Roche abandons potential blockbuster cholesterol drug

Posted under Blog, cardiovascular, cholesterol drug, Companies, dalcetrapib, Diagnostics, Eli Lilly, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Pipeline, Roche, Startups, Torcetrapib, Universities, Videos by rmcbride

After a review of lackluster efficacy data, Roche has thrown in the towel on developing one of the most promising drug candidates in the company's vast pipeline, dalcetrapib. And the Swiss drug giant's ($RHHBY) failure brings negative attention to similar drugs in development at Merck ($MRK) and Eli Lilly ($LLY) that raise "good" cholesterol to combat cardiovascular disease.

Dalcetrapib has gone down in flames after an interim assessment of a major Phase III trial, called dal-OUTCOMES, indicated that the HDL-raising drug lacked efficacy, Roche announced this morning. The company had hoped to show that adding the drug to the standard of care would benefit patients with coronary heart disease. The dal-OUTCOMES trial and all studies related to the program have been terminated.

Roche's fresh setback could trigger more angst about the prospects of drugs that raise good cholesterol, and analysts expect Merck and Lilly to feel the repercussions from this latest collapse. Pfizer ($PFE) previously ditched its own program in this field because a study showed that more patients on its drug, torcetrapib, died, Bloomberg reported. And Abbott ($ABT) raised doubts last year after reporting lackluster data on the company's own drug to boost good cholesterol.

"We anticipate a negative reaction driven by bad sentiment and we see other programs at risk as this is the second failure in this class following Pfizer's Torcetrapib," wrote Exane BNP Paribas analysts in a note, as quoted by Reuters.

Roche, the world's largest cancer drug provider, had banked on dalcetrapib to provide the company with a grand entrance into the cardio drug arena, and rosy projections of the drug's sales potential were in the neighborhood of $10 billion. The failure of the dalcetrapib program highlights the major challenge of improving on the standard-of-care statin therapies with new cardio drugs.

"Lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal and while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn't provide benefit to the patients in our study," Roche medical chief Dr. Hal Barron stated. The company is dropping dalcetrapib, but it remains "fully committed" to the cardiovascular disease field, he added.

- here's Roche's statement
- see Bloomberg's article
- check out the Reuters story
- and the Wall Street Journal's report

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Developers spotlight huge potential of new class of cholesterol drugs

Posted under Amgen, Blog, cholesterol, cholesterol drug, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Regeneron Pharmaceuticals, Startups, Universities, Videos by John Carroll

Previewing the upcoming meeting of the American College of Cardiology meeting in Chicago, Reuters goes in-depth on a new class of potential blockbusters that will muscle its way into the R&D spotlight. The drugs inhibit the PCSK9 protein, offering a fresh approach to dramatically reducing levels of "bad" cholesterol.

At the top of the list of contenders is Regeneron Pharmaceuticals' ($REGN) REGN 727, which reduced LDL up to 65% in clinical trials. On Sunday, Amgen ($AMGN) will produce early-stage data on its anti-PCSK9 program, called AMG 145. And Reuters adds that Merck ($MRK) and others will muscle rivals in the field for attention as well.

Mani Mohindru, an analyst with Think Equity, tells Reuters that she "can't believe the cardiologists won't be in awe of the LDL reductions."

The developers certainly seem to be in awe of the potential of a new class of drugs that could be offered to millions of patients. "PCSK9 is one of the most exciting targets in cardiovascular drug development today," said Michael Severino, Amgen's chief medical officer.

- here's the story from Reuters

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Karo Bio walks away from Phase III cholesterol drug due to safety risks

Posted under Blog, cholesterol drug, Companies, Diagnostics, Funding, Karo Bio, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Struggling biotech Karo Bio has nixed its lead program for the anti-cholesterol drug eprotirome and canceled plans to split the Swedish developer into two companies, one of which would have focused on advancing eprotirome. And the company's top brass are now trying to highlight their early-stage work and research of drugs that target nuclear receptors.

Eprotirome proved too unsafe despite its cholesterol-lowering effects seen in earlier trials. A toxicology study involving dogs showed that animals on both high and low doses of the drug suffered cartilage damage after 12 months of exposure, while animals in the control did not experience the same side effects. The results were damaging enough for the company to pull the plug on the program, which had cost Karo Bio about $15 million (SEK 100 million) through 2011.

"Eprotirome has been a project with great potential, but also a project with risks," Karo Bio CEO Per Bengtsson said in a statement. "Unfortunately, the [benefits do not outweigh the risks associated with long term use, which is] why we are forced to make this difficult decision."

Without the eprotirome program, Bengtsson now has to excite investors about the prospects of the company's other projects and collaboration with drug giant Pfizer ($PFE), which agreed to fund research of the biotech's research of drugs that target the RORgamma pathway to fight autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. But the clock is ticking: Karo Bio has enough cash now to keep its operations afloat for at least 12 months, the company said. The biotech has already undertaken staff cuts and other measures to conserve cash.  

- here's the release

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