Category: Healthcare

Bristol Myers Squibb and bluebird bio announce submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma

Post author By Michelle Dryden
Post date July 30, 2020
No Comments on Bristol Myers Squibb and bluebird bio announce submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma

BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient population

Companies are committed to working with the FDA to rapidly advance ide-cel through the regulatory review process

PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BLUE #BMS—Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020.

The submission is based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of ide-cel in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory (IMiD) agent, a proteasome inhibitor (PI) and an anti-CD38 antibody. Results from the study were shared during an oral presentation as part of the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.¹

Multiple myeloma is a cancer of plasma cells.² The cause of multiple myeloma is not known and currently there is no cure; however, there are a number of treatment options available that can lead to response.² Patients who have already been treated with some available therapies but continue to have progression of their disease have “relapsed” and “refractory” multiple myeloma, meaning their cancer has returned after they have received initial treatments. Patients with relapsed and refractory multiple myeloma that have been exposed to all three major drug classes, including an IMiD agent, a PI and an anti-CD38 antibody, have fewer treatment options and poor outcomes, including shorter response durations and lower overall survival.³

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the FDA, and PRIority MEdicines (PRIME) designation and validation of its Marketing Authorization Application (MAA) by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is not approved for any indication in any geography.

For Holders of Contingent Value Rights (CVR), Ticker BMY-RT

U.S. FDA approval of ide-cel by March 31, 2021 is one of the required remaining milestones of the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is U.S. FDA approval of liso-cel by December 31, 2020. The company is committed to working with FDA to progress both applications and achieve the remaining regulatory milestones required by the CVR.

About Ide-cel

Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio. Ide-cel was granted accelerated assessment by the European Medicines Agency (EMA) on March 26, 2020, and the MAA was validated by the EMA on May 20, 2020.

About KarMMa

KarMMa (NCT03361748) is a pivotal, open-label, single-arm, multicenter, multinational, Phase 2 study evaluating the efficacy and safety of ide-cel in adults with relapsed and refractory multiple myeloma in North America and Europe. The primary endpoint of the study is overall response rate as assessed by an independent review committee (IRC) according to the International Myeloma Working Group (IMWG) criteria. Complete response rate is a key secondary endpoint. Other efficacy endpoints include time to response, duration of response, progression-free survival, overall survival, minimal residual disease evaluated by Next-Generation Sequencing (NGS) assay and safety. The study enrolled 140 patients, of whom 128 received ide-cel across the target dose levels of 150-450 x 10⁶ CAR+ T cells after receiving lymphodepleting chemotherapy. All enrolled patients had received at least three prior treatment regimens, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and were refractory to their last regimen, defined as progression during or within 60 days of their last therapy.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, we’re developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, we’re working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. We’re putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, β-thalassemia and multiple myeloma using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

bluebird bio is a trademark of bluebird bio, Inc.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that ide-cel, or bb2121, may not achieve its primary study endpoint or receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

bluebird bio Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of ide-cel. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility that the BLA submission may not be accepted for filing by the FDA without the provision of further information or responses to additional requests, if at all, that ide-cel may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, and, if approved, whether ide-cel will be commercially successful, that the positive results for ide-cel may not continue in additional clinical trials, and that the collaboration with Bristol Myers Squibb may not continue or be successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Hyperlinks are provided as a convenience and for informational purposes only. Neither Bristol Myers Squibb nor bluebird bio bears responsibility for the security or content of external websites or websites outside of their respective control.

References

Munshi NC, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): initial KarMMa results. ASCO 2020 Virtual Scientific Program. Abstract #8503.
American Cancer Society. What is Multiple Myeloma? Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed June 2020.
Jagannath S, et al. KarMMa-RW: a study of real world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa. ASCO 2020 Virtual Scientific Program. Abstract #8525.

Contacts

Bristol Myers Squibb
Media Inquiries:

609-252-3345

media@bms.com

Rose Weldon

rose.weldon@bms.com

Investors:

Tim Power

609-252-7509

timothy.power@bms.com

bluebird bio

Media:
Victoria von Rinteln

617-914-8774

vvonrinteln@bluebirdbio.com

Investors:
Ingrid Goldberg

410-960-5022

igoldberg@bluebirdbio.com

Elizabeth Pingpank

617-914-8736

epingpank@bluebirdbio.com

Tags #BLA, #BMS, Antibody, B-Cell, Biologics License Application, bluebird bio, Bristol Myers Squibb, FDA, medicines, Myeloma, patients, Refractory, Relapse, Relapse#BLA

Healthcare

Daiichi Sankyo and AstraZeneca enter new global development and commercialization collaboration for Daiichi Sankyo’s ADC DS-1062

Agreement represents second collaboration between Daiichi Sankyo and AstraZeneca for a Daiichi Sankyo DXd antibody drug conjugate (ADC)
AstraZeneca to pay Daiichi Sankyo up to $6 billion in total consideration, including a $1 billion upfront payment and up to an additional $5 billion contingent upon achievement of future regulatory and sales milestones

TOKYO, MUNICH & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into a global development and commercialization agreement with AstraZeneca (LSE, STO, NYSE: AZN) for Daiichi Sankyo’s DS-1062, a TROP2 directed DXd antibody drug conjugate (ADC), currently in phase 1 clinical development for non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC).

Daiichi Sankyo and AstraZeneca will jointly develop and commercialize DS-1062 worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will manufacture and supply DS-1062.

This agreement represents the second global ADC collaboration between the two companies following a similar agreement in March 2019 for Daiichi Sankyo’s ENHERTU^®, a HER2 directed DXd ADC.

“DS-1062, one of our lead DXd ADCs that will form a pillar of our next mid-term business plan, has the potential to become a best-in-class TROP2 ADC in multiple tumors, including lung and breast cancers,” said Sunao Manabe, Representative Director, President and CEO of Daiichi Sankyo Company, Limited. “This new strategic collaboration with AstraZeneca, a company with extensive experience and significant expertise in the global oncology business, will enable us to deliver DS-1062 to more patients around the world as quickly as possible. As we have done with ENHERTU, we will jointly design and implement strategies to maximize the value of DS-1062.”

“We see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2,” said Pascal Soriot, Chief Executive Officer, AstraZeneca. “We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of ENHERTU to further expand our pipeline and leadership in oncology. We now have six potential blockbusters in oncology with more to come in our early and late pipelines.”

Financial Terms

Under the terms of the agreement, AstraZeneca will pay Daiichi Sankyo an upfront payment of $1 billion, of which $350 million is due upon execution, $325 million after 12 months and $325 million after 24 months. Contingent payments of up to $5 billion include $1 billion for achievement of future regulatory milestones, and $4 billion for sales-related milestones. Total payments under the agreement have the potential to reach up to $6 billion.

Daiichi Sankyo and AstraZeneca will share equally development and commercialization costs as well as profits from DS-1062 worldwide, except for Japan. Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates. AstraZeneca is expected to book sales in other markets worldwide, including China, Australia, Canada and Russia.

The upfront payment and regulatory milestones will be booked as revenue over the period in which Daiichi Sankyo has contractual performance obligations under this collaboration. Impact on Daiichi Sankyo’s consolidated financials for fiscal year ending March 31, 2021 will be announced at an appropriate time in the future. The collaboration is expected to enhance the corporate and shareholder value for Daiichi Sankyo over the mid- to long-term.

About TROP2

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is overexpressed in many cancers including up to 80 percent of patients with triple negative breast cancer.^[1] High TROP2 expression also has been identified in a majority of NSCLCs.² Research indicates that high TROP2 expression is associated with cancer cell growth and proliferation and poor patient survival.³ TROP2 is recognized as a promising molecular target for therapeutic development in various cancers.⁴

About DS-1062

DS-1062, a TROP2 directed ADC, is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-1062 is comprised of a humanized anti-TROP2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker with a customized drug-to-antibody ratio (DAR) of four to optimize the benefit-risk ratio for the intended patient population.

Preclinical studies have demonstrated that DS-1062 selectively binds to the TROP2 receptor on the surface of a tumor cell. It is proposed that DS-1062 is then internalized into the cancer cell where lysosomal enzymes break down the tetrapeptide-based linker and release the DXd payload.

DS-1062 is currently being evaluated in a phase 1 trial in patients with advanced solid tumors that are refractory to or relapsed from standard treatment or for whom no standard treatment is available. The study is currently enrolling patients with unresectable advanced NSCLC and unresectable/advanced or metastatic TNBC.

DS-1062 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About the Collaboration between AstraZeneca and Daiichi Sankyo

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU (a HER2 directed ADC) in March 2019, and DS-1062 (a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of ENHERTU and DS-1062.

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) currently is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial, and is under accelerated assessment in the EU for a similar potential indication.

U.S. FDA-Approved Indication for ENHERTU

ENHERTU is a HER2 directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.

Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

Contraindications

None.

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).

Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg prednisolone or equivalent). Upon improvement, follow by gradual taper (e.g., 4 weeks).

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, a decrease in neutrophil count was reported in 30% of patients and 16% had Grade 3 or 4 events. Median time to first onset was 1.4 months (range: 0.3 to 18.2). Febrile neutropenia was reported in 1.7% of patients.

Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. Based on the severity of neutropenia, ENHERTU may require dose interruption or reduction. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 10⁹/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 10⁹/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 10⁹/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. Permanently discontinue ENHERTU if LVEF of <40% or absolute decrease from baseline of >20% is confirmed. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.

Embryo-Fetal Toxicity

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Adverse Reactions

The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.

The most common adverse reactions (frequency ≥20%) were nausea (79%), fatigue (59%), vomiting (47%), alopecia (46%), constipation (35%), decreased appetite (32%), anemia (31%), neutropenia (29%), diarrhea (29%), leukopenia (22%), cough (20%), and thrombocytopenia (20%).

Use in Specific Populations

Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
Geriatric Use: Of the 234 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years and 5% were ≥75 years. No overall differences in efficacy were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (53%) as compared to younger patients (42%).
Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor.

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Please see accompanying full Prescribing Information, including Boxed WARNING, and Medication Guide.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

__________________________________________

References:

¹Zhao W. et al. Oncology Reports 40: 759-766, 2018.

²Zaman, S. et al. OncoTargets and Therapy 2019:12 1781–1790.

³Inamura, K. et al. Oncotarget. 2017; 8(17):28725-28735.

⁴Zeng, P. et al. Nature Scientific Reports 2016;6: e33658.

Contacts

Media Contacts:
Global/US:
Jennifer Brennan

Daiichi Sankyo, Inc.

jbrennan2@dsi.com
+1 908 992 6631 (office)

+1 201 709 9309 (mobile)

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

EU:
Lydia Worms

Daiichi Sankyo Europe GmbH

lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)

+49 176 11780861 (mobile)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Tags ADC, Antibody, AstraZeneca, Breast cancer, Cancer, Commercialization, Daiichi Sankyo, Development, DS-1062, Dxd, ENHERTU, Global, HER2, LSE, Lung, NYSE, Pascal Soriot, STO, Trials, TROP2, TROP2ADC

Healthcare

LabVantage COVID-19 LIMS solution implemented for onsite workplace health and safety

Post author By Michelle Dryden
Post date July 22, 2020
No Comments on LabVantage COVID-19 LIMS solution implemented for onsite workplace health and safety

—Leading Consumer Goods Company Offers Employee Health Testing at In-House Test Centers—

SOMERSET, N.J.–(BUSINESS WIRE)–#COVID–LabVantage Solutions, Inc., the leading provider of laboratory informatics solutions and services including purpose-built LIMS solutions that allow labs to go live faster and at a lower total cost, today announced that a Fortune 100 global consumer packaged goods (CPG) company has deployed the LabVantage COVID-19 LIMS solution to ensure employee health and safety in the workplace.

The U.S.-based CPG company opened an in-house COVID-19 testing center where employees can quickly and safely be tested for the SARS-CoV-2 virus that causes COVID illnesses. In-house health and laboratory professionals, using LabVantage’s purpose-built COVID-19 laboratory information management system (LIMS), can quickly schedule, collect samples, test, track, and report results.

The CPG company already uses the LabVantage enterprise LIMS across areas of its organization. When LabVantage announced its new purpose-built solution specific to the COVID-19 pandemic, the company was able to implement it in under six weeks for onsite employee testing that supports a safer workplace.

“LabVantage COVID-19 LIMS is a full-featured, pre-configured solution for companies, colleges, and universities looking for a way to keep their employees and students safe in the workplace or on campus with the confidence that comes with accurate and comprehensive testing,” said LabVantage CEO, John Heiser. “It’s illustrative of our ability to transform scientific data into knowledge that drives better outcomes for our business partners.”

Having the testing process onsite saves time and gives the employees the convenience of not having to go to a hospital or doctor’s office for a test. Employees displaying symptoms, or those who request a test, can be scheduled quickly for an appointment. LabVantage COVID-19 LIMS prepares the sample request, labels sample specimens, tracks all patient and sample data following privacy and security protocols such as HIPAA and GDPR, and handles results and reporting in a single easy-to-use interface.

Dr. Heiser pointed out that the LabVantage COVID-19 LIMS solution is ideal for companies that are equipped to conduct all testing-related work in-house, as well as for organizations that do not have their own testing facilities who work with third-party laboratories. In addition, LabVantage’s ISO-27001 certification, existing validation practices, and Certificate of Release allows companies to focus their validation efforts on critical functions while still being able to confidently point to a reliable solution.

The COVID-specific LIMS solution incorporates LabVantage’s deep knowledge of laboratory workflows, along with numerous features designed to make it easy for laboratories to perform coronavirus testing using RT-PCR, isothermal nucleic acid amplification, and serology methods. LabVantage COVID-19 LIMS can be hosted on the cloud or offered as SaaS and is highly scalable, which are important attributes as testing volumes escalate.

The LabVantage COVID-19 LIMS is available immediately. For more information on LIMS for coronavirus testing, visit here.

About LabVantage Solutions

A recognized leader in enterprise laboratory software solutions, LabVantage Solutions dedicates itself to improving customer outcomes by transforming data into knowledge. The LabVantage informatics platform is highly configurable, integrated across a common architecture, and 100% browser-based to support hundreds of concurrent users. Deployed on-premise, via the cloud, or SaaS, it seamlessly interfaces with instruments and other enterprise systems – enabling true digital transformation. The platform consists of the most modern laboratory information management system (LIMS) available, integrated electronic laboratory notebook (ELN), laboratory execution system (LES), and scientific data management system (SDMS); and, for healthcare settings, a laboratory information system (LIS). We support more than 1500 global customer sites in the life sciences, pharmaceutical, medical device, biobank, food & beverage, consumer packaged goods, oil & gas, genetics/diagnostics, and healthcare industries. Headquartered in Somerset, NJ, with global offices, LabVantage has, for four decades, offered its comprehensive portfolio of products and services to enable customers to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate record-keeping, and comply with regulatory requirements. For more information, visit labvantage.com.

Contacts

Media Contact:
Brandwidth Solutions LLC

Debra Harrsch

Phone: 215-997-8575

Email: dharrsch@BWSmarketing.com

Tags #Coronavirus, #Solution, Business, COVID-19, Enterprise, GDPR, Healthcare, HIPPA, John Heiser, LabVantage, LIMS, Onsite, SARS-CoV-2, Testing, Testing#Coronavirus

Healthcare

Bayer continues to earn top marks in 2020 Disability Equality Index

Post author By Michelle Dryden
Post date July 20, 2020
No Comments on Bayer continues to earn top marks in 2020 Disability Equality Index

Company earns score of 90 and recognized as a Best Place to Work for Disability Inclusion

WHIPPANY, N.J.–(BUSINESS WIRE)–For the second consecutive year, Bayer U.S. was recognized as a Best Place to Work for Disability Inclusion, earning a score of 90 in the 2020 Disability Equality Index (DEI). Bayer’s DEI score improved from 2019, recognizing the company’s continued growth. DEI is the most comprehensive disability inclusion assessment tool designed and embraced by both business leaders and disability advocates across the United States.

“Improving our policies and benefits for employees with disabilities has always been a priority for us,” said Philip Blake, President of Bayer U.S. “Increasing our score and being recognized as one of the best places to work for disability inclusion is a true honor and testament to Bayer’s commitment to bettering the lives of its employees and their families.”

Bayer is committed to sustaining an inclusive culture with a diverse workforce, which represents the communities it serves. As part of this commitment, the company partnered with Inclusion Works of Disability:IN, the leading nonprofit resource for business disability inclusion worldwide. In addition, the U.S. Bayer Diversity Advisory Inclusion Council (BDAIC) and Business Resource Groups (BRGs) are critical aspects of Bayer’s Inclusion and Diversity (I&D) strategy. ENABLE, one of Bayer’s Resource Groups, is dedicated to the overall wellness and development of employees and their families with disabilities.

“Aligned with our inclusive vision of Health for All and Hunger for None, we embrace and encourage our employees’ uniqueness and continue to work to build a culture where every employee feels a sense of belonging,” said Shakti Harris, Head of Bayer’s Inclusion & Diversity in the U.S. “This DEI recognition represents the hard work, passion, and commitment everyone at Bayer has given to get to this point. Not only is disability inclusion the right thing to do, but it’s naturally aligned with the communities and patients we serve.”

Created six years ago, the DEI guides businesses to impact the unemployment and underemployment of people with disabilities. This year the DEI evaluated inclusion criteria for culture and leadership, enterprise-wide access, employment practices, such as benefits, employment, education and accommodations, in addition to community engagement, and supplier diversity.

“The best way to attract, retain and grow talent with disabilities is to create an accessible, inclusive workplace. This year’s top scoring Disability Equality Index companies are demonstrating their commitment to many of the numerous leading disability inclusion practices featured in the DEI, recognizing that there’s still room for improvement,” said Jill Houghton, President and Chief Executive Officer of Disability:IN. “We are proud to have developed strong partnerships with corporate allies who are committed to advancing disability inclusion and equality across their businesses in the United States and around the world.”

In 2020, 247 corporations, including 143 Fortune 500 and 154 Fortune 1000 utilized the Disability Equality Index (DEI) to benchmark their disability inclusion efforts. Companies that scored an 80% or higher were recognized as a “Best Place to Work for Disability Inclusion.”

For more information on the 2020 Disability Equality Index, visit https://disabilityin.org.

About Disability:IN®

Disability:IN, formerly known as the US Business Leadership Network, is the leading nonprofit resource for business disability inclusion worldwide. Partnering with more than 220 corporations, Disability:IN expands opportunities for people with disabilities across enterprises. The organization and 30 affiliates raise a collective voice of positive change for people with disabilities in business. Through its programs and services, Disability:IN empowers businesses to achieve disability inclusion and equality, with the goal of advancing inclusion to the point when the organization is no longer necessary. Learn more at: www.disabilityin.org.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Carolyn Nagle

Bayer U.S.

Email: carolyn.nagle@bayer.com
Mobile: 201-419-0337

Social Media Channels
– Facebook: BayerUnitedStates
– Twitter: BayerUS
– Instagram: BayerUS
– YouTube: BayerUS

Tags Bayer, Bayer Diversity Advisory Inclusion Council (BDAIC), Benchmark, Business Resource Groups (BRGs), DEI, Disabilities, Disability Equality Index, ENABLE, Families, Health for All, Hunger for None, Inclusion Works, patients, Shakti Harris, Shakti HarrisBayer

Healthcare

European Medicines Agency validates Bristol Myers Squibb’s application for CAR T Cell Therapy Lisocabtagene Maraleucel (liso-cel)

MAA is for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade 3B

Application based on positive results from TRANSCEND NHL 001 study and additional TRANSCEND WORLD 001 study

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for lisocabtagene maraleucel (liso-cel), an investigational CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two prior therapies. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

Results from TRANSCEND NHL 001, the largest trial in third-line or greater R/R large B-cell lymphoma (LBCL), and additional data from the TRANSCEND WORLD study were the basis of the liso-cel application. The studies evaluated patients with R/R LBCL and included patients with a broad range of histologies and high-risk disease as well as those who received liso-cel in the outpatient setting.

“With more than 30% of patients diagnosed with diffuse large B-cell lymphoma ultimately relapsing after initial therapy and an expected overall survival of about six months for patients who have had two or more prior therapies, there is a need for new treatments,” said Stanley Frankel, M.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb.^1,2“The EMA’s validation of our application is a critical step toward bringing liso-cel to patients in Europe.”

The EMA previously granted liso-cel access to the PRIME scheme for the treatment of R/R DLBCL and, more recently, Accelerated Assessment status, reducing the maximum timeframe to 150 days for the EMA’s Committee for Medicinal Products for Human Use (CHMP) to review the application.

Liso-cel is an investigational therapy that is not approved for use in any country.

About TRANSCEND NHL 001

TRANSCEND NHL 001 is an open-label, multicenter, pivotal Phase 1 study to determine the safety, antitumor activity and pharmacokinetics of liso-cel in patients with R/R B-cell NHL, including DLBCL, HGL, PMBCL and Grade 3B FL. Mantle cell lymphoma is investigated in a separate cohort. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Key secondary outcome measures included complete response rate, duration of response and progression-free survival. The TRANSCEND program is a broad clinical program evaluating liso-cel in multiple indications and treatment lines.

About TRANSCEND WORLD

TRANSCEND WORLD is a single-arm, multi-cohort, multicenter, Phase 2 study to determine the efficacy and safety of liso-cel in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). The primary outcome measure was overall response rate (ORR). Secondary outcome measures included safety, complete response rate, event-free survival, progression-free survival, overall survival, duration of response, pharmacokinetics and health-related quality of life. The study was conducted in Europe and Japan.

About Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed.³ More than two-thirds of patients will not respond to or will relapse following second-line treatment.³ For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.^2,4

About Lisocabtagene Maraleucel (liso-cel)

Liso-cel is an investigational chimeric antigen receptor (CAR) T cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. Liso-cel aims to target CD19-expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment (scFv) targeting domain for antigen specificity, a transmembrane domain, a 4-1BB costimulatory domain hypothesized to increase T cell proliferation and persistence, and a CD3-zeta T cell activation domain. The defined composition of CAR-positive viable T cells (consisting of CD8 and CD4 components) in liso-cel may reduce CAR T product variability; however, the clinical significance of defined composition is unknown.

Bristol Myers Squibb: Advancing Cancer Research

About Bristol Myers Squibb

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the outcome of pricing and reimbursement negotiations in individual countries in Europe may delay or limit the commercial potential of lisocabtagene maraleucel (liso-cel) for the indication described in this release, that such product candidate may not receive regulatory approval from the U.S. Food and Drug Administration for the indication described in this release in the currently anticipated timeline or at all, and whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

References

Tilly H, Gomes da Silva M, Vitolo U, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26 Suppl 5:v116-v125.
Crump M, Neelapu SS, Farooq U et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017; 130(16): 1800-1808.
American Cancer Society. Types of B cell Lymphoma. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed July 2020.
Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Can. 2014; 3(1): 66-70.

Contacts

Bristol Myers Squibb

Media Inquiries:
609-252-3345

media@bms.com

Rose Weldon

rose.weldon@bms.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Tags Bristol-Myers Squibb BMS, CAR T Cell, European Medicines Agency EMA, Liso-cel, Lymphoma, Marketing Authorization Application MAA, Marketing Authorization Application MAABristol-Myers Squibb BMS

Healthcare

Humanigen expands partnership with Catalent biologics to manufacture investigational COVID-19 therapeutic candidate lenzilumab

Post author By Michelle Dryden
Post date July 16, 2020

Humanigen’s investigational monoclonal antibody, lenzilumab, was developed using Catalent’s proprietary GPEx^® cell line development technology

Expanded partnership established product supply for lenzilumab, an investigational Phase 3 product for COVID-19

Catalent’s OneBio^®integrated biologics suite expected to accelerate development, manufacturing and supply of lenzilumab for clinical trial use in COVID-19 patients and potential commercialization

SOMERSET, N.J. & BURLINGAME, Calif.–(BUSINESS WIRE)–Catalent and Humanigen, Inc. (HGEN) (“Humanigen”) today announced the expansion of their relationship, under which Catalent will provide development, manufacturing and commercialization services for lenzilumab, Humanigen’s proprietary Humaneered^® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.

Catalent is the leading global provider of advanced delivery technologies, development, manufacturing and clinical supply solutions for drugs, biologics, cell and gene therapies and consumer health products. Humanigen is a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s lead therapeutic candidate.

Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, the majority of whom showed rapid recovery and hospital discharge. A Phase 3 study is currently underway evaluating hospitalized COVID-19 patients.

“Based on lenzilumab’s promising clinical data, we are pleased to expand our relationship with Catalent to solidify our ability to manufacture and supply lenzilumab,” commented Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “If we are able to secure FDA approvals or Emergency Use Authorization, Catalent Biologics’ deep expertise and integrated OneBio solution will accelerate our ability to get this therapy to patients that need it most.”

“Catalent has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials,” commented Karen Flynn, President of Catalent Biologics and Chief Commercial Officer. “The experience we already have with lenzilumab, and our OneBio integrated offering from development to supply, make Catalent uniquely suited to support Humanigen in the journey to make this promising therapy available to COVID-19 patients as soon as possible following receipt of regulatory approvals.”

To date, Catalent Biologics has provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, Wisconsin to support Humanigen’s ongoing clinical trials across various disease categories. Under the expanded partnership, Catalent is also providing clinical supply support for Humanigen’s Phase 3 potential registration study in COVID-19 from its Philadelphia facility.

Lenzilumab was originally manufactured in Catalent’s Madison facility using Catalent Biologics’ proprietary GPEx^® cell line development technology. As part of the expanded partnership, Catalent intends to provide additional drug substance clinical supply for Humanigen’s clinical trials, Expanded Access Program (EAP), as well as additional late-stage development and clinical and potential commercial drug substance manufacturing and vial filling at its Madison and Bloomington, Indiana, sites.

Catalent Biologics’ Madison facility provides development and drug substance manufacturing, including GPEx cell line development, process development, process validation, formulation development, and clinical and commercial cGMP manufacturing. Its Bloomington facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging.

Catalent’s OneBio Suite is an integrated solution for the development, manufacturing, and supply of biologic drugs. Launched in May 2019, the suite of offerings is designed to integrate activities and accelerate timelines, reduce risk and simplify development with a single contract, program manager, and development timeline from cell line development to supply, with harmonized quality systems.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta^® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.

About Catalent Biologics

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx^® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com.

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, manufacturing, and clinical supply solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.™

Humanigen’s Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase III study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections or to be approved by FDA for such use or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections and elsewhere in the Company’s periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

Contacts

Chris Halling

+44 (0)7580 041073

chris.halling@catalent.com

Richard Kerns

+44 (0) 161 728 5880

richard@nepr.agency

Tags Biologics, CAR-T, Catalent, COVID-19, Humanigen, Lenzilumab, LenzilumabBiologics

Healthcare

Bristol Myers Squibb announces expiration and final results of Registered Exchange Offers

Post author By Michelle Dryden
Post date July 16, 2020

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY–Bristol-Myers Squibb Company (NYSE:BMY) (“Bristol Myers Squibb”) announced today the expiration and final results of its offers to exchange (the “Registered Exchange Offers”) any and all of its outstanding (i) $19,000,000,000 aggregate principal amount of senior unsecured notes previously issued on May 16, 2019 (“May Notes”) pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), and (ii) $18,545,623,000 aggregate principal amount of its outstanding senior unsecured notes previously issued on November 22, 2019 (the “November Notes” and, together with the May Notes, the “Original Notes”) pursuant to an exemption from the registration requirements of the Securities Act, for an equal principal amount of new notes in a transaction registered under the Securities Act (the “Registered Notes”).

The Registered Exchange Offer expired at 5:00 p.m., New York City time, on July 15, 2020 (the “Expiration Date”). As of the Expiration Date, the aggregate principal amounts of Original Notes set forth in the table below had been validly tendered and not validly withdrawn. Bristol Myers Squibb has accepted for exchange all such tendered Original Notes in the Registered Exchange Offers.

Title of Series of Original Notes	Amount Outstanding at Commencement	Amount Tendered as of the Expiration Date	Percentage
2.875% Senior Notes due 2020	$1,243,777,000	$1,186,279,000	95.38%
3.950% Senior Notes due 2020	$436,313,000	$425,282,000	97.47%
Senior Floating Rate Notes due 2020	$750,000,000	$712,942,000	95.06%
2.875% Senior Notes due 2021	$434,815,000	$406,758,000	93.55%
2.250% Senior Notes due 2021	$464,576,000	$452,743,000	97.45%
2.550% Senior Notes due 2021	$1,000,000,000	$963,195,000	96.32%
3.250% Senior Notes due 2022	$861,709,000	$855,002,000	99.22%
3.550% Senior Notes due 2022	$891,870,000	$890,930,000	99.89%
Senior Floating Rate Notes due 2022	$500,000,000	$485,088,000	97.02%
2.600% Senior Notes due 2022	$1,500,000,000	$1,488,572,000	99.24%
2.750% Senior Notes due 2023	$697,660,000	$688,878,000	98.74%
3.250% Senior Notes due 2023	$932,101,000	$924,851,000	99.22%
4.000% Senior Notes due 2023	$636,086,000	$624,976,000	98.25%
3.625% Senior Notes due 2024	$882,510,000	$882,403,000	99.99%
2.900% Senior Notes due 2024	$3,250,000,000	$3,208,481,000	98.72%
3.875% Senior Notes due 2025	$2,379,532,000	$2,368,581,000	99.54%
3.200% Senior Notes due 2026	$2,250,000,000	$2,243,559,000	99.71%
3.450% Senior Notes due 2027	$961,528,000	$960,491,000	99.89%
3.900% Senior Notes due 2028	$1,456,162,000	$1,450,092,000	99.58%
3.400% Senior Notes due 2029	$4,000,000,000	$3,968,935,000	99.22%
4.125% Senior Notes due 2039	$2,000,000,000	$1,995,600,000	99.78%
5.700% Senior Notes due 2040	$245,785,000	$245,637,000	99.94%
5.250% Senior Notes due 2043	$391,925,000	$388,625,000	99.16%
4.625% Senior Notes due 2044	$976,477,000	$975,977,000	99.95%
5.000% Senior Notes due 2045	$1,959,524,000	$1,958,923,000	99.97%
4.350% Senior Notes due 2047	$1,236,433,000	$1,236,433,000	100.00%
4.550% Senior Notes due 2048	$1,456,840,000	$1,447,340,000	99.35%
4.250% Senior Notes due 2049	$3,750,000,000	$3,749,500,000	99.99%
Total	$37,545,623,000	$37,186,073,000	99.04%

Upon the settlement of the Registered Exchange Offers, holders of Original Notes who validly tendered and did not validly withdraw such notes prior to the Expiration Date will receive a like principal amount of Registered Notes of the applicable series. Bristol Myers Squibb expects that such settlement will occur on or about July 17, 2020.

The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the issuance of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. Bristol Myers Squibb will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes. The Registered Exchange Offers do not represent a new financing transaction.

A Registration Statement on Form S-4 (File No. 333-238533) (the “Registration Statement”) relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on May 20, 2020 and was declared effective on June 15, 2020. The Registered Exchange Offers were made pursuant to the terms and subject to the conditions set forth in a prospectus dated June 16, 2020 (as the same may be amended or supplemented, the “Prospectus”), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement.

This press release is not an offer to sell or exchange or a solicitation of an offer to buy or exchange any of the securities described herein.

About Bristol Myers Squibb

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements are likely to relate to, among other things, our ability to execute successfully our strategic plans, including our business development strategy generally and in relation to our ability to realize the projected benefits of our acquisition of Celgene, the full extent of the impact of the novel coronavirus disease 2019 (COVID-19) pandemic on our operations and the development and commercialization of our products, the expiration of patents or data protection on certain products, including assumptions about our ability to retain patent exclusivity of certain products and the impact, and the result of governmental investigations. No forward-looking statement can be guaranteed.

Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to, risks relating to: integrating Bristol Myers Squibb’s and Celgene’s business and operations, including with respect to human capital management, portfolio rationalization, finance and accounting systems, sales operations and product distribution, pricing systems and methodologies, data security systems, compliance programs and internal controls processes; our ability to realize the anticipated benefits from the Celgene acquisition; the impact of our significant additional indebtedness that we incurred and our issuance of additional shares in connection with the Celgene acquisition on our ability to operate the combined company; various risks related to public health outbreaks, epidemics and pandemics, including the impact of the COVID-19 pandemic on our operations, the possibility of the COVID-19 pandemic delaying the timing of the FDA’s approval decisions and that we cannot reasonably assess or predict at this time the full extent of the adverse effect that the COVID-19 pandemic will have on our business, financial condition, results of operations and cash flows; challenges inherent in new product development, including obtaining and maintaining regulatory approval; increasing pricing pressures from market access, pharmaceutical pricing controls and discounting and other restrictions in the United States, the European Union and other regions around the world (including changes in rules and practices of managed care organizations and institutional and governmental purchasers); the possibility of difficulties and delays in product introduction and commercialization; our ability to obtain and protect market exclusivity rights and enforce patents and other intellectual property rights; the risk of certain novel approaches to disease treatment (such as CAR T therapy); industry competition from other manufacturers; the risk of an adverse patent litigation decision or settlement and exposure to other litigation and/or regulatory actions; the impact of any U.S. healthcare reform and legislation or regulatory action in the U.S. and markets outside the U.S. affecting pharmaceutical product pricing, reimbursement or access; changes in tax law and regulations; any decline in our future royalty streams; the failure of our suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; our ability to execute our financial, strategic and operational plans; our ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; our ability to attract and retain key personnel; our ability to effectively manage acquisitions, divestitures, alliances and other portfolio actions and to successfully realize the expected benefits of such actions; our dependency on several key products; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products, including, without limitation, interruptions caused by damage to our and our suppliers’ manufacturing sites; regulatory decisions impacting labeling, manufacturing processes and/or other matters; the impact on our competitive position from counterfeit or unregistered versions of our products or stolen products; the adverse impact of cyber-attacks on our information systems or products, including unauthorized disclosure of trade secrets or other confidential data stored in our information systems and networks; political and financial instability of international economies and sovereign risk; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; and issuance of new or revised accounting standards.

The foregoing list sets forth some, but not all, of the factors that could have an impact upon our ability to achieve results described in any forward-looking statements. All of the forward-looking statements that we make in this press release are qualified by (i) the information contained under this heading and (ii) the information discussed under the sections entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by the risk factors discussed in our Quarterly Reports on Form 10-Q and future filings with the Securities and Exchange Commission.

Persons reading this press release are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements are and will be based upon management’s then-current views and assumptions regarding future events and operating performance and are applicable only as of the dates of such statements. You also should understand that it is not possible to predict or identify all such factors and that this list should not be considered a complete statement of all potential risks and uncertainties. Investors also should realize that if underlying assumptions prove inaccurate or if unknown risks or uncertainties materialize, actual results could vary materially from our projections. Except as otherwise required by law, we are not under any obligation, and expressly disclaims any obligation, to update, alter, or otherwise revise any forward-looking statements included in this press release, whether written or oral, that may be made from time to time relating to any of the matters discussed in this press release, whether as a result of new information, future events or otherwise, as of any future date.

Contacts

Media:

media@bms.com
609-252-3345

Investors:

Tim Power

609-252-7509

timothy.power@bms.com

Tags Bristol-Myers Squibb Company, CAR T Therapy, Exchange Commission, Original Notes, Registered Exchange Offers, Registered Exchange OffersBristol-Myers Squibb Company

Healthcare

FDA grants priority review to Merck’s New Drug Application for Vericiguat

Post author By Michelle Dryden
Post date July 16, 2020

Application Based on First Contemporary Outcomes Study Focused Exclusively on Chronic Heart Failure Patient Population Following a Worsening Event

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), in combination with other heart failure therapies. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Jan. 20, 2021. Vericiguat is being jointly developed with Bayer AG.

“This submission builds on Merck’s commitment to patients with cardiovascular disease and long legacy of advancing cardiovascular research to meet unmet medical needs,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with the FDA as they review this New Drug Application for vericiguat.”

The application is based on results from the Phase 3 VICTORIA trial, which is the first contemporary outcomes study focused exclusively on a population with worsening chronic heart failure who are at high risk for cardiovascular mortality and repeated heart failure hospitalizations. Data from VICTORIA were presented at the virtual American College of Cardiology’s 69^th Annual Scientific Session together with World Congress of Cardiology (ACC.20/WCC) and published in The New England Journal of Medicine.

About the VICTORIA Trial

VICTORIA (NCT02861534) is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, Phase 3 study of vericiguat versus placebo when given in combination with available heart failure therapies in patients with worsening chronic heart failure (New York Heart Association class II-IV), a reduced left ventricular ejection fraction of <45% within 12 months prior to randomization following a decompensation event. The primary endpoint of the study was the composite of time to first occurrence of heart failure hospitalization or cardiovascular death. Secondary endpoints included time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalization, time to total heart failure hospitalizations (including first and recurrent events), time to the composite of all-cause mortality or heart failure hospitalization, and time to all-cause mortality.

The study enrolled a total of 5,050 patients who were randomly selected to receive either vericiguat once daily (titrated up to 10 mg) or placebo when given in combination with available heart failure therapies. The study was co-sponsored by Merck and Bayer, conducted under the scientific oversight of the Canadian VIGOUR Centre and the Duke Clinical Research Institute, and executed by Merck in more than 600 centers in 42 countries including in Europe, Japan, China and the U.S.

About Heart Failure with Reduced Ejection Fraction

HFrEF, formerly known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase. In the U.S., 6.5 million people have heart failure, and approximately 40-50% of these patients have HFrEF. Annually, approximately 30% of patients with symptomatic chronic heart failure will experience worsening of the disease, which is marked by progressive symptoms and/or a recent heart failure event. Approximately half of patients with worsening chronic HFrEF are rehospitalized within 30 days of a worsening event, and an estimated one in five patients with worsening chronic HFrEF will die within two years.

About the Worldwide Collaboration Between Bayer and Merck

Since October 2014, Bayer and Merck (known as MSD outside of the United States and Canada) have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and Merck.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media

Pamela Eisele, (267) 305-3558

Elizabeth Sell, (267) 305-3877

Investor

Peter Dannenbaum, (908) 740-1037

Michael DeCarbo, (908) 740-1807

Tags Cardiovascular, Drug, FDA, Heart, Laboratories, Merck, Trial, Vericiguat, Victoria, VictoriaCardiovascular