On February 1, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) Alligator Bioscience (Nasdaq Stockholm: ATORX), reported the appointment of Sumeet Ambarkhane, MD, as its Chief Medical Officer (Press release, Alligator Bioscience, FEB 1, 2022, View Source [SID1234607555]). In this role, Sumeet will provide medical leadership and direction in the development of Alligator’s best-in-class preclinical and clinical pipeline, including Alligator’s lead assets mitazalimab, a CD40 agonist currently in Phase II clinical development, and ATOR-1017, a 4-1BB agonist in Phase I.

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Sumeet is a seasoned professional with over 20 years of drug development experience in academia and in the biotechnology and pharmaceutical industries. Sumeet has a proven track record of advancing investigational medicines including immunotherapy-biologics, from early phases of development through regulatory approvals and adoption into clinical practice.

Sumeet comes to Alligator from MorphoSys AG, where he served as their Senior Global Program Medical Director. At MorphoSys AG, he led the clinical development for its hemato-oncology programs, including tafasitamab (Monjuvi), which was granted breakthrough therapy designation and subsequently an accelerated approval by FDA, in addition to conditional approval by EMA. Prior to MorphoSys, Sumeet spent seven years at UCB Pharmaceuticals, assuming roles of increasing responsibility and across geographies for the company’s immunology and neurology drug development portfolio.

Sumeet holds a Bachelor of Medicine, Bachelor of Surgery and Medical Doctorate degrees in medicine and clinical pharmacology from Seth G.S. Medical College and King Edward Memorial Hospital, University of Mumbai in India.

"We are thrilled to welcome a professional of Sumeet’s caliber to the Alligator team," says Søren Bregenholt, CEO, Alligator Bioscience. "His in-depth expertise in medical science, clinical development, experience from global regulatory submissions, and product registrations will significantly strengthen our efforts to further advance our novel immune-oncology pipeline."

On February 1, 2022 GlaxoSmithKline plc (LSE/NYSE: GSK) reported that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. (Gilead) concerning ViiV Healthcare’s patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus (HIV) (Press release, GlaxoSmithKline, FEB 1, 2022, View Source [SID1234607572]).

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ViiV Healthcare, GSK and Shionogi alleged that Gilead’s Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine, infringed certain of their patents relating to dolutegravir. As a result of the settlement, patent infringement cases in the US, UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada will be discontinued.

ViiV Healthcare, GSK, Shionogi and Gilead have entered into a global settlement agreement and a patent license agreement under which Gilead has been granted a worldwide licence to certain ViiV Healthcare patents relating to dolutegravir and a covenant not to enforce any patents controlled by ViiV Healthcare, GSK or Shionogi against Gilead in connection with any past or future claims of infringement relating to Biktarvy. ViiV Healthcare, GSK and Shionogi have also agreed not to enforce their patents against any future product containing bictegravir, to the extent that the patent enforcement relates to the bictegravir component of the product.

Financial Considerations
Under the terms of the global settlement and licensing agreement, Gilead will make an upfront payment of $1.25 billion to ViiV Healthcare which is expected in the first quarter of 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy ($6.09 billion in 2020) and in respect of the bictegravir component of any other future bictegravir-containing products sold in the US. These royalties will be payable by Gilead to ViiV Healthcare from 1 February 2022 until the expiry of ViiV Healthcare’s U.S. Patent No. 8,129,385 on 5 October 2027. Gilead’s obligation to pay royalties does not extend into any period of regulatory paediatric exclusivity, if awarded. Regulatory paediatric exclusivity would extend the period of exclusivity after the expiry of the ‘385 patent by six months from 5 October 2027 to 5 April 2028.

The upfront payment and royalty income will be distributed in proportion to the ordinary shareholding in ViiV Healthcare (GSK 78.3%, Pfizer 11.7%, Shionogi 10%) net of the contingent consideration liability (CCL) to Shionogi and applicable tax.

The upfront payment of $1.25 billion will be recorded in GSK’s financial results as an adjusting item in the income statement for the first quarter of 2022. The future royalty income will be recorded in total and adjusted results in the income statements for 2022 to 2027 inclusive. Both the settlement and the future royalty income increase the fair value of the CCL to Shionogi, and the Pfizer put option.* These increases in fair value will be reflected in GSK’s 2021 full-year and fourth-quarter results, and the associated charges will be recorded within adjusting items.

Cash in-flows from the upfront payment and future royalty income and cash out-flows from the CCL will be recorded in cash generated from operations. The resulting increased dividends to Shionogi and Pfizer will be included within financing cashflows. Full details of the operational accounting of the CCL can be found on pages 52-53 of GSK’s 2020 Annual Report.

On February 1, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Tuesday, February 15, 2022 at 2:00 p.m. Eastern Time (Press release, Personalis, FEB 1, 2022, View Source [SID1234607588]).

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The webcast link is available only for those who are attending the BTIG conference.

On February 1, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended December 31, 2021 (Press release, Bio-Techne, FEB 1, 2022, View Source [SID1234607556]). The quarterly dividend will be payable February 25, 2022, to all common shareholders of record on February 11, 2022. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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Bio-Techne also announced today that its board of directors has approved a new share repurchase program authorizing the repurchase of up to $400 million of common stock. The new share repurchase program begins February 2, 2022 and replaces the previous program. The timing and number of shares to be repurchased will depend on factors such as the share price, economic and market conditions, and corporate and regulatory requirements. The share repurchase program may be suspended, amended, or discontinued at any time and does not obligate the Company to acquire any specific dollar amount or number of shares of common stock.

On February 1, 2022 Hubro Therapeutics reported that on 31 January the first dose of FMPV-1 was successfully administered to the first subject in our phase I study FMPV-1-01 in healthy volunteers (Press release, Hubro Therapeutics, FEB 1, 2022, View Source [SID1234607573]). In the study FMPV-1 is co-administered with adjuvant GM-CSF. The study will assess safety and immune response in up to 16 subjects. In a first cohort eight subjects will be enrolled and, depending on the results, a second cohort of another eight subjects given a higher dose of FMPV-1 will follow. It is aimed at completing enrolment and active treatment in the study within the next six months.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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