Published May 5, 2022
Dive Brief:
Intercept Pharmaceuticals will sell rights to its liver disease drug Ocaliva outside of the U.S. to U.K.-based Advanz Pharma, which agreed to pay Intercept $405 million upfront in a deal announced by the companies Thursday. Intercept could receive another $45 million from Advanz should European regulators grant Ocavlia an extension of pediatric orphan drug exclusivity. Advanz will also pay Intercept royalties on any non-U.S. sales of Ocaliva in another liver condition known as non-alcoholic steatohepatitis, or NASH, for which it's currently being studied. As part of the deal, the "majority" of Intercept employees located outside of the U.S. will transfer over to work for Advanz. Intercept employed 437 staff at the end of last year, 118 of whom were based internationally. Dive Insight:
The upfront payment Advanz will exchange for ex-U.S. rights to Ocaliva is nearly equivalent to Intercept's market value at Wednesday's market close and will substantially increase the biotech's available cash on hand. In a statement, Intercept CEO Jerry Durso said the deal would help Intercept continue to invest in its U.S. business and to fund further drug development, such as in NASH. Intercept's first and only approved drug, Ocaliva is cleared in the U.S. and Europe to treat primary biliary cholangitis, an inflammatory liver disease that particularly affects bile ducts. Sales totaled $363 million in 2021, with $102 million coming from European countries. NASH, a widely prevalent but slow-developing disease that can lead to liver scarring, is viewed by the company and analysts as a broader opportunity for Ocaliva. But proving the drug can work to treat the disease, which can be challenging to definitively diagnose, has been a long road for Intercept. Encouraging early study results sent Intercept shares skyrocketing in value, but they've steadily sunk since, as the Food and Drug Administration wasn't convinced the benefits reported in follow-up testing outweighed the drug's risks. Other NASH drug developers reported clinical trial failures, too, raising doubts about how easily NASH could be treated. Intercept is currently awaiting updated results from a key study of Ocaliva in NASH, and expects new data from another trial in the third quarter of this year. To Brian Abrahams, an analyst at RBC Capital Markets, Thursday's deal gives Intercept additional capital to pursue NASH drug development in the U.S.
"We believe the deal likely reflects [management]'s confidence in continuing to pursue the NASH indication, based on its ongoing work," Abrahams wrote in a May 5 note to clients. Selling Ocaliva rights also gives Intercept new funding at a time when biotech stocks have retreated in the sector's sharpest market downturn in years, limiting opportunities for companies to raise money through secondary stock offerings. Shares in Intercept rose by more than 10% Thursday morning on news of the deal, contrasting with a nearly 3% decline in the XBI, a widely followed biotech stock index. Intercept plans to hold a conference call on Friday to discuss the deal and its earnings for the first quarter.

Intercept sells international rights to liver drug in $400M deal

MILPITAS, CALIF. & SURREY, ENGLAND--(BUSINESS WIRE)--
SS8 Networks , a leader in Lawful Intercept and Monitoring Center Platforms, today announced the acquisition of Creativity Software, a leading provider of mobile network location intelligence. The transaction expands SS8’s capabilities to include precise location data and significantly enhances its global reach. This is the second accretive acquisition in the last twelve months for SS8 and furthers its strategic growth plan by advancing its end-to-end solutions for communication service providers (CSPs) and public safety entities. It also gives SS8 the scale to respond to expected growth in both location and lawful intelligence markets as 5G brings increased bandwidth and encryption capabilities to mobile networks. “By adding Creativity Software’s passive and active location technology, SS8 can now offer a more robust portfolio of products to help CSPs comply with precise location data requests from public safety agencies,” said Dr. Keith Bhatia, CEO of SS8 Networks. “This acquisition underscores our focus on providing highly accurate location solutions that promote global security and support a safer society.”
Creativity Software, established in 2001, is privately owned and has a wealth of experience in the design and deployment of both passive and active location platforms. Their solution offerings and target markets also complement those of SS8, with current clients including mobile operators, emergency responders, and law enforcement and public safety agencies. “This deal represents a powerful combination of cultures and technologies,” said Richard Lee, Founder and CEO of Creativity Software. “As Creativity Software moves into its next exciting phase, the additional scale will allow us to continue developing cutting-edge Location-Based Services solutions with enhanced delivery and support for our new and existing customers, partners, and resellers.”
About SS8 Networks
SS8 , a network intelligence company, provides solutions to help customers quickly identify, track, and investigate devices and subjects of interest. SS8 is trusted by six of the largest intelligence agencies, eight of the fourteen largest communications providers, and five of the largest systems integrators in the world. For more information, visit www.SS8.com or follow us on Twitter @SS8 or LinkedIn . About Creativity Software
Creativity Software (CS) is a global leader in mobile network location intelligence and mobile data enablement technologies. CS enables Mobile Network Operators to drive profits from their network data through agile data enablement solutions and delivers accurate network location intelligence for Commercial Services, Emergency Services, and Law Enforcement worldwide. View source version on businesswire.com: https://www.businesswire.com/news/home/20220307005061/en/
Copyright Business Wire 2022

SS8 Networks Acquires Creativity Software

Acceler8 Testing Program Certification Allows for Integration of SS8’s Xcipio in NEC Networks
TOKYO & MILPITAS, Calif.–(BUSINESS WIRE)– #5GC — NEC Corporation (NEC; TSE: 6701) and SS8 Networks (SS8) , a leader in Lawful Intercept and Monitoring Center Platforms, today announced they are conducting interoperability testing between NEC’s 5G core and SS8’s lawful interception (LI) solution. The verification is expected to be completed in March this year. The certification supports NEC’s mission to deliver open, secure, and efficient 5G networks globally. Lawful interception solutions allow law enforcement agencies with the proper government authorization to legally intercept and monitor the telecommunications of subjects of interest. NEC is a leader in the integration of IT and network technologies, driving the adoption of 5G networks with end-to-end carrier-grade quality ranging from the core and transport to RAN and the edge. A pioneer in cloud-native 5G core, NEC enables operators to benefit from shorter time to market and immediate monetization. To continue advancing its solutions, NEC sought a partner with deep, international technical expertise to integrate an LI solution that meets various standards. With SS8’s Xcipio platform, NEC’s customers will have confidence that their network has been fully tested for compliant lawful interception mediation and administration anywhere in the world, satisfying ETSI, 3GPP, 5G, and other frameworks. “As 5G accelerates the speed and capacity of communications networks, the safety and security of our communities will continue to be a top priority. By integrating Xcipio, NEC is delivering customer solutions that improve productivity and efficiency and increase societal safeguards,” said Dr. Keith Bhatia, CEO of SS8 Networks. “SS8 is proud to partner with NEC to help usher in better 5G service.”
Completing SS8’s Acceler8 interoperability testing program certifies NEC’s ability to seamlessly connect SMF, UPF, and other 5G functions to Xcipio using ETSI and 3GPP standards. NEC operators will be empowered to deliver voice and other communications data when required. “NEC is excited to introduce this new global functionality within our 5G core. Interoperability with SS8’s innovative Xcipio solution will give our mutual customers a high-speed, low latency network that is fully compliant with the needs of law enforcement agencies worldwide. We are proud to work with leading industry partners such as SS8,” said Shigeru Okuya, Senior Vice President of NEC Corporation. About NEC Corporation
NEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of “Orchestrating a brighter world.” NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com .

NEC and SS8 Conduct Interoperability Verification of 5GC and Lawful Interception Solution

Sep 30, 2021 5:10pm
Behind the vast operation is right-wing group America’s Frontline Doctors, which was founded last year and has been spreading misinformation about COVID-19. (Getty/BrianAJackson)
A network of right-wing health providers has profited at least $15 million off of tens of thousands of patients seeking consultations for and buying ineffective COVID-19 treatments including hydroxychloroquine and ivermectin, The Intercept reported Tuesday. The Intercept obtained the data from an anonymous hacker, who got the records from CadenceHealth.us and Ravkoo and said the sites were “hilariously easy” to hack. The data included records from 281,000 patients, some of whose files contained protected health information. Other data provided to The Intercept included records of 340,000 prescriptions. Behind the vast operation is right-wing group America’s Frontline Doctors (AFLDS), which was created last year and has been spreading misinformation about COVID-19. It refers its numerous followers to telemedicine service SpeakWithAnMD.com, which uses the Cadence Health platform and charges $90 per consultation, according to The Intercept. Patients must reportedly submit payment first and then wait for a phone call, which for many does not come . Those who are able to speak with an “AFLDS-trained physician” then get prescribed the malaria and de-worming medications, both of which U.S. government agencies and the World Health Organization have said repeatedly not to use, as well as zinc or azithromycin, also shown to be ineffective. The prescriptions were reportedly delivered by Ravkoo, which works with local pharmacies. According to the records obtained by The Intercept, 72,000 people paid for $90 phone consultations, many of whom also had follow-up appointments for $59.99. More than half of those who received consultations were women, while more than a third were men. Older patients were more likely than other age groups to engage. Cadence Health said it shut its platform down after it was alerted to this news, The Intercept reported, effectively shuttering SpeakWithAnMD’s telemedicine platform. AFLDS’ founder was charged with violent entry and disorderly conduct following her involvement in the Jan. 6 Capitol riot. The group has continually argued against vaccines, mask mandates and restrictions on businesses as effective measures to stem the spread of COVID-19. The vast majority of deaths from the virus in the U.S. are preventable, according to health experts .

Right-wing physicians profit off of fake COVID-19 treatments, report finds

September 20, 2021 08:00 AM Eastern Daylight Time
CONCORD, Calif.--( BUSINESS WIRE )--Cerus Corporation (Nasdaq: CERS) today announced its participation in the Society for the Advancement of Blood Management (SABM) Virtual Annual Meeting, which is scheduled for September 22-25, 2021. On Thursday, September 23, Cerus will host an industry workshop, “Clinical need for and experience with the new Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex),” from 1:00-1:30p.m. EDT featuring two hospital customers currently using INTERCEPT Fibrinogen Complex. The workshop will feature the following presentations:
“Optimizing Massive Transfusion Protocols (MTP) in the Pediatric Setting”
Nicole Lea, MSN, APRN; Transfusion Safety Officer, Texas Children’s Hospital
“Introduction of INTERCEPT Fibrinogen Complex into our Transfusion Service”
Hedyeh Shafi, MD; Medical Director, Clinical Laboratory and Transfusion Service, Assistant Chief of Service, Department of Pathology, Kaiser-Permanente, Los Angeles
“Introducing a New Cryoprecipitated Coagulopathy Treatment: INTERCEPT Fibrinogen Complex”
Nadia Keltner, MSc, PhD; Associate Director Therapeutics Market Development, Cerus Corporation
To register for the annual meeting, including the industry workshop and additional SABM events, please visit https://sabm.org/annual-meeting/. Additionally, a replay of the industry workshop presentations will be available at https://intercept-cryoprecipitation.com/resources/news/. Cerus received approval from the U.S. Food and Drug Administration (FDA) in November 2020 for the INTERCEPT Blood System for Cryoprecipitation, which is used to produce INTERCEPT Fibrinogen Complex as well as Pathogen Reduced Plasma, Cryoprecipitate Reduced. The INTERCEPT Blood System for Cryoprecipitation was previously granted FDA Breakthrough Device designation based on its potential to improve treatment of massive hemorrhage, a life-threatening medical condition. In August, the U.S. Centers for Medicare & Medicaid Services (CMS) granted a New Technology Add-On Payment (NTAP) as well as a HCPCS Level II P-code for INTERCEPT Fibrinogen Complex. Founded in 2001, SABM is a professional society dedicated to improving patient outcomes through optimal blood management. SABM’s mission is to improve health, increase safety and reduce healthcare costs through the advancement of scientific knowledge and practice in patient blood management. Its members are comprised of blood center and hospital blood banking leaders who are focused on incorporating a range of blood management strategies with a vision of making comprehensive patient blood management the global standard of care. SABM’s annual meeting includes over 400 attendees from more than a dozen countries around the world. ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Contacts
Cerus Corporation

Cerus Corporation Announces INTERCEPT Fibrinogen Complex Customer Presentations at SABM Virtual Annual Meeting 2021

Philips (NYSE:PHG) is a diversified technology company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle, and Lighting. The company provides cardiac care, acute care and home healthcare, energy efficient lighting solutions, and new lighting applications, as well as male shaving and grooming and oral healthcare.

Philips

`` By leveraging Philips ' advanced telehealth solution , Intercept TeleMed has been able to build real partnerships with our hospitals and bedside staff to deliver proactive care to patients . ''

Philips, TeleMed Intercept\'s New Breed of Tele-ICU for Small Hospitals

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InterCept is a single-source provider of a broad range of technologies, products and services that work together to meet the technology and operating needs of financial institutions and merchants. InterCept's products and services include core data processing, check processing and imaging, electronic funds transfer, debit and credit card processing, data  communications management, and related products and services.

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Name	Work History	Title	Status
Bret Giles	MicroAge, SkyMall, The Sharper Image, and Ketchum	Founder	Current
John W Collins		Chief Executive Officer	Current
Gregory L Boggs		President, Chief Operating Officer	Current
Scott R Meyerhoff		Chief Financial Officer	Current
Laurens Leurink	Docly, Amadeus, Expedia, and Booking.com	Chief Executive Officer	Former

Name	Bret Giles	John W Collins	Gregory L Boggs	Scott R Meyerhoff	Laurens Leurink
Work History	MicroAge, SkyMall, The Sharper Image, and Ketchum				Docly, Amadeus, Expedia, and Booking.com
Title	Founder	Chief Executive Officer	President, Chief Operating Officer	Chief Financial Officer	Chief Executive Officer
Status	Current	Current	Current	Current	Former

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