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Vertex and Alios BioPharma Announce Exclusive Worldwide Licensing Agreement for Two Nucleotide Drug Candidates, Broadening Vertex's Efforts to Develop New Combinations of Medicines for Hepatitis C
-Vertex gains worldwide rights to two distinct nucleotide analogues, ALS-2200 and ALS-2158, that act on hepatitis C polymerase-
-Collaboration provides multiple opportunities to develop new "all-oral" combination regimens-
"We are excited to begin working with Vertex, as we believe that the
Alios nucleotide analogues provide an important opportunity to improve
patient care in hepatitis C," said
"The recent approval of INCIVEK was a milestone in hepatitis C care, and
today's announcement underscores our long-term commitment to further
improving the treatment of this disease with new combinations of
About ALS-2200 and ALS-2158
ALS-2200 and ALS-2158, currently in preclinical development, are highly
potent nucleotide analogues that appear in in vitro and
non-clinical studies to have a high barrier to drug resistance and the
potential to be dosed once-daily. Both compounds are designed to inhibit
the replication of the hepatitis C virus by acting on the NS5B
polymerase. Each compound has its own unique mechanism of action, which
supports the potential for developing these compounds together as a dual
nucleotide regimen and as part of combination therapy regimens with
Vertex's other approved and investigational medicines for chronic
hepatitis C, including INCIVEKTM (telaprevir), an
As part of this agreement, Vertex gains worldwide rights to both
compounds, further enabling the company to potentially expand
development and commercialization efforts in hepatitis C to areas
Future Development Plans: Alios and Vertex plan to initiate clinical development of each compound in the fourth quarter of 2011, which is expected to include studies of the compounds in healthy volunteers followed by short-duration safety and viral kinetic studies in people with hepatitis C. The goal of the first clinical studies of these compounds is to generate data to enable the initiation of Phase 2 studies as early as the end of 2012. These Phase 2 studies are expected to evaluate multiple combination regimens of ALS-2200, ALS-2158, INCIVEK and VX-222. The combination studies would be designed to generate sustained viral response (SVR or viral cure) data. Additional details on the clinical development program for ALS-2200 and ALS-2158 will be provided later in 2011 upon initiation of the first clinical study.
Terms of the Transaction
As part of the agreement, Alios will receive a
Important Information About INCIVEKTM (telaprevir) tablets
INCIVEKTM (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.
It is not known if INCIVEK is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Tell your healthcare provider about any side effect that bothers you or doesn't go away.
You are encouraged to report negative side effects of prescription drugs
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.2 However, approximately 60 percent of people with genotype 1 chronic hepatitis C do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with
hepatitis C.6 In
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in
For more information and to view Vertex's press releases, please visit www.vrtx.com.
About Alios BioPharma
Alios BioPharma is a biotechnology company located in
INCIVEK™ is a trademark of
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including statements
regarding (i) Vertex broadening its efforts to develop new combinations
of medicines for hepatitis C; (ii) multiple opportunities to develop new
"all-oral" combination regimens; (iii) the expectation that clinical
development of ALS-2200 and ALS-2158 will begin in 2011; (iv) the
potential to create an all-oral, interferon-free, combination therapy
that could improve the safety, efficacy and ease of administration for
patients; (v) Vertex's long-term commitment to further improving the
treatment of Hep C with new combinations of medicines; (vi) the anti-HCV
nucleotides having the potential to be leading agents in hepatitis C;
(vii) the goal of creating a highly potent all-oral regimen in the years
ahead; (viii) the potential for development of these compounds together
as a dual nucleotide regimen and as part of combination therapy regimens
with INCIVEK (telaprevir) and VX-222; (ix) the potential to expand
development and commercialization efforts in hepatitis C to areas
(VRTX - GEN)
2 Pearlman BL and
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
10 Pyenson B, Fitch K,
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact
of antiviral therapy for hepatitis C in
12 Davis GL, Alter MJ,
13 Blatt LM, Mutchnick MG, Tong MJ, et al. Assessment of
hepatitis C virus RNA and genotype from 6807 patients with chronic
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