LONDON – Family-owned Angelini Pharma is to buy Swiss startup Arvelle Therapeutics GmbH for $960 million, acquiring full European rights to the epilepsy drug cenobamate. The first tranche, of $610 million, will be paid following the EMA’s recommendation to approve cenobamate, which is expected at either the January or February meeting of the Committee for Medicinal Products for Human Use. The remaining $350 million is due when European sales of the oral therapy for treatment-resistant partial onset seizures reach $400 million.

India approves first COVID-19 vaccines, including domestically developed Covaxin

NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India. The DCGI also approved Covaxin, which was developed by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research and is still in phase III trials.

Biopharmas close out the year in positive territory

While everyone will be glad to see 2020 in their rearview mirror, the biopharmaceutical sector can count its blessings, as it emerges from a period where it has surprisingly received record public and private financings and enjoyed strong investor support. This is in sharp contrast to most of the global economy, which has been decimated by the ongoing pandemic. The fact that biopharma innovation has been viewed as the solution to defeating the deadly COVID-19 virus has certainly been a contributing factor to the sector’s success during the year. With three vaccines being approved in record time and now being made available, and several others poised to debut, biopharma companies both large and small enjoyed a strong December on the capital markets.

Calithera's phase II Cantata trial ends in discord

Failure for a metastatic renal cell carcinoma trial once expected to pave a path to registration for Calithera Biosciences Inc.’s lead candidate, telaglenastat, sent company shares 44% lower by midday. Around 30 jobs will be cut as the South San Francisco-based firm conserves cash to advance telaglenastat, a glutaminase inhibitor, for non-small-cell lung cancer and another asset, the arginase inhibitor CB-280, for the potential treatment of cystic fibrosis.

Terms are set in the new year’s first IPOs

Following a record-breaking 2020, terms were set for the first two biotech IPOs of 2021 in deals that could generate up to $300 million. Cullinan Oncology LLC, of Cambridge, Mass., set terms Jan. 4 for raising about $150 million by pricing 8.3 million shares in the $17 to $19 range. The company is building a pipeline that includes one candidate in a phase I/IIa study and six preclinical immuno-oncology therapeutic candidates and programs. Gracell Biotechnology Ltd., of Shanghai, set terms for its U.S. IPO the same day. The CAR T-cell developer also looks to raise $150 million by offering 8.8 million American depositary shares in a range of $16 to $18 million each. The company said the proceeds will be used to fund its R&D, including work on lead FasTCAR-enabled candidate, GC-012F, for treating relapsed/refractory multiple myeloma.

Chi-Med wins China approval for its first self-discovered oncology drug

HONG KONG – Hong Kong-headquartered Hutchison China Meditech Ltd. (Chi-Med) earned approval from China’s National Medical Products Administration for Sulanda (surufatinib) for the treatment of non-pancreatic neuroendocrine tumors, marking what CEO Christian Hogg called a “major milestone” as the first drug to be discovered and developed by Chi-Med without the support of a development partner.

New age for ADCs? Sutro’s positive ovarian phase I may herald more wins

Sutro Biopharma Inc. wowed Wall Street last month with data from a phase I trial testing STRO-002, a folate receptor alpha-targeting antibody-drug conjugate (ADC), in ovarian cancer. As of the Oct. 30 cutoff date, the compound had chalked up one complete response and nine partial responses in the challenging indication, which works out to a 32% overall response rate (10 out of 31) in evaluable patients. The results, albeit early stage, highlight success in recent years with ADCs. Approved products in the class have doubled since 2018 from five to 10, and more are lined up for pivotal data or regulatory decisions soon.

HHS sides with hospitals in 340B payment dispute

Rather than waiting on a court to rule on a lawsuit intended to force its hand, the U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to extend 340B discounts to outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. Citing the plain language of the law, the HHS Office of Inspector General opinion said when the drugs are sold by the manufacturer to the 340B provider, “the situs of delivery, be it the lunar surface, low-earth orbit, or a neighborhood pharmacy, is irrelevant.”

CVR off the table: BMS’ liso-cel remains under FDA review in 2021

Bristol Myers Squibb Co. issued a press release Jan. 1 confirming what many suspected, that FDA approval for lisocabtagene maraleucel (liso-cel) did not happen by the Dec. 31 deadline, thereby automatically terminating the contingent value rights agreement issued as part of its acquisition of Celgene Inc.

Holiday notice

BioWorld's offices were closed New Year's Day. No issue was published Friday, Jan. 1.

Also in the news

Advaccine, Ambryx, Antengene, Aptinyx, Arcturus, Astrazeneca, Atara, Ayala, Azurrx, Biocurepharm, Biohaven, Bioniz, Bristol Myers Squibb, Calithera, Dicerna, Entheon, Epivax, Eyepoint, Forge, F-star, Generation, Harpoon, Hoth, Inovio, Inozyme, Insmed, Inspirmed, Kaleido, Kedrion, Landos, Lantern, Matinas, MEI, Moderna, Novus, Oncorus, Opko, Pandion, Passage, Pfizer, Provention, Qu, Redx, Taysha, Tiziana, TLC, Wize