FOSTER CITY, Calif. and BAD
HOMBURG, Germany, Dec. 10, 2020 /PRNewswire/ -- 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.
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.
Gilead
Contacts:
|
MYR
Contact:
|
|
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Monica Tellado,
Investors
|
Florian Vogel,
CCO, MYR GmbH
|
(650)
522-5132
|
+49 (0) 6172-49 59
813
|
|
|
Marni Kottle,
Media
|
|
(650)
522-5388
|
|
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SOURCE MYR Pharmaceuticals