Top 10 Drug Patent Losses of 2014

In a way, the coming year isn't a big one for patent expirations. The total amount of sales jeopardized by patent expirations is $34 billion. That's more than the $28 billion this year, but far less than the $55 billion that hit in 2012. As for 2015? Forget about it. That year, products worth $66 billion will lose IP protection.

Plus, the drugs facing new competition won't all take a big hit in 2014. In fact, EvaluatePharma figures that the products newly open to generic competition will only lose $13 billion off their previous totals.

Roche - Job Opportunity

Marketing Unit Manager

The Position

Key Responsibilities:

• Develop and ensure appropriate and timely implementation of approved marketing plans and tactics
• Perform the required tasks associated with managing the budget per product and ensure proper allocation of resources to maximize sales
• Coordinate close cooperation and development of the "common language" between marketing, sales and medical team
• Design and propose corrective actions related to product strategy
• Develop and maintain strong collaborative relationships with key internal and external partners and vendors
• Provide ongoing coaching and feedback to support personal and professional development and superior performance of all direct reports

Drug, Patent and Hype: Quo Vadis Pharma Innovation?

 A recent research report reveals, though the pharmaceutical companies in the United States since mid 2000 have spent over US$ 50 billion every year to discover new drugs, they have very rarely been able to invent something, which can be called significant improvement over already existing ones.

As per available reports, from the year 2000  to 2010, the US-FDA, on an average, approved just 24 new drugs per year. This number is a sharp decline from the same of 1990, when on an average 31 new drugs were approved per year.

These studies throw open some important questions to ponder:

• What is then the real issue with pharma innovation?
• Is it declining quality or quantity (number)?
• What impacts the patients more?

Top 10 DTC Pharma Advertisers - H1 2013

The U.S. is one of only two countries that allow direct-to-consumer (DTC) advertising of pharmaceuticals, and opinions on whether doing so is a good idea are all over the place, even among doctors. Physicians complain that television ads overstate benefits and lead patients to pressure them to prescribe drugs they may not need. But they also acknowledge that the promotions can deflate the stigma of receiving treatment for some conditions, depression for example, and that is a good thing. Critics complain that drugmakers spend more on marketing than on research and development, a good soundbite in its own right, but one that is hard to verify.

Drugmakers put much more money into other forms of marketing, like detailing to doctors, and DTC advertising has been on the wane in recent years; it fell 11.5% to $3.47 billion in 2012. Still, Nielsen, which supplied the advertising numbers for this report, estimates an average of 80 drug ads air every hour of every day on American television. The top 10 pharma advertisers did spend $1.5 billion in the first 6 months of 2013, which is not exactly chump change.

Whatever your opinion, it is always fascinating to see who those top pharma advertisers are and which products they chose to push. And it can be fun to watch their ads. We present here the top 10 pharma advertisers for the first half of 2013, the most recent data available from Nielsen. We've included financial data on the top two or three products that they advertised. We also have links to the TV ads, courtesy to our readers from AdPharm, a company that tracks them for the advertising and pharmaceutical industries.

Read the report below:

1  Pfizer

2  Eli Lilly

3  AbbVie

4  Merck

5  Amgen

6  AstraZeneca

7  Allergan

8  Otsuka Pharmaceutical

9  GlaxoSmithKline

10  Johnson & Johnson

Market Access is Dead

 
Pharmaceutical Executive | By: John Glasspool
 

Paradigms change when questions emerge that the old paradigm can no longer answer. Market access has become a buzz word, as access to markets is as significant a hurdle to product uptake as registration itself. Initially a topic for pharmaceutical companies concerned about sales volume, it now affects all aspects of healthcare. The current understanding of market access will undergo a fundamental shift in perspective, away from a company-centered toward a patient-centric view of the problem. This column identifies several forces that challenge the current understanding of market access and lobbies for a comprehensive approach that aims to address the needs of all stakeholders, with a primary focus on what creates value for patients. 

What killed market access? 

 

There are four reasons why the current approach to market access is doomed to fail:

Top 10 generics makers by 2012 revenue

FiercePharma | Carly Helfand

The Hatch-Waxman Act shook up the generic drugs business in 1984, and almost 30 years later, it's safe to say the law had its desired effect. About 84% of the 4 billion prescriptions written each year are for generic drugs, saving patients and government programs billions of dollars a year. In other words, generic drugs are big business. And with a slew of blockbuster brands now off patent, it's a big business with growing pains.

As companies bulked up to take on copies of the world's best-selling drugs, a wave of mergers has swept the industry. Many credit Actavis ($ACT) CEO Paul Bisaro with starting that trend; then the Watson CEO, his 2012 takeover of Actavis sent a clear message of "go big or go home" reverberating throughout the generics business. Actavis hasn't stopped scouting for deals, and many of its peers have followed suit.

1M fake Xanax pills intercepted on their way to Egypt from China

Swiss authorities seized more than 1 million fake Pfizer Inc. Xanax anti-anxiety pills at Zurich airport, part of a wider crackdown on counterfeit medicines posing a public-health threat. Four crates weighing more than 400 kilograms (880 pounds) were intercepted while in transit from China to Egypt and ordered to be destroyed after tests determined the pills contained no active ingredients, Bern-based Swissmedic, the country’s drug regulator, said in a statement last week. 

Governments are fighting to safeguard the distribution of legitimate drugs and crack down on counterfeit products. Systematic checks of medical shipments are carried out every year, and imports of bogus medicines have been declining in Switzerland, Swissmedic said in June. Counterfeit drugs generated an estimated $75 billion in revenue in 2010, according to the National Association of Boards of Pharmacy. 

“I’m angry,” Erik Gordon, a professor of law and business at the University of Michigan in Ann Arbor, wrote in e-mailed comments. “When criminals counterfeit Hermes scarves, money is stolen. When they counterfeit pills, they kill people.” Each year more than 100,000 people around the world may die from substandard and counterfeit medications, according to an estimate by Amir Attaran, an associate professor at the University of Ottawa, and Roger Bate, an economist at the American Enterprise Institute. 

The fake Xanax couldn’t be recognized as counterfeit at first glance, said Swissmedic, whose official name is the Swiss Agency for Therapeutic Products. The regulator said it informed authorities abroad of the discovery, in particular in China and Egypt. No patients in Switzerland will be affected, it said. 

The Swiss regulator said in June that it had already seized about 90 shipments this year representing a high-potential health risk. It also has ordered the shutdown of Internet websites trading drugs illegally.

Μήλον της έριδας τα ΜΗΣΥΦΑ για σούπερ μάρκετ και φαρμακοποιούς- Τι λένε οι δύο πλευρές

 

Πηγή:www.reporter.gr 

Mετά τις βιταμίνες και τα συμπληρώματα διατροφής που παίρνουν το δρόμο για την πώλησή τους από τα σούπερ μάρκετ, η λίστα με τα μη συνταγογραφούμενα φάρμακα διευρύνεται με στόχο επιπλέον έσοδα της τάξεως των 100 εκατ. ευρώ. Σύμφωνα με πληροφορίες, η σχετική ρύθμιση θα θεσπιστεί νομοθετικά πολύ νωρίτερα από τα τέλη του έτους, ίσως ακόμη και μέσα στο μήνα καθώς έχουν πολλαπλασιαστεί οι πιέσεις της τρόικας προς αυτήν τη κατεύθυνση.

The top Phase III R&D setbacks of 2013

Πηγή: Fierce Biotech | John Carroll

The stats on Phase III success rates aren't good. About half end in failure--and that's after developers have had a chance to do some careful testing in humans. It's no wonder, then, that late-stage failures continue to inflict some punishing damage on the world's largest R&D organizations--which in most cases are still laboring to overcome the arrival of the patent cliff.

I've singled out what I consider the most significant Phase III setbacks of the year (so far). They were selected not just because they damaged or destroyed estimates on peak sales, but because they also reflected on the companies involved, influenced their research strategies or raised questions about a disease initiative that had grabbed the attention of everyone in the field.

It doesn't always seem possible, but failure doesn't have to be solely negative. The best organizations learn from their high-profile failures and the setbacks of others. What's amazing is how often failure is still immediately shoved out of public view, and how easy it is to convince analysts it was either really a success or completely unimportant. The wake-up call on R&D came long ago, but some groups are still fast asleep.

1  Tredaptive - Merck

2  Ramucirumab - Eli Lilly

3  Fostamatinib/Onglyza - AstraZeneca

4  Aleglitazar - Roche, pRED

5  Vercirnon - ChemoCentryx, GlaxoSmithKline

Sanofi, Teva face renewed backlash as job cuts hit home countries

Πηγή: FiercePharma | Tracy Staton

Two drug company reorganizations. Two goals in mind. One common obstacle. As Teva Pharmaceutical Industries copes with the Israeli backlash from last week's layoff announcement, Sanofi continues to feel the heat from French leaders on its own R&D restructuring scheme.

The situation Teva  now faces is eerily similar to Sanofi's  experience in France last year. Immediately after learning that job cuts would hit Teva's home country, Israel, local labor leaders vowed to strike. By this morning, government officials had jumped into the game. Reportedly, Israeli Finance Minister Yair Lapid and labor leaders "see eye to eye" on the need to protect Teva's employees. And State Comptroller Joseph Shapira called Teva's layoff plans "out of place."

Seven Disruptive Drugs for the Next Decade

 

The biopharmaceutical sector is built to breed innovation from the ground up. If you think about it, drug patents are only scheduled to last for a grand total of 20 years, and that is sometimes from the point at which a company begins preclinical trials. In other words, around half of a drug's protected period can be spent running pre-clinical and clinical tests on efficacy and safety. This means the bread-and-butter period of success for even the biggest blockbusters tends to only be about one decade.

To add, the march toward creating better drugs never stops. Just because a new hepatitis-C drug hit the market two years ago doesn't mean the other four companies making hep-C drugs are suddenly going to go home with their hands in their pockets pouting about what could have been. Biopharmaceutical companies need to always be on their toes and trying to outdo their last drug if they hope to maintain success. Like technology, these drugs become bull's-eyes as soon as they're approved by the Food and Drug Administration for the next group of biopharma companies to unseat.

That's why today I'm looking at seven drugs that I feel have the power to remain a disruptive force in their treatment field throughout the next 10 years. Some are already approved by the FDA; others are not. Obviously, there could be a lot of variables here as it's difficult to see 10 years out and understand what discoveries could be made, as well as what monkey wrench clinical trials or the FDA could throw out to the handful of drugs still in clinical stages mentioned below. What I do believe, though, is that each drug below has the tools to become a dominant force over the next decade and you should, at minimum, be watching their progress. Let's begin with three recently approved drugs that have incredible potential.

Teva cuts 5,000 jobs to save $2bn a year by 2017

 

Teva is slashing the size of its workforce by 10 per cent in an acceleration of its cost-reduction plans, saying it hopes to trim $2bn off its annual expenses by 2017. The cutbacks mean that around 5,000 employees will lose their jobs - with most going before the end of next year - which will reduce 2014 costs by $1bn. By 2015 the company expects to have made 70 per cent of its savings target.

Teva first started restructuring its business at the end of last year, when it said it was looking for $1.5bn to $2bn in 2017 cost reduction.

At the time, it said that sales would decline in 2013 thanks to increased competition for multiple sclerosis (MS) blockbuster Copaxone (glatiramer acetate) and leaner opportunities in generic drugs as the infamous pharma 'patent cliff' draws to an end.

The company had already started to jettison non-core assets - including some R&D programmes - but says it will now extend that effort.

"Teva will scale down oversized parts of the company, while growing its generics business and core R&D programme," said the company in a statement. Priority areas include high-value complex generics, expanding its presence in emerging markets and broadening its portfolio, especially in speciality and over-the-counter (OTC) medicines, it added.

Forget the merger between Roche and Novartis

According to Pharma industry analysts Novartis really is considering selling off a few of its units, in deals that could be worth $15 billion to $20 billion. And no, Roche and Novartis  aren't likely to embark on any big joint projects, much less consider a merger.

This is how Bernstein Research analyst Tim Anderson sees it. He visited both Swiss drugmakers recently and talked with the companies' top brass. Both seemed intent on quashing talk of a crosstown merger, recently triggered by Novartis board member Pierre Landolt's enthusiastic comments on the prospect. Novartis chief Joe Jimenez told Anderson that Landolt's opinion was his own and might not be shared; Roche CFO Alan Hippe said mega-mergers are too disruptive, and his company just isn't interested in them.

Job Opportunity - UCB

BRAND MANAGER IMMUNOLOGY   

The Brand Manager Immunology role is the lead marketer for a specific brand in several indications and works in partnership with the South Eastern Europe Franchise General Manager and EU Immunology Marketing Manager to develop the short, medium and long term strategy. The Brand Manager will lead the implementation of the brand plan with a high degree of autonomy and will support the Franchise General Manager as and when day to day issues occur, to ensure the right action plan is developed and implemented. He/she will be monitoring the agreed KPIs and recommending changes to strategy working closely  with the SEE General Franchise and EU Immunology Marketing Manager to agree financial estimates

Merck, AstraZeneca, Pfizer top list of biggest pharma job-cutters

Since the beginning of 2008, the 11 largest prescription pharmaceutical manufacturers have shed a combined 143,536 jobs according to data collated by Bloomberg.

Merck & Co. – which announced 8500 job cuts last week as part of an initiative to "sharpen its commercial and R&D focus" – has undergone the biggest reduction in headcount over the past five years. The US pharma giant has cut 46,140 jobs since the beginning of 2008, including 15,000 job losses in early 2010 as a result of the Schering-Plough acquisition a year earlier. A further 13,000 jobs were cut in 2011, which equated to a post-merger reduction in staff numbers of around 30 percent.

Loss of US exclusivity for Merck's asthma treatment Singulair was cited as a pre-cursor to the 2011 cuts and likely also played a role in last week’s announcement.

AstraZeneca has cut its workforce by the second highest amount over the past five years, having reduced its head count by 25,733 staff. Over that period, the company has on three occasions announced cuts in excess of 5000, most recently in April. Indeed, since March of this year, the company has reduced its headcount by approximately 9000 people as CEO Pascal Soriot looks to redirect the company’s strategy and commercial outlook. 

Pfizer has shed 16,517 jobs since the beginning of 2008, but notably made the vast majority of these cuts in two announcements prior to the loss of exclusivity for Lipitor in late 2011; Pfizer cut 8180 positions in 2009 and a further 6000 jobs in 2010. Subsequently, Pfizer has cut only a further 1600 positions.

 



Loss of exclusivity for key blockbuster products has acted as the key driver for Big Pharma’s trend to cut jobs over the past five years, both due to the impact on revenue but also pharma’s ability to reduce its sales and marketing spend as a result. It is perhaps no surprise then that the number of job cuts across the Big Pharma peer set peaked in 2010 (40,146 job losses) – just ahead of the co-called 'patent cliff' in 2011/12.
 
Big Pharma’s rate of headcount reduction has subsequently declined, although Merck’s announcement last week demonstrates that there is scope for further streamlining. One analyst suggested, for example, that Eli Lilly could be a prime candidate for cost cutting should its pipeline not deliver as anticipated over the next few years.