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• 29% ORR (7% CR) and 57% DCR (RECIST 1.1)
• 75% ORR in anti-PD-1-refractory patients
• 56% DCR (11% CR) in patients refractory to anti-CTLA-4 and anti-PD-1 combination therapy
• Presentation delivered by Moffitt’s Jonathan Zager, MD

KNOXVILLE, TN, Dec. 07, 2020 (GLOBE NEWSWIRE) — Provectus (OTCQB: PVCT) today announced that updated preliminary patient response, safety, and immune correlative data, as well as new preliminary PV-10-treated lesion response data, from the Company’s ongoing Phase 1b/2 study of autolytic cancer immunotherapy PV-10, an injectable formulation of Provectus’ proprietary small molecule rose bengal disodium (RBD), in combination with KEYTRUDA (pembrolizumab) for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade (CB) was presented at Melanoma Bridge 2020, held online from December 3-5, 2020.

The oral presentation, entitled “Response for combination of PV-10 autolytic immunotherapy and immune checkpoint blockade in checkpoint-refractory patients,” was presented by Dr. Jonathan Zager, Chief Academic Officer at Moffitt Cancer Center (Moffitt), and a surgical oncologist and Senior Member in Moffitt’s Departments of Cutaneous Oncology and Sarcoma. Dr. Zager is also the Director of Regional Therapies at Moffitt’s Donald A. Adam Comprehensive Melanoma Research Center and a Professor of Surgery at the Morsani School of Medicine of the University of South Florida.

Presentation materials are available on Provectus’ website by clicking on the links immediately below:

• 
  A video of Dr. Zager’s oral presentation
  ,
• 
  A copy of the presentation slides
  , and
• 
  A copy of the slides together with Dr. Zager’s print commentary
  .

Key highlights of the Melanoma Bridge 2020 presentation:

• Safety data on 18 patients
  • Consistent with the established patterns for single-agent use of each drug
  • Principally grades 1 and 2 injection-site reactions to PV-10
  • Principally grades 1 to 3 immune-mediated reactions to KEYTRUDA
• 14 patients evaluable for overall efficacy
  • Investigator-assessed RECIST v1.1
  • All patients (14): 7% complete response (CR) (1/14), 36% overall response rate (ORR) (3/14), and 64% disease control rate (DCR) (8/14)
  • Refractory to anti-PD-1 (4): 75% ORR (3/4)
  • Refractory to anti-CTLA-4 and anti-PD-1 combination therapy (9): 11% CR (1/9) and 56% DRR (5/9)
• 16 lesions treated with PV-10
  • 38% CR (6/16), 50% ORR (8/16), and 69% DCR (11/16)
• 5 patient-completed immune correlative assessments
  • DAMPs and T cells present in peripheral blood are indicative of innate and adaptive immune signaling, respectively
  • Upregulation of innate and adaptive immune responses appears to be maintained in CB-refractory subjects
  • PV-10-hallmark DAMP and functional T cell responses in CB-refractory patients are consistent with responses in CB-naïve patients who received either single-agent PV-10 or PV-10 and KEYTRUDA combination therapy in other Provectus melanoma clinical trials

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors said, “Immune checkpoint blockade-refractory metastatic melanoma is a high unmet medical need that only continues to grow, with low response, poor survival rates, and limited patient treatment options. This need is particularly acute for deeply refractory melanoma patients who fail ipilimumab and nivolumab combination therapy. This study’s safety, efficacy, and immune correlative data suggest PV-10 may play a critical role in overcoming acquired resistance to checkpoint blockade.”

About the Phase 1b/2 Combination Therapy Trial (NCT02557321)

A first expansion cohort of the Phase 1b portion of the study began enrolling patients with metastatic cutaneous melanoma who were CB-refractory in December 2018. This CB-refractory cohort extended an exploratory group of refractory patients enrolled into the study’s main cohort that primarily enrolled CB-naïve patients. CB-refractory patients with at least one injectable lesion and who were candidates for KEYTRUDA were eligible. Eligible subjects received the combination treatment of PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., over a period of up to 12 weeks), followed by only KEYTRUDA every three weeks for up to 24 months. The protocol allows for additional cycles of PV-10 beyond the fifth cycle for patients with additional injectable disease. The primary endpoint for the Phase 1b trial was safety and tolerability. ORR and progression-free survival were key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter).

About PV-10

Intralesional (IL) (aka intratumoral) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days.^1,2,3 This IL PV-10-induced functional T cell response may be enhanced and boosted in combination with CB.⁴ In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to tumors of the liver. In this Phase 1b/2 study, IL PV-10 was administered to melanoma tumors located at cutaneous, subcutaneous, soft tissue and nodal sites (it was not administered to visceral sites).

About Rose Bengal Disodium

RBD is 4,5,6,7-tetrachloro-2′,4′,5′,7′-tetraiodofluorescein disodium, a halogenated xanthene and Provectus’ proprietary lead molecule. Provectus’ current Good Manufacturing Practices (cGMP) RBD is a proprietary pharmaceutical-grade drug substance produced by the Company’s quality-by-design (QbD) manufacturing process to exacting regulatory standards that avoids the formation of uncontrolled impurities currently present in commercial-grade rose bengal. Provectus’ RBD and cGMP RBD manufacturing process are protected by composition of matter and manufacturing patents as well as trade secrets.

An IL formulation (i.e., by direct injection) of cGMP RBD drug substance, cGMP PV-10, is being developed as an autolytic immunotherapy drug product for solid tumor cancers. By targeting tumor cell lysosomes, RBD treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells, including a T cell mediated immune response against treatment refractory and immunologically cold tumors.^1,2,3 Adaptive immunity can be enhanced by combining CB with RBD.⁴ IL PV-10 is undergoing clinical study for relapsed and refractory adult solid tumor cancers, such skin and liver cancers.

IL PV-10 is also undergoing preclinical study for relapsed and refractory pediatric solid tumor cancers, such as neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.^5,6

A topical formulation of cGMP RBD drug substance, PH-10^®, is being developed as a clinical-stage immuno-dermatology drug product for inflammatory dermatoses, such as atopic dermatitis and psoriasis. RBD can modulate multiple interleukin and interferon pathways and key cytokine disease drivers.⁷

Oral formulations of cGMP RBD are undergoing preclinical study for relapsed and refractory pediatric blood cancers, such as acute lymphocytic leukemia and acute myelomonocytic leukemia.^8,9

Oral formulations of cGMP RBD are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk adult solid tumor cancers, such as head and neck, breast, pancreatic, liver, and colorectal cancers.

Different formulations of cGMP RBD are also undergoing preclinical study as potential treatments for multi-drug resistant (MDR) bacteria, such as Gram-negative bacteria.

Topical formulations of cGMP RBD are also undergoing preclinical study as potential treatments for diseases of the eye, such as infectious keratitis

Tumor Cell Lysosomes as the Seminal Cancer Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.¹⁰ Cancer progression and metastasis are associated with lysosomal compartment changes^11,12, which are closely correlated (among other things) with invasive growth, angiogenesis, and drug resistance¹³.

RBD selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus^1,14, external collaborators⁵, and other researchers^15,16,17 have independently shown that RBD triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via RBD: RBD-induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine hepatocellular carcinoma (HCC) cells can be viewed in this Provectus video of the process (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames, with a duration of approximately one hour). Exposure to RBD triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video of the process, with a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators in neuroblastoma cells to show that lysosomes are disrupted upon exposure to RBD.⁵

Tumor Autolytic Death via RBD: RBD causes acute autolytic destruction of injected tumors (via autolytic cell death), mediating the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens; release of these signaling factors may initiate an immunologic cascade where local response by the innate immune system may facilitate systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Mediated immune signaling pathways may include an effect on STING, which plays an important role in innate immunity.⁹

Orphan Drug Designations (ODDs)

ODD status has been granted to RBD by the U.S. Food and Drug Administration for metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Intellectual Property (IP)

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which cGMP RBD and related halogenated xanthenes are produced, avoiding the formation of previously unknown impurities that exist in commercial-grade rose bengal in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of RBD and CB (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035; US patent application numbers include 20200138942.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entirely- and wholly-owned family of small molecules called halogenated xanthenes. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.

References

1. Wachter et al. Functional Imaging of Photosensitizers using Multiphoton Microscopy. Proceedings of SPIE 4620, 143, 2002.

2. Liu et al. Intralesional rose bengal in melanoma elicits tumor immunity via activation of dendritic cells by the release of high mobility group box 1. Oncotarget 7, 37893, 2016.

3. Qin et al. Colon cancer cell treatment with rose bengal generates a protective immune response via immunogenic cell death. Cell Death and Disease 8, e2584, 2017.

4. Liu et al. T cell mediated immunity after combination therapy with intralesional PV-10 and blockade of the PD-1/PD-L1 pathway in a murine melanoma model. PLoS One 13, e0196033, 2018.

5. Swift et al. Potent in vitro and xenograft antitumor activity of a novel agent, PV-10, against relapsed and refractory neuroblastoma. OncoTargets and Therapy 12, 1293, 2019.

6. Swift et al. In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors. 2018 ASCO Annual Meeting, J Clin Oncol 36, 2018 (suppl; abstr 10557).

7. Krueger et al. Immune Modulation by Topical PH-10 Aqueous Hydrogel (Rose Bengal Disodium) in Psoriasis Lesions. Psoriasis Gene to Clinic, 8^th International Congress, Br J Dermatol 177.

8. Swift et al. In Vitro Activity and Target Modulation of PV-10 Against Relapsed and Refractory Pediatric Leukemia. 2018 ASH Annual Meeting, Blood 132, 2018 (suppl; abstr 5207).

9. Thakur et al. Association of heat shock proteins as chaperone for STING: A potential link in a key immune activation mechanism revealed by the novel anti-cancer agent PV-10. 2020 AACR VAM II, (abstr 5393).

10. Piao et al. Targeting the lysosome in cancer. Annals of the New York Academy of Sciences. 2016; 1371(1): 45.

11. Nishimura et al. Malignant Transformation Alters Intracellular Trafficking of Lysosomal Cathespin D in Human Breast Epithelial Cells. Pathology Oncology Research. 1998; 4(4): 283.

12. Gocheva et al. Distinct roles for cysteine cathepsin genes in multistage tumorigenesis. Genes & Development. 2006; 20(5): 543.

13. Fehrenbacher et al. Lysosomes as Targets for Cancer Therapy. Cancer Research. 2005; 65 (8): 2993.

14. Wachter et al. Imaging Photosensitizer Distribution and Pharmacology using Multiphoton Microscopy. Proceedings of SPIE 4622, 112, 2002.

15. Koevary. Selective toxicity of rose Bengal to ovarian cancer cells in vitro. International Journal of Physiology, Pathophysiology and Pharmacology 4(2), 99, 2012.

16. Zamani et al. Rose Bengal suppresses gastric cancer cell proliferation via apoptosis and inhibits nitric oxide formation in macrophages. Journal of Immunotoxicology, 11(4), 367, 2014.

17. Luciana et al. Rose Bengal Acetate photodynamic therapy-induced autophagy. Cancer Biology & Therapy, 10:10, 1048, 2010.

Trademarks

PV-10^® and PH-10^® are registered trademarks of Provectus, Knoxville, Tennessee, U.S.A.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Kenilworth, New Jersey, U.S.A.

FORWARD-LOOKING STATEMENTS:

The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in


Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019


and


Provectus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2020


.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

MIAMI, FL, Dec. 07, 2020 (GLOBE NEWSWIRE) — via NewMediaWire – Progressive Care Inc. (OTCQB:RXMD) (“Progressive Care” or the “Company”), a personalized healthcare services and technology company, is pleased to announce performance data for the month of October, which featured a strong jump in operating margins, significant sequential monthly growth in net revenues, and the establishment of sales growth related to rapid results COVID-19 testing.

• Consolidated net sales across all locations during October 2020 totaled $3,3M, representing a 7% sequential monthly growth.
• October margins increased to 27%, helping to drive a 53% sequential monthly jump in cash on hand.
• Prescriptions filled during October grew 1% on a sequential monthly basis.
• 340B pharmacy dispensing fees grew 119% in October on a year-over-year basis.
• The Company booked nearly $100K in revenues related to rapid results COVID-19 testing in October.

Management notes that gross sales saw a minor drop, driven by the Company’s aggressive push to prioritize generic medication alternatives over expensive branded medications, which offer savings to customers as well as wider profit margins for the pharmacy.

October was also a significant month as the Company saw its rapid results virus testing service expand substantially. The Company is focused on building the PharmcoRx brand as a solution for COVID-19 rapid testing by adding two new analyzers for PCR Testing: Abbott ID NOW and Cepheid. The Cepheid analyzer will allow the Company to simultaneously test for four types of infections: COVID-19, Flu A, Flu B and RSV, providing rapid results in 15 minutes.

“October was another strong month characterized by expanding margins and strong execution,” commented Alan Jay Weisberg, CEO and Chairman of Progressive Care. “We have secured a market-leading position in COVID-19 testing in Dade County and we look forward to becoming a major provider of COVID-19 vaccines next year.”

For more information about Progressive Care, please visit the company’s website. 

Connect and stay in touch with us on social media:

Progressive Care Inc. 

https://www.facebook.com/ProgressiveCareUS/ 

https://twitter.com/ProgressCareUS

PharmCo Rx 

https://www.facebook.com/pharmcorx/ 

https://twitter.com/PharmCoRx

ClearMetrX 

https://www.clearmetrx.com/

https://www.facebook.com/clearmetrx/

About Progressive Care Progressive Care Inc. (OTCQB: RXMD), through its subsidiaries, is a Florida health services organization and provider of prescription pharmaceuticals, compounded medications, provider of tele-pharmacy services, the sale of anti-retroviral medications, medication therapy management (MTM), the supply of prescription medications to long-term care facilities, and health practice risk management.

Cautionary Statement Regarding Forward-Looking Statements Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute 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. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance, and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding expansion in COVID-19 testing and expected distribution of COVID-19 vaccines. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target,” “intend” and “expect” and similar expressions, as they relate to Progressive Care Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.

Public Relations Contact:

Carlos Rangel
[email protected]

LONDON and CARLSBAD, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that the Company will present at the Needham Virtual Epilepsy & Pain – Specialty CNS Therapeutics Conference on Thursday, December 10, 2020 at 11:00am EST.

A live audio webcast of the presentation will be available through GW’s corporate website at www.gwpharm.com in the Investors section under Events & Presentations. A replay will be available soon after the live presentation.

About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX^® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX^® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

Enquiries:

GW Pharmaceuticals plc
Scott Giacobello, Chief Financial Officer	760 795 2200

MINNEAPOLIS, Dec. 07, 2020 (GLOBE NEWSWIRE) — OTCQB: (PETV) PetVivo Holdings, Inc. (www.petvivo.com) an emerging biomedical device company operating in the $19B veterinary market announced today it will be exhibiting at the American Association of Equine Practitioners (“AAEP”) Virtual Convention and Trade Show from December 5^th to December 8^th, 2020 that can be accessed online at https://convention.aaep.org/.

PetVivo is excited to meet with many of the more than 1,000 participants to talk about and introduce its lead product, KUSH^®, a medical device injection of sterilized, hydrogel microparticles that are wet, slippery and spongy used in the treatment of lameness and other joint related afflictions, such as osteoarthritis. AAEP is the largest veterinary equine conference in the United States and plays host to many of the top industry professionals. As a highlight to the conference, PetVivo is hosting a presentation about joint afflictions and therapeutic treatments, which includes information about its own cartilage mimicking medical device, KUSH^®. The presentation will feature a keynote speaker and expert in equine health, Tracy Turner, DVM, MS, Dipl. ACVS, Dipl. ACVSMR, who will provide beneficial insight on common lameness afflictions found in horses and the therapies he has used to treat such injured animals.

“I am incredibly excited to participate in the presentation hosted by PetVivo entitled “Kush^® – a Promising New Treatment for Joint Problems” to share my thoughts and insights regarding equine lameness and the beneficial treatments for such afflictions,” explained Dr. Tracy Turner.

Conference Details:

American Association of Equine Practitioners Virtual Convention and Trade Show

Dates:

Sunday, December 6, 2020 9:00am – 5:00pm

Monday, December 7, 2020 9:00am – 5:00pm

Tuesday, December 8, 2020 9:00am – 4:00pm

Location: Virtual

For more information about PetVivo, Inc. and Kush, please contact [email protected] or visit https://petvivo.com/

About PetVivo Holdings, Inc.

PetVivo Holdings Inc. (OTCQB: PETV) is an emerging biomedical device company currently focused on the manufacturing, commercialization and licensing of innovative medical devices and therapeutics for companion animals. The Company’s strategy is to leverage human therapies for the treatment of companion animals in a capital and time efficient way. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market much earlier than more stringently regulated pharmaceuticals and biologics.

PetVivo has a pipeline of seventeen products for the treatment of animals and people. A portfolio of eighteen patents protects the Company’s biomaterials, products, production processes and methods of use. The Company’s lead product Kush, a veterinarian-administered, intraarticular injection for the treatment of osteoarthritis in dogs and horses, is scheduled for expanded commercial sale later this year.

CONTACT:

John Lai, CEO
PetVivo Holdings, Inc.
Email: [email protected] 
(952) 405-6216

Forward-Looking commercial Statements:

The foregoing material may contain “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, each as amended. Such statements include, but are not limited to, any statements relating to our expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. These statements may be preceded by, followed by, or include the words “aim,” “anticipate,” “believe,” “estimate, “expect,” “forecast,” “intend,” “likely,” “outlook,” “plan,” “potential,” “project,” “projection,” “seek,” “can,” “could,” “may,” “should,” “would,” “will,” the negatives thereof and other words and terms of similar meanings. We caution that such statements may be subject to uncertainties and that actual results could differ materially from the forward-looking statements. There is no assurance that any forward-looking statements will materialize. Readers accordingly should not place undue reliance on these forward-looking statements, which do not reflect unknown or unanticipated events or circumstances occurring after the date of these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Attachment

• Osteoarthritis

WOODSIDE, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) —

WHO:                 
Socrates.ai, providers of the Employee Awesome Digital Conversation Hub

WHAT:

Will present “Return on Experience | Scaling HR While Providing an Ideal Employee First Experience” during this week’s HR Tech Roundtable.

WHEN:

Thursday, December 10, 2020, at 2 p.m. ET.

WHERE:

To register, visit https://virtual.hrtechroundtable.com/december-10.

DETAILS:

Scaling HR requires a solid foundation based on organized information and verified answers. During this case study presentation, Melissa Swisher, Chief Revenue Officer for Socrates.ai, will join Kevin McDonald, vice president, BPO Governance & HR Operations at The E.W. Scripps Company, to explore how Scripps used Content Transformation to achieve this while providing an Employee First experience.

Swisher and McDonald will consider the benefits of meeting employees where they are, offering a simple, easy-to-use solution via SMS, helping improve HR interactions for employees, and delivering the information needed without introducing a new platform. Attendees will learn about evolving with technology to move HR towards a more consumer-like employee experience.

To register, visit https://virtual.hrtechroundtable.com/december-10.

About Socrates
.ai

Socrates.ai builds on humanity in the best way possible – via real conversations in real-time. Leveraging artificial intelligence to pull together the HR and benefits answers and information that employees need into the world’s first Employee Awesome Digital Conversation Hub, Socrates.ai simplifies and transforms the entire experience, starting with HR and IT.

Since launching in 2017, Socrates.ai has raised more than $26 million in funding from leading venture capital firms and been named a Gartner “Cool” Vendor, Top 10 Virtual Assistant Solution Providers by CIO Magazine and Hot Startup by Business Insider, and one of six selected for Mercer’s inaugural HRTech Incubator Program. To learn more, visit socrates.ai.

Media Contact: 
Kate Achille
The Devon Group
[email protected] 
732-706-0123

DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that scientific findings that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) will be presented during the National Lipid Association (NLA) Scientific Sessions 2020, being held virtually from December 10 – 12, 2020. These findings will be featured in two Late Breaker and six e-Poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.

“We are pleased to support several Late Breaker and numerous e-Poster presentations at the upcoming NLA Scientific Sessions 2020,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “We continue to showcase data from our REDUCE-IT® study demonstrating the unique and proven efficacy of VASCEPA in cardiovascular risk reduction while providing support to investigators to explore other ways in which VASCEPA can potentially impact public health.”

Amarin added that the Late Breaker presentation of the VASCEPA COVID-19 CardioLink-9 Randomized Trial is of primary results from a trial supported by Amarin and HLS Therapeutics, Inc. that was conducted by independent investigators.

Featured Amarin-supported Late Breakers to be presented:

• 
  “EPA Levels and Cardiovascular Outcomes in the Reduction of Cardiovascular Events with
  
  
  Icosapent
  
  
  Ethyl–Intervention Trial”
  – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD – December 12, 4:30-5:15 pm CST

• 
  “
  
  
  First Human Trial of a Loading Dose of
  
  
  Icosapent
  
  
  Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial
  
  
  ”
  – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA – December 12, 4:30-5:15 pm CST

Other Amarin-supported


REDUCE-IT


abstracts to be presented include:

• 
  “
  
  
  REDUCE-IT USA
  
  
  : Results
  
  
  f
  
  
  rom the 3146 Patients Randomized in the United States”
  – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD

Other Amarin-supported abstracts providing mechanism of action insights include


*


:

• 
  “
  
  
  Eicosapentaenoic
  
  
  Acid Maintains Normal Membrane Cholesterol Distribution under Hyperglycemic Conditions unlike a Mixed Omega-3 Fatty Acid Supplement”
  

• 
  “Variability in Content of Omega-3 Fatty Acids and other Fatty Acids in Multiple Lots of a Widely Used Fish Oil Dietary
  
  
  Supplement
  
  
  ”
  

• 
  “
  
  
  Eicosapentaenoic
  
  
  Acid Improves Endothelial Nitric Oxide Bioavailability and Changes Fatty Acid Content in a Manner Distinct from Docosahexaenoic Acid”
  

• 
  “
  
  
  Eicosapentaenoic
  
  
   Acid Reduces Expression of Pulmonary Endothelial Angiotensin Converting Enzyme (ACE) Linked to Inflammation”
  

• 
  “
  
  
  Eicosapentaenoic
  
  
  Acid Reverses Endothelial Dysfunction following Exposure to the Cytokine IL-6 in Contrast to Docosahexaenoic and Arachidonic Acids”
   

  *Presented on behalf of all authors by R. Preston Mason, Ph.D., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, Elucida Research LLC, Beverly, MA

Additional information on NLA Scientific Sessions 2020 can be found here.

About Amarin

Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. VASCEPA is not yet approved and available in any other countries. Amarin, on its own or together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, Europe and the Middle East. For more information about Amarin, visit www.amarincorp.com.

About Cardiovascular Risk

The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.¹ In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.² Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.^3,4,5

About REDUCE-IT®

REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.⁶ The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.⁷ The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.⁸ These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.

About
VASCEPA
®
(
icosapent
ethyl) Capsules

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times. VASCEPA is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019.

Indications and Limitation of Use

VASCEPA is indicated:

• As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
  • established cardiovascular disease or
  • diabetes mellitus and two or more additional risk factors for cardiovascular disease.
• As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information

• VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
• VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
• It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
• VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
• Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
• Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
• Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
• Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

Effect of
VASCEPA
on Time to First Occurrence of Cardiovascular Events in Patients with

Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

	VASCEPA		Placebo		VASCEPA  vs Placebo
	N = 4089 n (%)	Incidence Rate (per 100 patient years)	N =4090 n (%)	Incidence Rate (per 100 patient years)	Hazard Ratio (95% CI)
Primary composite endpoint
Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)	705 (17.2)	4.3	901 (22.0)	5.7	0.75 (0.68, 0.83)
Key secondary composite endpoint
Cardiovascular death, myocardial infarction, stroke (3-point MACE)	459 (11.2)	2.7	606 (14.8)	3.7	0.74 (0.65, 0.83)
Other secondary endpoints
Fatal or non-fatal myocardial infarction	250 (6.1)	1.5	355 (8.7)	2.1	0.69 (0.58, 0.81)
Emergent or urgent coronary revascularization	216 (5.3)	1.3	321 (7.8)	1.9	0.65 (0.55, 0.78)
Cardiovascular death [1]	174 (4.3)	1.0	213 (5.2)	1.2	0.80 (0.66, 0.98)
Hospitalization for unstable angina [2]	108 (2.6)	0.6	157 (3.8)	0.9	0.68 (0.53, 0.87)
Fatal or non-fatal stroke	98 (2.4)	0.6	134 (3.3)	0.8	0.72 (0.55, 0.93)
[1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

FULL
VASCEPA

PRESCRIBING INFORMATION

CAN BE FOUND AT

WWW.


VASCEPA


.COM

.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential impact of VASCEPA in various clinical uses. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin Contact Information

Investor Inquiries:

Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
[email protected] (investor inquiries)

Solebury Trout
[email protected]

Media Inquiries:

Alina Kolomeyer
Communications
Amarin Corporation plc
In U.S.: +1 (908) 892-2028
[email protected] (media inquiries)

¹ American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.
² Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
³ Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
⁴ Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
⁵ Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease – New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
⁶ Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
⁷ Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
⁸ Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.

–
Amen
ded agreement
encompasses
enhanced
manufacturing collaboration
and regulatory support

-A
ccelerates
milestone payments
to Nabriva
,
including
fourth quarter 2020
payment of $1 million

DUBLIN, Ireland, Dec. 07, 2020 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the restructuring of its license agreement with Sinovant Sciences for XENLETA™ (lefamulin) in the greater China region. The restructured agreement provides for additional manufacturing collaboration and regulatory support [to be provided to Sinovant by Nabriva] that is expected to help expedite the delivery of XENLETA to patients in greater China. The restructured agreement accelerates components of the $5 million milestone payment to Nabriva that was previously payable upon regulatory approval of XENLETA in China, including a payment of $1 million in the fourth quarter of 2020.

In March 2018, Nabriva granted to Sinovant Sciences an exclusive license to develop and commercialize XENLETA (SNV001) in China. Under the original license agreement, Nabriva received a $5 million upfront payment and is eligible for up to approximately $90 million in additional payments tied to the successful completion of certain regulatory and commercial milestones related to XENLETA for community acquired bacterial pneumonia (CABP) in China. In addition, Nabriva will be eligible to receive low double-digit royalties on sales of XENLETA following regulatory approval in the greater China region. Sinovant Sciences is currently conducting a clinical trial of XENLETA in China.

About XENLETA
XENLETA™ (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.xenleta.com.

About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit https://www.nabriva.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in China, the timing of payments to Nabriva under its license agreement with Sinovant, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, the sufficiency of Nabriva Therapeutics’ existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACTS:

For Investors
Gary Sender
Nabriva Therapeutics plc
[email protected]

For Media
Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502

LAKE FOREST, Illinois, Dec. 07, 2020 (GLOBE NEWSWIRE) — Acquired Sales Corp. (OTCQB: AQSP) (www.AcquiredSalesCorp.com) announced today that its wholly-owned subsidiary Lifted Made, Zion, IL (www.LiftedMade.com), maker of hemp and hemp-derived products including CBD and delta 8 THC, has signed an exclusive agreement with Girish GPO, Des Plaines, IL (www.GirishGPO.com), to distribute certain of Lifted Made’s CBD and delta 8 THC products to independent pharmacies throughout the United States. In the exclusive agreement, Girish GPO has committed to distribute Lifted Made’s products to at least 500 independent pharmacies within 90 days, and to use its best efforts to distribute Lifted Made’s products to 2,500 independent pharmacies nationwide within 180 days. The initial term of the distribution agreement is six months, with yearly extensions possible thereafter.

Lifted Made’s hemp-derived products available for distribution under this agreement include CBD and nano CBD tinctures, CBD salves, CBD muscle gel, delta 8 THC gummies, delta 8 THC tinctures, delta 8 THC cartridges, delta 8 THC dabs, and a 510 compatible battery specifically designed for delta 8 THC cartridges.

Nicholas S. Warrender, AQSP’s COO and the CEO of Lifted Made, said, “Girish GPO’s huge national network of independent pharmacies is a very significant new distribution channel for Lifted Made, and allows Lifted Made to further diversify the types of retail outlets in which our products are sold. Our sales this quarter are surging, and this agreement will add further fuel to the fire!”

William C. “Jake” Jacobs, AQSP’s President and CFO, said “Girish GPO’s decision to exclusively distribute Lifted Made’s CBD and delta 8 THC products is a testament to the quality and reputation of Lifted Made’s brands. And very importantly, independent pharmacies are essential businesses which we expect will continue to remain open during the pandemic. We hope that this gives more access to our products during these difficult times.”

About Lifted Made and Acquired Sales Corp.



Lifted Made was founded in 2015 by CEO Nicholas S. Warrender. In February 2020, Lifted Made became a wholly-owned subsidiary of publicly traded 



Acquired Sales Corp.



 (OTCQB ticker symbol 



AQSP



). Lifted Made makes many delta 8 THC and other hemp and hemp-derived products, all of which can be purchased online at 



www.LiftedMade.com



. Acquired Sales Corp. also owns 4.99% of CBD-infused beverage and products maker 



Ablis Holding Company



, and of craft distillers Bendistillery Inc. d/b/a 



Crater Lake Spirits



 and 



Bend Spirits, Inc.




,

 Bend, Oregon. For more information about Acquired Sales Corp., visit 



www.AcquiredSalesCorp.com



.

Cautionary Note Regarding Forward-Looking Statements Certain statements in this document are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such information includes the growth and profitability strategies, and future products and plans of Lifted Made and Acquired Sales Corp. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors which may cause or contribute to the actual results of Lifted Made’s and Acquired Sales Corp.’s operations or the performance or achievements of these companies differing materially from those expressed or implied by the forward-looking statements. Lifted Made and Acquired Sales Corp. undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Actual results, performance or achievements could differ materially from those anticipated in such forward-looking statements as a result of certain other factors, including the risk factors set forth in Acquired Sales Corp.’s filings with the Securities and Exchange Commission.

CONTACTS:

Lifted Made

Attn: Nicholas S. Warrender, CEO
Phone: 224-577-8148
Email: [email protected]
Website: www.LiftedMade.com

Acquired Sales Corp.

Attn: William C. “Jake” Jacobs, President and CFO
Phone: 847-400-7660
Email: [email protected]
Website: www.AcquiredSalesCorp.com  

PRINCETON, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced the appointment of Marian Macsai, M.D., as Chief Medical Officer, and Eric Carlson, Ph.D., as Chief Scientific Officer, both of whom will join the executive leadership team, effective December 7, 2020.

“I’m thrilled to welcome Drs. Macsai and Carlson to the executive leadership team at Oyster Point, as both will help expand and strengthen our organization during this time of unprecedented growth,” said Jeffrey Nau, Ph.D., MMS, president and chief executive officer at Oyster Point Pharma. “Based on their industry expertise and unique experience in ocular surface diseases, Marian and Eric will add tremendous value to the organization and strategically grow their respective teams as we head into a pivotal year of expansion across our pipeline and with the potential for approval and launch of our lead investigational therapy, OC-01 (varenicline) nasal spray, for dry eye disease in 2021.”

Marian Macsai, M.D., comes to Oyster Point with three decades of experience in ophthalmology, and as Chief Medical Officer, she will oversee Medical Affairs and Clinical Development. Oyster Point’s newly appointed Chief Scientific Officer, Eric Carlson, Ph.D., whose career has been dedicated to identifying, developing, and furthering pharmaceutical developments in eye disease, will oversee the discovery and Research and Development pipeline.

“I am excited to join Oyster Point and partner with Jeff and the rest of the team as we strive to bring a potentially differentiated treatment option to patients suffering with dry eye disease,” Dr. Macsai said. “I look forward to helping build upon Oyster Point’s progress to date to further advance the lead OC-01 program, other potential indications and an emerging pipeline in areas of significant patient need.”

“With an impressive lead program and promising pipeline, I’m looking forward to applying my skillsets, capabilities, and experience in the space to help Oyster Point during an important time of transformation and further the company’s success in developing transformative ocular surface disease treatments,” said Dr. Carlson.

About Marian Macsai, M.D.

Marian Macsai most recently held a key leadership position as Chief of the Division of Ophthalmology for NorthShore University Health System, where she built the division from one doctor in one office to 19 MDs in 7 offices across the Northern Suburbs of Chicago. Dr. Macsai also serves as a Clinical Professor of Ophthalmology University of Chicago Pritzker School of Medicine.

Prior to her role with NorthShore University Health System, Dr. Macsai led as a Professor of Ophthalmology Vice Chair Department of Ophthalmology for Northwestern University Feinberg School of Medicine. She has served as the President of the Cornea Society, and Chair of the Eye Bank Association of America. In addition, Dr. Macsai was on the Ophthalmic Devices Advisory Panel of the FDA, the Advisory Committee on Blood and Tissue Safety and Availability, and she co-chairs a committee for the World Health Organization on Biovigilance and Surveillance in Transplantation of Medical Products of Human Origin. Dr. Macsai recently was honored with the American Academy of Ophthalmology Lifetime Fellow Award.

About Eric
Carlson, Ph.D.

Eric Carlson was most recently Chief Scientific Officer and Executive Vice President at Akorn Pharmaceuticals and previously Vice President, Global R&D at Aerie Pharmaceuticals and Senior Global Program Head of Ophthalmology at Alcon/Novartis. Dr. Carlson was also previously Assistant Professor, Department of Ophthalmology and Visual Sciences, Case Western Reserve University. Dr. Carlson holds a Ph.D in Cell and Molecular Biology from the University of Cincinnati College of Medicine. Dr. Carlson has specialized in the study of diseases of the eye since his university studies, after which he undertook a post-doctoral fellowship in ophthalmology at the Cleveland Clinic Foundation Cole Eye Institute.

About Oyster Point Pharma, Inc.

Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma’s lead product candidate, OC-01 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. In pre-clinical and clinical studies, OC-01 nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit. OC-01 nasal spray is an investigational new drug and has not been approved for any indication in any country. The safety and efficacy of OC-01 have not been established.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions and on information currently available to us. The forward-looking statements in this press release represent our views as of the date of this press release. These statements may include but are not limited to statements regarding future events, including any potential impacts of any government measures in response thereto, or future financial and operating performance and our plans for and the anticipated benefits of new hires, our product candidates, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones, including potential timing of NDA submission and potential commercialization. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the “Risk Factors” section in reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties.

Investor Contact
:

Tim McCarthy 
LifeSci Advisors, LLC 
(212) 915-2564 
[email protected]

Media Contact: 
Sheryl Seapy, W2O Group
(213) 262-9390
[email protected]

FISHERS, Ind., Dec. 07, 2020 (GLOBE NEWSWIRE) — Author Susan N. Harris has published a gentle resource that chronicles a Christian couple’s journey through the highs and lows they experienced after an unexpected cancer diagnosis thrust them into a reality they did not anticipate. In “Thy Will Be Done,” Susan shares her experience of suddenly losing her late husband, Brent, and her perspective on overcoming pain and suffering to live a life filled with faith and hope.

In the middle of a blessed life and marriage, Susan and Brent were suddenly faced with a stage-4 mucosal melanoma diagnosis in June of 2019. Written in a journal-style format, “Thy Will Be Done” provides a window into the couple’s experiences as they navigated a new, uncertain frontier in their relationship and lives.

Susan’s book originally stemmed from updates she had written to her and Brent’s families to keep them informed about medical changes and provide them with prayer requests. Interwoven within the journal entries are Susan’s thoughts and emotions while walking this path with her husband as he battled a rare and aggressive cancer.

“I think, especially with the ongoing COVID-19 pandemic, people have gone through so much loss,” Susan said. “I hope that this book will speak to those in the depths of their loss – whether their story is cancer-related like mine or not – and encourage them. I pray this journey Brent and I went on will show others that God is still working, even in the hardest of times.”

Ultimately, this memoir chronicles Susan and Brent’s true story – one in which the couple had to choose to live in the Father’s will, regardless of whether that lined up with their own. “Thy Will Be Done” invites readers to share in their struggles, triumphs, and surrender. Susan’s book provides refuge to those in crisis and points them toward hope as well as reminds those who are caring for a person with a terminal disease that they are not alone.

“Thy Will Be Done”
By Susan N. Harris
ISBN: 978-1-9736-9537-0 (hc)
ISBN: 978-1-9736-9538-7 (sc)
ISBN: 978-1-9736-9539-4 (e)
Available through WestBow Press, Barnes & Noble, and Amazon

About the author
Susan N. Harris was born and raised in Indiana and has an older sister and a younger brother. Harris grew up in the church, accepted Christ as her Savior as a young child, and has always been part of one church family or another depending on where she was living. She earned her Bachelor of Science degree in elementary education from Indiana University, where she met and began dating her husband, Brent. After she graduated, Harris taught early childhood for five years in central Indiana, and during that time, she and her husband married. Together they have three children – two girls and one boy. Harris was a stay-at-home mom for 15 years before returning to the classroom where she once again taught Pre-K for five years. After her husband received his cancer diagnosis in the summer of 2019, Harris took a leave of absence to care for him until his death five short months later. She currently resides in Fishers, Ind. To learn more, please visit www.susannharris.com or view a trailer for the book here.

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• Thy Will Be Done Jacket Art

Danielle Grobmeier
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