- Alpine is a clinical stage biotechnology
company focused on discovering and developing innovative,
protein-based immunotherapies –
- Alpine’s lead product, povetacicept,
demonstrated best-in-class potential in patients with IgA
nephropathy (IgAN); Phase 3 to initiate in H2 2024 -
- Povetacicept holds promise as a
pipeline-in-a-product, with clinical studies in additional serious
diseases underway -
- Alpine’s protein engineering and
immunotherapy expertise augments Vertex’s toolbox and capabilities
-
- Vertex to host investor call today, April 10,
at 4:30 pm ET -
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alpine
Immune Sciences, Inc. (Nasdaq: ALPN), a biotechnology company
focused on discovering and developing innovative, protein-based
immunotherapies, today announced that the companies have entered
into a definitive agreement under which Vertex will acquire Alpine
for $65 per share or approximately $4.9 billion in cash. The
transaction was unanimously approved by both the Vertex and Alpine
Boards of Directors and is anticipated to close later this
quarter.
Alpine’s lead molecule, povetacicept (ALPN-303), is a highly
potent and effective dual antagonist of BAFF (B cell activating
factor) and APRIL (a proliferation inducing ligand). Through Phase
2 development, povetacicept has shown potential best-in-class
efficacy in IgA nephropathy (IgAN). IgAN is a serious, progressive,
autoimmune disease of the kidney that can lead to end-stage-renal
disease. There are no approved therapies that target the underlying
cause of IgAN. IgAN is the most common cause of primary
(idiopathic) glomerulonephritis worldwide, affecting approximately
130,000 people in the U.S. Povetacicept is on track to enter Phase
3 clinical development in the second half of 2024.
Due to its mechanism of action as a dual BAFF/APRIL antagonist,
povetacicept holds the potential to benefit patients with other
serious autoimmune diseases of the kidney, such as membranous
nephropathy and lupus nephritis, as well as autoimmune cytopenias.
Clinical studies in renal indications and autoimmune cytopenias are
ongoing.
“Alpine is a compelling strategic fit for Vertex and furthers
our ambition of using scientific innovation to create
transformative medicines targeting serious diseases with high unmet
need in specialty markets,” said Reshma Kewalramani, M.D., FASN,
Chief Executive Officer and President of Vertex. “We look forward
to welcoming the talented Alpine team to Vertex and believe that
together we can bring povetacicept, a potential best-in-class
treatment for IgAN to patients faster. We also look forward to
fully exploring povetacicept’s potential as a
‘pipeline-in-a-product' and adding Alpine’s protein engineering and
immunotherapy capabilities to Vertex’s toolbox.”
“Today’s announcement marks a new chapter for Alpine,” said
Mitchell H. Gold, M.D., Executive Chairman and Chief Executive
Officer of Alpine. “It became clear during our discussions with the
Vertex team that we share many core values, including a commitment
to patients, our employees, and an intense drive for innovation.
Povetacicept has demonstrated potential best-in-class attributes in
IgA nephropathy and has broad development potential across a number
of other autoimmune and inflammatory conditions with significant
unmet need. We look forward to the opportunity, now more than ever,
to make a meaningful difference in the lives of patients worldwide
as part of Vertex.”
Transaction Terms
Under the terms of the merger agreement, Vertex will acquire
Alpine for $65 per share in cash, for a total equity value of
approximately $4.9 billion, or approximately $4.6 billion net of
estimated cash acquired. A subsidiary of Vertex will commence a
cash tender offer to purchase all outstanding shares of Alpine
common stock.
The transaction is expected to close in the second quarter of
2024, subject to certain conditions, including the tender of a
majority of the outstanding shares of Alpine common stock and the
expiration of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act and other customary conditions.
Advisors
Lazard is acting as financial advisor to Vertex. Skadden, Arps,
Slate, Meagher & Flom is serving as legal counsel to Vertex.
For Alpine, Centerview Partners is acting as exclusive financial
advisor and Fenwick & West LLP as legal counsel.
About IgA Nephropathy (IgAN)
IgAN is a serious, progressive, life-threatening chronic kidney
disease that is the most common cause of primary (idiopathic)
glomerulonephritis, affecting people worldwide including
approximately 130,000 people in the U.S. IgAN is thought to result
from deposition of circulating immune complexes consisting of
immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1)
in the renal glomerular mesangium, triggering kidney injury and
fibrosis. A high percentage of people with IgAN progress to
end-stage renal disease. There are no approved therapies that
target the underlying cause of IgAN.
About Povetacicept (ALPN-303)
Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell
activating factor) and APRIL (a proliferation inducing ligand)
cytokines, which play key roles in pathogenesis of multiple
autoimmune diseases via their roles in the activation,
differentiation and/or survival of B cells, T cells and innate
immune cells. Based upon an engineered TACI (transmembrane
activator and CAML interactor) domain, povetacicept has higher
binding affinity and greater potency in preclinical studies versus
other inhibitors of BAFF and/or APRIL alone and has demonstrated
potential best-in-class efficacy in a clinical trial in patients
with IgA nephropathy. Povetacicept is also in development for
multiple serious diseases including other autoimmune kidney
diseases and autoimmune cytopenias. Povetacicept is targeted to
enter Phase 3 in the second half of 2024.
Alpine will provide updated clinical data from RUBY-3, a phase
1b/2a study of povetacicept to investors during a conference call
scheduled for 5:15 pm ET today, April 10, 2024.
Vertex Conference Call and Webcast
Vertex will host a conference call and webcast at 4:30 pm ET
today, April 10, 2024. To access the call, please dial (833)
630-2124 (U.S.) or +1 (412) 317-0651 (International) and reference
the “Vertex Pharmaceuticals Conference Call.”
The conference call will be webcast live and a link to the
webcast can be accessed through Vertex's website at www.vrtx.com in
the “Investors” section. To ensure a timely connection, it is
recommended that participants register at least 15 minutes prior to
the scheduled webcast. An archived webcast will be available on the
company's website in the “Investors” section.
Alpine Conference Call and Webcast
Alpine will host a conference call and webcast at 5:15 pm ET
today, April 10, 2024.
The link to the webcast is available in the investor relations
section of the Company’s website at
https://ir.alpineimmunesciences.com/events and a replay will be
available on the Company's website for 90 days following the live
event.
About Alpine
Alpine is committed to leading a new wave of immune
therapeutics. With world-class research and development
capabilities, a highly productive scientific platform, and a proven
management team, Alpine is seeking to create first- or
best-in-class multifunctional immunotherapies via unique protein
engineering technologies to improve patients’ lives. Alpine has
entered into strategic collaborations with leading global
biopharmaceutical companies and has a diverse pipeline of clinical
and preclinical candidates in development.
About Vertex
Vertex is a global biotechnology company that invests in
scientific innovation to create transformative medicines for people
with serious diseases. The company has approved medicines that
treat the underlying causes of multiple chronic, life-shortening
genetic diseases — cystic fibrosis, sickle cell disease and
transfusion-dependent beta thalassemia — and continues to advance
clinical and research programs in these diseases. Vertex also has a
robust clinical pipeline of investigational therapies across a
range of modalities in other serious diseases where it has deep
insight into causal human biology, including acute and neuropathic
pain, APOL1-mediated kidney disease, autosomal dominant polycystic
kidney disease, type 1 diabetes, myotonic dystrophy type 1 and
alpha-1 antitrypsin deficiency.
Vertex was founded in 1989 and has its global headquarters in
Boston, with international headquarters in London. Additionally,
the company has research and development sites and commercial
offices in North America, Europe, Australia, Latin America and the
Middle East. Vertex is consistently recognized as one of the
industry’s top places to work, including 14 consecutive years on
Science Magazine's Top Employers list and one of Fortune’s 100 Best
Companies to Work For. For company updates and to learn more about
Vertex's history of innovation, visit www.vrtx.com or follow us on
LinkedIn, Facebook, Instagram, YouTube and Twitter/X.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements related
to Vertex, Alpine and the proposed acquisition of Alpine by Vertex
(the “Transaction”) that are subject
to risks, uncertainties and other factors. While Vertex believes
the forward-looking statements contained in this communication are
accurate, these forward-looking statements represent the beliefs of
Alpine and Vertex only as of the date of this communication, and
there are a number of risks and uncertainties that could cause
actual events or results to differ materially from those expressed
or implied by such forward-looking statements. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements, including all statements
regarding the intent, belief or current expectation of the
companies’ and members of their senior management teams.
Forward-looking statements are not purely historical and may be
accompanied by words such as “anticipates,” “may,” “forecasts,”
“expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,”
“estimates,” and other words and terms of similar meaning. Such
statements may relate to: the ability of Vertex to advance Alpine’s
platform technology and potential therapies, such as povetacicept,
on a timely basis; filings and approvals relating to the
Transaction; the expected timing of the completion of the
Transaction; the ability to complete the Transaction considering
the various closing conditions; difficulties or unanticipated
expenses in connection with integrating the companies; and any
assumptions underlying any of the foregoing.
Forward-looking statements are subject to certain risks,
uncertainties, or other factors that are difficult to predict and
could cause actual events or results to differ materially from
those indicated in any such statements due to a number of risks and
uncertainties. Those risks and uncertainties that could cause the
actual results to differ from expectations contemplated by
forward-looking statements include, among other things:
uncertainties as to the timing of the Transaction; uncertainties as
to how many of Alpine’s stockholders will tender their stock in the
offer; the possibility that competing offers will be made; the
possibility that various closing conditions for the Transaction may
not be satisfied or waived, including that a governmental entity
may prohibit, delay or refuse to grant approval for the
consummation of the Transaction; the effects of the Transaction on
relationships with employees, other business partners or
governmental entities; the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; that Vertex may not realize the
potential benefits of the Transaction; other business effects,
including the effects of industry, economic or political conditions
outside of the companies’ control; Transaction costs; and actual or
contingent liabilities related to the Transaction. In addition, the
product candidates being developed by Alpine are subject to all the
risks inherent in the drug development process, and there can be no
assurance that the development of these product candidates will be
commercially successful. Forward-looking statements in this
communication should be evaluated together with the many
uncertainties that affect Vertex’s and Alpine’s businesses,
particularly those risks listed under the heading “Risk Factors”
and the other cautionary factors discussed in the parties’ periodic
reports filed with the Securities and Exchange Commission (the
“SEC”), including Vertex’s annual report on Form 10-K for the year
ended December 31, 2023, and its quarterly reports on Form 10-Q and
current reports on Form 8-K, and Alpine’s annual report on Form
10-K for the year ended December 31, 2023, and its quarterly
reports on Form 10-Q and current reports on Form 8-K, as well as
the Solicitation/Recommendation Statement to be filed by Alpine and
the Tender Offer Materials to be filed by Vertex and Adams Merger
Sub, Inc., a direct wholly owned subsidiary of Vertex, all of which
are available, or will be available when filed, for free on the
SEC’s website at www.sec.gov. You should not place undue reliance
on these statements. All forward-looking statements are based on
information currently available to Vertex and Alpine, and Vertex
and Alpine disclaim any obligation to update the information
contained in this communication as new information becomes
available, except as required by law.
Additional Information and Where to Find It
The tender offer for the outstanding shares of common stock of
Alpine Immune Sciences, Inc. (“Alpine”) referenced in this
communication has not yet commenced. This communication is for
informational purposes only and is neither an offer to purchase nor
a solicitation of an offer to sell shares of Alpine, nor is it a
substitute for any tender offer materials that Vertex
Pharmaceuticals Incorporated (together with its subsidiaries,
“Vertex”), or Alpine will file with the SEC. At the time the tender
offer is commenced, Vertex will file with the SEC a Tender Offer
Statement on Schedule TO which will include an Offer to Purchase, a
related Letter of Transmittal and certain other tender offer
documents (together, the “Tender Offer Materials”), and Alpine will
file with the SEC a Solicitation/Recommendation Statement on
Schedule 14D-9 (the “Solicitation/Recommendation Statement”) with
respect to the tender offer. ALPINE’S SECURITY HOLDERS ARE URGED TO
READ THE TENDER OFFER MATERIALS AND THE SOLICITATION/RECOMMENDATION
STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY
DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Tender Offer
Materials, as well as the Solicitation/Recommendation Statement,
will be sent to all stockholders of Alpine at no expense to them.
The Tender Offer Materials and the Solicitation/Recommendation
Statement will be made available for free at the SEC’s website at
www.sec.gov. Additional copies may be obtained free of charge under
the “Investors” section of Vertex’s website at
https://investors.vrtx.com/financial-information/sec-filings or by
contacting Vertex by phone at (617) 341-6108 or by email at
InvestorInfo@vrtx.com, or by directing requests for such materials
to the information agent for the offer, which will be named in the
Tender Offer Materials. In addition to the Tender Offer Materials
and the Solicitation/Recommendation Statement, Alpine and Vertex
file periodic reports and other information with the SEC. Vertex’s
and Alpine’s filings with the SEC are also available for free to
the public from commercial document-retrieval services and at the
website maintained by the SEC at www.sec.gov and their respective
investor relations websites at the addresses above.
(VRTX-GEN)
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version on businesswire.com: https://www.businesswire.com/news/home/20240410250636/en/
Vertex Pharmaceuticals Incorporated Investors:
InvestorInfo@vrtx.com +1 617-341-6108 Media:
mediainfo@vrtx.com or U.S.: +1 617-341-6992 or Heather Nichols: +1
617-839-3607 or International: +44 20 3204 5275 Alpine Immune
Sciences, Inc. Media and Investor Relations Contacts:
ir@alpineimmunesciences.com media@alpineimmunesciences.com
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