Colorado Life Science Deal Flow

Alphasniffer is now BiOptix

arubenstein@rnaventures.com — Wed, 14 May 2008 09:51:00 -0500

It is not the first, will not be the last, name change that is. Alphasniffer (Boulder) has announced a new corporate identity, introducing…BiOptix. This modification in moniker echoes how the Colorado life science ecosystem is certainly maturing from a research and discovery engine to the logical progression of more of a commercialization focus, this second corporate name change announced in 2008 validates our regions evolution.

Corporate re-branding is not unique to the life sciences. I’ve listed a few name changes that you may or may not have been aware of. See how many of the list below you would have guessed correctly, the names on the left were the predecessors:

WAS Anderson Consulting IS Acenture
WAS Philip Morris IS Altria
WAS KPMG IS Bearing Point
WAS Backrub IS Google
WAS Computing Tabulating & Recording IS IBM
WAS Kentucky Fried Chicken IS KFC
WAS Jerry’s Guide to the WWW IS Yahoo
WAS United Telephone IS Sprint
WAS Tokyo Telecom IS Sony
WAS Brad’s Drink IS Pepsi
WAS Matsushita Electric IS Panasonic

BiOptix, established in 2003, is developing a proprietary technology for real-time, sensitive, label-free detection of medically and commercially important molecules such as DNA, proteins, toxins, contaminants and other compounds. Applications using this broad technology platform include real-time detection instruments for markets such as medical research, personalized medicine and diagnostics, pharmaceutical process control, defense and homeland security, and numerous other industrial demands. The core technology, known as SPR-CPI, was invented at BiOptix by Dr. John Hall, 2005 Physics Nobel Prize Laureate. Congratulations to Misha Plam, Slava Petropavlovskikh, Oyvind Nilsen and the entire team at BiOptix for achieving this maturation milestone!

A if for Agilent, B is for Boulder, C is for Nucleic Acid

arubenstein@rnaventures.com — Tue, 13 May 2008 09:43:37 -0500

Did you know that Agilent Technologies (NYSE: A) provides bio-analytical and electronic solutions to a variety of industries; the company's bio-analytical measurement business segment provides application-focused solutions that include instruments, software, consumables, and services that enable their customers to identify, quantify, and analyze physical and biological properties. Its product categories include gas chromatography, liquid chromatography, mass spectrometry, microfluidics, microarrays, atomic force microscopy, PCR instrumentation, software and informatics, and related bioreagents, as well as consumables and services.

A portion of that bioreagent business sits squarely in the middle of Boulder, as a result of the 2006 acquisition of SynPro, where the focus is on large-scale nucleic acid synthesis and purification for pharmaceutical ingredient manufacturing. Now the $5B a year Agilent plans to grow the Boulder nucleic acids unit as a result of another recent acquisition of the Dowpharma Nucleic Acid business unit. It is expected that up to thirty new hires will be made at the Boulder campus. Bring it!

Biologist with MBA Working to Bring Drugs to Market [del.icio.us]

arubenstein — Sun, 11 May 2008 18:08:28 -0500

Replidyne Provides 2008 Guidance

arubenstein@rnaventures.com — Fri, 09 May 2008 09:34:08 -0500

Yesterday Replidyne (NASDAQ: RDYN) held their annual shareholder meeting and 1Q08 conference call. With an anticipated burn rate of approximately $10M per quarter Replidyne’s current cash position just north of $78M positions operations to continue well into 2009. Considering the new strategic initiatives including restructuring, cash conservation and the difficult decision to terminate enrollment of the Phase III faropenem study management laid out the company plans to move forward with the C. difficile program with the goal of initiating a Phase I trial with REP 3123 as well as identifying an IND candidate from the DNA replication inhibition program. A spectrum of business development activity appears to be transpiring, though no details have been made public, some of which include: i) partnering talks are ongoing ii) looking at M&A opportunities, whereby the large cash position may make Replidyne more attractive to enable opportunistic actions and iii) a large international investment bank has been appointed to bring forth potential US and ROW opportunities, after all...the current market is frothy with deals. Needless to say with Replidyne’s seasoned and sophisticated management team it will not be surprising to see the share price and faropenem development pulled sharply out of their nose dives.

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BioBootCamp Day 1: Getting In Shape

arubenstein@rnaventures.com — Fri, 09 May 2008 09:28:45 -0500

It was buzz cuts and pushups, nuts and bolts, project management and IP protection, reimbursement and regulatory, & compliance and management teams all crammed into Day 1 of BioBootCamp, whoa, I am exhausted and we are only half-way through. Yes sir! Not only has the content been fantastic and the presenters polished, motivated and interactive but something interesting has happened this year on the recruit side…attendance has more than doubled from years past, and now the once vast double conference room, provided by the very gracious hosts at Holland and Hart, appears to be bursting at the seams, even with the no-shows (more laps for you when you arrive today). It was a wonderful feeling to look around the room and not recognize so many people. My take home after Day 1 is that there is even a higher interest/activity in entrepreneurial endeavors than anticipated. The room was bursting with MD’s, Ph.D.’s, MD/Ph.D.’s not to mention the MBA’s, industry folks, soon-to-be, first-time and serial-entrepreneurs…just an absolutely wonderful cross-section in attendance. Looking forward to Day 2…I had better start stretching.

Where Does Pharmion Go From Here?

arubenstein@rnaventures.com — Thu, 08 May 2008 22:20:13 -0500

In a recent interview with the Star-Ledger, New Jersey-based Celgene (NASDAQ: CELG) Chief Executive Officer Sol J. Barer, Ph.D. provided some insight as to the integration plans for Pharmion products and intellectual capital. Following is a portion of that Q&A.

Q: Celgene already was expanding its presence abroad. What does adding Pharmion do for you internationally?

A: We have a sales force all over Europe right now. We have a very good infrastructure that's very leveragable. We're selling Revlimid, and doing very well right now. With the Pharmion integration, we're adding thalidomide, which is approved in first-line multiple myeloma (in Europe). Revlimid is approved in relapsed or previously treated multiple myeloma. We also have a marketing approval for Vidaza, the first therapy that will show a survivability advantage in patients. Rather than partner, what we do is retain the value for our shareholders by building our own infrastructure - clinical, regulatory - around the world. We'll use distributorships in certain countries or certain regions.

Q: What happens to Pharmion's operations? Will you keep any presence in Colorado?

A: We're going through the integration planning process. We're looking at as many positions and many levels and all the products. We're very impressed with with a lot of people there, at all levels. As you combine two commercial, public entities, you don't need two CFOs, you don't need two CEOs -- thank god. There's clearly going to be overall consolidation. What we're going to try to do is retain as many of the people that are motivated and excited to stay with Celgene.

Q: A year ago, you said you might be looking for bigger quarters around Summit because the company was growing and you disliked satellite offices. What are your plans now?

A: We'll have multiple sites. (Pharmion) has a major clinical site in Kansas City, which we'll keep. We'll probably be adding a building or buildings here on-site. We've gotta live with the fact that there'll be multiple locations with the major company we're becoming. I'm pleased to say the sun never sets on Celgene, to borrow a phrase. It's difficult. We're used to addressing the company all at once, and now that can't happen. If it's 7 o'clock in the morning here, it's 9 at night in Japan but 4 in the morning in California. So when we try to have meetings, we try to move them around.

Q: Even before Pharmion, Celgene seemed to be stepping up its licensing and partnership deals. Will that continue?

A: A lot of these are driven by specific opportunities that often are difficult to predict. There will be a period of time subsequent to the Pharmion acquisition where a lot of integration will go on. While that will not affect the smaller deals, it probably will affect the larger collaborations, which would be a lower priority while we're integrating the new company.

Q: How has your job changed in the past year?

A: One of the big challenges is really, as we grow, to maintain the entrepreneurial spirit, the almost family atmosphere that's characterized Celgene through the years. I think that's been important to our success. I view that as one of my greater challenges.

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GW Carver Award to Gevo CEO

arubenstein@rnaventures.com — Wed, 07 May 2008 21:32:48 -0500

Perhaps not on many peoples radars…yet…Gevo (Denver) a next generation bio fuels company recently moved to town from Pasadena and Cal Tech, from where their intellectual property originates. Backed by Khosla Ventures and Sir Richard Branon’s Virgin Green Fund Gevo incorporates three novel technological elements enabling the scalable production of biofuels.

Recently during the World Congress on Industrial Biotechnology and Bioprocessing, BIO presented the first annual George Washington Carver Award to Gevo CEO Pat Gruber, Ph.D., MBA in recognition of his accomplishments in creating and commercializing a new plastic made from annually renewable resources.

Prior to joining Gevo, Dr. Gruber was the President and CEO of Outlast Technologies and held several management positions at Cargill. He has also served as President and CEO of Lactech, a technology development company, and was one of the founders of NatureWorks where he was the VP of Technology and Operations and Chief Technology Officer from 1997 until 2005. Dr. Gruber has served as a member of the Federal Advisory Committee for Biomass R&D and the Advisory Committee for the Energy Future Coalition and currently serves on the board of directors of Outlast Technologies, Gevo, Segetis, and Green Harvest Technologies.

Congratulations to Dr. Gruber and the entire team at Gevo and WELCOME TO COLORADO! We are thrilled you have made your new home here!

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BIO2008 + Twitter = Follow Me @arubenstein

arubenstein@rnaventures.com — Wed, 07 May 2008 20:58:08 -0500

Though still over a month away I am gearing up for BI0 2008 and yes blogging is part of the plan however, I will be posting ‘tweets’ via Twitter documenting my live experiences throughout the entire conference, as opposed to regular blog posts that I will get to at the end of the days. Twitter is a micro-blog; it allows for very short posts yet is extremely quick & easy to use. If interested, take a look at this video (if reading this post in email or RSS feed you will have to cruise on over to http://CLSDF.com to view it) for a quick explanation of Twitter. If so moved go and set up an account at http://twitter.com be sure to follow me @arubenstein and send a tweet if you wish for me to follow you back. As BIO approaches I will talk more about how to make accessing Twitter even simpler and easier than the web browser offering. Stay tuned...

Twitter in Plain English from leelefever on Vimeo.

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Array BioPharma: Secures $80M Debt Facility

arubenstein@rnaventures.com — Tue, 06 May 2008 09:40:53 -0500

With over $116M in cash on the books as-of 31 March that did not keep management at Array BioPharma (NASDAQ: ARRY) from securing an additional $80M debt facility from Deerfield Management. Deerfield currently holds in excess of 4.7M shares of Array or nearly 10% of the company. This new debt round will be drawn down in two $40M tranches in June and December of 2008.

Needless to say how costly it is to commercialize a drug, depending on the source a common number used today is $800M and about ten years to reach the market. Now think about that cost for a single agent, small molecule, biologic etc. relative to the incredibly robust pipeline at Array where there are currently six compounds in the clinic for oncology and inflammation, and add to that the work ongoing in the discovery program…$116M simply may not provide enough dry-powder to get a single candidate to the finish line, but at this point financing events are rather often about achieving value-inflection based milestones, like demonstrating proof-of-concept, an IND filing or moving a compound into or advancing in the clinic, and not getting to market.

So how does management raise the requisite financings to achieve such milestones while protecting existing shareholders from dilutive effects? The answer is...debt, and CEO Robert Conway & Company are doing outstanding work not only stewarding the clinical and pre-clinical stage assets at Array but concurrently deploying a carefully architected fiduciary approach to the financing needs.

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Attention Thirsty Denver BioBeers Attendees!

arubenstein@rnaventures.com — Mon, 05 May 2008 16:11:10 -0500

You may (or may not) know that the May edition of BioBeers will be held in Boulder. At the moment BioBeers, Inc. is in the process of securing BioBus transportation from Denver to Boulder and back. Please take a few minutes to indicate on the side-bar survey (left column on BioBeers.com if you are reading this in email or RSS reader) if you would i) be interested in the BioBeersBoulderBioBus and ii) if you would be willing to cough-up a few bucks for the round trip.

Kindly respond with your interest/preferences by Friday 9 May. Thank you.

More details (date/time/place) of May Boulder BioBeers to follow…

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It’s Starting to Look a lot Like BIO…

arubenstein@rnaventures.com — Mon, 05 May 2008 09:40:33 -0500

The pre-event planning material for the BIO 2008 conference is pouring in fast and furious. (Do you plan to attend? Would you like to meet? Please contact me to arrange arubenstein@rnaventures.com). So whilst perusing the Product Focus Zone publication I was incredibly excited to see BaroFold (Boulder) highlighted in the Protein Therapeutics chapter. Jeff Cleland, Ph.D., VP of Therapeutic Development will be presenting BaroFold at this year’s BIO and was heavily quoted throughout the chapter highlighting the protein therapeutics market and in particular the proprietary PreEMT protein refolding technology that incorporates the use of high hydrostatic pressure to force water between protein molecules causing the dissociation of aggregates and thereby forcing the protein into its most compact form. Traditional aggregate removal techniques as part of the manufacturing process include chaotropic agents like guanidine hydrocholoride or urea to solubilize hydrophobic proteins which must then be removed. The PreEMT technology reduces the complexity of the manufacturing process and improves the quality of the protein therapeutic by increasing yield, homogeneity, stability and reducing production cost.

In other recent BaroFold news Mr. Jon Saxe, JD, LLM has joined the Board of Directors. Most recently Mr. Saxe was President of PDL Biopharma (NASDAQ: PDLI), then Protein Design Labs.

Finally, BaroFeron, a proprietary recombinant human interferon beta being developed for the treatment of Multiple Sclerosis, is expected to enter Phase I trials in 2H08. BaroFeron may be differentiated from other interferon-beta products by improved safety and greater bioavailability enabled by BaroFold's proprietary PreEMTTM technology.

It is exciting to see Colorado already shinning on the global BIO stage. Plenty more to come on BIO…

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Off to Phase IV for Letairis® and the Market for Volibris®

arubenstein@rnaventures.com — Fri, 02 May 2008 10:06:25 -0500

Among the core assets that Gilead (Nasdaq: GILD) acquired from Myogen in 2006 for $2.5B was Letairis® (ambrisentan), for the treatment of pulmonary arterial hypertension (PAH), which was then approved by the FDA in mid 2007. After about a quarter in the market Gilead has initiated a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis® in patients with PAH who have failed to demonstrate an optimal response to sildenafil monotherapy (Viagra® is not just for ED ya know…). The primary endpoint of this study, known as Athena-1, is the change from baseline in pulmonary vascular resistance (the resistance to blood flow caused by constricted lung blood vessels) following 24 weeks of treatment. The long-term safety and efficacy measures will be examined for up to one year. There are additional planned follow-on Phase IV studies through 2009.

Folks around town may recall that GlaxoSmithKline (NYSE: GSK) owns the rights to commercialize ambrisentan for PAH in territories outside of the US. Recently GSK announced that the European Commission issued a marketing authorization for ambrisentan, under the trade name Volibris®, for the treatment of PAH in patients to improve exercise capacity, and the European product launch is now scheduled for 3Q08. Very exciting global news that can trace its roots back to Colorado! Naturally we will be closely tracking performance of Letairis® and Volibris® in the coming months and years

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BioBootCamp 2008: Drop and Give Me 50!

arubenstein@rnaventures.com — Thu, 01 May 2008 09:28:33 -0500

It is one week to go till BioBootCamp 2008 begins…are you ready to get your life-science start-up or start-up ideas in shape? Have you applied to attend? BioBootCamp is more than a 2-day business seminar, it is designed to help you jump start your new life science idea or company, this experience will provide you with not only a comprehensive overview of how to get your venture started, but will provide you exposure to experienced bioentrepreneurs and a nationally acclaimed faculty. By attending the BioBootCamp, you will learn how to avoid the legal pitfalls of starting and building a life science business, and will receive the assistance you may need to plan a solid foundation for your new business venture.

If you are interested in joining the growing numbers of Colorado life scientists eager to commercialize their ideas, click (here) for details on how to apply for this unique event (or copy/paste this link http://www.biobootcamp.com/apply.htm). This is a complimentary conference and there is no fee to apply or attend.

When: Thursday 8 May 7:30am – 5:00pm and Friday 9 May 7:30am – 2:00pm
Where: Holland & Hart 555 17th St. Suite 3200 Denver

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Insmed: Meeting Milestones!

arubenstein@rnaventures.com — Wed, 30 Apr 2008 09:06:02 -0500

Insmed (Nasdaq: INSM) provided a status update on their development program.

After recently receiving approval form the UK Medicines and Healthcare Regulatory Agency to initiate a clinical trial for INS-19 [a follow-on biologic of Amgen’s (Nasdaq: AMGN) Neupogen®] patient screening has begun and the first dosing is expected next month with similarity data to be reported in June.

INS-20 [a follow-on biologic of Amgen’s (Nasdaq: AMGN) Neulasta®], Insmed’s second follow-on biologic candidate completed pre- clinical pharmacological and pharmacokinetic studies, and plans to initiate clinical studies 4Q08.

A Phase II study of IPLEX™, a complex of recombinant human insulin-like growth factor-I and its binding protein IGFBP-3, in Myotonic Muscular Dystrophy has been initiated and received IRB approval and is actively recruiting patients with enrollment north of 50% remains on target to complete enrollment in 1H08 with interim data analysis expected

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Bard Center Needs Your Help!

arubenstein@rnaventures.com — Wed, 30 Apr 2008 09:03:34 -0500

Two MBA students at the University of Colorado, Bard Center for Entrepreneurship are examining how their institution may better support the Colorado life science ecosystem via the delivery of specifically tailored graduate degrees, certificates and continuing education offerings that may ultimately empower, improve and expand the local workforce.

Kindly set aside five minutes of your time to complete their survey (HERE) or copy and paste this link in your browser: http://www.surveymonkey.com/s.aspx?sm=095p4OMPQQCjTWJJ_2ba3oTg_3d_3d.

The survey is confidential though you may add your email address at the end to request the final results. Your opinions are important! Thank you for time.

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Help Wanted: CU Technology Transfer Office

arubenstein@rnaventures.com — Tue, 29 Apr 2008 09:20:55 -0500

The Technology Transfer Office at the University of Colorado is seeking an entry-level Life Sciences Licensing Associate for its office at the Anschutz Medical Campus. The License Associate identifies, solicits, and evaluates invention disclosures for patent and market potential, and marketing technologies to commercial partners and tracks and develops a portfolio of associated intellectual property. The License Associate will also ensure all assigned new invention disclosures are properly evaluated for ownership, patentability, and commercial viability; reasonably exercising professional, independent judgment in the selection and use of techniques, methods, and timing of decisions to complete all assigned responsibilities.

For a full job description, including minimum and preferred qualifications, please visit the Jobs at CU site (here).

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Evolutionary Genomics: Series A Undisclosed

arubenstein@rnaventures.com — Wed, 07 May 2008 20:53:59 -0500

Evolutionary Genomics (Lafayette) an agricultural technology company who addresses the critical need to increase the availability of biofuel feedstocks has closed an undisclosed Series A financing with Denver-based Altira Group; not to be confused with the Altria Group or its much better known previous name Philip Morris (NYSE: MO).

EG’s Adapted Traits Platform is used to screen gene adaptations in biofuel feedstocks such as corn, switchgrass, sugar cane, algae and soybeans to improve yield-related traits, such as grains per plant, grain weight, yield per acre, biomass, drought resistance and disease resistance.

Altria Group focuses their fund thesis on the traditional and renewable energy sectors. The commitment to EG came from their $176M Fund V. Investments from this fund have typically been made in the $5-$10M range with follow-on investments as warranted.

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SBIR/STTR Bill Passes in House

arubenstein@rnaventures.com — Sun, 27 Apr 2008 21:59:31 -0500

Lest you think the Colorado Bioscience Association merely flexes its muscle in Colorado…think again. Denise Brown and Company weighed in with significant support on Capital Hill re: HR5819 or the SBIR/STTR Reauthorization Act, which passed in the U.S. House of Representatives by a vote of 369 to 43.

All Colorado Representatives (Diana DeGette, Mark Udall, John Salazar, Marilyn Musgrave, Doug Lamborn and Ed Perlmutter) sans Tom Tancredo voted for the bill. Next stop is the US Senate.

HR5819 modifies the eligibility rules affecting venture capital backed (biotech) companies. The bill will increase access to critical, early-stage sources of funding for small businesses, including small biotechnology firms, thereby facilitating economic growth, job creation, and most importantly new breakthrough therapies for patients in need. Venture Capital and SBIR dollars may now work in a complementary manner to bring new therapies and innovations to the marketplace, ultimately to benefit patients and consumers. Potential great news for Colorado and the entire industry! We'll certainly pay close attention to the bill's progress.

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HB1001: A Bill Becomes Law! Hooray!!!

arubenstein@rnaventures.com — Thu, 24 Apr 2008 15:57:52 -0500

It has been quite a journey for House Bill 08-1001 and today was graduation day; the Bill became law with the stroke of Governor Ritter’s pen!!! HB08-1001 a $26.5M package, sponsored by Rep. Jim Riesberg, (D-Greeley), and Sen. Bob Bacon, (D-Fort Collins), provides grants for five years to Colorado start-up companies and research institutions seeking to commercialize new biotech drugs, biofuels, medical devices and nanotechnologies. The grants are capped at $150,000 for research institutions and $250,000 for companies.

Tom Cech, Ph.D. who is stepping down from his post as President of the Howard Hughes Medical Institute to return to Colorado was on hand for the signing ceremony and provided some very encouraging words about the future of Colorado life science. There are no misperceptions here, Colorado is not yet on par with San Fran, Boston and San Diego…yet however, the passing of HB08-1001 will certainly aid in accelerating the development of the State’s life science intellectual property and place it squarely on the commercialization trajectory.

Many many thanks should also be extended to the amazing work done by Denise Brown and the entire team at the Colorado BioScience Association. Be sure to let them know how much their behind-the-scenes efforts are appreciated, perhaps at the next CBSA BioBreakfast to be held 30 April 7:30am at the Denver Museum of Nature and Science.

Looking forward next to reporting on how and who these critical dollars will be deployed to. Stay tuned…more info to come.

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Replidyne Terminates Trial Enrollment to Preserve Cash

arubenstein@rnaventures.com — Wed, 23 Apr 2008 09:57:16 -0500

It is never a good feeling to wake up and hear that a pivotal late-stage clinical trial has terminated enrollment. However, there is a silver lining in such a difficult decision cloud…that is the sophisticated management at Replidyne (NASDAQ: RDYN) are savvy enough to examine the risk-reward profile for the continued burn of their remaining $78M cash position.

The Acute Exacerbation of Chronic Bronchitis study that has been halted is one in a package of four clinical trials, including two in community-acquired pneumonia and one in acute bacterial sinusitis, recommended as a way forward by the FDA for a new drug application submission for faropenem to treat these three adult community respiratory tract infections. Replidyne has not initiated the other three trials, and consistent with prior guidance, further faropenem development will depend on the securing a partner for the program.

Replidyne is required to conserve its cash position in order to maintain their array of research programs and to pursue strategic transactions. With cash in hand their remains an opportunity to advance the variety of additional pipeline assets such as the Clostridium difficile, DNA replication inhibition and pediatric faropenem programs. It is likely that there are meaningful value inflection points that may be achieved with these programs versus the obvious value previously demonstrated via the data from the previous nine Phase III and 3,000 patients enrolled in prior faropenem trials.

In fact, in my humble opinion, there appears to be so much value in Replidyne today that I am prepared to deviate a bit from my standard CLSDF protocol and make a prediction here…The oral community antibiotic market is very large and lucrative, with an average of 250 million prescriptions and sales of $7.5 billion per year over the last eight years. So rather than a seeking a partner deal, similar to what was disrupted with Forest Labs (NYSE: FRX), I predict a 2008 M&A transaction, and because of the program platform and the continued focus there that a big pharma deal north of $1B is in the works. Potential suitors may be GlaxoSmithKline (NYSE: GSK) via augmentin®, Pfizer (NYSE: PFE) via zithromax®, Ortho-McNeil via levaquin® or Abbott (NYSE: ABT) via omnicef®, just to name a few potential suitors. We shall see what happens…

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