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

Related Articles:
Advisory panels take up Gilead's Truvada, then Quad
Gilead spotlights key details from pivotal Quad study

FDA details kidney damage in Gilead’s Quad studies

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

With an FDA panel looming, agency staff raised concerns about the risk of kidney damage seen in studies of Gilead Sciences' ($GILD) HIV treatment Quad. The staff review comes days ahead of a panel of non-agency experts who will decide whether to back approval of the new four-drug pill, which could sure up Gilead's position as the leading maker of AIDS drugs for years to come if approved later this year.

The kidney damage could warrant monitoring of patients taking the drug, the FDA staff briefing said, according to Bloomberg. Studies showed that more kidney problems were seen among patients on Quad than other HIV meds, including four patients who suffered kidney failure and one who developed a rare condition that caused renal problems. However, fewer patients quit taking Quad in studies because of side effects than existing meds, a plus for Gilead's case for the combo pill to provide a safer option for treating patients.

Gilead has captured headlines this year for its nearly $11 billion buyout of Pharmasset to gain a footing in the hot field of oral hepatitis C treatments, yet the California biotech company's bread and butter has long been drugs for HIV. Quad offers Gilead a chance to keep the company's reign in the HIV market alive after its patents for top-seller Atripla end, Reuters reported. Also, Quad consists of four Gilead drugs and is taken once a day, while Atripla combines Gilead's two-drug treatment Truvada with Bristol-Myers Squibb's ($BMY) Sustiva.

The advisory panel meets on Friday to discuss Quad, and the FDA will factor in the panel's votes in the agency's decision on approval expected by Aug. 27, Bloomberg reported. Gilead's experimental drug is expected to become a blockbuster product if approved.

- read the Bloomberg article
- see Reuters' report

Related Articles:
Gilead spotlights key details from pivotal Quad study
Gilead asks FDA to approve blockbuster hopeful Quad against HIV

Lack of Gilead and BMS teamwork on hep C draws ire

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Funding, Gilead Sciences, Hepatitis C, Medical Devices, Medical Supply, Partnering, Pharmaceuticals, Startups, Universities, Videos by rmcbride

Gilead Sciences' ($GILD) reluctance to strike a collaboration deal with Bristol-Myers Squibb ($BMY) on a combo hepatitis C treatment has ruffled some feathers in the clinical community, after a small study showed that the companies' drugs worked well together in combating the liver-damaging disease. "The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders," Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, told The New York Times. Article

FDA hits brakes on Novartis’ hep C program after death

Posted under Abbott Laboratories, alisporivir, Blog, Bristol-Myers Squibb, Companies, DEB025, Diagnostics, FDA, Funding, Gilead Sciences, Hepatitis C, interferon, Medical Devices, Medical Supply, Novartis, pancreatitis, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos by rmcbride

Novartis appears to be well behind the top dogs in the hepatitis C race. U.S. regulators have put a hold on Novartis' ($NVS) clinical trial for an experimental hepatitis C drug alisporivir after cases of pancreatitis were reported in the trial and one patient in the study died. Yet the company hasn't determined that the death was linked to the drug.

The Swiss drug giant has been developing the compound--which blocks a protein linked with reproduction of the liver-damaging virus--amid the well-documented chase to bring safer and swifter treatments for the chronic disease to patients. The death and cases of pancreatitis occurred in a trial involving the use of the drug, also known as DEB025, in combination with pegylated interferon, Dow Jones Newswires reported.

Novartis hasn't been one of standouts in the hep C game--unlike companies with the closely watched interferon-free treatments in development such as Gilead Sciences ($GILD), Bristol-Myers Squibb ($BMY) and Abbott Labs ($ABT). And the setback in the development of alisporivir might not wound the Big Pharma very much.

"The role of the drug in the death remains to be determined. The case is open," Bank Sarasin analyst David Kaegi said, as quoted by Dow Jones, who noted that analysts were keeping very close tabs on the program.

- read the Dow Jones article
- and an Associated Press report

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Novartis lists its top blockbuster prospects for '11-'15
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Novartis snags preclinical hep C drug in $440M Enanta pact
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