Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting

• Late breaker oral presentation will feature first report of SVR₄ results from an interferon- and ribavirin-free, 12-week, triple DAA, investigational regimen of daclatasvir, asunaprevir and BMS-791325 in hepatitis C (HCV)
• Oral presentations on HCV investigational compounds daclatasvir, asunaprevir and peginterferon lambda-1a (Lambda) demonstrate diversity of portfolio
• Late breaker poster presentations will report Phase II data on Lambda in the treatment of HCV and chronic hepatitis B

Tuesday, October 16, 2012 11:28 am EDT

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 27 abstracts on the Company’s research in liver disease have been accepted for presentation at The Liver Meeting^® 2012, the 63^rd annual meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, November 9 – 13.

Bristol-Myers Squibb is studying a portfolio of compounds with the potential to address unmet medical needs for patients with liver disease, including the investigational compounds daclatasvir, asunaprevir, Lambda and BMS-791325 being studied in hepatitis C (HCV), Lambda being studied in hepatitis B (HBV), and BARACLUDE^®(entecavir). BARACLUDE is currently indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in aminotransferases (ALT or AST), or histologically active disease.

Key presentations include:

• A late breaker oral presentation of SVR₄ results with an interferon- and ribavirin (RBV)-free, 12-week regimen of daclatasvir, asunaprevir and BMS-791325 in a Phase II study of treatment-naïve patients with chronic HCV genotypes 1, 2 or 3
• An oral presentation of SVR₁₂ results with a regimen of daclatasvir and asunaprevir, with or without alfa interferon (alfa)/RBV, in a Phase II study of chronic HCV genotype 1 null responders
• A late breaker oral presentation on the first report of SVR₄ results from 12-week treatment arms of a Phase II study of daclatasvir and GS-7977, with or without RBV, in treatment-naïve patients with chronic HCV genotype 1, 2 or 3
• A late breaker poster presentation on SVR₁₂ results from the D-LITE Phase II study of Lambda in combination with RBV and either daclatasvir or asunaprevir in patients with chronic HCV genotype 1
• A late breaker poster presentation on Lambda versus alfa in a Phase II study of patients with chronic hepatitis B

“Bristol-Myers Squibb has a long-term commitment to viral hepatitis and has been at the forefront of the evolving science in both hepatitis B and C, where there remains considerable unmet medical need,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “In hepatitis C, we believe improving treatment outcomes requires a personalized approach to meet the needs of the diverse patient population. The data we are presenting at AASLD help expand our understanding of the potential efficacy and safety profiles of our investigational hepatitis C compounds and support our ongoing Phase III development programs.”

The Company will also show three presentations of outcomes research/real-world data that add to the understanding of the prevalence of and current treatment patterns in HBV, HCV and hepatocellular carcinoma (HCC).

The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the AASLD website at http://aasld2012.abstractcentral.com/.

 

Title		Date/Time
Chronic Hepatitis B: BARACLUDE (entecavir) Clinical Data
Entecavir + Adefovir Versus Lamivudine + Adefovir Or Entecavir Alone In Lamivudine-Resistant Chronic Hepatitis B: 96-Week Data From The DEFINE Study		November 10, 2:00 – 7:30 p.m.
Antiviral Efficacy of Entecavir in Black/African American and Hispanic patients with Chronic Hepatitis B who are nucleos(t)ide-naïve		November 10, 2:00 – 7:30 p.m.
Randomized, observational study of long-term entecavir treatment versus other standard of care nucleos(t)ide analog therapy in nucleos(t)ide-naïve patients with chronic hepatitis B from a ‘real-world’ clinical practice setting in China		November 10, 2:00 – 7:30 p.m.
Disease and Treatment Perceptions Among Asian Americans Diagnosed with Chronic Hepatitis B Infection		November 10, 2:00 – 7:30 p.m.
Hepatitis C: Direct-Acting Antiviral Data
Sustained Virologic Response in Chronic HCV Genotype (GT) 1-Infected Null Responders With Combination of Daclatasvir (DCV; NS5A Inhibitor) and Asunaprevir (ASV; NS3 Inhibitor) With or Without Peginterferon Alfa- 2a/Ribavirin (PEG/RBV)		November 11, 4:45 – 5:00 p.m.
First Ever Successful Use of Daclatasvir and GS-7977, an Interferon-Free Oral Regimen, in a Liver Transplant Recipient with Severe Recurrent Hepatitis C		November 10, 2:00 – 7:30 p.m.
Comparison of Pre-Existing and Emerging Resistance-Associated Variants in US, EU and Japanese HCV Genotype 1b Prior Interferon Alfa (IFN-α) Non Responders and IFN-α Ineligible Patients Treated with Daclatasvir and Asunaprevir		November 11, 8:00 a.m. – 5:30 p.m.
Characterization of HCV NS5A Resistance Variants in Naive Patients Infected with Genotypes 2 and 3 Receiving Short-Term Treatment of Daclatasvir in Combination with Pegylated Interferon-Alfa and Ribavirin		November 11, 8:00 a.m. – 5:30 p.m.
Characterization of HCV Genotype 1 NS5A Resistance Variants From the Phase 2b COMMAND-1 Study: Daclatasvir Plus Peginterferon-alfa /ribavirin in Treatment-naive Patients		November 11, 8:00 a.m. – 5:30 p.m.
Twelve- or 16-Week Treatment With Daclatasvir Combined With Peginterferon Alfa and Ribavirin for Hepatitis C Virus Genotype 2 or 3 Infection: Command GT2/3 Study		November 11, 8:00 a.m. – 5:30 p.m.
Daclatasvir, an NS5A Replication Complex Inhibitor, Combined With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive HCV-Genotype 1 or 4 Subjects: Phase 2b COMMAND-1 SVR12 Results		November 11, 8:00 a.m. – 5:30 p.m.
High Rate of Sustained Virologic Response with the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B inhibitor), With or Without Ribavirin, in Treatment-Naïve Patients Chronically Infected With HCV Genotype 1, 2, or 3		November 12, 3:15 – 3:30 p.m.
An Interferon-free, Ribavirin-free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment- Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection		November 12, 3:30 – 3:45 p.m.
Asunaprevir in Japanese Subjects in Phase 2: Exposure-Safety Versus US/EU-Based Subjects and Preliminary Assessment of Correlation with Single Nucleotide Polymorphisms (SNPs) in Liver Uptake Transporters		November 13, 8:00 a.m. – Noon
Effect of Hepatic Impairment on the Pharmacokinetics of Asunaprevir (BMS-650032, ASV)		November 13, 8:00 a.m. – Noon
Hepatitis C and B: PEG-Interferon Lambda Data
Peginterferon Lambda-1a (Lambda) is less likely to induce clinically significant neuropsychiatric symptoms during the treatment of chronic hepatitis C virus (HCV) infection, compared to Peginterferon alfa-2a (Alfa)		November 11, 8:00 a.m. – 5:30 p.m.
Peginterferon Lambda-1a (Lambda) is Associated With Less Autoimmune Thyroid Disease and Serious Autoimmune Disease Than Peginterferon Alfa- 2a (Alfa) When Used in Combination With Ribavirin (RBV) for the Treatment of Chronic Hepatitis C Virus Infection		November 11, 8:00 a.m. – 5:30 p.m.
Peginterferon Lambda, a New Potential Therapeutic Option for the Treatment of Chronic Hepatitis B: A Phase 2B Comparison with Peginterferon Alfa in Patients with HBeAg-Positive Disease		November 12, 8:00 a.m. – 5:30 p.m.
Sustained Virologic Response (SVR12) in HCV Genotype 1 Patients Receiving Peginterferon Lambda in Combination With Ribavirin and Either Daclatasvir or Asunaprevir: Interim Results From the D-LITE Study		November 12, 8:00 a.m. – 5:30 p.m.
Peginterferon Lambda–1a (Lambda) Compared to Peginterferon Alfa–2a (Alfa) in Treatment–Naïve Patients With HCV Genotypes (GT) 1 or 4: SVR24 Results From EMERGE Phase 2b		November 13, 8:45 – 9:00 a.m.
First Report of Peginterferon Lambda/Ribavirin in Combination With Either Daclatasvir or Asunaprevir in HCV Genotype 1 Japanese Subjects: Early Sustained Virologic Response (SVR4) Results From the D-LITE Japanese Sub-Study		November 13, Noon – 12:15 p.m.
Baseline CXCR3 Ligand Levels are Associated With Early Virologic Response to Treatment With Peginterferon Lambda-1a in Chronic Hepatitis C Patients in a Phase 2b Study		November 13, 8:00 a.m. – Noon
Pegylated Interferons Lambda-1a and Alfa-2a Display Different Gene Induction and Cytokine Release Profiles in Both Human Hepatocytes and Peripheral Blood Mononuclear Cells		November 13, 8:00 a.m. – Noon
Hepatitis C: Outcomes Research / Real-World Data
Genome-Wide Association Study to Identify Potential Single Nucleotide Polymorphisms Associated with Hepatocellular Carcinoma among Chronic Hepatitis C Patients		November 11, 8:00 a.m. – 5:30 p.m.
Reasons for Treatment (Tx) Discontinuation Among Hepatitis C (HCV) Patients Treated in Clinical Practice		November 13, 8:00 a.m.- Noon
Hepatocellular Carcinoma: Brivanib Data
Brivanib (BRI) versus Sorafenib (SOR) as First-line Therapy in Patients with Unresectable, Advanced Hepatocellular Carcinoma (HCC): Results from the Phase 3 BRISK-FL Study		November 12, 4:15 – 4:30 p.m.
Hepatocellular Carcinoma: Outcomes Research
Observations of Hepatocellular Carcinoma (HCC) Management Patterns from the Global HCC BRIDGE Study: Global Comparison of Outcomes by Locoregional Therapy		November 13, 8:00 a.m. – Noon

INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE (entecavir) Tablets:

INDICATION

BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating BARACLUDE (entecavir):

• This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease.
• Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.
• Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

• Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
• Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals.

Warnings and Precautions

• Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.
• Lactic acidosis with BARACLUDE (entecavir) use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Adverse Reactions

• In clinical trials in patients with compensated liver disease, the most common (≥3%) adverse reactions of any severity with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia.
• In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE, regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE (entecavir) patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes.

Drug Interactions

BARACLUDE is primarily eliminated by the kidneys, therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs.

Pregnancy and Nursing Mothers

• There are no adequate and well-controlled studies of BARACLUDE in pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits.
• There are no studies on the effect of BARACLUDE (entecavir) on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
• It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast-feeding or discontinue BARACLUDE in nursing women.

Pediatric Use

• Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established.

Renal Impairment

• Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis.
• The safety and efficacy of BARACLUDE in liver transplant recipients are unknown. Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.

Dosage and Administration

BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

The recommended dose of BARACLUDE:

• in nucleoside-naïve adults and adolescents (16+ yrs) with compensated liver disease is 0.5 mg once daily
• in adults and adolescents (16+ yrs) with compensated liver disease, and refractory to lamivudine or with known lamivudine or telbivudine resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L) is 1 mg once daily
• in adults with decompensated liver disease is 1 mg once daily

The optimal duration of treatment with BARACLUDE (entecavir) for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

Additional Information

BARACLUDE is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

Please see accompanying Full Prescribing Information, including Boxed WARNINGS, or click here.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

BARACLUDE^® (entecavir) is a registered trademark of Bristol-Myers Squibb.

Contact:

Bristol-Myers Squibb
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com

Source

Twice-daily INCIVO® (Telaprevir), in Combination With Peginterferon Alfa and Ribavirin, is Effective in Treating People Living With Genotype-1 Chronic Hepatitis C Virus

By Janssen Pharmaceutical

BEERSE, Belgium, October 16, 2012 -- /PRNewswire/ --

NOT INTENDED FOR US JOURNALISTS

- OPTIMIZE study results to be presented in late-breaking poster presentation at the American Association for the Study of Liver Diseases (AASLD) 2012 show non-inferior sustained virological response (SVR12) rates in previously untreated genotype-1 patients receiving an INCIVO® (telaprevir) based regimen twice-daily versus every eight hours -

Janssen Research & Development Infectious Diseases - Diagnostics BVBA (Janssen) will present results from the OPTIMIZE Phase 3 trial for INCIVO® (telaprevir), during a late-breaking poster presentation at the 63rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston (http://www.aasld.org/lm2012). The study, which was completed in September, investigates the efficacy and safety of the twice-daily dosing (BID) of telaprevir versus dosing every eight hours (q8h) in people chronically infected with genotype-1 hepatitis C virus (HCV) who had not been previously treated.^[1]

"This is the first Phase 3 study to evaluate twice daily dosing of the new class of protease inhibitors for the treatment of hepatitis C, so this will be significant news for patients and clinicians," said Maria Buti, Lead Study Investigator and Professor of Medicine at Hospital General Universitari VAll d'Hebron, Barcelona. "Telaprevir has already halved the treatment duration for the majority of people with hepatitis C whilst significantly improving cure rates, compared to previous standard of care, peginterferon alfa and ribavirin (PR). These data offers hope for yet further improvements to treatment regimens, with no compromise on cure rates."

The results demonstrated that BID dosing of telaprevir 1,125mg in combination with peginterferon alfa and ribavirin (PR), achieved similar cure rates, also known as sustained virological response (SVR12) to q8h dosing of telaprevir 750mg (74.3% versus 72.8%), thereby meeting its primary objective of non-inferiority versus q8h dosing.^[1] The safety and tolerability of telaprevir was comparable across dosing arms and consistent with previous studies. The most common adverse events experienced were fatigue, pruritus, anemia, nausea and rash.^[1]

OPTIMIZE was a randomized, open-label, multicenter Phase 3 study in patients with genotype-1 chronic HCV infection who had not been previously treated. During the study, 744 patients were randomized to either BID dosing of telaprevir 1,125mg or q8h dosing of telaprevir 750mg (current INCIVO® label), in combination with PR. At 12 weeks, telaprevir treatment ended and patients continued on PR alone for up to week 24 or week 48 depending on their viral response at week 4. Patients were followed up for a further 12 weeks to monitor cure rates (SVR12).^[1]

Additional telaprevir data to be presented at AASLD will include:

- Efficacy and safety of telaprevir in patients co-infected with HCV and HIV^[2]

- Interim analysis results from the telaprevir Global Early Access Programme highlighting the efficacy and safety of treatment amongst genotype-1 HCV patients with severe fibrosis or compensated cirrhosis^[3]

- Factors predictive of anemia development in treatment-experienced patients receiving telaprevir plus PR in the REALIZE trial^[4]

- Rate of disappearance of telaprevir resistant variants using clonal and population sequence data from Phase 3 studies^[5]

- Evaluation of liver and plasma HCV RNA kinetics and telaprevir levels in genotype-1 HCV patients treated with telaprevir (TVR) using serial fine needle aspirates (FNA)^[6]

- Deep sequencing of the HCV NS3/4A region confirms low prevalence of telaprevir-resistant variants both at baseline and end of study^[7]

About INCIVO®

INCIVO® (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic HCV in adult patients with compensated liver disease (including cirrhosis) who are treatment naïve, and who have previously been treated with interferon alfa (pegylated or non pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.^[8] INCIVO is a small molecule, selective inhibitor of the HCV serine protease, and a member of the new class of medicine for the treatment of genotype-1 chronic HCV, direct acting antivirals (DAAs). Unlike previous treatments, DAAs act directly on viral enzymes and prevent the virus from replicating. INCIVO was approved by the European Commission on 19 September 2011.

Telaprevir was developed by Janssen Research & Development Infectious Diseases - Diagnostics BVBA, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex Pharmaceuticals Incorporated (Vertex) and Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe Pharma). Janssen has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEK^[TM]. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries where it is being marketed as TELAVIC®.

Important Safety Information

Please see full Summary of Product Characteristics or visit http://www.emea.europa.eu for more details.

The overall safety profile of telaprevir is based on the Phase 2/3 clinical development programme containing 2,641 patients who received a telaprevir based regimen. In clinical trials, the incidence of adverse events of at least moderate intensity was higher in the telaprevir group than in the placebo group (both groups receiving peginterferon alfa and ribavirin). The most frequently reported adverse reactions (incidence ≥ 5.0%) of at least grade 2 in severity were anemia, rash, pruritus, nausea, and diarrhoea during the telaprevir treatment phase, and the most frequently reported adverse reactions (incidence ≥ 1.0%)of at least Grade 3 were anemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.^[8]

Rash events were reported in 55% of patients with a telaprevir based regimen compared to 33% of patients treated with peginterferon alfa and ribavirin only and more than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir combination treatment in 4.8% of patients. Rash led to discontinuation of telaprevir alone in 5.8% of patientsand 2.6% of patients discontinued telaprevir combination treatment for rash events compared to none of those receiving peginterferon alfa and ribavirin.^[8]

Hemoglobin values of < 10 g/dl were observed in 34% of patients who received telaprevir combination treatment and in 14% of patients who received peginterferon alfa and ribavirin. In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued telaprevir alone due to anemia, and 0.9% of patients discontinued INCIVO combination treatment due to anemia compared to 0.5% receiving peginterferon alfa and ribavirin.^[8]

About HCV

HCV is a blood-borne infectious disease that affects the liver.^[9],[10] With an estimated 130-210 million people infected worldwide,^[11]and three to four million people newly infected each year, HCV puts a significant burden on patients and society.^[12] Estimations indicate that HCV caused more than 86,000 deaths and 1.2 million disability-adjusted life-years (DALYs) in the WHO European region in 2002 (latest available data).^[13] Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.^[14] About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV (latest available data).^[13] The previously accepted standard treatment for HCV was peginterferon alfa combined with ribavirin,^[14] however this only cleared the virus for 40-50 percent of genotype-1 chronic HCV patients.^[15],[16]

About Janssen

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development Infectious Diseases - Diagnostics BVBA is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

1. Buti M, Agarwal K, Horsmans Y, et al. OPTIMIZE Trial: Non-inferiority of twice-daily telaprevir versus administration of every 8 hours in treatment-naïve, genotype 1 HCV infected patients. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

2. Sulkowski MS, Sherman KE, Soriano V , et al. Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final Study Results. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

3. Colombo M et al. Treatment of Hepatitis C Genotype 1 Patients with Severe Fibrosis or Compensated Cirrhosis: The International Telaprevir Early Access Program. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

4. Zeuzem S, DeMasi R, Baldini A, et al. Factors predictive of anemia development in treatment-experienced patients receiving telaprevir (T;TVR) plus peginterferon/ribavirin (PR) in the REALIZE trial. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

5. Sullivan J, De Meyer S, Haseltine E, et al. Rate of disappearance of telaprevir resistant variants using clonal and population sequence data from Phase 3 studies. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

6. Talal A, Dimova R, Zhang E, et al. Evaluation of Liver And Plasma HCV RNA Kinetics And Telaprevir Levels In Genotype 1 HCV Patients Treated With Telaprevir (TVR) Using Serial Fine Needle Aspirates (FNA). 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

7. Dierynck I, De Meyer S, Thys K, et al. Deep Sequencing of the HCV NS3/4A Region Confirms Low Prevalence of Telaprevir-resistant Variants Both at Baseline and End of Study. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

8. Incivo® Summary of Product Characteristics, updated 2011

9. Simin, M et al. Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.

10. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission

11. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011; 55: 245-264.

12. WHO. State of the art of vaccine research and development. Viral Cancers. Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).

13. Mühlberger, N et al. HCV-related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health. 2009; 9(34):1-14.

14. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Review of Vaccines 2008;7(7): 915-923.

15. McHutchison, J et al. Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection. N Engl J Med. 2009; 361:580-93.

16. The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20] Available from: http://www.hepctrust.org.uk/treatment/potential-new-drugs/Drugs+that+target+the+virus.

SOURCE Janssen Pharmaceutical

Source

Biotron Limited to report new clinical data from BIT225 Hepatitis C Phase 2a trial in a late-breaking presentation at the AASLD 2012 annual conference

- 100% of HCV trial patients receiving 400mg of BIT225 daily for 1 month, had undetectable virus at the 48 week time point

Sydney, NSW, Australia, October 16, 2012 - Biotron Limited ('Biotron'), a clinical-stage drug development company focused on development of new generation antiviral drugs, today announced that the Company will report new clinical data from its Phase 2a trial of BIT225
in patients infected with Hepatitis C virus (HCV). The data will be detailed in a late-breaking
presentation at the American Association for the Study of Liver Diseases (AASLD) 2012
annual conference in Boston, USA.

Previously released data from the 28 day Phase 2a trial of BIT225 demonstrated that BIT225
significantly increased the response to the current approved anti-HCV treatment, with improved outcomes for those patients infected with HCV. At the three-month time point 87% of patients who received BIT225 in addition to standard of care (SOC), interferon alfa-2b plus ribavirin (IFN/RBV), were clear of virus, compared to 63% of those receiving IFN/RBV alone.

The abstract titled “High sustained viral response with a HCV p7 inhibitor, BIT225: Antiviral
activity and tolerability of BIT225 plus pegylated interferon alfa 2b and weight-based ribavirin for 28 days in HCV treatment-naïve patients" will be presented in a late-breaking presentation on November 12 at The Liver Meeting® 2012, the 63rd annual meeting of the AASLD, which will take place from November 9-13 in Boston, Massachusetts.

Key new data that will be presented include results from the week 48 follow-up of trial participants. These latest results demonstrate that 100% of patients who received 400mg dose of BIT225 in addition to IFN/RBV maintained a sustained virological response (SVR), with virus levels below the limit of detection. Patients who received 200mg of BIT225 in addition to IFN/RBV had 87.5% SVR, while patients who only received treatment with IFN/RBV had 75% SVR.

The 48-week data extends the previous three-month data, and demonstrates that BIT225
appeared to continue to provide additional benefit to patients after the conclusion of dosing.
Biotron’s BIT225 targets the HCV viral protein p7, which has crucial roles in virus replication and reproduction. It is a new target, and BIT225 is a first-in-class direct acting antiviral for the treatment of HCV.

As well as being synergistic with current approved SOC HCV treatments, preclinical studies
have demonstrated that BIT225 also works well in vitro with some polymerase inhibitors, another new drug class in clinical development.

BIT225 is also in development for treatment of HIV, with a Phase 1b/2a trial currently in progress. BIT225 offers a unique opportunity for potential use in the HIV/HCV co-infected
population. A trial in this patient population is anticipated to commence before the end of
2012.

Source

Simeprevir (TMC435) Data In Hepatitis C To Be Presented At The Annual Meeting of the American Association for the Study of Liver Diseases

BOSTON, Oct. 16, 2012 /PRNewswire/ -- Janssen Research & Development Ireland (Janssen) will present new data on simeprevir (TMC435), an investigational protease inhibitor, in hepatitis C (HCV) patients at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which takes place November 9 to 13 in Boston.

"We are pleased that these data have been selected for presentation at the AASLD annual meeting," said Wim Parys , Head of Infectious Diseases, Janssen. "The data represent an important step forward in Janssen's efforts to understand the potential utility of simeprevir in a number of different treatment combinations and hepatitis C patient populations."

Simeprevir is being studied in Phase III trials as a once-daily oral treatment in combination with pegylated interferon (IFN) and ribavirin (RBV) for genotype 1 HCV patients. It is also being studied in separate Phase II studies with other direct-acting antiviral (DAA) agents as part of IFN-free regimens, with and without RBV.

The data to be presented at the 2012 annual meeting of the AASLD include:

Oral Presentation: Parallel Session 12, HCV New Agents: Hard to Treat Patients, Hynes Ballroom B & C, November 11, 4:45 - 6:15 p.m. (ET)

• Efficacy and tolerability of TMC435 150 mg once daily with peginterferon alfa-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials)
  • Lead Author: Fred Poordad, M.D., Alamo Medical Research Center, San Antonio, TX
• No clinically significant interaction between the investigational HCV protease inhibitor TMC435 and the immunosuppressives cyclosporine and tacrolimus
  • Lead Author: Sivi Ouwerkerk-Mahadevan , M.D., Janssen Research & Development

Poster Presentations: Clinical HCV 1, Poster Hall, November 11, 8:00 a.m. - 5:30 p.m. (ET)

• Safety and tolerability of TMC435 in combination with peginterferon alfa-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naive and -experienced patients (Phase IIb PILLAR and ASPIRE trials)
  • Lead Author: Michael W. Fried , M.D., University of North Carolina at Chapel Hill, Chapel Hill, NC
• No pharmacokinetic interaction between the investigational HCV protease inhibitor TMC435 and an oral contraceptive containing ethinylestradiol and norethindrone
  • Lead Author: Sivi Ouwerkerk-Mahadevan , M.D., Janssen Research & Development

About Simeprevir
Simeprevir (TMC435) is an NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB to treat chronic hepatitis C (HCV). Simeprevir is being studied in combination with pegylated interferon (IFN) and ribavirin (RBV), and in combination with direct-acting antiviral (DAA) agents in all oral IFN- free regimens, with and without RBV.

Global Phase III studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive patients, PROMISE in patients who have relapsed after prior IFN-based treatment and ATTAIN in treatment-experienced patients. In parallel to these trials, Phase III studies for simeprevir are ongoing in both treatment-naive and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 infected patients and in Japanese HCV genotype 1 patients.

Simeprevir is also being studied in Phase II IFN-free trials with or without RBV in combination with:

• Janssen's TMC647055 and ritonavir in treatment-naive, relapser or null responder HCV genotype 1 patients;
• Gilead Sciences, Inc.'s sofosbuvir (GS-7977) in null responder HCV genotype 1 patients; and
• Bristol- Myers Squibb 's daclatasvir in treatment-naive or previous null responder HCV genotype 1 patients.

For additional information about simeprevir, please visit www.clinicaltrials.gov.

About Hepatitis C
Hepatitis C (HCV), a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 170 to 210 million people are infected with HCV worldwide, with three to four million people newly infected each year.

About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Janssen Research & Development Ireland (Janssen)

PR Newswire (http://s.tt/1qb0J)

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Abbott's Investigational Interferon-Free Hepatitis C Treatment Regimen Achieved SVR12 (Observed Data) Rates in 99 Percent of Treatment-Naïve and 93 Percent in Prior Null Responders for Genotype 1 Patients in Phase 2b Study

October 15, 2012

Abbott Park, Illinois (NYSE: ABT) — Abbott today announced initial results from "Aviator," a phase 2b study of its interferon-free, investigational regimen for the treatment of hepatitis C (HCV). Initial results show sustained virological response at 12 weeks post treatment (SVR12) in 99 percent of treatment-naïve (n=77) and 93 percent of null responders (n=41) for genotype 1 (GT1) HCV patients taking a combination of ABT-450/r, ABT-267, ABT-333 and ribavirin for 12 weeks, based on an observed data analysis.

Full results from the study will be presented at the Latebreaker Session of The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston, November 9-13. Abstracts are available at www.aasld.org.

The observed data analysis used in this abstract does not include six patients who had not yet reached post-treatment week 12 or had missing values (data points) at the time of the abstract submission. All virologic failures and safety discontinuations were included in the analysis.

"There is a significant unmet medical need for genotype 1, the most common form of HCV in the U.S. and Europe," 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. "Results from this phase 2b study suggest that sustained virological response can be achieved without interferon in a high proportion of genotype-1 patients, including patients who have not responded to previous treatment. This is exciting news as we continue to study treatment options for patients."

"Based on the promising results we've seen, Abbott has selected a triple direct acting antiviral regimen, with and without ribavirin for phase 3 development," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "The ability to show sustained virological response in these patient populations, without the use of interferon, is extremely encouraging."

Study M11-652 (Aviator)

• Kris Kowdley, et al.; Monday, November 12 (3:00-3:15 p.m. ET)
  "A 12-Week Interferon-free Treatment Regimen with ABT-450/r, ABT-267, ABT-333 and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-Naïve Patients and 93% in Prior Null Responders with HCV Genotype1 Infection"

The objective of this phase 2b study was to assess the safety, and efficacy of ABT-450/r (dosed 100/100 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.

The 12-week regimen of three direct acting antivirals plus ribavirin had the highest SVR12 rates among the 8 and 12 week arms. Results from the 12 week treatment groups containing three direct acting antivirals plus ribavirin are summarized in the chart below.

 

	Treatment-naïve (N=79)	Null responders(N=45)
BL HCV RNA (log10 IU/mL)	6.5±0.6	6.6±0.5
BL IL28B non-CC genotype	72%	96%
SVR4	78/79 (99%)	42/45 (93%)
OD SVR12	76/77 (99%)	38/41 (93%)
PTW12 data missing*	2	4
Breakthrough	0	3
Relapse	1	0
OD SVR12 (GT1a)	52/53 (98%)	24/27 (89%)
OD SVR12 (GT1b)	24/24 (100%)	14/14 (100%)
OD SVR12 (IL28B non-CC)	54/55 (98%)	36/39 (92%)

*	Did not follow up (2 treatment-naïve patients and 1 null responder) or have not yet reached PTW12 (3 null responders)

Additional data presented in the abstract represent all 8- and 12-week arms (n=448) of this 14-arm study (571 patients enrolled: 438 treatment-naïve and 133 prior null responders). SVR₁₂ rates for other 8- and 12-week regimens ranged from 89-92 percent. Complete SVR₁₂ data for 8- and 12-week arms will be presented at the Liver Meeting.

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

Abbott Data at AASLD

In addition to Aviator, there are four poster presentations on Abbott's investigational medicines for the treatment of HCV:

• Tami Pilot-Matias et al.; Sunday, November 11 (8:00 a.m.-5:30 p.m. ET)
  "Characterization of Resistant Variants in NS3 and NS5B Detected in Subjects Treated with ABT-450/r, Ribavirin, and Either ABT-072 or ABT-333 in the Pilot and Co-Pilot Studies Who Experienced Virologic Breakthrough or Relapse"
• Preethi Krishnan et al.; Tuesday, November 13 (8:00 a.m.-12:00 p.m. ET)
  "Antiviral Activity and Resistance Profiles for ABT-267, a Novel HCV NS5A Inhibitor, In Vitro and During 3-Day Monotherapy in HCV Genotype-1 (GT1)-Infected Treatment-Naïve Subjects"
• Lane Kirbach et al.; Tuesday, November 13 (8:00 a.m.-12:00 p.m. ET)
  "Evaluation of Patient Preferences for Treatment Outcomes in Hepatitis C Virus (HCV)"
• Amit Khatri et al.; Sunday, November 11 (8:00 a.m.-5:30 p.m. ET)
  "Pharmacokinetics and Safety of Co-administered ABT-450 plus Ritonavir (ABT-450/r), ABT-267 and ABT-333 as a Single Dose in Subjects with Normal Hepatic Function and in Subjects with Mild, Moderate and Severe Hepatic Impairment"

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.

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 100 mg 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.

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 the Important Safety Information and full Prescribing Information for ritonavir.

About Abbott

Abbott (NYSE: ABT) 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.

Media:
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(847) 937-8712
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HCV - Whats Coming

Provided by NATAP.org

from Jules of NATAP: Next month in November the big annual liver meeting AASLD will take place, where we will see the latest new data on new HCV therapies. We already know from the European EASL meeting held in April 2012 that interferon-free therapy regimens composed of 2-4 new oral drugs will be developed. There are 6 new HCV drugs in phase 3 now: 3 new once-daily protease inhibitors, a potent first-in-class NS5A inhibitor, a potent first-in-class nucleotide, and the new PegLambda. In addition right behind this in phase 2b & 2a are many new HCV oral drugs including potent protease inhibitors, NS5A inhibitors, non-nucleoside polymerase inhibitors, a nucleoside, as well as a newly developed 2nd nucleotide. At EASL we received the first new data reporting 90% to 100% cure rates with interferon-free regimens of 2-4 new oral drugs. But this was data from the initial regimens, much improved regimens will be developed so this year at AASLD we will see early developments of these newer & better regimens to be. But we will see in the future highly optimized regimens, which will provide as much as 100% cure rates. For patients who are the most difficult to treat and who have usually failed previous therapies, including patients with cirrhosis, it will be more challenging to find 100% cure regimens, but researchers are intent on accomplishing this & I predict we will be able to do this either with interferon or IFN-free. In fact research results already showed as much as 100% cure rates with QUAD in highly experienced patients with 2 new oral HCV drugs + pegIFN/RBV, so it is doable but I think we will find better regimens as well for these hardest to treat patients. The new peginterferon called PegLambda is in phase 3, and looked in phase 2 to be more tolerable than the current peginterferons on the market.

Here are links to tables & discussions of these new drugs, including links to all the data presented for each drug.

HCV Update Selected Highlights: key new HCV drugs, timelines & recent news developments

6 New HCV Drugs in Phase 3 Now

New HCV Drugs: non nucleoside polymerase inhibitors

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The 63rd Annual Meeting of the American Association for the Study of Liver Diseases in Boston, MA - Hynes Convention Center: November 10 - 13, 2012

ALEXANDRIA, Va. and BOSTON, Oct. 10, 2012 /PRNewswire/ -- The Liver Meeting® is the premier Annual Meeting in the science and practice of hepatology, including the latest findings on new drugs, novel treatments, and the results from pilot and multicenter studies.

Approximately 10 percent of Americans have some form of liver disease, but fortunately, the research community has made great strides in recent years in developing new treatments for patients.

At this year's meeting, 2107 abstracts addressing these issues that will be presented, including 258 abstracts that will be presented in oral sessions. Those abstracts are available to members of the press at our website (www.aasld.org).

Boston, MA: November 10 – 13, 2012

• Poster Presentations: November 10 – 13
• Oral Presentations: November 11 – 13

An AASLD President's press conference highlighting key abstracts and issues presented at The Liver Meeting® is scheduled for Saturday, November 10 at 4:00 pm.

Founded in 1950, AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD has grown into an international society responsible for all aspects of hepatology, and our annual meeting attracts more than 8,000 physicians, surgeons, researchers, and allied health professionals from around the world.

Please contact AASLD at 703-299-9766 begin_of_the_skype_highlighting 703-299-9766 end_of_the_skype_highlighting for information about the above presentations, or to receive any additional information about The Liver Meeting® – or visit our website at www.aasld.org.

Please visit our website to register as press for the meeting, or contact Ann Haran at aharan@aasld.org with any questions.

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.xpresspress.com.

SOURCE American Association for the Study of Liver Diseases (AASLD)

RELATED LINKS
http://www.aasld.org/

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Hyperion Therapeutics to Report Results of HALT-HE Study at AASLD Plenary Session

PRESS RELEASE

Oct. 2, 2012, 6:56 p.m. EDT

SOUTH SAN FRANCISCO, Calif., Oct 2, 2012 (GlobeNewswire via COMTEX) -- Hyperion Therapeutics, Inc. announced today that the results of the HALT-HE Study will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) (The Liver Meeting(R)), taking place on November 9-13, 2012 in Boston, MA. The presentation, "Randomized, controlled, double-blind study of glycerol phenylbutyrate in patients with cirrhosis and episodic hepatic encephalopathy," will be made on Monday, November 12, 2012, at 8:45 a.m. ET in the Presidential Plenary Session I in the Hynes Convention Center Auditorium.

The abstract is published online at https://www.aasld.org/lm2012 and summarizes the following results: the study met its primary endpoint, a significant reduction in patients with Hepatic Encephalopathy (HE) events, and supports ammonia (NH3) as important in HE pathogenesis. The HALT-HE study was a Phase II, multi-center, randomized, double-blind trial of glycerol phenylbutyrate vs. placebo in 178 patients with episodic HE recruited from 28 sites in the United States, 9 sites in Russia and 7 sites in Ukraine.

About Hepatic Encephalopathy

HE is a serious but potentially reversible neurological disorder that can occur in patients with cirrhosis of any etiology or acute liver failure. HE comprises a spectrum of neurological signs and symptoms ranging from mild (e.g. minimal disorientation) to severe (e.g. coma, death) and is believed to occur when the brain is exposed to gut-derived toxins such as ammonia that are normally removed from the blood by a healthy liver. Based on the current epidemiological literature, Hyperion estimates that there are approximately one million patients in the United States with cirrhosis, of whom approximately 140,000 have overt HE.

About Glycerol Phenylbutyrate

Glycerol phenylbutyrate, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL(R), the only branded therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders. Glycerol phenylbutyrate holds orphan product designations in the United States and Europe for the maintenance treatment of patients with urea cycle disorders (UCD) and in the United States for the intermittent or chronic treatment of patients with cirrhosis and any grade of hepatic encephalopathy.

About Hyperion Therapeutics

Hyperion Therapeutics is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat disorders in the areas of orphan diseases and hepatology. Hyperion Therapeutics is developing Ravicti(TM) (glycerol phenylbutyrate) for two orphan indications: UCD and HE.

BUPHENYL(R) is a registered trademark of Ucyclyd Pharma, Inc.

Forward-Looking Statements:

To the extent that statements contained in this press release are not descriptions of historical facts regarding Hyperion, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations regarding the timing of the presentation of the results of the HALT-HE study in November. Hyperion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the business of the company in general, see Hyperion's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and any subsequent filings with the Securities and Exchange Commission.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Hyperion Therapeutics, Inc.

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Medivir announces that Simeprevir (TMC435) data will be presented at the upcoming AASLD Meeting

01-Oct-12 Stockholm, Sweden—Medivir AB (OMX: MVIR), announced today that four abstracts related to simeprevir (TMC435), have been accepted for presentation at the 63nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from November 9-13 in Boston, USA.

Simeprevir is a once daily potent HCV NS3/4A protease inhibitor in phase III clinical development for the treatment of chronic hepatitis C jointly developed by Medivir and Janssen Research & Development Ireland (Janssen).

AASLD PRESENTATIONS

Two of the abstracts will be presented as oral presentations and two as posters at the Hynes Convention Center in Boston.

ORAL PRESENTATIONS

Parallel Session 12, HCV New Agents: Hard to Treat Patients, Hynes Ballroom B & C, November 11, 16:45-18:15

· Efficacy and tolerability of TMC435 150 mg once daily with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials)

Fred Poordad, Michael W. Fried, Stefan Zeuzem, Peter Ferenci, Oliver Lenz, Rekha Sinha, Katleen Callewaert, Monika Peeters, Maria Beumont-Mauviel

· No clinically significant interaction between the investigational HCV protease inhibitor TMC435 and the immunosuppressives cyclosporine and tacrolimus
Sivi Ouwerkerk-Mahadevan, Alexandru Simion, Steven Mortier, Monika Peeters, Maria Beumont Mauviel

POSTER PRESENTATIONS

Clinical HCV 1, Poster Hall, November 11, 08:00-17:30

· Safety and tolerability of TMC435 in combination with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naïve and -experienced patients (Phase IIb PILLAR and ASPIRE trials)
Michael W. Fried, Fred Poordad, Stefan Zeuzem, Peter Ferenci, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Monika Peeters, Rekha Sinha, Maria Beumont-Mauviel

· No pharmacokinetic interaction between the investigational HCV protease inhibitor TMC435 and an oral contraceptive containing ethinylestradiol and norethindrone
Sivi Ouwerkerk-Mahadevan, Maria Beumont-Mauviel, Kurt Spittaels, Alexandru Simion, Monika Peeters

The abstracts have been published today and can be accessed on the AASLD website: http://www.aasld.org.

For more information about Medivir, please contact:

Medivir Direct: +46 8 440 6550 or:
Rein Piir, EVP Corporate Mobile: +46 708 537 292
Affairs & IR
M:Communications medivir@mcomgroup.com
Europe: Mary-Jane Elliott, +44(0)20 7920 2330
Amber Bielecka, Hollie Vile

About Simeprevir (TMC435)

Simeprevir is is a once daily potent HCV NS3/4A protease inhibitor jointly developed by Medivir and Janssen Research & Development Ireland (Janssen) to treat chronic hepatitis C virus infections.

Simeprevir is being developed both in combination with PegIFN/RBV and in combination with other Direct-acting Antiviral (DAA) agents in an all oral Interferon (IFN) free regimen, with or without Ribavirin (RBV).

Simeprevir is currently being evaluated in three global phase III studies, QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior PegIFN/RBV-treatment. In parallel to these trials, phase III studies for simeprevir in Japan, in both treatment naive and treatment experienced hepatitis C genotype-1 infected patients, are ongoing.

In parallel with the ongoing global phase III-studies, simeprevir is currently in three phase II Interferon free trials with or without Ribavirin.

· In the first trial simeprevir is evaluated in combination with GS7977 (Gilead) in null responder hepatitis C genotype-1 infected patients.
· In the second trial simeprevir is evaluated in combination wtih daclatasvir (BMS) in treatment-naïve or previous null responder hepatitis C genotype-1 infected patients.
· In the third trial simeprevir is evaluated in combination with TMC647055 (Janssen R&D) and ritonavir in low doses in treatment-naïve, relapser or null responder hepatitis C genotype-1 infected patients.

For additional information about simeprevir (TMC435) please see www.clinicaltrials.gov

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The World Health Organization estimates that nearly 170 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC (Centers for Disease Control and Prevention) has reported that more than three million people in the United States are chronically infected with HCV.

About Medivir

Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir (TMC435), a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Research & Development Ireland.

In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia and today Medivir has a broad product portfolio with prescription pharmaceuticals in the Nordics.

Medivir’s first product, the unique cold sore product Xerese^®/Xerclear^®, is launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDuo in Europe, Japan and Russia.

Medivir’s IPO was in 1996 and currently the company has around 180 employees.
For more information about Medivir, please visit the Company’s website: www.medivir.com

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people’s lives.

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