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Biogen to Participate in SVB Leerink’s 3rd Annual CNS Forum

On June 22, 2021 Biogen Inc. (Nasdaq: BIIB) reported that it will participate in SVB Leerink’s 3rd Annual CNS Forum. The webcast will be live on Tuesday, June 29, at 1:50 p.m. ET (Press release, Biogen, JUN 22, 2021, View Source [SID1234584282]). To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available following the presentation.

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Termination of a Material Definitive Agreement

On June 22, 2021, United Therapeutics Corporation (the "Company") and Medtronic, Inc. ("Medtronic") reported that agreed to discontinue further efforts to develop and commercialize the Implantable System for Remodulin ("ISR") (Filing, 8-K, United Therapeutics, JUN 23, 2021, View Source [SID1234584280]). By way of background, the ISR has been developed over the past 12 years in collaboration with Medtronic to deliver Remodulin (treprostinil) Injection for patients with pulmonary arterial hypertension ("PAH") via an implantable system developed by Medtronic. On February 25, 2019, Medtronic and the Company entered into a Commercialization Agreement governing the parties’ collaboration to commercialize the ISR in the United States (the "Commercialization Agreement"). Despite approval by the U.S. Food and Drug Administration ("FDA") of Medtronic’s premarket approval application ("PMA") for the ISR in December 2017, commercial launch of the product required Medtronic, as the applicant, to satisfy certain conditions to its PMA approval. Based on the evolution of treatment options and paradigms in PAH over the past few years, and the anticipated efforts required to satisfy the FDA’s conditions of approval, the Company and Medtronic have decided to discontinue further efforts to develop and commercialize the ISR. The Company and Medtronic plan to work together on a mutually-agreed approach to wind-down the development program, and to support patients already enrolled in clinical studies of the ISR, at the Company’s sole expense. Effective June 22, 2021, the parties mutually agreed to terminate the Commercialization Agreement. There were no penalties associated with the termination of the Commercialization Agreement.

Grant of Restricted Stock Units and Warrants to Employees in Genmab

On June 22, 2021 Genmab A/S (Nasdaq: GMAB) reported that at a board meeting the board decided to grant 15,241 restricted stock units and 16,335 warrants to employees of the company and three of the company’s subsidiaries (Press release, Genmab, JUN 22, 2021, View Source [SID1234584260]).

Each restricted stock unit is awarded cost-free and provides the owner with a right to receive one share in Genmab A/S of nominally DKK 1. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,698.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the board of directors in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Governance > Compensation > Restricted stock units.

The exercise price for each warrant is DKK 2,698. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 839.14.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the board of directors on February 23, 2021. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Governance > Compensation > Warrants.

Photocure: Asieris Announces First Patient Administration in Europe within the Phase III Clinical Trial for APL-1702 (Cevira)

On June 22, 2021 Photocure ASA (OSE:PHO) reported that its partner Asieris Pharmaceuticals (Asieris) has administered the first European patient in its phase III clinical trial for APL-1702 (Cevira) (Press release, PhotoCure, JUN 22, 2021, View Source [SID1234584253]).

Asieris announced dosing of the first patient in Europe in its multinational, multicenter, Phase III clinical trial called APRICITY that started last November. The photodynamic drug-device combination product APL-1702, Cevira, licensed to Asieris by Photocure, is being developed for a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL).

"The multinational phase III clinical trial for Cevira is an important milestone towards a non-surgical treatment of high-grade cervical dysplasia. This step shows once more that our partner Asieris is making great progress and is on track with their clinical program and development of this innovative photodynamic drug-device combination," says Daniel Schneider, Chief Executive Officer of Photocure.

In China, the clinical trial application for APL-1702, Cevira multinational Phase III trial was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2020. Photocure reported Asieris’ dosing of the first patient in China on November 11, 2020 (View Source).

HSIL is a pre-cancerous condition caused by a persistent HPV infection. Each year there are approximately 10 million cases of high-grade disease and over 500,000 new cases of cervical cancer worldwide. In China, approximately 2% of women develop HSIL each year.

PerkinElmer Agrees to Acquire Viral Vector Gene Delivery Leader SIRION Biotech

On June 22, 2021 PerkinElmer, Inc. (NYSE: PKI) ("PerkinElmer") reported it has entered into an agreement to acquire SIRION Biotech GmbH, a leading, global provider of viral vector-based technologies that drive improved delivery performance for cell and gene therapies (Press release, PerkinElmer, JUN 22, 2021, View Source [SID1234584258]). The acquisition is expected to close during the third quarter of 2021.

Headquartered in Munich, Germany, privately held SIRION has approximately 50 employees based in Germany, the U.S. and France. The company has established a strong licensing portfolio leveraged by over a dozen major pharmaceutical and biotech players researching more than twenty five diseases and conditions.

The addition of SIRION’s offerings will complement PerkinElmer’s Horizon Discovery portfolio which includes gene editing and modulation tools for CRISPR, CRISPRi and RNAi, custom cell lines for bio production and base editing technologies. Moreover, the acquisition will further broaden PerkinElmer’s existing cell and gene research solutions featuring industry-leading high content, in vivo, and cell painting screening technologies; innovative immunoassays; cell plate readers; and advanced automation, microfluidics and informatics and analytical platforms.

Commenting on the agreement to acquire the company, Prahlad Singh, president and chief executive officer of PerkinElmer, said, "Seventy percent of gene therapy trials today leverage viral vector approaches and we expect this to remain strong going forward given the demand for targeted, high-payload delivery in treating diseases like cancer. By combining SIRION’s innovative "payload" transport technology with our existing Horizon genetic material editing tools and phenotypic research solutions, we will be able to support organizations’ cell and gene therapy workflows as they look to streamline and accelerate their efforts."

Dr. Christian Thirion, CEO of SIRION, added, "Our team is excited to work with PerkinElmer to continue to grow our leading position in viral vector technologies for cell and gene therapy. We will benefit greatly from becoming part of the PerkinElmer portfolio, with increased access to genomics analysis, gene editing and base editing technologies, as well as a strong global infrastructure and reach."

To learn more about PerkinElmer’s full range of life sciences solutions, Informatics and OneSource services please visit: View Source