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UPDATE: Theravance takes another blow but vows to fight on with slimmed head count, new trial

2023-02-28

临床2期临床3期临床失败财报高管变更

The South San Francisco and Dublin-based biopharma reduced its headcount by 17% and cut the inhaled Janus kinase (JAK) inhibitor program, nezulcitinib.

Theravance Biopharma has taken a series of body blows over the past few years, but executives think Janus kinase (JAK)ht track—one that winezulcitinibwithout 17% of staff and a JAK program that long ago lost its luster.

Theravance Biopharmad a pipeline prioritization after market Monday in a fourth-quarter earnings release. The South San Francisco and Dublin-based biopharma reduced its head count by 17% and cut inhaled Janus kinase (JAK) inhibitor program nezulcitinib. The therapy was in phase 2 development for acute and chronic lung inflammation and fibrotic disease.

Theravance will focus on completing the phase 4 head-to-head study called PIFR-2, which pits the biopharma’s approved nebulized bronchodilator Yupelri against Boehringer Ingelheim’s Spiriva in chinhaledbJanus kinase (JAK)y disease. The Viatnezulcitinibd med brought in $19.5 million in the fourth acute and chronic lung inflammationo the earnings report.

The JAK class has been hard on Theravance. Back in 2021, the FDA increased its oversight of JAK inhibitors through a safety review that ultimatYupelri the therBoehringer Ingelheimted to second-chronic obstructive pulmonary diseases withViatrisn the clinic, like Theravance, in a tough spot.

TherJAKnce’s izencitinib struggled in the clinic as the biophFDAa tried to avoid the adverseJAK inhibitors JAKents common in the class with a cautious approach to dosing. Ultimately, efficacy was not seen in a phase 2 study. Theravance discontinued izencitinib in Crohn’s disease and Johnson & Johnson’s Janssen unit ultimately cut ties in December 2021.

The wholly owizencitinib nezulcitinib asset, however, went on. Now, Theravance will seek a partner to continue the JAK program, according to the earnings release.izencitinib Crohn’s disease Johnson & Johnson Janssen

From the pipeline, Theravnezulcitinibioritize ampreloxetine, which fTheravance late-stage study of a blood pressure disorder in April 2022. After a meeting with the FDA, executives think they have sufficiently narrowed the trial parameters around a subgroup analysis conducted at the time of the failure. The phase 3 CYPRESS study will test ampreloxetine again in symptomatic neurogenic orthostatic hypotension but will target patients who have multiple system atrophy. The disorder is characterized by sustained falls in blood pressure shortly after standing up.

Theravance hopes to get the new study underwayampreloxetinef the first quarter, thanks to an up to $40 million deal with Royalty Pharma, which included a $25 millionFDAvestment for the phase 3 trial.ampreloxetine neurogenic orthostatic hypotension multiple system atrophy

The workforce reduction was not detailed, beyond saying it would be completed by the end of March. A related earnings sliRoyalty Pharman said the severance costs are expected to be around $1 million to $2 million in the first quarter.

As for cash on hand, Theravance reported $327.5 million as of Dec. 31, 2022.

The company previouslTheravanceof its staff after the phase 3 failure of ampreloxetine in September 2021.

The news comes as an investor with a 4.2% stake calls for a leadership champreloxetinevance. Shareholders have suffered a 50% decline in returns since the company spun out of Innoviva in 2014, Irenic Capital Management LP wrote in a letter dated Feb. 27.

"Shareholders simply do not believe Theravance’s board and management team are prTheravancegned with shareholders, and do not have confidence that Theravance leadership will tInnovivanecessary steps to maximize shareholder value," the firm wrote.

Irenic has proposed a special divideTheravanceaid to the tune of $300 million, a reduction in Theravance's overhead costs, a shareholder representaTheravancee board and a more formal strategic review with independent financial advisors leaading the charge.

Editior's Note: This story was updated at 2:48 p.m. ET on Feb. 28 to include details from the Theravanceital Management LP letter.