NSAIDs are an $11-12+ billion market, yet the problems with these drugs continue to make headlines. The most recent study examined data from nearly 450,000 patients, and concluded (our emphasis): All NSAIDs, including naproxen, were found to be associated with an increased risk of acute myocardial infarction. Risk of myocardial infarction with celecoxib was
Last week, the US Centers for Disease Control published a rather alarming report on drug overdose deaths in the US. Here are a few items which we found surprising and/or interesting: On The Rise – Age-adjusted drug overdose deaths have steadily increased since the late 1990s. But now we’re seeing “hockey stick”
Can we ESKAPE the problem which may kill thousands of human beings over the next decades? First, what is ESKAPE? Initially coined by Dr. Louis Rice, ESKAPE is a handy acronym for six of the most common antibiotic-resistant pathogens. These are: Enterococcus faecium Staphlococcus aureus Klebsiella pneumoniae Acinetobacter baumanni Pseudomonas aeruginosa Enterbacter sp. As Rice puts it,
We’re actively seeking guest bloggers for LacertaBio.com! The ideal guest blogger: Is currently involved in business development and licensing Currently works for a pharma, biotech, VC, PE, or consultancy Is able to write 500+ word articles related to business development and licensing The key is to have high quality, original, insightful articles. We’re not looking to repeat
A quick search resulted in several recent examples of US-based pharma companies executing “inversions” to reduce taxes via the acquisition of companies in Ireland: Salix merges with Cosmo Technologies, the Irish subsidiary of Cosmo Pharmaceuticals of Italy, for >20% of the combined company. Both companies focus on GI, so strategically is makes some sense. What’s
Our friends at Pharmaphorum posted an overview of the recent WHO guidance for the treatment of hepatitis C. Of note, These new oral drugs are able to cure almost all patients of the disease (in combination with standard treatment), increasing the cure rate in patients and also cutting the length of treatment needed.
Much ink has already been spilled discussing the acquisition of Ranbaxy from Daiichi by Sun Pharma in an all stock transaction. A good analysis by a former Ranbaxy executive provides some interesting insights: The valuation of Ranbaxy is attractive at this point in time when USFDA and regulatory issues are at a peak. And
Yesterday, MannKind Corporation annouced that the FDA voted 13-1 in favor of an approval for Afrezza. You can find the press release here. We’ve Seen This Movie Before For nearly a year, an inhaled insulin product (Exubera, Pfizer) was on the market. While Exubera was as effective as short-acting insulin, the high cost of
This week, the financial press is going bonkers over the acquisition of WhatsApp by Facebook for $19 billion in cash, stock, and Facebook tchotkes. We’re not experts in this space, so we’ll defer to others to explain all of this too us. For an excellent explanation of the “Why” behind the transaction, check out Benedict
Are we the only ones shocked by this? Despite efforts by the Obama administration to ease shortages of critical drugs, shortfalls have persisted, forcing doctors to resort to rationing in some cases or to scramble for alternatives, a government watchdog agency said on Monday. The number of annual drug shortages — both new and
Yesterday the Wall Street Journal summarized the current situation in antibiotic drug development and commercialization. To summarize: Big Pharma is slowly returning to antibiotic (really, antibacterial) drug discovery and development Physicians are caught between resistance to old antibacterials and a lack of new ones New pricing models similar to cancer pricing are needed to
This week we’re greeted with the following headlines: The FDA Approvals of 2013: A Watershed? US new drug approvals slip in 2013 vs prior year An ominous trend resurfaces as new drug approvals plunge in 2013 Is it really all that bad? Is our industry doomed? The headlines are driven by the 27
Those of us of a certain vintage will remember the days when interferon was the only option for hepatitis C patients. Then, the pegylated versions were launched and rapidly became successful products. However, the goal of an interferon-free regimen was still a pipe dream. Today, we’re still not to the point where interferon-free
Ed Silverman at Pharmalot reports today that BI is closing Ben Venue once and for all: More than two years after Ben Venue Laboratories began encountering serious quality control issues that resulted in numerous product shortages, the troubled manufacturer is closing down permanently by the end of the year… About 1,100 employees are
September is a strange month, isn’t it? It’s the unofficial end of summer, so we’re all getting back into the swing with everyone back in the office. Yet there is a “newness” to September, perhaps in part due to the back-to-school activities and students returning to university campuses. Further, it’s not the end
At Lacerta Bio, we believe that business development is a process…a process with discrete steps, activities, timeframes, and deliverables. Yet many companies, fully aware of how to run the process, still have difficulties either in- or out-licensing assets. Even though entire books have been written on the subject, business development in our industry
Texas-based Pernix Therapeutics announced a $30 million divestment of a portfolio of generic assets to Breckenridge: Under the terms of the agreement, Breckenridge will pay Pernix $20 million in an upfront payment and $10 million which is to be paid in two equal installments over the next two years. The
We don’t normally comment on stock activity, but the market response to the Perrigo Elan announcement caught our eye: As was pointed out in The Guardian: Perrigo, which makes over-the-counter medicines and vitamins, said it would make annual savings of more than $150m (£98m) in taxes and operating costs by moving its headquarters
Just sign a piece a paper and drive off with a new car. They sure make it sound east, don’t they? Yet VW does have a good point. They, as the seller, want to make it as easy on the buyer as possible. This thought is essentially what we were trying to convey
As we bring 2012 to a close, we’re looking back at a few of the interesting events that took place. It was a challenge to whittle this down to a manageable number. So we decided to go with three. So, without further ado: Pfizer acquires NextWave – This one really surprised a lot of the
While we were recovering from our turkey-induced slumbers, we read the shocking news that Michael Porter’s Monitor Group has filed for bankruptcy, and is being acquired by Delloitte . The best coverage of this story has been by Steve Denning, and we encourage you to read his articles here and here. The Economist also has
An intriguing graph was posted on Twitter the other day: Now we understand the argument, and it’s a good one: As the population ages, there will be more long-term illness, which will drive the demand for healthcare (diagnostics, drugs, monitoring, services, etc.). So from an investor point of view, there will be (hopefully) no shortage
In researching our latest project, we came across some startling statistics. A report published by the Crohn’s and Colotis Foundation of Canada noted: This landmark document revealed that over 200,000 Canadians suffer from inflammatory bowel disease. IBD affects more people than multiple sclerosis or HIV and is almost as prevalent as epilepsy and Type 1
Pharmaceutical outsourcing to CROs is certainly nothing new. However, this week we learned that pharmaceutical giant Lilly and AMRI signed an interesting insourcing / outsourcing agreement. In this deal, AMRI will hire 40 chemists to work on Lilly projects. However, these chemists will not work in Albany or in any of the other AMRI facilities
Lacerta Bio spent the week at the AAPS ( American Association of Pharmaceutical Scientists ) annual conference . Over 8,000 pharmaceutical scientists, service providers, and others came to AAPS in DC to talk pharmaceutical science, especially formulation development, translational research, pharmacokinetics, and manufacturing. As the name suggests, AAPS is a science-driven conference. Thus, the tone
Call us late to the party, but in August of this year, KPMG published Future Pharma: Five Strategies to Accelerate the Transformation of Pharmaceutical Industry… The entire report is available here (PDF link) . We won’t rehash the five challenges discussed there (e.g., increased competition, low growth markets, declining R&D productivity, etc.). What we found
In our view, there are two basic types of biotech business development-related due diligence. The first is external , where the team gathers and analyzes data about a target company or technology exclusively using external data sources, such as market & equity research, physician interviews and surveys, conferences & symposia, and so forth. The second
In a few weeks, Lacerta Bio will return to DC to participate in the annual convention and celebrate the 25th anniversary of the American Association of Pharmaceutical Scientists (AAPS). AAPS is a special organization for us. We and many of our colleagues have been members since our graduate school days. The conferences have always been
Some members of the media are ebullient with the news that Merck is “getting into venture capital.” However, as In Vivo is reporting, Merck is undertaking two initiatives that are quite different from direct venture investing in biotechs: First, Merck is establishing the Global Health Innovation Fund to invest in non-pharmaceutical health care spaces: It’s
Yesterday’s Financial Times reported that pharmacists in Spain are struggling to continue operating their businesses due to a lack of payment from the Regional governments. “We depend 80 to 90 per cent on the health system, and it’s the first time they’ve stopped paying,” says Ms Espinosa, who is president of the regional pharmacists’ federation.
As FiercePharma correctly points out, GSK’s Q II report reflects the overall industry trends quite accurately: The rest of Glaxo’s report, like the rest of Big Pharma’s Q2 results so far, reflect current industry trends; sales in U.S. and Europe are on the wane, thanks in part to pricing pressures from cash-strapped governments. Cost-cutting helped
Luke Timmerman at Xconomy wrote a provocative piece today entitled The Missing Ingredient in Today’s Biotech: Guts. His thesis is that the industry is so paralyzed by fear and insecurity that it lacks the collective fortitude to take risks, even if they seem delusional. To quote: If the industry–VCs, scientists, entrepreneurs, everybody—can’t get the mojo back, then we
The pharmaceutical industry has benefitted mankind by developing life-saving and life-sustaining drugs. However, recent turmoils have led many to question the value provided by the industry. Matt Herper tackles these complex issues across two blog posts.
The June, 2011 issue of Nature Drug Discovery has a interesting short article based on a survey conducted by our good friends at PharmaVentures. The authors surveyed 180 business development executives on their perceptions surrounding deal making. One of the survey’s findings is that biotech BD executives believe that pharma licensees have greater power in driving
We posted in February the news that Pfizer was closing their large R&D facility in Kent, UK. It was with some surprise that we learn that the facility is already up for sale, as being reported by BBC News and Reuters. It is hoped that the “Discovery Park” will eventually house a blend of companies performing sophisticated
There is a fascinating discussion taking place over at Derek Lowe’s blog today on one-man drug companies: …some of them are not quite down to one person, but you can count the employees on your fingers. In all of these cases, everything is being contracted out. Aside from the samples given in the post, and
Today we learn that Rigel has raised $130 million in financing, in part, to develop candidates in rheumatoid arthritis and other areas. But, as reported by Xconomy, the real gem may be R343 for the treatment of asthma. Essentially, the Big Pharma partner, as part of its cost-cutting and portfolio review, took a Rigel drug
This week we learn that two novel pain medications will never see the light of day: Novartis had reached the market with the COX-II inhibitor Prexige (rebranded as the unusually positive name of Joicela), until regulators forced Novartis to pull the drug from the market in 2007. Taking a biomarker/ personalized medicine approach did not
We regret that we were unable to attend the panel discussions at BioTrinity last week. However, an excellent summary was posted on the PharmaPhorum web site. Of note: 1. Investment syndication is becoming increasingly important. 2. Big pharma/Big biotech are looking at earlier-stage assets, perhaps more so than ever. Even early-stage technologies coming out of
Fred Frank, a highly respected investment banker, greeted us on Tuesday morning with this missive: Venture capitalists, who make high-risk investments in start-ups, are tired of waiting years for biotech companies to generate real products and be marketable as initial public offerings, bankers said. They’d rather invest in companies that could go public in just a
Drug development costs of $1 billion are often quoted. A new study estimates costs to be much lower, based on a different statistical approach.
We were intrigued by a comment made on Twitter regarding pharma employee involvement with social media: [It’s] important to allow all employees to engage within guidelines and not restrict with bureaucracy We have worked both with and within several pharma companies over the years. One thing that has been consistent is the blocking of web
This evening, @AstraZenecaUS held a fascinating Twitter chat (hashtag #RxSave). The focus of the discussion was on pharma-sponsored prescription savings plans. AZ was also looking for advice on how to best communicate with patients and caregivers about these programs, such as AZandMe.com We found this to be a fascinating discussion, for several reasons: Communicating about
There is a lot of good commentary and analysis of last week’s JP Morgan Healthcare conference, most notably here, here, and here. Here are a few of our thoughts as we look back at the conference: 1. Maybe it’s because it’s the start of a new year, or perhaps it’s that we’ve come out of
The past few months have seen a number of reports describing how national governments are using policy to spur local pharmaceutical industry growth. We have already described examples from Brazil, Russia, and Russia again. Today we learn that the Indian government is reportedly looking to cap foreign direct investment in pharmaceutical (and related) companies to
Earlier this week we wrote about the emerging trend of increasing state government involvement in the pharmaceutical industry. Today we learn about what the government in Brazil is doing. Of interest: The state-led complex’s future evolution poses challenges for Brazil’s health system and domestic producers, as well as for western companies increasingly eager to tap
Our good friends at Drug Delivery Technology have, as of January, changed the name of their publication to Drug Development and Delivery. Why is this significant? We think that drug delivery and drug development will become increasingly synonymous. Indeed, we’ve blogged in the past about some of the areas where traditional drug delivery techniques can
Last week we wrote about the Russian government’s desire to grow their national pharmaceutical infrastructure. Our reading of the situation is that the government will “suggest” that ex-Russia companies who want to do business in the country will be asked to build manufacturing plants, invest in local R&D, etc. Today, Novartis announced a $500 million
Here is a sample of announcements from today alone regarding the pharmaceutical industry in India: First, UK-based Reckitt Benckiser is acquiring Paras Pharmaceuticals for $726 million. Paras makes a variety of over-the-counter products for pain and cough and cold. Next, both Merck and Watson Pharma are making it very clear that they are interested in
Earlier this week, Prime Minister Putin announced that the Russian government will invest nearly $4 billion to modernize the pharmaceutical industry in Russia. Of note: Putin said he wanted 90 percent of Russia’s vital medicines and 50 percent of its medical equipment to be domestically produced by 2020. Other reports suggest that ~80% of Russia’s
There is fascinating news today from Pfizer, who have decided to bypass the wholesalers in Australia and market directly to community pharmacies. To quote, “In order to develop stronger partnerships with pharmacists and better adapt to the changing environment, we have decided that a dedicated field force with specific pharmacy experience and a direct distribution model
The Indian pharmaceutical market is highly fragmented. How can pharma companies make money? PharmaTimes characterizes the market for us in summary form.
PharmaPhorum has an excellent analysis on launch evolution across pharmerging markets, such as China, Brazil, Russia, and so forth. A few items of note: 1. The author projects that by 2012, Brazil and China will enter the top 10 largest markets, by sales (with India at #11 and Venezuela at #12). However, they include Germany
Today we learn that Lilly is acquiring Avid Radiopharmaceuticals: Lilly will acquire all outstanding shares of Avid for an upfront payment of $300 million, subject to adjustment based on existing cash on hand at closing. Avid stockholders will also be eligible for up to $500 million in additional payments contingent upon potential future regulatory and commercial milestones for florbetapir.
The October, 2010 issue of Life Science Leader has an interesting article entitled Orphan Drugs: Big Pharma’s Next Act? The premise is that Big Pharma is turning towards orphan drug opportunities because they are faster and less expensive to develop, yet have near-blockbuster potential. Indeed, the article correctly notes that companies such as Genzyme and Cephalon
A former business development colleague of mine used to refer to some prospects as having “champagne tastes with beer wallets.” His meaning was clear. It’s one thing to want champagne, but it’s another to actually be able to afford it. This is especially true when all you can afford is Coors Light. I was reminded
Today we learned that Lilly will close their Singapore R&D facility. This facility was focused on drug discovery in cancer and diabetes. I leave it to the powers that be within Lilly to determine whether this is a wise decision or not. However, as my colleague told me this morning, “Yes, but they still need
Drug delivery is not dead! In fact, drug delivery can ba a valuable tool for developing and commercializing drugs faster and at lower cost versus NCEs.
Late last month, Johnson and Johnson (J&J) announced the results of Phase III clinical trials comparing tapentadol extended release compared to oxycodone controlled release and placebo. In this study, J&J reported that tapentadol ER was superior to placebo on multiple measures, including a significantly higher percentage of patients achieving at least a 50% improvement in
Today we read the news that GSK will spin out a team of fourteen scientists and patents into a standalone company. Convergence Pharmaceuticals will focus on the development of pain management products. GSK retains an 18% ownership stake in the new company. Generally speaking, I think this is a fabulous idea. I would like to
Today we hear the news that Covance has done it again. Today they acquired two European R&D sites from Sanofi for $25 million. In addition, Sanofi agreed to purchase R&D services from these facilities for up to $2.2 billion over 10 years. This follows a similar deal struck with Lilly in the US in 2008.
Welcome to my new blog and web site! Lacerta Bio has been organized to provide a range of pharmaceutical and biotechnology business development services. Please visit our About page to learn more about what we do. Current projects can also be found here. In this blog, I hope to capture some of my thoughts on