidelines, on when an app crosses the threshold and becomes a medical device.   With Walgreens now incentivizing “doing everyday healthy activities” to earn Balance® Rewards customer loyalty points, and Apple’s sensors monitoring body functions and activity levels, a new wave of technology integration is getting ready to surround us. The success of Johnson and Johnson’s app clearly shows that the pharmaceutical companies who will win, are going to be the ones focused on improving the health of patients and not those just trying to find a new way to distribute their medicines. After Pfizer’s failed efforts to promote their stop-smoking drug Chantix their new app, Quitter’s Circle is clearly a step in the right direction. The app is designed to help those who want to quit smoking through educational, social and financial support and does not promote Chantix at all.   Our viewWhile Big Pharma is working on developing apps, there are new age competitors who are waiting to attack in case the pharmaceutical industry fails. Google’s establishment of Calico, their bio-tech initiative, headed by ex-Genentech CEO and former chairman of the board at Apple, Arthur Levinson  is just one such example. The big question going forward, as both big pharm and the technology giants, focus on digital health is who does a better job taking care of the wellness of people?  

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https://www.pharmacompass.com/radio-compass-blog/a-prescription-for-mobile-pharma-apps

#PharmaFlow by PHARMACOMPASS
02 Jul 2015