On October 8, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported provided a preliminary update on its third-quarter 2020 financial results and the pace of its business recovery from the COVID-19 pandemic (Press release, Bausch Health, OCT 8, 2020, View Source [SID1234568244]).

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Bausch Health expects third-quarter 2020 revenue to be greater than $2.1 billion, which would be a sequential increase of approximately 28% compared to the second quarter of 2020. Reported revenue in the second quarter of 2020 declined 23% compared to the second quarter of 2019, and the Company expects third-quarter 2020 reported revenue to decline approximately 3% compared to the third quarter of 2019.

Additionally, based on the pace of recovery of its various businesses observed in the third quarter of 2020 and assuming its businesses continue to rebound from the impact of the COVID-19 pandemic, Bausch Health currently expects its full-year 2020 revenue and Adjusted EBITDA (non-GAAP) to be around the midpoint of its current guidance ranges of $7.80 – $8.00 billion for revenue and $3.15 – $3.30 billion for 2020 Adjusted EBITDA (non-GAAP).

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The financial results estimates proposed above within the full-year guidance ranges reflect our assumptions due to the recovery of the Company’s business from the actual impacts of the COVID-19 pandemic in the third quarter. These impacts have affected the Company’s assumptions regarding base performance and growth rates. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

The Company will release its full financial results for the third quarter of 2020 on Tuesday, Nov. 3, 2020. Bausch Health will host a conference call and live web cast at 8:00 a.m. ET to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

On October 8, 2020 CARISMA Therapeutics Inc., a biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the company will present at upcoming virtual healthcare industry conferences in October 2020 (Press release, Carisma Therapeutics, OCT 8, 2020, View Source [SID1234568243]).

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Cell & Gene Meeting on the Mesa, October 12-16, 2020:
The presentation given by Steven Kelly, President and CEO, will be available to view on-demand throughout the entirety of the conference.
Macrophage-directed Therapies Summit, October 27-29, 2020:
Michael Klichinsky, PhD, Co-Founder and Vice President of Discovery Research, will present virtually and participate in a panel discussion on October 29, 2020. Both will be accessible via webcast.

On October 8, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange, reported that the company plans to release third quarter 2020 financial results on October 22, 2020 (Press release, eHealth Insurance, OCT 8, 2020, View Source [SID1234568242]).

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Chief Executive Officer Scott Flanders and Chief Financial Officer Derek Yung will host the earnings conference call beginning at 5 p.m. Eastern Time on October 22nd to discuss these results.

Individuals interested in listening to the conference call may do so by dialing (877) 930-8066 for domestic callers and (253) 336-8042 for international callers. The participant passcode is 8351208.

A telephone replay will be available two hours following the conclusion of the call for a period of 7 days and can be accessed by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The call ID for the replay is 8351208. The live and archived webcast of the call will also be available on the company’s website at www.ehealthinsurance.com under the Investor Relations section.

On October 8, 2020 Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee") reported that the 505(b)(2) New Drug Application (NDA) for FP-001 LMIS 50mg, or CAMCEVI 42MG, a ready-to-use 6-month depot formulation of leuprolide mesylate, has been accepted for review by the U.S. Food and Drug Administration (FDA) (Press release, Foresee Pharmaceuticals, OCT 8, 2020, View Source [SID1234568241]).

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In its Day-74 letter, the FDA stated that the New Drug Application (NDA) for CAMCEVI 42MG is sufficiently complete to permit a substantive review. The goal date under the Prescription Drug User Fee Act (PDUFA) is May 27, 2021.

"This marks another important regulatory milestone for the CAMCEVI franchise," said Dr. Ben Chien, Founder and Chairman of Foresee. "We are confident that if approved, with a strong commercial partnership in the US, CAMCEVI 42MG and the CAMCEVI franchise will provide patients, as well as healthcare providers, a safe and easy-to-use treatment option with its differentiated ready-to-use profile. We look forward to the successful launch of the CAMCEVI franchise."

The NDA submission for CAMCEVI 42MG is supported by a previously communicated successful Phase 3 clinical study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI 42MG injection every 6 months was demonstrated to be effective, safe and well tolerated.

On October 8, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (FDA) has granted two Orphan Drug Designations (ODDs) to two of the company’s apoptosis-targeting assets: the MDM2-p53 inhibitor, APG-115, for the treatment of acute myeloid leukemia (AML); and the Bcl-2/Bcl-xL inhibitor, APG-1252, for the treatment of small-cell lung cancer (SCLC) (Press release, Ascentage Pharma, OCT 8, 2020, View Source [SID1234568240]). With these two latest designations, Ascentage Pharma has obtained a total of six ODDs from the FDA for four of the company’s investigational drug candidates .

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The term "orphan drugs" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan disease is defined as a disease or condition with a prevalence of less than 200,000 patients in the country. Since the Orphan Drug Act was passed in 1983, the US government has provided incentives and policy support to encourage development of orphan drugs. Drug candidate granted ODDs by the FDA will qualify for various development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, research grant awarded by the FDA, and, most importantly, 7 years of US market exclusivity upon approval.

The MDM2-p53 inhibitor APG-115 for the treatment of AML

AML is a highly heterogenous hematologic malignancy that is more common in the elderly population with a median age at diagnosis of 68 years[1]. The most recent data from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) estimates that there will be 19,940 new cases of AML and an estimated 11,180 deaths from this disease in the United States in 2020. Despite the recent advances in therapeutics, the 5-year survival rate of AML remains at 25%–30%, which still represents a significant unmet medical need.

APG-115 is an orally administered, selective, small-molecule inhibitor of MDM2. APG-115 has strong binding affinity to MDM2 and is designed to activate the tumor-suppressing activity of p53 by blocking the MDM2-p53 protein-to-protein interaction (PPI). APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumors and hematologic malignancies in China and the US.

The Bcl-2/Bcl-xL inhibitor APG-1252 for the treatment of SCLC

Lung cancer remains the leading cause of cancer death in the United States[2]. Lung cancer is divided into two main histopathological types: non-small cell lung cancer (NSCLC) and SCLC, with 13-15% of lung cancers classified as SCLC[2],[3]. SCLC is a rare and highly aggressive cancer with a low 5-year survival rate[3]. Patients with relapsed/refractory SCLC have few treatment options, all of which offer modest response rates.

Being developed by Ascentage Pharma, APG-1252 is a novel small-molecule drug candidate that restores apoptosis by selectively inhibiting Bcl-2 and Bcl-xL proteins simultaneously. APG-1252 is currently being investigated in Phase I dose-escalation studies in patients with advanced cancers in the US and Australia, a Phase Ib/2 study of APG-1252 plus paclitaxel in patients with relapsed/refractory SCLC in the US, and a Phase I dose-escalation study of APG-1252 single agent in patients with SCLC in China. The clinical data of APG-1252 generated thus far have shown a favorable safety profile and preliminary efficacy in patients with SCLC and other advanced solid tumors.

"AML and SCLC are both devastating and life-threatening diseases which have high unmet clinical needs globally. For APG-115, this designation marks the second ODD of the molecule from the FDA, while it is the very first time for APG-1252 to obtain an ODD," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "All the ODD-related supporting policies in the US will help us to accelerate the global clinical development and commercialization of these two drug candidates, and allow more patients to benefit as soon as possible."

References

[1] DeSantis CE, Lin CC, Mariotto AB, et al. Cancer Treatment and Survivorship Statistics, 2014. CA Cancer J Clin 2014;64:252-271.

[2] Siegel R, Miller K, Jemal A. Cancer Statistics, 2020. American Cancer Society. CA Cancer J Clin 2020;70:7–30.

[3] Lu T, Yang X, Huang Y, et al. Trends in the incidence, treatment, and survival of patients with lung cancer in the last four decades. Cancer Manag Res. 2019; 11: 943–953.