Primary peritoneal carcinoma

LEXINGTON, KY / ACCESSWIRE / March 5, 2024 / NX Development Corp. (NXDC) has achieved another milestone as we proudly announce the recent granting of orphan-drug status by the U.S. Food and Drug Administration (FDA) for Gleolan (aminolevulinic acid HCl). This designation was provided for the "real-time detection and visualization of epithelial ovarian tumors during debulking surgery." NXDC Logo Logo of NXDC Dr. Salvatore DeSena, CEO of NX Development Corp., shared this excitement, stating, "On behalf of our entire team, I am proud to announce that NX Development Corp. secured orphan-drug status for Gleolan in ovarian, fallopian tube, and primary peritoneal cancer. This achievement demonstrates NXDC's commitment to exploring new and innovative uses for Gleolan to help patients and surgeons in their fight against these cancers." "This important milestone underlines the capabilities of aminolevulinic acid HCl in fluorescence-guided surgery. As a group, we aim to expand this further, also to other countries as well, providing support to patients and healthcare professionals combating cancer globally," said Dr. Ulrich Kosciessa, Chairman of the Board of NXDC and CEO of photonamic GmbH & Co KG. (Pinneberg, Germany), parent company to NXDC. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Gleolan has gained clinical recognition for its use in visualizing malignant glioma tissue during surgery. About NX Development Corp.: NX Development Corp., a wholly-owned subsidiary of photonamic GmbH & Co. KG., a member of the SBI Holdings Inc. Group (Tokyo, Japan), is dedicated to revolutionizing cancer care through innovative solutions and groundbreaking developments in fluorescence-guided surgery. About Gleolan Contact Information Raquel R. adminpeopledept@nxdevcorp.com Alicia M. mediamarketing@nxdevcorp.com SOURCE: NX Development Corp. View the original press release on newswire.com.

Adds flagship antibody-drug conjugate (ADC) ELAHERE® (mirvetuximab soravtansine-gynx) for folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) to AbbVie's portfolio ImmunoGen's pipeline complements AbbVie's existing oncology pipeline with potential to be transformative across multiple solid tumors and hematologic malignancies ImmunoGen's late-stage development programs for ELAHERE provide opportunity to expand into earlier lines of therapy and additional patient populations AbbVie reaffirms previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25 which now includes a $0.42 per share dilutive impact related to the ImmunoGen acquisition and the pending Cerevel Therapeutics acquisition AbbVie updates previously issued 2024 first-quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30 which now includes a $0.04 per share dilutive impact related to the ImmunoGen acquisition NORTH CHICAGO, Ill., Feb. 12, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that it has completed its acquisition of ImmunoGen (NASDAQ: IMGN). With the completion of the acquisition, ImmunoGen is now part of AbbVie. "Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," said Robert A. Michael, president and chief operating officer, AbbVie. "The addition of ImmunoGen's treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie." ELAHERE® (mirvetuximab soravtansine-gynx) is the first and only antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in ovarian cancer. The FDA granted accelerated approval for ELAHERE in folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) patients based on response data. Results from a confirmatory trial currently under review by the FDA show that ELAHERE is the first targeted agent to offer a survival benefit in PROC, with label expansion opportunities across larger segments of the ovarian cancer market. ImmunoGen's follow-on pipeline of ADCs further builds on AbbVie's existing solid tumor pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies. Through focused R&D efforts, AbbVie has developed novel ADC technology and has unique strengths in antibody engineering, drug linker chemistry and toxin research. AbbVie and ImmunoGen's combined capabilities represent an opportunity to deliver potentially transformative ADC therapies to patients. ImmunoGen's investigational Phase 1 asset, IMGN-151, is a next-generation FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications. Pivekimab sunirine, currently in Phase 2, is an investigational anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN. For additional background on the acquisition, please read the announcement press release here and view AbbVie's investor presentation here. Financial Terms AbbVie has acquired all outstanding ImmunoGen common stock for $31.26 per share. It is expected that ImmunoGen's common stock will cease to trade on the NASDAQ stock exchange prior to market open on February 12, 2024. AbbVie expects its acquisition of ImmunoGen to be accretive to AbbVie's diluted EPS beginning in 2027 and significantly accretive over the long-term. Full-Year 2024 Outlook AbbVie is reaffirming its previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25. This guidance now includes a $0.42 per share dilutive impact related to the completed ImmunoGen acquisition, as well as the pending Cerevel Therapeutics acquisition, which is anticipated to close in mid-2024. AbbVie's 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2024, as both cannot be reliably forecasted. AbbVie is updating its previously issued 2024 first-quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30. This guidance now includes a $0.04 per share dilutive impact related to the ImmunoGen acquisition. AbbVie's 2024 first-quarter adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred in the quarter, as both cannot be reliably forecasted. About ELAHERE (mirvetuximab soravtansine-gynx) ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The prescribing information includes a boxed warning. ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue ELAHERE for Grade 4 ocular toxicities. Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin. Please see full Prescribing Information, including Boxed Warning for ELAHERE. About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the ability to realize the anticipated benefits of the ImmunoGen acquisition on the anticipated timeframe or at all, risks that the cost to consummate the ImmunoGen acquisition or to obtain the anticipated benefits of the acquisition could be greater than expected, the risk that the ImmunoGen business will not be integrated successfully, disruption from the ImmunoGen acquisition making it more difficult to maintain business and operational relationships, the diversion of management's attention from ongoing business operations and opportunities, negative effects of the consummation of the acquisition on business or employee relationships or the market price of AbbVie's common stock and/or operating results, significant transaction costs, the assumption of unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition or ImmunoGen's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie

Tepkinly has received accelerated approval from the FDA and a conditional marketing authorisation from the European Commission as third-line therapy in adult patients with DLBCL. Image Credit: JHVEPhoto / Shutterstock. The UK’s National Institute for Health and Care Excellence (NICE) has recommended AbbVie ’s Tepkinly (epcoritamab) as a third-line treatment option for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). NICE has endorsed Tepkinly in DLBCL patients whose cancer has returned or has not responded to at least two previous treatments. The therapy is only recommended for patients who have already either received Roche’s Polivy (polatuzumab vedotin) or it is either contraindicated or not tolerated. Tepkinly is a bispecific CD20 CD3 T-cell engager. The therapy was developed by Genmab using DuoBody technology and was licensed by AbbVie , along with two other bispecific antibodies, DuoHexaBody-CD37 and DuoBody-CD3x5T4. In May 2023, Tepkinly received accelerated approval from the US Food and Drug Administration (FDA) as a third-line therapy in adult patients with DLBCL. The drug is marketed as Epkinly in the US. The therapy was also granted conditional marketing authorisation from the European Commission (EC) for the same indication as approved by the FDA. The NICE recommendation, along with the FDA and EC approval, were based on data from the Phase I/II EPCORE NHL-1 trial (NCT03625037). The 139 patients enrolled in the study showed an overall response rate of 62% and a complete response rate of 39%. The therapy also prevented the growth or spread of the DLBCL for an average of 15.6 months. See Also: Vivet wins $5.3m grant to develop gene therapy for rare metabolic disorder UK MHRA approves GSK’s momelotinib for myelofibrosis anaemia Tepkinly generated $14m in US sales in Q3 2023, as per AbbVie’s financials. GlobalData forecasts that its first-to-market advantage could propel Epkinly sales to exceed $1.8bn in 2029. GlobalData is the parent company of Pharmaceutical Technology . AbbVie has recently invested in expanding its oncology pipeline with an acquisition of ImmunoGen for approximately $10.1bn in November 2023. The deal is expected to close in mid-2024 and will give AbbVie access to the company’s lead antibody-drug candidate, Elahere (mirvetuximab soravtansine-gynx). In November 2022, the therapy received accelerated approval to treat folate receptor alpha (FRα)-positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Additionally, AbbVie signed a collaboration agreement with BigHat Biosciences to identify and develop antibody therapies in oncology and neuroscience indications, in December 2023. The company paid a $30m upfront payment, with an option to pay up to approximately $325m in research and development and commercial milestone-based payments along with tiered royalties on net sales.