On July 29, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that the Taiwan Food and Drug Administration (FDA) has granted Pediatric and Rare Severe Disease Priority Review Designation for sacituzumab govitecan-hziy (SG), an investigational treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, JUL 29, 2021, View Source [SID1234585418]).

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"Receiving Pediatric and Rare Severe Disease Priority Review Designation for SG in Taiwan is an important milestone in the ongoing development of this novel drug candidate, and follows the Orphan Drug Designation previously granted by the Ministry of Food and Drug Safety in South Korea," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We look forward to working closely with regulatory authorities to bring this treatment to patients in Taiwan as quickly as possible as we continue to pursue our goal of advancing potentially first-in-class medicines for patients in Greater China and other parts of Asia."

Pediatric and Rare Severe Disease Priority Review Designation is granted by the Taiwan FDA to new drugs intended to address unmet medical need and treat a serious condition in which the prevalence of the disease is less than five per ten thousand. According to the Taiwan FDA, if a drug meets the criteria required to receive this designation, the drug shall be approved by expedited review process.

Under the trade name Trodelvy, the U.S. FDA previously granted accelerated approval to SG in April 2020 and then expanded its previous indication with full approval in April 2021 for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. In May 2021 Everest announced China National Medical Products Administration accepted Biologics License Application with priority review for SG for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. That application is currently under review.

About Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy.

The Ministry of Food and Drug Safety (MFDS) in South Korea has granted Fast Track Designation and Orphan Drug Designation (ODD) to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

On July 29, 2021 HanAll Biopharma (KRX: 009420.KS) reported that the company had achieved sales of 23.4 billion won, operating profit of 1.6 billion won, and net profit of 3.3 billion won in the second quarter of 2021 (Press release, HanAll Biopharma, JUL 29, 2021, View Source [SID1234585417]).

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In the first half of this year, cumulative sales were reported as 51.2 billion won, a 15% increase compared to the same period last year, and operating profit increased by 56% to 7 billion. In particular, with increased sales in major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product; operating margin was at 14%, indicating an increase of 362 basis-point in profitability compared to the first half of last year.

As of the end of the first half, HanAll Biopharma maintained a stable financial status with a debt ratio of 25% and assets of 201.9 billion won, equity of 161.2 billion won, and liabilities of 40.6 billion won.

[R&D Pipeline]

– HL161 (a novel, fully human, subcutaneous anti-FcRn antibody therapeutic for autoimmune diseases)

HL161 (INN: batoclimab), an antibody-drug for autoimmune diseases caused by pathogenic antibodies, is currently undergoing clinical trials in the US, and China through its partners Immunovant and Harbor BioMed.

In early June, global partner Immunovant announced plans to resume clinical trials, which were put on hold in February this year due to an issue related to increased cholesterol. As a result of a detailed analysis of patients participating in the clinical trials, it said lipid elevations are predictable and manageable. It plans to return to the clinic and initiate a pivotal MG trial in late 2021 or early 2022 as well as resume its trial in WAIHA on a similar timeframe. In addition, the company has a plan to initiate at least two additional clinical studies over the next 12 months, including another pivotal trial in 2022.

Meanwhile, HanAll Biopharma is preparing a Phase 3 clinical trial for the treatment of myasthenia gravis in Japan in collaboration with Immunovant.

In China, Harbour BioMed is conducting clinical trials in myasthenia gravis, thrombocytopenia, and neuromyelitis optica. In July, it announced positive topline results from the Phase 2 clinical trial of batoclimab in myasthenia gravis.

Batoclimab demonstrated a statistically significant improvement (p=0.043) compared to placebo in patients with myasthenia gravis on MG-ADL (Myasthenia Gravis Activities of Daily Living), the primary endpoint of the study. In addition, the drug induced rapid, substantial and persistent clinical improvement over placebo as measured by all four predefined clinical efficacy scales – MG-ADL, QMG (Quantitative Myasthenia Gravis), MGC (Myasthenia Gravis Composite) and MG-QoL (Myasthenia Gravis Quality of Life).

Furthermore, batoclimab has shown to be overall safe and well-tolerated, with incidence of adverse events (AE) comparable to placebo, majority of AEs characterized as mild, no serious adverse events (SAE) and no discontinuation due to AEs. Harbor BioMed plans to enter Phase 3 clinical trial of HL161 in myasthenia gravis in China in the second half of this year.

– HL036 (a novel, topical anti-TNF biologic therapy for dry eye disease)

HL036 (INN: tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is a novel biologic treatment under development to treat inflammatory eye diseases by inhibiting TNF, which could cause inflammation in the eye. To target the dry eye disease market in the US, clinical trials are in progress in the US since Phase 2 and the first Phase 3 clinical trial for dry eye disease was completed in the first half of last year.

HanAll Biopharma submitted the IND for the second Phase 3 clinical trial (study name: VELOS-3) to the U.S. FDA on July 22, and is expected to begin clinical trials in the third quarter of this year and have topline results by the first half of next year.

The VELOS-3 study is a Phase 3, multicenter, randomized, double-masked and placebo-controlled study evaluating the efficacy and safety of tanfanercept (HL036) ophthalmic solution 0.25% compared to placebo in subjects with dry eye disease. Following two week screening period, 300 patients with dry eye disease will be randomized into treatment group and placebo. Each group will benefit administration of tanfanercept or placebo twice per day respectively for eight weeks.

Harbor BioMed, a license holder for the Chinese market, started a pivotal Phase 3 trial in dry eye disease in the first half of the year, and is still in progress. The first patient administration was started in March, and the efficacy and safety of tanfanercept will be evaluated in patients with dry eye disease throughout the study.

– HL189 (tanfanercept)

HanAll Biopharma is planning to expand tanfanercept, which is being developed in dry eye disease, with new inflammatory eye disorders including uveitis. The company will make a decision for the asset in the second half to the year.

– HL186/HL187 (novel immune-oncology therapies)

Currently, HanAll Biopharma is jointly developing a novel immune-oncology antibodies that target TIGIT and TIM-3 with Daewoong Pharmaceutical, and will take a step forward to preclinical study.

On July 29, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that Ofer Haviv, Evogene’s President and CEO, will present at the Jefferies Virtual Industrials Conference, 2021 taking place on August 3-4,2021 (Press release, Evogene, JUL 29, 2021, View Source [SID1234585416]). Mr. Haviv’s presentation will focus on Evogene’s disruptive technologies; its tailor-made engines for product discovery and development and its fields of activity through its main subsidiaries and will take place on Tuesday, August 3, 2021, at 09:00 am, EST.

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Investors attending the conference who wish to meet with Mr. Haviv, may contact Evogene’s Investor Relations team at [email protected] or through the conference’s online meeting platform.

On July 29, 2021 Blueprint Medicines Corporation (NASDAQ:BPMC) reported financial results and provided a business update for the second quarter ended June 30, 2021 (Press release, Blueprint Medicines, JUL 29, 2021, View Source [SID1234585415]).

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"In the second quarter, we achieved one of our foundational corporate goals, securing U.S. approval of AYVAKIT for advanced systemic mastocytosis, and the launch of this therapy is off to a great start with broad prescriber demand," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "In addition, we continued to progress our expanding clinical portfolio with the initiation of the Phase 1/2 trial of BLU-945, the initiation of the Phase 2/3 HARBOR trial of BLU-263 and the announcement of a strategic research collaboration with MD Anderson to accelerate the development of BLU-222, all of which exemplify the potential impact of our next wave of therapeutic candidates. This commercial and clinical progress, combined with our financial strength, provides a robust foundation for future growth as we look to address the needs of many more patients with cancer and hematologic disorders."

Second Quarter 2021 Highlights and Recent Progress

AYVAKIT/AYVAKYT (avapritinib): systemic mastocytosis (SM) and gastrointestinal stromal tumor (GIST)

Recorded $8.5 million in net product revenue during the second quarter of 2021 for AYVAKIT/AYVAKYT, which was approved by the U.S. Food and Drug Administration (FDA) in June 2021 for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL). Read the press release announcing the expansion of the FDA label for AYVAKIT into advanced SM here. AYVAKIT received its initial approval from the FDA in 2020 for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. Please click here to see the full Prescribing Information for AYVAKIT and visit www.AYVAKIT.com for more information on AYVAKIT.
GAVRETO (pralsetinib): RET-altered cancers

Recorded $2.9 million in net product revenue during the second quarter of 2021 for GAVRETO, which was approved by the FDA in September 2020 for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test and in December 2020 for the treatment of patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. Blueprint Medicines is commercializing GAVRETO in the U.S. together with Genentech, Inc., a member of the Roche Group. Please click here to see the full Prescribing Information for GAVRETO and visit www.GAVRETO.com for more information on GAVRETO.
Reported updated data from the Phase 1/2 ARROW clinical trial of GAVRETO in metastatic RET fusion-positive NSCLC and other advanced solid tumors at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data showed high response rates to GAVRETO in treatment-naïve patients with RET fusion-positive NSCLC, clinical activity across a number of RET fusion-positive tumor types and a safety profile consistent with previously reported results. Read the press release here.
BLU-263: SM

Initiated the HARBOR trial, a randomized, double-blind, placebo-controlled Phase 2/3 trial in non-advanced SM.
BLU-945: treatment-resistant EGFR-driven NSCLC

Initiated the global Phase 1/2 trial of BLU-945 in patients with treatment-resistant EGFR-driven NSCLC.
BLU-222: Cyclin E-aberrant cancers

Announced a strategic research collaboration with The University of Texas MD Anderson Cancer Center focused on accelerating development of BLU-222, an investigational precision therapy designed to target cyclin-dependent kinase 2 (CDK2). Read the press release here.
Corporate:

Announced the appointment of Percy Carter, MBA, Ph.D., as Chief Scientific Officer. In this role, Dr. Carter oversees all research and preclinical development. Read the press release here.
Key Upcoming Milestones

The company expects to achieve the following near-term milestones:

Present preclinical data supporting combination of BLU-945 and BLU-701 in treatment-naïve EGFR-driven NSCLC in the second half of 2021.
Initiate a Phase 1 trial of BLU-701 in patients with treatment-resistant EGFR-driven NSCLC in the second half of 2021.
Initiate a Phase 1 trial of BLU-222, a CDK2 inhibitor targeting cyclin-E aberrant cancers, in the first half of 2022.
Disclose topline data for the registration-enabling Part 2 of the PIONEER trial of AYVAKIT in non-advanced systemic mastocytosis in mid-2022.
Second Quarter 2021 Financial Results

Revenues: Revenues were $27.3 million for the second quarter of 2021, including $8.5 million of net product revenues from sales of AYVAKIT/AYVAKYT, $2.9 million of net product sales from GAVRETO and $15.9 million in collaboration revenues. Blueprint recorded revenues of $8.3 million in the second quarter of 2020, including $5.7 million of net product revenues from sales of AYVAKIT and $2.7 million in collaboration revenues. The increase in net product revenues was driven by increased sales quantity and the increase in collaboration revenues was primarily driven by the sales of drug substance and drug product to our collaboration partners.
Cost of Sales: Cost of sales was $6.5 million for the second quarter of 2021, as compared to $0.1 million for the second quarter of 2020. Cost of sales includes manufacturing costs associated with our products sales as well as costs associated with the sale of drug product to our collaboration partners. The increase in costs of product sales was primarily driven by the lower margin product sales to our collaboration partners during the second quarter of 2021.
R&D Expenses: Research and development expenses were $80.0 million for the second quarter of 2021, as compared to $91.1 million for the second quarter of 2020. This decrease was primarily due to decreased expenses associated with clinical supply manufacturing activities and reimbursement from the global development cost sharing arrangement under our collaboration with Roche for pralsetinib, partially offset by increased costs related to early discovery activities. Research and development expenses included $10.5 million in stock-based compensation expenses for the second quarter of 2021.
SG&A Expenses: Selling, general and administrative expenses were $49.3 million for the second quarter of 2021, as compared to $42.2 million for the second quarter of 2020. This increase was primarily due to increased costs associated with building our commercial infrastructure for commercialization of AYVAKIT/AYVAKYT and GAVRETO, partially offset by reimbursement under our collaboration with Roche for pralsetinib. General and administrative expenses included $13.8 million in stock-based compensation expenses for the second quarter of 2021.
Net Loss: Net loss was $108.4 million for the second quarter of 2021, or a net loss per share of $1.86, as compared to a net loss of $123.5 million for the second quarter of 2020, or a net loss per share of $2.28.
Cash Position: As of June 30, 2021, cash, cash equivalents and investments were $1,380.1 million, as compared to $1,549.7 million as of December 31, 2020.
Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss second quarter 2021 financial results and recent business activities. The conference call may be accessed by dialing 844-200-6205 (domestic) or +44-208-0682-558 (international) and referring to conference ID 619159. A webcast of the call will be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Upcoming Investor Conference

Blueprint Medicines will participate in the 2021 Wedbush Pacgrow Healthcare Virtual Conference on Tuesday, August 10, 2021. Christina Rossi, Chief Commercial Officer, will participate in a panel discussion, "Building Back a Better Commercial Infrastructure – Selling in COVID Times," beginning at 8:35 a.m. ET. A live webcast of the panel discussion will be available by visiting the Investors & Media section of Blueprint Medicines’ website at View Source A replay of the webcast will be archived on Blueprint Medicines’ website for 30 days following the presentation.

On July 29, 2021 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has commenced an underwritten public offering to sell $1,800,000,000 of senior notes (Press release, Centene , JUL 29, 2021, View Source [SID1234585414]). The $1,800,000,000 offering of senior notes will include an add-on to its 2.450% senior notes due 2028 (the "2028 Notes") and new senior notes due 2031 (together with the 2028 Notes, the "Notes"), subject to market and other conditions. The 2028 Notes will constitute a further issuance of the $1,800,000,000 aggregate principal amount of 2.450% senior notes due 2028 that were issued on July 1, 2021 and will have the same terms as such notes, other than the issue date and the issue price.

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Centene intends to use the net proceeds from the offering of the Notes, together with a portion of the proceeds of certain term loans under the Company’s proposed amended and restated credit agreement and cash on hand to redeem all of its outstanding 5.375% senior notes due 2026 and all of WellCare Health Plans, Inc.’s, a Delaware corporation and a wholly-owned subsidiary of the Company, outstanding 5.375% senior notes due 2026 (together, the "Note Redemptions"), including all premiums, accrued interest and costs and expenses related to the Note Redemptions. Pending the application of the net proceeds of the offering for the foregoing purposes, net proceeds may be temporarily used for general corporate purposes. The foregoing does not constitute a notice of redemption or an obligation to issue a notice of redemption for the outstanding notes of any series.

J.P. Morgan, Barclays, BofA Securities, Truist Securities and Wells Fargo Securities are acting as joint book-running managers for the offering of the Notes.

This offering is being made pursuant to an effective shelf registration statement and prospectus and a related preliminary prospectus supplement filed by the Company with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus and the related preliminary prospectus supplement, the registration statement and other documents that Centene has filed with the SEC for more complete information about Centene and this offering.

Copies of the prospectus supplement and related prospectuses for this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling +1 (866) 803-9204; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by calling (888) 603-5847; from BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; from Truist Securities by email at [email protected]; and from Wells Fargo Securities, LLC, 550 S. Tryon Street, 5th Floor, Charlotte, North Carolina 28202, Attention: Leveraged Syndicate.

This press release is neither an offer to purchase nor a solicitation of an offer to buy any securities, including the Notes. There shall not be any sale of the securities described herein in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.