Sanofi will replace Pfizer as the world’s biggest drug maker by revenue next year, according to new forecasts.

Pfizer’s nine-year reign at the top has been driven by sales of its anti-cholesterol drug Lipitor, which made $13.4 billion in peak annual sales.

But Lipitor will go off patent in the US this month and in Europe early next year – a process that will shrink revenue from the drug to just $2 billion a year by 2016.   

Sanofi is now expected to take its place at the top, followed by Novartis, Pfizer and GlaxoSmithKline, according to industry analysts at EvaluatePharma.

Sanofi strength

EvaluatePharma (EP) are projecting annual sales growth of 4% over the next four years for Sanofi, meaning the French firm will be capable of holding on to the top spot. 

EP says the strength for Sanofi is the culmination of a decade of mega-mergers starting with the 1999 acquisition of Synthélabo in a deal worth around $30 billion, and later its $63 billion deal with Aventis in 2004.  

The $20 billion takeover of Genzyme earlier this year has cemented its future success, and EP believes that sales of its new biotech’s enzyme replacement therapies should be enough to keep Sanofi at the top of the table until at least 2016. 

Genzyme’s drugs will also help offset the loss of revenues from its anticoagulant Plavix, which loses US patent protection next year, and ongoing generic erosion of anticoagulant Lovenox and chemotherapy Taxotere. 

Novartis will also remain firmly in second place for the coming years based on the predicted strength of its MS pill Gilenya and blood cancer treatment Tasigna - these should be enough to help offset the loss of by blood pressure drug Diovan, which has been bringing in over $6 billion in peak annual sales. 

Its recent $48 billion acquisition of eye specialist Alcon will also help the group’s top-line sales outside of drug products, illustrating the strength of diversification for the firm.

Merck to struggle

Merck, which is currently in fourth position, will drop to sixth next year. Despite buying Schering-Plough for $41 billion in 2009, the US firm will struggle to expand its drugs business over the next four years, according to EP, letting faster growing companies GlaxoSmithKline and Roche climb ahead. 

Teva reaches top 10

A notable entrant to the top ten next year will be the Israeli generics drug maker Teva, which is predicted to post strong 7% annual sales growth over the period with both its generic and branded drug segments expanding.

This has been achieved largely through an aggressive acquisition policy that has seen the company make five multi-billion dollar deals in the last seven years, including its recent $6.5 billion purchase of US biopharmaceutical firm Cephalon. 

Firm	Rank: 2011	2012	2014	2016	Rx/OTC sales: 2011	2012	2014	2016
Sanofi	3	1	1	1	$48bn	$52bn	$55bn	$58bn
Novartis	2	2	2	2	$50bn	$50bn	$52bn	$55bn
Pfizer	1	3	3	3	$54bn	$50bn	$50bn	$52bn
GSK	5	6	5	4	$39bn	$41bn	$46bn	$51bn
Roche	6	4	4	5	$39bn	$44bn	$46bn	$49bn
Merck	4	5	6	6	$42bn	$42bn	$41bn	$43bn
J&J	8	8	7	7	$25bn	$27bn	$29bn	$32bn
AZ	7	7	8	8	$32bn	$29bn	$28bn	$26bn
Teva	12	10	10	9	$17bn	$20bn	$23bn	$24bn
Abbott*	9	9	9	10	$22bn	$24bn	$24bn	$24bn

*Abbott has recently announced that it will split into two separate firms - one focusing on pharma products and other on medical devices and diagnostics

Source: EvaluatePharma

Προσφυγή της φαρμακευτικής εταιρείας Galenica στο ΣτΕ για τις τιμές των φαρμάκων

Στο Συμβούλιο της Επικρατείας προσέφυγε η Galenica, προκειμένου να κριθεί αντισυνταγματική, αντίθετη στην Ευρωπαϊκή Σύμβαση Δικαιωμάτων του Ανθρώπου (ΕΣΔΑ), αλλά και στη Συνθήκη της Ευρωπαϊκής Ένωσης, η πρόσφατη απόφαση των υπουργών Υγείας και Εργασίας που καθορίζει την τιμή των συνταγογραφούμενων φαρμάκων.

Η φαρμακευτική εταιρεία υποστηρίζει, με την προσφυγή της, ότι η υπουργική απόφαση εκδόθηκε αντίθετα με τις συνταγματικές επιταγές (άρθρο 43), καθώς παρόμοια θέματα ρυθμίζονται μόνο με Προεδρικό Διάταγμα. Θεωρεί επίσης ότι η υπουργική απόφαση είναι αντίθετη με την Ευρωπαϊκή Σύμβαση Δικαιωμάτων του Ανθρώπου (ΕΣΔΑ), αλλά και τη Συνθήκη της Ευρωπαϊκής Ένωσης.

Ακόμη, η εταιρεία υποστηρίζει ότι είναι παράνομος ο τρόπος υπολογισμού της τιμής των συνταγογραφούμενων φαρμάκων, πολύ περισσότερο μάλιστα όταν προβλέπει, ως «οιονεί ποινή», επιστροφή χρημάτων στον φορέα κοινωνικής ασφάλισης, όταν υπάρχει διαφορά από την τιμή αναφοράς, πολλαπλασιαζόμενη με τον συντελεστή 1,5.

Η τιμή αναφοράς είναι η ανωτάτη τιμή αποζημίωσης των φαρμακευτικών εταιρειών από τους φορείς κοινωνικής ασφάλισης και καθορίζεται από μια εξίσωση, η οποία περιλαμβάνει, μεταξύ των άλλων, και το κόστος ημερησίας θεραπείας του κάθε φαρμακευτικού προϊόντος.

Τέλος, όπως υποστηρίζει η εταιρεία, η καθοριζόμενη ανώτατη τιμή των φαρμάκων δεν μπορεί να είναι κατώτερη του κόστους παραγωγής και διάθεσης των φαρμακευτικών ιδιοσκευασμάτων, ενώ με την επίμαχη υπουργική απόφαση υποχρεούται να προμηθεύει τους ασφαλισμένους των φορέων κοινωνικής ασφάλισης με φάρμακα κάτω του κόστους.

Η ΤΟΥΟΤΑ εισέρχεται στην αγορά των ιατρικών μηχανημάτων

Νέες τεχνολογίες από την αυτοκινητοβιομηχανία χρησιμοποιούνται τώρα στη δημιουργία νέων ιατρικών μηχανημάτων. Αισθητήρες, μικροί κινητήρες και εξελιγμένο λογισμικό ηλεκτρονικών υπολογιστών που βασίζονται στην τεχνογνωσία της Toyota, ενσωματώνονται τώρα σε νέα μηχανήματα για τον άνθρωπο.

Η Toyota παρουσίασε πρόσφατα μια νέα συναρπαστική ρομποτική τεχνολογία με σκοπό να βοηθήσει τους ανθρώπους που αντιμετωπίζουν κινητικά προβλήματα, λόγω εγκεφαλικών επεισοδίων,  νόσων των αρθρώσεων, αγγειακών νόσων  ή άλλων χρονίων παθήσεων να κινούνται πάλι με άνεση. Με δεδομένο ότι οι παθήσεις αυτές  καθώς και η γήρανση του πληθυσμού αυξάνει με ταχύτατους ρυθμούς παγκοσμίως, η Toyota βλέπει την ιατρική τεχνολογία να αποτελεί σημαντική επιχειρηματική ευκαιρία.

Η εταιρεία στοχεύει να λανσάρει στην παγκόσμια αγορά τις πρώτες ιατρικές συσκευές της το 2013. 

Στην ίδια κατεύθυνση με την Toyota κινείται ήδη και η ανταγωνίστρια της Honda.

Δείτε το σχετικό Video

Ο ΙΑΤΡΙΚΟΣ ΣΥΛΛΟΓΟΣ ΔΕΝ ΔΕΧΕΤΑΙ ΤΑ ΝΕΑ ΣΥΝΤΑΓΟΛΟΓΙΑ

Επιμένει ο Ιατρικός Σύλλογος Αθηνών (ΙΣΑ) να καλεί τους γιατρούς να συνεχίσουν να συνταγογραφούν όπως κάνουν μέχρι σήμερα, παρά τις οδηγίες της διοίκησης του Εθνικού Οργανισμού Παροχής Υπηρεσιών Υγείας (ΕΟΠΥΥ) να ξεκινήσουν από χθες να συνταγογραφούν όλοι στα συνταγολόγια του ΙΚΑ.

Μέσω e-mail και sms που στάλθηκαν αιφνιδιαστικά στους γιατρούς, άλλαξε  ο τρόπος συνταγογράφησης. Οι γιατροί του ΟΠΑΔ και του ΟΑΕΕ κλήθηκαν να συνταγογραφούν (από χθες) ως να είναι συμβεβλημένοι του ΙΚΑ-ΕΤΑΜ ή του ΕΟΠΥΥ χωρίς να έχουν υπογράψει σύμβαση και χωρίς κανένα νομικό πλαίσιο, όπως τόνισε χθες ο πρόεδρος του ΙΣΑ Γιώργος Πατούλης.

Όπως ανέφερε ο ίδιος, οι γιατροί του ΟΠΑΔ και του ΟΑΕΕ δεν έχουν παραλάβει τα νέα συνταγολόγια και επανέλαβε ότι ο ΙΣΑ καλεί τα μέλη του να μην τα παραλάβουν. Ο σύλλογος καλεί τα μέλη του να συνεχίσουν να συνταγογραφούν όπως έκαναν μέχρι σήμερα και να μην υπακούσουν στις «πρόχειρες εντολές των δοτών διοικητών». Καλεί επίσης τους φαρμακοποιούς, μέσα από τα συλλογικά τους όργανα, να αγνοήσουν τα sms του ΕΟΠΥΥ και να συνεχίσουν κανονικά να δέχονται τις συνταγές των γιατρών.

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Are Health Apps the Cure for Anything That Ails You?

Health Policy Forum | By Rochelle Sharp*

With about 9,000 consumer health apps currently available in the iTunes store, it seems like almost all smart phone users can download their way to better health these days.

The store offers a mindboggling array of creative apps, including ones that calculate calories burned during exercise, create soundtracks to help people fall asleep, and display pictures that can elicit memories from Alzheimer’s patients. If the store doesn’t offer something for what ails you now, it probably will soon. The selections will proliferate within the next year, with an additional 4,000 consumer apps expected by next summer, industry experts say.

But all this innovation creates a bewildering set of problems. It’s hard to figure out what apps are available, let alone which work best. Health apps may have the potential to dramatically improve people’s lives, but those based on misleading or bogus information can cause serious harm.

“Apple isn’t testing apps for their scientific validity,” said Dan Cohen, a social worker who has reviewed apps for their effectiveness.

Given the stakes, it’s no surprise that the government is starting to regulate these smart phone applications. Just last month, the Federal Trade Commission brought its first cases against the makers of two health apps. Each claimed to cure acne with colored lights emitted from cell phones.

“Smart phones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” the FTC chairman said, when announcing the crackdown. The agency cited the makers of AcneApp, which had sold about 11,600 downloads of its $1.99 app, and the developers of AcnePwner, which sold 3,300 downloads of its 99 cent app.

The Food and Drug Administration (FDA), meanwhile, proposed regulations this summer for apps that could be considered medical devices. The agency, which is seeking comments on its proposals until Oct. 19, may focus on apps that are accessories to established medical devices used by doctors, such as smart phone apps that can display X-rays.

It could also regulate apps that transform smart phones into medical devices by using sensors or other attachments. Already, the FDA has approved gadgets that turn smart phones into blood pressure-monitoring cuffs and pocket ultrasound machines.

Apps that connect to consumer devices, such as blood glucose meters, may be regulated, too, if the apps display or analyze the meters’ readings, the FDA says.

The majority of health apps will almost certainly not be considered medical devices and will escape government scrutiny. But some app developers are voluntarily going through the laborious FDA clearance process, in part, to convince the medical community that their products have real clinical value.

WellDoc, a Baltimore-based health care company, got FDA approval last year for its DiabetesManager, which provides automated diabetes coaching for patients. The app also was tested in a randomized clinical trial conducted by the University of Maryland’s medical school, which found that patients had a statistically significant improvement in their blood glucose levels after using the app for a one-year period.

Scientists have found flaws with other apps.

When a George Washington University professor conducted the first content analysis of behavior-modification apps, she discovered that few of the 47 smoking-cessation apps available in 2009 followed evidence-based health guidelines. Lorien Abroms, a public health professor, concluded that the apps had “serious weaknesses” because they did not link to quit lines or clinics or suggest ways for smokers to get social support from family and friends.

She argues that public health apps should be developed from evidence-based guidelines and should offer users the chance to receive text messages. Studies show that text messaging can help people change unhealthy behaviors.

Many public health organizations have developed useful apps. The American Heart Association has one to help people find walking paths, while the New York City Department of Health, in its effort to help reduce the spread of sexually transmitted diseases, lists places that give away free condoms.

Such health apps are already popular and may soon be ubiquitous – with 500 million consumers projected to be using them by 2015. Nine percent of smart phone owners surveyed last year said they use health apps, Pew Research Center study found. Younger people downloaded them most frequently, with 15 percent of smart phone owners between the ages of 18 and 29 using them. Black owners also had higher user rates, with 15 percent of those surveyed taking advantage of them, compared to 11 percent of Hispanics and 7 percent of whites.

The most popular types of consumer health apps focus on fitness and diet, according to a report released last month by MobiHealthNews, which tracks mobile health issues. About 16 percent of available apps in the iTunes store focus on cardio fitness, with some running apps claiming millions of users, MobiHealthNews says. Another 14 percent of apps are aimed at improving people’s diets, while another 11 percent deal with stress and relaxation.

“Consumers trying to keep up with the ever-changing app market may want to consult medical societies, like the American Cancer Society,” says Cohen, who evaluates apps. Alternatively, they could download Cohen’s own app, Healthful Apps, which highlights some of the most effective, user-friendly health apps available. Cohen said he spent more than a year perusing and testing apps before coming up with his list. He focuses on apps in eight categories, including relaxation, caregiving, memory improvement, and communication. Among his favorites: iTriage, an app designed by two emergency room physicians that helps patients understand their symptoms and provides information about the closest clinics and hospitals – including wait times at some emergency rooms.

Cohen says that he sometimes uses the Asleep app when he has insomnia, and also likes sleep apps that send different sound tones to each ear, called binaural tones. He is a fan of Panic Control, an app designed by a California psychiatrist that helps people during panic attacks, as well as apps that test people’s hearing and vision. He likes such testing apps, not because they can replace doctors, but because they can serve an important public health function of encouraging people to seek professional help when they need it.

For caregivers of the elderly, Cohen likes Elder 411, an app designed by a geriatric care manager filled with more than 500 pieces of advice, and Alzheimer’s Cards, an app filled with pictures that can spark memories, based on the book, “Simple Pleasures for Special Seniors.”

For an app that has completely transformed the lifestyle of people with disabilities, he picks Proloquo2Go, a text to speech app that allows people with autism, cerebral palsy, and various brain injuries to communicate more easily. Cohen also endorses Pain Care, which recently won the “Project HealthDesign” challenge sponsored by the Robert Wood Johnson Foundation and California HealthCare Foundation. The app lets patients track pain symptoms and share data with their doctors. It is designed to help people figure out what exacerbates their pain and what treatments are most effective.

It’s impossible to know how the next generation of consumer apps could change patients’ lives. But almost everyone agrees with one statement made by FDA deputy director William Maisel, when he spoke at the agency’s recent hearings on apps and said.

“These types of products will revolutionize the way we deliver health care.”

*Rochelle Sharpe is a Pulizter Prize-winning journalist with more than 25 years of health writing experience.