Abbott Presents Promising Phase 2b Interferon-free Hepatitis C Results at 2012 Liver Meeting®

Abbott Presents Promising Phase 2b Interferon-free Hepatitis C Results at 2012
                                Liver Meeting®

  PR Newswire

  ABBOTT PARK, Illinois, Nov. 10, 2012

- Investigational Triple-DAA Regimen plus Ribavirin Treatment for 12 Weeks
Demonstrated High SVR(12) Rates in Intent-to-Treat Analysis

- Phase 3 Registrational Program Currently Enrolling

ABBOTT PARK, Illinois, Nov. 10, 2012 /PRNewswire/ -- Results from Abbott's
phase 2b clinical trial, "Aviator," demonstrated high sustained viral response
rates at 12 weeks post-treatment (SVR(12)) in all 8- and 12-week arms, with
combinations of direct acting antivirals (DAAs) given with and without
ribavirin (RBV). Results will be presented at the President's Press Conference
and the latebreaking clinical trials session at the Liver Meeting, the Annual
Meeting of the American Association for the Study of Liver Disease (AASLD) in
Boston.

Based on promising results from Aviator, Abbott has selected triple-DAA
regimens, with and without ribavirin, to move forward into phase 3 clinical
trials. Topline intent-to-treat results for the 12-week, triple-DAA regimen
with ribavirin are as follows:

  *SVR(12) in treatment-naïve genotype 1 (GT1) patients was 97.5 percent (77
    of 79), and 93.3 percent (42 of 45) in GT1 null responder patients
  *In GT1a patients, SVR(12) was achieved in 96 percent (52 of 54) of
    treatment naïve patients and 89 percent (25 of 28) of null responder
    patients
  *In GT1b patients, SVR(12) was achieved in 100 percent of treatment naïve
    (25 of 25) and null responder patients (17 of 17)

In addition, results from the 12-week triple-DAA regimen without RBV in
treatment naïve patients showed:

  *SVR(12) was achieved in 87.3 percent (69 of 79) of GT1 patients
  *SVR(12) in GT1a patients was 83 percent (43 of 52)
  *SVR(12) in GT1b patients was 96 percent (24 of 25)

"Based on the high SVR(12) results with Abbott's triple-direct acting
antiviral regimen in GT1 patients, it appears we are moving closer to
potential oral treatment regimens that do not require interferon to treat
HCV," said Kris Kowdley, M.D., director of the Liver Center of Excellence in
the Digestive Disease Institute at Virginia Mason Medical Center, and Clinical
Professor of Medicine at the University of Washington in Seattle."This is
encouraging news for the many patients who are unable or unwilling to take
interferon."

About Study M11-652 (Aviator) This phase 2b study assesses the safety, and
efficacy of ABT-450/r (dosed 100/100mg to 200/100mg QD), ABT-267 (25mg QD),
ABT-333 (400mg BID) and ribavirin in non-cirrhotic treatment-naïve patients
and prior peg-interferon/ribavirin null responders for 8, 12 or 24 weeks.
Enrollment was open to GT1-infected patients regardless of IL28B host genotype
and ribavirin dosing was weight-based. Results from the treatment groups are
summarized in the chart below.

                               Treatment-Naïve                    Null Responders
Duration       8 weeks                 12 weeks                      12 weeks
              ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r ABT-450/r

              ABT-267   ABT-333   ABT-267   ABT-267   ABT-267   ABT-267   ABT-267

              ABT-333   RBV       RBV       ABT-333   ABT-333   RBV       ABT-333

Regimen       RBV                                     RBV                 RBV
Number dosed     80        41        79        79        79        45        45
Relapses          9         4         5         5         1         5         0
Breakthroughs     0         1         1         1         0         0         3
Lost to
Follow up
(LTFU) or
withdrew
consent           1         1         2         4         1         0         0
                87.5%     85.4%     89.9%     87.3%     97.5%     88.9%     93.3%
SVR(12)
(ITT)[1]       (70/80)   (35/41)   (71/79)   (69/79)   (77/79)   (40/45)   (42/45)
                88.6%     87.5%     92.2%      92%      98.7%     88.9%     93.3%
SVR(12)
(OD)[2]        (70/79)   (35/40)   (71/77)   (69/75)   (77/78)   (40/45)   (42/45)
                 84%       79%       85%       83%       96%       81%       89%
SVR(12) (ITT)
GT1a           (47/56)   (23/29)   (44/52)   (43/52)   (52/54)   (21/26)   (25/28)
                 96%      100%      100%       96%      100%      100%      100%
SVR(12) (ITT)
GT1b           (23/24)   (12/12)   (27/27)   (24/25)   (25/25)   (18/18)   (17/17)

[1] ITT (Intent-to-treat) population: includes all patients who received at
least one dose of study drug

[2] OD (Observed data): Excludes patients with values missing for reasons
other than virologic failure or discontinuation due to AEs

"The 93.3 percent SVR(12) seen with triple-DAA therapy with ribavirin in
previous null responder patients in Aviator is noteworthy given the limited
treatment options with interferon-based therapies for this patient
population," said Scott Brun, M.D., divisional vice president, Infectious
Disease Development, Abbott. "As the data from the Aviator study have matured,
we are encouraged that we have continued to see high SVR(12) rates. Results
from Aviator have allowed Abbott to confidently move into larger, confirmatory
Phase 3 trials with the goal of being the first company to bring an
interferon-free treatment regimen to genotype 1 patients."

Aviator Safety Results Four of 448 patients (one percent) in the 8- and
12-week arms discontinued due to adverse events. Of five serious AEs
(1percent), one (arthralgia or joint pain) was possibly study drug-related.
In the trial, the most common adverse events were fatigue (28 and 27percent)
and headache (28 and 31percent) for treatment naïve and null responders
respectively.

About the Hepatitis C Virus Hepatitis C is a liver disease affecting as many
as 170 million people worldwide. The virus is primarily spread through direct
contact with the blood of an infected person. HCV increases a person's risk of
developing chronic liver disease, cirrhosis, liver cancer and death; and liver
disease associated with HCV infection is growing rapidly.

Of the six main genotypes of hepatitis C, genotypes 1, 2 and 3 are the most
widespread. Genotype 1 is the most common genotype in the U.S. and the most
difficult to treat with interferon based therapies. Patients with genotypes 2
and 3 are more likely than individuals with genotype 1 to respond to therapy
with peg-interferon or the combination of peg-interferon and ribavirin.

About Abbott's HCV Development Programs Abbott's HCV portfolio includes
investigational medicines with three different mechanisms of action, including
protease (ABT-450/r), polymerase (ABT-333) and NS5A (ABT-267) inhibitors,
currently being studied in clinical trials. ABT-450 is being developed with
low dose ritonavir which enhances the pharmacokinetic properties of ABT-450.
The use of ritonavir 100mg with ABT-450 for the treatment of HCV is
investigational.

ABT-450 was discovered during the course of a collaboration between Abbott and
Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include
protease inhibitors. ABT-450 is being developed by Abbott for use in
combination with Abbott's other investigational medicines for the treatment of
HCV. Abbott is well-positioned to explore combinations and co-formulations of
these medicines.

On Monday, November 12 at 5:30 p.m. EST, Abbott will host an investor webcast
to discuss the phase 2b Aviator data, as well as our recently initiated phase
3 registrational program. The webcast can be accessed on Abbott's investor
relations website at abbottinvestor.com.

Ritonavir Use in Treatment of HIV Ritonavir is in a class of medicines called
the HIV protease inhibitors. Ritonavir is used in combination with other
anti-HIV medicines to treat people with human immunodeficiency virus (HIV)
infection. Ritonavir is for adults and for children greater than 1 month in
age and older.

Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of
passing HIV to others. People taking ritonavir may still get opportunistic
infections or other conditions that happen with HIV infection. Some of these
conditions are pneumonia, herpes virus infections, and Mycobacterium avium
complex (MAC) infections.

Ritonavir Safety in Treatment of HIV Patients should not take ritonavir with
certain medicines, as these can cause serious or life-threatening problems
such as irregular heartbeat, breathing difficulties, or excessive sleepiness.
Patients should not take ritonavir if they have had a serious allergic
reaction to any of its ingredients. Some patients taking ritonavir may develop
liver and pancreas problems, which can cause death.

Patients may develop large increases in triglycerides and cholesterol,
diabetes, high blood sugar, changes in body fat, increased bleeding in people
with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients
may develop signs and symptoms of infections that they already have after
starting anti-HIV medicines. For more information, please see Important
Safety Information and Full Prescribing Information .

About Abbott Abbott is a global, broad-based health care company devoted to
the discovery, development, manufacturing and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs approximately 91,000 people and markets its products in more than 130
countries.

Abbott's news releases and other information are available on the company's
website at www.abbott.com .

Website: http://www.abbott.com
Contact: Tracy Sorrentino, +1-847-937-8712, Roseanne Durril,+1-847-938-6114;
Financial: Larry Peepo, +1-847-935-6722, Liz Shea, +1-847-935-2211
 
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