On February 4, 2021 Shanghai Fosun Long March Medical Science Co., Ltd. (Fosun Long March) reported that it has executed a non-binding Letter of Intent (LOI) with bioAffinity Technologies, Inc. providing for Fosun to evaluate CyPath Lung, a non-invasive test for the early detection of lung cancer, with an expectation of negotiating and entering into binding agreements to commercialize the early lung cancer diagnostic in China (Press release, BioAffinity Technologies, FEB 4, 2021, View Source [SID1234574691]).

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Fosun Long March is a high-tech in-vitro diagnostics enterprise active in manufacturing, marketing, and research and development of diagnostic and laboratory instruments and reagents. Fosun Long March is a wholly owned company of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, stock code: 02196.HK; 600196.SH). Fosun Pharma is a leading healthcare company in China and is listed on the Shanghai Stock Exchange and on the Main Board of the Hong Kong Stock Exchange.

Dr. Yuejian Zhang, Chief Executive Officer of Fosun Long March, said, "We are impressed with the results of the CyPath Lung test validation trial that showed high accuracy in detecting lung cancer in people at high risk for the world’s most deadly cancer. CyPath Lung is patient-friendly and reasonably priced, making it a good fit in the China market. The test could make a very positive impact. Whilst China represents a little under 20% of the world’s population, it accounts for almost 24% of cancer diagnoses and 30% of cancer-related deaths worldwide in 2020, of which 18% are due to lung cancer. We look forward to proceeding with the collaboration with bioAffinity Technologies and working together to launch CyPath Lung in China."

Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies, said, "Fosun Long March is a driving force in healthcare, bringing medical breakthroughs to China and the world that improve the health and clinical outcomes of patients. We are very excited to be working with Fosun Long March in advancing CyPath Lung. China represents a $5 billion market for CyPath Lung. An estimated 780,000 people will be diagnosed with lung cancer annually in China, most often at late stage. CyPath Lung is proven to detect lung cancer at early stages, providing opportunities for more effective and less caustic treatments that can save lives."

Ms. Zannes continued, "CyPath Lung offers a simple, cost-effective and highly accurate test. Patients collect their sputum samples at home, a significant benefit during this time of COVID-19 that will last well after the pandemic subsides. Samples are processed at a central laboratory including use of a proprietary porphyrin that labels cancer. Single-cell analysis is performed at extraordinary speed by flow cytometry and data fed through our automated AI-designed platform to provide physicians with results in minutes. CyPath Lung showed 92% sensitivity and 87% specificity in detecting lung cancer in high-risk, heavy smokers who had lung nodules smaller than 2 cm or no nodules in the lung. The detection of small lung nodules in people who have early stage cancer can dramatically increase lung cancer survival."

On February 4, 2021 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported financial results for the third quarter of fiscal year 2020 (period ended December 31, 2020) (Press release, Takeda, FEB 4, 2021, View Source [SID1234574582]).

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TAKEDA CHIEF FINANCIAL OFFICER COSTA SAROUKOS commented:

"Our third-quarter results demonstrate the resilience of our business model and the depth of our portfolio, with strong growth generated by our 14 global brands. As a values-based and R&D driven biopharmaceutical company, we remain focused on bringing life-transforming treatments to people with high unmet needs around the world. With the first of our seven potential filings in the next 12 months complete, we look forward to delivering the next generation of potentially transformative medicines and maintaining our commitment to patients, our people and the planet.

"While maintaining business momentum, we also continue to deliver on our financial commitments, realizing strong year-to-date margins and cash flow, and exceeding our target for non-core asset divestitures. This progress reflects our ability to effectively and efficiently integrate the operations of Takeda and Shire, as we capture synergies and focus investment in our key business areas.

"Takeda’s strong financial performance in Q3 allows us to confirm management guidance for FY2020, with further growth acceleration expected in Q4 as we conclude the fiscal year. Reflecting on the transformation of Takeda over the past few years and the world-class R&D engine we have built, we look to 2021 as an important inflection point, filled with a number of pivotal milestones that will position us for long-term sustainable growth."

(1) Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source
(2) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
(3) Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as purchase accounting effects and transaction related costs.
(4) Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, and including proceeds from sales of plant, property and equipment, as further adjusted to exclude the acquisition of intangible assets and the acquisition of investments, and to include the proceeds from sales and redemption of investments and proceeds from sales of business, net of cash and cash equivalents divested.

FY2020 Q3 YTD RESULTS DEMONSTRATE TAKEDA’S CONTINUED RESILIENCE

Reported revenue, at JPY 2,427.5 billion (~$23.5B), was impacted primarily by foreign exchange and divestitures, however Takeda delivered year-to-date underlying revenue growth of 1.1% in the third quarter of FY2020, which was driven by strong growth in ENTYVIO, TAKHZYRO, and Immunoglobulin, and was consistent with full year guidance of "low-single-digit growth."

Takeda delivered reported operating profit of JPY 358.7 billion (~$3.5B), which grew 120.7%, reflecting lower purchase price accounting (PPA) and integration costs. Core operating profit, which adjusts for PPA and non-recurring items, declined year-on-year to JPY 780.6 billion (~$7.6B) owing to foreign exchange impact and divestitures. The core operating profit margin was 32.2%. Underlying core operating profit grew 8.5% year-on-year. Underlying core operating profit margin, which adjusts for the impact of foreign exchange and divestiture effects, was 32.1%, driven by synergies and OPEX efficiencies.

Takeda’s reported net profit was JPY 178.9 billion, a 320.8% increase compared with the same period in the prior year.

Operating cash flow increased by 25.9% to JPY 610.0 billion, strengthening Takeda’s balance sheet and more than enabling the Company to satisfy dividend, debt, and interest payments. Free cash flow, which also reflects capital expenditures and proceeds from asset sales, was JPY 717.5 billion (~$7.0B). This represented a decrease of 3.8% in reported free cash flow versus the prior year; the growth rate was impacted by the ~JPY 375.5BN cash received in July 2019 for XIIDRA. Robust cash flow enabled further de-leveraging in Q3 and led to a 3.6x net debt/adjusted EBITDA ratio at the end of the period.

The overall impact of the global spread of COVID-19 on Takeda’s consolidated financial results for the nine-month period ended December 31, 2020 was not material, with several offsetting factors. There were adverse effects due to COVID-19 observed in certain therapeutic areas, especially in Neuroscience during periods when stay-at-home restrictions were in place reducing patient visits to medical care providers. This trend has fluctuated throughout the nine-month period, especially in recent months, as transmission of COVID-19 has increased significantly in many parts of the world. These adverse impacts have been partially offset by benefits from prescribing trends during the pandemic, such as an expansion of certain products with a more convenient administration profile that was observed in the early phase of the outbreak. With regard to operating expenses, voluntary suspension of certain business activities such as business travel and events in response to COVID-19 led to lower spending. As a result of these factors, the impact on Takeda’s profit was immaterial.

For the latest Takeda communications regarding COVID-19, please click here to visit the COVID-19 Information Center on Takeda’s website.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS
Takeda’s five key business areas — Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience — with JPY 1,982.1 billion of reported revenue representing approximately 82% of total Q3 YTD revenues – delivered year-on-year underlying revenue growth of 4.4%. Takeda’s 14 global brands, with reported revenue of JPY 910.3 billion (~$8.8B) in aggregate, delivered a 15.4% increase in Q3 YTD underlying revenue growth compared to a year before.

Gastroenterology
The Gastroenterology franchise with JPY 588.8 billion in reported revenue represented 24% of sales, with underlying revenue growth of 14%. This was spearheaded by continued exceptional growth through expanded first line share of gut-selective ENTYVIO in the U.S., EU, and Japan.

Rare Diseases
The Rare Diseases franchise with JPY 446.7 billion in reported revenue represented 18% of sales, with underlying revenue growth declining 3%. The hereditary angioedema portfolio saw 16% underlying revenue growth, driven by continued excellent performance from TAKHZYRO, which continues to expand the hereditary angioedema prophylaxis market. Rare Hematology declined 11% on an underlying basis, with the competitive landscape in line with expectations. Rare Metabolic declined 1% on an underlying basis, but excluding NATPARA the portfolio saw 7% growth. Takeda is working closely with the U.S. Food and Drug Administration (FDA) on a proposed plan to resupply NATPARA in the U.S. and had announced earlier in FY2020 that the required device modifications and product testing will likely delay availability beyond FY2020.

PDT Immunology
PDT Immunology with JPY 313.0 billion in reported revenue represented 13% of sales, with underlying revenue growth of 9% driven by continued strong Gammagard-Liquid demand in the U.S. and subcutaneous IG worldwide. Albumin sales declined 10% versus prior year, partially due to phasing and supply dynamics in China in 2019 and in some part due to a temporary interruption in submitting batches of Albumin Glass for release in China in Q3, for which we expect a resolution soon.

Oncology
Oncology with JPY 318.5 billion in reported revenue represented 13% of sales, with underlying revenue growth of 3%. Takeda’s portfolio continues to expand indications as growth brands offset the decline of older products in the portfolio.

Neuroscience
Neuroscience with JPY 315.1 billion in reported revenue represented 13% of sales, declining 2% on an underlying basis. The portfolio experienced a slowdown in momentum attributable to COVID-19 stay-at-home restrictions that reduced patient visits and diagnoses. A recovery of prescribing trends has been noted, but new patient starts are not yet back to pre-COVID levels.

Q3 YTD Global Brand Highlights

COST SAVINGS AND DIVESTITURES
Synergy deliverables and operational efficiencies supported margin performance, as Takeda delivered a year-to-date underlying core operating profit margin of 32.1%. Takeda is also deleveraging rapidly, with a net debt/adjusted EBITDA ratio of 3.6x at the end of Q3 (December 31, 2020), down from 3.8x in March 2020, even after the full-year dividend payment. Gross debt principal has reduced JPY 1.3TN (~$12.5B) in two years since the quarter ending March 31, 2019 (close of the Shire acquisition was announced on January 8, 2019), and Takeda is on course to meet its medium-term deleveraging goal of 2x within FY2021-FY2023.i

Takeda exceeded its $10B non-core asset divestiture target and has announced 11 deals since January 2019 to date for a total aggregate value of up to ~$11.6 billion, most recently including:

The completion of the previously announced sale of a portfolio of select OTC and prescription products to Hypera S.A. for a total value of $825 million USD. (Press Release)
The completion of the previously announced sale of TachoSil Fibrin Sealant Patch to Corza Health, Inc. for €350 million. (Press Release)
The completion of the previously announced sale of a portfolio of select prescription products to Cheplapharm for a total value of $562 million USD. (Press Release)
The completion of the previously announced sale of a portfolio of select products to Celltrion Inc. for a total value of $278 million USD inclusive of milestone payments. (Press Release)
An agreement to divest a portfolio of non-core prescription pharmaceutical products sold in China to Hasten Biopharmaceutic Co., Ltd. for $322 million USD, subject to customary legal and regulatory closing conditions. (Press Release)
Takeda further exceeded its original $700 million target and Q2 total of $1.1B for incremental cash from sales of real estate and securities, receiving ~$1.4B to date. As a result, the Company is raising its full year FY2020 Free Cash Flow forecast by JPY 50 billion to JPY 750 – 850 billion.

PIPELINE UPDATE: R&D PROGRESS WITH SUBMISSION OF TAK-721, THE FIRST OF SEVEN POTENTIAL FILINGS IN THE NEXT 12 MONTHS

Takeda has built a world-class, state of the art R&D engine and has generated a diverse and dynamic pipeline of approximately 40 clinical-stage new molecular entities (NMEs) that is beginning to deliver. The company’s Wave 1 pipeline NMEs, representing potential best-in-class/first-in-class therapies, has a number of notable anticipated near-term late-development milestones, pivotal data readouts or pivotal study starts.

Takeda’s pipeline portfolio has the potential to contribute significantly to its growth over the next decade, and remains on track to deliver on its milestone goals. Since Q2, one of its twelve near-term pivotal milestones has already been met (Maribavir phase 3 data readout). This is also one of five pivotal data readouts expected through fiscal year 2022, with additional near-term development milestones expected across all Wave 1 programs.

Takeda’s R&D engine continued to advance its Wave 1 pipeline, with recent highlights including:

TAK-721 has been granted priority review from the FDA and remains on track to be the first FDA-approved agent to treat eosinophilic esophagitis. TAK-721 previously received both Breakthrough Therapy designation and Orphan Drug designation from the FDA. (Press Release)
TAK-003, Takeda’s tetravalent dengue vaccine candidate, continued to protect against dengue illness with an acceptable safety profile in the two years safety and efficacy follow-up published in The Journal of Infectious Diseases in December 2020. Regulatory submissions to the EMA and dengue endemic countries are expected in FY2020 Q4, containing three years of safety and efficacy follow-up; this data is to be presented at a medical meeting in FY2021.
Mobocertinib (TAK-788), a potential new oral standard of care for NSCLC patients with EGFR Exon20 insertion mutations, demonstrated clinically meaningful and durable responses in data presented at the 2020 World Conference on Lung Cancer (WCLC), with a confirmed objective response rate of 35% as assessed by investigator and a median duration of response of 17.5 months. It remains on track for FDA submission in Q4 2020 for Platinum Pretreated Patients with EGFR Exon20 insertion mutations. (Press release)
Maribavir (TAK-620) met its phase 3 primary endpoint for the treatment of transplant recipients with refractory/resistant cytomegalovirus infections (Press release). Positive Phase 3 data for TAK-620 will be presented at the Transplantation & Cellular Therapy Meetings (TCT) on February 12 and the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting on March 14-17. Takeda anticipates FDA filing for maribavir as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy in H1 FY2021.
Other Notable Updates
In 2020, Takeda ranked first in NDA approvals in China, with four approvals including TAKHZYRO (Press Release), ENTYVIO, ADCETRIS, and REPLAGAL.

At the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December 2020, Takeda presented nine abstracts on key learnings from real-world data and retrospective studies. Takeda continues to gather and apply real-world evidence in the treatment of hemophilia, von Willebrand disease (VWD) and sickle cell disease (SCD) and advance personalized treatment in its ongoing commitment to people living with bleeding disorders. (Press Release)

At the 2020 American College of Allergy, Asthma and Immunology (ACAAI) Virtual Annual Scientific Meeting, Takeda shared final results from the Phase 3 HELP Study Open-Label Extension that demonstrate TAKHZYRO (lanadelumab-flyo) injection as a potential long-term preventive treatment option in patients with Hereditary Angioedema. The results were also published in the November 2020 issue of ACAAI’s journal Annals of Allergy, Asthma & Immunology. (Press Release)

Lastly, Takeda is excited about the recent regulatory progress of a number of transformative therapies, including the FDA approval for the Supplemental New Drug Application (sNDA) of ICLUSIG (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML. (Press Release)

KEY CORPORATE INITIATIVES

Several examples of corporate achievements in Q3 demonstrate Takeda’s progress toward its vision — "discover and deliver life-transforming treatments, guided by our commitment to Patients, our People and the Planet."

Patients:
Takeda Demonstrates Industry Leadership in 2021 Access to Medicines Index
Takeda was ranked sixth overall in the 2021 Access to Medicine (AtM) Index. A rigorous, biennial research project, the AtM Index combines data-collection, verification, scoring and analysis to compare 20 of the world’s largest pharmaceutical companies on their efforts to address access to medicines. The company achieved notable high scores in all three technical areas evaluated by the Index, including being ranked first in "Governance of Access". Takeda also demonstrated strong performance in the areas of health strengthening and compliance. This ranking demonstrates Takeda’s values-driven strategy and how an ‘Access First’ approach across its Growth & Emerging Markets region is helping patients overcome access challenges in a more sustainable manner. (Press Release)

People:
Takeda Receives Global Top Employer Recognition
Takeda was one of only 16 companies to be named as a global Top Employer for 2021, an accolade the company has now received for a fourth consecutive year. The Top Employers Institute provides annual award certification to companies with outstanding culture, work environments, benefits and opportunities for their people based on the results of its HR Best Practices Survey. Takeda excelled globally in the areas of Values, Ethics & Integrity, Organizational Change, Leadership, Sustainability, Performance Management and Engagement and was also certified as a Top Employer in four regions and 38 countries. This honor demonstrates Takeda’s continued commitment to creating an exceptional people experience for its global workforce. (Press Release)

Planet:
Takeda Achieves Carbon Neutral Goal
Takeda recently announced it achieved carbon neutrality in its value chain for its fiscal year 2019. This milestone was met by a continued focus on internal energy conservation measures, procurement of green energy, and investment in renewable energy certificates and high-quality, verified carbon offsets. Such actions collectively address 100 percent of Takeda’s fiscal year 2019 scope 1, 2 and 3 emissions and represent a significant step forward in Takeda’s sustainability journey. Minimizing the environmental impact of its business is a critical priority for Takeda and at the heart of its purpose: achieving Better Health for People, Brighter Future for the World. (Press Release)

Read more about how Takeda continues to deliver on its commitments to patients, people and the planet through its purpose-led sustainability commitment in its 2020 Sustainable Value Report: View Source

COVID-19 UPDATE
Guided by its values, Takeda’s response to COVID-19 has focused on protecting the health and safety of employees, striving to ensure its medicines are available to patients who rely on them and playing a part to reduce transmission and support the communities where its employees live and work. Takeda has also undertaken a number of efforts to help the world respond to COVID-19, most recently including:

World’s Leading Life Science Companies Now Enrolling COMMUNITY, A Global Platform Trial For Hospitalized Patients with COVID-19

Press Release

Takeda initiates a clinical phase 1/2 study in Japan of TAK-919, Moderna’s COVID-19 vaccine candidate

Press Release

Takeda licensed TAK-919 (Moderna) and TAK-019 (Novavax) COVID-19 vaccines in Japan, with approvals expected in FY2021

(Press Release), (Press Release)

FY2020 GUIDANCE
Full-Year Management Guidance Confirmed; Reported EPS Upgrade on More Favorable Tax Rate Assumption and Increased Forecast for Free Cash Flow Reflecting Additional Sale of Securities

Takeda has solid growth momentum heading into Q4 FY2020 and potential for accelerated underlying growth and achieving an underlying core operating profit margin in the mid-30s over the medium term.
Core and underlying guidance for FY2020 remains unchanged.

Key Assumptions in FY2020 Forecast
Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of its 14 global brands, and accelerated realization of cost synergies.

FY2020 guidance also reflects the following key assumptions, including (i) that there will not be an additional 505(b)2 competitor for subcutaneous VELCADE launched in the U.S. within FY2020; (ii) includes the impact of divestitures disclosed by Takeda as through February 4, 2021, with the exception of the divestment of Takeda Consumer Healthcare Company and non-core assets in China; and (iii) management’s current expectations regarding COVID-19.

Based on currently available information, Takeda believes that its financial results for FY2020 will not be materially affected by COVID-19 and, accordingly, Takeda’s FY2020 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2020, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in additional impacts on Takeda’s business, results of operations or financial condition, as well as resulting in significant deviations from Takeda’s FY2020 forecast.

For more details on Takeda’s Q3 FY2020 results and other financial information, please visit: View Source

Further Information
Takeda will share details regarding its commercial strategy in emerging markets and progress on its pipeline at its upcoming Growth & Emerging Markets Strategic Update call on March 11, 2021 and part 2 of its Wave 1 Pipeline Market Opportunity call on April 6, 2021, respectively.

On February 4, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its fourth quarter and full year 2020 financial results and operational highlights before open of U.S. markets on Thursday, March 4, 2021 (Press release, Autolus, FEB 4, 2021, View Source [SID1234574620]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm GMT to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 2268057. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 2268057.

On February 4, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (the "Company"), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported three abstracts featuring its PSMA-targeted pipeline of product candidates have been selected for poster presentations at the upcoming 2021 American Society for Clinical Oncology Genitourinary (ASCO GU) Virtual Meeting, which will be held from February 11-13, 2021 (Press release, Lantheus Medical Imaging, FEB 4, 2021, View Source [SID1234574637]). Two of the abstracts relate to PyL, the Company’s PET/CT imaging agent for prostate cancer, and the third abstract relates to 1095, the Company’s radiopharmaceutical therapeutic for metastatic castration resistant prostate cancer.

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The presentations will be made available for the duration of conference.

Details for the ASCO (Free ASCO Whitepaper) GU presentations based on Company-sponsored studies are as follows:

Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET
Session Title: Poster Session: Prostate Cancer – Advanced Disease
Title: A prospective phase II/III study of PSMA-targeted 18F-DCFPyL-PET/CT in patients (pts) with prostate cancer (PCa) (OSPREY): A sub analysis of disease staging changes in PCa pts with recurrence or metastases on conventional imaging.
Presenter: Jeremy C. Durack, M.D., M.S., Memorial Sloan Kettering Cancer Center
Abstract No: 32

Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET
Session Title: Poster Session: Prostate Cancer – Advanced Disease
Title: PSMA-targeted imaging with 18F-DCFPyL-PET/CT in patients (pts) with biochemically recurrent prostate cancer (PCa): A phase III study (CONDOR) – A sub analysis of correct localization rate (CLR) and positive predictive value (PPV) by standard of truth.
Presenter: Frederic Pouliot, M.D., Ph.D., F.R.C.S.C., Centre Hospitalier Universitaire (CHU) de Québec-Université Laval
Abstract No: 33

Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET
Session Title: Trials in Progress Poster Session: Advanced Prostate Cancer
Title: A multicenter, randomized, controlled phase II study: Efficacy and safety of PSMA-targeted radioligand therapy I-131-1095 (1095) plus enzalutamide (enza) in 18F-DCFPyL PSMA scan avid, metastatic castration-resistant prostate cancer (mCRPC) patients post-abiraterone (abi) progression (ARROW).
Presenter: Oliver Sartor, M.D., Tulane Cancer Center
Abstract No: TPS187

On February 4, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that its partner Promedico Ltd., a member of the Neopharm Group, has received a principal approval letter from the Israeli Ministry of Health, Israel’s regulatory agency responsible for the approval of new medicines, granting the approval of XPOVIO (selinexor) for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma (DLBCL) (Press release, Karyopharm, FEB 4, 2021, View Source [SID1234574655]). The approved indications for XPOVIO are a) in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and b) for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

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Karyopharm expects Promedico to receive a registration license providing commercial and marketing authorization for XPOVIO in Israel during the second quarter of 2021. Separately, today’s announcement follows Karyopharm’s recently announced adoption of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending conditional approval for NEXPOVIO (selinexor) in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Karyopharm expects to receive a final decision from the European Commission by April 2021.

"The approval of XPOVIO in Israel represents its first regulatory approval outside the United States and is a tremendous milestone for both Karyopharm and the patients we hope to serve in the future," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "The approval of XPOVIO in Israel further demonstrates our commitment to expand XPOVIO’s reach to cancer patients across the globe who are in need of novel therapies. We look forward to continuing to work closely with our dedicated partner, Promedico, and its world-class team to bring XPOVIO to patients in Israel."

Karyopharm has previously entered into an exclusive distribution agreement with Promedico, a member of the Neopharm Group, a leader in launching and marketing novel therapies in Israel, for the commercialization of XPOVIO (selinexor) in Israel and the Palestinian Authority.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

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XPOVIO (selinexor) is a prescription medicine approved in the U.S.:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection(21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.