| Infusion Nurses Society References Totect(R) (Dexrazoxane For Injection) as the Only Antidote for the Treatment of Anthracycline Extravasation Reference cited in Infusion Nursing: An Evidence-Based Approach Third Edition ROCKAWAY, N.J., Dec. 14 /PRNewswire-- The third edition of Infusion Nursing: An Evidence-Based Approach, published by the Infusion Nurses Society (INS), includes Totect®, the only FDA-approved treatment for anthracycline extravasation.(1) Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin that have been used in the treatment of various types of cancer since the early 1970s.(2) According to the INS publication: "In September 2007, the FDA approved the first anthracycline extravasation treatment, Totect (dexrazoxane for injection), which has a 98% efficacy in diminishing tissue damage and allows the majority of patients to continue with scheduled chemotherapy." "In addition to ensuring the availability of Totect in the clinic, all nurses should be aware that it is critical to administer the antidote as soon as possible, and at least within six hours of the anthracycline extravasation," said Linda Person, RN, MSN, AOCN, Advanced Practice Nurse, Ambulatory, USC/Norris Cancer Hospital. "The growing number of Totect citations in the literature is supported by strong clinical data and the absence of Totect in the hospital or clinic could be considered a liability risk." In addition to this INS citation, ASCO/ONS Chemotherapy Administration Safety Standards, published in 2009 in the Journal of Clinical Oncology, defines extravasation management procedures and references the third edition of the Chemotherapy and Biotherapy Guidelines and Recommendations for Practice published by the Oncology Nursing Society, citing Totect® as the only FDA-approved treatment for anthracycline extravasation.(3) read more>>
| FOR IMMEDIATE RELEASE
INFUSION NURSES SOCIETY REFERENCES TOTECT® (Dexrazoxane for injection) AS THE ONLY ANTIDOTE FOR THE TREATMENT OF ANTHRACYCLINE EXTRAVASATION
Reference cited in Infusion Nursing: An Evidence-Based Approach Third Edition
ROCKAWAY, N.J., December 9, 2009 – The third edition of Infusion Nursing: An Evidence-Based Approach, published by the Infusion Nurses Society (INS), includes Totect®, the only FDA-approved treatment for anthracycline extravasation. Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin that have been used in the treatment of various types of cancer since the early 1970s.
According to the INS publication: “In September 2007, the FDA approved the first anthracycline extravasation treatment, Totect (dexrazoxane for injection), which has a 98% efficacy in diminishing tissue damage and allows the majority of patients to continue with scheduled chemotherapy.”
“In addition to ensuring the availability of Totect in the clinic, all nurses should be aware that it is critical to administer the antidote as soon as possible, and at least within six hours of the anthracycline extravasation,” said Linda Person, RN, MSN, AOCN, Advanced Practice Nurse, Ambulatory, USC/Norris Cancer Hospital. “The growing number of Totect citations in the literature is supported by strong clinical data and the absence of Totect in the hospital or clinic could be considered a liability risk.”
In addition to this INS citation, ASCO/ONS Chemotherapy Administration Safety Standards, published in 2009 in the Journal of Clinical Oncology, defines extravasation management procedures and references the third edition of the Chemotherapy and Biotherapy Guidelines and Recommendations for Practice published by the Oncology Nursing Society, citing Totect® as the only FDA-approved treatment for anthracycline extravasation.
read more>>
| TOPOTARGET AND CARDINAL HEALTH REACH PURCHASE AND DISTRIBUTION SERVICES AGREEMENT
Totect® for the Treatment of Anthracycline Extravasation
Now Available Through Cardinal Health Specialty Pharmaceutical Distribution ROCKAWAY, N.J., September 17, 2008 – TopoTarget USA, Inc., the U.S. subsidiary of TopoTarget A/S, a Denmark-based biotechnology firm specializing in cancer treatment, announced today that it has reached agreement with Cardinal Health for the wholesale purchase and distribution of Totect® (dexrazoxane hydrochloride for injection). Under the terms of the agreement, Cardinal Health will serve as an authorized distributor of Totect®, the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for the treatment of extravasation from intravenous anthracycline chemotherapy, the accidental leakage of chemotherapy drugs into surrounding tissue.
The agreement effectively expands institutional access to Totect®, thereby allowing greater numbers of health professionals to initiate timely treatment of anthracycline extravasation, a medical emergency that can result in serious, debilitating tissue injury.
“The wholesale purchase and distribution agreement with Cardinal Health is an important milestone for TopoTarget, as it roughly doubles the number of providers in the U.S. who are able to access Totect®,” commented John L. Parsons, Jr. President of TopoTarget USA, Inc. “With its broad reach and long-established institutional relationships throughout the country, Cardinal Health is an ideal partner for TopoTarget as we seek to make Totect® more widely available to hospitals and cancer treatment centers.”
read more>>
| TOTECT® PRODUCT UPDATE
TopoTarget USA, Inc. Introduces Totect® Kit with New Price Option
TopoTarget USA, Inc. is offering a new lower-priced option for a complete Totect® (dexrazoxane for injection) emergency kit for the treatment of anthracycline extravasation (AEV). The new Totect® kit will be priced at $6,500 for the full three-day emergency treatment as of September 18, 2008.
The new pricing option will help increase access to Totect® for oncology practices, hospitals, infusion centers, and clinics. Small local and regional physician practices and hospitals treat the majority of AEVs in the U.S., so under the new price, these organizations should have greater ability to stock Totect®. TopoTarget is committed to helping make Totect® accessible and within arm’s reach to treat patients within six hours after an AEV. Clinical studies show that treatment of AEV with Totect® within this critical six-hour window significantly reduces the need for surgical debridement.
In addition to its commitment to providing greater access to Totect®, TopoTarget supports extravasation education and awareness programs with numerous professional organizations, including the Hematology/Oncology Pharmacists Association (HOPA), the American Society of Health System Pharmacists (ASHP), the Oncology the Nursing Society (ONS) and the American Society of Clinical Oncology (ASCO), among others. TopoTarget also provides education for patients and caregivers as well as dedicated telephone support for reimbursement. read more>>
| European Oncology Nursing Society (EONS) calls for adopting new guidelines across Europe to protect nurses and patients involved in cancer treatment.
Geneva, Switzerland – March 28th 2008: The European Oncology Nursing Society (EONS) is today calling for new guidelines to be adopted across Europe to help all nurses involved in cancer care manage extravasations, thereby improving treatment for cancer patients overall.
Extravasation is caused by the leaking of fluids used in chemotherapy from the blood vessels into surrounding tissue, which can lead to severe and permanent disabilityi. It is relatively uncommon, estimated to occur in 0.1% to 1.0% of all anthracycline treatmentsii, however it can be debilitating,
disabling and requires immediate attention from those involved in administering intravenous chemotherapy. Over 100,000 doses of chemotherapy and a million intravenous (IV) infusions are given every day worldwideiii. read more>
| To the OMX
Investor News No. 02-08 / Copenhagen, March 18, 2008 New International Diagnosis Code Created Following Savene®/TOTECT® Approvals
“We're pleased to announce that CMS has approved a new code for extravasation of vesicant chemotherapy,” said John Parsons, Chief Commercial Officer of TopoTarget. “Although vesicant extravasations are thought to occur infrequently, reliable incidence data do not exist. CMS will now be able to more accurately determine how often vesicant extravasations occur. In addition,
reimbursement for extravasation treatment is contingent upon having a corresponding diagnosis. This new diagnosis code will facilitate the coding and reimbursement process.” “We have been very pleased with the response TOTECT® has received since it was launched in the US in October 2007,” said Peter Buhl Jensen, CEO of TopoTarget. “The establishment of an ICD-9-CM code specifically for extravasation of vesicant chemotherapy will aid in TOTECT® treatment reimbursement and help us learn more about the incidence of vesicant extravasation especially
anthracycline extravasation.”
read more>>
| CONTACT: Maria Gordon Shydlo/Melanie Nadeau
Padilla Speer Beardsley
(212) 752-8338
FOR IMMEDIATE RELEASE
TOPOTARGET ENHANCES TOTECT® REPLACEMENT KIT POLICY
− New Six-Year Replacement Kit Policy – click here for full policy
− TOTECT® the Only FDA-Approved Treatment for Anthracycline Extravasation –
ROCKAWAY, N.J. (February 5, 2008) – TopoTarget USA, Inc., the U.S. subsidiary of
TopoTarget A/S, a Denmark-based biotechnology firm specializing in cancer treatments,
enhanced and extended its replacement kit policy to six years for TOTECT® (dexrozoxane for
injection) on all kits purchased, effective immediately. TOTECT® is the only treatment approved
by the U.S. Food and Drug Administration (FDA) for extravasation from intravenous
anthracycline chemotherapy, the accidental leakage of chemotherapy drugs into surrounding
healthy tissue.
“While TOTECT® has only been available for a few months, cancer centers have already begun
adopting this Orphan and patent-protected drug therapy and we have reports of successful
outcomes following the use of this treatment,” said John Parsons, president of the U.S. subsidiary
and global chief commercial officer. “As part of our on-going discussions with physicians,
nurses and pharmacists, we have seen an opportunity to significantly extend the TOTECT®
replacement kit policy, which should accelerate stocking of this emergency treatment kit. TopoTarget’s initial replacement kit policy allowed for a replacement kit at no cost if the initial
purchased TOTECT® kit was not used before its expiration date. The new enhanced policy is
applicable to all TopoTarget customers who purchased a TOTECT® Emergency Treatment Kit(s)
since its launch on October 16, 2007. Through this enhanced replacement kit policy, purchasers
are guaranteed free replacement of TOTECT® kits for a period of six years from date of purchase
on all kits, thus maximizing the purchaser’s investment in this emergency anthracycline
extravasation treatment.
read more>>
| CONTACT: Maria Gordon Shydlo/Deanna Decker Padilla Speer Beardsley (212) 752-8338 FOR IMMEDIATE RELEASE TOTECT® NOW AVAILABLE FROM TOPOTARGET USA First and Only FDA-Approved Treatment for Anthracycline Extravasation ROCKAWAY, N.J. (October 16, 2007) – TopoTarget USA, Inc., the U.S. subsidiary of TopoTarget A/S , a Denmark-based biotechnology firm specializing in cancer treatment, announced today that TOTECT® (dexrazoxane hydrochloride for injection) is now available to cancer treatment facilities throughout the United States through its distributor ASD Healthcare and Oncology Supply, both AmeriSource Bergen companies. TOTECT® is the one and only treatment approved by the U.S. Food and Drug Administration (FDA) for extravasation from intravenous anthracycline chemotherapy, the accidental leakage of chemotherapy drugs into surrounding tissue. The company received approval, under an orphan drug designation, from the FDA on September 6, 2007.
read more>>
| To the OMX
Announcement No. 36-07 / Copenhagen, 16 October 2007
TopoTarget launches TOTECT® in the US
- Only FDA-Approved Treatment for Anthracycline Extravasation -
Copenhagen, Denmark – 16 October 2007 – TopoTarget A/S (OMX:TOPO) – has announced that TopoTarget USA, Inc., the US subsidiary of TopoTarget A/S , has made TOTECT® available to cancer facilities throughout the US. TOTECT® is the only FDA-approved treatment for extravasation from intravenous anthracycline chemotherapy, the accidental leakage of chemotherapy drugs into surrounding tissue. The company received approval from the US Food and Drug Administration on 6 September 2007.
read more>>
| | |
|
