2019’s top 15 clinical trial flops (and a flip-flop)

Clinical trials are the most important step of getting a new drug approved for marketing, as well as the most expensive, and it’s no secret that the odds of bringing a project from first-in-human testing through to market are pretty long.

Once a program reaches the pivotal trial stage, the odds are supposed to improve, of course. But every year, plenty of drugs fail at the last hurdle after millions or even billions of dollars have been invested in them.

Δείτε το φαρμακείο σας με τα μάτια του πελάτη

Η λίστα αυτή αποτελεί ένα πρακτικό διαγνωστικό εργαλείο με μορφή ερωτηματολογίου που θα σας βοηθήσει να εντοπίσετε τυχόν αδυναμίες στην εμπορική λειτουργία του φαρμακείου σας και ταυτόχρονα να ιεραρχήσετε και να προγραμματίσετε την υλοποίηση αναγκαίων διορθωτικών παρεμβάσεων, με σκοπό τη βελτιστοποίησή της.

Για να «κατεβάσετε» τη λίστα στον υπολογιστή σας και να την εκτυπώσετε πατήστε στην εικόνα.

Top 9 Drugs With the Biggest Price Increases Over 2 Years

Nine widely-used medications have experienced substantial price surges over the past 2 years, adding $5.1 billion to overall drug spending during this time period, according to a new report.

The authors of the report, the Institute of Clinical and Economic Review (ICER) claimed 7 of the 9 drugs were lacking sufficient clinical evidence to support such price increases, but several pharmaceutical manufacturers took issue with the methodology used in the analysis.

Of the drugs listed, the ICER indicated that lenalidomide and dimethyl fumarate were the only 2 with new clinical evidence. In appendix published with the report, however, several manufacturers challenged ICER's methodology and findings. For example, the assessment only includes indications representing greater than 10% of use, not accounting for smaller indications such as rare diseases that may reflect improvements in net health benefit. 

The World's Pharma Lords: Which Countries Buy & Sell the Most Drugs?

The pharmaceutical industry is incredibly valuable and is continuing to grow. But just how much of the world’s imports and exports involve pharmaceuticals? To understand the impact of the pharmaceutical industry on the world’s economy, we created two visualizations to demonstrate pharmaceutical imports and exports by country in 2018.

   The United States is, by far, the world’s biggest importer of pharmaceuticals at $99.7 billion. As the opioid crisis in the United States carries on, pharmaceutical companies are being scrutinized, as was demonstrated in the Johnson and Johnson settlement.

Store Atmospherics: Κρίσιμος παράγοντας επιτυχίας του φαρμακείου

Άρθρο  στο περιοδικό "ΦΑΡΜΑΚΕΥΤΙΚΟΣ ΚΟΣΜΟΣ"
 
Για να το διαβάσετε ή να το εκτυπώσετε πατήστε στην εικόνα

The top 10 drug launches of 2019

Angus Liu | Fiercepharma

Cancer is probably the most sought-after indication in the biopharma world, but it’s missing from 2019's class of top drug launches. Instead, treatments in immunology and rare genetic diseases have grabbed the limelight.

We considered two EvaluatePharma projections in January and February to rank this year’s top 10 drug launches by 2024 sales. At the top of the list is Alexion’s Soliris follow-up, Ultomiris, which nabbed an FDA nod at the end of 2018, two months ahead of its scheduled decision date.

As part of CEO Ludwig Hantson’s plan for Alexion to pivot away from ultrarare diseases and reach more patients, the biotech has priced Ultomiris at a 10% discount to Soliris and is aiming to convert 70% of Soliris patients to the improved therapy. Paroxysmal nocturnal hemoglobinuria (PNH), the current condition Ultomiris is approved in, is a rare disease that involves the immune system.

STP: Powering Marketing Success

pharmexec.com | Gary Lyon*

NASCAR followers will likely recognize the famous red oval logo of STP, originally an acronym for “scientifically treated petroleum”. As a gasoline additive, STP is designed to prolong engine life and improve performance. Could “STP” also be a proven boost to healthcare marketing effectiveness? This article briefly explores the role and impact of three elements — I would argue the most important elements — of marketing planning that drive business success: Segmentation, Targeting and Positioning.

Segmentation

Segmentation is the process of dividing large, diverse markets into smaller, more homogenous sub-groups on the basis of one or more differentiating criteria. Traditionally, these criteria have included demographic or psychographic (lifestyle) factors but attitudinal and behavioural factors are equally important. 

The top 15 pharma companies by 2018 revenue

FiercePharma | Eric Sagonowsky

The pharma industry is always in flux, but the big names always turn up near the top of yearly sales rankings. This year is no different, with Johnson & Johnson, Roche, Pfizer, Novartis and Merck & Co. taking the top 5 spots in Big Pharma companies by 2018 sales. 

In fact, the top 15 names are the same against prior year rankings, but the order has shifted. Last year’s No. 5, Sanofi, slipped to No. 7 as its sales sank almost 2% year over year. Gilead Sciences, famously under hepatitis C pricing pressure for years, sank even farther in 2018, slipping three positions to No. 13. 

On the flip side, Bristol-Myers Squibb climbed from No. 15 to No. 12. And if the company scores its massive Celgene buyout, it’ll be even higher next year. Adding Celgene’s $15 billion in 2018 revenue would have given BMS nearly $38 billion in annual sales, ranking it among the top 10 pharma companies by annual sales 

And next year’s ranking will see at least one entirely new entrant in Takeda. The Japanese biopharma recently scooped up Shire but hasn't released its combined financials for 2018 to make it eligible for the rankings. 

Forget thinking about 'the patient.' Pharma's shifting to consumer-centric marketing instead

FiercePharma | Beth Snyder Bulik

Pharma and healthcare aren't just thinking about patients anymore. They're thinking about customers.

It's a shift similar to what happened in the tech world in the late ‘80s, says Scott Rabschnuk, who leads Hill Holliday Health. He worked in technology industry marketing in the ‘90s, when tech companies still called the people they served “end users,” a patronizing term that suggested an industry dominated by experts with little interest in the humans at the end of the line, he said.

For pharma and healthcare marketers now, the tech industry's evolution from treating customers as a faceless mass of end users to considering their input as consumers can be translated to the shift these days toward addressing patients directly. Yesterday's patients, who only got pharma information filtered through their doctors, are today’s informed consumers who actively participate in their own healthcare—and shouldn't be ignored. Pharma marketers have had to become better at creating more consumer-marketing customer relationships, Rabshnuk said.

GENESIS Pharma: συνεργασία με την Amicus Therapeutics®

Την εμπορική συνεργασία με την Amicus Therapeutics ανακοίνωσε η Genesis Pharma για τη διάθεση της μιγαλαστάτης στην Ελλάδα, την Κύπρο, τη Ρουμανία και τη Βουλγαρία, την πρώτη από του στόματος χορηγούμενη θεραπεία και το πρώτο φάρμακο ιατρικής ακριβείας για τη νόσο του Fabry.

Η φαρμακευτική εταιρεία GENESIS Pharma, που δραστηριοποιείται στην ευρύτερη περιοχή της Νοτιοανατολικής Ευρώπης, ανακοινώνει ότι η διεθνής φαρμακευτική εταιρεία βιοτεχνολογίας Amicus Therapeutics, που δραστηριοποιείται στο πεδίο των σπάνιων και ορφανών νοσημάτων, της παραχωρεί τα αποκλειστικά εμπορικά δικαιώματα της μιγαλαστάτης στην Ελλάδα, την Κύπρο, τη Ρουμανία και τη Βουλγαρία.

Top 10 drugs losing exclusivity in 2019

FiercePharma | Eric Palmer Mar 4, 2019

Pharma companies do their best to fight off patent expirations and generic competition as long as possible to protect their big moneymakers. But this year looks like the end of the line for many of the industry's top brands.

Pfizer’s Lyrica, GlaxoSmithKline’s Advair, Roche’s Rituxan, Gilead’s Harvoni and many other drugs are slated or expected to face new generic competition this year. Each has navigated a different path to the patent cliff, but they'll all end up delivering a heavy financial blow to their makers. 

For several companies included in the list, new generic pressure is already here. Amgen, for instance, started dealing with competition for Neulasta and Epogen last year, thanks to biosimilars from Mylan, Coherus and Pfizer. It remains to be seen just how much—and how quickly—biosimilars will hurt the profitable brands.

Other drugs face more uncertainty as they lose some of their IP protections. Enbrel, for instance, is another profitable drug that's nearing the cliff, but Amgen executives recently said their court fight against would-be biosim rival Sandoz will take a while to play out, so it's uncertain when the drug could face competition.

No bigger lineup of drugs is facing copycats for the first time than the one at Roche. Executives for the cancer giant have told investors they're expecting U.S. competition in 2019 for Rituxan, Herceptin and Avastin. Together, the trio of cancer megablockbusters pulled in more than $10 billion in the U.S. last year, Roche reported, representing a huge target for biosim companies.

Pfizer’s Lyrica and Glaxo’s Advair are two household names making an appearance in this year's ranking—again. Pfizer was slated to lose Lyrica exclusivity at the end of last year, but the FDA blessed the drugmaker with a 6-month extension for testing the drug in a set of pediatric patients. Glaxo, for its part, will finally face new Advair competition after numerous delays among would-be copycats. Mylan just recently scored FDA approval for its generic, and the company launched it in February. 

Γιατί το φαρμακείο χρειάζεται Αποτελεσματικό Μάρκετινγκ περισσότερο από άλλες επιχειρήσεις

Άρθρο στο περιοδικό ΦΑΡΜΑΚΕΥΤΙΚΟΣ ΚΟΣΜΟΣ που μόλις κυκλοφόρησε.

https://docdro.id/jSQpTBK

ΕΟΦ: Νέα εγκύκλιος σχετικά με τη Διαφήμιση των Φαρμακευτικών Προϊόντων

Κατάργηση της υπ’ αρ. 96583/24-9-2019 προηγούμενης τροποποιητικής Εγκυκλίου.

Για να κατεβάσετε τη νέα εγκύκλιο πατήστε http://snip.ly/l0rr71

How Pharmacists Can Help Ensure That Patients Take Their Medicines

Source: Harvard Business Review, January 31, 2019

By Humaira Ameer* & Sachin H. Jain*

What if there was a way to significantly improve health outcomes, reduce hospital and nursing home admissions, and save $105 billion in health spending? There is one such compelling opportunity: a greater systemic focus on medication adherence. When health care professionals use the term “medication adherence,” what we’re really referencing is whether or not patients take their medicines as prescribed. Shockingly, about half the time, they don’t. And the consequences of non-adherence are great.

One of the leading studies of the topic found that “approximately 125,000 deaths per year in the United States are due to medication non-adherence.” No wonder, then, the World Health Organization (WHO) has determined that “increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments.”

Medicare and Medicaid patients with multiple chronic conditions who tend to take multiple medications account for a disproportionate share of all health spending in America. Recognizing the important opportunity to improve the care for such patients, CareMore Health, a division of Anthem, Inc. that serves Medicare and Medicaid beneficiaries, launched a program. It was designed to leverage the clinical expertise of pharmacists to identify the root causes of non-adherence and hyper-personalize solutions to better support the patients we serve.

Our discovery: The reasons patients don’t take medicines vary significantly; consequently, to improve adherence, you have to customize the solution for each individual. This is a significant departure from past efforts to improve adherence, which have tried to apply a single solution across a whole population.

Novartis puts Artificial Intelligence on the job to help reps say the right things to the right doctors

FiercePharma | Eric Sagonowsky

Artificial intelligence is a big buzzword in R&D right now, but at Novartis, it's hard at work in the sales department, too.

Amid far more meetings with digital companies at the J.P. Morgan Healthcare Conference this year, Novartis’ pharma CEO Paul Hudson said he expects 2019 to be the “beginning of the tech disruption” for pharma, in everything from marketing to supply chain.

In past years at JPM, Hudson mainly checked out early-stage biotech companies for potential partnerships, he told FiercePharma. This year? It’s about half health-tech companies, he said.

Obviously, Novartis is jumping right in, as part of CEO Vas Narasimhan's push to transform the entire company using digital tech. In the field, the drugmaker has equipped salespeople with an AI service that suggests doctors to visit and subjects to talk up during their meetings.