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May 3 Quick Takes: Spinout to provide $9B BD boost to Merck; plus Moderna, Sarepta, Intra-Cellular and more

May 4, 2021 | 1:38 AM GMT

A planned spinout by Merck & Co. Inc. (NYSE:MRK) of its women’s health business, legacy brands and biosimilars into Organon will add $9 billion to the pharma’s BD war chest, according to a company investor day presentation. The spinout, a key piece in Merck’s strategy to drive innovation, is expected to begin trading on the New York Stock Exchange June 3. Kevin Ali will be CEO of the newco; Ali has led the company’s enterprise portfolio strategy and previously served as president of MSD International and president of emerging markets.

Reinforcements for COVAX as Moderna joins 

Moderna Inc. (NASDAQ:MRNA) could eventually supply 500 million doses of its COVID-19 vaccine to the COVAX facility, should COVAX co-leader Gavi, the Vaccine Alliance, exercise an option for up to 466 million doses in 2022. The company expects to begin delivery of 34 million doses in 4Q21 under the deal, which covers the 92 Gavi COVAX Advance Market Commitment (AMC) low- and middle-income countries. Moderna will supply the doses at its lowest tiered price.

Setting up Exondys’ successor at Sarepta 

Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) rose 9% to $71.11 Monday on Phase II data that could set up SRP-5051 as the company’s successor to Exondys 51 eteplirsen. In the dose-escalation MOMENTUM study, dystrophin protein levels were 6.55% of normal in biopsies, collected at a median of 12 weeks, from four Duchenne muscular dystrophy patients amenable to exon 51 skipping who received 30 mg/kg monthly SRP-5051; the dystrophin levels were eight times higher than in biopsies from DMD patients who received Exondys 51, a phosphorodiamidate morpholino oligomer (PMO) that induces exon 51 skipping. SRP-5051 also led to a mean exon skipping, measured in a PCR assay, of 10.79% — an 18-fold increase in skipping vs. Exondys 51. SRP-5051 is a peptide phosphorodiamidate morpholino oligomer (PPMO) to induce dystrophin exon 51 skipping.

Intra-Cellular sNDA for Caplyta under review

FDA is due to issue a decision by Dec. 17 on an sNDA from Intra-Cellular Therapies Inc. (NASDAQ:ITCI) for Caplyta lumateperone to treat depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The dual serotonin (5-HT2A) receptor agonist and dopamine receptor phosphoprotein modulator is approved to treat schizophrenia.

Longitude leads Alpha-9’s $11M A round

Alpha-9 Theranostics Inc’s $11 million series A round, led by Longitude Capital, will enable the company to advance its portfolio of radiotherapeutics and diagnostics for solid and hematologic malignancies. BVF Partners and undisclosed insiders also participated in the financing.

Sirnaomics spinout secures $10M seed 

Sirnaomics Inc. spinout RNAimmune Inc. will accelerate its R&A on mRNA vaccine and drug discovery using its $10 million seed financing, which was led by Smooth River and Hong Kong Hongrun and saw participation from Shanghai Walga Biotechnology, High Forest Investment and Terra Magnum Sigma. RNAimmune, which was founded in early 2020, is focused on infectious diseases, cancer and rare diseases.

Astellas ends deal with Cytokinetics

Cytokinetics Inc. (NASDAQ:CYTK) will regain rights to skeletal sarcomere activators for all indications from Astellas Pharma Inc. (Tokyo:4503), which terminated a co-development and commercialization deal, from which Cytokinetics was eligible for up to $450 million in milestones. The termination of the partnership, which began in 2013, will go into effect Nov. 1.

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