Thursday, October 18, 2012

UPDATE: Abbott Hepatitis C Regimen Suppresses Virus in New Study

Investment Commentary

UPDATE: Abbott Hepatitis C Regimen Suppresses Virus in New Study

--Abbott reports positive data for three all-oral hepatitis drugs from clinical trial

--Results help Abbott choose regimen for late stage studies

--Positive data also reported for Bristol-Myers drugs

(Adds details about Bristol-Myers drugs in fourth and 18th-19th paragraphs, analyst comments in 20th paragraph, and updates stock prices.)

By Peter Loftus

An experimental all-oral drug regimen developed by Abbott Laboratories (ABT) suppressed the hepatitis C virus in most patients in a new clinical trial.

The results helped guide Abbott to decide on a regimen based on three experimental drugs that the company is taking into larger, late stage clinical trials. Abbott hopes to begin selling a new hepatitis C therapy in 2015, assuming trial results are positive and regulators give the green light, and the company has suggested annual sales could eventually exceed $2 billion.

Abbott, Gilead Sciences Inc. (GILD) and others are racing to introduce the next generation of drugs for an expected multibillion-dollar hepatitis C market. A selling point for drugs in development is they can be taken orally, minus an injectable component of the current standard treatment, a treatment that patients have difficulty tolerating.

The new Abbott results--together with new hepatitis C drug data from Bristol-Myers Squibb Co. (BMY)--suggest Gilead still faces solid competition to its perceived status as the leader in the hepatitis C race.

A summary of the results of the new Abbott study was posted online Monday by the American Association for the Study of Liver Diseases in advance of its November conference, where the full data will be presented.

Hepatitis C is a viral disease that attacks the liver, and is believed to afflict about 180 million people world-wide, with more than four million in the U.S., according to the National Institute of Allergy and Infectious Diseases. At-risk groups include people who had blood transfusions before 1992, when a screening test for the virus was developed.

Abbott has previously reported positive results from midstage studies of its various experimental hepatitis C drugs.

The new study, titled "Aviator," tested three experimental Abbott drugs in a midstage, or Phase 2b, clinical trial of people with hepatitis C. One of the drugs, ABT-450, is a so-called protease inhibitor, which is in the same class of drugs as two that went on sale last year--Merck & Co.'s (MRK) Victrelis and Vertex Pharmaceuticals Inc.'s (VRTX) Incivek. Incivek is marketed outside the U.S. by Johnson & Johnson (JNJ) as Incivo. ABT-450 was given along with a boosting agent known as ritonavir.

The other two experimental drugs used in the latest study are ABT-267, known as an NS5A inhibitor, and ABT-333, a non- nucleoside NS5B inhibitor. Also, some patients were given the drug ribavirin, which is a staple of current hepatitis C therapy.

The trial tested various combinations of these drugs for varying durations up to 24 weeks of treatment, in both patients who had undergone prior treatment and those new to treatment.

The study tracked how many patients had a sustained virologic response 12 weeks after the end of treatment, a measure known as SVR12. Sustained virologic response is roughly equivalent to being virus-free or having nearly undetectable viral levels.

The regimen with the highest SVR12 rates contained the Abbott experimental drugs--ABT-450 with ritonavir, ABT-267 and ABT-333--plus ribavirin for 12 weeks.

This regimen led to an SVR12 rate of 99% in 77 patients who hadn't received prior treatment, and 93% among 41 patients who hadn't responded well to therapy containing the injectable drug interferon. A small number of patients in each of these groups didn't have 12-week follow-up results or hadn't yet reached 12 weeks post-treatment, so the final SVR12 rates could change when those results come in.

The SVR12 rates for other therapy groups in the 571-patient study ranged from 89% to 92%, according to the AASLD summary.

About 1% of patients discontinued treatment because of adverse events. The most common adverse events were fatigue and headaches.

Abbott will test this regimen, with and without ribavirin, in late stage, or Phase 3, clinical trials. In one of these trials,ABT-450, ritonavir and ABT-267 will be coformulated in a single pill, which will reduce the pill count from that of the Phase 2 study. The 300-patient trial is expected to begin recruiting soon.

Scott Brun, Abbott's divisional vice president of infectious disease development, said the company was encouraged by the results, which need to be confirmed in the larger studies.

New data on orally administered hepatitis C drugs developed by Bristol-Myers Squibb Co. (BMY) also appeared positive. A 12-week regimen containing Bristol's daclatasvir, asunaprevir and BMS-791325 produced a sustained virologic response in 94% of one group of patients four weeks after treatment, according to a summary posted by AASLD.

Bristol experienced a major setback in August when it scrapped development of a once-promising hepatitis C drug obtained in its $2.5 billion purchase of Inhibitex earlier this year. Bristol cited safety concerns that arose in a clinical trial.

Analysts said the new data released Monday suggest Bristol may still be able to move forward with other drugs in an all-oral regimen, despite the recent setback.

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