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Abbott Acquires HCV Protease Inhibitors from Enanta Pharma
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"ABBOTT AND ENANTA FORM WORLDWIDE ALLIANCE TO DEVELOP AND COMMERCIALIZE HCV PROTEASE INHIBITORS"
DECEMBER 12, 2006, press release from companies
Note from Jules Levin: Abbott is developing HCV polymerase inhibitors in-house so this new development allows them to pursue the development of combination therapy with a regimen consisting of polymerase plus protease inhibitors.
"ABBOTT AND ENANTA FORM WORLDWIDE ALLIANCE TO DEVELOP AND COMMERCIALIZE HCV PROTEASE INHIBITORS"
DECEMBER 12, 2006, press release from companies
ABBOTT PARK , ILL., and WATERTOWN, Mass., December 12, 2006 - Abbott and Enanta Pharmaceuticals announced today that the companies have signed a worldwide agreement to develop and commercialize hepatitis C virus (HCV) NS3 and NS3/4A protease inhibitors. Enanta has discovered several HCV protease inhibitors that have demonstrated attractive efficacy and pharmacokinetic profiles in pre-clinical studies.
"Abbott's innovative work in the protease inhibitor field against the Human Immunodeficiency Virus (HIV) has provided the momentum and the foundation for our research interest in HCV infection," said John Leonard, M.D., vice president, Global Pharmaceutical Research and Development, Abbott. "Enanta has done compelling work in its HCV protease inhibitor program, and we look forward to working together on the advancement of this global program."
"Abbott is a market leader in the field of antiviral therapies, and we have a shared vision and commitment to the discovery and development of promising HCV therapies that address this high unmet medical need globally," stated Jay R. Luly, Ph.D., president and CEO of Enanta Pharmaceuticals.
Under the terms of the agreement, Abbott gains worldwide access to Enanta's substantial intellectual property position for a variety of different types of compounds, which includes several issued U.S. patents. Abbott also gains access to Enanta's drug discovery capabilities in the HCV NS3 and NS3/4A protease inhibitor field. The closing of the transaction is subject to antitrust clearance under the Hart-Scott-Rodino Act.
Upon closing, Enanta will receive an upfront payment of $57 million, which includes a cash payment and an equity investment. If all potential clinical and regulatory milestones are met, additional payments of up to $250 million will be made to Enanta, and further payments will be due if multiple products develop from the program. Enanta will receive double-digit royalties and holds an option to fund 40 percent of development costs and U.S. commercialization efforts (sales and promotion costs) in exchange for a 40-percent profit share in the United States on medicines from this alliance that result in commercial approval.
"Through this alliance, we will enhance our HCV protease inhibitor program and allow both companies to participate in the long-term value creation of these compounds by leveraging Enanta's core expertise in chemistry and drug discovery with Abbott's proven track-record in the discovery, development, and commercialization of antiviral therapies," stated Yujiro S. Hata, senior vice president of Business Development at Enanta Pharmaceuticals.
About Hepatitis C Virus
Hepatitis C is a liver disease affecting more than 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer, and death. Liver disease associated with HCV infection is growing rapidly, and current therapies only provide sustained benefit in about half of patients with the genotype 1 form of the virus. Specifically targeted antiviral therapies for HCV, such as NS3/4A protease inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.
About Enanta
Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the anti-infective field. At the heart of Enanta is its commitment to innovative chemistry that surpasses traditional medicinal chemistry approaches. The company's successful integration of chemistry with biology has created a new class of macrolide antibiotics that overcome bacterial resistance. Antibacterial focus areas include community respiratory tract infections as well as hospital and community infections relating to MRSA. Additionally, Enanta has discovered antiviral agents targeted against the Hepatitis C virus (HCV). Enanta is a privately held company with offices in Watertown, Mass. More information about the company can be found at www.enanta.com.
HCV Protease Inhibitors
Enanta is applying its chemistry expertise to the discovery of NS3/4A protease inhibitors to be used against the Hepatitis C virus (HCV). For its first HCV program, Enanta entered into a strategic alliance with Chiron Corporation in 2002 that involved structure-based drug design, synthesis of compounds, testing of lead compounds in enzyme and whole cell assays, as well as in vivo models. In 2005, Enanta and Chiron announced a new agreement to develop and commercialize Chiron's portfolio of hepatitis C virus (HCV) protease inhibitors, leveraging Enanta's unique medicinal chemistry expertise and capabilities. Enanta also has been granted a non-exclusive license to Chiron's HCV technology to further enable the research and development of HCV therapeutics.
Enanta has developed significant expertise and know-how in the field of HCV protease inhibitors. The Company has established an SAR strategy to create novel and proprietary series and leads that demonstrate significant potency in the enzyme and cell-based replicon assay. Further, Enanta has created and continues to grow its substantial and unique IP position in the HCV protease arena.
Enanta has identified many promising lead series and several lead candidates that have sub nM potency in the replicon assay, good bioavailability, attractive liver levels, and potential for QD dosing.
Small molecule HCV inhibitors are exciting for a number of reasons. Since HCV cannot integrate into the host genome - unlike HIV - there is hope that a direct antiviral strategy could eradicate hepatitis C from the blood, liver, and other infected sites, leading to a potential cure for HCV infection. Oral strategies (versus intravenous) are more convenient options for chronic disease, leading to better compliance and expanding the population of patients deemed suitable for therapy. HCV small molecules may prove to be safer and better tolerated than IFN/RBV-based approaches, which have significant liver related side-effects.
There are several major opportunities for HCV small molecules: (1) replacement for RBV in combination with IFN, (2) add-on to IFN/RBV therapy, (3) re-treatment of the nearly 50% of patients who do not respond to IFN/RBV, and (4) first-line treatment among the 500,000-plus HCV patients in the U.S. alone who have been diagnosed but have not undergone IFN/RBV therapy. Over the long term, we believe small molecules, especially as combination therapy, could challenge IFN-based treatment in the first line setting.
Oral small molecule approaches are likely to have lower manufacturing costs than IFN/RBV, supporting lower price points and thus expanding its global appeal, particularly in certain countries in Asia, South America and Eastern Europe. Small molecule candidates are less likely to interfere with anti-HIV medications than RBV. Since over 300,000 HIV patients are co-infected with HCV, this will be an important product differentiator, versus RBV therapy.
Market Opportunity of HCV Protease Inhibitors
In 2004, the global Hepatitis C Virus (HCV) market was approximately $3 billion with expectations to exceed $7 billion by 2007. Of the 170 million patients infected worldwide, in the US alone, 2.7 million patients were infected with HCV in 2004 and with even greater frequency in the Western Pacific and Southeast Asia, with 62.2 and 32.3 million infected respectively. Current treatment includes an IFN-based regimen; however, it is estimated that with the proliferation of HCV antivirals such as HCV Protease Inhibitors, the number of patients in the US treated annually will increase from approximately 70,000 in 2004 to 170,000 in 2010. By 2010, HCV Protease Inhibitors are estimated to be used in more than 20% of treated HCV patients, representing over 15% prescription share among antivirals, mirroring the transformation protease inhibitors had on the HIV market. Based on these assumptions and the viral load reduction demonstrated in the clinic by numerous HCV NS3/4A protease inhibitors, compounds from this product class are projected to have true blockbuster potential.
ABBOTT PARK , ILL., and WATERTOWN, Mass., December 12, 2006 - Abbott and Enanta Pharmaceuticals announced today that the companies have signed a worldwide agreement to develop and commercialize hepatitis C virus (HCV) NS3 and NS3/4A protease inhibitors. Enanta has discovered several HCV protease inhibitors that have demonstrated attractive efficacy and pharmacokinetic profiles in pre-clinical studies.
"Abbott's innovative work in the protease inhibitor field against the Human Immunodeficiency Virus (HIV) has provided the momentum and the foundation for our research interest in HCV infection," said John Leonard, M.D., vice president, Global Pharmaceutical Research and Development, Abbott. "Enanta has done compelling work in its HCV protease inhibitor program, and we look forward to working together on the advancement of this global program."
"Abbott is a market leader in the field of antiviral therapies, and we have a shared vision and commitment to the discovery and development of promising HCV therapies that address this high unmet medical need globally," stated Jay R. Luly, Ph.D., president and CEO of Enanta Pharmaceuticals.
Under the terms of the agreement, Abbott gains worldwide access to Enanta's substantial intellectual property position for a variety of different types of compounds, which includes several issued U.S. patents. Abbott also gains access to Enanta's drug discovery capabilities in the HCV NS3 and NS3/4A protease inhibitor field. The closing of the transaction is subject to antitrust clearance under the Hart-Scott-Rodino Act.
Upon closing, Enanta will receive an upfront payment of $57 million, which includes a cash payment and an equity investment. If all potential clinical and regulatory milestones are met, additional payments of up to $250 million will be made to Enanta, and further payments will be due if multiple products develop from the program. Enanta will receive double-digit royalties and holds an option to fund 40 percent of development costs and U.S. commercialization efforts (sales and promotion costs) in exchange for a 40-percent profit share in the United States on medicines from this alliance that result in commercial approval.
"Through this alliance, we will enhance our HCV protease inhibitor program and allow both companies to participate in the long-term value creation of these compounds by leveraging Enanta's core expertise in chemistry and drug discovery with Abbott's proven track-record in the discovery, development, and commercialization of antiviral therapies," stated Yujiro S. Hata, senior vice president of Business Development at Enanta Pharmaceuticals.
About Hepatitis C Virus
Hepatitis C is a liver disease affecting more than 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer, and death. Liver disease associated with HCV infection is growing rapidly, and current therapies only provide sustained benefit in about half of patients with the genotype 1 form of the virus. Specifically targeted antiviral therapies for HCV, such as NS3/4A protease inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.
About Enanta
Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the anti-infective field. At the heart of Enanta is its commitment to innovative chemistry that surpasses traditional medicinal chemistry approaches. The company's successful integration of chemistry with biology has created a new class of macrolide antibiotics that overcome bacterial resistance. Antibacterial focus areas include community respiratory tract infections as well as hospital and community infections relating to MRSA. Additionally, Enanta has discovered antiviral agents targeted against the Hepatitis C virus (HCV). Enanta is a privately held company with offices in Watertown, Mass. More information about the company can be found at www.enanta.com.
HCV Protease Inhibitors
nbsp;
Enanta is applying its chemistry expertise to the discovery of NS3/4A protease inhibitors to be used against the Hepatitis C virus (HCV). For its first HCV program, Enanta entered into a strategic alliance with Chiron Corporation in 2002 that involved structure-based drug design, synthesis of compounds, testing of lead compounds in enzyme and whole cell assays, as well as in vivo models. In 2005, Enanta and Chiron announced a new agreement to develop and commercialize Chiron's portfolio of hepatitis C virus (HCV) protease inhibitors, leveraging Enanta's unique medicinal chemistry expertise and capabilities. Enanta also has been granted a non-exclusive license to Chiron's HCV technology to further enable the research and development of HCV therapeutics.
Enanta has developed significant expertise and know-how in the field of HCV protease inhibitors. The Company has established an SAR strategy to create novel and proprietary series and leads that demonstrate significant potency in the enzyme and cell-based replicon assay. Further, Enanta has created and continues to grow its substantial and unique IP position in the HCV protease arena.
Enanta has identified many promising lead series and several lead candidates that have sub nM potency in the replicon assay, good bioavailability, attractive liver levels, and potential for QD dosing.
Small molecule HCV inhibitors are exciting for a number of reasons. Since HCV cannot integrate into the host genome - unlike HIV - there is hope that a direct antiviral strategy could eradicate hepatitis C from the blood, liver, and other infected sites, leading to a potential cure for HCV infection. Oral strategies (versus intravenous) are more convenient options for chronic disease, leading to better compliance and expanding the population of patients deemed suitable for therapy. HCV small molecules may prove to be safer and better tolerated than IFN/RBV-based approaches, which have significant liver related side-effects.
There are several major opportunities for HCV small molecules: (1) replacement for RBV in combination with IFN, (2) add-on to IFN/RBV therapy, (3) re-treatment of the nearly 50% of patients who do not respond to IFN/RBV, and (4) first-line treatment among the 500,000-plus HCV patients in the U.S. alone who have been diagnosed but have not undergone IFN/RBV therapy. Over the long term, we believe small molecules, especially as combination therapy, could challenge IFN-based treatment in the first line setting.
Oral small molecule approaches are likely to have lower manufacturing costs than IFN/RBV, supporting lower price points and thus expanding its global appeal, particularly in certain countries in Asia, South America and Eastern Europe. Small molecule candidates are less likely to interfere with anti-HIV medications than RBV. Since over 300,000 HIV patients are co-infected with HCV, this will be an important product differentiator, versus RBV therapy.
Market Opportunity of HCV Protease Inhibitors
In 2004, the global Hepatitis C Virus (HCV) market was approximately $3 billion with expectations to exceed $7 billion by 2007. Of the 170 million patients infected worldwide, in the US alone, 2.7 million patients were infected with HCV in 2004 and with even greater frequency in the Western Pacific and Southeast Asia, with 62.2 and 32.3 million infected respectively. Current treatment includes an IFN-based regimen; however, it is estimated that with the proliferation of HCV antivirals such as HCV Protease Inhibitors, the number of patients in the US treated annually will increase from approximately 70,000 in 2004 to 170,000 in 2010. By 2010, HCV Protease Inhibitors are estimated to be used in more than 20% of treated HCV patients, representing over 15% prescription share among antivirals, mirroring the transformation protease inhibitors had on the HIV market. Based on these assumptions and the viral load reduction demonstrated in the clinic by numerous HCV NS3/4A protease inhibitors, compounds from this product class are projected to have true blockbuster potential.
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