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Generic Reyataz-r/Truvada & Rifabutin Deal by Clinton/Pfizer/Generic Cos
  from Jules: so, what is the future of HIV drug development. With such generics being manufactured overseas including EFV, now Reyataz, Truvada, and perhaps others coming, what will happen in the USA after USA patents run out. Will formularies require patients to first try generic EFV or Reyataz before Atripla. The 3TC patent runs out soon and next year we will see if formularies require prescibers to use generic 3TC and break up Atripla. EFV patent runs out in 2013 so will insurers require generic EFV to be used instead of Atripla, what about when Reyataz patent runs out. Perhaps more important is the reliability of these generic manufactured drugs, have they been manufactured with the same rigor that the FDA requires from USA manufacturers like BMS, GSK, Gilead and Abbott, I have my serious concerns that these generics are not as good. Last year the FDA said a big generic manufacturer was not up to par in making drugs. These are some of the issues that may be having an effect on the drying up of new HIV drug development. If profits are reduced or even dry up why should HIV drug makers based in the USA try to develop new HIV drugs. For that matter, what about HCV drug development which is subject to some much more stringent concerns. HIV drugs are taken for a lifetime which makes their profit generation different from HCV drugs which will be taken for 24 weeks or in some cases perhaps longer, as HCV is cureable with short-term one time therapy. In 10 years many if not all patients in the USA will be cured from HCV. So what is the incentive to develop second-line oral HCV drugs for salvage, and what is the incentive to provide other programs?
Pfizer agrees to cut price of TB drug
By Andrew Jack in London
Financial Times
Published: August 6 2009 19:56 | Last updated: August 6 2009 19:56
Pfizer on Thursday became the first research-based pharmaceutical company to agree a deal with the Clinton Foundation that substantially cuts the price of a medicine for patients in low-income countries.
The move, which signals fresh flexibility from the US company over drug pricing in developing countries, also undercuts Pfizer's generic competitors.
It will result in a 60 per cent reduction on the current western price of rifabutin, a tuberculosis treatment for patients with HIV.
Jeff Kindler, Pfizer's chief executive, stressed that the discount would still allow the drug to be sold at a small profit. "Long-term success and sustainability will come from commercially viable models," he said.
Pfizer's agreement comes at a time of growing willingness by research-based pharmaceutical companies to offer discounts on their medicines as they expand business in emerging economies and respond to pressure to boost drugs access for the world's poorest.
The action has followed sharp reductions in drug prices for HIV medicines in the past few years as drug manufacturers have begun selling generic medicines into poorer countries, supported by funding from international donors.
The deal, brokered by the Clinton HIV/Aids Initiative, part of the foundation established by former US President Bill Clinton, was accompanied by a separate agreement with Mylan, the US based generics group, to reduce the price of a "second line" combination treatment for HIV, prescribed once patients fail to respond to an initial cocktail of drugs.
Mylan will reduce the price of four HIV drugs that are off-patent - atazanavir, ritonavir, tenofovir and lamivudine - to $475 a year, falling to $425 a year from 2010, which is 28 per cent less than current prices. It will also make ritonavir available in a heat-stable version more suitable for tropical climates.
Rifabutin, which is given to patients with TB who are already taking second line antiretroviral medicines for HIV, will be sold by Pfizer through a procurement network co-ordinated by the Clinton Foundation.
The drug is no longer protected by a patent from Pfizer, and is also sold by at least two other generic manufacturers, Lupin of India and Med Shine Pharma of China. But the deal will result in the US company which developed the drug offering it at a lower price than its rivals.
Daniel Berman from Medecins sans Frontieres' essential medicines campaign, welcomed the discounts, but warned that funding from donors to buy drugs at lower prices was under threat.

Bill Clinton, drugmakers announce cheaper HIV drugs
Thu Aug 6, 2009
NEW YORK (Reuters) - Former U.S. President Bill Clinton and drugmakers Pfizer and Matrix Laboratories Ltd announced a deal on Thursday to lower the cost of treatments for patients with drug-resistant forms of HIV/AIDS.
Second-line antiretroviral therapies and a drug used to treat tuberculosis for those with drug-resistant HIV/AIDS will be made available at a reduced cost and in more convenient regimens, saving as many as hundreds of thousands of lives in the developing world, Clinton said.
"Today's announcement will help ensure we can sustain treatment over a lifetime and better treat patients with both HIV and TB, two key steps in turning the tide of the global HIV/AIDS pandemic," Clinton told reporters at his foundation's headquarters in Manhattan.
Starting in 2010, Matrix, a unit of U.S.-based Mylan Inc, will make four drugs available at a cost of $425 per year. The discount will result in $400 million in savings over the next five years compared to prices commonly paid for alternative regimens, the foundation said.
In addition, Matrix said it would create a more convenient regimen for taking the drugs, allowing patients to take pills just once per day.
Pfizer will offer the tuberculosis drug rifabutin in 10 countries for $1 per dose, or $90 for a full course of treatment over six months.
Tuberculosis is the leading cause of death among those with HIV/AIDS, Clinton said.
(Reporting by Edith Honan, Editing by Michelle Nichols and Eric Beech)
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