New study confirms worst fears about Merck’s HIV vaccine

Posted under Biologics, Blog, Companies, Diagnostics, Funding, HIV, HIV/AIDS, Medical Devices, Medical Supply, Merck, NIH, Pharmaceuticals, R&D, Startups, Universities, Videos by John Carroll

Five years ago Merck ($MRK) investigators stunned everyone working in the AIDS research field with the news that they were abruptly halting a study of a prospective HIV vaccine after the data began to make clear that it wasn't only failing to guard against the virus, but appeared to increase the risk of becoming infected. Now researchers have followed up to confirm that the worst case scenario was true.

The sudden about-face on the vaccine forced investigators as well as the NIH to do some serious rethinking about the R&D work being done on HIV vaccines. Not knowing exactly what went wrong, another big trial was scrapped on a similar vaccine. And as The New York Times reports today, further work has been carried out in slow motion, delivering at best mixed results.

The new study tracked the health of 1,836 men enrolled in the Merck trial for a further two years. Almost 10% later became infected, with uncircumcised men and men with high levels of antibodies for the Type 5 adenovirus most at risk. As the vaccine was constructed using a weakened adenovirus 5, scientists speculate that may have boosted the presence of CD4 cells in the blood, creating the kind of "target-rich" environment that HIV thrives on.

But that's conjecture. Investigators still aren't certain what went wrong, only concluding that the result had to be biologic. As a cautionary tale, the Merck trial will continue to serve as a reality check for everyone in the field.

- here's the story from The New York Times

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FDA panel OKs Gilead’s key HIV drug Quad

Posted under Blog, Companies, Diagnostics, FDA, Funding, Gilead Sciences, HIV, Medical Devices, Medical Supply, Pharmaceuticals, Quad, Regulatory, Startups, Universities, Videos by rmcbride

Gilead Sciences ($GILD) has notched a victory in the company's campaign for Quad. The four-in-one pill for HIV won support from an FDA advisory committee Friday, bolstering the Foster City, CA-based company's efforts to gain approval of the drug and maintain its top position in the market for HIV and AIDS drugs.

The FDA's Antiviral Drugs Advisory Committee voted 13-1 that Quad is a safe and effective drug for HIV patients who haven't received prior treatment for the immune system-attacking disease. U.S. regulators weigh such non-binding advice in the agency's decisions on drug approvals, and the FDA is expected to take action on Gilead's application for Quad by August 27.

Gilead's future success in the HIV market relies heavily on the approval of Quad, which could provide the company with a $1 billion-plus seller after patents on its top-selling drug Atripla expire. With Quad, Gilead combines four of its compounds--the experimental integrase inhibitor elvitegravir and boosting agent cobicistat, as well as the approved Truvada, which includes emtricitabine and tenofovir disoproxil fumarate. The drug is the first single tablet, once-daily drug that delivers an integrase inhibitor, according to Gilead.

"With new government guidelines recommending that people diagnosed with HIV begin treatment early, it is important that we continue to simplify and improve HIV therapy," said Gilead's HIV therapeutics chief Dr. Andrew Cheng said in a statement. "The Quad is the latest example of Gilead's ongoing efforts to develop highly effective and well tolerated single tablet regimens for people living with HIV."

In a late-stage clinical study, Quad was 88% effective in stymying HIV, compared with 84% disease suppression in patients on Gilead's drug three-drug combo drug Atripla. Yet there are concerns that more patients on Quad suffered kidney problems in studies and that female patients were under-represented in trials. As Reuters reports, regulators could require patients on Quad to be monitored for kidney damage.

"There are plenty of alternatives to Quad," said Dr. Michelle Estrella, of Johns Hopkins University School of Medicine, as quoted by Reuters. Estrella was the only FDA panel member to vote against approval of Quad. "There's no huge hurry in approving this drug before the outstanding studies are completed."

Gilead triumphed at two advisory committee sessions this week, having won the FDA panel's backing on Thursday for approval of Truvada as a preventive therapy for patients at risk of getting HIV.

- here's the release
- check out Reuters' article

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Support seen for U.S. plan to speed nods for ‘breakthrough’ drugs

Posted under Blog, Cancer Drugs, Companies, Diagnostics, FDA, Funding, HIV, Janet Woodcock, Kalydeco, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos, Xalkori, Zelboraf by rmcbride

Drug companies have clamored for the FDA to provide a more efficient pathway to gain product approvals, and this year the agency and U.S. lawmakers appear to be supportive of a plan that would help pharma groups race to the market with breakthrough drugs.

As Reuters reports today, the plan is expected to become law this year, formalizing a regulatory pathway that allows the FDA to let drugmakers conduct speedier trials with fewer patients prior to approval when their treatments provide major benefits for patients. The system would be akin to the agency's accelerated approach to ushering life-sustaining HIV treatments onto the market.

U.S. regulators have shown a willingness to take urgent action on reviews of breakthrough drugs. For instance, the agency stamped an approval of Vertex's ($VRTX) cystic fibrosis therapy Kalydeco after a quick three-month priority review rather than the standard 10-month review period. And the agency has acted quickly on applications for string of cancer meds such as Pfizer's ($PFE) lung cancer drug Xalkori and Roche's ($RHHBY) Zelboraf for skin cancer that showed impressive results in the clinic, Reuters reported.

Such approvals helped the industry see an uptick in market nods for new drugs, yet there are still significant barriers in place that keep development cycles even for powerful new meds long and expensive. Dr. Janet Woodcock, the FDA's top drug regulator, has been a vocal advocate for giving the agency greater latitude to approve breakthroughs.

"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" Woodcock said in March, as quoted by Reuters.

- check out Reuters' article

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NIH, U.S. agencies pay for nearly half of global health R&D

Posted under Blog, Companies, Diagnostics, FDA, Funding, Global Health Technologies, HIV, Medical Devices, Medical Supply, NIH, Pharmaceuticals, R&D, Startups, Universities, Videos by rmcbride

Uncle Sam has been a champion of backing research of global health concerns that plague populations well outside of U.S. borders, according to a study by Global Health Technologies. In fact, U.S. agencies led by the National Institutes of Health have footed 45% of the bill covering research of diseases such as HIV and other scourges to global health, spending $12.7 billion over the past decade. Yet much of that funding went into basic research, and the study calls for greater focus on backing work to translate findings into treatments. Article