– 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 –
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).
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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.
Gilead Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the ability of the parties to complete the transaction in
a timely manner or at all; the possibility that various closing
conditions for the transaction may not be satisfied or waived,
including the possibility that a governmental entity may prohibit,
delay or refuse to grant approval for the consummation of the
transaction; uncertainties relating to the timing or outcome of any
filings and approvals relating to the transaction; difficulties or
unanticipated expenses in connection with integrating the
companies, including the effects of the transaction on
relationships with employees, other business partners or
governmental entities; the risk that Gilead may not realize the
expected benefits of this transaction; the ability of Gilead to
advance MYR GmbH’s product pipeline and successfully commercialize
Hepcludex; the ability of the parties to initiate and complete
clinical trials involving Hepcludex in the currently anticipated
timelines or at all; the possibility of unfavorable results from
one or more of such trials involving Hepcludex; uncertainties
relating to regulatory applications and related filing and approval
timelines, including the risk that FDA may not approve Hepcludex
for the treatment of HDV in the anticipated timelines or at all,
and any marketing approvals, if granted, may have significant
limitations on its use; any assumptions underlying any of the
foregoing; and other risks and uncertainties detailed from time to
time in Gilead’s periodic reports filed with the U.S. Securities
and Exchange Commission (the “SEC”), including current reports on
Form 8-K, quarterly reports on Form 10-Q and annual reports on Form
10-K. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. Investors are cautioned that any such forward-looking
statements are not guarantees of future performance and involve
risks and uncertainties and are cautioned not to place undue
reliance on these forward-looking statements. All forward-looking
statements are based on information currently available to Gilead,
and Gilead assumes no obligation and disclaim any intent to update
any such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20201210005315/en/
Gilead Contacts: Monica Tellado, Investors (650)
522-5132
Marni Kottle, Media (650) 522-5388
MYR Contact: Florian Vogel, CCO, MYR GmbH +49 (0) 6172-49
59 813
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