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Monthly Archives: December 2012

December 20, 2012 | By Márcio Barra

After Pfizer Inc. and Johnson & Johnson Bapineuzumab failure and Eli Lilly Solaneuzumab not so great results in meeting the clinical endpoints in a phase III trial back in August, it would be expected that pharma companies would steer clear from the amyloid hypothesis which has dominated alzheimer research these last two decades. However, while other theories have re-emerged – the Tau theory, a hypothesis which states if the Tau proteins are hyperphosphorylated they can lead to the creation of tangles in brain cells –,  the amyloid theory is still backed up by a number of stakeholders. Eli Lilly’s Solaneuzumab, while ineffective in lower stages of the disease, has “showed a 34% reduction in cognitive decline”, in patients with mild disease,  and so many companies are focusing to create therapies that intervene before the damage is done and identify affected people much earlier, based on amyloid aggregation levels.

The question then is which theory is right? Tau, amyloid, both, none? Alzheimer’s disease is still a mystery to modern science, but these multi millions trials that are conducted, even when falling, help shed some light in the disease mechanism and pathology and help move investigation towards new developments. Phase III trials are currently underway for Rember, a drug from TauRX pharmaceuticals and the first Tau Aggregation Inhibitor. If successful in meeting the primary clinical endpoints, it’s sure to be a blockbuster. If not, investigation can move towards another hypothesis.

Another recent development, this last Tuesday, 18 December, General Electric Healthcare and Merck announced that GE healthcare will supply Flutemetamol, an imaging agent, to Merck for use in investigation regarding their Alzheimer’s disease drug MK-8931, another amyloid targeting drug that recently started a phase II/III clinical trial in patients. A global phase III trial will follow, titled EPOCH. Merck hopes to use Flumetamol, a positron emission tomography (PET) imaging agent that can detect beta amyloid in the brain, to help select patients for the trials and evaluate it as a companion diagnostic tool. This is another effort in solving the puzzle that is Alzheimer’s disease, and, like cancer, multiple pathways are sure to be involved in the disease’s pathogenesis. All theories are worth a shot.

Sources:

http://www.fiercebiotech.com/story/eli-lilly-ditches-fda-filing-alzheimers-hope-solanezumab/2012-12-12

http://taurx.com/

http://www.businesswire.com/news/rxtimes/20121203005589/en/Merck-Initiates-Phase-IIIII-Study-Investigational-BACE

http://uk.reuters.com/article/2012/12/18/merck-gehealthcare-idUKL1E8NI2ZZ20121218

December 19, 2012 | By Márcio Barra

Eliquis, the blood thinner co-developed by Pfizer and Bristol-Myer Squibb

Since Pfizer’s Lipitor patent expired last year in November, their colesterol-lowering statin that gave the company $9.6 billion in revenue in 2011, Pfizer has been shriking down more and more to help contain costs. As part of Pfizer’s CEO Ian Read’s promise to investment analysts to chop off $1 billion in savings in 2012, back in October this year, Pfizer Canada laid off 11% of its workforce, a majority of them from the sales and Marketing Department.

Now, news of more lay offs are coming in from the U.S. Bloomberg reported that Pfizer is now firing almost 20% of their primary-care sales force, comprised of roughly 3000 people.

Eliquis recent approval may signal a turn of this trend, as the company may require more workforce this spring if the FDA follows Europe foot trails and approves it for sale. The company new found focus on niche markets however, may signal the end of the usual massive sales support workforce for a drug.

Source:

http://www.bloomberg.com/news/2012-12-18/pfizer-to-fire-about-20-percent-of-u-s-primary-care-sales-force.html

http://www.theglobeandmail.com/report-on-business/pfizer-to-cut-300-canadian-jobs/article4711980/

December 18, 2012 | By Márcio Barra

FDA just gave the green light on three new drugs last Friday, December 15th, all of them of orphan status.
The first is the new leukemia drug Ponatinib, from Aria Pharmaceuticals. Iclusig™ (ponatinib) is a BCR-ABL inhibitor, an abnormal tyrosine kinase expressed in chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. This drug was specifically designed, through computational methods, to inhibit this enzyme activity.
The second is Signifor, from Novartis. It is the first approved therapy in the U.S. for Cushing’s disease, a rare condition where an individual produces and overproduction of Cortisol. Signifor, a multireceptor-targeted somatostatin analogue, binds and activates 4 of the 5 somatostain, inhibiting secretion of adrenocorticotropic hormone. It was approved for use in Europe back in April, by EMA.
The third is Raxicumab, from GlaxoSmithKline, a monoclonal antibody developed by Human Genome Sciences, who was bought by GSK back in July 16, 2012, for $3.6 billion. Raxicumab is intended to treat patients poisoned with anthrax, a lethal disease caused by the bacterium Bacillus anthracis. It acts through a novel mechanism which blocks the bacterium toxin.
Raxicumab approval is the first time that the FDA approves a monoclonal antibody for the market without any efficacy studies conducted in humans. Due to ethical concerns (as Bacillus anthracis is a lethal bacteria), only safety studies were conducted in healthy volunteers, with efficacy studiesconducted in animal models.

Source:

http://www.fiercebiotech.com/story/fda-green-lights-new-anti-anthrax-rare-disease-drugs-glaxosmithkline-and-no/2012-12-17

December 18, 2012 | By Márcio Barra

the option

The field in question, re-added in the new dispatch (click image to increase)

In an odd turn, the Portuguese Government published in December 10th the Dispatch nº 15700/2012, which approves the new model of medical prescription. In this model, the patient is obliged to declare, in a field in the front of the medical prescription, if they will or will not exert the right of choice regarding his medication.

This new model, which is being heavily criticized by the Portuguese “Ordem dos Farmacêuticos” (Link), is an update to a version published in October this year, where that field wasn’t available, and which was approved by the secretary of health state as the final version. The Ordem dos farmacêuticos pointed that incoherence in their press release, and said that the existence of such a field violates Law nº. 11/2012, from March 8th, and regulated by Ordinance n.º 137-A/2012, from May 11th, which states that a drug must be prescribed according to active substance (DCI), and not by brand. The existence of such a field is said to “bind the patient to an decision made earlier in a medical appointment, when in the act of buying a drug, besides having the power to create absolutely contradictory situations”

The National Pharmaceutical Association, in light of these events, prompted pharmacies to disobey a physician’s prescriptions, arguing that the right of option between a branded drug and a generic must be made by the patient when buying a drug.

Sources:

http://www.ordemfarmaceuticos.pt/scid/ofWebInst_09/defaultArticleViewOne.asp?categoryID=1492&articleID=6342

http://www.jn.pt/paginainicial/interior.aspx?content_id=2947800

http://www.portaldasaude.pt/NR/rdonlyres/2CFC0E9B-1757-4AF1-9DF4-581FDC98F6C2/0/despacho15700modelosRM.pdf