Category: Pharmaceutical

NSAIDs: More Bad News 
Posted on May 15, 2017

  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

Drug Overdose Deaths: What Can Pharma Do? 
Posted on Mar 09, 2017

  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 This Problem? 
Posted on Nov 03, 2016

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, 

Wanted: Guest Bloggers 
Posted on Jul 28, 2014

  We’re actively seeking guest bloggers for! 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

Another Day, Another Inversion 
Posted on Jul 14, 2014

  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

More Concerns About Unaffordable Hep C Treatments 
Posted on Apr 09, 2014

    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.

Indian Pharma Industry: Is the sun setting…or rising? 
Posted on Apr 08, 2014

    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

Exuberant over Inhaled Insulin Again? 
Posted on Apr 02, 2014

  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

Where Is Biotech’s WhatsApp? 
Posted on Feb 21, 2014

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

Drug Shortages: Danger and Opportunity? 
Posted on Feb 12, 2014

  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

Novel Antibiotics: We Need Them 
Posted on Jan 24, 2014

    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

FDA Approvals: Is it really as bad as they say? 
Posted on Jan 07, 2014

    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

Making progress against Hepatitis C 
Posted on Nov 20, 2013

    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

Ben Venue to close: Wither Parenterals? 
Posted on Oct 03, 2013

    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 Tips 
Posted on Sep 03, 2013

    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

How to improve your business development process 
Posted on Aug 27, 2013

    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

Pernix exits generics (sort of) 
Posted on Aug 13, 2013

          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

Perrigo Elan: Markets not happy with Papa 
Posted on Aug 06, 2013

    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

Biotech Business Development: The Volkswagen Lesson 
Posted on Jun 10, 2013

    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

Stories of Interest in 2012 
Posted on Dec 17, 2012

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

The Decline and Fall of The Monitor Empire 
Posted on Nov 26, 2012

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

But who will pay? 
Posted on Oct 08, 2012

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

IBD: Problem is worse than we suspected 
Posted on May 21, 2012

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

Insourcing: A new outsourcing approach? 
Posted on Nov 09, 2011

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

AAPS: Impressions and Observations 
Posted on Oct 27, 2011

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

KPMG and Future Pharma 
Posted on Oct 21, 2011

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

When does due diligence start? 
Posted on Oct 12, 2011

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

AAPS Conference 
Posted on Oct 04, 2011

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

Merck is a VC! Our problems are solved! 
Posted on Sep 16, 2011

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

A Rainy Day for Spanish Pharmacists 
Posted on Aug 26, 2011

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.

GSK gets it 
Posted on Jul 26, 2011

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

All you need is…guts 
Posted on Jul 11, 2011

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

Dear Pharma, What Went Wrong? 
Posted on Jun 23, 2011

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.

Is deal-making becoming more difficult? 
Posted on Jun 20, 2011

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

Sandwich Shoppe For Sale 
Posted on Jun 14, 2011

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

The Era of the One Man Pharma Band (With Updates) 
Posted on May 31, 2011

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

One man’s junk = another man’s treasure 
Posted on May 27, 2011

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

Update: Pain continues to be painful 
Posted on Apr 22, 2011

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

BioTrinity Panel Discussions 
Posted on Apr 21, 2011

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

VCs Abandoning Biotech for the Web? 
Posted on Apr 07, 2011

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

Cost of drug development may not be $1 billion after all 
Posted on Mar 07, 2011

Drug development costs of $1 billion are often quoted. A new study estimates costs to be much lower, based on a different statistical approach.

Pharma not into Social Media? Can’t blame them. 
Posted on Feb 22, 2011

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

AstraZeneca Boldly Goes Into The Twitterverse 
Posted on Feb 16, 2011

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 We found this to be a fascinating discussion, for several reasons: Communicating about

Thoughts on JP Morgan Conference 
Posted on Jan 17, 2011

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

More Government Involvement in Pharma Industry 
Posted on Jan 04, 2011

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

Brazil’s prescription for pharma: More Government involvement 
Posted on Dec 23, 2010

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

Drug Development and Delivery: What’s in a name? 
Posted on Dec 21, 2010

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

More on Russia…Is the US Next? 
Posted on Dec 20, 2010

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

India, India, and more about India 
Posted on Dec 13, 2010

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

Russian government spurs pharma growth 
Posted on Dec 10, 2010

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

Pfizer bypassing wholesalers in Oz 
Posted on Dec 06, 2010

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 Connection 
Posted on Nov 22, 2010

The Indian pharmaceutical market is highly fragmented. How can pharma companies make money? PharmaTimes characterizes the market for us in summary form.

Launch evolution across Pharmerging Markets 
Posted on Nov 15, 2010

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

Lilly Shows Interest in Alzheimer’s Diagnostics 
Posted on Nov 08, 2010

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.

Orphan Drugs & Venture Capital Backed Companies 
Posted on Oct 23, 2010

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

Biosimilars, Champagne, and Beer 
Posted on Oct 19, 2010

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

Lilly to close Singapore drug discovery center 
Posted on Oct 18, 2010

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 Dead? Hardly! 
Posted on Oct 07, 2010

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.

Why is Pain such a Pain? 
Posted on Oct 05, 2010

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

GSK Spinout – Great, but let’s be realistic 
Posted on Oct 05, 2010

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

Covance does it again…this time in Europe 
Posted on Sep 30, 2010

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.

Posted on Sep 28, 2010

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

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