EuroBiotech Report—Galapagos data, Vernalis CRL, Orchard names CEO, Roche offloads drug and CRUK inks trial pact


Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with Galapagos, which followed FibroGen by getting a stock bump in the back of idiopathic pulmonary fibrosis data. Galapagos framed the data as clearing it to advance into a late-stage trial, although the phase 2 study’s relatively small size and short duration mean it is a long way from showing the drug works.

Vernalis thinks its drugs work. The problem is it keeps failing to persuade the FDA to approve them. A rejection for CCP-08 made Vernalis 0-2 for the year. Orchard Therapeutics named a former PTC Therapeutics executive as its CEO. Roche offloaded the rights to IL-13 monoclonal antibody lebrikizumab in certain indications. Cancer Research UK took a stake in Biotecnol in return for supporting a phase 1 trial of a T-cell engager. And more. - Nick Taylor  

1. Galapagos to take IPF drug into late-stage trial after ph2 win

Belgian biotech Galapagos has chalked up a positive phase 2a trial for its idiopathic pulmonary fibrosis drug GLPG1690, saying it halted the relentless decline in lung function normally seen in patients.

2. Back-to-back FDA rejections leave Vernalis reeling

The FDA has rejected Vernalis’ filing for approval of CCP-08. Vernalis wanted to bring CCP-08 and CCP-07 to market in time for the 2017-18 cough-cold season, but back-to-back FDA rejections have scuttled its plans.

3. Orchard Therapeutics hires ex-PTC executive Mark Rothera as new CEO

Orchard Therapeutics, a 2016 Fierce 15 winner and ultra-rare disease startup, has hired Mark Rothera as its new president and chief.

4. Roche in part-sale of mixed bag lebrikizumab to Dermira

California dermatology biotech Dermira will take on exclusive worldwide rights to IL-13 monoclonal antibody lebrikizumab from Roche, although the big pharma holds on to its rights for the medication in certain indications.

5. CRUK, Biotecnol team up for T-cell engager trial

Biotecnol has teamed up with Cancer Research UK (CRUK) to take its T-cell engager into the clinic. The agreement sees CRUK take a stake in the Anglo-Portuguese biotech in return for help testing a 5T4-CD3 bispecific antibody in patients with lung cancer and other solid tumors.

And more articles of note>>