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 firstname.lastname@example.org.
Background GPR119 Activation leads to glucose-dependent insulin secretion and the release of GIP and GLP-1. This mechanism has generated a great deal of excitement in the diabetes research community, as it strongly mimics processes which take place during digestion. Additionally, this mechanism is superior to GLP-1 only approaches, without the problems associated with sulfonylureas andRead More»
Anaplastic Lymphoma Kinase (ALK) is emerging as an important target for novel, safe, oral anti-cancer therapies. First identified in 1994, ALK is believed to affect nearly 100,000 new NSCLC patients globally. In fact, ALK inhibition has potential in a wide variety of cancers, such as NSCLC, Lymphomas, inflammatory myofibroblastic tumors (IMT), neuroblastoma, and ovarian cancers. Our client’sRead More»
Background There are two general mechanisms of action for treating osteoporosis: Anti-Resorption Agents inhibit the normal resorption of bone, thereby slowing bone loss. But, this approach does not trigger de novo bone formation. Biphosphonates like zoledronic acid and disodium pamidronate are marketed examples of anti-resorption agents. Anabolic Agents are a relatively new approach to treatingRead More»
According to DiMasi, we’re now looking at $2.6 billion to develop a new drug.
Now DiMasi has been performing this analysis and refreshing the data for decades. The arguments against “the number” are well-known:
1. “The Number” is a combination of out-of-pocket costs and opportunity costs.
2. The calculation is based on a limited survey of development programs from pharma (although we can never be sure who was surveyed and what the raw data look like, for obvious competitive reasons). In fact, a lack of detail on the raw data makes the entire methodology difficult to place into context.
3. The number fails to take into account government spending (i.e., grant) which can be a critical component of any new drug development program.
Here are a few items we noticed from the summary presentation (we cannot reproduce the slides here due to copyright, but you can find them here):
1. R&D Expenditures, adjusted for inflation, (page 6) increased rapidly from 1983-2006, then flattened. Meanwhile, approvals have remained in the 15-30 p.a. range (with a spike in the late 1990s).
2. The dataset includes drugs which entered FIM trials from 1995-2007. We would argue that including data from that far back could skew the end result. However, we have no idea which indications are included, the number of patients per trial, cost per subject, etc., etc. Earlier versions of this analysis had data by therapeutic category (see, for example, DiMasi, et al., 1995).
The 1995 paper (email us if you want it) has a great deal of detail. For example, mean Phase III costs back then for NSAID development were $35.9 million, versus $18 million for cardiovascular. Would the same proportions carry over with the current data set? Probably not.
3. Post-Approval costs (page 22) are enormous; $466 million out of pocket per approved new compound. But again, who knows what this number really means?
Overall, DiMasi paints a picture where drug development costs (especially clinical costs) increased quite a bit during this study period, while drug approvals actually declined. This we already knew.
However, with the lack of clarity around the data set, it is quite difficult to draw substantive conclusions beyond this. Perhaps a future publication will shed more light on what these numbers are and what they really mean.
Earlier this week, The Economist travels over well-trod ground in an article on pharmaceutical industry M&A: It used to be all about achieving sheer scale, and building a broad portfolio of potential treatments for a range of illnesses. Now it is increasingly about drug companies concentrating on what they do best, and getting out of
Today we announced our new relationship with Copenhagen-based Ventac Partners. You will see more and more information about this relationship, our projects, and also the new companies we will be forming in 2015 and beyond. But why do it? Expanded Scale – Past and present clients know that we bring external experts to work on
Can’t get there from here… We’re back from another excellent BIO Europe convention. Held in Frankfurt, this year’s version was attended by over 3,000 industry colleagues, experts, investors, and hangers-on. We spent the bulk of our time in one-on-one partnering meetings and receptions. So we did not attend any of the presentations or the