- Adds clinical-stage portfolio of oral small
molecule Factor D inhibitors to Alexion’s pipeline -
- Provides opportunity to enhance treatment for
PNH patients experiencing extravascular hemolysis (EVH), potential
first-in-class C3 glomerulopathy (C3G) therapy & promising
development platform for Factor D inhibition in additional
alternative pathway complement-mediated rare diseases -
- Initial all-cash transaction for $6.30 per
share; total transaction of up to $8.30 per share with potential
additional contingent considerations -
- Conference call and webcast scheduled for
today, October 16, 2019, at 8:00 a.m. EDT -
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Achillion
Pharmaceuticals, Inc. (NASDAQ:ACHN) today announced that they have
entered into a definitive agreement for Alexion to acquire
Achillion, a clinical-stage biopharmaceutical company focused on
the development of oral small molecule Factor D inhibitors to treat
people with complement alternative pathway-mediated rare diseases,
such as paroxysmal nocturnal hemoglobinuria (PNH) and C3
glomerulopathy (C3G). Achillion currently has two clinical-stage
medicines in development, including danicopan (ACH-4471) in Phase 2
and ACH-5228 in Phase 1.
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the full release here:
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“Alexion has demonstrated the transformative impact that
inhibiting C5 can have on multiple rare and devastating diseases.
However, we believe this is just the beginning of what’s possible
with complement inhibition,” said Ludwig Hantson, Ph.D., Chief
Executive Officer of Alexion. “Targeting a different part of the
complement system – the alternative pathway – by inhibiting Factor
D production addresses uncontrolled complement activation further
upstream in the complement cascade, and importantly, leaves the
rest of the complement system intact, which is critical in
maintaining the body’s ability to fight infection. We believe this
approach has the opportunity to help patients with diseases not
currently addressed through C5 inhibition. We look forward to
applying our nearly three decades of complement and development
expertise to unlock the potential of oral Factor D inhibitors and
bring these benefits to patients.”
“We have established great momentum – discovering and advancing
several small molecules into clinical development that have the
potential to treat immune-related diseases associated with the
alternative pathway of the complement system,” said Joe Truitt,
President and Chief Executive Officer at Achillion. “Having already
demonstrated proof-of-concept and proof-of-mechanism with our lead
candidate, danicopan (ACH-4471), in PNH and C3G, respectively, we
believe there is significant opportunity for Factor D inhibition in
the treatment of other diseases as well. Alexion is an established
leader in developing medicines for complement-mediated diseases,
and we look forward to working together to accelerate our objective
of bringing novel therapies to patients as quickly as possible and
ensuring that the broad promise of this approach is fully realized.
We thank our employees, investigators and partners for their
incredible work and commitment.”
Transaction Details The initial consideration of
approximately $930 million, or $6.30 per share of Achillion common
stock, will be funded with cash on hand. As part of the
acquisition, Alexion will also be acquiring the cash currently on
Achillion’s balance sheet. As of September 30, 2019, this was
approximately $230 million; the actual amount will be determined as
of the transaction close. The transaction includes the potential
for additional consideration in the form of non-tradeable
contingent value rights (CVRs), which will be paid to Achillion
shareholders if certain clinical and regulatory milestones are
achieved within specified periods. These include $1.00 per share
for the U.S. FDA approval of danicopan and $1.00 per share for
ACH-5228 Phase 3 initiation.
Alexion’s acquisition of Achillion is subject to the approval of
Achillion shareholders and satisfaction of customary closing
conditions and approval from relevant regulatory agencies,
including clearance under the Hart-Scott Rodino Antitrust
Improvements Act. Pending these approvals, the transaction is
expected to close in the first half of 2020.
Conference Call Alexion will host a conference call and
webcast today, October 16, 2019, at 8:00 a.m. EDT to discuss the
acquisition. To participate in this call, dial (866) 762-3111 (USA)
or (210) 874-7712 (International), passcode 5426458, shortly before
8:00 a.m. EDT. A replay of the call will be available for a limited
period of time following the call. The audio webcast can be
accessed on the Investors page of Alexion’s website at:
http://ir.alexion.com.
About Factor D Factor D is an essential serine protease
and critical control point in the alternative pathway (AP) of the
complement system, a part of the innate immune system. Achillion’s
complement platform is focused on advancing oral small molecules
that inhibit the AP and can potentially be used in the treatment of
immune-related diseases in which complement AP plays a critical
role. Potential indications currently being evaluated for these
compounds include PNH, C3G and immune complex-mediated
membranoproliferative glomerulonephritis (IC-MPGN).
About Paroxysmal Nocturnal Hemoglobinuria (PNH) PNH is a
chronic, progressive, debilitating and life-threatening ultra-rare
blood disorder characterized by hemolysis (destruction of red blood
cells) that is mediated by uncontrolled activation of the
complement system, a component of the body’s immune system.
Patients with PNH may experience a wide range of signs and
symptoms, such as fatigue, difficulty swallowing, shortness of
breath, abdominal pain, erectile dysfunction, dark-colored urine
and anemia. The most devastating consequence of chronic hemolysis
is thrombosis, which can occur in blood vessels throughout the
body, damaging vital organs and causing premature death. PNH is
primarily a disease of intravascular hemolysis (IVH), where the red
blood cell destruction occurs within the blood vessels. C5
inhibition addresses the complications of IVH and the increases in
LDH that cause thrombosis and even death in patients with PNH.
However, a small portion of patients – less than 10 percent –
receiving a C5 inhibitor continue to experience clinical
extravascular hemolysis (EVH), where the red blood cell destruction
occurs outside the blood vessels. As a result, these patients are
transfusion dependent despite treatment but do not have bone marrow
failure or aplastic anemia. Inhibiting Factor D in the alternative
pathway (AP) of the complement system offers the possibility of
selectively blocking AP activity and protecting against the
destruction of RBCs, while leaving the rest of the complement
system intact to fight infection.
About C3 Glomerulopathy (C3G) C3G is an ultra-rare kidney
disease for which there is no approved treatment. The disease is
characterized by the deposition of C3 protein fragments in the
filtering units (glomeruli) of the kidney, caused by overactivation
of the complement alternative pathway (AP). Over time, the chronic
deposition of C3 fragments results in permanent kidney damage and
kidney failure. Today, C3G patients are treated with steroids and
broad-acting immunosuppressants to slow the progression of kidney
damage. Oral Factor D inhibitors have demonstrated
proof-of-mechanism to interrupt the overactivation of the AP and
reduce C3 fragment deposition, providing a potential treatment
approach for targeting the underlying cause of C3G.
About Alexion Alexion is a global biopharmaceutical
company focused on serving patients and families affected by rare
diseases through the discovery, development and commercialization
of life-changing therapies. As the global leader in complement
biology and inhibition for more than 20 years, Alexion has
developed and commercializes two approved complement inhibitors to
treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as
well as the first and only approved complement inhibitor to treat
atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine
receptor (AchR) antibody-positive generalized myasthenia gravis
(gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion
also has two highly innovative enzyme replacement therapies for
patients with life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency
(LAL-D). In addition, the company is developing several
mid-to-late-stage therapies, including a second complement
inhibitor, a copper-binding agent for Wilson disease and an
anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G
(IgG)-mediated diseases as well as several early-stage therapies,
including one for light chain (AL) amyloidosis and a second
anti-FcRn therapy. Alexion focuses its research efforts on novel
molecules and targets in the complement cascade and its development
efforts on the core therapeutic areas of hematology, nephrology,
neurology, and metabolic disorders. Alexion has been named to the
Forbes’ list of the World’s Most Innovative Companies seven years
in a row and is headquartered in Boston, Massachusetts’ Innovation
District. The company also has offices around the globe and serves
patients in more than 50 countries. This press release and further
information about Alexion can be found at: www.alexion.com.
[ALXN-G]
About Achillion Pharmaceuticals Achillion is a
clinical-stage biopharmaceutical company focused on advancing its
oral small molecule complement inhibitors into late-stage
development and commercialization. Research has shown that an
overactive complement system plays a critical role in multiple
disease conditions including the therapeutic areas of nephrology,
hematology, ophthalmology and neurology. Achillion is initially
focusing its drug development activities on complement-mediated
diseases where there are no approved therapies or where existing
therapies are inadequate for patients. Potential indications being
evaluated for its compounds include paroxysmal nocturnal
hemoglobinuria (PNH), C3 glomerulopathy (C3G), and immune complex
membranoproliferative glomerulonephritis (IC-MPGN). The company has
received Breakthrough Therapy designation for danicopan for
treatment in combination with a C5 monoclonal antibody for patients
with paroxysmal nocturnal hemoglobinuria (PNH) who are sub-optimal
responders to a C5 inhibitor alone. Each of the product candidates
in the company’s oral small molecule portfolio was discovered in
its laboratories and is wholly owned. To advance its
investigational product candidates into Phase 3 clinical trials and
commercialization, the company plans to work closely with key
stakeholders including healthcare professionals, patients,
regulators and payors. More information is available at
http://www.achillion.com.
[ACHN-G]
Forward-Looking Statements This press release includes
forward-looking statements related to the proposed acquisition of
Achillion by Alexion, including: the acquisition provides an
opportunity to enhance treatment for PNH patients experiencing
extravascular hemolysis (EVH); therapeutic benefits of Achillion
products, including potential first-in-class C3 glomerulopathy
(C3G) therapy and promising development platform for Factor D
inhibition in additional alternative pathway complement-mediated
rare diseases; Alexion believes its work on C5 complement
inhibition is just the beginning of what’s possible with complement
inhibition; Alexion believes inhibiting a different part of the
complement pathway has the opportunity to help patients with
diseases not currently addressed through C5 inhibition; using its
complement inhibitor platform, Achillion has several small
molecules in clinical development that have the potential to treat
immune-related diseases associated with the alternative pathway of
the complement system; Alexion believes there is significant
opportunity for Factor D inhibition in the treatment of other
diseases as well; Alexion will ensure the broad promise of
Achillion’s approach is fully realized; the anticipated closing
date of the acquisition; and Achillion’s complement platform is
focused on advancing oral small molecules that inhibit the AP and
can potentially be used in the treatment of immune-related diseases
in which complement AP plays a critical role. A number of important
factors could cause actual results to differ materially from those
indicated by such forward-looking statements, including: the risk
that the proposed acquisition of Achillion by Alexion may not be
completed; the failure to receive the required stockholder approval
necessary to complete the acquisition; the failure (or delay) to
receive the required regulatory approvals of the proposed
acquisition; the failure of the closing conditions set forth in the
acquisition agreement to be satisfied (or waived); the anticipated
benefits of the Achillion platform and therapies not being
realized; future clinical trials of Achillion products not proving
that the therapies are safe and effective to the level required by
regulators; decisions of regulatory authorities regarding the
adequacy of the research and clinical tests, marketing approval or
material limitations on the marketing of Achillion products; delays
or failure of product candidates to obtain regulatory approval;
delays or the inability to launch product candidates due to
regulatory restrictions; unanticipated expenses; interruptions or
failures in the manufacture and supply of products and product
candidates; failure to satisfactorily address matters raised by the
FDA and other regulatory agencies; the possibility that results of
clinical trials are not predictive of safety and efficacy results
of products in broader patient populations; the possibility that
clinical trials of product candidates could be delayed or
terminated prior to completion for a number of reasons; the
adequacy of pharmacovigilance and drug safety reporting processes;
and a variety of other risks set forth from time to time in
Alexion's or Achillion’s filings with the SEC, including but not
limited to the risks discussed in Alexion's Quarterly Report on
Form 10-Q for the period ended June 30, 2019 and in its other
filings with the SEC and the risks discussed in Achillion’s
Quarterly Report on Form 10-Q for the period ended June 30, 2019
and in its other filings with the SEC. Alexion and Achillion
disclaim any obligation to update any of these forward-looking
statements to reflect events or circumstances after the date
hereof, except when a duty arises under law.
Additional Information about the Proposed Transaction and
Where to Find It In connection with the proposed transaction,
Achillion will file a proxy statement on Schedule 14A with the SEC.
Additionally, Achillion plans to file other relevant materials with
the SEC in connection with the proposed transaction. This material
is not a substitute for the proxy statement or any other document
which Achillion may file with the SEC. The definitive proxy
statement will be sent or given to the stockholders of Achillion
and will contain important information about the proposed
transaction and related matters. INVESTORS IN AND SECURITY HOLDERS
OF ACHILLION ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER
RELEVANT DOCUMENTS THAT ARE FILED OR FURNISHED OR WILL BE FILED OR
WILL BE FURNISHED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR
SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY
BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE
PROPOSED TRANSACTION BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT
INFORMATION ABOUT THE TRANSACTION, RELATED MATTERS AND THE PARTIES
TO THE TRANSACTION. The materials to be filed by Achillion with the
SEC may be obtained free of charge at the SEC’s website at
www.sec.gov or in the “Investors & News” section of Achillion’s
website at www.achillion.com.
Centerview Partners served as Achillion’s exclusive financial
advisor, while Skadden, Arps, Slate, Meagher & Flom LLP served
as its legal advisor.
Participants in the Solicitation This communication does
not constitute a solicitation of a proxy from any stockholder with
respect to the proposed transaction. However, Alexion, Achillion
and their respective directors and executive officers may be
considered participants in the solicitation of proxies in
connection with the proposed transaction. Information about the
directors and executive officers of Alexion is set forth in its
Annual Report on Form 10-K for the year ended December 31, 2018,
which was filed with the SEC on February 6, 2019, and its proxy
statement for its May 14, 2019 annual meeting of stockholders,
which was filed with the SEC on March 26, 2019. Information about
the directors and executive officers of Achillion is set forth in
its Annual Report on Form 10-K for the year ended December 31,
2018, which was filed with the SEC on March 7, 2019, and its proxy
statement for its May 30, 2019 annual meeting of stockholders,
which was filed with the SEC on April 15, 2019. Additional
information concerning the interests of the participants in the
solicitation, which may, in some cases, be different than those of
Achillion’s stockholders generally, will be set forth in the proxy
statement relating to the transaction when it becomes available.
You may obtain these documents (when they become available) free of
charge through the website maintained by the SEC at
http://www.sec.gov. Copies of the documents filed with the SEC by
Alexion will be available free of charge on Alexion’s internet
website at http://www.alexion.com under the tab, “Investors” and
under the heading “SEC Filings” or by contacting Alexion’s Investor
Relations Department at investorrelations@alexion.com. Copies of
the documents filed with the SEC by Achillion will be available
free of charge on Achillion’s internet website at
http://www.Achillion.com under the tab “Investors and News” and
under the heading “SEC Filings” or by contacting Achillion’s
Investor Relations Department through
http://ir.achillion.com/contact-us.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191016005257/en/
Alexion: Media Megan Goulart, 857-338-8634 Senior
Director, Corporate Communications Investors Susan
Altschuller, Ph.D., 857-338-8788 Vice President, Investor Relations
Achillion: Media Susanne Heinzinger, 215-709-3032
Senior VP, Corporate Communications Investors A. Clayton
Robertson, 215-709-3078 Manager, Investor Relations
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