Ovid Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. signed a pact giving the latter global rights to develop and commercialize soticlestat (TAK-935/OV-935), a first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase for the treatment of developmental and epileptic encephalopathies including Dravet syndrome and Lennox-Gastaut syndrome. New York-based Ovid could bank as much as $856 million in payments, including $196 million up front, followed by regulatory and commercial milestone rewards plus tiered double-digit royalties. The original 2017 collaboration between Ovid and Takeda, of Osaka, Japan, is concluding, and Ovid bears no further development or milestone obligations. Takeda plans to start phase III studies in children and adults with both conditions in the second quarter of this year. Shares of Ovid (NASDAQ:OVID) were trading midday at $4.12, up $1.16, or 39%.

Sofinnova Partners closes out crossover fund at $535M

DUBLIN – Sofinnova Partners closed out its crossover fund at €445 million (US$535 million), a total, it said, that makes it Europe’s largest crossover investor in biotech. It’s almost three years since Paris-based Sofinnova Partners completed an initial close at €275 million. “We didn’t set a bar – we thought between €250 million and €400 million would be great,” Antoine Papiernik, chairman and managing partner at Sofinnova, told BioWorld. Since then, European biotech has scaled new heights in terms of securing investment. Since the first close, Sofinnova has completed 10 investments in public and private biopharma and medical devices companies.

Century closes $160M series C round as first programs edge toward trials

Century Therapeutics Inc. raised $160 million in a series C round to progress its preclinical pipeline of allogeneic cell therapies for cancer, which are derived from induced pluripotent stem cells (iPSCs), and to expand its operational, laboratory and production facilities across several locations. The Philadelphia-based company, which raised $250 million across its series A and B rounds from founding investor Versant Ventures, Leaps by Bayer (the investment arm of Bayer AG) and strategic partner Fujifilm Cellular Dynamics Inc. (FCDI), has from the beginning set out its stall as a fully integrated cell therapy company. That meant building in-house capabilities in protein engineering, gene editing and manufacturing, as well as ensuring it has enough critical mass in each of those areas to be competitive.

Caribou Biosciences raises $115M series C to advance CRISPR tech, cell therapy pipeline

Berkeley, Calif.-based Caribou Biosciences Inc. has raised $115 million in an oversubscribed series C financing co-led by Farallon Capital Management, PFM Health Sciences and Ridgeback Capital Investments. Proceeds from the round will be used to advance its CRISPR technology platform and pipeline of off-the-shelf genome-edited CAR T and CAR-NK cell cancer therapies, including CB-010, its lead CAR T program, now in a phase I trial for patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

FDA approves new once-daily ADHD drug Azstarys

A new once-daily attention deficit hyperactive disorder (ADHD) drug developed by prodrug specialist Kempharm Inc. has won FDA approval under the brand name Azstarys. The medicine combines serdexmethylphenidate, Kempharm's prodrug of the CNS stimulant dexmethylphenidate (d-MPH), with immediate-release d-MPH, the core medicine in the now off-patent product Focalin, a refined formulation of Ritalin. U.S. commercial rights for the Azstarys, approved via the FDA's 505(b)(2) pathway, were licensed to Gurnet Point Capital affiliate Commave Therapeutics SA (formerly known as Boston Pharmaceuticals SA) in 2019.

Biopharma companies invested more on R&D in 2020

According to an analysis conducted by BioWorld of the 2020 financial reports filed by public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the year increased by 23% compared to the same period last year. The 100 companies that were included in the analysis collectively invested a total of $44 billion in R&D compared to almost $35 billion invested in 2019. Biopharma companies conducting research on therapies and vaccines to treat COVID-19 were a significant contributing factor to the jump in R&D expenses.

Janux strengthens its coffer with a $56M series A

Little more than two months after cutting a deal with Merck & Co. Inc. that could top $1 billion, Janux Therapeutics Inc. has closed a $56 million series A. Janux, of San Diego, is developing immunotherapies designed to trigger the immune system to kill specific tumors while leaving the healthy tissue alone. T-cell engagers, the company said, bind to a tumor cell and use the patient’s T cells to eliminate the tumor. The company said it will use the money to advance its preclinical pipeline and put its first candidate into the clinic in the first half of next year. The financing was led by Avalon Ventures, along with new investors Orbimed and RA Capital Management, and existing investors Bregua and Correlation Ventures.

Senate Finance Committee renders tie vote on Becerra to run HHS

The U.S. Senate Finance Committee hearing for the appointment of Xavier Becerra as Secretary of Health and Human Services ended in a tie vote, which not unexpectedly ran along party lines. The nomination of Becerra was controversial on several fronts, but the outcome nonetheless sends the nomination to the Senate floor, where Vice President Kamala Harris may cast the deciding vote in what is likely to be a 50-50 deadlock.

After Nasdaq, Sciclone turns to HKEX with $281M IPO to diversify pipeline

Four years after leaving Nasdaq, Sciclone Pharmaceuticals Holdings Ltd. returned to the market March 3, issuing 116 million shares to raise HK$2.18 billion (US$281 million) on the Hong Kong Stock Exchange (HKEX). Shares were priced at HK$18.8 each. With Morgan Stanley, CICC and Credit Suisse as joint sponsors, Sciclone hopes the IPO will help it expand its pipeline to reduce reliance on its core product, Zadaxin (thymalfasin).

Real world study shows COVID-19 vaccines reduce serious disease in elderly

LONDON – A further U.K. real world study of COVID-19 vaccines has found a single dose dramatically reduces the chances of the most elderly and frail being admitted to the hospital as a result of serious infection. The study covers every person over 80 years of age admitted to one of two hospitals in Bristol with acute respiratory disease, from Dec. 18, 2020, 10 days after the U.K.’s COVID-19 vaccination program began, to Feb. 26, 2021. Comparing the immunization rates between patients who had a positive test for SARS-CoV-2 on hospital admission, and of controls whose tests were negative, the effectiveness of one dose of either the Pfizer Inc./Biontech SE or Astrazeneca plc vaccines has been estimated. The Pfizer/Biontech vaccine was 71.4 % effective in preventing symptomatic illness severe enough to result in hospitalization; Astrazeneca’s vaccine was 80.4% effective. The median age of the Pfizer/Biontech vaccinated group was 87 and of the Astrazeneca group 88. All the patients had multiple co-morbidities.

WTO head: Vaccine companies must license sites in emerging countries

As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the organization’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.” She noted that the normal global capacity of vaccine production is 3.5 billion doses, but 10 billion doses are needed.

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