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Monthly Archives: November 2013

November 25,2013 | By Márcio Barra

Soliris, from Alexion, a monoclonal antibody and the first therapy approved for the treatment of the ultra-rare disease paroxysmal nocturnal hemoglobinuria. The rarity of the disease prompted the drug to be priced at $440,000 per year.

Last week, IMS released a report entitled “The Global Use of Medicines: Outlook through 2017″, predicting that total spending on medicines will reach the $1 trillion threshold in 2014. Expenditure is expected to hit to $1.2 trillion by 2017, representing a 5-7 % growth rate from 2013. That’s an increase of up to $260 billion over the next 5 years. In 2012, global spending stopped shy of $1 trillion, reaching $965 billion alongside a 2.6% growth rate.

The reasons pointed out by the report for this expected increase in growth rate? Greater access to medicines by the world’s rapidly expanding middle class, alongside stronger economic prospects in developed nations, especially China. It is important to make a distinction here, as expenses are not the same as profits, since most of the growth will be fuelled by generic prescriptions as many blockbuster drugs will come off-patent and costs with the growing geriatric population rise. A prime example of this is Japan, a country with historically low generic use but with an ever growing geriatric population, making a branded drug marketplace something unsustainable. Japan, North America and European markets are expected to see an annual spending growth of 1-4 %, owing to the current austerity measures targeted at medicine expenditure containment in Europe, the uncertainties of the affordable Health Care act in the US, and the aforementioned shift of focus from branded to generics in Japan and in the rest of these economies.

As for China, it will officially be the world’s second-largest drug market by 2017, as the country undergoes an expansion of its healthcare system with the goal of reaching universal coverage by 2020. This expansion will push its drug market towards a 14% to 17% expansion through 2017 and China is expected to represent 34% of total growth in global medicine spending over the next five years. It is worth pointing out that this growth rate is lower than the growth forecasts of previous years, since China’s economic growth has slowed. Like the UK and many other countries, the Chinese Government is more and more focused on imposing limits on drug prices to reduce healthcare costs in China and expand medical care to its aging population. This could ultimately limit the access of foreign brands into the Chinese market and in IMS’s worst case scenario make the market grow only $144 billion over the next 5 years. In the best case scenario, growth goes up to $187 billion if the country’s private insurance industry takes off and manages to support the uptake of new, expensive drugs.

These new, expensive drugs are called specialty medications, better known as biologic drugs, which are expected to grow 30% by 2017 worldwide. While these drugs face a major hurdle in the form of extremely high prices that are not especially well received by austerity stricken countries, the lack of competition from biosimilars gives these drugs ample market time.

IMS also noted that developed and emerging markets will focus on different disease areas. The top classes in developed markets by 2017 for developed countries, for example, will be oncology, diabetes, anti-TNFs and pain, with a heavy emphasis on specialty medications, whereas developed markets will focus on pain, CNS drugs and antibiotics, mostly small molecules.

The full report is available at www.theimsinstitute.org. An iTunes app is also available at
https://itunes.apple.com/app/ims-institute/id625347542..

November 22,2013 | By Márcio Barra

I have to add Aubagio to this image

Biogen Idec’s multiple sclerosis drug Tecfidera (dymethil Fumarate ) won today designation as a “new active substance” in Europe by the European Medicines Agency, giving it added protection against generic copies and paving the way its approval in European soil.

The designation, issued by the Committee for Medicinal Products for Human Use and posted today on the EMA’s website, gives an additional 10 years of patent protection for Tecfidera, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) posted this decision on its website today, updating a previous opinion.

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November 21, 2013 | By Anabela Farrica

Johnson & Johnson agreed on Tuesday to pay at $2.47 billion to settle thousands of lawsuits that arose over its DePuy unit’s artificial hip implants. The company will pay around $250.000 to each patient of the about 8,000 who had to undergo surgery to remove a defective implant as of August 31st 2013, plus related medical expenses- meaning the deal could very well cost nearly $4 billion to J&J. Payments will be inversely proportional to the time the patient dealt with the implant before its removal.

The settlement was proposed to a federal judge in Ohio and it has to be approved by at least 94% of the eligible claimants before going forward. It is not possible to predict the final outcome at this point, since some patients might decide to advance for individual lawsuits.

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November 21,2013 | By Márcio Barra

Daiichi Sankyo’s edoxaban proved as effective and safer than warfarin in a Phase III trial of patients with atrial fibrillation, according to the results presented at the American Heart Association Scientific Sessions yesterday and published simultaneously online in The New England Journal of Medicine.

The trial, entitled ENGAGE AF-TIMI 48, compared two daily dosages of Edoxaban, 60 mg and 30 mg, against warfarin, dose-adjusted to achieve an international normalized ratio (INR) of 2.0 to 3.0, in the largest – 21,105 patients across 46 countries – and longest – 2.8 years average follow-up – clinical trial in the company’s history.

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November 11,2013 | By Márcio Barra

The first drug developed in Portugal, Eslicarbazepine acetate, from pharmaceutical BIAL, received on Friday approval from the U.S. Food and Drug Administration (FDA) for marketing in the United States.

Branded as Aptiom, the drug was approved as an add-on medication to reduce the frequency of partial seizures associated with epilepsy. The FDA based its approval primarily on three clinical trials, where Aptiom was shown to reduce the frequency of seizures in testing the drug against a placebo, while the ratings of depression and patients’ self-reported quality of life phases showed improvements over pre-treatment baseline during the extension. Participating subjects continued to use their previous anti-epileptic medications throughout the trials.

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