Category: Biotech

The Life Sciences in Wyoming – Part Three of Three 
Posted on Dec 11, 2014

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. Now, in the third and final installment, Dr. Lindemann summarizes some of the life science companies

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

Biocon Mylan Biogenerics Partnership 
Posted on Feb 14, 2013

Today we learn that generics giant Mylan has entered into a partnership with India-based Biocon to focus on insulin analog biosimilars: Under the terms of this collaboration, Mylan will have the rights to develop and market Biocon’s Glargine (the generic version of Sanofi’s Lantus®), Lispro (the generic version of Eli Lilly’s Humalog®) and Aspart (the

Predictions for 2013 
Posted on Jan 02, 2013

Happy New Year! For many companies, 2012 was a challenging year. How will 2013 play out? Here are a few ideas we’ve discussed internally as we look forward to 2013: Innovation versus Revenue – Companies (and their investors) talk a lot about innovation. And indeed, innovation is important. However, what companies really really want is

Biosimilars: Three things you need to know 
Posted on Nov 24, 2012

We’ve had the good fortune to work with a biosimilars client this year. Working in this space has given us an opportunity to read and listen to many experts in this enormous area. More recently, we also attended a panel discussion at BIO Europe 2012 on the subject. Looking through our project notes, there are

Slow summer? Hardly 
Posted on Jul 17, 2012

Thank goodness for Twitter. How else can one keep up with all of the news and happenings in our industry during the “slow” month of July? Here are a few stories of interest that we’ve spotted: Truvada for HIV Prevention – This is truly a remarkable development in HIV. While the industry struggles to develop

Flamel – Eclat and NicOx – Altacor: What can we learn? 
Posted on Mar 21, 2012

The past seven days have brought us two very interesting transactions. First, on March 14, Lyon-based Flamel announced their acquisition of St. Louis-based Eclat Pharmaceuticals. The press release contains a number of interesting nuggets, but this one caught our eye: Mr. Willard concluded, “We expect that the combination of Mike’s [Anderson] drug development and regulatory

Pfizer Biocon signals the end for biosimilars? Hardly… 
Posted on Mar 15, 2012

Earlier this week we learned that Pfizer will return to Biocon rights to biosimilar versions of various insulin derivatives: As of March 12, 2012, all rights licensed to Pfizer will revert to Biocon, and all insulin distributed under the brand name UniviaTM and GlarviaTM will be commercially available from Biocon Ltd. only, and will be

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

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

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

Shiraz or Fuller’s Best? 
Posted on Sep 28, 2011

Earlier this month, Keith Powell posed an interesting question:  The economies of California and the UK are similar, as are the university networks. Why then, does California boast the most successful biotechnology companies and the UK no significant success? Dr. Powell is in a unique position to compare California and the London/Oxford/Cambridge triangle. He is

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

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

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

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

VCs Avoiding the Creep 
Posted on May 05, 2011

Today’s In Vivo Blog post summarizes comments that we have been hearing from our clients as well. Namely, that deals are increasingly shifting towards back-ended Royalties and earn-outs, at the expense of larger upfront payments. Companies are now facing an interesting dilemma. Suppose a company has a lead product candidate ready for Phase II clinical testing. One

Carpe diem: What mergers can do for you 
Posted on Apr 25, 2011

This is a fantastic piece in Nature by Anu Acharya, CEO of Ocimum Biosolutions in India. I recommend reading the article in full. A few key points that struck us as we read it: 1. Mergers are not exclusive to large, multinational companies. Small companies can grow through mergers, provided…. 2. …that the core team

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

Report on BioTrinity Partnering, April 12-14 
Posted on Apr 19, 2011

Last week, Lacerta Bio attended the annual BioTrinity Partnering and Investment Conference in Newbury, UK. This was our first time at this conference. So how was the conference? A few observations: 1. We had no trouble scheduling and conducting high-quality meetings on behalf of our clients. Our calendars were completely filled on both partnering days.

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

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

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.

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

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

EMA Publishes “Biosimilar Friendly” Guidelines 
Posted on Nov 29, 2010

The EMA has recently published guidelines for the development of monoclonal antibody-containing biosimilar products.

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

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.

Genes are Natural, and Not Patentable 
Posted on Oct 31, 2010

Fascinating turn of events on Friday, when the DOJ: said on Friday that human and other genes should not be eligible for patents because they are part of nature This story will not go away, as the Patent Office has essentially taken the opposite point of view. Stay tuned…

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

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

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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