On June 9, 2022 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the company has entered into an exclusive collaboration with Pint Pharma GmbH to register and promote ORLADEYO (berotralstat) in the pan-Latin America (LATAM) region (Press release, BioCryst Pharmaceuticals, JUN 9, 2022, View Source [SID1234615812]).

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"We are pleased to join forces with Pint Pharma to bring our oral, once-daily therapy to hereditary angioedema patients in LATAM who are in need of a new treatment option. Pint Pharma is the ideal partner for BioCryst based on the team’s deep experience in rare diseases that spans multiple aspects of commercialization and their established network across this important region," said Charlie Gayer, chief commercial officer of BioCryst.

"Our partnership with BioCryst is significant for Pint Pharma given the critical unmet need among HAE patients in LATAM who are seeking an innovative treatment option for this serious disease. ORLADEYO has successfully launched in multiple markets across the globe, and we are privileged to leverage our expertise to support BioCryst in introducing this prophylactic therapy to the region," said David Munoz, chief executive officer and co-founder of Pint Pharma.

Under the terms of the agreement, Pint Pharma will be responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in the pan-LATAM region.

Pint Pharma is an Austria-based pharmaceutical company that has extensive experience developing, registering and commercializing rare disease and specialty treatments throughout Latin America and Europe.

About ORLADEYO (berotralstat)
ORLADEYO (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

U.S. Indication and Important Safety Information

INDICATION
ORLADEYO (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

IMPORTANT SAFETY INFORMATION

An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.

The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).

Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.

The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.

On June 9, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that China’s National Medical Products Administration (NMPA) has approved Trodelvy (sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, JUN 9, 2022, View Source [SID1234615844]). This is the first drug that Everest has obtained New Drug Application (NDA) approval to launch in China. In May 2021, the NMPA accepted Everest’s NDA for Trodelvy with Priority Review designation.

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"We are extremely excited for Trodelvy’s NDA approval in China as Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. This marks a significant milestone for Everest with our first drug approved in our home market, where we hope to continue to bring innovative therapies to people with urgent medical needs," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We want to extend our gratitude to the NMPA and the Center for Drug Evaluation for the Priority Review and fast approval."

"The NMPA approval of Trodelvy will provide an important and new treatment option for Chinese women with metastatic triple-negative breast cancer – a very aggressive and challenging to treat form of the disease. We would like to thank the investigators and patients who participated in the clinical trials for making this possible," said Yang Shi, Chief Medical Officer for Oncology/Immunology at Everest Medicines. "We will continue to work with our partner, Gilead, to advance clinical research of Trodelvy across multiple tumor types as well as earlier lines of therapy."

In November 2021, Everest announced topline results from its Phase 2b EVER-132-001 study of Trodelvy in 80 people, which met its primary endpoint with a 38.8% overall response rate (ORR). The results were consistent with those from the global Phase 3 ASCENT study, thus showing similar efficacy and safety in the Chinese population.

"Patients with triple-negative breast cancer are in urgent need of new and effective treatment options. I have witnessed the introduction of sacituzumab govitecan (Trodelvy) into China, and led the registrational clinical study in the nation," said Professor Binghe Xu, academician of the Chinese Academy of Engineering and director of the National New Drug (Anti-Cancer) Clinical Research Centre who is the principal investigator of Trodelvy’s registrational study in China. "I am glad that sacituzumab govitecan has shown similar positive results in the domestic clinical study as those from the global trial. As a clinician, I hope that this new drug can reach patients as early as possible to save more lives."

"There is a significant unmet need among metastatic triple-negative breast cancer patients in China who are waiting eagerly for a better treatment option to extend their lives," said Kevin Guo, Chief Commercial Officer at Everest Medicines. "With the Trodelvy approval in China, we will rapidly expand our sales team to launch this novel product in the fourth quarter this year and bring it to as many hospitals and patients in China as possible."

In addition to mainland China and Singapore where Trodelvy has been approved, Everest is closely coordinating with regulatory bodies in South Korea, Taiwan and Hong Kong to review its applications for Trodelvy for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

In December 2021, the Ministry of Food and Drug Safety (MFDS) of South Korea accepted a New Drug Application (NDA) for Trodelvy. Trodelvy was previously granted Fast Track Designation and Orphan Drug Designation in South Korea.
In December 2021, the Taiwan Food and Drug Administration accepted submission of NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
In January 2022, the Health Sciences Authority of Singapore approved the Company’s NDA for Trodelvy for the treatment of second-line and later-line metastatic TNBC.
In March 2022, an NDA was submitted to the Department of Health, the Hong Kong Special Administrative Region, China, for Trodelvy for the treatment of second-line metastatic TNBC.
Conference Call Information

A live conference call will be hosted on June 13, 2022 at 8:00 AM Beijing Time (June 12, 2022 at 8:00 PM U.S. Eastern Time).

The live webcast of the conference call will be available at View Source

To ask questions during the Q&A section, participants shall access the call by dialing the following numbers:

A replay will be available shortly after the call and can be accessed by visiting the Company’s website at View Source

About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells do not have estrogen and progesterone hormone receptors and have limited or no human epidermal growth factor receptor 2 (HER2) expression. Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy (Sacituzumab Govitecan)

Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.

Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, Trodelvy was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer and was also included in the updated 2022 Guidelines for Breast Cancer Diagnosis and Treatment of the Chinese Society of Clinical Oncology in April.

*The TRODELVY trademark is used under license from Gilead Sciences, Inc.

On June 9, 2022 Forbion, a leading European life sciences venture capital firm, reported the first €470 million (USD 500 million) close of its Forbion Growth Opportunities Fund II ("Forbion Growth"), focused on investing in late-stage European life sciences companies, exceeding its €450 million target size (Press release, Forbion Capital Partners, JUN 9, 2022, View Source [SID1234615813]).

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This new Growth Opportunities Fund has attracted several new institutional investors, including pension funds PME and PMT, the Ewing Marion Kauffman Foundation and Reggeborgh, who join returning investors Pantheon, Wealth Management Partners and Eli Lilly and Company.

The second Forbion Growth Opportunities Fund will continue to invest in mostly European, later-stage biopharma companies, developing novel therapies for areas of high medical need. The Fund will target this market segment with three proven strategies: providing private growth capital for mature clinical development-stage assets, furnishing pre-IPO funding to companies pursuing a public listing in the near-term, and injecting capital and hands-on capabilities to under-valued public companies. In these financings, Forbion Growth Opportunities II aims to take leading positions with investment sizes of up to €70 million per deal. The team’s goal is to build a portfolio of 15 such investments in the most promising late-stage European life sciences companies.

Forbion expects to reach its €600 million hard cap, completing the raising of Forbion Growth Opportunities Fund II over the summer.

Sander Slootweg, Managing Partner and co-founder of Forbion said: "The European market for late stage, private life sciences investments is large and remains significantly underserved. The increase in the number of institutional investors committing to the Forbion Growth Opportunities Fund II is a testament to our successful track record in investing in late clinical stage life sciences companies. A recent example is the sale of Gyroscope Therapeutics to Novartis for a total consideration of $ 1.5 billion earlier this year, after a mere nine month hold period."

Dirk Kersten, General Partner, added: "In the past two years, we have successfully deployed Forbion Growth Opportunities Fund I, providing growth capital to a selected number of high-quality European life sciences companies. Forbion Growth has built the most experienced and sizeable team in Europe focusing on the late-stage segment, and is ready to continue investing in ambitious life sciences companies looking to accelerate their growth. We are therefore very excited to announce this substantial first close of Forbion Growth Opportunities Fund II, and look forward to the final close of the fund later this year."

On June 9, 2022 AstraZeneca reported that it will showcase data demonstrating the Company’s commitment to redefine care in haematology at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, 9 to 12 June 2022 (Press release, AstraZeneca, JUN 9, 2022, View Source [SID1234615829]).

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A total of five approved and potential new medicines from AstraZeneca will be featured across 16 abstracts, including one oral presentation. These include long-term follow-up data for Calquence (acalabrutinib) in adults with previously untreated and relapsed or refractory chronic lymphocytic leukaemia (CLL).1,2 Additionally, Alexion, AstraZeneca’s Rare Disease group, will present an analysis of long-term survival data from the clinical trial programme evaluating Ultomiris (ravulizumab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).3 One-year safety and efficacy data from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris will also be presented.4

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "At this year’s European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, we are demonstrating our strength across a broad spectrum of haematological malignancies, and specifically in chronic lymphocytic leukaemia, to help improve outcomes for these patients. The data from our portfolio and pipeline represent the outcome of years of dedication and passion focused on delivering improved treatment options that can have a long-term impact for patients with chronic, hard-to-treat and rare blood conditions."

Christophe Hotermans, MD, PhD, Senior Vice President, Global Medical Affairs, Alexion, said: "The collective clinical and real-world data being presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting will strengthen the body of scientific evidence supporting the effective and well-tolerated use of targeted C5 complement inhibition, which is the standard of care in paroxysmal nocturnal haemoglobinuria. The data reinforce targeting of the terminal complement system through C5 inhibition to reduce intravascular haemolysis and thrombosis in this devastating disease."

Redefining expectations for patients with CLL

Updated data from the ELEVATE-TN Phase III trial at approximately five years of median follow-up will highlight longer-term safety, progression-free survival (PFS) efficacy results and overall survival rates for Calquence in combination with obinutuzumab and alone compared to obinutuzumab plus chlorambucil in adults with previously untreated CLL.1
Updated data from the ASCEND Phase III trial at approximately four years of median follow-up will highlight longer-term safety and PFS efficacy results of Calquence alone compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab in adults with relapsed or refractory CLL.2
A pooled analysis of data among previously untreated and relapsed or refractory CLL patients with higher-risk genomic features taking Calquence will explore the efficacy of Calquence-based regimens for these sub-groups of patients, regardless of line of therapy.5
A crossover analysis from the ELEVATE-TN trial will test the hypothesis that treatment crossover upon disease progression from the obinutuzumab plus chlorambucil arm to the Calquence arm bolstered overall survival for the obinutuzumab plus chlorambucil arm at 47 months of follow-up.6
Improving understanding of hard-to-treat blood cancers

A post-hoc analysis of the ACE-LY-004 Phase II trial will highlight the clinical benefit seen with patients taking Calquence who had one prior therapy and with highly proliferative variants of relapsed or refractory mantle cell lymphoma (MCL).7
Final results at five-year median follow-up from the WM-001 Phase II trial will highlight response rates and tolerability seen with Calquence in patients with previously untreated or relapsed or refractory Waldenström macroglobulinemia (WM).8
Early results from a Phase II trial will show the efficacy and tolerability of Calquence in patients with relapsed or refractory marginal zone lymphoma (MZL).9
Advancing treatment and care for patients with PNH

Pooled, long-term, survival data for more than four years from the Ultomiris PNH clinical trial programme will highlight long-term use of Ultomiris in the treatment of adults with PNH.3 Ultomiris has the largest clinical trial programme in PNH, with the longest follow-up, and demonstrates the benefits of immediate, complete and sustained terminal complement inhibition in this rare disease.
Data through one year on the efficacy, safety and treatment administration satisfaction will be presented from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris with an on-body delivery system in adults with PNH who had received prior intravenous treatment with Soliris (eculizumab).4
Key AstraZeneca presentations during EHA (Free EHA Whitepaper) 2022

Lead author

Abstract title

Presentation details

Calquence (acalabrutinib)

Sharman, JP

Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naive Chronic Lymphocytic Leukemia: 5-Year Follow-up of ELEVATE-TN

Abstract # P666

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Ghia, P

Acalabrutinib vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Results at ~4 Years of Follow-up

Abstract # P668

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Davids, MS

Long-term Efficacy of Acalabrutinib-Based Regimens in Patients With Chronic Lymphocytic Leukemia and Higher-risk Genomic Features: Pooled Analysis of Clinical Trial Data

Abstract # P667

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Gaitonde, P

Adjusting Survival Data for Treatment Crossover in the ELEVATE-TN Trial by Using a Historical Cohort of Patients Treated with Chemoimmunotherapy in Front-Line Chronic Lymphocytic Leukemia

Abstract # PB1877

e-Publication

Online Only

12 May 2022

Le Gouill, S

Post Hoc Analysis of Patients With Highly Proliferative Variants of Mantle Cell Lymphoma Treated With Acalabrutinib

Abstract # P1131

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Owen, R

Acalabrutinib in Treatment-Naive or Relapsed/Refractory Waldenström Macroglobulinemia: 5-Year Follow-up of a Phase 2, Single-Arm Study

Abstract # P1130

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Strati, P

Acalabrutinib in Patients With Relapsed/Refractory (R/R) Marginal Zone Lymphoma (MZL): Results of a Phase 2, Multicenter, Open-label Trial

Abstract # P1129

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Ultomiris (ravulizumab)

Kulasekararaj, A

Long-Term Complement Inhibition and Survival Outcomes in Patients with Paroxysmal Nocturnal Hemoglobinuria: An Interim Analysis of the Ravulizumab Clinical Trials

Abstract # P812

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Yenerel, M

Efficacy, Treatment Administration Satisfaction and Safety of Subcutaneous Ravulizumab Through 1 Year in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Prior Intravenous Eculizumab

Abstract # P813

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

Soliris (eculizumab)

Nishimura, J

Real-World Outcomes of Eculizumab Treatment in Patients with Paroxysmal Nocturnal Hemoglobinurea: A Systematic Literature Review and Evidence Synthesis

Abstract # PB1934

e-Publication

Online Only

12 May 2022

Rovó, A

Real-World Evidence of Safety and Effectiveness of Eculizumab and Switch to Ravulizumab in a Swiss Patient Population With Paroxysmal Nocturnal Hemoglobinuria

Abstract # P834

Poster Presentation

Poster Session

10 June 2022

16:30 – 17:45 CEST

ALXN1820

Kim, S

Properdin-Blocking Antibodies Attenuate Complement Alternative Pathway Activation Triggered by Cell-Free Heme in Sickle Cell Disease Models

Abstract # S267

Oral Presentation

Session – Sickle Cell Disease: Novel Biomarkers and Therapies

12 June 2022

11:30 – 12:45 CEST

Notes

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. We have expanded our commitment to patients with haematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide innovative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

By targeting haematological conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On June 9, 2022 Isotopia Molecular Imaging and the Centre for Probe Development and Commercialization (CPDC) reported that Isotopia’s technology for the production of n.c.a. Lu-177 has been successfully transferred into CPDC’s GMP facility and that CPDC has shipped its first doses of commercial n.c.a. Lu-177 (Press release, Isotopia Molecular Imaging, JUN 9, 2022, View Source [SID1234615845]).

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n.c.a. Lu-177 is currently the most commonly used radiometal for targeted radiotherapy. As the popularity of the isotope increases, the need for a constant radio-isotope supply on time is essential. Isotopia is thus adding a new production site in North America at CPDC, strengthening its global footprint in the n.c.a. Lu-177 supply chain, ensuring redundancy and shorten delivery time for global supply.

CPDC is a global leading CDMO (Contract Development and Manufacturing Organization) for the GMP manufacturing and supply of radiopharmaceuticals.

"We have successfully achieved a stable and reliable n.c.a. Lu-177 supply in North America" said Dr. Bruno Paquin, CEO of CPDC, "CPDC and Isotopia are proud to offer this unique value proposition for CPDC’s clients and beyond, empowering CPDC to become an all-encompassing radiopharmaceutical CDMO."

As a global leader specializing in radiopharmaceutical research, development, and manufacturing, Isotopia recognizes the importance of a stable and reliable supply of medical isotopes for manufacturing life-saving therapies.

Isotopia and CPDC are committed to the production of n.c.a. Lu-177, as well as collaborating on developing GMP manufacturing processes for other emerging medical isotopes.

Isotopia’s CEO & Co-Founder, Dr. Eli Shalom, stated "The CPDC manufacturing site is the first step towards Isotopia’s global footprint plan to ensure efficient production of Lu-177 and will be added to its existing Drug Master File (DMF). Together with the site in Israel and the near future site in Europe, we create full security of the product to patients on time and great value to pharma companies."

To learn more about this important milestone, come and meet us at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 annual meeting, held June 11-14, in Vancouver, BC, Canada where Isotopia Molecular Imaging and CPDC (as AtomVie Global Radiopharma Inc., the new CDMO spin-off of CPDC) will be exhibiting.