Pharmalitet: November 2014

Friday, November 28, 2014

Conspirology... The beginning...

Thursday, November 27, 2014

Wednesday, November 26, 2014

Tuesday, November 25, 2014

The higher failure rate...

While the average time it takes to bring a drug through clinical trials has grown shorter in recent years, the rate of success of those drugs has gone down by almost half, to just 12 percent.

Almost all the attention from Tuesday's release by the Tufts Center for the Study of Drug Development focused on the eye-popping $2.6 billion cost it cited as needed to develop a new drug.

But just as important as the cost — which has gone up 145 percent since 2003 — is the failure rate of drugs that make it to human trials. According to economist Joseph DiMasi, the principal investigator for the study, that failure rate has increased significantly.

"The higher failure rate had a substantial impact on R&D costs. Higher out-of-pocket costs of conducting R&D, and proportionally more failures in clinical testing, are what really drove the increase in costs per approved drug," DiMasi said during a presentation Tuesday.

Based on an analysis of 1,442 experimental drugs that were in clinical tests in recent years through the end of 2013, DiMasi said the overall chance that a drug entering clinical development will be approved for marketing is just under 12 percent. That's down from 11 years ago, when the study set a success rate for drugs that enter human trials of 21.5 percent.

"Approximately seven out of eight compounds that enter the clinical testing pipeline will fail in development," he said. "Put another way, you need to put an average of 8.5 compounds in clinical development to get one approval."

DiMasi arrived at that figure using a weighted average, since as of the study, just 7 percent of the 1,442 drugs had actually been approved. Fully 80 percent had been abandoned by the companies developing them, and the other 13 percent were still in active development. DiMasi said it's likely that many of the drugs in later development will eventually earn approval, hence the overall 12 percent rate.

The chances of a drug moving from Phase 2 to Phase 3 testing was found to be 36 percent, while the rate at which a drug that finished Phase 3 tests went on to have an application for approval was 62 percent.

Another fact DiMasi said is increasingly relevant to the startup-heavy Massachusetts biotech scene: Small biotechs tend to push drugs from early into late-stage development more frequently than large companies, only to have them fail in later stages.

"There's reason to believe that small biotech firms will tend to keep their drugs in development longer than larger firms might, because, they are single or two-product firms, and if the product fails, the company goes under," he said.
http://www.bizjournals.com/boston/blog/bioflash/2014/11/tufts-study-it-takes-eight-drugs-in-clinical.html?page=all

Monday, November 24, 2014

To be healthy and wealthy. The numbers.

Sunday, November 23, 2014

15 jahren Putin. I win - you lose, sign here...

Global pharma spending 'to soar 30% by 2018' - when health is a critical resource...

Global spending on medicines is set to soar by as much as 30% from 2013 to 2018, and by the latter year total expenditures will be nearly $1.3 trillion, according to new forecasts.

The world pharma market will increase at a compound average growth rate (CAGR) of 4%-7% during 2013-18, rising $305-$335 billion over the period (based on constant exchange rates) compared with $194 billion growth seen in the previous five-year period, 2009-13, when the CAGR was 5.2%, says the research, from the IMS Institute for Healthcare Informatics.

This fast growth will be driven primarily by increased specialty drug innovation, greater access to medicines and reduced impact of patent expiries, says the study. It also forecasts that annual spending growth will spike this year at $70 billion, up from $44 billion in 2013 and $26 billion in 2012 and will moderate in the years to 2018, although remaining at higher levels than those seen during 2009-13.

“The higher level of spending growth we’re projecting over the next five years reflects an unusual combination of higher spending on the surge of innovative medicines for patients and lower savings from patent expiries,” says Murray Aitken, IMH Health senior vice president and executive director of the IMS Institute.

“This is particularly evident this year and next in developing countries, and especially in the US, which accounts for more than a third of the global market,” he adds.

The developed markets – led by the US, the five major European markets (France, Germany, Spain, UK and Italy) and Japan – will be the primary drivers of this increased growth; while they will moderate as cost-containment measures further limit price levels, rising volumes will continue to contribute to overall market growth. Only France and Spain will see a contraction in pharmaceutical spend per capita in 2018, as a result of policies aimed at curbing spending growth.

The 21 “pharmerging” markets which currently account for 25% of global medicines expenditures will increase their spending by more than 50% by 2018, with a CAGR of 8%-11% over the forecast period as they continue to broaden access to treatments due to their expanding economies and ongoing government efforts to provide universal health coverage. By 2018, over 80% of growth in the pharmerging markets will be attributed to non-branded medicines, including greater use of biologic drugs.

China, which is already the world’s second-largest pharmaceutical market, will reach spending levels of $155-$185 billion in 2018, the report adds.

Specialty medicines are expected to contribute 40% of total global spending growth to 2018, with higher expenditures particularly in the developed markets. Much of this growth will be from products which bring patients new treatment options, with particularly notable advances expected in the areas of oncology, autoimmune, respiratory, antiviral and immunosuppressant therapies.

The recent surge in cancer drug innovation will continue and contribute to global spending on all oncology drugs, which is set to rise from $65 billion in 2013 to around $100 billion in 2018, while the introduction and uptake of potent new hepatitis C therapies are forecast to producing spending totalling about $100 billion in the five years to 2018, the report forecasts.

Moreover, almost 200 new drugs are expected to be launched in the next five years. Over 2,000 products are currently in late-stage development, a quarter of which are oncology drugs. However, the IMS Institute notes that the availability of new medicines to patients worldwide varies significantly by country and disease area and that, on average, fewer than half the medicines launched during the previous five years are now available across the major developed markets.

- The IMS Institute points out that its estimates are measured at ex-manufacturer level and do not factor in a range of rebates, discounts, taxes and other adjustments that affect the net amount received by manufacturers. The impact of these factors is estimated to reduce growth by $60-$80 billion, or around 25% of the increase forecast, over the next five years, it says

They have done it! Biotech's 3 Most Influential CEOs

http://www.fool.com/investing/general/2014/11/20/biotechs-3-most-influential-ceos.aspx

Friday, November 21, 2014

The correct propaganda!

Wednesday, November 19, 2014

Monday, November 17, 2014

No money - no children...

Personally I do not have any comments...

Pfizer, the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation have teamed up to expand access to the drug giant’s injectable contraceptive Sayana Press (medroxyprogesterone acetate) in 69 of the world’s poorest countries.

The collaboration will effectively subsidise the sale of Pfizer’s contraceptive, which is already available throughout Africa for around $1.50 a dose, so that qualified purchasers can get it at the cheaper price of $1 per dose, giving the poorest women in these countries access at reduced or no cost.

Sayana Press combines a long-acting, reversible, contraceptive with an all-in-one pre-filled, single-use, non-reusable Uniject injection system that eliminates the need to prepare a needle and syringe. This allows the the drug to be administered by health workers to women at home or in other convenient settings.

“Pfizer saw an opportunity to address the needs of women living in hard-to-reach areas, and specifically enhanced the product’s technology with public health in mind,” said John Young, president of Pfizer's global established pharma business.

More than 200 million women in developing countries want to delay pregnancy or prevent undesired pregnancy but are not using any method of contraception. “Far too many women die or are harmed because of unwanted pregnancies,” said Michael Anderson, chief executive at the Children’s Investment Fund Foundation, noting that the Pfizer deal will help expand the choice of affordable contraceptives