-Conference call to be held today at 9:00 a.m.
ET-
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
announced today that on Saturday, September 9, 2017, it received
notice of termination of the worldwide license and collaboration
arrangement on hepatitis C with Janssen Pharmaceuticals, Inc.
(Janssen), one of the Janssen Pharmaceutical Companies of Johnson
& Johnson. The notice follows the decision by Janssen announced
today to discontinue the development of the investigational
hepatitis C treatment regimen JNJ-4178, a combination of three
direct acting antivirals: AL-335, odalasvir and simeprevir.
“We are disappointed by Janssen's decision to
discontinue HCV development given the positive data presented in
phase 2a with JNJ-41781, demonstrating a 100% cure rate after
only six weeks of therapy," stated Milind Deshpande, Ph.D.,
President and Chief Executive Officer of Achillion. “While we
believe that patients worldwide would benefit from convenient,
short-duration therapies like JNJ-4178, we remain fully focused on
advancing our factor D portfolio of complement alternative pathway
inhibitors in areas where patient needs are greatest, and using our
strong balance sheet of almost $370 million in cash and cash
equivalents at June 30, 2017 to do so."
Since entering into the Janssen license
arrangement in 2015, Achillion has focused on and advanced multiple
small molecule factor D inhibitors of the complement alternative
pathway. The first oral factor D inhibitor to demonstrate complete
suppression of the alternative pathway, ACH-4471, is now in
development for PNH, as well as C3G and IC-MPGN. In August 2017,
Achillion announced positive interim data from a phase 2
three-month, dose-ranging trial with ACH-4471 for patients with
untreated PNH. In addition to its plans to continue this study of
untreated PNH patients, Achillion anticipates initiating a second
phase 2 study in PNH patients who sub-optimally respond to
treatment with eculizamab, the current standard of care.
Also during the second half of 2017, Achillion
anticipates initiating patient dosing in two phase 2 trials of
ACH-4471 for patients with low C3 levels due to C3G or IC-MPGN. The
first is an open-label, 14-day trial expected to enroll up to 10
patients, while the second is a placebo-controlled, double-blinded
six-month trial expected to enroll 20 patients. "We believe the
data we have generated to date in our factor D platform are
compelling and point to the potential long-term value of our
portfolio. We look forward to advancing our goal of bringing factor
D inhibitors to patients in need of such therapies," commented Dr.
Deshpande.
Webcast and Dial-in
Information
Achillion will host a conference call and
simultaneous webcast on Monday, September 11, 2017 at 9:00 a.m. ET.
To participate in the conference call, please dial (866) 205-4820
in the U.S. or (419) 386-0004 for international callers. A live
audio webcast of the call will be accessible at
http://www.achillion.com or http://ir.achillion.com. Please
connect to Achillion's website several minutes prior to the start
of the broadcast to ensure adequate time for any software download
that may be necessary.
A replay of the webcast will be available for 30
days on http://www.achillion.com. Alternatively, a telephonic
replay of the conference call will be available starting at 11:30
a.m. ET on September 11, 2017, through 12:05 p.m. ET on September
15, 2017 by dialing (855) 859-2056 or (404) 537-3406. The replay
passcode is 84176694.
About Achillion’s Complement Alternative
Pathway (AP) Factor D Inhibitor Platform
Achillion has leveraged its internal discovery
capabilities and a novel complement-related platform to develop
small molecule factor D inhibitor compounds that target the
complement AP. Factor D is an essential serine protease involved in
the AP, a part of the innate immune system. Achillion's complement
platform is focused on seeking to advance small molecule compounds
that inhibit factor D and can potentially be used in the treatment
of immune-related diseases in which the AP plays a critical role.
Potential indications currently being evaluated for these compounds
include paroxysmal nocturnal hemoglobinuria (PNH), C3
glomerulopathy (C3G), immune-complex membranoproliferative
glomerulonephritis (IC-MPGN), and geographic atrophy (GA), an
advanced form of dry age-related macular degeneration.
About Paroxysmal Nocturnal
Hemoglobinuria (PNH)
PNH is thought to be caused by a mutation
resulting in the absence of receptors normally present on red blood
cells (RBCs) that interact with the AP. The AP of the complement
system typically functions normally in these patients but due to
the lack of key receptors, known as CD55 and CD59, on the surface
of PNH RBCs, the AP treats these cells as foreign and destroys them
via hemolysis in the circulatory system (intravascular) and in the
liver or spleen (extravascular). Factor D is a critical protein
within the amplification loop of the AP and it is believed that
inhibiting it could control the AP response. Furthermore, this
mechanism of action represents a potentially distinct and unique
therapeutic approach for controlling intravascular and
extravascular hemolysis associated with PNH.
About C3 Glomerulopathy
(C3G)
C3G is a rare renal disease which is believed to
be the result of over-activity of the AP. There is currently no
cure available for C3G, no approved treatment to prevent disease
progression and a poor prognosis for patients, of whom
approximately 30-50% require dialysis or kidney transplant 10 years
after diagnosis. ACH-4471 has been shown in vitro to inhibit
alternative pathway activity, potentially decreasing the formation
of C3 protein fragments. This mechanism of action is believed to be
a distinct approach to potentially controlling the underlying cause
of this disease.
About Achillion
Pharmaceuticals
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) is
a science-driven, patient-focused company seeking to leverage its
strengths across the continuum from discovery to commercialization
in its goal of providing better treatments for people with serious
diseases. The company employs a highly-disciplined discovery and
development approach that has allowed it to build a platform of
potent and specific complement factor D inhibitors for AP-mediated
diseases. Achillion is rapidly advancing its efforts to become a
fully-integrated pharmaceutical company with a goal of bringing
life-saving medicines to patients with rare diseases. More
information is available at http://www.achillion.com.
Cautionary Note Regarding
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 important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements.
Achillion may use words such as “expect,” “anticipate,” “project,”
“target,” “intend,” “plan,” “aim,” “believe,” “seek,” “estimate,”
“can,” “could,” “focus,” “will,” “look forward,” “goal,” “may,”
“potential,” and similar expressions to identify such
forward-looking statements. These forward-looking statements
include statements about: the potential benefits of, and potential
indications for, Achillion’s compounds that inhibit factor D,
including the potential for its compounds to treat PNH, C3G,
IC-MPGN, geographic atrophy and other diseases; plans to continue
the phase 2 trial of ACH-4471 in untreated PNH patients; the
timing for initiation of clinical trials in PNH, C3G and IC-MPGN
with ACH-4471; the timing for interim or final results from
Achillion’s clinical trials; statements concerning
Achillion’s ability to achieve its strategic goals, and statements
concerning its plans, and prospects, including those relating to
ACH-4771, ACH-5228 and its complement factor D inhibitor program;
and the Company’s beliefs regarding the potential benefits of
JNJ-4178. Among the important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements are risks relating to, among other
things, Janssen’s termination of the collaboration agreement, and
Achillion’s ability to: advance the preclinical and clinical
development of its complement factor D inhibitors under the
timelines it projects in current and future preclinical studies and
clinical trials; obtain and maintain patent protection for its
technologies and drug candidates and the freedom to operate under
third party intellectual property; demonstrate in any current and
future clinical trials the requisite safety, efficacy and
combinability of its drug candidates; obtain and maintain necessary
regulatory approvals; establish commercial manufacturing
arrangements; identify, enter into and maintain collaboration
agreements with third-parties; compete successfully in the markets
in which it seeks to develop and commercialize its product
candidates and future products; manage expenses; manage litigation;
raise the substantial additional capital needed to achieve its
business objectives; and successfully execute on its business
strategies. These and other risks are described in the reports
filed by Achillion with the U.S. Securities and Exchange
Commission, including its Quarterly Report on Form 10-Q for the
fiscal quarter ended June 30, 2017, and any subsequent SEC
filings.
In addition, any forward-looking statement in
this press release represents Achillion's views only as of the date
of this press release and should not be relied upon as representing
its views as of any subsequent date. Achillion disclaims any duty
to update any forward-looking statement, except as required by
applicable law.
____________________
1 Gane, E. et al. Short duration treatment with AL-335 and
odalasvir, with or without simeprevir, in treatment naïve patients
with hepatitis C infection with or without cirrhosis. Journal of
Hepatology. 2017: 66(1):S82.
Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
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