Latest news from the biotech sector:
Nabriva Therapeutics grossed $92.25 million in a revamped IPO on Nasdaq. The appetite for the stock was evident but mixed. The Vienna-based anti-infectives developer priced 9 million American Depositary Shares (ADSs) at $10.25 million each, having originally planned to sell 6 million ADSs for between $15 and $17 each. To add insult to injury, the final offer price suffered a last-minute 0.25 discount from the $10.50 the company had initially set out in its registration statement. The stock, which began trading Sept. 18 under the ticker symbol NBRV, opened at a healthy $11.39, suggesting the final adjustment was unnecessary. The stock closed that day at $13.24, up $2.99 or 29.2 percent. The company will net around $79.5 million from the transaction to fund its pipeline of pleuromutilin antibiotics, of which the lead molecule lefamulin, is due to enter a phase III trial in community-acquired bacterial pneumonia this fall. An additional 1.35 million ADSs are available to cover overallotments. Europe’s ongoing economic confusion is a likely contributor to the apparent uncertainty surrounding the offering. Although the Nasdaq Biotechnology Index is some way off the all-time high it reached in July, it has been trending upward since the start of September and is recovering some of the ground it lost in August.
The EMA has opened a public consultation on the use of digital sensors embedded within pills to measure adherence and physiologic response, after concluding that form of tracking should be given its seal of approval as a biomarker in clinical trials. Specifically, the EMA has considered the use of Redwood Shore, Calif.-based Proteus Digital Health‘s ingestible event marker, which can be co-formulated with drugs to form digital medicines that, when triggered by fluid in the stomach, send out signals to sensors embedded in a patch on the patient’s skin. The EMA’s assessment indicates the Proteus technology is an accurate way of measuring compliance and could be used to optimize the running of clinical trials. Once the technology passes public scrutiny and gets formal approval, it will streamline the process of applying to conduct trials of drugs in which the company’s device is embedded. The consultation started in Europe as the FDA accepted the new drug application for the first digital medicine, which combines the Proteus ingestible sensor with Tokyo-based Otsuka Pharmaceutical‘s Abilify (aripiprazole), an antipsychotic that is approved for the treatment of schizophrenia and bipolar disorder.
Oryzon Genomics, one of Spain’s flagship biotech firms, is seeking to give the country’s sector greater national and international visibility by listing its shares on the main market of the Madrid Stock Exchange (Bolsa de Madrid) in the coming weeks, after which it plans to seek a listing on Nasdaq. The company is not seeking any direct cash from the Spanish leg of the process. "It’s not going to be an IPO; it’s going to be a listing," company co-founder and CEO Carlos Buesa told BioWorld Today. "That way, we can do it very quickly — in Spain, it takes quite a bit of time to do a regular IPO." It intends to sidestep that problem by raising cash in advance of or after the listing. "We can do either a mezzanine round before or a follow-on transaction later on," he said. It will become the first pure-play biotech firm to list on Madrid’s main market — several firms already are listed on its secondary market. Barcelona-based Oryzon shot to prominence last year on the strength of a deal worth up to $500 million with Basel, Switzerland-based Roche on its lysine-specific demethylase-1 (LSD1 or KDM1) inhibitor program. Deals on that scale are rare for Spanish biotechnology, which remains immature for a country of its size. It is, however, on an upward trajectory. "The appetite for biotechnology in Spain is growing," Buesa said, citing the recent €36.6 million ($41 million) funding round closed by Palma, Majorca-based Laboratoris Sanifit as evidence. Further deals are in the offing.
Trends in CRO activity:
There has been a significant increase in the number of CROs using electronic trial master file (eTMF) applications from just one year ago, according to a report from Veeva Systems. The "Veeva 2015 Paperless TMF Survey: Annual CRO Report" was a global study of TMF owners that found 38% of CROs surveyed now use eTMF applications versus just 21% in 2014. A number of benefits are prompting CROs’ adoption of eTMF technology. More than half (58%) say faster study startup is a key driver, while 50% cite cost savings. The industry-wide study also shows a notable shift away from paper and paper-based processes. CRO respondents are adopting electronic processes across content-intensive areas, including clinical operations, regulatory, drug safety and data management. The data management area saw the largest decrease in its use of paper, down from 27% in 2014 to 8% in 2015. Clinical operations, which manages the greatest number of TMF documents overall, also saw a sharp decline from 47% in 2014 to 34% in 2015. When it comes to inspection-readiness, particularly, most CROs see improvements in the number of missing documents (92%); misfiled documents (89%); duplicate documents (86%); incomplete documents and/or missing signatures (84%); and expired documents (81%). Additionally, the report found more than half (57%) report improved audit- and inspection-readiness as a result of eTMF adoption.