On March 6, 2020 AmerisourceBergen reported that it is continuing its strategic relationship with the American Oncology Network, LLC (AON), a high-growth medical oncology provider with a focus on supporting the long-term viability of oncology treatment in community-based settings (Press release, AmerisourceBergen, MAR 6, 2020, View Source [SID1234555282]). AmerisourceBergen will support AON in its effort to accelerate key strategic priorities to scale its integrated value-based care delivery model nationwide.

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AON currently serves an expanding network of partner practices across 11 states, providing dedicated end-to-end administrative support, access to an extensive array of centralized ancillary services, and proven practice management expertise. Delivered through its local market, physician-led model, AON empowers community-based practices with the necessary tools, support and capital to effectively navigate today’s increasingly dynamic healthcare landscape and practice value-based care within the community at scale.

"Our partnership with AmerisourceBergen is an important part of our effort to grow our network, expand our solution suite, and deliver exceptional services to our partner practices and their patients," said AON CEO Brad Prechtl, MBA.

AON Board Member & Chairman Dr. Stephen Orman added, "AmerisourceBergen is an industry leader with a proven track record of achieving exceptional results, and we look forward to collaborating further to expand our national oncology network."

AmerisourceBergen’s ION Solutions supports AON with GPO contracting. Oncology Supply handles distribution of chemotherapy and supportive care products to AON practices. Additional integrated service offerings available to AON practices through ION and Oncology Supply include:

Dedicated account teams that actively consult on inventory and create operational efficiencies
Robust inventory of specialty and full-line oral, infusible and injectable products
Technology, analytics and informatics solutions to drive higher-quality and lower-costs
Inventory management solutions
Centralized library of precision medicine testing recommendations and resources through ION Solutions’ Precision Medicine Center
Ongoing educational conference series designed to facilitate peer-to-peer learning and networking and strengthen the community of independent oncologists
The largest, longest-tenured pharmacy program that assists community oncology practices in successfully optimizing a medically integrated dispensing program
"As a company that’s pharmaceutical-centered and community focused, we strive for partners like AON," said Brian Ansay, President Specialty Physician Group Purchasing, AmerisourceBergen. "AON’s physician-led model and patient-centric services are creating new opportunities in community oncology, and we are excited about their vision for the future."

AON is physician led and physician governed. For more information about AON, please visit: www.AONcology.com.

On March 6, 2020 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported the financial and operating results for Nicox and its subsidiaries (the "Nicox Group") for the year ended December 31, 2019, as approved by the Board of Directors on March 5, 2020, and provided upcoming 2020 key milestones (Press release, NicOx, MAR 6, 2020, View Source [SID1234555261]).

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2019 Financial Summary
Net revenue1 for the full year 2019 was €6.9 million (€2.1 million in net royalties, €4.8 million in upfront and milestone payments), compared to €4.0 million (€1 million in net royalties and €3 million in an upfront payment) for the full year 2018.

Operating expenses for the period 2019 decreased to €25.5 million from €26.5 million for the 12 months to December 31, 2018. Research and development expenses increased by €1.4 million reflecting the investments in the successful clinical trials for NCX 470 and NCX 4251 while administrative and other expenses decreased by €2.4 million.

Net loss of the Nicox Group for the full year 2019 was €18.9 million against €18.4 million in the full year 2018.

As of December 31, 2019, the Nicox Group had cash and cash equivalents of €28.1 million as compared with €22.1 million at December 31, 2018. The December 31, 2019 cash position does not include the last tranche of loan under the bond financing agreement with Kreos Capital which was drawn down in December 2019 but received on January 2, 2020, adding approximately €7.7 million to the year-end cash position of the Group.

As of December 31, 2019, the Nicox Group had a financial debt of €11.1 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 adjusted to approximately €18.8 million by including the last tranche of loan drawn down in December 2019.

Events after the Reporting Period
Nicox successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) (see Press Release of March 5, 2020). The Mont Blanc trial, the first Phase 3 clinical trial of NCX 470, is expected to start by the end of Q2 2020, with top-line results expected in Q3 2021. The Mont Blanc trial will be initiated with 0.065% and 0.1% doses of NCX 470, with one dose being selected during the trial through an adaptive design.
Nicox received approval from the U.S. Patent and Trademark Office of a formulation patent for NCX 470, extending the U.S. patent coverage to 2039 (see Press Release of February 3, 2020). Nicox has also received approval of this patent in Japan.
Nicox presented NCX 470 Dolomites Phase 2 results at the Glaucoma 360 New Horizons Forum (February 7, 2020) and at the American Glaucoma Society (AGS) Annual Meeting (February 27 – March 1, 2020). NCX 4251 Danube Phase 2 results were also presented at AGS.
Nicox’s research activities are being concentrated on nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors program for glaucoma for which we expect to be able to announce an Investigational New Drug (IND)-track candidate in 2020 and therefore we are terminating our research collaboration with Cyclerion Therapeutics, Inc.
We strengthened our Clinical Development function by appointing Kristie Veasey to the position of Director Clinical Operations, effective March 2, 2020. Reporting to Dr. José Boyer, Vice President of Clinical Development, Ms. Veasey will be responsible for leading clinical operations for some of our upcoming clinical trials. She brings over 19 years of experience in clinical research and development in both the Pharmaceutical Industry and Clinical Research Organizations, with the majority of her professional experience in the therapeutic area of ophthalmology including at Lexitas Pharma Services, Clearside Biomedical and Inspire Pharmaceuticals, Inc.
Key Expected Upcoming Milestones
NCX 470 Phase 3 clinical trial preparation: Phase 3 clinical trial (‘Mont Blanc’) is expected to be initiated by the end of Q2 2020.
NCX 4251: Meeting with the U.S. FDA is scheduled in Q1 2020 to discuss the next steps of the clinical development plan.
ZERVIATETM U.S. launch: Commercial launch of ZERVIATETM (cetirizine ophthalmic solution), 0.24% in the U.S. is planned by Nicox’s partner Eyevance Pharmaceuticals in H1 2020.
Presentations on Nicox’s ophthalmology research and development programs at key U.S. scientific conferences including the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.

On March 6, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported the closing of its previously announced rights offering (the "Rights Offering") (Press release, CTI BioPharma, MAR 6, 2020, View Source [SID1234555283]). At the closing, CTI BioPharma sold and issued an aggregate of 15,698,995 shares of its common stock (the "Common Stock") and an aggregate of 4,429.2423 shares of its series X convertible preferred stock (the "Series X Preferred") pursuant to the exercise of subscription rights and Oversubscription Rights in the Rights Offering by existing holders of CTI Biopharma’s Common Stock and series O convertible preferred stock. The Rights Offering was fully backstopped by certain existing stockholders of CTI BioPharma who agreed to purchase any shares of Common Stock and/or Series X Preferred offered in the Rights Offering that were not subscribed for (the "Oversubscription Rights"). CTI BioPharma raised aggregate gross proceeds of approximately $60.0 million in the Rights Offering.

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Of the total shares of Common Stock and Series X Preferred sold and issued in the Rights Offering, certain affiliates of BVF Partners L.P. purchased 3,047 shares of Series X Preferred, Stonepine Capital, LP purchased 3,267,127 shares of Common Stock and 673.2873 shares of Series X Preferred, OrbiMed Private Investments VI, LP purchased 4,520,600 shares of Common Stock and 298 shares of Series X Preferred and New Enterprise Associates, Inc. purchased 3,390,450 shares of Common Stock and 410.955 shares of Series X Preferred, in each case, pursuant to the exercise of their subscription rights and Oversubscription Rights.

The Rights Offering was made pursuant to CTI BioPharma’s effective shelf registration statement on file with the Securities and Exchange Commission (the "SEC") and a prospectus supplement and accompanying prospectus filed with the SEC on February 14, 2020.

JMP Securities served as financial advisor to CTI BioPharma in connection with the Rights Offering.

On March 6, 2020 AstraZeneca reported that the Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (≥25%) of PD-L1, or for Imfinzi plus tremelimumab in patients regardless of their PD-L1 expression (Press release, AstraZeneca, MAR 6, 2020, View Source [SID1234555262]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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José Baselga, Executive Vice President, Oncology R&D, said: "AstraZeneca remains committed to addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients. The results from this trial will inform our comprehensive Phase III development programme in bladder cancer. We look forward to the results of the Phase III NILE trial also in the 1st-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease."

The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous trials. The data will be presented at a forthcoming medical meeting.

Imfinzi is being developed in patients with unresectable, locally advanced or metastatic bladder cancer in the Phase III NILE trial either in combination with chemotherapy or with chemotherapy and tremelimumab. Imfinzi is also being tested in earlier stages of bladder cancer in the Phase III NIAGARA trial in combination with chemotherapy, and in the Phase III POTOMAC trial in combination with SoC Bacillus Calmette-Guerin immunotherapy.

Imfinzi is approved for patients with locally advanced or metastatic bladder cancer previously treated with platinum-containing chemotherapy in 15 countries, including the US.

Bladder cancer

In 2018, approximately 550,000 people were diagnosed with bladder cancer around the world and 200,000 died from the disease.1 Locally advanced and metastatic bladder cancer remains an area of unmet medical need and typically only one in seven patients are alive five years after diagnosis.2 Urothelial cancer (UC) is the most common form of bladder cancer.3 UC is the 10th most common cancer worldwide and the 13th most common cause of cancer death.1,4 PD-L1 is widely expressed in tumour and immune cells in patients with bladder cancer and helps tumours evade detection from the immune system.5

DANUBE

DANUBE is a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of both cisplatin eligible and ineligible patients with unresectable, Stage IV (metastatic) UC. The trial compared Imfinzi monotherapy or Imfinzi plus tremelimumab versus cisplatin and gemcitabine or carboplatin and gemcitabine chemotherapy. The trial was conducted in more than 220 centres across 24 countries, including centres in the US, Canada, Europe, South America, Asia, Australia and the Middle East.

Eligible patients included those with transitional cell carcinoma of the urothelium, including renal pelvis, ureters, urinary bladder, and urethra. High PD-L1 was defined as ≥25% of tumour cells (TC) or tumour-infiltrating immune cells (IC) expressing membrane PD-L1 if ICs involved >1% of the tumour area, or TC≥25% or IC=100% if ICs involved ≤1% of the tumour area.

The primary endpoints of the trial were OS in high PD-L1 patients treated with Imfinzi monotherapy, and OS in patients treated with Imfinzi plus tremelimumab regardless of their PD-L1 status. The DANUBE trial addresses a post-approval commitment in agreement with the US Food and Drug Administration from the May 2017 accelerated US approval of Imfinzi in previously treated patients with advanced bladder cancer.

Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in 61 countries, including the US, Japan, China and across the EU, based on the Phase III PACIFIC trial. Imfinzi recently received its first global approval for the 1st-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with SoC chemotherapy in Singapore.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumours.

Tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and neck cancer and liver cancer.

AstraZeneca’s approach to Immuno-Oncology (IO)

Immuno-oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca believes that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On March 6, 2020 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported the rescheduling of its fourth quarter and annual 2019 financial results and company update from Wednesday, March 11, 2020 to Wednesday, March 18, 2020 after market close (Press release, Cumberland Pharmaceuticals, MAR 6, 2020, View Source [SID1234555284]). A conference call and live Internet webcast will be held on Wednesday, March 18, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9759981. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high quality prescription brands to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and oncology market segments. These medical specialties are categorized by moderately concentrated prescriber bases that we believe can be penetrated effectively by targeted sales forces. The Company’s portfolio of FDA approved brands includes:

Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
Caldolor (ibuprofen) Injection, for the treatment of pain and fever;
Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation;
Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
Vaprisol (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
Vibativ (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
RediTrex (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.
For more information on Cumberland’s approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company’s website www.cumberlandpharma.com.

The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD"), Hepatorenal Syndrome ("HRS") and Portal Hypertension ("PH").