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.
If you need assistance finding or assessing business development and/or partnership opportunities, contact us at firstname.lastname@example.org.
Lacerta Bio is seeking both parenteral and ophthalmic (topical) products for in-licensing on behalf of a US-based client. Key criteria are: > Products which can be developed via the 505(b)(2) regulatory process in the US > No specific therapeutic area or indication > Injectable could be infusion, prefilled syringe, or related presentation > Ophthalmics areRead More»
Lacerta Bio is pleased to present two novel antibiotics with excellent properties on behalf of our client. The first is a peptide antibiotic which inhibits cell wall synthesis, making it suitable for the intravenous treatment of troublesome Gram Positive bacteria, such as MRSA, VRE, and many other resistant pathogens. The second is a liposlycodepsipeptide suitableRead More»
Our European client has developed a series of novel, patented salt forms of the most popular NSAIDS on the market (ibuprofen, naproxen, etc.). Clinical data demonstrates three important properties of these new compounds: Enhanced Safety – In multiple clinical studies, our client has shown that these novel salt forms have lower rates of severeRead More»
The recent news that Novartis is closing its Colorado-based generics manufacturing facility brought back a few memories.
A company spokesperson blamed “above-average pricing pressure“. The products were described as “oral…for a variety of conditions…expensive to make…and no longer competitive.
Medicare Part D studies clearly show generic price deflation is quite real, even when some generic products experiencing massive price increases. According to the GAO,
Overall, prices declined by 59 percent…from the first quarter of 2010 through the second quarter of 2015.
Novartis/Sandoz is not the only company experiencing such pressures.
Earlier this year. Teva announced the sale or closure of 15 manufacturing plants around the world, resulting in thousands of lost jobs.
Ten to fifteen years ago, acquiring and building generics businesses were the business models du jour for some big pharma companies.
For example, Pfizer acquired Greenstone through its 2003 acquisition of Pharmacia.
In 1996, Ciba-Geigy merged with Sandoz, resulting in Novartis. Then, in 2003, Novartis consolidated all of its generics business under a revived Sandoz corporate brand.
And so on.
Yet, the pressure on physicians and patients to use generics has never been greater…anything to avoid expensive brands, some with minimal incremental therapeutic benefit.
So, what happened?
Pharmacy chains, wholesalers, and PBMs have been merging and/or forming massive buying groups with incredible buying power. For example, Express Scripts is part of the Walgreens Boots Alliance, a group purchasing organization. Other examples include the CVS partnership with Cardinal Health, and the Walmart / McKesson partnership.
Plain Ol’ Economics
Increased buyer power pressures suppliers to compete against each other on price for commodity products. That’s classic Porterian Five Forces at work here.
The FDA is taking steps to accelerate the processing of filed ANDAs. For 2018, we could be looking at ANDA review times of 10 months, and 8 months for priority reviews, and amazing improvement for a process which used to take 2 years.
This is not a business for the feint of heart. It requires operational excellence and efficiency, a global presence, scale, and ruthless willingness to add and remove products in response to ever-changing market dynamics.
In a sense, the generics industry has always been this way. But changing customer and regulatory dynamics have definitely caused a shift in who survives in this industry. The move by some generic companies towards higher-margin products, especially biosimilars, makes complete sense in light of these dynamics.
Is out-licensing difficult? Yes, of course it is. But how difficult is it? Is this something which can be quantified? And, why would we want to quantify this anyway? These data from MedTrack show Partnerships in two therapeutic areas over time, by stage of development. Now we recognize that these data may have some issues. For
This post is in response to a prospective client, who asked us about the required depth and complexity required in a financial model(s) when out-licensing. It’s an interesting question. So in this post, we’ll take a step back to examine this issue. The folks at Bain and Company recently published a short white paper entitled How
The humble lime…sour, sweet, juicy, and an essential ingredient in many desserts and beverages. Lime also (supposedly) has many health benefits, including weight loss, improved digestion, and improved skin. But the lime also has another benefit…it is one key to improving your out-licensing. At our upcoming Out-Licensing Masterclass in Boston, we will spend a great