Partnership leverages Palette’s specialty sales team to increase promotional footprint of PYLARIFY within the urology call point
SANTA BARBARA, Calif. and STOCKHOLM, Sweden, February 24, 2022— Palette Life Sciences (“Palette”), a global medical device company dedicated to improving prostate radiation therapy outcomes, announced the signing of an Agreement with Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH) to support the promotion of PYLARIFY® (piflufolastat F 18) in the United States. PYLARIFY injection is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence of recurrent and/or metastatic prostate cancer. PYLARIFY was approved by the U.S. Food and Drug Administration in May 2021.
The Agreement provides for Palette’s specialty Urology and Radiation Oncology sales team to fortify Lantheus’ substantial promotional efforts and reach additional U.S. healthcare professionals. The non-exclusive agreement covers an initial one-year term with the opportunity for extension.
Palette’s specialty sales team is expected to begin PYLARIFY promotional efforts in April 2022, educating healthcare practitioners on the availability and benefits of the product. Palette’s specialty sales team was built to support its growing commercial portfolio in the United States.
“This partnership is an important demonstration of Palette’s commitment to providing solutions to physicians and patients across urological disorders, including prostate cancer,” said James Leech, Vice President of Strategy & Corporate Development, Palette Life Sciences. “We are excited to help accelerate Lantheus’ commercial efforts for this novel product and provide promotional support that enables multiple detailing synergies among our sales team within the urology call point. Our commercial team’s strong relationships with many urologists can help drive further awareness of the role of PYLARIFY, a PSMA-targeted PET imaging agent for prostate cancer patients in the U.S.”
“We are pleased to collaborate with Palette to expand our own promotional efforts, as well as the promotional efforts of our PET manufacturing partners, with a dedicated urology and radiation oncology sales team,” said Paul Blanchfield, Chief Commercial Officer, Lantheus. “Following the successful launch and rapid adoption of PYLARIFY, we are doubling down on our commitment to improve patient outcomes by increasing our ability to reach even more physicians who can use PYLARIFY to help find, fight and follow prostate cancer.”
Under the terms of the Agreement, Palette will be compensated by Lantheus for their promotional activities on a fee-for-service basis. Lantheus will maintain responsibility for all other aspects of commercialization of PYLARIFY.
About PYLARIFY® (piflufolastat F 18) Injection
PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6
PYLARIFY® (piflufolastat F 18) Injection
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information
Warnings and Precautions
Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.
To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.
About Palette Life Sciences
Palette Life Sciences is a fully integrated life sciences company. Palette Life Sciences’ products improve patient outcomes in urology and urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. The company’s portfolio of available products includes Barrigel®, Deflux®, Solesta®, and Lidbree™. Palette Life Sciences moves rapidly to leverage novel applications of existing technologies to create breakthrough medical solutions. This focus enables the company to serve those often overlooked by traditional medical companies and improve patient quality of life. Led by experienced healthcare executives, Palette Life Sciences is headquartered in Stockholm, Sweden, with offices in Santa Barbara, California, Dallas, Texas, Sydney, Australia, and Tokyo, Japan. Learn more at http://www.palettelifesciences.com.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the evaluation of PSMA PET images; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
1. Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.
2. Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.
3. Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.
4. Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290-
5. Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689
6. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company