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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 imaging

ST. LOUIS--(BUSINESS WIRE)--Oct. 9, 2013-- Mallinckrodt (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 diagnosing patients.”

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 radionuclides.
• 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.

ADVERSE REACTIONS

• 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 false negatives.
• 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 vomiting.
  • 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 pediatric patients.
• Since indium In-111, pentetreotide is eliminated primarily by renal excretion, use in patients with impaired renal function should be carefully considered.

See Full Prescribing Information for additional Important Risk Information

ABOUT MALLINCKRODT:

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.
² 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.

Source: Mallinckrodt

Mallinckrodt
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