Neoplasms

Blood and Lymph Conditions

All Conditions

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Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Homoharringtonine

Enzyme Inhibitors

Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.

Induction:

1.25 mg/m\^2 subcutaneously, twice daily for 14 consecutive days every 28 days until response. Patients not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.

Maintenance:

1.25 mg/m\^2 subcutaneously, twice daily for 7 consecutive days in a 28-day cycle, for up to 3 years.

Omacetaxine mepesuccinate

Jorge Cortes, MD

Andreas Hochhaus, MD Prof Dr

To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.

Point mutations within the ABL kinase domain of the BCR-ABL gene are emerging as the most frequent mechanism for resistance to imatinib and resultant reactivation of kinase activity. The risk of mutation development is particularly high in patients who are beyond chronic phase, as well as those with a long duration of disease prior to imatinib therapy.

The T315I kinase domain (KD) point mutation has merited particular attention, as T315I expressing CML cells are markedly resistant to imatinib. CML patients with the T315I KD mutation, therefore, do not respond to continued treatment with imatinib, and preliminary clinical data indicate that neither of two newer tyrosine kinase inhibitors will have activity in patients with T315I KD mutation either.

Omacetaxine mepesuccinate (HHT) is a potent inducer of apoptosis (programmed cell death) in myeloid cells and inhibits angiogenesis (blood vessel formation). In Phase 2 studies, HHT has demonstrated clinical activity in patients with CML, both as a single agent and in-combination with other chemotherapeutic drugs. HHT works via a different mechanism than imatinib or other tyrosine kinase inhibitors (TKI's), and HHT has been shown to inhibit in vitro CML cell lines which harbor the T315I KD mutation and are highly resistant to imatinib. Therefore, CML patients who have the T315I KD mutation may still respond to treatment with HHT. HHT may therefore be an attractive therapeutic option for patients with the T315I KD mutation.

On this basis, a multicenter clinical trial is being conducted of HHT therapy for CML patients who have failed prior imatinib therapy and have the T315I KD mutation.

Patients will be treated with an induction course consisting of subcutaneous (SC) HHT twice daily for 14 consecutive days every 28 days. Patients who demonstrate a response, may receive maintenance therapy for up to 24 months, consisting of subcutaneous (SC) HHT twice daily for 7 days every 28 days.

Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine) (CGX-635) in the Treatment of Patients With Chronic Myeloid Leukemia. (CML) With the T315I BCR-ABL Gene Mutation

Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.

Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last \>= 8 weeks to be considered meaningful.

Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy.

Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.

Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.

Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.

Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows \>0% - 35% Ph+ cells.

Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy.

TEAE are any untoward events that were newly occurring or worsening from Baseline.

Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug.

Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.

A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

A participant is only counted once in each category (at worst severity or strongest relationship).

Cytogenetic response categories:

* Complete: 0% Ph+ cells
* Partial: \>0%-35% Ph+ cells
* Minor: \>35%-65% Ph+ cells
* Minimal: \>65%-95% Ph+ cells
* No Response: \>95% Ph+ cells
* Unevaluable: \<20 metaphases were examined and/or response could not be assigned

MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region \[BCR\] gene and Abelson proto-oncogene \[ABL\] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.

MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region \[BCR\] gene and Abelson proto-oncogene \[ABL\] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.

Complete Response (CHR)

* Chronic phase must last at least 8 weeks: WBC \<10\*10\^9/liter, platelets \<450\*10\^9/liter, myelocytes + metamyelocytes \<5% in blood, no blasts or promyelocytes in blood, \<20% basophils in peripheral blood, no extramedullary involvement.
* Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5\*10\^9/liter, platelets 100\*10\^9/liter, no blood blasts, bone marrow blasts \<5%, no extramedullary disease.

Partial Response - CHR plus one or more of the following:

* Persistence of splenomegaly with a reduction of ≥50% from pre-treatment
* Platelets \> 450\*10\^9/L
* Presence of immature cells in the peripheral blood
* 5% to 25% blasts in the bone marrow
* If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (\<100\*10\^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as \<5% bone marrow blasts.

Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).

Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).

Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).

The percentage of participants achieving response with extramedullary disease at Baseline was to be summarized, if the sample size was sufficient. This analysis was not done as the sample was ultimately insufficient

Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).

Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m\^2 twice a day (BID) for the 14 consecutive days.

Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.

Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last \>= 8 weeks to be considered meaningful.

Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.

Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.

Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.

Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows \>0% - 35% Ph+ cells.

Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.

Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.

Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.

Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.

Cephalon

ChemGenex Pharmaceuticals

Teva Branded Pharmaceutical Products R&D, Inc.

Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.

Omacetaxine

Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.

CML: Chronic Phase

Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.

CML: Accelerated Phase

Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.

CML: Blast Phase

Total

Age, Continuous

Sex: Female, Male

Caucasian

Black

Hispanic

Asian

Other

Race/Ethnicity, Customized

Height

Weight

Body Surface Area (BSA)

Class I

Class II

Class III

Class IV

* Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
* Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
* Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
* Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bed-bound patients.

New York Heart Association (NYHA) Classification

Grade 0

Grade 1

Grade 2

Grade 3

* Grade 0: Fully active, able to carry on all pre-disease activities without restriction;
* Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
* Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;
* Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours;
* Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.

Eastern Cooperative Oncology Group Performance Status

Time from Initial Chronic Myeloid Leukemia (CML) Diagnosis

Intent to treat population includes all participants who provide written informed consent and receive at least one dose of study medication.

Director, Clinical Research

Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m\^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.

Total Participants

Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population

Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population

>=1 TEAE

>= 1 SAE

Worst severity: Grade 1

Worst severity: Grade 2

Worst severity: Grade 3

Worst severity: Grade 4

Worst severity: Grade 5

Relation to drug: Unrelated

Relation to drug: Possibly

Relation to drug: Probably

Relation to drug: Unknown

With hematologic toxicity

Discontinued treatment due to AE

Deaths during study or follow-up

Deaths during study (outcome of SAE)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total

Complete

Partial

Minor

Minimal

No Response

Unevaluable

Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)

Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.

Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS

Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL

Complete response

Partial response

Hematologic improvement

Return to chronic phase

No evidence of leukemia

No response

Percentage of Participants in Each Hematologic Response Category

Intent to treat population of study participants who had extramedullary disease at baseline. Analysis not performed due to insufficient sample size.

Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response

100% reduction

75-99% reduction

50-74% reduction

25-49% reduction

1-24% reduction

0% reduction

Not assessable

Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL

Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL

Intent to treat population of participants who had a response to treatment

Number of Treatment Cycles Needed to Achieve Best Hematologic Response

Intent to treat population of participants who had a cytogenetic response

Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response

Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response

Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response

Intent to treat population of participants who had a response

Kaplan-Meier Estimates for Duration of Best Hematologic Response

Kaplan-Meier Estimates for Duration of Best Cytogenetic Response

Kaplan-Meier Estimates for Time to Disease Progression

Kaplan-Meier Estimates for Overall Survival

Overall Study

Leukemia, Myeloid, Chronic-Phase

Leukemia, Myeloid, Accelerated Phase

Blast Crisis

Cell Transformation, Neoplastic

Carcinogenesis

Neoplastic Processes

Central Nervous System Depressants

Other Dietary Supplements

Amino Acids

Benzocaine

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tannic Acid

Tyrosine

Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.

Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous (IV) infusion daily on Days 1-5 of each 4 week treatment cycle. Participants who do not achieve a meaningful hematologic or cytogenetic response by the end of the fourth cycle are discontinued from the study. Otherwise, participants may continue additional cycles of this combined treatment for a maximum of 12 cycles.

Participants who achieved a molecular or cytogenetic response, or a complete hematologic remission (CHR), could undergo subsequent cycles with a maintenance schedule of homoharringtonine 2.5 mg/m\^2 by continuous 24-hour IV infusion daily for 2 days every 4 weeks. Dose escalations in subsequent cycles were allowed by one day at a time if the participant was unable to maintain CHR in the maintenance schedule.

Taken by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. For the first cycle of therapy only, imatinib was started on Day 4 of homoharringtonine treatment.

Adam R Craig, M.D., PhD

Jorge Cortes, M.D.

This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with Gleevec (imatinib mesylate). Because these patients may still be sensitive to Gleevec, adding Homoharringtonine may restore a response to Gleevec or the combined treatment may promote a better response than using Gleevec alone.

Every 4 weeks, the study medicine Homoharringtonine will be given by vein daily for 5 days along with continuing daily doses of the approved medicine Gleevec taken by mouth. The safety and effectiveness of this combined treatment in CML patients will be studied. Patients who do not achieve a meaningful hematologic or cytogenetic response after 4 cycles or less will be discontinued. Otherwise, patients may continue additional cycles of this combined treatment for a maximum of 12 cycles.

Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)

A Phase II Open-Label Study of the Intravenous Administration of Homoharringtonine (CGX-635) Combined With the Oral Administration of Gleevec in the Treatment of Patients With Chronic Myeloid Leukemia (CML) in Chronic, Accelerated, and Blast Phase

Participants in accelerated or blast phase who converted to at least CML-chronic phase.

CML in accelerated phase meets one or more of the following criteria: \>=15% - \<30% blasts in peripheral blood or bone marrow, \>=30% blasts + promyelocytes in peripheral blood or bone marrow, \>=20% basophils in peripheral blood; platelet count \<100\*10\^9/L unrelated to therapy or clonal evolution. CML in blast phase have \>=30% blasts in the bone marrow or presence of extramedullary disease.

Meaningful responses include (in descending order of health)

* Complete Hematologic Remission (CHR)
* Partial Hematologic Remission (PHR)
* Hematologic Improvement (HI)
* Partial Response (PR)
* Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts \<15%, peripheral blasts and promyelocytes \<30%, peripheral basophils \<20%, and platelets \>100\*10\^9/L.

Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics.

A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells \< 10\*10\^9/L, absolute neutrophil count \>=1\*10\^9/L, platelets \>=100\*10\^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease.

Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments.

A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:

* Results in death;
* Is life threatening;
* Requires inpatient hospitalization or prolongation of existing hospitalization;
* Results in persistent or significant disability/incapacity;
* Is a congenital anomaly/birth defect;
* Is medically important.

The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related.

Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as:

No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%

Homoharringtonine + Imatinib Mesylate

This study was intended to follow a Simon two stage design to test 18 patients in each stratum (chronic, accelerated and blast phase) for efficacy. Only 15 were enrolled, an insufficient number for a formal statistical analysis of efficacy.

No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation	NCT00375219	Chronic Myeloid...	Omacetaxine mep...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)	NCT00114959	Myeloid Leukemi... Myeloid Leukemi... Blast Phase Myeloid Leukemi...	Homoharringtoni... Imatinib Mesyla...	16 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation	NCT00375219	Chronic Myeloid...	Omacetaxine mep...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.

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