Genzyme Announces Financial Assistance for Thyrogen®
In order to support patient access to Thyrogen (thyrotropin alfa for injection), Genzyme’s Co-Pay Assistance helps with out-of-pocket costs that exceed $100 for eligible patients with commercial insurance. For eligible patients with no insurance or insurance that does not cover Thyrogen, Genzyme offers a Financial Assistance Program. Finally, for patients who do not qualify for the Financial Assistance Programs, case managers are available to help you connect with independent co-pay assistance foundations that can support out-of-pocket costs associated with Thyrogen.
To learn more, simply call ThyrogenONE® at 1-888-497-6436, Monday through Friday, 8:00 AM to 8:00 PM EST, or visit www.thyrogen.com.
Do you have commercial health insurance?
The Co-Pay Assistance Program can help you with the cost of Thyrogen (thyrotropin alfa for injection). If your out-of-pocket costs associated with Thyrogen are over $100, you may be eligible for assistance for up to $1,000 of your out-of-pocket expenses per calendar year.
Note: No claim for reimbursement of any out-of-pocket expense amount covered by the Thyrogen Co-Pay Assistance Program may be submitted to any third-party payer, whether public or private. The Thyrogen Co-Pay Assistance Program is available only in the United States and cannot be combined with any other rebate/coupon, free trial, or similar offer. Genzyme reserves the right to rescind, revoke, or amend this Program without notice.
Do you have government health insurance?
The Thyrogen Co-Pay Assistance Program does not cover prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), or other federal or state programs (including any state prescription drug assistance programs).
Call your ThyrogenONE case manager to get more information on independent co-pay assistance foundations that may be able to help.
Are you uninsured?
The Patient Assistance Program is committed to providing Thyrogen to patients in need. If you medically need Thyrogen as recommended by your physician, and are uninsured or have a plan that does not cover Thyrogen, then Genzyme may be able to provide Thyrogen free of charge.
To learn more, or determine if you might qualify for assistance, contact your doctor’s office. ThyrogenONE is also available to answer any questions you have and help facilitate financial assistance conversations with your doctor.
Note: Genzyme’s Patient Assistance Program may be discontinued at any time at the discretion of the Patient Assistance Program Committee. ©2016
WOODCLIFF LAKE, NJ, September 15, 2015 – The Light of Life Foundation, ThyCa: Thyroid Cancer Survivors’ Association, Inc., and Eisai Inc. today announced the launch of Myths and Truths About Thyroid Cancer, an interactive, educational campaign designed to help dispel the myth that thyroid cancer is a “good cancer.” Because most thyroid cancers can be successfully treated, many are told if you are going to get cancer, thyroid cancer is the one to have, which has led to this misperception. However, whether successfully treated or not, the truth is all cancers can have a significant impact on a person’s life, beginning with the shock and distress of hearing the word “cancer” at diagnosis. In honor of Thyroid Cancer Awareness Month and the tens of thousands who receive a thyroid cancer diagnosis each year, Myths and Truths About Thyroid Cancer illustrates the life-changing realities of this disease.
“As a thyroid cancer survivor, I urge people to stop referring to thyroid cancer as the ‘good cancer,’ as I believe it downplays patients’ experiences,” said Joan Shey, founder of the Light of Life Foundation. “I hear time and time again from patients how difficult their diagnosis and treatment were and that their scars are more than skin deep. My hope is that this campaign can educate about the many types of thyroid cancer and change the thyroid cancer conversation.”
“Being part of a community of survivors is very important for people coping with thyroid cancer,” said Gary Bloom, thyroid cancer survivor and co-founder and executive director of ThyCa: Thyroid Cancer Survivors’ Association. “ThyCa takes this to heart, which is why we are proud to provide support and resources to the thyroid cancer community. We also know more needs to be done to elevate awareness of thyroid cancer and what patients need in terms of support for the rest of our lives.”
Join the #TruthAboutTC Challenge
September is Thyroid Cancer Awareness Month. Watch this video to see how you can help us spread the word and raise $50,000 for Thyroid Cancer support through this campaign with the Light of Life Foundation, Thyca and Eisai.
Eiasi is pleased to announce that LENVIMATM (lenvatinib) is now approved for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).
The incidence of thyroid cancer has steadily increased globally over the last 50 years, and as the most common endocrine malignancy, there remains a need for additional treatment options, particularly for patients with DTC whose cancer no longer responds to radioactive iodine (RAI) therapy. The most common types of thyroid cancer, papillary and follicular, are classified as differentiated thyroid cancer (DTC) and account for approximately 90 percent of all cases.
While most patients with DTC are curable with surgery and radioactive iodine treatment, these treatments aren’t effective for some and the prognosis for those patients whose cancers persist or recur is poor. The safety and efficacy of LENVIMA was evaluated in a pivotal clinical trial involving 392 RAI-R DTC patients with radiographic evidence of disease progression within 12 months prior to randomization. The clinical trial showed that patients treated with LENVIMA had a statistically significant prolongation in progression-free survival compared to those receiving placebo. The most common adverse reactions observed in greater than or equal to 30% of LENVIMA-treated patients, in order of decreasing frequency, were: hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia (PPE) syndrome, abdominal pain, and dysphonia.
We are pleased to be able to offer an additional treatment option to appropriate patients with locally recurrent or metastatic, progressive, RAI-R DTC. At Eisai, our human health care mission to give first thought to patients and families is the driving force behind our commitment to help increase the benefits health care provides to patients, especially those whose diseases have limited treatment options.
As such, Eisai is committed to ensuring patients have access to medicines from which they may benefit and is dedicated to working to ensure that our products are available to those who need them. Patients can visitwww.LenvimaReimbursement.com andwww.LenvimaSavingsProgram.com to learn more about Eisai’s services and reimbursement support programs.
We thank you for your continued support and commitment to patients suffering from locally recurrent or metastatic, progressive, RAI-refractory DTC and their families. We hope you will share this important news with your constituents.
LENVIMA (lenvatinib) is indicated for the treatment of patients with locally recurrent, or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
Important Safety Information - Warnings and Precautions
Hypertension was reported in 73% of LENVIMA-treated patients (of which 44% were ≥ Grade 3) and 16% of patients in the placebo group. Control blood pressure prior to treatment and monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly during treatment. Withhold LENVIMA for Grade 3 hypertension; resume at a reduced dose when hypertension is controlled at ≤ Grade 2. Discontinue LENVIMA for life-threatening hypertension.
Cardiac dysfunction was reported in 7% of LENVIMA-treated patients (2% Grade 3 or greater). Monitor patients for clinical symptoms or signs of cardiac decompensation. Withhold LENVIMA for development of Grade 3 cardiac dysfunction until improved to Grade 0 or 1 or baseline. Resume at a reduced dose or discontinue LENVIMA depending on the severity and persistence of cardiac dysfunction. Discontinue LENVIMA for Grade 4 cardiac dysfunction.
Arterial thromboembolic events were reported in 5% of LENVIMA-treated patients; events of Grade 3 or greater were 3%. Discontinue LENVIMA following an arterial thrombotic event. LENVIMA has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.
4% of LENVIMA-treated patients experienced an increase in ALT and 5% experienced an increase in AST that was Grade 3 or greater. Monitor liver function before initiation and during treatment with LENVIMA. Withhold LENVIMA for the development of ≥ Grade 3 liver impairment until resolved to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue LENVIMA depending on the severity and persistence of hepatotoxicity. Discontinue LENVIMA for hepatic failure.
Proteinuria was reported in 34% of LENVIMA-treated patients (of which 11% were Grade 3). Monitor for proteinuria before initiation of, and periodically during treatment. Obtain a 24 hour urine protein if urine dipstick proteinuria ≥2+ is detected. Withhold LENVIMA for ≥ 2 grams of proteinuria/24 hours and resume at a reduced dose when proteinuria is <2 gm/24 hours. Discontinue LENVIMA for nephrotic syndrome.
Events of renal impairment were reported in 14% of LENVIMA-treated patients. Renal failure or impairment ≥ Grade 3 was 3% in LENVIMA-treated patients. Withhold LENVIMA for development of Grade 3 or 4 renal failure/impairment until resolved to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue LENVIMA depending on the severity and persistence of renal impairment.
Events of gastrointestinal perforation or fistula were reported in 2% of LENVIMA-treated patients. Discontinue LENVIMA in patients who develop gastrointestinal perforation or life-threatening fistula.
QT/QTc interval prolongation was reported in 9% of LENVIMA-treated patients (2% Grade 3 or greater). Monitor ECG in patients with congenital long QT syndrome, CHF, bradyarrhythmias, or patients taking drugs known to prolong the QT interval. Monitor and correct electrolyte abnormalities in all patients. Withhold LENVIMA for the development of ≥ Grade 3 QT interval prolongation. Resume LENVIMA at a reduced dose when QT prolongation resolves to Grade 0 or 1 or baseline.
Hypocalcemia ≥ Grade 3 was reported in 9 % of LENVIMA-treated patients. Monitor blood calcium levels at least monthly and replace calcium as necessary during LENVIMA treatment. Interrupt and adjust LENVIMA dosing as necessary depending on severity, presence of ECG changes, and persistence of hypocalcemia.
Reversible posterior leukoencephalopathy syndrome (RPLS) was reported in 3 patients across clinical studies in which 1108 patients received LENVIMA. Confirm the diagnosis of RPLS with MRI. Withhold LENMIVA for RPLS until fully resolved. Resume at a reduced dose or discontinue LENVIMA depending on the severity and persistence of neurologic symptoms.
Hemorrhagic events occurred in 35% of LENVIMA-treated patients and in 18% of the placebo group. The incidence of Grade 3-5 hemorrhage was similar between arms at 2% and 3%, respectively. The most frequently reported hemorrhagic event was epistaxis (11% Grade 1 and 1% Grade 2). Discontinuation due to hemorrhagic events occurred in 1% of LENVIMA-treated patients. There was one case of fatal intracranial hemorrhage among 16 patients who received LENVIMA and had CNS metastases at baseline. Withhold LENVIMA for the development of Grade 3 hemorrhage until resolved to Grade 0 to 1. Resume at a reduced dose or discontinue LENVIMA depending on the severity and persistence of hemorrhage. Discontinue LENVIMA in patients who experience Grade 4 hemorrhage.
LENVIMA impairs exogenous thyroid suppression. Elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of LENVIMA-treated patients. Monitor TSH levels monthly and adjust thyroid replacement medication as needed.
LENVIMA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LENVIMA and for at least 2 weeks following completion of therapy.
Advise women not to breastfeed during treatment with LENVIMA.
The most common adverse reactions observed in LENVIMA-treated patients vs. placebo treated patients respectively were hypertension (73% vs 16%), fatigue (67% vs 35%), diarrhea (67% vs 17%), arthralgia/myalgia (62% vs 28%), decreased appetite (54% vs 18%), weight decreased (51% vs 15%), nausea (47% vs 25%), stomatitis (41% vs 8%), headache (38% vs 11%), vomiting (36% vs 15%), proteinuria (34% vs 3%), palmar-plantar erythrodysesthesia syndrome (32% vs 1%), abdominal pain (31% vs 11%), and dysphonia (31% vs 5%).
For more information about LENVIMA and for the full Product Information visit www.LENVIMA.com.
FOR IMMEDIATE RELEASE
Scott Santiamo (Media)
Susan Mesco (Investors)
+1 908 450-5599
+1 908 450-5516
FDA Approves Natpara® (parathyroid hormone) for Injection as an Adjunct to Calcium and Vitamin D to Control Hypocalcemia in Patients with Hypoparathyroidism
First FDA-approved parathyroid hormone for hypoparathyroidism
Supported by largest clinical program ever conducted in patients with hypoparathyroidism
BEDMINSTER, N.J. -- January 23, 2015 -- NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Natpara (parathyroid hormone) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH. Natpara, a bioengineered replica of human PTH, is expected to be available in the second quarter of 2015.
Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be wellcontrolled on calcium supplements and active forms of vitamin D alone. Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute postsurgical hypoparathyroidism.
“Natpara is a significant advance in the care of hypoparathyroidism and we are very pleased to offer the first and only parathyroid hormone approved for people living with this rare disorder. In clinical studies, Natpara has been shown to increase serum calcium levels and reduce the need for large doses of calcium and active vitamin D,” said Francois Nader, MD, president and chief executive officer of NPS Pharma. “We extend our thanks to the patients and physicians who participated in our clinical development program, as we could not have achieved this important milestone without their contributions.”
Hypoparathyroidism is a rare endocrine disorder in which the parathyroid glands fail to produce sufficient amounts of parathyroid hormone (PTH) or where the hormone lacks biologic activity. PTH plays a central role in a variety of critical physiological functions in the body. Insufficient levels of PTH lead to low levels of calcium and high levels of phosphate in the blood, and an inability to convert native vitamin D into its active state, which helps the body properly absorb oral calcium. Parathyroid hormone increases serum calcium by increasing renal tubular calcium reabsorption, increasing intestinal calcium absorption (i.e., by converting native vitamin D (25 OH) into its active form (1,25 OH2 vitamin D)) and by increasing bone turnover which releases calcium into the circulation.
“As someone who has endured the challenges of living with this rare disorder for more than 50 years and seen all five of my children diagnosed with it, I know first-hand how devastating hypoparathyroidism can be and how important it is to have new treatment options,” said James Sanders, president of the
Hypoparathyroidism Association. “It’s critical that companies like NPS Pharma continue to research and develop medicines for people with rare diseases, as so many of us are often overlooked.”
The FDA approval of Natpara was supported by 12 pharmacology studies and four company-sponsored efficacy and safety studies. The pivotal Phase 3 study, known as REPLACE, was a randomized, double-blind, placebo-controlled study and the largest clinical trial conducted to date in patients with hypoparathyroidism.
“Patients with hypoparathyroidism may benefit from having a replica of the actual human parathyroid hormone molecule that they are lacking,” said Tamara Vokes, MD, professor of medicine at the University of Chicago, and program director of the University of Chicago Fellowship Training Program in Diabetes, Endocrinology and Metabolism. “In clinical studies, Natpara has been shown to control hypocalcemia in patients with hypoparathyroidism and reduce their need for oral calcium and active vitamin D.”
Natpara will be made available through a Risk Evaluation and Mitigation Strategy (REMS) Program to mitigate the potential risk of osteosarcoma.
Natpara contains a Boxed Warning citing the potential risk of osteosarcoma. See below for Important Safety Information about Natpara, including the Boxed Warning, and Warnings and Precautions.
In Europe, the European Medicines Agency (EMA) has validated and initiated its review of NPS Pharma’s marketing authorization application for Natpar™.
NPS Pharma is committed to ensuring that patients have access to our medicines. To assist patients and healthcare professionals in facilitating care with Natpara, NPS Pharma has a free support program called NPS Advantage that includes a dedicated team of care coordinators and specialized nurses for patients treated with Natpara. This program is designed to help patients navigate all aspects of care and includes help with insurance authorizations and appeals, answering questions about Natpara and its use, and locating resources for patients to connect them to care. For more information, please visit www.npsadvantage.com.
NPS Pharma also provides support to independent non-profit organizations that provide assistance to patients who need help covering out-of-pocket medication costs.
About Natpara® (parathyroid hormone) for Injection
Natpara® (parathyroid hormone) for injection is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Natpara is a bioengineered replica of human parathyroid hormone.
Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be wellcontrolled on calcium supplements and active forms of vitamin D alone. Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute postsurgical hypoparathyroidism.
In clinical studies, Natpara has been shown to increase serum calcium levels while reducing the need for oral calcium and active vitamin D and, in some cases, eliminate the need for active vitamin D altogether. The most common adverse reactions associated with Natpara and occurring in greater than 10% of individuals were: paresthesia, hypocalcemia, headache, hypercalcemia, nausea, and hypoesthesia, diarrhea, vomiting, arthralgia, hypercalciuria and pain in extremity.
Natpara is self-administered once daily by subcutaneous injection. The starting dose of Natpara is 50 mcg once daily.
Natpara received orphan drug status for the treatment of hypoparathyroidism from the FDA in 2007 and the EMA in 2013.
Important Safety Information
What is NATPARA?
• NATPARA is a prescription parathyroid hormone (PTH) used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low PTH blood levels (hypoparathyroidism).
• NATPARA is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk of bone cancer (osteosarcoma).
• NATPARA was not studied in people with hypoparathyroidism caused by calcium sensing receptor mutations.
• NATPARA was not studied in people who get sudden hypoparathyroidism after surgery.
• It is not known if NATPARA is safe and effective for children 18 years of age and younger. NATPARA should not be used in children and young adults whose bones are still growing.
What is the most important information I should know about NATPARA?
NATPARA may cause serious side effects, including:
Possible bone cancer (osteosarcoma).
• During animal drug testing, NATPARA caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take NATPARA will have a higher chance of getting osteosarcoma.
• NATPARA is only available through the NATPARA Risk Evaluation and Mitigation Strategy (REMS) Program. The purpose of the NATPARA REMS program is to inform patients about the potential risk of osteosarcoma associated with the use of NAPTARA. For more information about this REMS program, call 1-855-628-7272 or go to www.NATPARAREMS.com.
High blood calcium (hypercalcemia)
• NATPARA can cause some people to have a higher blood calcium level than normal.
o Your doctor should check your blood calcium before you start and during your treatment with NATPARA
o Tell your doctor if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs that you have too much calcium in your blood.
Low blood calcium (hypocalcemia)
• People who stop using or miss a dose of NATPARA may have an increased risk of severe low blood calcium levels
• Tell your doctor if you have tingling of your lips, tongue, fingers and feet, twitching of face muscles, cramping of feet and hands, seizures, depression, or have problems thinking or remembering.
Tell your doctor right away if you have any of these signs and symptoms of high or low blood calcium levels.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the most common side effects of NATPARA?
The most common side effects of NATPARA include
• Tingling, tickling, or a burning feeling of your skin (paresthesia), headache and nausea
These are not all the possible side effects of NATPARA. For more information, ask your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the NPS Adverse Event/Product Complaint Line at 1-855-215-5550 or by calling the Food and Drug Administration (FDA) at 1-800-FDA- 1088 or www.fda.gov/medwatch.
U.S. full prescribing information for Natpara, including boxed warning, is available at http://www.npsp.com/file_depot/0-10000000/0-10000/262/folder/2023/NatparaPI.pdf
About NPS Pharma
NPS Pharma is a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases. The company’s current therapeutic areas of focus are gastrointestinal disease and endocrine disorders. These include Short Bowel Syndrome, a potentially fatal gastrointestinal disorder in which patients may have to rely on parenteral nutrition for their survival; Hypoparathyroidism, a complex endocrine disorder in which the parathyroid glands are either absent or damaged, and the body produces insufficient or no parathyroid hormone; and Autosomal Dominant Hypocalcemia, an ultra-rare, genetic disorder of calcium homeostasis caused by mutations of the calcium-sensing receptor gene. NPS Pharma continues to seek in-licensing opportunities to develop new therapies for a broad range of rare diseases, and complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Janssen Pharmaceuticals, and Kyowa Hakko Kirin. NPS Pharma has operations in the U.S., Canada, Europe, Latin America and Japan. Learn more at: www.npsp.com
“NPS Pharma” and “NPS Pharmaceuticals” are the company's trademarks.
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on the company's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward looking statements include, but are not limited to, statements concerning the company’s future financial performance and plans for the commercialization of its products, beliefs or expectations regarding our products in development, statements concerning the company’s plans for international expansion, beliefs or expectations regarding potential revenue and earnings from product sales, including beliefs regarding our ability to grow sales, expectations regarding the market size for our products, including those in development, and beliefs or expectations regarding our operating expenses. Risks associated to the company's business include, but are not limited to, the risks associated with any failure by the company to successfully commercialize Gattex/Revestive (teduglutide [rDNA origin]) for injection and Natpara (parathyroid hormone) for injection, including the risk that physicians and patients may not see the advantages of Gattex/Revestive or Natpara and may therefore be reluctant to utilize the products, the risk that private and public payers may be reluctant to cover or provide reimbursement for Gattex or Natpara, the risks associated with the company's strategy, global macroeconomic conditions, the impact of changes in management or staff levels, the effect of legislation effecting healthcare reform in the United States, as well as other risk factors described in the company's periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form
5 of 5
10-K and Form 10-Qs. All information in this press release is as of the date of this press release and the company undertakes no duty to update this information, whether as a result of new information, future events or otherwise.
U.S. Prescribing Information for Thyrogen Revised to Include Use of Wider Range of Radioiodine in Patients
Revised label will facilitate use of Thyrogen to greater number of patients for postoperative thyroid remnant ablation
CAMBRIDGE, Mass. – Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced the Food and Drug Administration (FDA) approved revised prescribing information for the use of Thyrogen® (thyrotropin alfa for injection) to widen the dose range of radioiodine (RAI) when used for thyroid remnant ablation. Thyrogen is used before radioiodine treatment to enhance uptake of the radiotracer and allows patients to start and continue taking their thyroid hormone replacement therapy thus avoiding the untoward effects associated with hypothyroidism. Previously the amount of radioiodine was fixed at 100 mCi, whereas physicians may now select a dose from the range of 30-100 mCi.
“The incidence of thyroid cancer is rapidly increasing in the United States,” said Bryan Haugen, M.D., Professor of Medicine at the University of Colorado and immediate past President of the American Thyroid Association. “Today’s FDA revision to widen the administered dose range of RAI for patients being prepared for remnant ablation with Thyrogen allows important management flexibility for physicians and treatment options for patients.”
The revised Prescribing Information (PI) for use of Thyrogen in ablation is based on the results of the two largest prospective studies ever conducted in thyroid cancer. The studies, published in the New England Journal of Medicine in May 2012, compared ablation success among patients receiving recombinant human thyrotropin (rhTSH) and patients undergoing thyroid hormone withdrawal (THW) at both low and high doses of radioiodine. In both studies, patients receiving Thyrogen rather than THW had fewer hypothyroid symptoms and preserved quality of life.
"The best path to achieve thyroid remnant ablation must be one that involves the least whole body radiation dose, the least early and late side-effects, the best quality of life, and the least healthcare costs, as demonstrated in the these two landmark studies,” said Ujjal Mallick, M.D., Northern Centre for Cancer Care, Freeman Hospital, Newcastle UK.
Professor Martin Schlumberger, M.D., Institut Gustave Roussy, University Paris Sud, Paris, France, said, “The revised PI for Thyrogen provides a new option for many physicians who may be wanting to reduce radioiodine use due to uncertainty about impact of dosing on recurrences and mortality in low-risk patients as well as short- and long-term safety concerns.”
These findings have been reflected in the clinical studies section in the updated Full Prescribing Information.
Thyrogen® (thyrotropin alfa for injection) is for patients with well-differentiated thyroid cancer. Thyrogen is approved as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging. Thyrogen is also approved in the U.S. and Europe as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® and Thyrogen® are registered trademarks of Genzyme Corporation. All rights reserved.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forwardlooking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Genzyme update on supply of Thyrogen®
Genzyme would like to provide an update on the supply outlook of Thyrogen for the remainder of 2012 as well as 2013. As previously communicated, Genzyme is able to deliver a more consistent and predictable level of Thyrogen in 2012 and this remains their expectation for the duration of this year.
The company has made significant progress in their manufacturing operations and supply continues to improve. Genzyme's primary focus continues to be restoring uninterrupted supply of product. At this time, they anticipate that they will have sufficient supply to meet all patient demand globally in 2013.
Genzyme understands the challenges that their supply constraints present to the Thyroid community and want to reassure you that their manufacturing recovery remains on track. While supply continues to stabilize, the company advises health care providers to acquire Thyrogen through their normal distribution channels. Genzyme continues to advise health care providers not to schedule any new Thyrogen treatments until they have secured product.
Please reach out to your local representative to order Thyrogen, and for additional information as Genzyme expects regional variations on the availability of Thyrogen to occur. Since there is limited inventory, changes to their current manufacturing plan can impact the timing of Thyrogen availability.
Philadelphia Couple Raises Money for Thyroid Cancer Research
“When I heard Dr. Mandel talk about her team’s research and the way it could improve care for thyroid cancer patients like me, I knew I had to get involved,” said Ellen Fishman, a thyroid cancer survivor.
Ms. Fishman was already working to make a difference for thyroid cancer survivors through the help of Joan Shey, founder of the Light of Life Foundation, a non-profit dedicated to thyroid cancer research and patients. Together, Ms. Fishman and Ms. Shey organized a gala in the spring to raise money for thyroid cancer research.
Ms. Fishman had met Dr. Susan Mandel, MD, MPH, a professor at the Hospital of the University of Pennsylvania, at an Abramson Cancer Center conference, where patients, families, and survivors learned about thyroid cancer from experts on the Penn Medicine faculty. In addition to becoming an advocate, Ms. Fishman decided to switch her care to HUP and direct the proceeds from the gala to support Dr. Mandel’s research.
Because of the gala’s success, Ellen and her husband, Harris, were able to join the Light of Life Foundation to present a check for $25,000 to Penn Medicine for Dr. Mandel’s research on July 13. Dr. Mandel has been researching new approaches to thyroid cancer follow up in patients at both low and high risk for thyroid cancer recurrence.
Funding for fellows as well as faculty is essential. Dr. Gabe Smolarz, MD, MSB, CCD, a fellow in Dr. Mandel’s group, recently conducted a promising clinical research project funded by donors like the Fishman family and Light of Life Foundation. He studied recurrence rates for patients with low-risk thyroid cancer and concluded that long-term invasive testing is not required for these patients, saving time and money for both patients and physicians.
Said Ms. Fishman, “We plan to hold the gala every year. Investing in this research is investing in a better future for so many local families.”
Read more at Penn-Medicine.