Aptevo Therapeutics Resumes IXINITY Manufacturing; Anticipates Re-Entering the Market in the Second Quarter of 2017
January 04 2017 - 7:58AM
Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company
focused on developing novel oncology and hematology therapeutics,
today announced that it has resumed IXINITY® manufacturing
operations and anticipates that new supply of IXINITY will be
available beginning in the second quarter of 2017.
Today’s announcement follows a Notice of
Interruption in Manufacturing submitted by Aptevo to the Food and
Drug Administration (FDA) and reported in the Company’s Quarterly
Report on Form 10-Q, filed on November 14, 2016. The IXINITY
supply interruption relates to ongoing bulk drug substance (BDS)
manufacturing challenges, which Aptevo believes have now been
addressed.
“We are very pleased by the rapid progress our
team has made to solve the bulk drug substance IXINITY
manufacturing challenges,” said Marvin L. White, President and
Chief Executive Officer. “We have identified the root cause of the
out-of-specification BDS result that led to the supply interruption
for IXINITY and have implemented the necessary corrective measures
to support resuming commercial production. At this time, we have
resumed routine manufacturing activities and expect to have new
IXINITY supply available for patients beginning as early as the
second quarter of 2017.”
“Most importantly, we are grateful to patients
for their support and encouragement as we worked through this
manufacturing challenge. We look forward to reestablishing
the supply of IXINITY and to once again providing patients access
to their factor IX replacement therapy of choice.
As we look ahead to 2017, we anticipate several
important milestones, beginning first with the reintroduction of
IXINITY in the market. We were very satisfied with the sales
curve for IXINITY in 2016, following our launch in mid-2015 and are
optimistic about our ability to resume this trajectory and continue
to grow market share for IXINITY in 2017 and beyond.
In addition, we anticipate seeing preliminary
data readouts from our 2 clinical-stage programs in 2017. First,
preliminary results from the ongoing dose-escalation Phase 1 study
of MOR209/ES414 should be available in mid-2017. Also,
preliminary data from combination studies with otlertuzumab is
anticipated in the second half of 2017.
We are also very excited about the strong
progress we are making advancing multiple preclinical ADAPTIR™
candidates focused on highly attractive molecular targets, and plan
to provide more information around upcoming IND filings in the
latter part of 2017. In parallel with these efforts, we are
intently exploring new partnership and collaboration opportunities
around our ADAPTIR platform to further validate and drive value for
this program,” remarked Mr. White.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a biotechnology
company focused on novel oncology and hematology therapeutics to
meaningfully improve patients’ lives. Our core technology is the
ADAPTIR™ (modular protein technology) platform. Aptevo has four
commercial products in the areas of hematology and infectious
diseases, as well as various investigational stage product
candidates in immuno-oncology.
Safe Harbor Statement
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Any statements, other than statements of
historical fact, including, without limitation, statements
regarding Aptevo’s outlook, financial performance or financial
condition, our technology and related pipeline, collaboration and
partnership opportunities, commercial portfolio and any other
statements containing the words “believes,” “expects,”
“anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will”
and similar expressions are forward-looking statements. These
forward-looking statements are based on Aptevo’s current
intentions, beliefs and expectations regarding future events.
Aptevo cannot guarantee that any forward-looking statement will be
accurate. Investors should realize that if underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize,
actual results could differ materially from Aptevo’s expectations.
Investors are, therefore, cautioned not to place undue reliance on
any forward-looking statement. Any forward-looking statement speaks
only as of the date of this press release, and, except as required
by law, Aptevo does not undertake to update any forward-looking
statement to reflect new information, events or circumstances.
There are a number of important factors that
could cause our actual results to differ materially from those
indicated by such forward-looking statements, including possible
negative effects on our business operations, assets or financial
results as a result of the separation; a deterioration in our
business or prospects; the ability of our contractors and suppliers
to supply product and materials; our ability and the ability
if our contractors and suppliers to maintain compliance with cGMP
and other regulatory obligations; the results of regulatory
inspections; adverse developments in our customer-base or markets;
adverse developments in the U.S. or global capital markets, credit
markets or economies generally; and changes in regulatory, social
and political conditions. Additional risks and factors that may
affect results are set forth in our filings with the Securities and
Exchange Commission, including Aptevo’s most recent Quarterly
Report on Form 10-Q, as filed on November 14, 2016. The foregoing
sets forth many, but not all, of the factors that could cause
actual results to differ from our expectations in any
forward-looking statement.
Source:
Aptevo Therapeutics
Stacey Jurchison
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com
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