Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Enobia Pharma Corp of Montréal, Canada was purchased by Alexion Pharmaceuticals Inc., of Cheshire, Conn., at the end of 2011 for $610 million up front and $470 million in sales and regulatory milestones. Was this the result of good strategic planning?  More...

Valeant recently made several attempts to get into confidential discussions and due diligence with ISTA. Valeant has a history of acquiring companies that have niche products on the market  and the ISTA acquisition would be in line with their business strategy to minimize their development investment and focus on marketing and sales.  ISTA has several products on the market already and is in a good position to launch several more in the next few years so they probably looked like a worthwhile take over target.  After getting rebuffed by ISTA, Valeant tried an unusual tactic of trying to get the shareholders of ISTA to pay attention by publishing an open letter that proposed doubling their share price with a $6.50/share buyout offer. More...

The news that Momenta is acquiring Virdante’s Sialic Switch assets leaves me wondering about the timing.  Virdante received $47.8M in Series A funding back in 2009 which should have been enough to let them get through Phase 1 and 2a clinical trials.  Instead Virdante is opting to sell their primary program at the preclinical stage for $4.5M upfront.  It seems to me that they are missing out on a potentially big inflection point in the value creation chain – proof of concept in humans.  Have they run out of money or did they have too much sunk cost to attract new financing?  Those are the only reasons I can come up with to explain why the investors would be willing to cash out now. More...

Every company has creative initiative and some core competencies; activities that require these attributes should remain inside.  All else is fair game for outsourcing as long as outsourcing is done effectively.  Although there are many guides for finding contract research organizations (CRO) and contract manufacturing organizations (CMO), there are few for understanding how to work with them effectively.  Outsourcing is a skill that has to be taught and practiced to make it work for each pharmaceutical company.  This is especially important for small startup companies that need the CRO resources, but are not far enough along in their funding efforts to afford mistakes. More...