May 2012

 

   

 

TopBioMarketing    Insight 

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Pharma, Biotech & Medical Device  

Greetings!

 

Welcome to BioMarketing Insight's monthly newsletter.  

 

We all know that funding is tight and that in order to obtain funding there are five elements that a start-up needs to de-risk for investors: 1) the team, 2) the market, 3) the technology, 4) IP, and 5) regulatory. Jill Milne, CEO of Catabasis Pharmaceuticals obtained funding in 2010 when few investors were investing in start-ups. Recently she shared with me how she was able to de-risk these five elements.

                                                                                                    

Read on to learn more about this topic and other current news. On the right are quick links to the topics covered in this month's newsletter. The next newsletter will be published on June 15th.  Since the BIO convention is taking place, I will be discussing what's going on at BIO.

                                                                                                       

We encourage you to share this newsletter with your colleagues using the social media icons at the top left or by simply forwarding the newsletter via email.

 

Please email me, Regina Au, if you have any questions, comments, or suggestions.

 

Sincerely,

Regina Au

Principal, Strategic Marketing Consultant

BioMarketing Insight 

Save the Date - June 21, 2012 - BIO Convention

 

I will be moderating a breakout session at the BIO Convention entitled:

 

"Using Systems Biology to "Fast-Track" Development and Approval of Novel Therapeutics and Diagnostics."

Date: Thursday, June 21st, 2012

Time: 10:00 - 11:30 am.    

Track:  Personalized Medicine and Diagnostics

Session ID: 1188

Room: 258-B 


Description:
Brief overview of Systems Biology and how its application can determine more precisely and quickly which biomarkers are relevant to specific diseases for diagnosis or therapeutic intervention. This approach can also determine subgroups or different genotypes within these diseases in developing a diagnostic test that will determine whether a patient will respond to a specific drug with minimal side effects.

Drugs can now be targeted for a specific set of patients resulting in higher efficacy. In return, the FDA requirements for the number of patients required for the phase I-III trials maybe smaller, the cost and time for R&D will be reduced and the approval time will be shorter.

Speakers:

1) David Hill, PhD - Research Scientist in Cancer Biology and Associate Director of the Center for Cancer Systems Biology (CCSB) at the Dana-Farber Cancer Institute (DFCI).

2) Glenn Miller, PhD - Vice President / Head of Personalized Medicine, Astra Zeneca

3) Steven Tregay, PhD - Founder, President, and CEO of Forma Therapeutics

4) FDA Speaker - TBD

  

For more information on the speakers, click hereFor more info on BIO, click here.

      

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In This Issue
Save the Date - June 21, 2012 - BIO Convention
When the Economy Gets Tough, You Need to De-Risk the Investment Process
Closing Thoughts
New Technology - "Gladstone Scientists Make Beating Cardiac Cells Inside the Heart"
Seventeen Medical Device and Fourteen Pharma/Biotech Funding Deals
Twenty-eight Acquisitions
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 When the Economy Gets Tough, You Need to De-Risk the Investment Process 

 

Co-founders Jill Milne, CEO and Mike Jirousek, CSO of Catabasis Pharmaceuticals secured $39.6 million Series A funding in 2010 back when investment money was tight and VCs were shying away from start-ups.

 

Jill Milne
Jill Milne, CEO of Catabasis

How were they able to secure such a significant amount of funding?

 

They de-risked the five elements that investors are most concerned about when investing: 1) the team, 2) the market, 3) the technology 4) Intellectual Property (IP), and 5) regulatory. I had spoken with Jill as to what they (Jill and Mike) had done to be successful in securing their Series A funding.

 

A little background on Jill--prior to Catabasis, Jill was part of the founding team at Sirtris Pharmaceuticals (acquired by GlaxoSmithKline) and worked at Polaris Venture Partners on the formation of Sirtris. After the founding of Sirtris, Jill joined Discovery Biology, where she led the company's SIRT1 Program, which produced several first-in-class NCEs that are currently in Phase 1 and 2 studies.

 

Prior to Sirtris, Jill was the worldwide head of the Drug Pfinder Program at Pfizer Global Research and Development. As head of this global program, she was responsible for identifying and evaluating opportunities across all of Pfizer's therapeutic areas of interest. Jill holds a Ph.D. from Harvard University in biological chemistry.

 

It is no surprise that Jill started another company with her co-founder Mike Jirousek and having worked for a Venture company, she knew their concerns and what she needed to do to make investors feel comfortable. So what did they do to de-risk the five elements?

 

1) The Team - Jill obviously has a great background, both technical and business, having experience working in big pharma, a venture company and in a start-up. She also had her Board of Directors, Scientific Advisory
Board, Clinical Advisory Board, and business consultants all on board before she started raising money. Catabasis has an extensive list of experts in all areas of business and science advising them. Venture companies look highly on this.

 

2) The Market - According to Daphne Zohar, Pure Tech Venture, venture people start with the unmet need first and then look at the market opportunity. That is exactly what Jill and Mike did. What was the unmet need that they were passionate about? They identified the diabetes market as a very large unmet need because a lot of companies have tried to develop diabetes drug and have failed for Type 2 diabetes. The market opportunity has already been identified as a significant opportunity but the question they asked themselves is "why has so many drugs failed?"

 

They recruited diabetes expert Dr. Steve Shoelson, as co-founder of Catabasis. Dr. Shoelson currently serves as the chairman of the company's scientific advisory board and heads the Section of Cellular and Molecular Physiology at Joslin Diabetes Center and is Professor of Medicine at Harvard Medical School. Dr. Shoelson "pioneered the role of inflammation in chronic disease states such as type 2 diabetes mellitus, translating his findings in the laboratory to clinical outcomes in studies including the TINSAL-T2D clinical trial." Read on about the technology.

 

3) The Technology - In analyzing the diabetes market and from the work of Dr. Shoelson they found that there were no drugs available in the diabetes market that addressed inflammation.

 

Studies in the past have shown that "high-dose salicylate and inactivation of IKK-β prevent fat-induced insulin resistance in skeletal muscle by blocking fat-induced defects in insulin signaling and action and represent a potentially novel class of therapeutic agents for type 2 diabetes." 

 

"Animal experiments and clinical intervention studies indicate that omega-3 fatty acids have anti-inflammatory properties and, therefore, might be useful in the management of inflammatory and autoimmune diseases."   

 

Each compound by itself can work to inhibit inflammation. So, could two compounds given together simultaneously produce a synergistic affect in activating the anti-inflammatory pathways? The proprietary SMART-linker technology was developed linking salicylate and omega-3 fatty acids (DHA/EPA). Their technology will link salicylate with DHA (docosahexaenoic acid) or EPA (eicosapentaenoic acid).

 

These compounds also have other beneficial affect on lipids, inflammatory bowel disease, rheumatoid arthritis and muscular dystrophy. Catabasis currently has drug programs for Type 2 diabetes, hypertriglyceridemia, multiple sclerosis, and ultra orphan inflammatory diseases.

 

4) Intellectual Property - Once Jill and Mike had identified the type of technology they wanted to develop; they started filing their patent before they officially started their company and before they had their third co-founder, a diabetes expert, join the company. This gave them the freedom to discuss their technology when recruiting experts to their various advisory boards and raising money from VCs.

 

5) Regulatory - Salicylate and essential omega-3 fatty acids are known entities in the literature and clinical trials, and used widely used in the market. Thus regulatory approval would be easier to obtain compared with a new compound that has not been proven. The proprietary SMART-linker technology would be the only new entity but it functions as a secondary component to improve the delivery, potency, and efficacy of the drug.


Contact me should you have any questions or  feedback on this topic. 

   

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Closing Thoughts  

 

In a time when funding is tight, the more one can de-risk the investment process, the more likely one is to secure funding. Jill and Mike did just by paying attention to all five key elements. While this is a pharmaceutical example, this also applies to biotech, medical device, and diagnostics.

 

We all know innovation is the key to success. However, innovation is a double edge sword since the technology has not been proven and therefore deemed "risky."  More in depth understanding of diseases and the systems they affect through basic research is critical to de-risk both the technology and regulatory elements. The systems biology approach to drug development can be very instrumental in de-risking these two elements. For more information on the systems biology approach, click here.   

 

For an interactive discussion on the benefits of using the systems biology approach for drug development, please join me and an outstanding panel of speakers who each have over 20 years in academics and industry at the BIO Convention Personalize Medicine breakout session on June 21st from 10:00 - 11:30 am in room 258-B.

 

Contact me should you have any questions or feedback in this area. 

 

New Technology - "Gladstone Scientists Make Beating Cardiac Cells Inside the Heart "

 

Researchers at the J. David Gladstone Institutes, affiliates of the University of California, San Fransico were successful in injecting three genes inside the damaged region of a mouse heart and within a month, non-beating cells that normally form scar tissue had converted into beating heart muscle cells.

 

"We're not necessarily using stem cells but we're taking advantage of controlling the fate of cells and reprogramming them into whatever we want," said Dr. Deepak Srivastava, director of the Gladstone Institute of Cardiovascular Disease.

 

May 2012_New Tech
Graphic: Gladstone Institutes / Giovanni Maki

The new technique uses three genes called Gata4, Mef2c and Tbx5, known to plays a role in forming and developing the heart was successful in lab mice, Srivastava said.

 

This research, pioneered by Gladstone and published in Nature could transform the treatment of heart attacks since heart muscle doesn't naturally regenerate. This method could also avoid the use of stem cells to regenerate heart muscle.

 

For the full story in The San Francisco Business Times, click here.   

 

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Seventeen Medical Device and Fourteen Pharma/Biotech Funding Deals

 

To determine whether funding is picking up, I will be focusing on all types of funding that are $1 million or greater in seed investments and series A or B (or the valley of death) that are pre-IPO. Even though VCs are investing, they continue to invest in their existing portfolio companies and less in start-ups. Incubators, state funding, and business competitions are great for initial seed money but not enough to keep the company going long-term.  These are worldwide funding deals. 

 

Partnerships and licensing deals with upfront payments and milestones will not be included.

 

Medical device funding includes IT companies because they are the current focus of investors for faster return on investments.  

 

May 2012_device
Funding deals are in chronological order by date
 

$0 = No financial terms disclosed. For more information, read more....

 

 

May 2012_pharma2
Funding deals are in chronological order by date.
 

$0 = No financial terms disclosed. For more information, read more...     

 

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Twenty-eight Acquisitions

 

Acquisitions continue to be made for both medical device (15) and pharma/biotech (13). This month there were five companies (Express Scripts, Hologic Inc., AstraZeneca, Nestle, and Amgen)  that have made billion dollar acquisitions.  Covidien continues to acquire companies with two purchases this month.     

 

 

May 2012_acquisitions
Acquisitions are in chronological order by date with Medical Device/Diagnostics followed by Pharma/Biotech.  Due to the large range in dollar value, acquisitions over $6 billion are in bold numbers.

   

$0 = No financial terms disclosed. For information on specific companies, read  more ....

 

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About BioMarketing Insight

We help companies de-risk their product development process by conducting the business due diligence to ensure that it is the right product for the right market and the market potential for the product meets the business goals of the company. We can then develop marketing strategies to drive adoption for the product.

 

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