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 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will participate in a fireside chat at the Jefferies Gene Therapy/Editing Summit on Wednesday, October 27, 2021 at 10:30 am ET (Press release, Decibel Therapeutics, OCT 20, 2021, View Source [SID1234591569]).

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A live webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.

On October 20, 2021 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan] reported its third quarter sales 2021 (January 1 – September 30, 2021) (Press release, Chugai, OCT 20, 2021, View Source [SID1234591568]).

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Roche owns 59.89% of Chugai’s outstanding shares (61.16% of the total number of shares issued excluding treasury stock) as of the end of September 2021.

Its investor updates and presentation materials can be found on its website (View Source).
Chugai’s performance for the period of January 1 to September 30, 2021 is included in the announced Roche Group’s results.

On October 20, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the company has ranked first in the pharmaceuticals sector for the "2021 Award for Excellence in Corporate Disclosure" granted by the Securities Analysts Association of Japan (SAAJ) to promote the quality and fairness of corporate disclosure (Press release, Astellas, OCT 20, 2021, View Source [SID1234591566]).

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Astellas was highly evaluated mainly in the following areas:

Significant improvement in IR stance, with the top management’s proactive information dissemination and engagement in dialogue
IR group has sufficient accumulated information, and securities analysts and institutional investors are having a useful dialogue with IR personnel
Announcement of a medium-term plan ("Corporate Strategic Plan 2021" *1), a full explanation of subsequent progress with concrete measures for achievement, and a capital allocation policy
Stock market needs are incorporated into the disclosure materials of the medium-term plan
Astellas’ raison d’être is "to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products." With research and development at the heart of the company, Astellas constantly takes on challenges to deliver innovative new drugs and medical solutions by leveraging its core capabilities. In addition, Astellas aims to sustainably enhance its enterprise value by being chosen and trusted by all the stakeholders including customers, shareholders, employees and community.

Upon receiving the award, Kenji Yasukawa, President and CEO, Astellas, stated as follows:
"Our disclosure philosophy is to make our products on the market and the clinical trial results known in a timely and appropriate manner, as well as proactively explain to the stakeholders not only the features of the projects under research and development, but also the potential impact on society when they are launched. In addition, we strive to make the opportunity to provide information flexibly in line with the requests and needs of the stakeholders so that we do not unilaterally disseminate information. As a result of these efforts, we believe that we were able to improve the perception of our advocacy activities and our disclosure philosophy, which led to this recognition."

Astellas will continue to disclose information in a timely, appropriate, and fair manner, as well as proactively engage in dialogue with stakeholders and further improve transparency. Astellas will continue to strive to enhance and improve the quality of its disclosure.

On October 19, 2021 /PRNewswire/ — PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported that the patent for PMC-309, one of the Company’s first immuno-oncology assets, has been granted by IP Australia, the Australian government agency that administers intellectual property rights (Press release, PharmAbcine, OCT 19, 2021, View Source;bmode=view&idx=8574626&t=board [SID1234649186]).

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The Australian grant represents PMC-309’s third global patent approval since it received grants from Russia in June 2021 and South Korea in July 2021. The Company also plans to get more patents approved in other countries, including the U.S, Canada, China, Japan, European nations, and etc.

PMC-309 is a first-in-class antibody that antagonizes VISTA (V-domain Ig Suppressor of T cell Activation) and is in development to treat various tumor types. VISTA plays a pivotal role in maintaining the immunosuppressive environment around the tumor cells and is expressed primarily on immunosuppressive cells, such as MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). Blocking VISTA pathways on immunosuppressive cells promotes T cells’ immune responses and leads to better anti-tumor effects.

According to the nonclinical data of PMC-309 presented at AACR (Free AACR Whitepaper) (American Association for Cancer Research) 2021, PMC-309 showed promising anti-tumor effects comparable to an existing anti-PD-1 drug. However, when used in combo with an anti-PD-1 drug, PMC-309 demonstrated significantly improved tumor growth inhibitions than either mono therapies.

In April 2021, PharmAbcine initiated IND-enabling studies of PMC-309. The studies are required to establish the safety profile in animals before entering the human trial. The Company expects to enter a Phase I global trial in 2022.

"This patent grant is one of the key milestones that underlines our approach to help patients with unmet medical needs with a novel first-in-class antibody candidate and builds stronger intellectual property position in the immuno-oncology field," said Dr. Jin-San Yoo, CEO of PharmAbcine. "Our team believes that PMC-309, with its unique mode of action that does not overlap with the existing drugs, will be a new treatment option in both mono and combo therapies for patients who do not respond well to the current immunotherapies."