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Product Development

April 27 Quick Takes: Merck, Gilead move to expand access to COVID-19 antivirals; plus Exscientia-Softbank, Lilly, Aldeyra, LogicBio, Canbridge, Daiichi, Ultivue, Provention

Apr 28, 2021 | 2:01 AM GMT

Initiatives by Merck & Co. Inc. (NYSE:MRK) and Gilead Sciences Inc. (NASDAQ:GILD) will expand availability of the companies’ antivirals in India as the country’s COVID-19 crisis continues.

Gilead is providing its seven Indian licensing partners with technical assistance, support for new manufacturing facilities and donated API to scale up production of Veklury remdesivir. The company is also donating at least 450,000 vials of Veklury to India. Gilead’s global licensing program for the therapy provides royalty-free licenses to nine companies to support access in 127 countries.

Merck has entered into non-exclusive licensing agreements for molnupiravir with five established Indian generics companies to accelerate access to the oral antiviral in India and more than 100 low- and middle-income countries. Merck is developing the therapy with Ridgeback Biotherapeutics L.P.

With $525M Exscientia deal, Softbank continues run on biopharmas

With at least eight life sciences investments in the book for the year, Softbank has turned to Oxford, U.K.-based AI play Exscientia Ltd. for its latest deal. At $225 million, the round falls far short of the firm’s $900 million injection into Pacific Biosciences of California Inc. (NASDAQ:PACB) in February. SoftBank Vision Fund 2i led the series D round, which also drew backing from Novo Holdings A/S, Blackrock, Bristol Myers Squibb Co. (NYSE:BMY) and nine additional disclosed investors. SoftBank is providing an additional $300 million equity commitment that can be drawn at the Company’s discretion.

Lilly drops CD73 program as it reports first quarter EPS miss

It was weaker-than-expected COVID-19 antibody sales that led Eli Lilly and Co. (NYSE:LLY) to miss its first quarter estimates, but the earnings report also revealed shifts in Lilly’s broader pipeline. The pharma reported a 16% year-over-year gain in 1Q21 revenue to $6.8 billion on adjusted EPS of $1.87, compared with consensus estimates of $2.12. The company lowered 2021 earnings per share guidance to $7.80-$8 to reflect the shift in COVID-19 antibody sales. Lilly also dropped a trio of programs: a Phase I cancer program in the crowded CD73 inhibitor space, an ANGPTL38 mAb for cardiovascular disease in Phase I, and Phase III psoriasis candidate mirikizumab, a humanized IgG4 monoclonal antibody that binds to the p19 subunit of IL-23.

Aldeyra closes in on NDA after latest allergic conjunctivitis data

Aldeyra Therapeutics Inc. (NASDAQ:ALDX), whose shares gained 36% to $14.85 Tuesday, plans to discuss with FDA an NDA submission for reproxalap based on data showing the ophthalmic solution met the primary and secondary endpoints in the Phase III INVIGORATE trial to treat allergic conjunctivitis. On the primary endpoint, the small molecule covalent inhibitor of reactive aldehyde species reduced ocular itching vs. vehicle (p<0.0001 at all 11 prespecified time points from 110-210 minutes). Reproxalap also lowered ocular redness and tearing and overall ocular severity scores (p<0.0001 for all).

Options aplenty in LogicBio’s Canbridge, Daiichi Sankyo deals

Canbridge Pharmaceuticals Inc. has gained exclusive global rights to sL65, an AAV capsid LogicBio Therapeutics Inc. (NASDAQ:LOGC) produced using its capsid platform, to support development of Fabry and Pompe disease gene therapies. The deal includes options to use sL65 for two more indications and an option for exclusive rights to methylmalonic acidemia gene therapy LB-001 in China, Taiwan, Hong Kong and Macao. LogicBio will receive $10 million up front for the Fabry and Pompe programs and is eligible for $581 million in payments including opt-in fees and milestones as well as up to double-digit royalties.

Separately, LogicBio and Daiichi Sankyo Co. Ltd. (Tokyo:4568) agreed to collaborate on developing therapies for two undisclosed indications using the biotech's gene insertion platform. The Japanese pharma gained an option to negotiate and acquire a worldwide license for the two programs. Financial terms are undisclosed.

Ultivue raises $50M to expand multiplex biomarker assay footprint

Ultivue Inc., which provides researchers and scientists with multiplex biomarker assays for tissue phenotyping and digital pathology, will expand commercialization and increase the scope of its R&D initiatives using a newly raised $50 million series D round. New investors include Ally Bridge Group, Pura Vida Investments and Tao Capital Partners; existing investors in the financing include Arch Venture Partners, Northpond Ventures and Applied Ventures.

No ‘prevention’ for Provention

Look for shares of Provention Bio Inc. (NASDAQ:PRVB) to move on Wednesday after a postmarket regulatory update on Type I diabetes program teplizumab shaved 6% off the company’s stock. Provention said FDA recommended that it remove the term “prevention” from its proposed indication, favoring use of “delay” alone. The company also reiterated that agency concerns related to a PK comparability issue could push back FDA’s decision on the anti-CD3 mAb. An FDA advisory committee meeting to discuss the BLA is slated for May 27.

ANGPTL38 – Angiopoietin-like 8
CD73 (NT5E) – Ecto-5’-nucleotidase
IL-23 – Interleukin-23 

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