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Lilly announces details of presentations at the 2024 American Society of Hematology (ASH) Annual Meeting

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Eli Lilly (NYSE: LLY) announced upcoming presentations at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, December 7-10. The key highlight is the Phase 3 BRUIN CLL-321 study results of Jaypirca® (pirtobrutinib), evaluating its effectiveness versus idelalisib plus rituximab or bendamustine plus rituximab in BTK inhibitor pretreated patients with CLL/SLL. This is the first randomized Phase 3 study focusing on BTK inhibitor pretreated CLL population. Additional presentations include real-world data analyses on overall survival in CLL/SLL patients and pre-clinical data for a novel BAFF-RxCD3 bispecific antibody.

Eli Lilly (NYSE: LLY) ha annunciato le presentazioni imminenti al 66° Congresso Annuale dell'American Society of Hematology (ASH) che si terrà a San Diego, dal 7 al 10 dicembre. Il punto saliente è rappresentato dai risultati dello studio di Fase 3 BRUIN CLL-321 riguardante Jaypirca® (pirtobrutinib), che valuta la sua efficacia rispetto a idelalisib più rituximab o bendamustina più rituximab in pazienti con CLL/SLL già trattati con inibitori BTK. Questo è il primo studio randomizzato di Fase 3 che si concentra sulla popolazione di pazienti con CLL già trattati con inibitori BTK. Ulteriori presentazioni includono analisi di dati reali sulla sopravvivenza globale in pazienti con CLL/SLL e dati preclinici per un nuovo anticorpo bispecifico BAFF-RxCD3.

Eli Lilly (NYSE: LLY) anunció las próximas presentaciones en el 66° Congreso Anual de la American Society of Hematology (ASH) que se llevará a cabo en San Diego del 7 al 10 de diciembre. El enfoque principal son los resultados del estudio de Fase 3 BRUIN CLL-321 sobre Jaypirca® (pirtobrutinib), que evalúa su efectividad en comparación con idelalisib más rituximab o bendamustina más rituximab en pacientes con CLL/SLL previamente tratados con inhibidores de BTK. Este es el primer estudio aleatorizado de Fase 3 que se centra en la población de CLL previamente tratada con inhibidores de BTK. Presentaciones adicionales incluyen análisis de datos del mundo real sobre la supervivencia general en pacientes con CLL/SLL y datos preclínicos para un nuevo anticuerpo biespecífico BAFF-RxCD3.

엘리 릴리 (NYSE: LLY)는 샌디에고에서 12월 7일부터 10일까지 열리는 66회 미국 혈액학회 (ASH) 연례 회의에서의 발표를 알렸습니다. 주요 하이라이트는 제이피르카® (피르토브루틴)의 3상 BRUIN CLL-321 연구 결과로, BTK 억제제에 대한 치료를 받은 CLL/SLL 환자에서 이 약물의 효과를 이델라리셉 + 리툭시맙 또는 벤다무스틴 + 리툭시맙과 비교하여 평가합니다. 이는 BTK 억제제를 이전에 치료받은 CLL 환자군에 초점을 맞춘 첫 번째 무작위 3상 연구입니다. 추가 발표에는 CLL/SLL 환자들의 전체 생존에 대한 실제 데이터 분석과 새로운 BAFF-RxCD3 이중특이성 항체에 대한 전임상 데이터가 포함됩니다.

Eli Lilly (NYSE: LLY) a annoncé les présentations à venir lors de la 66e Réunion Annuelle de l'American Society of Hematology (ASH) à San Diego, du 7 au 10 décembre. Le point fort est les résultats de l'étude de Phase 3 BRUIN CLL-321 concernant Jaypirca® (pirtobrutinib), évaluant son efficacité par rapport à l'idélalisib plus rituximab ou à la bendamustine plus rituximab chez des patients atteints de CLL/SLL déjà traités par des inhibiteurs de BTK. Il s'agit de la première étude randomisée de Phase 3 se concentrant sur la population de CLL ayant déjà été traitée par des inhibiteurs de BTK. Les présentations supplémentaires incluent des analyses de données du monde réel sur la survie globale des patients atteints de CLL/SLL et des données précliniques sur un nouvel anticorps bispécifique BAFF-RxCD3.

Eli Lilly (NYSE: LLY) hat kommende Präsentationen auf dem 66. Jahrestreffen der American Society of Hematology (ASH) in San Diego vom 7. bis 10. Dezember angekündigt. Der Schwerpunkt liegt auf den Ergebnissen der Phase-3-Studie BRUIN CLL-321 zu Jaypirca® (pirtobrutinib), die die Wirksamkeit im Vergleich zu Idelalisib plus Rituximab oder Bendamustin plus Rituximab bei mit BTK-Inhibitoren vorbehandelten Patienten mit CLL/SLL bewertet. Dies ist die erste randomisierte Phase-3-Studie, die sich auf die mit BTK-Inhibitoren vorbehandelte CLL-Bevölkerung konzentriert. Weitere Präsentationen umfassen Analysen von realen Daten zur Gesamtüberlebenszeit bei CLL/SLL-Patienten und präklinische Daten zu einem neuartigen BAFF-RxCD3-bispezifischen Antikörper.

Positive
  • First randomized Phase 3 study (BRUIN CLL-321) met its primary endpoint in BTK inhibitor pretreated CLL population
Negative
  • None.

Insights

The announcement of presentations at ASH focuses on Jaypirca (pirtobrutinib), with key data from the Phase 3 BRUIN CLL-321 study. While this study has already met its primary endpoint, the detailed results using more recent data cuts (August 2024) will be important for understanding the drug's competitive position in the BTK inhibitor space. The study's unique focus on BTK inhibitor pretreated CLL patients makes it particularly significant.

The real-world data presentations on treatment sequences and continuity of care in CLL/SLL will provide valuable insights into Jaypirca's potential market positioning. Additionally, the presentation of LY4152199, a novel BAFF-RxCD3 bispecific antibody, suggests Lilly's commitment to expanding its hematology pipeline.

However, as this is a future conference announcement without current data disclosure or financial implications, the immediate impact on investment decisions is

INDIANAPOLIS, Nov. 5, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Jaypirca® (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition taking place Dec. 7-10 in San Diego.

In an oral presentation, Lilly will report results from the Phase 3 BRUIN CLL-321 study, which is evaluating pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). BRUIN CLL-321, which previously met its primary endpoint, is the first randomized Phase 3 study to evaluate an exclusively BTK inhibitor pretreated CLL population. The submitted abstract utilized a February 2024 data cut-off date, and the presentation will utilize an August 2024 data cut-off date.

Additionally, Lilly will have poster presentations that share analyses of real-world data, including looking at overall survival associated with treatment sequences in patients with CLL/SLL, and pre-clinical data for a first-in-class B-cell activating factor receptor (BAFF)-RxCD3 bispecific antibody for the treatment of certain B-cell malignancies.

A full list of abstract titles and viewing details are listed below:

Jaypirca (pirtobrutinib)
Presentation Title: BRUIN CLL-321: Randomized Phase 3 Trial of Pirtobrutinib Versus Idelalisib Plus Rituximab (IdelaR) or Bendamustine Plus Rituximab (BR) in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Abstract Number: 886
Presentation Date & Time: Monday, Dec. 9, 3:30 p.m. PST
Location: Marriot Marquis San Diego Marina, Marriott Grand Ballroom 5-6
Presenter: Jeff P. Sharman

Presentation Title: Overall Survival Associated with Real-World Treatment Sequences in Patients with CLL/SLL in the United States
Abstract Number: 5114
Presentation Date & Time: Monday, Dec. 9, 6-8 p.m. PST
Location: San Diego Convention Center, Halls G-H
Presenter: Joanna Rhodes

Presentation Title: Continuity of Care for Patients with Chronic Lymphocytic Leukemia: An Analysis of Real-World Data
Abstract Number: 5033
Presentation Date & Time: Monday, Dec. 9, 6-8 p.m. PST
Location: San Diego Convention Center, Halls G-H
Presenter: Sameh Gaballa

LY4152199 (investigational BAFF-RxCD3 bispecific antibody)
Presentation Title: LY4152199, a First-in-Class BAFF-RxCD3 Bispecific Antibody for the Treatment of B-Cell Malignancies
Abstract Number: 2785
Presentation Date & Time: Sunday, Dec. 8, 6-8 p.m. PST
Location: San Diego Convention Center, Halls G-H
Presenter: Wei Yang

About Jaypirca® (pirtobrutinib)
Jaypirca® (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.

INDICATIONS FOR JAYPIRCA®
Jaypirca® is a kinase inhibitor indicated for the treatment of

  • Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
  • Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORTANT SAFETY INFORMATION FOR JAYPIRCA® (pirtobrutinib)

Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. In a clinical trial, Grade ≥3 infections occurred in 24% of patients with hematologic malignancies, most commonly pneumonia (14%); fatal infections occurred (4.4%). Sepsis (6%) and febrile neutropenia (4%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor patients for signs and symptoms, evaluate promptly, and treat appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred in 3% of patients, including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (17%). Major hemorrhage occurred in patients taking Jaypirca with (0.7%) and without (2.3%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor patients for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider benefit/risk of withholding Jaypirca 3-7 days pre- and post-surgery depending on type of surgery and bleeding risk.

Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. In a clinical trial, Grade 3 or 4 cytopenias, including decreased neutrophils (26%), decreased platelets (12%), and decreased hemoglobin (12%), developed in Jaypirca-treated patients. Grade 4 decreased neutrophils (14%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly during treatment. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients who received Jaypirca. In a clinical trial of patients with hematologic malignancies, atrial fibrillation or flutter were reported in 3.2% of Jaypirca-treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.5%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.5%). Patients with cardiac risk factors such as hypertension or previous arrhythmias may be at increased risk. Monitor for signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea) and manage appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Second Primary Malignancies: Second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients. The most frequent malignancy was non-melanoma skin cancer (4.6%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.

Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. Upon confirmation of DILI, discontinue Jaypirca.

Embryo-Fetal Toxicity: Jaypirca can cause fetal harm in pregnant women. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of potential fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.

Adverse Reactions (ARs) in Patients Who Received Jaypirca

The most common (≥20%) ARs in the BRUIN pooled safety population of patients with hematologic malignancies (n=593) were decreased neutrophil count (46%), decreased hemoglobin (39%), fatigue (32%), decreased lymphocyte count (31%), musculoskeletal pain (30%), decreased platelet count (29%), diarrhea (24%), COVID-19 (22%), bruising (21%), cough (20%).

Mantle Cell Lymphoma

Serious ARs occurred in 38% of patients. Serious ARs occurring in ≥2% of patients were pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%). Fatal ARs within 28 days of last Jaypirca dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).

Dose Modifications and Discontinuations: ARs led to dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dosage modification in >5% of patients included pneumonia and neutropenia. ARs resulting in permanent discontinuation in >1% of patients included pneumonia.

Most common ARs (15%), excluding laboratory terms (all Grades %; Grade 3-4 %): fatigue (29; 1.6), musculoskeletal pain (27; 3.9), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), pneumonia (16; 14), bruising (16; -).

Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in 10% of Patients: hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), calcium decreased (19; 1.6), AST increased (17; 1.6), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), alkaline phosphatase increased (11; -), ALT increased (11; 1.6), potassium increased (11; 0.8). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Serious ARs occurred in 56% of patients. Serious ARs occurring in ≥5% of patients were pneumonia (18%), COVID-19 (9%), sepsis (7%), and febrile neutropenia (7%). Fatal ARs within 28 days of last Jaypirca dose occurred in 11% of patients, most commonly due to infections (10%), including sepsis (5%) and COVID-19 (2.7%).

Dose Modifications and Discontinuations: ARs led to dose reductions in 3.6%, treatment interruption in 42%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dose reductions in >1% included neutropenia; treatment interruptions in >5% of patients included pneumonia, neutropenia, febrile neutropenia, and COVID-19; permanent discontinuation in >1% of patients included second primary malignancy, COVID-19, and sepsis.

Most common ARs (20%), excluding laboratory terms (all Grades %; Grade 3-4 %): fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), dyspnea (22; 2.7), hemorrhage (22; 2.7), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9).

Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in 20% of Patients: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), platelet count decreased (30; 15), sodium decreased (30; -), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), lipase increased (21; 7), alkaline phosphatase increased (21; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).

Drug Interactions

Strong CYP3A Inhibitors: Concomitant use with Jaypirca increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid use of strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dosage according to approved labeling.

Strong or Moderate CYP3A Inducers: Concomitant use with Jaypirca decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid concomitant use of Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dosage according to approved labeling.

Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Concomitant use with Jaypirca increased their plasma concentrations, which may increase risk of adverse reactions related to these substrates for drugs that are sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.

Use in Special Populations

Pregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca and advise use of effective contraception during treatment and for one week after last dose. Presence of pirtobrutinib in human milk is unknown. Advise women not to breastfeed while taking Jaypirca and for one week after last dose.

Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients <65 years of age.

Renal Impairment: Severe renal impairment increases pirtobrutinib exposure. Reduce Jaypirca dosage in patients with severe renal impairment according to approved labeling.

PT HCP ISI MCL_CLL AA JUN2024

Please see Prescribing Information and Patient Information for Jaypirca.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY

Jaypirca® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

© Lilly USA, LLC 2024. ALL RIGHTS RESERVED.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jaypirca® (pirtobrutinib) as a treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor, and as a treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor, and LY4152199 for the treatment of patients with B-cell malignancies and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that studies will be completed as planned, that future study results will be consistent with the results to date, that Jaypirca will prove to be a safe and effective treatment for relevant indications, or that Jaypirca will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

  1. Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5
  2. Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1
  3. Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7

Refer to:

Kyle Owens; owens_kyle@lilly.com; (332) 259-3932 – media


Joe Fletcher; jfletcher@lilly.com; (317) 296-2884 – investors

 

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)

 

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SOURCE Eli Lilly and Company

FAQ

When will Eli Lilly (LLY) present the BRUIN CLL-321 Phase 3 study results?

Eli Lilly will present the BRUIN CLL-321 Phase 3 study results on December 9, 2024, at 3:30 p.m. PST during the ASH Annual Meeting in San Diego.

What is the significance of Eli Lilly's (LLY) BRUIN CLL-321 study?

BRUIN CLL-321 is the first randomized Phase 3 study to evaluate an exclusively BTK inhibitor pretreated CLL population, and it has met its primary endpoint.

What treatments does Eli Lilly's (LLY) BRUIN CLL-321 study compare?

The study compares Jaypirca (pirtobrutinib) versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated patients with CLL/SLL.

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