Legal Notices and Usage Terms

Azedra.com (the “Website”) is owned and operated by Progenics Pharmaceuticals, Inc. (“Progenics”) from its offices in New York, NY, United States of America.

Progenics welcomes its customers, partners, suppliers, investors, employees, the scientific community, as well as the general public to this Website.

Progenics grants you the right to use this Website subject to the terms and conditions of use set forth below (this “Terms of Use Agreement”).

The information provided on this Website is for general informational and educational purposes only. This Website may provide information about medical conditions and their treatment. Progenics makes no representation that material on this Website is appropriate or available for use outside of the United States of America. Individuals that choose to access this Website from other locations do so on their own initiative and are responsible for compliance with local laws if and to the extent that local laws are applicable. Please read and review this Terms of Use Agreement carefully before accessing or using this Website. By accessing or using this Website, you acknowledge that you have read, understood and agreed to this Terms of Use Agreement. If you do not agree to this Terms of Use Agreement, you may not access or use the Website.

The information on this Website is provided “AS IS” without warranty of any kind whether express or implied, including, but not limited to, the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. Progenics will use reasonable care to ensure that information is accurate at the time it is added to this Website but cannot guarantee this and does not accept any liability to update the information. In addition, Progenics does not accept any liability, howsoever arising, for the accuracy, completeness, use of or reliance on the information contained on this Website.

This Website may contain general information relating to various medical conditions and their treatment or direct or indirect references to Progenics’ products or product candidates. Such information is provided for informational purposes, should not be considered complete and is not meant to be a substitute for advice provided by qualified healthcare provider. You should consult a qualified healthcare provider if you have or suspect you have any health problems or should you have any healthcare-related questions. You should never disregard medical advice or delay in seeking it because of something you have read here.

All text, graphics, photographs, trademarks, logos, visual interfaces, artwork, computer code and all other related content contained on this Website is owned by Progenics or third parties and is protected by trade dress, copyright, patent and trademark laws, and various other intellectual property rights and unfair competition laws. Any reproduction, publication, further distribution or public exhibition of materials provided through this Website, in whole or in part, is strictly prohibited. You may not, distribute, modify, transmit, reuse, repost, or use the content of the Website for public or commercial purposes, including the text, images, audio, or video, without the express prior written consent of Progenics.

This Website may contain links to web sites owned or operated by third parties. The linked sites are not under the control of Progenics, which is not responsible for the content available on any linked sites. Such links do not imply endorsement of material on any linked sites and Progenics disclaims all liability with regard to your access to such linked sites. Progenics provides links to other web sites as a convenience to users, and access to such linked sites is at your own risk.

Nothing on this Website constitutes an invitation or offer to invest or deal in the securities of Progenics or an invitation by Progenics to enter into a contract with a user of this Website.

Statements in the documents or information appearing anywhere in this Website or linked to from this Website regarding Progenics’ business which are not historical facts, are “forward-looking statements” that involve risks and uncertainties including, but not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialization, the impact of competitive products, patents and other risks and uncertainties, detailed from time to time in periodic reports including Progenics’ most recent Annual Report on Form 10-K and Progenics’ other filings with the Securities and Exchange Commission (SEC) available at www.sec.gov.

Failure to abide by this Terms of Use Agreement is a material breach of this Terms of Use Agreement for which Progenics may pursue all rights and remedies it has pursuant to this Terms of Use Agreement, and any other rights and remedies it may have at law or in equity. Specifically, you agree that Progenics may, in its sole discretion and without prior notice, terminate your access to this Website for violations of this Terms of Use Agreement or other agreements or guidelines which may be associated with your use of this Website.

You agree to defend, indemnify, and hold Progenics, its officers, directors, partners, employees, agents, licensors, and suppliers, harmless from and against any claims, actions or demands, liabilities and settlements including without limitation, reasonable legal and accounting fees, resulting from, or alleged to result from, your violation of this Terms of Use Agreement.

PROGENICS SPECIFICALLY DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THIS WEB SITE, EVEN IF Progenics HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THIS WEB SITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THIS WEB SITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THIS WEB SITE, OR RELATED INFORMATION OR PROGRAMS. Because some countries and states do not allow the exclusion or limitation of liability for consequential or incidental damages, all disclaimers, limitations and other terms of this paragraph shall apply to the greatest extent permitted by law.

This Website and its content are intended to comply with the laws and regulations in the U.S.  Although the information on this Website is accessible to users outside of the U.S., the information pertaining to Progenics’ products is intended for use only by residents of the U.S. Other countries may have laws, regulatory requirements and medical practices that differ from those in the U.S. This Website links to other sites produced by Progenics’ various operating divisions and subsidiaries, some of which are outside the U.S. Those sites may have information that is appropriate only to that particular originating country. Progenics reserves the right to limit provision of its products or services to any person, geographic region or jurisdiction and/or to limit the quantities or any products or services it provides. Any offer for any product or service made on this Website is void where prohibited.

This Terms of Use Agreement and your use of the Website shall be governed by the laws of the United States of America and the State of New York without regard to its conflicts of laws principles. Any legal action or proceeding related to this Website shall be brought exclusively in a federal or state court of competent jurisdiction sitting in New York.

Progenics reserves the right to alter or delete materials from this Website at any time at its discretion.

Indication

AZEDRA® (iobenguane I 131) is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Important Safety Information

Warnings and Precautions:

  • Risk from Radiation Exposure: AZEDRA contributes to a patient’s overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of AZEDRA are greater in pediatric patients than in adults. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with AZEDRA consistent with institutional good radiation safety practices and patient management procedures.
  • Myelosuppression: Severe and prolonged myelosuppression occurred during treatment with AZEDRA. Among the 88 patients who received a therapeutic dose of AZEDRA, 33% experienced Grade 4 thrombocytopenia, 16% experienced Grade 4 neutropenia, and 7% experienced Grade 4 anemia. Five percent of patients experienced febrile neutropenia. Monitor blood cell counts weekly for up to 12 weeks or until levels return to baseline or the normal range. Withhold and dose reduce AZEDRA as recommended in the prescribing information based on severity of the cytopenia.
  • Secondary myelodysplastic syndrome, leukemia, and other malignancies: Myelodysplastic syndrome (MDS) and acute leukemias were reported in 6.8% of the 88 patients who received a therapeutic dose of AZEDRA. The time to development of MDS or acute leukemia ranged from 12 months to 7 years. Two of the 88 patients developed a non-hematological malignancy.
  • Hypothyroidism: Hypothyroidism was reported in 3.4% of the 88 patients who received a therapeutic dose of AZEDRA. Initiate thyroid-blocking medications starting at least 1 day before and continuing for 10 days after each AZEDRA dose to reduce the risk of hypothyroidism or thyroid neoplasia. Evaluate for clinical evidence of hypothyroidism and measure thyroid-stimulating hormone (TSH) levels prior to initiating AZEDRA and annually thereafter.
  • Elevations in blood pressure: Eleven percent of the 88 patients who received a therapeutic dose of AZEDRA experienced a worsening of pre-existing hypertension defined as an increase in systolic blood pressure to ≥160 mmHg with an increase of 20 mmHg or an increase in diastolic blood pressure to ≥ 100 mmHg with an increase of 10 mmHg. All changes in blood pressure occurred within the first 24 hours post infusion. Monitor blood pressure frequently during the first 24 hours after each therapeutic dose of AZEDRA.
  • Renal toxicity: Of the 88 patients who received a therapeutic dose of AZEDRA, 7% developed renal failure or acute kidney injury and 22% demonstrated a clinically significant decrease in glomerular filtration rate (GFR) measured at 6 or 12 months. Monitor renal function during and after treatment with AZEDRA. Patients with baseline renal impairment may be at greater risk of toxicity; perform more frequent assessments of renal function in patients with mild or moderate impairment. AZEDRA has not been studied in patients with severe renal impairment.
  • Pneumonitis: Fatal pneumonitis occurred 9 weeks after a single dose in one patient in the expanded access program. Monitor patients for signs and symptoms of pneumonitis and treat appropriately.
  • Embryo-fetal toxicity: Based on its mechanism of action, AZEDRA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating AZEDRA. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with AZEDRA and for 7 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the final dose.
  • Risk of infertility: Radiation exposure associated with AZEDRA may cause infertility in males and females. Radiation absorbed by testes and ovaries from the recommended cumulative dose of AZEDRA is within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

Adverse Reactions:

  • The most common severe (Grade 3–4) adverse reactions observed in AZEDRA clinical trials (≥ 10%) were lymphopenia (78%), neutropenia (59%), thrombocytopenia (50%), fatigue (26%), anemia (24%), increased international normalized ratio (18%), nausea (16%), dizziness (13%), hypertension (11%), and vomiting (10%). Twelve percent of patients discontinued treatment due to adverse reactions (thrombocytopenia, anemia, lymphopenia, nausea and vomiting, multiple hematologic adverse reactions).

Drug Interactions:

  • Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of AZEDRA. These drugs were not permitted in clinical trials that assessed the safety and efficacy of AZEDRA. Discontinue the drugs listed in the prescribing information for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of AZEDRA. Do not administer these drugs until at least 7 days after each AZEDRA dose.

For important risk and use information about AZEDRA, please see Full Prescribing Information.

To report suspected adverse reactions, contact Progenics Pharmaceuticals, Inc. at 844-668- 3950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference: AZEDRA® prescribing information. New York, NY: Progenics Pharmaceuticals, Inc.; 08 2018.