EUSA Pharma (EUSA)

Oncology Corporate Profile

HQ Location

1717 Langhorne-Newtown Road,Suite 201
Langhorne, PA 19047

Company Description

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, oncology supportive care and critical care products. The company currently has nine products on the market, including Erwinase® (Erwinaze™ in the USA) and Kidrolase® for treatment of acute lymphoblastic leukaemia, Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy, the antibiotic surgical implant Collatamp®, ProstaScint® for imaging the extent and spread of prostate cancer, and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. EUSA also has several products in late-stage development, notably Leukotac®, a monoclonal antibody in phase III development for treatment of steroid resistant acute Graft versus Host Disease (aGvHD).

Website: http://www.eusapharma.com

Brand Generic Indication
Caphosol?? Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.

ProstaScint??capromab pendetideIndium In 111 ProstaScint?? (Capromab Pendetide) is indicated as a diagnostic imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer, thought to be clinically-localized after standard diagnostic evaluation (e.g. chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases. It is not indicated in patients who are not at high risk. Indium In 111 ProstaScint?? is also indicated as a diagnostic imaging agent in postprostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease. The imaging performance of Indium In 111 ProstaScint?? following radiation therapy has not been studied.



The information provided by Indium In 111 ProstaScint?? imaging should be considered in conjunction with other diagnostic information. Scans that are positive for metastatic disease should be confirmed histologically in patients who are otherwise candidates for surgery or radiation therapy unless medically contraindicated. Scans that are negative

for metastatic disease should not be used in lieu of histological confirmation.



ProstaScint?? is not indicated as a screening tool for carcinoma of the prostate nor for readministration for the purpose of assessment of response to treatment.

Quadramet??samarium Sm-153 lexidronamQUADRAMET?? is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

Soltamox_?tamoxifen citrateMetastatic Breast Cancer

Tamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate is an alternative to ophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate therapy.



Adjuvant Treatment of Breast Cancer

Tamoxifen citrate is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial. Tamoxifen citrate reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer. Ductal Carcinoma in Situ (DCIS) In women with DCIS, following breast surgery and radiation, tamoxifen citrate is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate therapy for patients with breast cancer.



Reduction in Breast Cancer Incidence in High Risk Women

Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate is indicated only for high-risk women. _??High risk_?? is defined as

women at least 35 years of age with a 5-year predicted risk of breast cancer ? 1.67%, as calculated by the Gail Model.



Examples of combinations of factors predicting a 5-year risk ? 1.67% are:



Age 35 or older and any of the following combination of factors:

_?? One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or

_?? At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or

_?? LCIS



Age 40 or older and any of the following combination of factors:

_?? One first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or

_?? At least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or

_?? One first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia.



Age 45 or older and any of the following combination of factors:

_?? At least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or

_?? One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more.



Age 50 or older and any of the following combination of factors:

_?? At least 2 first degree relatives with a history of breast cancer; or

_?? History of one breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or

_?? History of at least two breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more.



Age 55 or older and any of the following combination of factors:

_?? One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or

_?? History of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older.



Age 60 or older and:

_?? 5-year predicted risk of breast cancer ? 1.67%, as calculated by the Gail

Model.



For women whose risk factors are not described in the above examples, the Gail Model is necessary to estimate absolute breast cancer risk. Health Care Professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-833-3533. There are no data available regarding the effect of tamoxifen citrate on breast cancer incidence in women with inherited mutations (BRCAl, BRCA2). After an assessment of the risk of developing breast cancer, the decision regarding therapy with tamoxifen citrate for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate therapy. In the NSABP P-1 trial, tamoxifen citrate treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk.

View additional information on commercial products here »

This company does not have any pipeline products

Source


http://www.eusapharma.com

Recent News Headlines

EUSA Pharma Files Kidney Cancer Drug In The EU

3/1/2016 06:58 am

(PharmaTimes [UK]) Mar 1, 2016 - UK-headquartered EUSA Pharma has filed a marketing application for kidney cancer drug tivozanib with the European Medicines Agency.

AVEO and EUSA Pharma Announce Exclusive Licensing Agreement for Tivozanib in Europe

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(Yahoo! Finance) Dec 19, 2015 - EUSA to submit marketing authorization application for tivozanib in advanced RCC in Q1 2016.

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Can MRI Be Used to Identify 'Biologically Inert' DCIS?

3/16/2015 11:01 am

(Medscape Medical News) Mar 13, 2015 - MRI of the breast can detect more biologically relevant ductal carcinomas in situ (DCIS) than mammography and could be used to stratify risk for a more targeted therapeutic approach, new findings suggest.

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Jazz Pharma to Buy EUSA For Up to $700M

4/27/2012 11:36 am

(Yahoo! Finance/Associated Press) Apr 26, 2012 - Drugmaker Jazz Pharmaceuticals PLC said Thursday it will buy cancer drug maker EUSA Pharma Inc. in a deal worth as much as $700 million.

Jazz Pharma to Buy EUSA For Up to $700M

4/27/2012 11:03 am

(Yahoo! Finance/Associated Press) Apr 26, 2012 - Drugmaker Jazz Pharmaceuticals PLC said Thursday it will buy cancer drug maker EUSA Pharma Inc. in a deal worth as much as $700 million.

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(TheStreet) Feb 2, 2012 – EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that it has acquired the exclusive worldwide development and commercialization rights to ASPAREC® for the treatment of acute lymphoblastic leukemia (ALL) from Alizé Pharma.

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