Award-Winning Journalist And Cancer Survivor Joan Lunden Partners With Amgen To Launch ‘At Home With Joan’ To Empower Patients Battling Cancer

On October 24, 2017 Amgen (NASDAQ:AMGN) reported the launch of At Home with Joan, a campaign led by breast cancer survivor and advocate Joan Lunden (Press release, Amgen, OCT 24, 2017, View Source [SID1234521118]). This campaign aims to empower patients diagnosed with cancer to be active participants in their treatment plan in order to understand and navigate the risks associated with strong chemotherapy, including infection as manifested by febrile neutropenia, or a low blood cell count with fever.1

Motivated by her own cancer battle and passion for sharing valuable health information with the public, the iconic journalist traveled the country to get up close and personal with four breast cancer survivors also treated with strong chemotherapy. Together, they share their stories in order to inspire others to be an advocate and play an active role on their healthcare team. In the At Home with Joan campaign, Lunden reinforces the number one piece of advice she wished she knew before her diagnosis: that you are your own best advocate.

More than 1.6 million Americans will be diagnosed with cancer this year and among those that develop febrile neutropenia, more than 80 percent require hospitalization.2,3 According to the National Cancer Institute, patient-clinician communication plays an important role in optimizing health outcomes for patients with cancer.4

The cornerstone of the campaign is a series of videos, available at www.AtHomeWithJoan.com, which feature one-on-one, intimate conversations at home between Lunden and breast cancer survivors discussing topics such as:

The importance of educating yourself about your treatment options and having open dialogue with your doctor
Why a strong support network and partnering with your healthcare team is critical
Staying positive and maintaining a sense of control throughout the experience
Patient experiences with treatment to reduce the risk of infection associated with strong chemotherapy
“While I’ve been on thousands of assignments throughout my career, I feel that perhaps my most important one is my current mission to educate and empower others to better understand their cancer and treatment options available so that they can play an active role in their care,” said Lunden. “With so much information out there and critical decisions to make, it’s normal to feel overwhelmed. By sharing our stories, we can learn from each other. It is my hope that these heartfelt conversations with courageous, inspiring survivors will provide candid perspectives and tips on how to advocate for yourself and ask the right questions early on.”

At Home with Joan also features conversations between Lunden and Edward George, M.D., medical oncologist, and Tina Pryor, RN, oncology nurse, which focus on what to expect from treatment with strong chemotherapy, tips for doctors’ appointments including what questions to ask, what to wear to treatments, coping with hair loss and ways to reduce the frequency of clinic visits by helping to protect yourself from infection right from home.

Like Lunden and the At Home with Joan participants, many newly diagnosed cancer patients will undergo strong chemotherapy and may be unaware of the potential risks associated with this type of treatment, including infection, as manifested by febrile neutropenia, and the important questions to ask their care team.

“While strong chemotherapy targets tumor cells that are rapidly dividing, what many patients don’t realize is it can also affect other cells, including blood cells,” said Dr. George. “As an oncologist, a reduction of white blood cell count is one of my biggest concerns because it can leave patients susceptible to infection and hospitalization. This is a serious topic that patients need to be aware of so they can speak to their doctor about treatment options to help prevent it.”

“My hope as an oncology nurse is that each patient’s healthcare team has discussed treatment options that help reduce the risk of infection, including Neulasta (pegfilgrastim) Onpro, which is applied the same day as a patient’s chemotherapy appointment, so they can spend more time at home with their families,” said Pryor. “These patients want to get back to their normal life and recover in the comfort of their own home. As a member of their support team, I want patients to know there are treatment options to help bring back that normalcy and comfort that frequent clinic and hospital visits interrupt.”

To view the eight-part video series and learn more about upcoming community events featuring Lunden, fellow survivors and cancer experts, visit www.AtHomeWithJoan.com. Additional resources include a printable Doctor Discussion guide for patients to bring to their appointments with important questions to ask about treatment.

About Joan Lunden
As the longest running female host ever on early morning television, Joan Lunden was the co-host of Good Morning America for nearly two decades. Lunden is an award-winning journalist, bestselling author, health and wellness advocate, international speaker, and a mom of seven children. After being diagnosed with breast cancer in June of 2014, Lunden made it her mission to educate and inspire others about breast cancer prevention, treatment, and survival. Lunden speaks all over the country about her breast cancer journey, health & wellness, inspiration, and success.

About Neulasta (pegfilgrastim)
Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. In a pivotal clinical trial, in patients with nonmyeloid malignancies undergoing myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia, treatment with Neulasta was shown to significantly reduce the incidence of febrile neutropenia.

Neulasta is administered by manual injection and is also available via the Neulasta Onpro kit, which was approved by the U.S. Food and Drug Administration in 2014 and includes a specially designed, single-use prefilled syringe co-packaged with an on-body injector for Neulasta.

For more information about Neulasta, visit www.Neulasta.com and www.NeulastaHCP.com.

Important Safety Information Regarding Neulasta
Contraindication
Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic Rupture
Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta for ARDS. Discontinue Neulasta in patients with ARDS.

Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions.

Allergies to Acrylics
The on-body injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Use in Patients with Sickle Cell Disorders
Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Glomerulonephritis
Glomerulonephritis has been reported in patients receiving Neulasta. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of Neulasta. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose‐reduction or interruption of Neulasta.

Leukocytosis
White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBCs during pegfilgrastim therapy is recommended.

Capillary Leak Syndrome
Capillary leak syndrome has been reported after granulocyte colony‐stimulating factor (G‐CSF) administration, including Neulasta, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life‐threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells
The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded. The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

Please see additional Neulasta Safety Information, by visiting www.amgen.com/medpro/products.html.

Please see the Neulasta Full Prescribing Information by clicking here

Myriad Submits BRACAnalysis® CDx Application for Regulatory Approval in Japan for HER2- Metastatic Breast Cancer

On October 24, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for use in HER2- metastatic breast cancer patients (Press release, Myriad Genetics, OCT 24, 2017, View Source [SID1234521116]).

“This regulatory submission as a companion diagnostic for a PARP inhibitor outside the United States reflects another important major milestone as Myriad seeks to become a global leader in personalized medicine,” said Mark C. Capone, president and chief executive officer, Myriad Genetics. “We believe there is broad applicability across all healthcare systems for our suite of companion diagnostics tests to improve the quality of care and lower healthcare costs.”

Myriad estimates there are greater than 10,000 cases of HER2- metastatic breast cancer per year in Japan which would be eligible for testing with BRACAnalysis CDx. Myriad will support testing in the Japanese market through its United States FDA approved laboratory.

Jazz Pharmaceuticals to Report 2017 Third Quarter Financial Results on November 7, 2017

On October 24, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2017 third quarter financial results on Tuesday, November 7, 2017, after the close of the financial markets (Press release, Jazz Pharmaceuticals, OCT 24, 2017, View Source [SID1234521128]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EST/9:30 p.m. GMT to discuss third quarter 2017 financial results and provide a business and financial update.

Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 95499424

A replay of the conference call will be available through November 14, 2017 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 95499424

Myriad to Announce Fiscal First-Quarter 2018 Financial Results on November 7, 2017

On October 24, 2017 Myriad Genetics, Inc. (NASDAQ: MYGN) reported that it will hold its fiscal first-quarter 2018 sales and earnings conference call with investors and analysts at 4:30 p.m. ET on Tuesday, November 7, 2017 (Press release, Myriad Genetics, OCT 24, 2017, View Source [SID1234521129]). During the call, Mark C. Capone, president and CEO and Bryan Riggsbee, CFO, will provide an overview of Myriad’s financial performance for the fiscal first-quarter and provide a business update.

To listen to the call, interested parties in the United States may dial 800-701-6414 or +1 303-223-4376 for international callers. All callers will be asked to reference reservation number 21859999. The conference call also will be available through a live webcast and a slide presentation pertaining to the earnings call will also be available under the investor section of our website at www.myriad.com. A replay of the call will be available two hours after the end of the call for seven days and may be accessed by dialing 800-633-8284 within the United States or +1 402-977-9140 for international callers and entering reservation number 21859999.

Neurocrine Biosciences Announces Conference Call and Webcast to Report Third Quarter 2017 Results

On October 24, 2017 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that the Company will report third quarter 2017 results after the Nasdaq market close on November 1, 2017 (Press release, Neurocrine Biosciences, OCT 24, 2017, View Source [SID1234521131]). Neurocrine will then host a live conference call and webcast to discuss its financial results and provide a Company update that day at 5:00pm Eastern Time (2:00pm Pacific Time).

Participants can access the live conference call by dialing 866-831-8713 (US) or 203-518-9713 (International) using the conference ID: NBIX. The call can also be accessed via the webcast through the Company’s website at View Source

If you are unable to attend the webcast and would like further information on this announcement, please contact the Investor Relations Department at [email protected]. A replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 800-839-4013 (US) or 402-220-2982 (International) using the conference ID: NBIX. The call will be archived for one month.