– Gilead to Acquire Hepcludex™, a First-in-Class Entry Inhibitor, for Treatment of Chronic Hepatitis Delta Virus (HDV), Adding Immediate Revenue After Closing of Transaction –
– Hepcludex Was Conditionally Approved in Europe in July 2020 Based on Phase 2 Data and Submission for Accelerated Approval in United States is Anticipated in Second Half of 2021 –
– Acquisition Builds on Gilead’s Strength as a Global Leader in Virology and Liver Diseases with Addition of First Marketed Product for Treatment of HDV –
FOSTER CITY, CA, USA & BAD HOMBURG, Germany I December 10, 2020 I Gilead Sciences, Inc. (Nasdaq: GILD) and MYR GmbH, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis delta virus (HDV), today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MYR for approximately €1.15 billion in cash, payable upon closing of the transaction plus a potential future milestone payment of up to €300 million (both payments subject to customary adjustments).
The acquisition will provide Gilead with Hepcludex™ (bulevirtide), which was conditionally approved by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020. MYR has since launched Hepcludex in France, Germany and Austria, and continues to prepare for launch in certain other markets throughout 2021. It is expected that this transaction will accelerate the global launch of Hepcludex. Hepcludex is a first-in-class treatment for HDV that blocks viral entry into liver cells through binding to NTCP. It is the first and currently the only medicine conditionally approved for HDV by the EMA, and MYR anticipates submission for accelerated approval in the United States in the second half of 2021. The U.S. Food and Drug Administration (FDA) has granted the medicine both Orphan Drug and Breakthrough Therapy designations for chronic HDV infection.
HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within 5 years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have hepatitis B virus (HBV). At least 12 million people worldwide are likely currently co-infected with HDV and HBV. HDV co-infection leads to more serious liver disease than HBV alone and is associated with a faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death. In the United States and Europe, there are collectively more than 230,000 people living with HDV, which remains underdiagnosed globally.
“HDV is a devastating disease with high unmet medical need. With Hepcludex we have the opportunity to address that need with a first-in-class therapy,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to working with the team at MYR to realize the full potential of Hepcludex for patients with HDV worldwide. This will build on the work that Gilead has been doing for almost two decades to innovate and improve therapies for viral hepatitis.”
“We are proud of our achievement in bringing Hepcludex from preclinical stage to patients in need within such a short timeframe,” said Dmitry Popov, Chief Executive Officer, MYR GmbH. “We are excited to join Gilead, whose experience in the hepatitis field and global infrastructure will realize the full potential of Hepcludex and provide access to as many patients as possible around the world with this debilitating disease.”
Hepcludex (bulevirtide) is an entry inhibitor that binds to NTCP, an essential HBV and HDV receptor on hepatocytes, blocking the ability of HDV to enter hepatocytes. Bulevirtide has been tested in more than 500 patients in completed and ongoing clinical studies. The benefit of bulevirtide has been demonstrated by an effective reduction of HDV RNA levels and improvement of liver inflammation. In the MYR202 study, which was a controlled, open-label Phase 2 study, 54 of 90 patients treated with bulevirtide plus tenofovir disoproxil fumarate (TDF) had at least a 2 log10 HDV RNA decline or undetectable HDV RNA at week 24 versus 1 of 28 patients given TDF alone. Almost half of patients treated with bulevirtide and TDF also showed a normalization in the blood levels of the liver enzyme ALT, indicating an improvement of liver disease, as compared to 7% of patients who received TDF alone.
In the Phase 2 MYR203 study evaluating a 48-week treatment course of bulevirtide, a further 15 patients were treated with Hepcludex 2mg daily monotherapy for 48 weeks. In this limited dataset, the safety and efficacy profiles were similar to patients treated for 24 weeks in combination with TDF in the MYR202 study. Interim 24-week data from the ongoing Phase 3 study MYR301 of bulevirtide is anticipated in the first half of 2021 and is expected to serve as the basis for filing in the United States.
Terms of the Agreement
Under the terms of the sale and purchase agreement, Gilead will acquire MYR for approximately €1.15 billion in cash, payable upon closing of the transaction plus a potential future milestone payment of up to €300 million upon U.S. FDA approval (both payments subject to customary adjustments). After the closing, in addition to enhancing Gilead’s revenue growth, the acquisition of MYR is expected to be neutral to non-GAAP EPS in the first two years after close and moderately accretive thereafter. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and receipt of merger control approvals in certain European jurisdictions.
Goldman Sachs & Co. LLC is acting as financial advisor to Gilead. UBS Europe SE is acting as financial advisor to MYR. Gibson, Dunn & Crutcher, Mayer Brown LLP, and Flick Gocke Schaumburg are serving as legal counsel to Gilead and Freshfields Bruckhaus Deringer Rechtsanwälte Steuerberater PartG mbB is serving as legal counsel to MYR.
Additional Information
Additional information about the agreement can be found at Gilead’s Investors page at http://investors.gilead.com.
About Hepcludex (bulevirtide)
Hepcludex is the first drug conditionally approved for the treatment of HDV in adults with compensated liver disease in Europe. Hepcludex blocks the NTCP receptor on the surface of hepatocytes and prevents the entry of HBV/HDV into hepatocytes and viral spread within the liver. Hepcludex is administered subcutaneously as monotherapy or in patients being treated with a nucleoside/nucleotide analogue. Hepcludex has received Orphan Drug Designation for treatment of HDV infection from EMA and from the FDA. Hepcludex has been granted PRIority MEdicines (PRIME) scheme eligibility by EMA for the treatment of HDV infection and Breakthrough Therapy designation by the FDA. Bulevirtide is an investigational agent in the U.S. and outside of the European Economic Area; in these regions the safety and efficacy have not been established.
The most commonly reported serious adverse reaction was an exacerbation of hepatitis after treatment discontinuation, and most commonly reported adverse reactions were an increase in bile salts and injection site reactions. The safety and efficacy of Hepcludex in patients with decompensated cirrhosis have not been established and therefore its use is not recommended. See the Summary of Product Characteristics, which includes contraindications and special warnings and precautions, for further product information, available at www.eua.europa.eu.
About MYR GmbH
MYR GmbH is a private, commercial stage biotechnology company headquartered in Bad Homburg, Germany. The company is dedicated to the development of bulevirtide; bulevirtide is a first-in-class entry inhibitor which binds to the NTCP receptor for HDV and other indications. MYR started operations in 2011 and has been supported by its founders, private and venture capital investors including the High-Tech-Gründerfonds (www.htgf.de/en/). For more information on MYR, please visit the company’s website at www.myr-pharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
SOURCE: Gilead Sciences
Post Views: 311
– Gilead to Acquire Hepcludex™, a First-in-Class Entry Inhibitor, for Treatment of Chronic Hepatitis Delta Virus (HDV), Adding Immediate Revenue After Closing of Transaction –
– Hepcludex Was Conditionally Approved in Europe in July 2020 Based on Phase 2 Data and Submission for Accelerated Approval in United States is Anticipated in Second Half of 2021 –
– Acquisition Builds on Gilead’s Strength as a Global Leader in Virology and Liver Diseases with Addition of First Marketed Product for Treatment of HDV –
FOSTER CITY, CA, USA & BAD HOMBURG, Germany I December 10, 2020 I Gilead Sciences, Inc. (Nasdaq: GILD) and MYR GmbH, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis delta virus (HDV), today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MYR for approximately €1.15 billion in cash, payable upon closing of the transaction plus a potential future milestone payment of up to €300 million (both payments subject to customary adjustments).
The acquisition will provide Gilead with Hepcludex™ (bulevirtide), which was conditionally approved by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020. MYR has since launched Hepcludex in France, Germany and Austria, and continues to prepare for launch in certain other markets throughout 2021. It is expected that this transaction will accelerate the global launch of Hepcludex. Hepcludex is a first-in-class treatment for HDV that blocks viral entry into liver cells through binding to NTCP. It is the first and currently the only medicine conditionally approved for HDV by the EMA, and MYR anticipates submission for accelerated approval in the United States in the second half of 2021. The U.S. Food and Drug Administration (FDA) has granted the medicine both Orphan Drug and Breakthrough Therapy designations for chronic HDV infection.
HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within 5 years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have hepatitis B virus (HBV). At least 12 million people worldwide are likely currently co-infected with HDV and HBV. HDV co-infection leads to more serious liver disease than HBV alone and is associated with a faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death. In the United States and Europe, there are collectively more than 230,000 people living with HDV, which remains underdiagnosed globally.
“HDV is a devastating disease with high unmet medical need. With Hepcludex we have the opportunity to address that need with a first-in-class therapy,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to working with the team at MYR to realize the full potential of Hepcludex for patients with HDV worldwide. This will build on the work that Gilead has been doing for almost two decades to innovate and improve therapies for viral hepatitis.”
“We are proud of our achievement in bringing Hepcludex from preclinical stage to patients in need within such a short timeframe,” said Dmitry Popov, Chief Executive Officer, MYR GmbH. “We are excited to join Gilead, whose experience in the hepatitis field and global infrastructure will realize the full potential of Hepcludex and provide access to as many patients as possible around the world with this debilitating disease.”
Hepcludex (bulevirtide) is an entry inhibitor that binds to NTCP, an essential HBV and HDV receptor on hepatocytes, blocking the ability of HDV to enter hepatocytes. Bulevirtide has been tested in more than 500 patients in completed and ongoing clinical studies. The benefit of bulevirtide has been demonstrated by an effective reduction of HDV RNA levels and improvement of liver inflammation. In the MYR202 study, which was a controlled, open-label Phase 2 study, 54 of 90 patients treated with bulevirtide plus tenofovir disoproxil fumarate (TDF) had at least a 2 log10 HDV RNA decline or undetectable HDV RNA at week 24 versus 1 of 28 patients given TDF alone. Almost half of patients treated with bulevirtide and TDF also showed a normalization in the blood levels of the liver enzyme ALT, indicating an improvement of liver disease, as compared to 7% of patients who received TDF alone.
In the Phase 2 MYR203 study evaluating a 48-week treatment course of bulevirtide, a further 15 patients were treated with Hepcludex 2mg daily monotherapy for 48 weeks. In this limited dataset, the safety and efficacy profiles were similar to patients treated for 24 weeks in combination with TDF in the MYR202 study. Interim 24-week data from the ongoing Phase 3 study MYR301 of bulevirtide is anticipated in the first half of 2021 and is expected to serve as the basis for filing in the United States.
Terms of the Agreement
Under the terms of the sale and purchase agreement, Gilead will acquire MYR for approximately €1.15 billion in cash, payable upon closing of the transaction plus a potential future milestone payment of up to €300 million upon U.S. FDA approval (both payments subject to customary adjustments). After the closing, in addition to enhancing Gilead’s revenue growth, the acquisition of MYR is expected to be neutral to non-GAAP EPS in the first two years after close and moderately accretive thereafter. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and receipt of merger control approvals in certain European jurisdictions.
Goldman Sachs & Co. LLC is acting as financial advisor to Gilead. UBS Europe SE is acting as financial advisor to MYR. Gibson, Dunn & Crutcher, Mayer Brown LLP, and Flick Gocke Schaumburg are serving as legal counsel to Gilead and Freshfields Bruckhaus Deringer Rechtsanwälte Steuerberater PartG mbB is serving as legal counsel to MYR.
Additional Information
Additional information about the agreement can be found at Gilead’s Investors page at http://investors.gilead.com.
About Hepcludex (bulevirtide)
Hepcludex is the first drug conditionally approved for the treatment of HDV in adults with compensated liver disease in Europe. Hepcludex blocks the NTCP receptor on the surface of hepatocytes and prevents the entry of HBV/HDV into hepatocytes and viral spread within the liver. Hepcludex is administered subcutaneously as monotherapy or in patients being treated with a nucleoside/nucleotide analogue. Hepcludex has received Orphan Drug Designation for treatment of HDV infection from EMA and from the FDA. Hepcludex has been granted PRIority MEdicines (PRIME) scheme eligibility by EMA for the treatment of HDV infection and Breakthrough Therapy designation by the FDA. Bulevirtide is an investigational agent in the U.S. and outside of the European Economic Area; in these regions the safety and efficacy have not been established.
The most commonly reported serious adverse reaction was an exacerbation of hepatitis after treatment discontinuation, and most commonly reported adverse reactions were an increase in bile salts and injection site reactions. The safety and efficacy of Hepcludex in patients with decompensated cirrhosis have not been established and therefore its use is not recommended. See the Summary of Product Characteristics, which includes contraindications and special warnings and precautions, for further product information, available at www.eua.europa.eu.
About MYR GmbH
MYR GmbH is a private, commercial stage biotechnology company headquartered in Bad Homburg, Germany. The company is dedicated to the development of bulevirtide; bulevirtide is a first-in-class entry inhibitor which binds to the NTCP receptor for HDV and other indications. MYR started operations in 2011 and has been supported by its founders, private and venture capital investors including the High-Tech-Gründerfonds (www.htgf.de/en/). For more information on MYR, please visit the company’s website at www.myr-pharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
SOURCE: Gilead Sciences
Post Views: 311
