Category: Drug Development


Looking Backward, Looking Forward 
Posted on Jan 03, 2017

  I believe it is fair to say that 2016 was a bit unusual. Thinking about the terminology many of us learned last year leads us to that conclusion: snowflake, alt right, safe spaces, and so on.    While peace was finally achieved in the Western Hemisphere (Colombia), it is escalating in the Middle East

Some Comments On Marijuana 
Posted on Dec 15, 2016

The recent elections in the United States is bringing many long-standing policies into question. And, the continued legalization of marijuana is one of them.  At Lacerta Bio, we have consistently held the opinion that marijuana has many potential medical benefits, and that laws need to change in order to provide legitimate patient access to this

The $25 Coffee Mug 
Posted on Sep 30, 2016

Our recent trip to Stockholm and the Nordic Life Science Days conference was quite enlightening, especially as we publicly discuss drug prices (yet again).  One presentation at NLSD by SwedenBio enlightened us on how a different system and society views drug pricing. From the Swedish socialist perspective, one of their aims (aside from job creation) is to provide their citizens

The Age of Virtual Pharma: Creative Financing and Exit Models 
Posted on Feb 22, 2016

  At last month’s Biotech Showcase, a panel discussion was held discussing different models for advancing assets without resorting to a license. The link to the discussion is here. It was an interesting discussion because each speaker detailed their own experience in advancing assets without partnering. Examples include risk sharing relationships with CROs and investors. A few

Would Mefloquine Be Approved Today? 
Posted on Aug 25, 2015

  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

Adaptive Licensing: An Idea Ready For Prime Time? 
Posted on May 28, 2015

  We  just finished reading a terrific academic piece by Jack Scannell and colleagues at the University of Oxford. Entitled Financial Returns on R&D: Looking Back at History, Looking Forward to Adaptive Licensing, the authors discuss adaptive licensing in the context of historical returns on R&D in our industry. (Email us if you would like

Employee-Free Biotechs: A Virtual Panacea? 
Posted on Apr 13, 2015

  Last week Reuters published an article summarizing the “virtual” biotech business model. It was a strange article, considering that this is not a new approach. Indeed, we wrote about this model as far back as 2011. According to Reuters, The new model has grabbed attention as venture capitalists strive to improve returns in a notoriously

On Failure 
Posted on Mar 30, 2015

These past few weeks I have noticed how negative and bimodal we have become when clinical results are announced. More and more, Phase II and III results are labeled #FAIL on Twitter, causing stock prices to plummet. This is occurring even though management teams are not declaring these programs dead. Why is this? Since when did

The Class of 2014: Both Large and Innovative 
Posted on Feb 02, 2015

Lisa Jarvis has prepared a handy overview of the new drug approvals in 2014: For the pharmaceutical industry, 2014 was one for the record books: sky-high merger and acquisition activity, unprecedented levels of financing, and, last but not least, a peak in new drug approvals. The Food & Drug Administration’s green light for 41 new molecular entities—the

Finally, Some Sense 
Posted on Jan 22, 2015

Today, Bruce Booth published yet another terrific post, where he discusses the current biotech investment bubble from the private word of venture backed biotechs (and, he puts many mainstream journalists to shame with this analysis). We think one of the more interesting insights in the post is this one, One would think with a big spike

Mind The Gap: An Interview with David Grainger of Index Ventures 
Posted on Nov 26, 2014

Mind The Gap… We’re late to this party, but a really good interview of David Grainger from Index Ventures was published in July of this year. We encourage you to read the entire interview. In the meantime, here are a few items which caught our eye: Market Backwards Approach – Index Ventures takes a “market backwards” approach

A Billion Here, A Billion There 
Posted on Nov 21, 2014

The new DiMasi estimates for R&D costs were published this week. You can get a PDF of their slides here, while Ed Silverman has a nice summary in the WSJ. 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

Pharma Likes Deals: Is This News? 
Posted on Nov 17, 2014

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

The Life Sciences in Wyoming – Part Two of Three 
Posted on Nov 07, 2014

There’s more to Wyoming than this.  In Part One of his series, Dr. Garrett Lindemann discussed some of the challenges facing Wyoming as it grows its life science industry. In Part Two of this series, Dr. Lindemann highlights some of the life science companies which are already operating in Wyoming. The concept of a state or region

Combination Products: Is A Different Regulatory Approach Needed? 
Posted on Sep 15, 2014

  This morning, California-based Avanir Pharmaceuticals announced that their combination of dextromethorphan HBr and quinidine sulfate (AVP-923) hit their Phase II endpoints in Alzheimer’s Disease: Treatment with AVP-923 was associated with significantly reduced agitation as measured by the primary endpoint, the agitation/aggression domain score of the neuropsychiatric inventory (NPI) compared to placebo (p=0.00008).  The reduction

The Industrialization of Pharma R&D 
Posted on May 21, 2014

  An excellent analysis of the AstraZeneca pipeline performance was recently published in Nature Review. The objective of this study was to identify and assess key factors which drive R&D performance: Maintaining research and development (R&D) productivity at a sustainable level is one of the main challenges currently facing the pharmaceutical industry. In this article, we

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

How much does it cost to develop a drug? We’ll never know. 
Posted on Aug 21, 2013

How much does it cost to develop an approved drug? We may never know, but Matt Herper from Forbes takes an interesting approach to come up with some estimates.

Treatments for Hot Flashes: Winners and Losers 
Posted on Jul 08, 2013

    In a surprise decision last week, the US FDA decided to approve Brisdelle, a low-dose formulation of paroxetine, for the treatment of menopausal hot flashes. This comes on the heels of the FDA granting a CRL to Depomed for their sustained release version of gabapentin for the same indication. Interestingly, the Advisory committee

Oral Insulin Capsule Entering Phase II 
Posted on May 23, 2013

    Oramed announced last week that their oral insulin capsule is ready for Phase II trials in the US: Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and

Let Us Now Praise Pharma 
Posted on May 22, 2013

    In 1941, Let Us Now Praise Famous Men was published. This unusual book is an account of Southern sharecroppers in the Deep South in 1936. It is a difficult read, but as title suggests, the authors suggest that these poor folks should be praised for trying, for living, and for doing the best they

A blockbuster on $1 a day pricing? 
Posted on Apr 19, 2013

    Yesterday, North Carolina-based Pozen gave a detailed Investor Update, focused on PA32540, a “Coordinated-Delivery Tablet Containing Enteric-Coated Aspirin and Immediate-RElease Omeprazole.” Information on the company’s pipeline is available here, while the investor presentation (lengthy PDF) is here. At Lacerta Bio, we follow the drug delivery/reformulation space quite closely. We happen to have a

No incentive to Indian pharma to innovate 
Posted on Apr 05, 2013

    Very interesting point made by Ranjit Shahani from Novartis India: The immense talents in India’s pharmaceutical companies should be focused on R&D of medicines that will help the people and the economy of India that go far beyond simply copying others’ inventions. Without patents there will be few new medicines and without new medicines

Signal, Noise, and Clinical Trial Results 
Posted on Apr 01, 2013

At Lacerta Bio, we’ve been reading the fascinating book, The Signal and The Noise by Nate Silver. The book is a terrific review of how and why forecasts often fail, and why some of them occasionally do succeed. The key philosophy in the text is Silver’s avocation for a Bayesian mindset to statistics and forecasts, and the

Preclinical Biotech Deals 
Posted on Mar 04, 2013

The always excellent Bruce Booth wrote a good summary of the key Preclinical deals we’ve seen so far this year. The post is available here. Some of his broader questions are especially interesting: Are these types of deals going to replace the typical Series B round? – For certain cases, such as highly innovative science, the answer

Observations from JPM 2013 
Posted on Jan 22, 2013

Lacerta Bio, along with approximately 10,000 other life science investors, executives, consultants, service providers, hangers-on, and many others, congregated in San Francisco for a variety of conferences, including the JP Morgan Healthcare Conference, the EBD Biotech Showcase, OneMed Place, and other conferences. We spent the bulk of our time at the “speed dating” meetings at

What is innovation? 
Posted on Nov 09, 2012

Bruce Booth (yet again) published a terrific post on his blog, entitled “NextWave of Pharma Innovation?” His premise is that reformulations, like the once-daily liquid methylphenidate product, Quillivant XR, is not “innovative.” But let me now share my broader concern and where my enthusiasm for the deal dims: why is Pharma spending hundreds of millions for

More Me-Too Products, Not Fewer 
Posted on Sep 26, 2012

An article by our good friend Derek Hennecke in the September issue of Drug Development & Delivery really struck a nerve with us…but in a good way. To quote (with our emphasis): An essay in the Journal of the American Medical Association published in February of last year argued that drugs seeking FDA approval should

Bye bye Bapi 
Posted on Aug 07, 2012

We were disappointed to read this yesterday: Pfizer ($PFE) and Johnson & Johnson ($JNJ) have nixed development of one of the most closely watched drugs in their pipelines, bapineuzumab, after two Phase III clinical trials for the experimental Alzheimer’s therapy ended in failure. The decision comes as no surprise as the program was given slim odds of

Pricing as a product differentiator 
Posted on Jul 11, 2012

A recent article in Forbes by ex-Pfizer President or R&D John LaMattina asks a provocative question: Will Pricing Be a Key Differentiator For New Drugs? I recall some 10-15 years ago speaking with a product manager who said “You should be able to get a 5% price increase by rolling out of bed in the

Factors for successful virtual medtech 
Posted on Jul 06, 2012

Our good friend Raman Minhas at ATPBio has a really good post today on the critical factors for a medtech company to be successful using a virtual organizational model. Raman’s critical factors, with our comments, are: The Team –  In Raman’s case study, he notes that the founders had a tremendous network to tap into.

Unmeet needs should drive drug development, not money 
Posted on Jun 05, 2012

One again, Bruce Booth published a terrific post entitled Contrarian Opportunities in Biotech Venture.  The crux of the article is that while big pharma is licensing in areas such as oncology, many VCs are molding their portfolios to fit the “downstream” demand. Critically, as many pharmas have moved out of therapeutic areas such as anti-infectives,

Burrill Speaks, We Agree 
Posted on Feb 21, 2012

The February, 2012 issue of Life Science Leader has a wide-ranging interview with G. Steven Burrill. It’s an interesting, insightful read, and we can recommend the interview. Mr. Burrill makes an interesting point several times in the interview that are worth repeating: Let’s not just assume that we will always be going through a lengthy

Biosimilar product development guidelines 
Posted on Feb 10, 2012

UPDATE (21 February) – Here is a decent video interview of Rachel Sherman, head of the Office of Medical Policy for the FDA, on the Biosimilar guidelines: BioCentury This Week Today we add the 351(k) pathway for product development, joining 505(b)(2), 510(k), and others. Yes, its the draft guidelines for biogenerics from the US FDA: “When

Tau Wins…Sort Of 
Posted on Feb 07, 2012

Last week, the NY Times published an interesting article on the cause of Alzheimer’s Disease. The article describes experiments in a new mouse model which may confirm, once and for all, that the tau protein is responsible for the “spread” of the disease from cell to cell. There are hundreds of papers in the literature

Drug Delivery Summit Report 
Posted on Dec 05, 2011

Lacerta Bio was privileged to give a short talk at the first (and hopefully annual) Drug Delivery Summit in London late last month. While lightly attended, the two-day conference brought several important points to light. First, drug delivery is truly alive and well. Several speakers from multinational pharmaceutical companies illustrated how formulation innovation can be

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

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

GSK invests in UK biotech start-up 
Posted on Aug 22, 2011

GSK announced that it has taken a ~25% stake in a new spin out. This is a terrific way to create new companies and advance more molecules into the clinic, especially for indications like tinnitus, which are not typically ares of interest for big pharma. These are NCEs from GSK’s portfolio, so they have a

Summer Blogging 
Posted on Aug 19, 2011

Posts have been light lately, due to vacations, summer hours, etc. However, we’ve remained busy with client work and keeping up with the news. A few recent news items of interest: What Hollywood can teach us about drug development: Forbes’ Matthew Herper published a terrific article on what’s broken with the pharma product development model.

Biosimilars: Are We There Yet? 
Posted on Aug 04, 2011

Today’s New England Journal of Medicine contains a short article by Kozlowski et al entitled Developing the Nation’s Biosimilars Program (link to PDF). Here, the authors attempt t provide a framework for answering a deceptively complex question, namely: How similar is similar enough when it comes to the substitution of complex biologic drug products in

Looking for a job in pharma? Good luck 
Posted on Jul 14, 2011

Today, KPMG is reporting results from a survey of pharmaceutical executives. In this survey, respondents said they will increase their acquisition activity in the coming year in order to gain new therapies and new customers. In the KPMG survey, 83 percent of executives said it is likely their company will be involved in a merger

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

The SmartCells Story 
Posted on Jun 13, 2011

Bruce Booth from Atlas Ventures has a fascinating story on his blog. We won’t steal Bruce’s thunder. Instead, we encourage you to read it there first. The gist of the story is how a small company was able to develop a highly innovative diabetes product to the point where Merck acquired the company. This resulted in a

Drug Resistance = Opportunity 
Posted on May 17, 2011

Bloomberg has a good round up of several emerging pharmaceutical companies developing antibiotics. As the article notes, Big Pharma has largely moved away from antibiotic development for a number of commercial reasons. But, the unmet needs are still there, creating opportunities for product development. This is good news, as the demand for novel antibiotics will

Innovation for Chronic Conditions 
Posted on May 09, 2011

There is an excellent editorial in the May issue of Nature Biotechnology entitled Inadequately met needs. In it, the author points out that the US is moving away from innovative, branded Rx towards older, cheaper generic medications. This movement is resulting in a decrease in the sales of newly-approved medications. Now this is not news.

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

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

EU Not Jazzed about Fibromyalgia Either 
Posted on Mar 25, 2011

It was recently announced that the EMA has rejected Xyrem for the treatment of fibromyalgia. Interestingly, Xyrem is already approved in Europe for the treatment of narcolepsy with cataplexy. We have written about the many unmet needs in fibromyalgia previously. Surprisingly, no drug is approved in Europe for fibromyalgia. This is rather unfortunate, as fibromyalgia,

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.

The Sandwich Shoppe is Closed 
Posted on Feb 07, 2011

There has been a lot of commentary this week on Pfizer’s announcement that their highly respected research center in Sandwich, UK, will be closed. The original press release suggested that the decision was based on  Pfizer’s decision to exit therapeutic areas such as allergy, respiratory, and urology, which are based in Sandwich. Wall Street analysts loved

Impressions from JP Morgan – Day One 
Posted on Jan 12, 2011

In our meetings and informal discussions, there were three items we heard again and again: 1. Last year was a terrible fund raising year from a VC-backed company perspective. 2. This year will be much better. Indeed, there is a palpable sense of optimism that more companies will receive more funding in 2011, but… 3.

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

Backing Biosimilars 
Posted on Nov 23, 2010

BioPharm Int’l recently published a nice overview of where the FDA debate is on biosimilars. Highlights: There is broad support for legislation which clarifies the path for biosimilars to be developed. Innovator companies and generic companies are, as expected, far apart on issues such as data exclusivity, preclinical and clinical trial requirements, and other issues

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

Is FDA Jazzed about Fibromyalgia? Not so much… 
Posted on Oct 13, 2010

It is regrettable that the FDA issued a complete response letter to Jazz Pharmaceuticals for JZP-6. If there is a disease that can use some innovation, it’s fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form. In the letter, the FDA discusses a number of topics, including the 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

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