On October 7, 2020, Cumberland Pharmaceuticals Inc. (the "Company" or "Cumberland") reported that it entered into a Third Amendment to the Revolving Credit Note and Fourth Amendment ("Fourth Amendment") to the Revolving Credit Loan Agreement with Pinnacle Bank (the "Pinnacle Agreement") (Filing, 8-K, Cumberland Pharmaceuticals, OCT 7, 2020, View Source [SID1234568266]). The original Pinnacle Agreement was dated July 31, 2017. The Fourth Amendment provides for a principal available for borrowing of up to $15 million and Cumberland has the ability to request an increase of up to an additional $5 million, upon the satisfaction of certain conditions and approval by Pinnacle Bank. If fully expanded, the Fourth Amendment would provide a maximum principal available for borrowing of up to $20 million, which was also the maximum aggregate principal available for borrowing under the previously amended Pinnacle Agreement.

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The Fourth Amendment extends the maturity date of the Pinnacle Agreement through October 1, 2022.
The interest rate on the Pinnacle Agreement, as amended, is based on LIBOR plus an interest rate spread. The pricing provides for an interest rate spread of 1.75% to 2.75% above LIBOR with a minimum LIBOR of 0.90%. Cumberland is subject to a financial covenant, maintenance of either the Funded Debt Ratio or a Tangible Capital Ratio, as defined, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of the Company’s assets.

On October 7, 2020 Genor Biopharma of Shanghai reported that it raised $371 million in its Hong Kong IPO, pricing the offering at the top of the range (Press release, Genor Biopharma, OCT 7, 2020, View Source [SID1234568220]). In early trading, Genor rose 22%, giving the company a market capitalization of $1.8 billion. Founded in 2007, Genor has a portfolio of 15 mAbs and recombinant fusion proteins, comprising novel drugs and biosimilars that target indications in cancer, metabolic and autoimmune diseases. Hillhouse, which led a $160 million Series B financing in Genor earlier this year, owns 30% of the company’s shares post-IPO.

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On October 7, 2020 Propella Therapeutics Inc. (Propella), a leader in the development of innovative best-in-class prescription products, reported the issuance of a U.S. patent for a new drug treatment for metastatic prostate cancer (Press release, Propella Therapeutics, OCT 7, 2020, View Source [SID1234568209]). The patent covers new molecules that are designed to provide significant advantages over the current standard of care. The patent, titled Abiraterone Prodrugs, protects certain novel prodrugs. These are biologically inactive compounds that the body converts into the active pharmacological agent, abiraterone.

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"This patent protects our ability to develop and market safe, effective, and long-acting drugs for the treatment of metastatic prostate cancer and other conditions related to the overproduction of androgens," said Propella President and CEO William Moore, PhD. "This protection gives Propella and its investors further confidence to complete promising preclinical studies and file its Investigational New Drug (IND) application in the first quarter of 2021."

Abiraterone is a potent CYP 17 enzyme inhibitor that prevents the synthesis of testosterone and other androgens that fuel prostate cancer cells. The current treatment uses abiraterone acetate, which patients take by mouth, once a day. This produces varying blood concentrations of abiraterone, including high levels that can be toxic, and low blood levels that may not be effective against cancer tumors. Propella’s prodrug abiraterone decanoate has been shown to profoundly reduce testosterone levels for three months following a single injection.

Internationally recognized expert in systemic therapies for patients with advanced urologic cancers, Neal D. Shore, MD, FACS, from the Carolina Urologic Research Center stated, "The preclinical data in primates show that testosterone reductions that result from the abiraterone prodrug depot injection are consistent with those clinically observed with oral abiraterone acetate. I am enthusiastic for the potential of this new more ‘patient-friendly’ treatment option for some metastatic prostate cancer patients."

On October 7, 2020 Biocare Medical, a leading provider of innovative, automated immunohistochemistry (IHC) reagents and instrumentation, reported the launch of three novel IVD IHC antibody markers at the forefront of clinical diagnostic and research applications (Press release, Biocare Medical, OCT 7, 2020, View Source [SID1234568208]). These three markers SMAD4 [EP618Y], BAP1, and BCA-225 [Cu-18] may aid pathologists in critical prognostic and diagnostic decisions – impacting patient outcome. Each new marker is available as an IVD grade antibody in ready to use and concentrated formats, leveraging maximum flexibility for your laboratory.

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BAP1 Antibody – Biocare’s rabbit polyclonal BAP1 is an excellent biomarker that may aid in diagnosis of multiple types of cancers including uveal melanoma, malignant mesothelioma, cutaneous melanoma, and renal cell carcinoma. Protein expression of BAP1 using immunohistochemistry may serve as a rapid and cost-effective means of identifying uveal melanoma patients with aggressive disease.1 Loss of BAP1 staining is associated with higher risk for tumor growth and metastasis.2

BCA-225 [Cu-18] Antibody – Biocare’s mouse monoclonal offering of BCA-225 is a well known clinical marker for breast carcinomas. BCA-225 expression was found to be common in adenocarcinomas of the breast (98%).3 Adenocarcinoma that metastasizes from an unknown primary site is a significant oncologic problem. When used in a panel, BCA225 may serve as a predictive marker to identify tumors of unknown origin.4

SMAD4 [EP618Y] Antibody – Biocare’s rabbit monoclonal offering of SMAD4 [EP618Y] may aid prognosis through varying expression. Loss of SMAD4 correlated significantly with decreased survival in all colon cancer patients. High SMAD4 expression, however, was significantly associated with increased survival, especially in colon cancer patients. SMAD4 loss, and to a lesser extent weak expression, is strongly associated with poor survival regardless of stage.5,6

The launch of these antibodies continue Biocare Medical’s long-standing history of providing novel, high-quality reagents to customers looking to advance their research and diagnostic efficiency in the laboratory. These new markers will provide a cost-effective expansion to pathologists looking to elevate clinical utility and diagnostic clarity.

On October 7, 2020 Edwards Lifesciences (NYSE: EW), reported its operating results for the quarter ended September 30, 2020 after the market closes on Wednesday, October 21, 2020, and will host a conference call at 5:00 p.m. ET that day to discuss those results (Press release, Edwards Lifesciences, OCT 7, 2020, View Source [SID1234568207]).

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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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To participate in the conference call, dial (877) 704-2848 or (201) 389-0893. For 72 hours following the call, an audio replay can be accessed by dialing (877) 660-6853 or (201) 612-7415 and using conference number 13710472. The call will also be available via live or archived webcast on the "Investor Relations" section of the Edwards web site at ir.edwards.com.