On October 20, 2021 Enzychem Lifesciences (KOSDAQ: 183490) reported that positive Phase 2 results from a U.S. clinical trial of its lead candidate EC-18 in chemoradiation-induced oral mucositis (CRIOM). EC-18, a novel, first-in-class, small molecule oral immunomodulator, reduced the duration and incidence of severe oral mucositis in patients with head and neck cancer undergoing concurrent chemoradiation therapy (Press release, Enzychem Lifesciences, OCT 20, 2021, View Source [SID1234591606]).

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CRIOM is a painful and debilitating side effect of chemoradiation in which patients experience severe mouth ulcerations that significantly impacts everyday activities, such as eating, swallowing, and talking. The pain from severe ulcerations can prevent a patient’s intake of solid food and fluids, leading to malnutrition and dehydration that requires hospitalization. Patients with the most severe form of oral mucositis often have to discontinue or modify their cancer treatment.

"Severe CRIOM affects almost 75% of patients being treated with concomitant chemoradiation for head and neck cancers with symptoms that are so severe that they challenge a patients’ ability to tolerate optimal treatment," said Dr. Stephen Sonis, Professor, Harvard School of Dental Medicine and Key Advisor for the U.S. Phase 2 CRIOM Study. "Despite its frequency and burden it places on patients and their caregivers, there is no approved pharmaceutical intervention. The results observed with EC-18 support its continued development and offer encouragement as an effective CRIOM therapy."

"We are delighted to announce these positive results from our Phase 2 U.S. study, which confirm that EC-18 is safe and well-tolerated," said Ki-Young Sohn, CEO & Chairman, Enzychem Lifesciences. "In addition, EC-18 may have a number of key advantages, including oral route of administration and convenience of use. We are excited to advance this novel candidate into a pivotal study and will also evaluate EC-18 for other radiation-induced inflammatory diseases."

The Phase 2 U.S. study evaluated EC-18 in oral mucositis in patients with concomitant chemo-irradiation (standard fractionated Intensity-Modulated Radiation Therapy with cisplatin) for cancers of the mouth, oropharynx, hypopharynx and nasopharynx. In Stage 1 of the study, 24 subjects were randomized to receive one of three doses of EC-18 (500 mg, 1000 mg, or 2000 mg; unit dose of 500 mg) or placebo. For Stage 2 of the study, 81 patients were randomized to receive either placebo or 2000 mg of EC-18 twice-daily over a period of approximately 7 weeks.

EC-18 successfully met both its primary and secondary endpoints in terms of efficacy and safety in the Phase 2 U.S. study. Patients on EC-18 reported a reduction in the duration of severe oral mucositis (SOM) through a short-term follow-up period from 13.5 days to 0 day (100% reduction) in comparison to the placebo arm. EC-18 also reduced the incidence of SOM through completion of radiation by 37.1% in comparison to the placebo arm (65% vs. 40.9%). The incidence of SOM through a short-term follow-up period was reduced by 35.1% in comparison to the placebo arm (70% vs. 45.5%). No serious adverse events (SAE) were reported between placebo and EC-18 groups and none of the SAEs were related to EC-18. Safety was also comparable across arms with all adverse events (AEs) attributable to expected chemoradiation-related toxicity. One-year long-term follow-up for tumor outcomes is ongoing.

Based on positive Phase 2 data, Enzychem plans to file for Breakthrough Therapy Designation to the FDA later this year, and advance EC-18 into a global Phase 3 clinical program.

On October 20, 2021 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2021 financial results (Press release, Biogen, OCT 20, 2021, View Source [SID1234591629]).

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"The potential uptake of ADUHELM in the U.S. is delayed, but we continue to believe in its long-term potential. At the same time, Biogen has continued to execute well across its leading MS, SMA and biosimilars businesses, and we are particularly encouraged by the ongoing launch of VUMERITY," said Michel Vounatsos, Biogen’s Chief Executive Officer. "2021 continues to be a transformative year for Biogen with the launch of ADUHELM and the initiation of the rolling submission for lecanemab in Alzheimer’s disease. In addition, along with Sage Therapeutics we are pursuing a filing for zuranolone in depression."

Third Quarter 2021 Financial Results
• Third quarter total revenue of $2,779 million decreased 18% versus the prior year at both actual currency and constant currency*. o Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, of $1,820 million decreased 19% versus the prior year at actual currency and 20% at constant currency. o SPINRAZA revenue of $444 million decreased 10% versus the prior year at actual currency and 11% at constant currency. o ADUHELM revenue was $0.3 million. o Biosimilars revenue of $203 million decreased 2% versus the prior year at actual currency and 4% at constant currency. 2
• Third quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $329 million and $2.22, respectively.
• Third quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $710 million and $4.77, respectively. A reconciliation of GAAP to Non-GAAP financial measures included in this news release can be found in Table 4 at the end of this news release. * Percentage changes in revenue growth at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period.Beginning in the second quarter of 2021 material upfront payments and premiums paid on the acquisition of common stock associated with significant collaboration and licensing arrangements along with the related transaction costs incurred are no longer excluded from Non-GAAP R&D and SG&A expenses. Non-GAAP financial results for the third quarter of 2020 have been updated to reflect the $601 million payment related to the collaboration with Denali Therapeutics Inc. along with the associated transaction costs and income tax effect. o Third quarter 2021 GAAP and Non-GAAP R&D expense includes a $125 million upfront payment related to our collaboration with InnoCare Pharma Limited. In addition, during the third quarter we suspended further development of BIIB111 (timrepigene emparvovec) in choroideremia and BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa and recorded $39 million of estimated clinical trial close-out costs and manufacturing commitments. o Third quarter 2021 GAAP and Non-GAAP SG&A expense increased versus the prior year primarily due to investments in support of the launch of ADUHELM. Beginning in the second quarter, upon FDA approval, the reimbursement from Eisai for its share of U.S. ADUHELM SG&A expenses is reflected in collaboration profit sharing rather than SG&A.

3 • Third quarter 2021 GAAP amortization and impairment of acquired intangible assets was $111 million, including an impairment charge of $15 million related to BIIB111 and a $28 million impairment charge related to BIIB112. These amounts are excluded from Non-GAAP financial results. Non-GAAP amortization was $7 million.
• Third quarter 2021 GAAP and Non-GAAP collaboration profit sharing was a net expense of $21 million, which includes a reimbursement of $51 million from Eisai Co., Ltd. (Eisai) related to the commercialization of ADUHELM in the U.S.
• Third quarter 2021 GAAP other expense was $503 million, primarily driven by unrealized losses on our strategic equity investments of $424 million. Third quarter 2021 Non-GAAP other expense was $79 million, primarily driven by interest expense.
• Third quarter 2021 effective GAAP and Non-GAAP tax rates were (8.9%) and 14.5%, respectively. The third quarter 2021 effective GAAP tax rate was impacted by non-cash tax favorability from both the unrealized losses on our strategic equity investments and the previously described impairment charges related to BIIB111 and BIIB112. Financial Position
• As of September 30, 2021, Biogen had $7,271 million in total debt. Cash, cash equivalents, and marketable securities totaled $3,923 million. This resulted in net debt of $3,348 million.
• In the third quarter of 2021 Biogen repurchased approximately 2.2 million shares of the Company’s common stock for a total value of $750 million.
As of September 30, 2021, there was $2,800 million remaining under the share repurchase program authorized in October 2020.
• For the third quarter of 2021 the Company’s weighted average diluted shares were 149 million.
• Third quarter 2021 cash from operations was $805 million. Capital expenditures were $42 million, and free cash flow, defined as cash flow from operations less capital expenditures, was $763 million.

On October 20, 2021 Roche reported strong growth in the first nine months – outlook for 2021 raised (Press release, Hoffmann-La Roche, OCT 20, 2021, View Source [SID1234591570])

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Group sales up 8%1 at constant exchange rates (CER); 6% in Swiss francs
Pharmaceuticals Division sales grow 5% in the third quarter and are now in line with the prior year for the first nine months; continued strong growth of newly launched medicines
Diagnostics Division sales grow 18% in the third quarter and 39% in the first nine months due to high demand for COVID-19 tests, a strong recovery in the base business and the newly launched diagnostics platforms
Highlights in the third quarter:
FDA approves cancer immunotherapy Tecentriq (early-stage lung cancer) and grants Priority Review for eye medicine faricimab
Positive study results for Polivy (blood cancer) and Ronapreve (COVID-19)
FDA grants Breakthrough Therapy Designation to gantenerumab (Alzheimer’s disease); final study results expected in second half of 2022
Share purchase agreement with long-term partner TIB Molbiol to expand molecular diagnostics portfolio
Outlook raised
*Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others
CEO Severin Schwan on the results: "The demand for coronavirus tests remained high in the third quarter due to the Delta variant. Together with the recently launched medicines and diagnostics platforms they contributed to the strong sales growth. We also made significant progress in our product pipeline in the third quarter, including with Polivy, the first medicine in 20 years to significantly improve outcomes in a form of aggressive blood cancer. Based on the results achieved so far, we are raising our outlook for the full year."

Outlook raised for 2021
Sales are now expected to grow in the mid-single digit range, at constant exchange rates (before: in the low to mid-single digit range). Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.

Group results
Group sales increased by 8% (6% in CHF) to CHF 46.7 billion in the first nine months of the year.

Pharmaceuticals Division sales remained stable at CHF 33.4 billion. Since summer there have been signs of recovery from the COVID-19 pandemic and the biosimilar impact is slowing down as expected (Pharma sales: -9% in the first quarter, +4% in the second quarter and +5% in the third quarter).

In the United States, sales declined by 5% over the first nine months, with stable year-on-year sales since the summer.

Competition from biosimilars for the established cancer medicines MabThera/Rituxan, Avastin and Herceptin led to an overall decline, partly offset by sales of Actemra/RoActemra, Hemlibra, Ocrevus and Tecentriq, as well as for Evrysdi (spinal muscular atrophy) and Phesgo (breast cancer), which were launched only last year.

Sales in Europe increased by 3%. Sales growth of new medicines (Ronapreve, Ocrevus, Hemlibra and Kadcyla) more than offset the impact of biosimilars.

In Japan, sales increased by 20%. Growth was driven by the new medicines Ronapreve, Tecentriq, Enspryng and Hemlibra. This more than offset the impact of biosimilars and government price cuts.

Sales in the International region grew 2%, driven by strong demand for Perjeta and Ronapreve. Sales growth in China (+2%) resulted from continued strong uptake of Perjeta, Alecensa and other innovative cancer medicines.

The Diagnostics Division achieved strong sales growth of 39% to CHF 13.3 billion in the first nine months. Growth was 18% in the third quarter compared to the already very strong third quarter last year. Demand for COVID-19 testing remained high in the third quarter, driven primarily by the Delta variant. As a result, Roche’s industry-leading portfolio of COVID-19 tests again contributed significantly to the division’s overall sales growth.

The base business, still heavily impacted by the pandemic in 2020, showed strong growth in the first nine months of 2021: after a significant recovery in the first half of the year (+17% in the first quarter, 31% in the second quarter), strong growth of 11% was also achieved in the third quarter.

Sales grew strongly in all regions: Europe, Middle East and Africa +54%, Asia-Pacific +35%, North America +18% and Latin America +63%.

In September Roche signed a definitive share purchase agreement with TIB Molbiol. Roche and TIB Molbiol have been working together for more than 20 years on tests and reagents for pathogens such as SARS, anthrax, MERS, the novel H1N1 swine flu virus and, most recently, the SARS-CoV-2 virus and its variants. This acquisition will add a range of infectious disease tests to Roche’s broad portfolio of molecular diagnostic solutions.

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Third Quarter Sales 2021 Webinar
There will be a live webinar for investors and analysts today, Wednesday, 20 October at 2:00 pm CEST. To access the webinar, please click here.

On October 20, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that on October 20, 2021, it granted conditional awards ("LTIP Awards") under the Long Term Incentive Plan adopted by HUTCHMED in 2015 ("LTIP") (Press release, Hutchison China MediTech, OCT 20, 2021, View Source [SID1234591587]).

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Aimed at attracting and retaining top talent, the Remuneration Committee of HUTCHMED appointed an independent advisor to conduct a compensation benchmarking research on peer group U.S. and China biotech companies. The Remuneration Committee comprehensively reviewed the compensation and share-based incentives policies of HUTCHMED and its subsidiaries (the "Group") and established an attractive policy to ensure the Group is able to recruit and retain top talent. Vesting of share-based awards under the policy is in line with that peer group.

The compensation of the Independent Non-executive Directors ("INEDs") of HUTCHMED is structured approximately as one-third cash (in the form of Directors’ fees) and two-thirds restricted share units (in the form of non-performance related LTIP awards). Such restricted share units vest over four years in lieu of cash. All Directors’ compensation arrangements are approved by the Board of Directors with the relevant Directors declaring their interest and abstaining from voting where it relates to their fees/restricted share units. In addition, the Nomination Committee of HUTCHMED assesses the independence of all the INEDs every year having regard to the criteria under the applicable corporate governance code adopted by the Company. Therefore, the current compensation arrangements will not compromise the INEDs independence.

Non-performance-related LTIP Award for the HUTCHMED Financial Year 2021 ("Non-performance LTIP Awards") – a one-off cash amount was granted to each grantee and will be used by the trustee administering the LTIP (the "Trustee") to purchase shares in HUTCHMED ("Shares") which will be subject to a vesting period of four years. HUTCHMED has granted the following Non-performance LTIP Awards to the following Directors:

Award Holder Cash amount for the Non-performance LTIP Awards
Mr Simon To (Executive Director) US$250,0001
Dr Dan Eldar (Non-executive Director ("NED")) US$250,000
Ms Edith Shih (NED) US$250,0002
Mr Paul Carter (INED) US$250,000
Dr Karen Ferrante (INED) US$250,000
Mr Graeme Jack (INED) US$250,000
Professor Tony Mok (INED) US$250,000

Notes:

(1) Similar to the arrangement for his Director’s fees, this cash amount would be used by the Trustee to buy Shares which will be held by the Trustee until the LTIP concerned is vested, with 25% to be vested in each of the next four years, whereupon the Shares will be received by or for the account of his employer, Hutchison Whampoa (China) Limited.
(2) Similar to the arrangement for her Director’s fees, this cash amount would be used by the Trustee to buy Shares which will be held by the Trustee until the LTIP concerned is vested, with 25% to be vested in each of the next four years, whereupon the Shares will be received by or for the account of her employer, Hutchison International Limited

The cash amount will be used by the Trustee to buy Shares which will be held by the Trustee until the underlying Non-performance LTIP Awards are vested. 25% of the Shares bought by the Trustee will vest on each anniversary of the grant of the Non-performance LTIP Awards for the next four years.

As each of the Directors is a connected person of HUTCHMED, the grant of the LTIP Awards to each of them constitutes a connected transaction of HUTCHMED under Chapter 14A of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the "Hong Kong Listing Rules"). As the grant of the LTIP Awards to each of the Directors involves an amount less than the relevant de minimis level, it is fully exempt from the connected transaction requirements under Chapter 14A of the Hong Kong Listing Rules pursuant to the exemption under Rule 14A.76.

Further announcements will be made in due course at the time the Non-performance LTIP Awards are vested, when the number of the Shares to which each Director is entitled will be known. The above Directors additionally have the right to elect on acceptance of the grant of their awards to have part of their awards held (on behalf of the Director by the Trustee) pending vesting in the form of cash in order to satisfy any tax liability in respect of their awards.

The Directors are persons discharging management responsibility (PDMRs) for the purposes of the Market Abuse Regulation (EU) 596/2014 ("MAR") and the information in this announcement is provided in accordance with the requirements of Regulation 19(3) of MAR.

The LTIP does not constitute a share option scheme or an arrangement analogous to a share option scheme for the purpose of Chapter 17 of the Hong Kong Listing Rules.

On October 20, 2021 Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its liquid biopsy assay, Exo-PDAC (Press release, Biological Dynamics, OCT 20, 2021, View Source [SID1234591607]). The test is designed to provide early detection for pancreatic ductal adenocarcinoma (PDAC), one of the most aggressive and lethal forms of cancer worldwide.

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"Early detection of pancreatic cancer in elevated risk individuals may help save a lot of lives," said Scott Lippman, MD, Director of Moores Cancer Center at UC San Diego Health. "The promise of Biological Dynamics’ cutting-edge exosomal isolation technology is addressing a critical, unmet medical need in our multidisciplinary and multi-dimensional fight against pancreatic cancer."

PDAC is projected to become the second leading cause of cancer-related deaths by 2040, due primarily to the fact that the disease is asymptomatic in its early stages. Therefore, patients are typically diagnosed during advanced stages of disease progression when treatments are limited. Detecting early PDAC biomarkers could help identify vulnerable patients before the disease progresses or metastasizes. However, it requires a high degree of sensitivity and specificity that conventional laboratory testing methods lack.

The Exo-PDAC diagnostic assay identifies exosomal biomarkers related to an elevated risk of pancreatic cancer, such as individuals with new-onset diabetes, a family history of pancreatic cancer, certain germline mutations, and other relevant factors that might be determined by the United States Preventive Services Task Force (USPSTF). Exo-PDAC is the first assay to use Biological Dynamics’ Verita platform, a novel alternating current electrokinetic-based technology applied for early disease detection, including cancer, Alzheimer’s disease, and infectious diseases. The test requires a small amount of blood from patients, which is then analyzed with minimal sample preparation or processing.

"For far too long, patients have needed innovative technologies with the potential to detect cancer at the earliest stages, and we look forward to working closely with the FDA, to do exactly that, with our pancreatic cancer test," said Biological Dynamics CEO Raj Krishnan, PhD. "And for us, this is an important milestone as we accelerate our vision of improving global health outcomes by advancing our unique multiomics platform for multiple cancers and other diseases."

According to the FDA, "The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization, consistent with the Agency’s mission to protect and promote public health."