(Filing, Annual, BioLineRx, 2015, MAY 31, 2016, View Source [SID:1234512873])
On May 31, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has acquired Sividon Diagnostics, a leading breast cancer prognostic company, for €35 million upfront with the potential for €15 million in additional performance-based milestones (Press release, Myriad Genetics, MAY 31, 2016, View Source [SID:1234512945]). The transaction closed on May 31, 2016. Myriad expects the deal to be neutral to both revenue and earnings in fiscal year 2017. A discussion on the details and strategy underlying the transaction will be provided on a conference call today at 4:30 pm EDT.
"Sividon brings to Myriad the best-in-class breast cancer prognostic test and strengthens our market leading oncology portfolio of high value personalized medicine products," said Mark C. Capone, president and CEO, Myriad Genetic Laboratories. "The EndoPredict test will be the foundational product of our newly initiated kit-based strategy and allow Myriad to leverage its global oncology distribution to bring this important test to patients worldwide."
"We are excited to be integrated with the global leader and pioneer in personalized medicine," said Christoph Petry, CEO of Sividon Diagnostics. "Myriad has the reimbursement, regulatory, and commercial expertise to make this product very successful, especially as we seek distribution in the United States and broader reimbursement coverage in Europe."
Sividon Diagnostics was spun out of Siemens Healthcare Diagnostics in 2010 as part of a management buyout. Their core EndoPredict product is a kit-based RNA expression test that evaluates 12 genes to assess the aggressiveness of breast cancer on a molecular level. The test is currently CE Marked on the Siemens Versant instrument, however, Myriad is transitioning the product to the Thermo Fisher QuantStudio platform as a key step in the international kit strategy. EndoPredict has been evaluated in 5 major studies incorporating more than 4,000 patients, utilized on a clinical basis in over 13,000 patients worldwide, and is extensively referenced in clinical guidelines across the globe. In a head-to-head study, it has been shown to outperform the prognostic ability of the leading first generation test while providing definitive answers with no intermediate results.
Benefits of the Transaction
Synergistic Product Within the 4in6 Strategy: EndoPredict evaluates the aggressiveness of breast cancer to help patients decide whether to safely forgo chemotherapy and will be added into our existing oncology commercial channel, creating significant opportunities for operating leverage.
Substantial Market Opportunity: Myriad believes the global market opportunity for EndoPredict is greater than $600 million with the majority of that market existing in major European countries, Canada, and the United States. We estimate that this market is less than 25 percent penetrated on a global basis and EndoPredict should benefit from a significant expansion in reimbursement in the coming years.
Best-in-Class Product: EndoPredict has been studied in approximately 4,000 patients and utilized in over 13,000 patients, and has consistently demonstrated the best ability to predict which patients are at low risk for distant metastases in both node negative and node positive patients. Additionally, the kit-based format provides unique advantages in the marketplace and EndoPredict will be the foundational product in Myriad’s global kit-based strategy.
Broadens Comprehensive Product Offering in Oncology: Myriad currently sells market leading tests in oncology for hereditary cancer and companion diagnostics. EndoPredict answers another important clinical question for breast cancer patients by identifying which can safely forgo chemotherapy. Oncology customers can increasingly rely on Myriad as a single source trusted advisor answering questions across the entire continuum of care with unmatched quality.
Myriad intends to fund the transaction entirely through cash on hand. At the end of the fiscal third quarter Myriad had cash and cash equivalents of $286 million on hand.
On May 31, 2016 Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported the unveiling of an initiative that illustrates the perspectives of those impacted by rare cancers, created in partnership with photographer Rick Guidotti of Positive Exposure (Press release, Baxalta, MAY 31, 2016, View Source [SID:1234512924]). The photo exhibit, Rare Cancer Illuminated: a View From Within, debuts on June 2 in Chicago as part of The Atlantic’s "The Search for Answers: Fighting Rare Cancers," which Baxalta is underwriting.
"The Search for Answers: Fighting Rare Cancers"
This press release has an accompanying Smart Marketing Page providing further details about the organization, products and services introduced below. You can access the Smart Marketing Page via the following link: View Source
People living with rare and underserved cancers often experience difficulty with disease recognition, late or inaccurate diagnosis,1 limited treatment options, and scarcity of clinical trial availability or registries.2 Through photography, Guidotti and Baxalta aim to raise awareness and understanding of the unique challenges that rare cancer communities face and encourage greater collaboration to achieve more efficient diagnoses, treatment, access, and support.
The exhibit gathers individuals connected by various types of rare adult, pediatric, and adolescent cancers, such as pancreatic cancer, myelodysplastic syndromes (MDS), and acute lymphoblastic leukemia (ALL), and aims to illuminate the passion that drives them daily. While there is no international consensus on the definition of rare cancer, it is defined as fewer than 15 per 100,000 cases per year in the U.S.3 In Europe, rare disease is defined as those with a prevalence of fewer than 50 per 100,000 cases.3 Underserved cancers are typically referred to as those receiving inadequate physical or emotional resources.
"At Baxalta, our mission is to improve the lives of individuals affected by rare cancers through the use of innovative technologies and approaches, such as harnessing the body’s immune system," said David Meek, Executive Vice President and President, Oncology, Baxalta. "Our collaboration with Positive Exposure aims to raise awareness of rare cancers and to unite the community to drive action."
Guidotti founded the not-for-profit organization, Positive Exposure, in 1998, to celebrate and understand human diversity. Using photography, Guidotti aims to change public perception by helping people to see beyond standard definitions of beauty and arrive at their own interpretation. Rare Cancer Illuminated: a View From Within features photographs by Guidotti of rare cancer community members including those who have been diagnosed with cancer, their family and friends, advocacy organizations, and healthcare professionals. The exhibit will travel to Europe later this year.
"Baxalta’s commitment to serving rare cancer communities aligns with my vision to see beyond disease or diagnosis and celebrate our shared humanity," said Guidoitti, Founder, Positive Exposure. "We hope that people who experience this exhibit are able to take away a greater sense of understanding and compassion for communities that are up against these challenges, and feel empowered to learn more and become part of the effort to bring solutions."
The exhibit includes representation from leading advocacy organizations including: American Cancer Society Cancer Action Network; Austrian Childhood Cancer Organization; the Myelodysplastic Syndromes (MDS) Foundation, Inc.; PAN-Austria (Patient Advocacy for Adolescents and Young Adults with Neoplasia); Pancreatic Cancer Action; Stupid Cancer, Inc.; and TEB e.V. Germany (translated to Tumors and Diseases of the Pancreas). Together, their stories focus on the need for improved delivery and access to critical resources and support worldwide.
The Atlantic’s "The Search for Answers: Fighting Rare Cancers," underwritten by Baxalta, will take place on June 2 from 2:00-5:00 p.m. CDT in Chicago ahead of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The event will focus on topics such as the fight against rare cancer, the role of advocacy organizations, the White House’s Moonshot Initiative, patient access, and support networks. Confirmed speakers include: Richard Schilsky, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Chief Medical Officer and co-author of Value Framework; American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld; and Kim Thiboldeaux, President and Chief Executive Officer of the Cancer Support Community.
This event is open to media; please RSVP directly to The Atlantic’s Sydney Simon ([email protected]; 202-266-7338) to attend. A live stream of the afternoon’s conversations will be available beginning at 2:30 p.m. CDT on June 2 on AtlanticLIVE’s website where it will be archived for later viewing.
On May 31, 2016 Kite Pharma, Inc., (Nasdaq:KITE) ("Kite") a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported four presentations relating to its clinical programs will be delivered at the upcoming 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Kite Pharma, MAY 31, 2016, View Source [SID:1234512909]).
"Our presence at this year’s ASCO (Free ASCO Whitepaper) reinforces our progress toward delivering a breakthrough personalized cell therapy for patients with refractory hematological malignancies who have limited or no treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "These data represent a key milestone in our trajectory to advance personalized T cell immuno-oncology and ultimately address critical unmet medical needs."
Data to be presented include results from Kite’s SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive non-Hodgkin lymphoma (NHL). Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.
Data from a Phase 1-2a study evaluating anti-CD19 CAR T cell therapy after low-dose chemotherapy in people with advanced lymphoma will be presented in a Late-Breaking Abstract oral session by James N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the National Cancer Institute (NCI) Center for Cancer Research. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI.
Kite will also provide an update on patients with chemorefractory aggressive NHL from the Phase 1 portion of the ZUMA-1 study and present a poster on the study design of ZUMA-4, an ongoing Phase 1/2 study of KTE-C19 in children and young adults with previously treated acute lymphoblastic leukemia.
Presentations at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting:
Anti-CD19 chimeric antigen receptor T cells preceded by low-dose chemotherapy to induce remissions of advanced lymphoma
Date: Monday, June 6, 2016, 4:42-4:54 PM CDT
Location: Hall D2
Abstract Number: LBA3010
Presenter: James Kochenderfer, M.D., Experimental Transplantation and Immunology Branch, National Cancer Institute, Bethesda, MD
Outcomes in refractory aggressive diffuse large b-cell lymphoma (DLBCL): results from the international SCHOLAR-1 Study
Date: Monday, June 6, 2016, 1:15-2:45 PM CDT
Abstract Number: 7516
Presenter: Michael Crump, M.D., FRCPC, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Ongoing complete remissions (CR) in the phase 1 of ZUMA-1: a phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in subjects with refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL)
Date: Monday, June 6, 2016, 8:00-11:30 AM CDT
Location: Poster Board 115, Hall A
Abstract Number: 7559
Presenter: Sattva Swarup Neelapu, M.D., The University of Texas MD Anderson Cancer Center, Houston, TX
ZUMA-4: A phase 1/2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in pediatric and adolescent subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL)
Date: Monday, June 6, 2016, 8:00-11:30 AM CDT
Location: Poster Board 65a, Hall A
Abstract Number: TPS7075
Presenter: Alan S. Wayne, M.D., Children’s Hospital Los Angeles, Los Angeles, CA
On May 31, 2016 Transgene (Paris:TNG) (Euronext Paris: TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, reported that a poster on the ongoing Pexa-Vec Phase 3 trial in first line advanced HCC patients will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting on June 4th, in Chicago, IL, USA (Press release, Transgene, MAY 31, 2016, View Source [SID:1234512908]).
Date and Time: Saturday, June 4, 2016, 8:00 a.m. – 11:30 a.m. CDT
Abstract Title: PHOCUS: A Phase 3 randomized, open-label study comparing the oncolytic immunotherapy Pexa-Vec followed by Sorafenib (SOR) vs SOR in patients with advanced hepatocellular carcinoma (HCC) without prior systemic therapy.
Abstract Number: TPS4146
Location: Hall A
Poster Board: #130b
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Presenter: Ghassan K. Abou-Alfa, MD – Memorial Sloan Kettering Cancer Center
The abstract is available via the following link: View Source
PHOCUS trial: study initiated in January 2016 in HCC and actively recruiting
The PHOCUS clinical trial is a multinational, randomized Phase 3 open label study with the oncolytic immunotherapy, Pexa-Vec, in patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC). This trial is being led by Transgene’s partner, SillaJen, Inc. The trial is evaluating the use of Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar), the only approved drug for advanced HCC.
The study is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. Patients will be randomized 1:1 to one of two treatment groups: one which will receive Pexa-Vec followed by sorafenib and one which will receive sorafenib alone. The study will be conducted at approximately 140 sites worldwide, including in North America, Asia, Australia and Europe. SillaJen, Inc. reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this global Phase 3 clinical trial. The primary endpoint of the study is overall survival. Secondary objectives include safety, as well as assessments for tumor responses between the two groups as measured by the following endpoints: time to progression, progression-free survival, overall response rate and disease control rate. To learn more about the trial, please visit View Source;rank=15 or www.pexavectrials.com.
About HCC (Hepatocellular carcinoma)
According to recent statistics (GLOBOCAN 2012), there were over 780,000 new cases of liver cancer worldwide in 2012 and over 745,000 deaths due to this disease. In Europe, there were estimated to be over 63,000 new cases and over 62,000 deaths from liver cancer. In the U.S., according to the American Cancer Society, over 35,000 new cases of liver cancer were expected to be diagnosed in 2015 and 24,000 deaths projected from the disease. Hepatocellular carcinoma is estimated to account for over 80% of all liver cancer. Currently there are few treatment options for advanced HCC patients, with only one drug, sorafenib, approved for the treatment of HCC. With a low five-year survival rate, especially for patients diagnosed at later stages of disease, and limited available therapies, new treatments are urgently needed.
Pexa-Vec (pexastimogene devacirepvec) is an oncolytic immunotherapy armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: the lysis (breakdown) of cancer cells through viral replication, the reduction of the blood supply to tumors through vascular disruption, and the stimulation of the body’s immune response against cancer cells. The lead indication for Pexa-Vec is hepatocellular carcinoma (HCC, liver cancer); trials in other cancer types are underway or planned.
SillaJen, Inc. has partnered with Transgene and Lee’s Pharmaceutical to develop and commercialize Pexa-Vec in major markets outside of the United States. Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe, while Lee’s Pharmaceutical retains exclusive development and commercial rights in Hong Kong and The People’s Republic of China.
About SillaJen, Inc., Transgene’s Partner for Pexa-Vec
SillaJen, Inc. is a private, South Korean based biotechnology company headquartered in Busan South Korea, with satellite offices in Seoul, South Korea and San Francisco, CA. The company is focused on the development and commercialization of oncolytic immunotherapy products using the SOLVETM platform, including its lead product Pexa-Vec, which is currently in Phase 3 trials for the treatment of advanced primary liver cancer. Additional information about SillaJen is available at www.sillajen.com.