SEATTLE, Jan. 04, 2017 (GLOBE NEWSWIRE) -- 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