Valneva announces HSR clearance for Lyme vaccine collaboration with Pfizer
08 Giugno 2020 - 6:00PM
Saint-Herblain (France), June 8 2020 – Valneva
SE (“Valneva” or “the Company”) announced today that the
antitrust-related condition precedent for its Lyme vaccine
collaboration agreement (the “Agreement”) with Pfizer (NYSE: PFE)
has been met. As a result, the Agreement is now effective and
Valneva will receive a $130 million upfront payment.
Valneva and Pfizer announced their collaboration
at the end of April 2020 to develop and commercialize Valneva’s
Lyme disease vaccine candidate VLA15, which is currently in Phase 2
clinical studies.
Following execution of the Agreement, Pfizer and
Valneva notified the US Federal Trade Commission and the Antitrust
Division of the Department of Justice in accordance with applicable
antitrust law including the Hart Scott Rodino Antitrust
Improvements Act.
Under the terms of the Agreement, Valneva and
Pfizer will work closely together throughout the development of
VLA15. Valneva is eligible to receive a total of $308 million cash
payments consisting of the $130 million upfront payment described
above, $35 million in development milestones and $143 million in
early commercialization milestones. Valneva will fund 30% of
all development costs through completion of the development
program, and in return Pfizer will pay Valneva tiered royalties
starting at 19%. Pfizer will lead late-stage development and have
sole control over commercialization.
VLA15 is the only active Lyme disease vaccine
program in clinical development today, and covers six serotypes
that are prevalent in North America and Europe. The program was
granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) in July 20171. Valneva has completed patient
enrolment and follow-up for VLA15’s two Phase 2 studies in more
than 800 people and expects to report first Phase 2 results in July
2020.
About Lyme Disease Lyme disease
is a systemic infection caused by Borrelia bacteria transmitted to
humans by infected Ixodes ticks2. It is considered the most common
vector borne illness in the Northern Hemisphere. According to the
U.S. Centers for Disease Control and Prevention (CDC),
approximately 300,000 Americans3 are diagnosed with Lyme disease
each year with at least a further 200,000 cases in Europe4. Early
symptoms of Lyme disease (such as a gradually expanding
erythematous rash called Erythema migrans or more unspecific
symptoms like fatigue, fever, headache, mild stiff neck, arthralgia
or myalgia) are often overlooked or misinterpreted. Left untreated,
the disease can disseminate and cause more serious complications
affecting the joints (arthritis), the heart (carditis) or the
nervous system. The medical need for vaccination against Lyme
disease is steadily increasing as the disease footprint
widens5.
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. Valneva’s portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. Valneva has various vaccines in
development including unique vaccines against Lyme disease and
chikungunya. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with over 500 employees. More
information is available at www.valneva.com
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineDirector of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing and completion of research, development and clinical trials
for product candidates, the ability to manufacture, market,
commercialize and achieve market acceptance for product candidates,
the ability to protect intellectual property and operate the
business without infringing on the intellectual property rights of
others, estimates for future performance and estimates regarding
anticipated operating losses, future revenues, capital requirements
and needs for additional financing. In addition, even if the actual
results or development of Valneva are consistent with the
forward-looking statements contained in this press release, those
results or developments of Valneva may not be indicative of their
in the future. In some cases, you can identify forward-looking
statements by words such as "could," "should," "may," "expects,"
"anticipates," "believes," "intends," "estimates," "aims,"
"targets," or similar words. These forward-looking statements are
based largely on the current expectations of Valneva as of the date
of this press release and are subject to a number of known and
unknown risks and uncertainties and other factors that may cause
actual results, performance or achievements to be materially
different from any future results, performance or achievement
expressed or implied by these forward-looking statements. In
particular, the expectations of Valneva could be affected by, among
other things, uncertainties involved in the development and
manufacture of vaccines, unexpected clinical trial results,
unexpected regulatory actions or delays, competition in general,
currency fluctuations, the impact of the global and European credit
crisis, and the ability to obtain or maintain patent or other
proprietary intellectual property protection. In light of these
risks and uncertainties, there can be no assurance that the
forward-looking statements made during this presentation will in
fact be realized. Valneva is providing the information in these
materials as of this press release, and disclaim any intention or
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise.
1
https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/
2 Stanek et al. 2012, The Lancet 379:461–473
3 As estimated by the CDC,
https://www.cdc.gov/lyme/stats/humancases.html.
4 Estimated from available national data. Number largely
underestimated based on WHO Europe Lyme Report as case reporting
is
highly inconsistent in Europe and many LB infections go
undiagnosed; ECDC tick-borne-diseases-meeting-report5 New
Scientist, Lyme disease is set to explode and we still don’t have a
vaccine; March 29, 2017
https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/
- 2020_06_08_Pfizer_Lyme_Collaboration_Clearance PR_EN_Final