Sanofi to present oncology strategy, provide update on portfolio and emerging pipeline

Sanofi to present oncology strategy, provide update on portfolio and emerging pipeline

PARIS – April 2, 2020 – Sanofi Chief Executive Officer Paul Hudson along with R&D and commercial leaders will provide an overview of Sanofi’s oncology strategy and progress update of its related key products and pipeline programs. Sanofi’s oncology strategy is focused on four core therapeutic areas with four anchor treatments the company believes have the potential to transform patient care.

The four areas of strategic focus within oncology, including multiple myeloma, skin, lung, and breast cancers. Sanofi’s four anchor oncology treatments include Sarclisa® (isatuximab-irfc), an anti-CD38 monoclonal antibody and Libtayo® (cemiplimab-nwlc), a PD-1 checkpoint inhibitor1 and the pipeline programs – an investigational anti-CEACAM 5 antibody drug conjugate and SERD (‘859), an investigational oral selective estrogen receptor degrader.

“We are rapidly building momentum with the execution of our oncology strategy, with several developments on both our pipeline and marketed treatments. Additionally, we are assembling a world-class development and marketing team to support our growth in this core area,” said Hudson. “We believe our efforts and treatments have the potential to make a significant difference in the lives of people living with cancer.”

“We’ve developed a focused oncology strategy, and are making significant clinical progress to support our ambitions,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. “With a deep toolbox of therapeutic platforms enabling us to discover highly differentiated molecules, Sanofi has a tremendous opportunity to continue our momentum and build a sustainable presence in oncology.”

The virtual investor event will be held today from 4:00-5:30 pm CET/10:00-11:30 am EST. Sanofi speakers include:

  • Paul Hudson, Chief Executive Officer
  • John Reed, Global Head of Research and Development
  • Dietmar Berger, Chief Medical Officer and Global Head of Development
  • Peter Adamson, Global Head of Development, Oncology
  • Alex Zehnder, Global Franchise Head, Oncology

Additional information about today’s oncology presentation can be found at:

https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/2020-oncology-presentation

 

About Sanofi

 

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

 

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

 

Sanofi, Empowering Life

 


Media Relations Contact
Ashleigh Koss
Tel.: +1 908 205 2572

Ashleigh.Koss@sanofi.com

Quentin Vivant
Tél.: +33 (0)1 53 77 46 46

mr@sanofi.com


Investor Relations Contact
Felix Lauscher
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com

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 forward-looking 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 fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  Any material effect of COVID-19 on any of the foregoing  could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties 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, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.


 

1 Partnered with Regeneron

 

 

 

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Santhera Announces Completion of ReveraGen’s Long-Term Extension Study with Vamorolone in Duchenne Muscular Dystrophy


Pratteln, Switzerland, June 2, 2020 – Santhera Pharmaceuticals (SIX: SANN) announces that partner ReveraGen Biopharma Inc. has completed a long-term, open-label extension study of 24 months duration with vamorolone in patients with Duchenne muscular dystrophy (DMD). Including 6 months treatment in the preceding study, ReveraGen has now obtained safety and efficacy data with vamorolone over a period of 2.5 years in 41 boys with DMD.

Eligible for enrolment into the now completed 24-month long-term, open-label extension study (VBP15-LTE, clinicaltrials.gov ID: NCT03038399) were boys who had previously completed the 6-month dose escalation study VBP15-003 (clinicaltrials.gov ID: NCT02760277). Data from this VBP15-003 study in comparison to natural history study data demonstrated dose-dependent improvement in timed function tests. Vamorolone was reported to be safe and well tolerated up to the highest dose tested (6.0 mg/kg/day) [1].

“With most participants continuing treatment with vamorolone long-term, we have assembled a solid safety database, with 106 patient-years of vamorolone exposure in DMD boys, with no serious adverse events attributable to vamorolone to date,” said Eric Hoffman, PhD, Vice President of Research at ReveraGen BioPharma. “We will now analyze the efficacy data and plan to report the results in upcoming scientific conferences and publications.”

All 46 patients who completed the VBP15-003 study requested to continue vamorolone treatment in the long-term extension, rather than transition to corticosteroids. This VBP15-LTE study enabled dose escalation and de-escalation at the preference of the physician and family (suggested range 2.0 to 6.0 mg/kg/day). Of the 41 participants completing end-of-study visit after 24 months, 27 ended at 6.0 mg/kg/day (66%), 11 at 2.0 mg/kg/day (27%), and 3 at 4.0 mg/kg/day (7%). Thus, the majority of physicians/families chose treatment at the highest tested dose of vamorolone by the end of the VBP15-LTE study. Upon their expressed wish, the large majority of the boys completing the 2-year VBP15-LTE study have transitioned to Expanded Access Programs (USA, Canada, Israel) or compassionate use programs (UK, Sweden, Australia) to receive continued vamorolone treatment.

The currently ongoing Phase 2b VISION-DMD study (VBP15-004; clinicaltrials.gov: NCT03439670) is designed as a pivotal trial to demonstrate efficacy and safety of vamorolone administered orally at doses of 2.0 mg/kg/day and 6.0 mg/kg/day versus prednisone 0.75 mg/kg/day and placebo over a treatment period of 24 weeks. The study is currently being conducted at 33 sites across North America, Europe, Israel and Australia. For more information: https://vision-dmd.info/2b-trial-information.

Vamorolone has been granted Orphan Drug status in the US and in Europe, and has received Fast Track and Rare Pediatric Disease designations by the US FDA. In November 2018, Santhera acquired from Idorsia Pharmaceuticals Ltd (SIX: IDIA), who has an option to an exclusive, worldwide license to vamorolone, the option to an exclusive sub-license to vamorolone in all indications and all countries worldwide, except Japan and South Korea.

About Vamorolone – first-in-class dissociative steroid
Vamorolone is a first-in-class drug candidate that binds to the same receptors as corticosteroids but modifies the downstream activity of the receptors [2, 3]. This has the potential to ‘dissociate’ efficacy from typical steroid safety concerns and therefore could replace existing corticosteroids, the current standard of care in children and adolescent patients with DMD. There is significant unmet medical need in this patient group as high dose corticosteroids have severe systemic side effects that detract from patient quality of life. Vamorolone is being developed by US-based ReveraGen BioPharma Inc. with participation in funding and design of studies by several international non-profit foundations, the US National Institutes of Health, the US Department of Defense and the European Commission’s Horizon 2020 program.

About the clinical development program of Vamorolone in patients with DMD
The clinical development program with vamorolone in patients with DMD was initiated following a clinical pharmacology study (VBP15-001) in healthy volunteers in which biomarker assessments indicated reduced occurrence of side effects typical for traditional corticosteroid drugs like bone fragility, metabolic disturbance, immune suppression [4].

The Phase 2a program with vamorolone consisted of two studies that were conducted back-to-back in 48 boys with DMD aged 4 to <7 years (VBP15-002 and VBP15-003). These studies with a combined duration of 6 months investigated the efficacy, safety and tolerability of oral administration of vamorolone at doses of 0.25, 0.75, 2.0 and 6.0 mg/kg/day (12 boys per treatment group). Data from these studies reported that vamorolone was safe and well tolerated and over a period of 6 months with dose- and time-related improvements in various timed function tests and motor function outcomes [1, 5]. Vamorolone treatment led to increased serum levels of osteocalcin, a biomarker of bone formation, suggesting possible reduction of bone morbidities typically associated with corticosteroids. Biomarker outcomes for adrenal suppression and insulin resistance also indicated better tolerability of vamorolone treatment, relative to published studies of corticosteroid therapy.

Patients completing VBP15-003 study were offered continued treatment with vamorolone under the 24-month long-term open-label extension study (VBP15-LTE) which has now been successfully completed.

References:
[1] Hoffman EP et al. (2019). Vamorolone trial in Duchenne muscular dystrophy shows dose-related improvement of muscle function. Neurology 93: e1312-e1323.
[2] Heier CR at al. (2013). VBP15, a novel anti‐inflammatory and membrane‐stabilizer, improves muscular dystrophy without side effects. EMBO Mol Med 5: 1569–1585.
[3] Heier CR et al. (2019). Vamorolone targets dual nuclear receptors to treat inflammation and dystrophic cardiomyopathy. Life Science Alliance DOI 10.26508/lsa.201800186.
[4] Hoffman EP et al. (2018). Phase 1 trial of vamorolone, a first-in-class steroid, shows improvements in side effects via biomarkers bridged to clinical outcomes. Steroids 134: 43-52.
[5] Conklin LS et al. (2018). Phase IIa trial in Duchenne muscular dystrophy shows vamorolone is a first in-class dissociative steroidal anti-inflammatory drug. Pharmacological Research 136:140-150.

About ReveraGen BioPharma
ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders. The development of ReveraGen’s lead compound, vamorolone, has been supported through partnerships with foundations worldwide, including Muscular Dystrophy Association USA, Parent Project Muscular Dystrophy, Foundation to Eradicate Duchenne, Save Our Sons, JoiningJack, Action Duchenne, CureDuchenne, Ryan’s Quest, Alex’s Wish, DuchenneUK, Pietro’s Fight, Michael’s Cause, and Duchenne Research Fund. ReveraGen has also received generous support from the US Department of Defense CDMRP, National Institutes of Health (NCATS, NINDS, NIAMS), and European Commission (Horizons 2020). www.reveragen.com

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. Santhera is building a Duchenne muscular dystrophy (DMD) product portfolio to treat patients irrespective of causative mutations, disease stage or age. A marketing authorization application for Puldysa® (idebenone) is currently under review by the European Medicines Agency. Santhera has an option to license vamorolone, a first-in-class anti-inflammatory drug candidate with novel mode of action, currently investigated in a pivotal study in patients with DMD to replace standard corticosteroids. The clinical stage pipeline also includes lonodelestat (POL6014) to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases, as well as omigapil and an exploratory gene therapy approach targeting congenital muscular dystrophies. Santhera out-licensed ex-North American rights to its first approved product, Raxone® (idebenone), for the treatment of Leber’s hereditary optic neuropathy (LHON) to Chiesi Group. For further information, please visit www.santhera.com

Raxone® and Puldysa® are trademarks of Santhera Pharmaceuticals.

For further information please contact:
Santhera
public-relations@santhera.com or
Eva Kalias, Head External Communications
Phone: +41 79 875 27 80
eva.kalias@santhera.com

ReveraGen
Eric Hoffman, CEO
Phone: + 1 240-672-0295
eric.hoffman@reveragen.com

Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
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MeMed Receives CE Mark for Two Pioneering Technologies: The MeMed BV™ Test and MeMed Key™ Point-of-Need Platform

MeMed Receives CE Mark for Two Pioneering Technologies: The MeMed BV™ Test and MeMed Key™ Point-of-Need Platform

 Cutting-edge instrument platform and a novel host-immune response signature test rapidly distinguish between viral and bacterial infections to improve patient outcomes

HAIFA, Israel, June 2, 2020 – MeMed Ltd., a leader in host response-based solutions, today announced that it has received a CE Mark in Europe for use of its diagnostic test MeMed BV™ and point-of-need platform MeMed Key™.

“At its core, MeMed is about decoding the signals of the host-immune response to help physicians make better informed decisions that improve patients’ lives,” said Eran Eden, MeMed’s co-founder and CEO. “The CE-IVD mark brings us closer to impacting patients around the globe. We believe MeMed BV™ and MeMed Key™ will be a major addition to the clinical arsenal, improving outcomes for patients with acute infections, lowering healthcare costs and combating antibiotic resistance. We are indebted to the United States Department of Defense and the European Commission for their continuous support, helping us reach this significant milestone, as well as to our research collaborators who are generating an unprecedented amount of clinical evidence in the US, Europe and other regions around the globe.”

MeMed BV™ measures host-immune response proteins from a small sample of blood and applies machine learning in order to accurately distinguish between bacterial and viral infections. This provides actionable information enabling better informed antibiotic and antiviral treatment decisions. By relying on the immune response, rather than direct pathogen detection, MeMed BV™ complements conventional technologies, allowing rapid and accurate diagnosis even when the infection site is inaccessible. MeMed BV™ has been validated by an unprecedented level of high-quality real-world data from over 15,000 patients and multinational, double-blind clinical studies, published in leading peer-reviewed journals, showing over 90% sensitivity and specificity (NPV>98%) across multiple pathogens.1–5

MeMed Key™ is a cutting-edge technology platform that allows highly sensitive and rapid measurements of multiple proteins at the point of need, and specifically it runs MeMed BV™ within 15 minutes.

“The CE Mark clearance of our MeMed Key™ instrument marks an exciting milestone that builds on years of development work,” said Kfir Ovid, MeMed’s co-founder, CTO and Chairman. “The MeMed Key™ platform is not only paving the way for wide implementation of the MeMed BV™ test, but also opens the way to highly sensitive, rapid and multiplexed protein measurements at the point of care, which, so far, was mainly available using expensive central lab equipment. Leveraging the MeMed Key™ platform will allow us to expand our host-response test pipeline to other indications outside infectious diseases, furthering our efforts to continue addressing big clinical dilemmas and areas of unmet need. We are now expanding our partnerships to make these technologies widely available.”

Professor Louis Bont, MD, PhD, Division of Pediatric Immunology and Infectious Disease, University Medical Center, Utrecht, the Netherlands, noted: “While traditional diagnostics focus on identifying the disease-causing viruses or bacteria, this technology works differently. It identifies whether the patient’s immune system is actively fighting a bacterial or viral infection. Our international, double-blind study conducted and published in Lancet ID1 and BMJ Paediatrics5, as well as studies by others, showed that this host-response solution enables more accurate diagnoses compared to today’s routine tests and will meaningfully aid clinicians in improving antibiotic treatment decisions. This diagnostic is an essential step in our collaborative fight against antimicrobial resistance.”

In addition to the CE Mark in Europe, MeMed has received AMAR clearance from the Israeli Ministry of Health to market and sell MeMed BV™ and MeMed Key™.


About MeMed

Our mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. For additional information on MeMed, please visit http://www.me-med.com.

About MeMed BV™
MeMed BV™ is a pioneering immune-based protein signature test, developed and validated over the course of decade-long collaborations with leading academic and commercial partners. It provides physicians with an indispensable tool to distinguish between bacterial and viral infections and address key clinical dilemmas with over 90% sensitivity and specificity (NPV>98%) across multiple pathogens, times from symptom onset and irrespective of colonizers.1–4  MeMed BV™ measures and computationally integrates the levels of three immune system proteins: TRAIL, IP-10 and CRP. When run on the MeMed Key™ instrument platform, the MeMed BV™ test provides a result within 15 minutes. MeMed BV™ has been validated by an unprecedented level of high-quality clinical data from more than 15,000 patients and multinational, double-blind clinical studies, which have been published in leading peer-reviewed journals (including PediatricsThe Lancet IDPLOS OneBMJ Peds and European Journal of Clinical Microbiology & Infectious Diseases). The MeMed BV™ test has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.


About MeMed Key™
MeMed Key™ is a first-of-its-kind technology platform, enabling highly sensitive measurements of multiple proteins, within minutes, at the point of need. It opens the way to quantification of a vast array of human proteins in healthy and disease states, where and when it actually matters. The MeMed Key™ development program has been partially funded by the US Department of Defense and the EU Commission. MeMed Key™ has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.

MeMed Contacts:
Media: Adee Mor, VP Marketing, MeMed
pr@me-med.com  
IR: Kfir Emmer, VP Finance, MeMed
kfir.emmer@me-med.com
Phone: +972-4-8500302

References
1. Oved, K. et al. A Novel Host-Proteome Signature for Distinguishing between Acute Bacterial and Viral Infections. PLoS ONE, e0120012 (2015).
2. van Houten, C. B. et al. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis (2016).
3. Srugo, I. et al. Validation of a Novel Assay to Distinguish Bacterial and Viral Infections. Pediatrics
4. Ashkenazi-Hoffnung, L. et al. A host-protein signature is superior to other biomarkers for differentiating between bacterial and viral disease in patients with respiratory infection and fever without source: a prospective observational study. Eur. J. Clin. Microbiol. Infect. Dis. (2018).
5. van Houten, C, et al. Update of a clinical prediction model for serious bacterial infections in preschool children by adding a host-protein-based assay: a diagnostic study. BMJ Paediatrics Open (2019).

Attachment

MeMed Receives CE Mark for Two Pioneering Technologies: The MeMed BV™ Test and MeMed Key™ Point-of-Need Platform

MeMed Receives CE Mark for Two Pioneering Technologies: The MeMed BV™ Test and MeMed Key™ Point-of-Need Platform

 Cutting-edge instrument platform and a novel host-immune response signature test rapidly distinguish between viral and bacterial infections to improve patient outcomes

HAIFA, Israel, June 2, 2020 – MeMed Ltd., a leader in host response-based solutions, today announced that it has received a CE Mark in Europe for use of its diagnostic test MeMed BV™ and point-of-need platform MeMed Key™.

“At its core, MeMed is about decoding the signals of the host-immune response to help physicians make better informed decisions that improve patients’ lives,” said Eran Eden, MeMed’s co-founder and CEO. “The CE-IVD mark brings us closer to impacting patients around the globe. We believe MeMed BV™ and MeMed Key™ will be a major addition to the clinical arsenal, improving outcomes for patients with acute infections, lowering healthcare costs and combating antibiotic resistance. We are indebted to the United States Department of Defense and the European Commission for their continuous support, helping us reach this significant milestone, as well as to our research collaborators who are generating an unprecedented amount of clinical evidence in the US, Europe and other regions around the globe.”

MeMed BV™ measures host-immune response proteins from a small sample of blood and applies machine learning in order to accurately distinguish between bacterial and viral infections. This provides actionable information enabling better informed antibiotic and antiviral treatment decisions. By relying on the immune response, rather than direct pathogen detection, MeMed BV™ complements conventional technologies, allowing rapid and accurate diagnosis even when the infection site is inaccessible. MeMed BV™ has been validated by an unprecedented level of high-quality real-world data from over 15,000 patients and multinational, double-blind clinical studies, published in leading peer-reviewed journals, showing over 90% sensitivity and specificity (NPV>98%) across multiple pathogens.1–5

MeMed Key™ is a cutting-edge technology platform that allows highly sensitive and rapid measurements of multiple proteins at the point of need, and specifically it runs MeMed BV™ within 15 minutes.

“The CE Mark clearance of our MeMed Key™ instrument marks an exciting milestone that builds on years of development work,” said Kfir Ovid, MeMed’s co-founder, CTO and Chairman. “The MeMed Key™ platform is not only paving the way for wide implementation of the MeMed BV™ test, but also opens the way to highly sensitive, rapid and multiplexed protein measurements at the point of care, which, so far, was mainly available using expensive central lab equipment. Leveraging the MeMed Key™ platform will allow us to expand our host-response test pipeline to other indications outside infectious diseases, furthering our efforts to continue addressing big clinical dilemmas and areas of unmet need. We are now expanding our partnerships to make these technologies widely available.”

Professor Louis Bont, MD, PhD, Division of Pediatric Immunology and Infectious Disease, University Medical Center, Utrecht, the Netherlands, noted: “While traditional diagnostics focus on identifying the disease-causing viruses or bacteria, this technology works differently. It identifies whether the patient’s immune system is actively fighting a bacterial or viral infection. Our international, double-blind study conducted and published in Lancet ID1 and BMJ Paediatrics5, as well as studies by others, showed that this host-response solution enables more accurate diagnoses compared to today’s routine tests and will meaningfully aid clinicians in improving antibiotic treatment decisions. This diagnostic is an essential step in our collaborative fight against antimicrobial resistance.”

In addition to the CE Mark in Europe, MeMed has received AMAR clearance from the Israeli Ministry of Health to market and sell MeMed BV™ and MeMed Key™.


About MeMed

Our mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. For additional information on MeMed, please visit http://www.me-med.com.

About MeMed BV™
MeMed BV™ is a pioneering immune-based protein signature test, developed and validated over the course of decade-long collaborations with leading academic and commercial partners. It provides physicians with an indispensable tool to distinguish between bacterial and viral infections and address key clinical dilemmas with over 90% sensitivity and specificity (NPV>98%) across multiple pathogens, times from symptom onset and irrespective of colonizers.1–4  MeMed BV™ measures and computationally integrates the levels of three immune system proteins: TRAIL, IP-10 and CRP. When run on the MeMed Key™ instrument platform, the MeMed BV™ test provides a result within 15 minutes. MeMed BV™ has been validated by an unprecedented level of high-quality clinical data from more than 15,000 patients and multinational, double-blind clinical studies, which have been published in leading peer-reviewed journals (including PediatricsThe Lancet IDPLOS OneBMJ Peds and European Journal of Clinical Microbiology & Infectious Diseases). The MeMed BV™ test has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.


About MeMed Key™
MeMed Key™ is a first-of-its-kind technology platform, enabling highly sensitive measurements of multiple proteins, within minutes, at the point of need. It opens the way to quantification of a vast array of human proteins in healthy and disease states, where and when it actually matters. The MeMed Key™ development program has been partially funded by the US Department of Defense and the EU Commission. MeMed Key™ has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.

MeMed Contacts:
Media: Adee Mor, VP Marketing, MeMed
pr@me-med.com  
IR: Kfir Emmer, VP Finance, MeMed
kfir.emmer@me-med.com
Phone: +972-4-8500302

References
1. Oved, K. et al. A Novel Host-Proteome Signature for Distinguishing between Acute Bacterial and Viral Infections. PLoS ONE, e0120012 (2015).
2. van Houten, C. B. et al. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis (2016).
3. Srugo, I. et al. Validation of a Novel Assay to Distinguish Bacterial and Viral Infections. Pediatrics
4. Ashkenazi-Hoffnung, L. et al. A host-protein signature is superior to other biomarkers for differentiating between bacterial and viral disease in patients with respiratory infection and fever without source: a prospective observational study. Eur. J. Clin. Microbiol. Infect. Dis. (2018).
5. van Houten, C, et al. Update of a clinical prediction model for serious bacterial infections in preschool children by adding a host-protein-based assay: a diagnostic study. BMJ Paediatrics Open (2019).

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FDA approves Roche’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

  • Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma
  • Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care
  • Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot programme

Basel, 2 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

“We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “The application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world.”

“The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” said Dr Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center. “For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favourable tolerability profile.”

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions.1 Simultaneous applications were submitted to regulators in the United States, Australia, Canada and Singapore under Project Orbis. Additionally, the FDA rapidly reviewed and approved the application under its Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

The approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib. IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Serious adverse reactions (Grade 3-4) occurred in 38% of people in the Tecentriq and Avastin arm. The most frequent serious adverse reactions (≥2%) were bleeding in the gastrointestinal tract, infections and fever. These results were published in the New England Journal of Medicine on 14 May 2020.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMbrave150 study
IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable or metastatic HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints were IRF-assessed overall response rate (ORR) per RECIST and mRECIST.

About hepatocellular carcinoma
HCC is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide.2 Every year, more than 750,000 people worldwide are diagnosed with HCC,2,3 with the majority of cases in Asia and almost half of all cases in China.3,4 In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise.5-7 HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage.2 The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.8

About the Tecentriq and Avastin combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer. In the US, Tecentriq in combination with Avastin is approved for people with unresectable or metastatic HCC.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Food and Drug Administration. Project Orbis. [Internet; cited 2020 Mar] Available from:
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.
[2] Llovet JM et al. Hepatocellular carcinoma. Nat Rev Dis Primers. 2016;2:16018.
[3] World Health Organisation: Globocan 2018 – Liver cancer factsheet. [Internet; cited 2020 Mar] Available from: http://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf.
[4] World Health Organisation: Globocan 2018 – China factsheet. [Internet; cited 2020 Mar] Available from: http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
[5] American Cancer Society: Key statistics about liver cancer. [Internet; cited 2020 Mar] Available from: https://www.cancer.org/cancer/liver-cancer/about/what-is-key-statistics.html.
[6] Rawla P et al. Update in global trends and aetiology of hepatocellular carcinoma. Contemp Oncol (Pozn). 2018;22(3):141-150.
[7] Pimpin L et al. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. J Hepatol. 2018;69(3):718-735.
[8] Giannini EG et al. Prognosis of untreated hepatocellular carcinoma. Hepatology. 2015;61(1):184-190.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein

Attachment

Allogene Therapeutics Announces Pricing of Public Offering of Common Stock

SOUTH SAN FRANCISCO, Calif., June 01, 2020 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), today announced the pricing of an underwritten public offering of 11,702,128 shares of its common stock at a price to the public of $47.00 per share. The gross proceeds from this offering are expected to be approximately $550.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Allogene. The offering is expected to close on or about June 4, 2020, subject to customary closing conditions. In addition, Allogene has granted the underwriters a 30-day option to purchase up to 1,755,319 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

Goldman Sachs & Co. LLC, Jefferies LLC and Cowen and Company, LLC are acting as joint lead book-running managers for the offering. Piper Sandler & Co. is also acting as book-running manager. Canaccord Genuity LLC, William Blair & Company, L.L.C. and Oppenheimer & Co. Inc. are acting as co-lead managers.

The securities described above are being offered by Allogene pursuant to a shelf registration statement (including a prospectus) filed on November 5, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, or by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding the completion and timing of the public offering. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 10-Q for the quarter ended March 31, 2020 filed on May 6, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com

Jushi Holdings Inc. to Temporarily Close Two Philadelphia BEYOND / HELLO™ Locations

BOCA RATON, Fla., June 01, 2020 (GLOBE NEWSWIRE) — Jushi Holdings Inc. (“Jushi” or the “Company”) (CSE: JUSH) (OTCQX: JUSHF), a globally-focused, multi-state cannabis and hemp operator, issued the following statement from Jushi’s Chairman and Chief Executive Officer Jim Cacioppo regarding the temporary closing of its BEYOND / HELLO™ Center City and Northern Liberties store locations in Philadelphia amid ongoing demonstrations. 

Statement from Jushi’s Chairman and Chief Executive Officer Jim Cacioppo:

We fully support an individual’s right to freedom of speech and the touching peaceful demonstrations that we have seen around the country. We are heartbroken by the murder of George Floyd and the pain it is causing communities across the country that we not only work in, but live and love.

Unfortunately, certain opportunistic bad actors have at times manifested unacceptable behaviors. This past weekend, our Center City and Northern Liberties locations in Philadelphia were broken into, making it impossible for us to safely operate. In addition to these two temporary store closures, we have limited our hours at certain locations in Pennsylvania and Illinois. Please check www.beyond-hello.com for the latest details. It is our hope to begin safely servicing our customers soon from the impacted store locations and apologize for any inconvenience this may cause our patients and customers.

As committed members of the cannabis movement, we will also continue to fight for equality and work to overturn racially biased laws that ruin lives and unequally target disenfranchised communities and people of color. 

About Jushi Holdings Inc.
We are a globally focused cannabis and hemp company led by an industry leading management team. In the United States Jushi is focused on building a multi-state portfolio of branded cannabis and hemp-derived assets through opportunistic acquisitions, distressed workouts and competitive applications. Jushi strives to maximize shareholder value while delivering high quality products across all levels of the cannabis and hemp ecosystem. For more information please visit www.jushico.com or our social media channels, InstagramFacebookTwitter and LinkedIn.

Forward-Looking Information and Statements
This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “is expected,” “budget,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases or may contain statements that certain actions, events or results “may,” “could,” “would,” “might” or “will be taken,” “will continue,” “will occur” or “will be achieved”. The forward-looking information and forward-looking statements contained herein may include, but are not limited to, information concerning the expectations regarding Jushi, or the ability of Jushi to successfully achieve business objectives, and expectations for other economic, business, and/or competitive factors.

By identifying such information and statements in this manner, the Company is alerting the reader that such information and statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such information and statements. In addition, in connection with the forward-looking information and forward-looking statements contained in this press release, the Company has made certain assumptions. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information and statements are the following: the ability of Jushi to successfully achieve business objectives, including with regulatory bodies, employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including changes in the financial markets; changes in applicable laws; and compliance with extensive government regulation, as well as other risks and uncertainties which are more fully described in the Company’s Filing Statement dated December 5, 2019 and other filings with securities and regulatory authorities which are available at www.sedar.com.  Should one or more of these risks, uncertainties or other factors materialize, or should assumptions underlying the forward-looking information or statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected.

Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws. All subsequent written and oral forward-looking information and statements attributable to the Company or persons acting on its behalf is expressly qualified in its entirety by this notice.

For further information, please contact:

Investor Relations
Michael Perlman
Executive Vice President of Investor Relations and Treasury
Investors@jushico.com
(561) 453-1308

Media Contact
Ellen Mellody
MATTIO Communications
Ellen@Mattio.com
(570) 209-2947

SIGA Changes its 2020 Annual Meeting of Stockholders to Virtual Format

NEW YORK, June 01, 2020 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that it will host its 2020 Annual Meeting of Stockholders (the “Annual Meeting”) as a virtual-only meeting that will be held via live audio webcast due to the public health and safety concerns related to the COVID-19 pandemic, recommendations and orders from federal, state and local authorities, and to support the health and well-being of its stockholders, employees, and others.

The previously announced date and time of the Annual Meeting, Tuesday, June 16, 2020 at 10:30 a.m. Eastern Daylight Time, as disclosed in the proxy materials previously distributed by the Company, has not changed. Stockholders will not be able to attend the Annual Meeting in person.  A notice regarding this change to a virtual meeting format is being filed with the Securities and Exchange Commission together with this press release.

Attending the Meeting; Process for Submitting Questions

Stockholders as of the close of business on April 24, 2020 are entitled to attend the Annual Meeting.  Stockholders of record wishing to attend the annual meeting may do so by visiting https://web.lumiagm.com/294073489, entering the 11-digit control number included on the proxy card, voting instruction form or notice they previously received and entering the password “siga2020” (the password is case sensitive).  Stockholders holding their shares through a broker, bank or other intermediary as of the close of business on April 24, 2020 and wishing to attend may do so by visiting the same website, by logging in as a guest and providing the additional identifying information requested at such time.  All stockholders may log into the meeting platform beginning at 10:15 a.m. Eastern Time on June 16, 2020.  If you have questions regarding access to the annual meeting, please visit https://go.lumiglobal.com/faq.

Prior to the Annual Meeting, stockholders may submit questions relating to the subject matter of the meeting via email to annualmeetingquestion@siga.com.  All questions from stockholders must be received by 5:00 p.m. Eastern Time on Thursday, June 11, 2020.  Questions will be answered depending on the availability of time and members of management participating in the Annual Meeting.

Voting

All stockholders, whether or not planning to attend the virtual Annual Meeting, will be required to vote promptly in advance of the meeting by using one of the methods described in the proxy materials for voting prior to the Annual Meeting. The proxy card included with the previously distributed proxy materials will not be reissued and may continue to be used to vote shares in connection with the Annual Meeting.  Stockholders who have already voted do not need to take any additional action.  Stockholders who have not yet voted are urged to submit their votes promptly, as voting will not be available during the meeting.

ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®

SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a stockpile of TPOXX in the Strategic National Stockpile under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is here https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf.  In September 2018, SIGA signed a contract of more than $600 million with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.

ABOUT SMALLPOX1

Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally-occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine’s side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in SIGA’s filings with the Securities and Exchange Commission, including SIGA’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC’s web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.

The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.

Contacts:

Investors
David Carey
212-867-1768
david.carey@finnpartners.com

Media
Stephanie Seiler
206-713-0124
stephanie.seiler@finnpartners.com

1http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769

Guardant Health Announces Proposed Public Offering of Common Stock

REDWOOD CITY, Calif., June 01, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) (“Guardant Health”), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, announced today the commencement of a proposed underwritten public offering of 10,000,000 shares of its common stock (3,000,000 of which are being offered for sale by Guardant Health and 7,000,000 are being offered for sale by SoftBank Investment Advisers). In addition, Guardant Health and SoftBank Investment Advisers expect to grant the underwriter a 30-day option to purchase up to 1,500,000 additional shares of common stock (450,000 additional shares from Guardant Health and 1,050,000 additional shares from SoftBank Investment Advisers) at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Guardant Health intends to use the net proceeds from the offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by Guardant Health, primarily for general corporate purposes, including working capital, sales and marketing activities, general and administrative matters and capital expenditures. Guardant Health will not receive any proceeds from the sale of shares in the offering by SoftBank Investment Advisers.

J.P. Morgan Securities LLC is acting as sole book-running manager of the offering.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed by Guardant Health with the U.S. Securities and Exchange Commission (the “SEC”) and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding the proposed offering of Guardant Health’s common stock, the timing and size of and mix of primary and secondary shares in the proposed offering, the grant of the option to purchase additional shares and the anticipated use of the net proceeds from the proposed offering. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond Guardant Health’s control, include, among others, the risks described in Guardant Health’s preliminary prospectus supplement dated June 1, 2020 and the documents incorporated in the prospectus supplement by reference. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Guardant Health disclaims any obligation to update these forward-looking statements, except as required by law.

Investors:
Carrie Mendivil
investors@guardanthealth.com

Media:
Anna Czene
press@guardanthealth.com

Amedisys Completes Acquisition of AseraCare Hospice

BATON ROUGE, La., June 01, 2020 (GLOBE NEWSWIRE) — Amedisys, Inc. (NASDAQ:AMED), a leading provider of home health, hospice and personal care, announced today that, through one of its wholly owned subsidiaries, it has closed on its acquisition of Homecare Preferred Choice, Inc., doing business as AseraCare Hospice (“AseraCare Hospice” or “AseraCare”), a national hospice care provider with an executive office in Plano, Texas and administrative support center in Fort Smith, Arkansas.

Under the terms of the agreement, Amedisys acquired 100 percent of the ownership interests in AseraCare Hospice for a cash purchase price of $235 million, which is inclusive of a $32 million tax asset bringing the net purchase price to $203 million. The Company did not use any of the funds received by the Company from the Public Health and Social Services Emergency Fund that was appropriated by Congress to the Department of Health and Human Services in the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act to fund the acquisition.

“AseraCare has been on our radar for a long time. We have long admired their strong culture, focus on patients and employees and commitment to always providing high-quality care,” stated Paul Kusserow, Amedisys’ president and chief executive officer. “We are excited about the opportunity, as one company, to bring the gift of hospice to more communities.”

Founded in 1994, AseraCare Hospice cares for more than 2,100 patients daily and employs more than 1,200 hospice professionals in 44 locations across 14 states, generating approximately $117 million in annual revenues.

This acquisition adds greater scale to Amedisys’ high-quality, nationwide network. Combined, our new hospice operations will include 190 care centers in 35 states, with an average daily census of approximately 14,000 patients and approximately 7,000 hospice employees.

“We feel privileged to welcome AseraCare Hospice into the Amedisys family. We share our commitment to delivering compassionate, patient-centered care to patients and their families, and a culture of engagement and support to our colleagues and caregivers,” said Anthony Mollica, Amedisys’ president of hospice. “We are all in the hospice business because we care. For us, this is not our job; caregiving is our calling.”

This acquisition is the fourth hospice acquisition for Amedisys since 2019. The Company acquired and integrated Compassionate Care Hospice in February 2019, RoseRock Healthcare in April 2019 and Asana Hospice in January 2020.  

“AseraCare and Amedisys have always shared an absolute and sacred commitment to help our patients live each day to its fullest, one person, one family and one community at a time,” stated AseraCare President Larry Deans. “I am fully confident that Amedisys will continue and build upon our mission-driven purpose and high-quality care for our patients and families for years to come.”

Media Contact: Investor Contact:
   
Kendra Kimmons Nick Muscato
Vice President of Marketing & Communications Vice President of Strategic Finance
225-299-3708 615-928-5452
kendra.kimmons@amedisys.com  nick.muscato@amedisys.com 

About AseraCare Hospice

AseraCare is a leading provider of hospice services caring for more than 2,100 patients and families per day. The company operates 44 locations in 14 states. For more information about AseraCare visit: www.aseracare.com.

About Amedisys:

Amedisys, Inc. is a leading healthcare at home Company delivering personalized home health, hospice and personal care. Amedisys is focused on delivering the care that is best for our patients, whether that is home-based personal care; recovery and rehabilitation after an operation or injury; care focused on empowering them to manage a chronic disease; or hospice care at the end of life. More than 2,600 hospitals and 67,000 physicians nationwide have chosen Amedisys as a partner in post-acute care. Founded in 1982, headquartered in Baton Rouge, La. with an executive office in Nashville, Tenn., Amedisys is a publicly held company. With more than 21,000 employees in 524 care centers within 39 states and the District of Columbia, Amedisys is dedicated to delivering the highest quality of care to the doorsteps of more than 415,000 patients and clients in need every year. For more information about the Company, please visit: www.amedisys.com

Forward-Looking Statements

When included in this press release, words like “believes,” “belief,” “expects,” “strategy,” “plans,” “anticipates,” “intends,” “projects,” “estimates,” “may,” “might,” “will,” “would,” “should” and similar expressions are intended to identify forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the expected effects of the AseraCare Hospice acquisition and the Company’s hospice strategy. These forward-looking statements involve a variety of risks and uncertainties that could cause actual results to differ materially from those described therein. These risks and uncertainties include, but are not limited to the following: our ability to realize the anticipated benefits of the acquisition of AseraCare Hospice, the impact of the COVID-19 pandemic, including the measures that have been and may be taken by governmental authorities to mitigate it, on our business, financial condition and results of operations, changes in or our failure to comply with existing federal and state laws or regulations or the inability to comply with new government regulations on a timely basis, changes in Medicare and other medical payment levels, our ability to open care centers, acquire additional care centers and integrate and operate these care centers effectively, competition in the healthcare industry, changes in the case mix of patients and payment methodologies, changes in estimates and judgments associated with critical accounting policies, our ability to maintain or establish new patient referral sources, our ability to consistently provide high-quality care, our ability to attract and retain qualified personnel, our ability to keep our patients and employees safe, changes in payments and covered services by federal and state governments, future cost containment initiatives undertaken by third-party payors, our access to financing, our ability to meet debt service requirements and comply with covenants in debt agreements, business disruptions due to natural disasters or acts of terrorism, our ability to integrate, manage and keep our information systems secure, our ability to realize the anticipated benefits of acquisitions, and changes in law or developments with respect to any litigation relating to the Company, including various other matters, many of which are beyond our control.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on any forward-looking statement as a prediction of future events. We expressly disclaim any obligation or undertaking and we do not intend to release publicly any updates or changes in our expectations concerning the forward-looking statements or any changes in events, conditions or circumstances upon which any forward-looking statement may be based, except as required by law.