Achillion burnishes buyout prospects, snags fast track for hep C drug

Posted under ACH-3102, Achillion, Achillion Pharmaceuticals, Blog, Companies, Diagnostics, fast-track designation, Funding, Hepatitis C, Medical Devices, Medical Supply, Michael Kishbauch, NS5A inhibitor, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos by john

Achillion CEO Michael Kishbauch hasn't been the least bit shy about touting the company's buyout prospects. Quick to boast about the biotech's promising hepatitis C drugs, he's been raising hopes and stirring buyout buzz with every appearance. And today Kishbauch is sporting another feather in his cap: An FDA fast-track designation for a hep C program--ACH-3102--he's claiming as a next-gen NS5A inhibitor.

Normally, fast track designation for a Phase I treatment wouldn't cause much of a stir. It gives a company a chance to shave four months off the review process, putting them in closer contact with regulators as they roll through the trial process in search of an approval. But just last January Achillion ($ACHN) landed fast track status for its mid-stage drug ACH-1625. And the biotech believes that it's on track to produce a combo drug that can work against a broad range of hep C genotypes without interferon.

Those selling points have helped bolster the company's share price in recent months as investors gambled on a possible buyout along the lines of Pharmasset and Inhibitex.   

"We are very pleased with the granting of a Fast Track designation for ACH-3102, which we believe highlights this second-generation NS5A inhibitor's attributes that include pan-genotypic coverage of HCV and potential for maintained activity against NS5A mutant strains of HCV," commented Kishbauch in a statement. "We are excited to leverage the superior profile of ACH-3102 in combination with our Phase II protease inhibitor, ACH-1625, as we seek to create an optimized, potentially best-in-class potent, well-tolerated, once-daily regimen to treat HCV, which will enter combination studies during the third quarter of this year."

- get the press release
- here's the AP report

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Bristol turns to blockbuster pipeline as Plavix goes generic

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Eliquis, Funding, Generic, Hepatitis C, M&A, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Plavix, Startups, Universities, Videos, Yervoy by rmcbride

Bristol-Myers Squibb ($BMY) has enticed other drugmakers to mimic its strategy of buying up mid-sized biotechs, and the New York-based pharma has seen some of those bets pay off with approvals of drugs such as Yervoy, acquired from Medarex ($MEDX). With clot-buster Plavix facing generic competition, the company is banking on some more wins in its pipeline to replace revenue from declining sales of its top seller.

Plavix sales slipped 4% in the first quarter to $1.69 billion, while sales of newer meds such as melanoma treatment Yervoy and hepatitis B drug Baraclude made solid gains, Bloomberg reported. And the news service provided some analysis on the role of the company's top pipeline prospects, which promise to enable Bristol to weather the loss of Plavix to generics if approved.

For starters, the FDA is expected to make a decision on approval of Eliquis, Bristol and Pfizer's ($PFE) potential blockbuster blood thinner, by June 28. In the meantime, analysts are keeping an eye on Bristol's progress in the development of oral treatments for hepatitis C that don't require injections of interferon. Bristol upped its stake in the oral hepatitis C race in January with the $2.5 billion buyout of Inhibitex ($IHNX), and recently the company hitched up with Johnson & Johnson and Medivir on an interferon-free combo therapy. 

"We want to understand how [HepC is] going to fit into things," Les Funtleyder, an analyst and portfolio manager at Miller Tabak & Co., told Bloomberg. "There's going to be some combination therapy, and it almost certainly requires some partnering, because not everybody's going to have all that's required."

- check out Bloomberg's article

Special Report: Eliquis - 15 top blockbuster contenders

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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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