Lacerta Bio is a business development consultancy specializing in identifying, assessing, negotiating, and closing licensing and partnership opportunities for the pharmaceutical, biotechnology, and drug delivery industries.
We also work with and support internal business development teams with market research, competitive intelligence, financial modeling, and other support services.
In November, 2014, we announced a merger with Copenhagen-based Ventac Partners. The combination of Lacerta Bio and Ventac Partners will dramatically increase the types of services we can offer our clients, as well as expand our geographic reach.
If you need assistance finding or assessing business development and/or partnership opportunities, contact us at email@example.com.
Would You Like To Expand Your Business Into China? Or Perhaps You Seek An Investor or Development Partner? China is a large and growing opportunity for Western life science companies, as: Life Science in China is Booming – China’s life science industry has been growing at more than 20%+ per year, and is expect toRead More»
Lacerta Bio is pleased to represent the opportunity to in-license an innovative, approved parenteral formulation of diclofenac for acute / postoperative pain. While parenteral diclofenac products are available in a number of markets, our client’s formulation is clinically proven to have superior safety and efficacy characteristics. Key product benefits over the currently marketed product include:Read More»
Lacerta Bio is pleased to represent the opportunity to in-license an innovative, approved topical formulation of diclofenac for pain. While topical diclofenac products are available in a number of markets, our client’s formulation is clinically proven to have superior safety and efficacy characteristics. This topical diclofenac has a number of advantages over available topical diclofenacRead More»
Last week, we had the good fortune of spending a week in India, along with our colleagues from Ventac Partners. Our trip took us through the cities of Mumbai, Pune, and Bangalore. Our main focus was a visit with a major client, a CDMO with multiple facilities across the country.
Here are a few of our observations from a very interesting week in India:
There is no question that some Indian pharmaceutical manufacturers are facing some difficult times right now. Since 2013, a dozen or more manufacturers have been cited by the US FDA for data integrity and other issues. Some plants have been banned outright from exporting to the US.
Yet, Indian companies are not alone. A quick review of the FDA web site shows that plants and companies around the world have similar issues.
Now these concerns over manufacturing are spilling over into the contract research space, especially on the clinical side.
So is the CDMO industry in India declining?
We certainly don’t think so, at least from what we saw.
Irrespective of what is reported by the press, the factors which drove this shift towards India remain intact:
One facility we visited was an ultra-modern drug discovery center, complete with modern labs, equipment, and a spotless vivarium. Another facility was on a 9-10 acre, well-manicured campus surrounded by palm trees and a stunning open-air cafe.
Who wouldn’t prefer to work there compared to some towns in the Northeastern US?
It was interesting to listen to scientists when they provided their backgrounds. We would estimate that of all the PhD-level folks we met, 75% or more earned their advanced degrees from a University in the US, Canada, or the UK. Many were returnees from the US, having spend their post-doc and early professional careers in Big Pharma in the US.
Qualifications like these don’t come cheap anywhere. But if highly qualified, English-speaking scientists with ample facilities are readily available, who wouldn’t want to take advantage of this?
Now is everything in India picture perfect?
No, it certainly isn’t.
There are definite problems which were observable, even to casual visitors.
For example, rolling blackouts are common, even in major cities like Bangalore.
Now many companies have their own power supplies, so this is not an issue. But it is a little unsettling when the power goes out in an already dark neighborhood.
And, India continues to struggle with issues of poverty, illiteracy, and the wide gap between those that have and those who do not. Health care, clean water, and sanitation are visible problems in the areas we visited.
In fact, it was these contrasts, such as a modern R&D center in the midst of a challenging neighborhood which were the most unsettling aspect of our trip.
We don’t think the Indian pharmaceutical industry, especially the CDMO/CRO segment, is going to decline and fall anytime soon. Sure, there may be peaks and troughs, and issues with oversupply/excess capacity will affect the market. But these are normal behaviors of any market.
Importantly, India now has rules in place which forbid First-In-Man trials unless the NCE was “born” in India (or owned by an Indian company). This leads us to believe that companies will want their NCEs to be discovered there in order to enable entry into formulation development, scale up, and early Phase I studies.
Certainly the facilities and expertise are reality available. So the strategy makes sense, especially for companies looking for Target Validation, Hit-to-Lead services, and Screening services.
The fact remains that the people available to do the work, combined with excellent facilities (problem facilities aside) will likely keep those direct flights from Newark to Mumbai close to capacity for the foreseeable future.
As part of my preparations for an upcoming trip to India, my physician prescribed a 6-week prophylactic course of mefloquine to prevent malaria. The weekly dosing schedule prompted me to review the package insert. As it turns out, mefloquine has an unusually long half-life (2-4 weeks), making it perfect for weekly dosing. A review of the
Michael Gilman, CEO of Padlock Therapeutics, wrote a terrific post recounting his experiences from in-licensing assets from Big Pharma. Mike’s perspective is unique in that he has managed to pull this off not once, but twice. It has been our experience that doing this once is incredibly difficult. But why? Mike gives a few
The July/August issue of Drug Development and Delivery has an extensive report on the business and science of formulation and drug delivery. The report is based on the data in the PharmaCircle database. The report is divided into various “Top Ten” categories, such as Ten Notable Drug Delivery Technologies of 2014, Transactions, etc., etc.