Fierce Pharma Asia—Daiichi’s €1B expansion; Astellas’ $800M cell-therapy bet; Novartis India’s strategic review

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来源: FiercePharma

Daiichi Sankyo's expansion in Germany, Astellas and Kelonia's deal, and Novartis' strategic review of an Indian unit made our news this week.

Daiichi Sankyo is building additional antibody-drug conjugate capacity at its German site. Astellas partnered with Kelonia on cell therapy tech. Novartis launched a strategic review of a subsidiary in India that's focused on older meds. And more.

1. Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany

Daiichi Sankyo is doubling down on the production of antibody-drug conjugates by directing about 1 billion euros ($1.08 billion) into expanding its facility near Munich, Germany. The expansion is expected to create at least 350 new jobs by 2030 when Daiichi plans to wrap up the project. Aside from cancer-treating ADCs, the expansion will also boost capacity for cardiovascular medicines.

2. Astellas-owned Xyphos offers more than $800M for Kelonia's in vivo delivery know-how

Astellas, through its subsidiary Xyphos, has penned a deal worth more than $800 million with Kelonia to combine the companies' expertise on up to two cell therapy programs. Kelonia’s lentiviral particle offers targeted delivery of genetic material, whereas Xyphos boasts a convertible CAR platform that modifies the NKG2D receptor. The goal is to make the CARs more adaptable and able to reach multiple targets.

3. Novartis, zeroing in on innovative meds, launches strategic review of India outfit

Novartis unveiled a strategic review of its 70.68% position in Novartis India Limited, a locally-listed unit that handles some old, off-patent meds in bone and pain, immunology and neuroscience. The shares owned by Novartis were worth about $161 million as of the end of 2023. The review doesn’t affect Novartis Healthcare Private Limited, which has its own commercial and R&D teams.

4. AstraZeneca touts 'overwhelming' Tagrisso win among 3 lung cancer portfolio advancements

The second antibody-drug conjugate in AstraZeneca and Daiichi Sankyo’s partnership is getting closer to the market. The FDA has accepted the pair’s application for TROP2-targeted datopotamab deruxtecan in previously treated nonsquamous non-small cell lung cancer and assigned a target decision date in December. The drug didn’t benefit patients with squamous tumors in a phase 3 trial.

5. Daiichi blasts 'malicious and defamatory' marketing complaints but still gets hit with serious violation

Daiichi Sankyo’s marketing communications around its cholesterol-lowering drugs, Nilemdo and Nustendi, have run afoul of the U.K.’s Prescription Medicines Code of Practice Authority. The issue came from complaints alleging that Daiichi failed to announce a contraindication in its public materials. But Daiichi noted that the complaints featured “somewhat malicious and defamatory” wording.

6. Everest to continue mRNA ascent alone after shedding Providence partnership

China’s Everest Medicines has terminated an mRNA COVID vaccine collaboration with Providence Therapeutics. Everest plans to develop its own products utilizing the mRNA platform that it accessed through the partnership. Everest needs to cough up $4 million to end the deal, and Providence will be eligible for milestones and royalties related to the rabies and shingles vaccines the companies have been working on.

Other News of Note:

7. Innovent's Tepezza rival one step closer to Chinese approval after phase 3 eye disease win

8. Following FDA rejection, Sanofi and Regeneron's Dupixent gains Japanese approval in hives condition

9. Biocytogen offers Gilead antibody capabilities in 3-year research pact (release)

10. FDA slams Chinese API maker with warning letter on heels of issuing Form 483

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