EuroBiotech Report: PhIII flops, Valneva axes vaccine, Medivir split and Ferring


Welcome to the latest edition of our weekly EuroBiotech Report. The last days of August brought a pair of late-phase setbacks. Adocia was the first to post disappointing data. The French company saw BioChaperone PDGF miss the primary endpoint in its long-delayed Phase III Indian diabetic foot ulcer trial, prompting it to abandon plans to run late-stage studies in the U.S. and Europe. While Adocia expressed surprise at the outcome, the week’s other Phase III readout was always seen as something of a long shot. But, with the Phase III data potentially putting pay to Vectura’s ambition to win approval of Flutiform in chronic obstructive pulmonary disease, the outcome nonetheless represents a blow to the business. In the wake of a Phase II/III failure of its own, Valneva scrapped a vaccine program. Ferring Pharmaceuticals will be hoping the drug it picked up from Seikagaku this week fares better in its Phase III trials. If the data pass muster, Ferring will commercialize the pain drug in the U.S. and embark on its own development programs to crack other markets. Medivir confirmed it will split its business in two, a process that will create a new independent biotech with a Phase II osteoarthritis asset. And more. Nick Taylor

1. Adocia scraps diabetic foot ulcer program following PhIII flop

Adocia (EPA:ADOC) has cut loose its diabetic foot ulcer program after the drug failed a Phase III trial. The drug, BioChaperone PDGF, was penciled in to start pivotal trials in Europe and the U.S., but weak data from an Indian Phase III study have prompted Adocia to halt all development of the asset.

2. Vectura slides after PhIII miss dents hopes of using Flutiform in COPD patients

Weak Phase III data have dealt a blow to Vectura’s (LON:VEC) hopes of seeing Flutiform approved for use in chronic obstructive pulmonary disease (COPD) patients. Vectura shares fell as much as 10% after it revealed the Phase III study missed its primary endpoint, quashing near-term hopes of expanding the use of a drug it acquired in the £441 million ($576 million) merger with Skyepharma.

3. Valneva writes off hospital-acquired infection vaccine following PhII/III miss

Valneva (EPA:VLA) has given up on its vaccine against the hospital-acquired infection Pseudomonas aeruginosa. The vaccine was positioned to be picked up by GlaxoSmithKline ($GSK), but weak Phase II/III data torpedoed both that possibility and Valneva’s interest in forging ahead with development.

4. Ferring buys rights to PhIII pain drug from Seikagaku

Ferring Pharmaceuticals has secured the rights to a Phase III treatment of radicular leg pain outside of Japan from Seikagaku. The drug, condoliase, is seen by Ferring as giving patients with lumbar disc herniation a nonsurgical way of managing the leg pain resulting from their condition.

5. Medivir commits to splitting commercial, R&D units into independent businesses

Medivir (STO:MVIR-B) is pushing ahead with previously mooted plans to cleave its business in two. The action will see the Johnson & Johnson ($JNJ)-partnered drug developer split its operation into two independent companies, one of which will gain its pipeline programs, the other of which will take responsibility for its commercial unit.

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