Over 15 million Americans that regularly use Prevacid, Prilosec, Nexium, Protonix, and Aciphex for quick relief of heart burn and acid reflux, may have a bigger issue on their hands. CNN reports the results of a new study shows that users of these medications, known as proton pump inhibitors (PPIs), are at a huge increased risk of kidney failure. By huge, we mean a 96% increased risk in developing kidney failure and a 28% increased risk of chronic kidney disease over those who use the alternative histamine H2 receptor blocker medications. With research backing the idea that PPIs are overprescribed and overused, and a study suggestion that use should be cut back, we could see a higher demand for the H2 blocker alternatives.
LabCorp, Covance and INC Research – combined, does this equal a new, full-service giant in the drug services space?Bloomberg reports there may not be enough synergy with Covance’s lab services for LabCorp to get their money’s worth. Bloomberg was clearly distracted by a squirrel and missed the point. The potential deal’s strategic value isn’t in the labs business. The value comes from adding INC’s Phase II/III development capabilities; an historical weakness in the Covance business. Now, LabCorp may have maxed out its credit card for the Covance takeover but that’s a different issue. It will be interesting to see what unfolds as they balance debt with the search for a partner that appeals to their stakeholders.
Who cares that the NASDAQ Biotechnology Index (NBI) is down more than 14% in 2016? Not VCs. According to the MoneyTree™ Report from PricewaterhouseCoopers LLP and the National Venture Capital Association, based on data provided by Thomson Reuters, approximately $1.8 billion was invested in biotech companies, representing 118 deals. This represents an 11% increase in dollars and a 19% increase in deals, compared with 4Q2015. But the devil is in the details. First-time funding in 1Q was down 29% in dollars and 37% in deals. For now this is good news as VC firms seem to be backing companies they have already invested in. This will allow development projects to move forward, which is good news for larger biopharmaceutical companies (they need the compounds) and for CROs and CMOs.
Mother always said, “You can lead a horse to free data but you can’t make him analyze it.” A recent study by the editors of The Journal of the American Medical Association revealed that few academic institutions and small biopharma firms make use of clinical trial data made available by large pharmaceutical companies. The Journal noted that, while centralized databases are bringing together more and more results from a wide variety of clinical trials, analyzing existing data in new and different ways can be costly. Further, data gathered for one purpose might not meet the endpoints of subsequent studies. These results may lead some to reassess the value of the initiative against the administrative and I.T. costs of participation.
As part of the union of parent companies Pfizer and Hospira, which occurred in September of 2015, the embedded contract manufacturers for the brands, Pfizer CentreSource and Hospira One2One, have also become one—Pfizer CentreOne. The new name for the merged CMO, announced this week, retains elements of each contract manufacturer’s prior name to convey the combined capabilities to the sponsor audience, namely Pfizer CentreSource’s long history of small molecule API synthesis, steroids and hormones and Hospira One2One’s sterile injectable fill-finish. The combined capabilities may offer a single solution for those outsourcers whose drug substance and drug product needs match the united offering.
The numbers are out, and pharmaceutical sales are way up. A wholesale spending increase of 12.2% on prescription drugs between 2014 and 2015 continues the trend of historically high drug sales over recent years. The $425 billion dollar price tag on total drug spending last year is mostly thanks to specialty drugs and newly approved therapies on the market. In the end however, net spending increase hovers around a moderated 8.5%, due to rebates and price concessions offered by many pharma companies. Access to care has become an important consideration for pharmaceutical companies, especially in light of the increasing cost of innovative medicines.
Is “scary” an official CDC classification or is this just the CDC keeping it real? The Zika virus, which has now been confirmed in 346 cases in the US, is the topic of discussion as the virus continues to spread and athletes from around the world prepare to visit Brazil for the 2016 Summer Olympics. News of the virus seemed to be waning, but the principal deputy director of the CDC, Dr. Anne Schuchat announced Monday, “Everything we look at with this virus seems to be a bit scarier than we initially thought.” With no vaccine likely to hit the market anytime soon, look for global health leaders to apply serious pressure and possibly encourage companies to join GSK, Sanofi, and Inovio Pharmaceutical in the race.