CALDEIRÃO DE BOLSA

Twelve weeks of treatment with two Gilead drugs plus the immune system booster ribavirin yielded an interim cure rate of 100% in treatment-naive hepatitis C patients.

A 12-week regimen consisting of three Abbott drugs plus ribavirin demonstrated a final cure rate of 97% of treatment-naive hepatitis C patients and 93% of "null" responders -- the hardest-to-treat patients because they've failed previous therapy.

The score so far: Gilead 100%, Abbott 97%. Close, but Gilead wins, which means shares are likely to move significantly higher when trading opens Monday.

The Food and Drug Administration on Monday approved a new Gilead Sciences HIV medicine that combines four ingredients into one pill.

The product, previously called Quad, will be sold under the brand name Stribild. It is meant to treat people infected with human immunodeficiency virus who haven't been previously treated with other HIV medicines.

The agency said Stribild provides a complete treatment regimen for HIV infection, the virus that causes AIDS, in one pill. It combines Gilead's existing HIV drug Truvada, which contains the ingredients emtricitabine and tenofovir, and two new ingredients, elvitegravir and cobicistat.

HIV must be treated with more than one drug and, until recent years, patients needed to take multiple pills daily. Stribild will be available later this week, Gilead said.

There is an existing three-medicine product, Atripla, that can also be used alone or in combination with other HIV drugs. Atripla is a combination of Gilead's Truvada with Bristol-Myers Squibb Sustiva.

Doctors say single-pill, once-daily regimens like Atripla and Stribild improve patient adherence to prescribed therapies compared with regimens that require multiple pills or dosing more than once a day.

Gilead recorded $3.2 billion in Atripla sales last year. Some analysts predict sales of Stribild will top more than $2 billion annually by 2020.

Stribild's approval was expected after an FDA advisory panel voted 13 to 1 in favor of agency approval of the drug, although the product's potential price had become controversial. Earlier this month, 13 Democratic members of Congress signed a letter to Gilead Chief Executive John C. Martin expressing concern that Gilead may charge as much as $34,000 annually for the new medicine.

A Gilead spokeswoman said the cost to drug wholesalers will be about $28,500 a year. The company said it would provide discounts to state AIDS drug assistance programs and has also set up a patient financial-assistance program.

Stribild was approved with FDA's toughest boxed warning, stating the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal.

One of two studies submitted to the FDA in support of Stribild's approval compared it to Atripla as initial therapy for HIV infection. The study, involving about 700 patients, met its goal of showing both drugs were similar in treating HIV by suppressing the so-called viral load. The study found that 88% of Quad recipients had viral suppression 48 weeks after starting treatment, versus 84% of Atripla users.

The other 700-patient study compared Stribild to patients taking Truvada in addition to another HIV drug, atazanavir/ritonavir. It showed the Quad reduced viral load in 90% of patients after 48 weeks compared with 87% of patients being treated with the other drugs.

Tridion Escreveu:Realmente as biotech não são para mim...estava a tentar perceber se eram, mas definitivamente não são!

São muito temperamentais!

Tridion Escreveu:tugadaytrader, quando falei em gap estava a falar do 1º, o que dá início à ilha reversiva.

Mas quando existe um gap up, é prática aceitável ajustarmos o stop na mesma proporção da subida ou nem por isso?

Obrigado.

Tridion Escreveu:tugadaytrader, quando falei em gap estava a falar do 1º, o que dá início à ilha reversiva.

Mas quando existe um gap up, é prática aceitável ajustarmos o stop na mesma proporção da subida ou nem por isso?

Obrigado.

Tridion Escreveu:Elias, quando estamos perante um gap up desses a onde é que devemos por o stop, para nos protegermos dum ilha reversiva?

Thanx.

Tridion Escreveu:Elias, quando estamos perante um gap up desses a onde é que devemos por o stop, para nos protegermos dum ilha reversiva?

Thanx.