Actinium Pharmaceuticals, Inc. Expands R&D Capabilities with New Research Facility to Enhance Development of Next Generation Antibody Radiation Conjugates Leveraging Its Proprietary AWE Platform PR Newswire NEW YORK, Oct. 14, 2020 NEW YORK, Oct. 14, 2020 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today announced the launch of its new research and development lab facility in New York City. This new research facility expands Actinium's internal R&D capabilities and will be focused on developing novel Antibody Radiation Conjugate (ARC) candidates, ARC therapeutic combination strategies, and supporting AWE platform research collaborations. Actinium's R&D efforts will employ a multidisciplinary approach leveraging its team's expertise and experience in cancer cell biology, radiochemistry, radiation sciences, immunology and oncology drug development. The proprietary AWE technology platform, protected by over one hundred and twenty-five patents, is the foundation for Actinium's R&D and exploits multiple different radioisotope payloads including the potent alpha-emitter, Actinium-225. (PRNewsfoto/Actinium Pharmaceuticals, Inc.) This new research facility will function under the guidance of Dr. Dale Ludwig, Ph.D. the Company's Chief Scientific & Technology Officer, who has over twenty-five years of oncology discovery research and development experience, including supporting the development and launch of Erbitux®, Cyramza^TM, Portrazza®, and Lartruvo^TM as well as the clinical advancement of at least 10 additional therapeutic antibodies and Antibody Drug Conjugates while at Eli Lilly and, previously, ImClone Systems Inc. The research facility will be managed and staffed by Ph.D. level scientists who will contribute their respective expertise in areas of drug discovery, radiation chemistry, and translational research to advance novel ARC programs and investigations into combination therapeutic strategies. "Our new research facility will allow us to significantly accelerate our preclinical and clinical development of novel ARC programs and investigate mechanistic ARC therapeutic combinations, which utilize our expertise in radioimmunobiology, our AWE Technology Platform capabilities,
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced Time Is Nephrons, the first-ever lupus nephritis (LN) disease-state awareness campaign for healthcare professionals (HCPs). The initiative aims to highlight the importance of active screening for early diagnosis to potentially minimize the impact on kidney function and improve long-term outcomes for every patient with LN.
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“Unfortunately, for many patients, the signs of lupus nephritis are subtle, yet a single flare of LN can potentially shorten the life span of the kidney by decades. Our ongoing engagement with the lupus nephritis community revealed a key role for Aurinia to help change the course of the patient journey by creating a comprehensive resource for healthcare professionals with the latest disease monitoring and management methods,” said Neil Solomons, M.D., Chief Medical Officer at Aurinia Pharmaceuticals. “We are excited to launch the Time Is Nephrons initiative which, along with our patient-focused disease awareness campaigns, aims to enhance awareness and the outlook for patients in need.”
Lupus nephritis is one of the most serious complications of systemic lupus erythematosus (SLE) and is caused by an inflammation of the kidney leading to proteinuria. If left untreated, LN can lead to irreversible kidney damage, kidney failure, or even death. In patients with LN, renal damage may start prior to the first clinically detected episode; therefore, patients should be actively and routinely screened for signs of the disease. Patients with LN who achieve a complete response as measured by decreases in proteinuria and a urine protein-to-creatinine ratio (UPCR) of less than 0.5 gm/gm can achieve better long term kidney outcomes such as avoidance of kidney failure, dialysis, or need for transplantation.
Aurinia Pharmaceuticals is a late-stage
Jazz Pharmaceuticals plc (JAZZ) has enjoyed an extended rally thanks to headline-grabbing announcements in the past few months. Once lifted in August, the company’s revenue outlook needs a further upgrade per our analysis of historical data in light of ongoing product launches. JAZZ’s liquidity is robust enough to weather the effect of declining cash flows even as the management expects the margins to come under pressure amid the ongoing product launches and clinical trials.
As generics make the market entry rivaling the company’s leading drug Xyrem, a new product launch is underway, targeting a swift conversion of the existing patient base. Meanwhile, moves are afoot to bolster the oncology franchise highlighting the attempts at revenue diversification. Our EBITDA forecasts for the year beat the consensus estimates, and with the current forward EV/EBITDA multiple, it indicates a modest undervaluation. Yet, despite a series of catalysts ahead, JAZZ continues to underperform the market on a YTD (year-to-date) basis, encouraging us to raise its outlook to a ‘Buy’.
Catalysts Spark a Rally
After the emerging competition and a failed late-stage clinical trial darkened its prospects in the first few months of the year, Jazz Pharmaceuticals has made a remarkable turnaround lately, forcing the management to roll back the dreary outlook they set earlier. Thanks to a series of catalysts and the upgraded guidance, the stock had made a swift comeback gaining ~41.3% in the past six months, outperforming the ~26.1% rise in the NBI (NASDAQ Biotechnology Index). In June, FDA signed off JAZZ’s Zepzelca (lurbinectedin) for adults with relapsed metastatic SCLC (small cell lung cancer) on or after platinum-based chemotherapy. One of the two types of lung cancers, SCLC has a poorer prognosis compared to NSCLC (non-small cell lung cancer), highlighting the importance of the development for an indication
With its recent invocation of the Defense Production Act, the Trump administration intends to combat the coronavirus and address some of the shortfalls it has exposed in the areas of manufacturing and supply chains of medicines and healthcare supplies.
The DPA is typically exercised during wartime to support the work of the Federal Emergency Management Agency and the Department of Homeland Security. In this case, President Trump invoked the DPA to restore pharmaceutical and medical supply chains to the United States in an attempt to address those issues.
COVID-19 has already offered a glimpse into what could happen if there was a drug shortage and the U.S. did not have a domestic pharmaceutical supply chain. At the beginning of the pandemic, there was a brief but noticeable shortage of over-the-counter painkillers. According to the Commerce Department, 95% of ibuprofen consumed in the U.S. is made in China.
And although there was some debate about the accuracy of the numbers surrounding drugs made abroad, few people would deny that there are advantages to having a robust and stable domestic supply chain for pharmaceutical and medical goods.
One of the most attractive locations for domestic pharmaceutical production is Puerto Rico. The island is still reeling from the devastating impact of Hurricane Maria and has seen significant economic decline due to tourism restrictions during the COVID-19 lockdowns.
Puerto Rico is already home to manufacturing facilities run by 12 of the world’s top-grossing pharmaceutical companies. In 2018, Puerto Rico manufactured 5 out of 10 of the world’s top selling drugs.
That manufacturing was once even more vigorous, owing its genesis to the Tax Reform Act of 1976. Section 936 of the Act exempted from taxation corporate income generated in US territories like Puerto Rico. This exemption led to
Eton Pharmaceuticals (NASDAQ:ETON) -6% announces public offering to sell common shares.
Closing date is October 14, 2020.
Net proceeds will be used primarily for general corporate purposes, which may include research and development activities, capital expenditures, selling, general and administrative costs, and to meet working capital needs.
Price, volume and terms have yet to be determined.
Source: Press Release