Mallinckrodt Pharmaceuticals Extends Patent Coverage for Octreoscan™ (Kit for the Preparation of Indium In-111 Pentetreotide)
Exclusive license agreement extends the company’s long legacy in nuclear
ST. LOUIS--(BUSINESS WIRE)--Oct. 9, 2013--
(NYSE: MNK) announced today that the company has licensed, from its
inventors, a third U.S. patent for Octreoscan™ imaging agent, a
longstanding product in its Global Medical Imaging business segment.
Octreoscan imaging agent is a diagnostic radiopharmaceutical, used to
detect certain neuroendocrine tumors. The patent, U.S. 6,123,916,
effective through September 26, 2017, covers the use of Octreoscan
imaging agent to detect Merkel cell carcinoma, a type of neuroendocrine
tumor, which is a rare, aggressive form of skin cancer.
When approved by the Food and Drug Administration in June 1994,
Octreoscan imaging agent was the first peptide-based imaging agent to
receive regulatory approval in the United States. It is uniquely
targeted for neuroendocrine tumors bearing somatostatin receptors1
and provides valuable clinical information to support diagnosis and
selection of a treatment plan.2,3 Neuroendocrine tumors
are rare and may be difficult to detect. They can be found throughout
the body in organs such as the lungs and gastrointestinal tract.
“Octreoscan imaging agent demonstrates our leadership in nuclear
imaging, as a core product in our portfolio for nearly 20 years,” said
Elaine Haynes, Vice President and General Manager, Imaging, North
America at Mallinckrodt. “Because neuroendocrine tumors may take many
years to detect, these patients face a difficult journey. We are proud
to offer nuclear medicines to aid physicians in their important role of
This marks the third U.S. patent listed in the FDA Orange Book for
Octreoscan imaging agent; U.S. patents 5,753,627 and 5,776,894 were
granted in 1998.
INDICATIONS AND USAGE
Octreoscan® Kit for the Preparation of Indium In-111
Pentetreotide is an agent for the scintigraphic localization of primary
and metastatic neuroendocrine tumors bearing somatostatin receptors.
IMPORTANT RISK INFORMATION
WARNINGS AND PRECAUTIONS
DO NOT ADMINISTER IN TOTAL PARENTERAL NUTRITION (TPN) ADMIXTURES OR
INJECT INTO TPN INTRAVENOUS ADMINISTRATION LINES; IN THESE SOLUTIONS,
A COMPLEX GLYCOSYL OCTREOTIDE CONJUGATE MAY FORM.
The sensitivity of scintigraphy with indium In-111 pentetreotide may
be reduced in patients concurrently receiving therapeutic doses of
octreotide acetate. Consideration should be given to temporarily
suspending octreotide acetate therapy before the administration of
indium In-111 pentetreotide and to monitoring the patient for any
signs of withdrawal.
Therapy with octreotide acetate can produce severe hypoglycemia in
patients with insulinomas. Precautions should be taken to prevent
hypoglycemia in these patients.
The contents of the two vials supplied with the kit are intended
only for use in the preparation of indium In-111 pentetreotide and are
NOT to be administered separately to the patient.
As with any other radioactive material, appropriate shielding
should be used to avoid unnecessary radiation exposure to the patient,
occupational workers, and other persons.
Radiopharmaceuticals should be used only by physicians who are
qualified by specific training in the safe use and handling of
To help reduce the radiation dose to the thyroid, kidneys, bladder,
and other target organs, patients should be well hydrated before the
administration of indium In-111 pentetreotide. It is also recommended
that patients be given a mild laxative before and after administration
of indium In-111 pentetreotide.
Indium In-111 pentetreotide should be tested for labeling yield of
radioactivity prior to administration. The product must be used within
six hours of preparation.
To maintain sterility, it is essential that directions are followed
carefully. Aseptic technique must be used during the preparation and
administration of indium In-111 pentetreotide.
Octreotide acetate and the natural somatostatin hormone may be
associated with cholelithiasis, presumably by altering fat absorption
and possibly by decreasing motility of the gallbladder. A single dose
of indium In-111 pentetreotide is not expected to cause cholelithiasis.
Serious adverse reactions may include bradycardia and decreased
hematocrit and hemoglobin (one reported case of each in clinical
trials involving 538 patients).
Adverse effects observed at a rate less than 1% of 538 patients
include dizziness, fever, flush, headache, hypotension, changes in
liver enzymes, joint pain, nausea, sweating, and weakness. These
adverse effects were transient.
False Positive/ False Negative Results: From the clinical trials,
overall, including all tumor types with or without the presence of
somatostatin receptors, there were 3/508 false positives and 104/508
Pentetreotide is derived from octreotide which is used as a
therapeutic agent to control symptoms from certain tumors. The usual
dose for indium In-111 pentetreotide is approximately 5 to 20 times
less than for octreotide and is subtherapeutic.
Common adverse reactions of octreotide include nausea, injection
site pain, diarrhea, abdominal pain/discomfort, loose stools, and
Hypertension and hyper- and hypoglycemia have also been reported
with the use of octreotide.
USE IN SPECIFIC POPULATIONS
Breast feeding: It is not known if this drug is excreted in human
milk, caution should be exercised when indium In-111 pentetreotide is
administered to a nursing woman.
Pediatrics: Safety and effectiveness have not been established in
Since indium In-111, pentetreotide is eliminated primarily by renal
excretion, use in patients with impaired renal function should be
Prescribing Information for additional Important Risk
Mallinckrodt is a leading global specialty pharmaceuticals business that
develops, manufactures, markets and distributes specialty pharmaceutical
products and medical imaging agents. The company’s Specialty
Pharmaceuticals segment includes branded and generic drugs, and the
Global Medical Imaging segment includes contrast media and nuclear
imaging agents. Mallinckrodt has approximately 5,500 employees worldwide
with sales in roughly 70 countries. The company’s 2012 revenue totaled
$2.1 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
1 Octreoscan™ imaging agent package insert.
Rufini M, Calcagni M, Baum R. Imaging of Neuroendocrine Tumors. Sem Nucl
Med. 2006; 36: 228-247.
3 Lebtahi R, Cadiot G, Sarda L,
et al. Clinical impact of somatostatin receptor scintigraphy in the
management of patients with neuroendocrine gastroenteropancreatic
tumors. J Nucl Med. 1997; 38: 853-85.
Lynn Phillips, 314-654-3263
Vice President, Investor Relations