We’ve Moved! Come Visit Us at the New URL!

This is the final post for Colorado Life Science Deal Flow (http://rnaventures.blogspot.com). We have packed up and moved to the new and improved Life Science Deal Flow site (http://LifeScienceDealFlow.com). If you have not yet clicked on over to the new site then you are missing out on the wine and cheese being served. While visiting the Life Science Deal Flow site be certain to renew your subscription – simply click on your preferred mode of delivery, i.e. email or RSS. For those of you selecting email delivery, be certain to look for the separate subscription activation email (it may have gone to the junk mail folder if it is not in your in box) and click on the link to activate.

We certainly hope you enjoy the broadened content offering at LifeScienceDealFlow.com. Please send any press releases, hot-tips, questions and comments to arubenstein@rnaventures.com.

My back is aching from all of the moving but I believe you will enjoy all of the moist and chewy early-stage life science company goodness being served up at Life Science Deal Flow – it’s not just a new coat of paint…

Colorado Life Science Deal Flow is signing off…in 3…2…1…

Memories,
Like the corners of my mind
Misty water-colored memories
Of the way we were
Scattered pictures,
Of the smiles we left behind
Smiles we gave to one another
For the way we were
Can it be that it was all so simple then?
Or has time re-written every line?
If we had the chance to do it all again
Tell me, would we? could we?
Memries, may be beautiful and yet
Whats too painful to remember
We simply choose to forget
So its the laughter
We will remember
Whenever we remember...
The way we were...
The way we were...

Under Construction | CLSDF to the All New LSDF!

Good morning. Please note blog coverage this week of 12 October will be spotty as a result of new changes being implemented, particularly:

1) The evolution of [Colorado] Life Science Deal Flow (version 1.0 currently located at the url http://rnaventures.blogspot.com) is progressing to the new Life Science Deal Flow blog (version 2.0 located at the url http://CLSDF.com). Note: the previous url redirect from CLSDF.com to rnaventures.blogspot.com has now been officially terminated.

2) A new “look and feel” is being deployed, to include logo modifications, a new cool color palete, and an improved and easy to navigate site layout, etc.

3) New advertising options will become available that combine with the Life Science Deal Flow sister site http://OnBioVC.com to provide unique and targeted combined advertising campaigns that leverage i. site-based (LSDF & OnBioVC) ii. subscription-based (email and RSS) and iii. print-based (Monthly OnBioVC Trend Analysis reports) exposure. (contact me arubenstein@rnaventures.com for more information), and finally…

4) If you are asking yourself “why this, why now?” Well...perhaps you have too much free time on your hand however, this catalyst for change, specifically the broadening of content covered from Colorado-specific entities to more national and international in scope is a result of both the maturation of the ecosystem and indication from folks of a high interest in an expansion of the content funnel.

Certainly we understand some faithful readers may be lost as a result of the new Life Science Deal Flow orientation (we have appreciated your steadfast patronage over the years). For those focused solely on Colorado life science content I encourage you to follow the coverage provided by our friends at Rocky Radar. To those of you who continue on this new evolutionary branch with us, first allow me to thank you for your loyalty, support and inspiration, and please be aware that a slight modification to your email and/or RSS feed will be requested (directions will be provided) when we return to the air. As always please forward tips, requests, questions and comments to me at arubenstein@rnaventures.com.

Please Stay Tuned! We Will Return to the Air Shortly!

Omeros | Lackluster IPO Debut a Good Sign?

Omeros (NASDAQ: OMER) launched itself onto the Nasdaq global marketplace yesterday with its initial public offering of 6.82M shrs priced at $10 raising approximately $68M less underwriting expenses. Its foray however, was more dud then thud relative to its peers in the Biopharma IPO Class of 2009. For Omeros is the only clinical-stage, pre-commercial, pre-revenue entity to get out and it would appear that the market is not going to reward entities at this stage of development as demonstrated by an immediate sell-off of some nearly 20% before clawing back a bit on this first day of trading to close at $8.73 per share.

This debut provides a very interesting piece of data, though with an N=1 it is hardly statistically significant, nevertheless let’s try and make this “empirical” statement – Pick your analogy, the biopharma public markets are thawing, the biopharma public markets window is opening etc., what is now been demonstrated is that the IPO route for pre-clinical biopharma is less liquidity opportunity for early investors and more financing event to capitalize operations.

Therefore a takeaway here may be to expect big pharma M&A to remain hyper-active for the foreseeable future. Though such a collection of trends may not be ideal for life science entities as options and leverage arms may be limited it is however, a sign that as the public markets claw and scratch their way back that newly positively trading companies are theoretically higher quality going concerns that are being demanded by the street; a clear message that irrational exuberance is no longer accepted…at least in the life science healthcare sector.

AGA Medical Holdings | Back in the Queue

AGA Medical (Plymouth, MN) developer of interventional devices for the minimally invasive treatment of structural heart defects and peripheral vascular disorders, first filed with the intention to reach the public market in 2008 (‘nuff said), now on the heels of what is shaping up to be, dare one say, an active 2H09 life science IPO market with three entities out [Mead Johnson Nutrition (NYSE: MJN), Cumberland Pharma (NASDAQ: CPIX) and Talecris (NASDAQ: TLCR)] and now three in the filed queue planning to get out prior to year’s end. As the first snowfall is expected today in Boulder, CO it is feeling uncharacteristically warm and fuzzy inside – can ‘it’ thaw concurrent with old man winter settling in?


The AGA deal again makes sense, that is generally speaking…a pattern is emerging where these entities who have surfaced on the public markets are commercial-stage, certainly not pre-clinical or early-clinical but Phase IIb or later. It sounds as if AGA had revenue circa 2008 in the $180M range with a positive net income to boot. The offering is expected to be priced in the $19 to $21 range on 13.75M shares therefore raising an anticipated $260M to $289M less underwriter expenses. The deal is expected to be managed by Bank of America (NYSE: BAC), Citigroup (NYSE: C), Deutsche Bank (NYSE: DB), Leernik Swann, Wells Fargo (NYSE: WFC) and Natixis Bleichroeder.

Founded in 1995 by Dr. Kurt Amplatz, a former University of Minnesota professor and researcher, AGA Medical’s range of Amplatzer® products help improve patient outcomes, reduce length of hospital stay and accelerate patient recovery times. Amplatzer® products advanced the treatment of the most common congenital “holes in the heart,” such as atrial septal defects, patent foramen ovale and ventricular septal defects. More than 1,500 articles supporting the benefits of Amplatzer® products have been published. AGA Medical markets Amplatzer® products in 101 countries worldwide.

Note: According to the [C]LSDF 2009 Biopharma IPO Watch List confidence in the new issues appears to be maintained as the bottom has not dropped out post issuance; an additional encouraging sign of the receptivity of the markets.

Allos | Get it When You Can...

Many a seasoned and sophisticated biopharma executive have described to me the reality of when an entity does not need to raise capital it should because at some point it will be needed, and by not needing it, the situation may, just may…lend itself to perhaps lowering the cost of capital due in part to the leverage of not exactly needing it at the time of the raise (Wow, that was a mouthful). Now that Allos Therapeutics (NASDAQ: ALTH) has hung out their ‘open for business’ sign with the recent approval of Folotyn™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma is additional capital required? Well building a commercial enterprise may take upwards of $10 to $20M, there are now scaled manufacturing needs and let us also consider the broad ongoing clinical pursuits for follow-on indications of Folotyn™. No doubt, all capital intensive pursuits.

A quick scan of the most recent balance sheet for Allos indicates cash and cash equivalents plus short term investments totaling approximately $105M, certainly that has evaporated throughout the second quarter at a burn rate of perhaps $14.1M (cash from operations plus cap ex), leaving a guesstimated cash position at around $80 - $90M today? Not exactly an uncomfortable place to be sitting. So what is one to do sitting in this seemingly well capitalized position? Correct! Go out and raise more money! And that is exactly what the plan is.

Allos has announced the price of a new public offering of 14,000,000 shrs of common stock set at $7.10 yielding a planned gross proceeds of $99.4M, expected to close on 13 October. Allos has also granted the underwriters a 30-day option to purchase up to an aggregate of 2,100,000 additional shares of common stock to cover over-allotments, if any. The deals’ underwriters include J.P. Morgan Securities, Citigroup Global Markets, Leerink Swann, JMP Securities, Needham & Company, and RBC Capital Markets.

Get it when you can…

Inviragen | Series A $15M and M&A

Inviragen (Ft. Collins, CO) a preclinical-stage vaccine company focused on emerging global infectious diseases, closed a $15M Series A financing and in the process merged the assets of Singapore-based SingVax. Participants in the round include Charter Life Sciences, Venture Investors, Bio*One Capital and Phillip Private Equity. This initial round of institutional capital comes on the heels of a $600,000 grant, announced in September, from the National Institute of Allergy and Infectious Disease to partially support continued development of a dengue vaccine.

The new funding is expected to push a number of vaccine candidates into the clinic and yield proof-of-concept and efficacy data. The lead vax is designed to protect against dengue fever, a mosquito-borne disease that threatens 3.6 billion people living in tropical and subtropical regions around the globe; 36 million cases of dengue fever are thought to occur per year WW, the most severe form of the disease, dengue hemorrhagic fever, leads to the deaths of approximately 20,000 people annually.

Rounding out the robust Inviragen pipeline include vaccines against Hand, Foot and Mouth disease, Japanese encephalitis, West Nile, chikungunya, avian- (H5N1) and swine-origin (H1N1) influenza and, a combination plague and smallpox vaccine for biodefense.

GlobeImmune | Presenting Phase II Data @ AASLD

GlobeImmune (Louisville, CO) a clinical-stage company focused on developing targeted immunogens for the treatment of cancer and infectious diseases, has had an abstract (“GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves End of Treatment Response at 48 Weeks Versus PEG-IFN/Ribavirin in Naïve Genotype 1 Chronic HCV Patients”) for their investigational hepatitis C virus product candidate accepted for presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (31 Oct. to 4 Nov. 2009 Boston, MA).

GlobeImmune will also present at AASLD end-of-treatment, 48-week data in interferon-naïve patients from a Phase II clinical study investigating the efficacy and safety of GI-5005 plus peg-interferon (peg- IFN) and ribavirin, the current standard of care, in patients with genotype 1 chronic HCV infection compared to patients receiving only SOC.

Chronic hepatitis C infection, a viral liver disease, is a major health epidemic worldwide. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, 4 million live in the United States with an additional 5 million in Western Europe. Approximately 20-30% of all hepatitis C patients will face life threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma and 30% of liver transplants in the United States. The incidence of new symptomatic infections of hepatitis C has been estimated to be 13 cases/100,000 persons annually. For every one person who is infected with the AIDS virus, there are more than four infected with hepatitis C. The Centers for Disease Control and Prevention estimate that there are up to 230,000 new hepatitis C infections in the U.S. every year. Currently, 8,000 to 10,000 deaths each year are attributed to hepatitis C.

The GI-5005 Tarmogen expresses a fusion protein encompassing sequences from both HCV NS3 and Core proteins. NS3 and Core are abundantly expressed in infected cells, are required for viral replication and contain targets that are recognized by both CD4+ "helper" and CD8+ "killer" T cells. Both the Core and NS3 proteins are highly conserved among HCV genotypes 1a and 1b, the HCV strains most prevalent in the U.S. In December 2007, GI-5005 initiated a multi-center, randomized, Phase 2 study in combination with standard of care (pegylated interferon plus ribavirin).

Biodesix | First Tranche of $10M Series B

Biodesix (Broomfiled, CO) a commercial-stage molecular diagnostics company focused on proteomic-based diagnostics, closed the first tranche of a $10M Series B financing. The company is enabling personalized health care via their mass spectrometry-based molecular profiling proprietary platform technology, ProTS®, to discover and validate diagnostic tests for the improvement of patient outcomes.

Biodesix' first product, VeriStrat®, a pretreatment serum proteomic test for patients with advanced non-small cell lung cancer is now commercially available for physicians to help guide their treatment of patients (view the demo [HERE]). The test identifies patients who are likely to have good or poor outcomes after treatment with EGFR-TKIs. Samples are processed in Biodesix' CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat® has been validated in clinical studies with over 1000 patients, and the Company is engaging in additional studies to further validate the test and to explore the clinical utility of VeriStrat® in other solid epithelial tumors and with other EGFR inhibitors.

October | Breast Cancer Awareness Month

In recognition of October as Breast Cancer Awareness Month [C]LSDF is highlighting a few of the early-stage entities who are on the front-line in the battle against breast cancer that have been recently funded and are offering interesting scientific approaches in an effort to yield novel potential treatments, diagnostics and cures.

If you are interested in providing your individual support please visit the Susan G. Komen Search for the Cure™ info and donation page [HERE].

• Aragon Pharmaceuticals based in San Diego, CA, is a discovery-stage small molecule company focused on therapeutics for the treatment of hormone-resistant cancers, with an initial focus on prostate and breast cancer.
• Quantum Immunologics based in Tampa, FL is a clinical-stage biopharmaceutical company focused on breast cancer.
• Alethia Biotherapeutics based in Montréal, Québec is a development-stage biotechnology company focused therapeutic monoclonal antibodies for the treatment and prevention of severe bone loss, ovarian cancer, and metastatic breast cancer.
• Micrima based in Bristol, England is an early-stage stage company focused on radio wave technology to improve detection of breast cancer.
• Cianna Medica based in Aliso Viejo, CA is a brachytherapy medical device company focused on women’s health and dedicated to the innovative treatment of early-stage breast.
• Sanarus Medical based in Pleasanton, CA provides minimally invasive products for the diagnosis and treatment of breast tumors.
• Sopherion Therapeutics based in Princeton, NJ is a late-stage oncology company with a potential first-line therapy in combination with cyclophosphamide for patients with metastatic breast cancer.
  

Talecris | And Then There Were Three!

Part of the [C]LSDF ongoing series Watching the Bio IPO Market.

Talecris Biotherapeutics (NASDAQ: TLCR) made a thunderous debut with its Initial Public Offering on the Nasdaq today, offering 50,000,000 shares at $19 and raising $950M in the process. The fun however, did not stop there as the third life science offering of the year powered through the remainder of day, ringing the closing bell at $21.15, or a market cap of ~$1.06B! Speaking of ringing the bell, look for Talecris CEO Larry Stern to ring the opening bell at the Nasdaq on Friday morning (2 October 2009).

According to the [C]LSDF IPO Watch List the three companies to get out this year have raised in aggregate ~$1.85B, what is of particular interest is how they have responded by the very least maintaining or bettering their opening valuation (see price chart below).


What I find to be of particular interest in the case of Talecris is the story behind the story – or more specifically, the early investors who were handsomely rewarded by the street today. Just to put this tale into context Talecris is a robust entity, 2008 financials indicate revenue of $1.4B and a net income of $66M and thus account for (IMHO) the makings of a completely legitimate offering from a (potential) going-concern perspective.


Back in 2005 private equity (then) behemoth Cerberus Capital Management and Ampersand Ventures acquired from Bayer (XETRA: BAY.DE) their Talecris (then NPS Biotherapeutics) franchise for $590M, as part of a reorg effort. In the interim Cerberus placed some massive bets on Chrylser, who filed for bankruptcy protection and GMAC, who found themselves in need of a government bailout to the tune of $5B. Needless to say Cerberus was taking their lumps and the limited partners were clamoring for a return of their capital therefore, a liquidity opportunity for Talecris was paramount; the first shot came via a planned IPO circa 2007 but as the public markets then turned to ice the filing was killed; strike one. The next effort came back in August of 2008 when a potential monster $3.1B deal for Talecris was placed on the table by Australian blood plasma company CSL, this deal however fell apart primarily due to antitrust concerns. So in 2009 third-times-a-charm and Talecris finally gets out, in a still challenging environment.

What does this IPO mean to Cerberus? Well, various sources have reported that the fund owned 74% of Talecris prior to the IPO and retained approximately 38% post IPO, based on day 1’s closing price that values their piece of the action in the ballpark of $400M but don’t feel too bad for Cerberus as it appears as though over $800M in dividends were distributed in 2005-06. So all in maybe a return of $1.2B, call it maybe 2.5-3X. It is being widely reported that Cerberus was all in for less than $100M and therefore returns of 20-25X are being touted – I can’t quite get my head wrapped around that math and the distributions from a percent ownership perspective. If you know better than [C]LSDF, and that is probably most folks, will you please provide some insight? Or if there are any super-motivated MBA students out there I’m certain this would make for a fascinating case study. One thing I do know for certain is that the life science IPO market will remain an interesting place to observe.

Tape-Delay from the RMLSIC | That’s a Wrap!

The Rocky Mountain Life Science Investor Conference yielded a sense of sophistication and intensity catalyzed by the aggregation of high-quality presenting companies and top-tier venture and corporate investors. I was hardly surprised that then rumor, hearsay and innuendo combined to yield quite a bit of buzz throughout the oak paneled hallways of the Ritz Carlton about “interest”, “follow-on meetings”, and yes even “term sheets” and “syndicated deals”. Perhaps the most important take-away for this author is the continued realization that location in the obvious clusters is not a prerequisite for funding, rather great science and IP, great management and great market opportunity are the combined elements that often create opportunity for an entity when it goes shopping for an institutional round of financing.

We have previously covered the presenting companies:

Part I – The Diagnostic companies [HERE]
Part II – The Biopharma companies [HERE]
Part III – The Medical Device companies [HERE]

Here then is a list of those participating venture and corporate investors:

Venture Capital Funds

• Bay City Capital
• Frazier Healthcare Ventures
• HIG Ventures
• High Country Venture
• Hunt Bio Ventures
• Keld
• Mesa Verde Venture Partners
• Morgenthaler Ventures
• Redscript Ventures
• Sequel Venture Partners
• Skyline Ventures
  
• Sun Mountain Capital
• Technology Partners
• Telegraph Hill Partners
• Thomas, McNerney & Partners
• vSpring Capital
• Yasuda Enterprise Development
  

Corporate Investors

• Amgen (NASDAQ: AMGN)
• Celgene (NASDAQ: CELG)
• Covidien (NYSE: COV)
• Genentech (NYSE: DNA)
• Johnson & Johnson (NYSE: JNJ)
• Eli Lilly (NYSE: LLY)
  
• NovaQuest [Quintiles]
  

And to those individuals, associations and entities who made it all possible, a collective thank you and see you at the 2010 Rocky Mountain Life Science Investor Conference!

Sponsors
AZBio, Bowne & Co. (NYSE: BNE), Capital Advisors Group, Colorado Bioscience Association, Forest City Science + Technology Group, Cooley Godward Kronsih, Doresy & Whitney, Ernst & Young, Fitzsimons Redevelopment Authority, High Country Venture, inVentiv Clinical, Johnson & Johnson, Johnson & Johnson Development Corp., Montana Biosience Alliance, Morgenthaler Ventures, NMBio, Oklahoma Bioscience Association, PhRMA, Rocky Mountain Venture Capital Association, Sequel Venture Partners, Silicon Valley Bank, TriNet, Ubiquity, Utah Office of Economic Development and vSpring Capital.

Looking for Some of This?

[Update | Add Domain Associates, Domain Partners, VIII $500M to the early-stage drug and device sectors; bringing recently closed funds up to $1,925M]

Recently Boston, MA-based Excel Venture Management announced the close of the new $125M Excel Medical Fund. The portfolio is a planned balance across healthcare IT and services, diagnostics, and medical devices, plus life science platforms that address adjacent markets which may include energy, chemicals, defense and agriculture. It is made unambiguously clear that single molecule drug companies need not apply – for such an approach is not of interest to their principals. Initial investments are in the $1M to $5M range and it appears at least five investments have been made to date, these include 1. Aileron Therapeutics (who is developing Stapled Peptides, an entirely new therapeutic modality that can target all human diseases) 2. BioTrove (who provides micro- and nano-scale technologies to the research and diagnostics markets) 3. Dormir (an integrated provider of sleep diagnostic services, therapy and equipment) 4. MedVentive (provider of healthcare IT business intelligence solutions) and 5. Synthetic Genomics (who is designing metabolic pathways for the production of biochemicals and next generation biofuels from a variety of feedstocks).

Additional life science funds that have closed within the last twelve months include Essex Woodlands Ventures $900M Fund VIII which invests across the spectrum of drug, device and service companies in North America, Europe and Asia, and Morgenthaler Ventures checked in with their $400M Fund IX, who in their press release indicated a continued focus on early-stage investing.

So sum it all up and approximately $1,425M in new early-stage life science capital is needing to be put to work and eventually returned at some hopeful market exceeding multiple to the fund's limited and managing partners. What are you doing to make your entity “investable”?

OnBioVC | July '09 Trend Analysis Available

Hot off the press! (and, better late than never…) The July 2009 OnBioVC | Trend Analysis study is now available for FREE via download [HERE]. Over $668M flowed into early-stage biopharma, diagnostic and device companies in the seventh month of 2009 and over $3,821M year-to-date! Find out who is investing in what and where.

Word on the street is that money is sitting on the sideline, not willing to be put to work in early-stage life science companies. A quick sort of the July data at OnBioVC.com shows that perhaps such a thesis is not on point; why in 31 days observed were 8 Series A financings raising $59.7M, or 1 in 5 deals were done as an entities first institutional round, throw in the B’s and we are talking 54% of July deals accounting for $326.4M.

A little trick for leveraging the data found at OnBioVC; say you are a pre-clinical oncology company looking to identify potential investors…simply go to the drop-down box on OnBioVC.com, select “X-Oncology”, observe the list of “Series A” financings then wa-la, you will find in each post all of the participating investors and hyperlinks to their sites. If you have any questions or problems on how to effectively mine the data at OnBioVC shoot me an email at arubenstein@rnaventures.com. Wishing you statistically significant data!

Allos THx | Significant Milestone Achieved!!!

Now, some 48-hours later, it may be considered old news that Allos Therapeutics (NASDAQ: ALTH) received from FDA accelerated approval for Folotyn™ (pralatrexate) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn™ is the first and only drug approved by FDA for PTCL and represents a new treatment option for patients with relapsed or refractory PTCL. Allos anticipates entering the market with Folotyn™ in the US in October. The sound of champagne corks popping can be heard echoing up and down the Front Range as the Colorado life science ecosystem celebrates this significant and important milestone and simultaneously breaths a collective sigh of relief.

Let’s then take a bit of a closer look at Allos, their approved product, market and pipeline, shall we? (As always…if there is any erroneous data or statements identified and requiring correction please leave a comment below or email arubenstein@rnaventures.com and we will update with or without (your choice) attribution).

Hematological malignancies account for approximately 15% of all cancers and are categorized into four groups, 1. Multiple Myeloma, 2. Myelodysplastic Syndromes, 3. Leukemia – which includes acute myeloid, acute lymphoblastic, chronic myeloid, and chronic lymphocytic leukemia, and 4. Lymphoma – which is divided into Hodgkin’s and non-Hodgkin lymphoma. NHL is further grouped into:

• Cutaneous T-cell lymphoma
• Follicular lymphoma
• Mantle cell lymphoma
• Diffuse large B-cell lymphoma, and
• Peripheral T-cell lymphoma
  

According to the American Cancer Society, non-Hodgkin lymphoma incidence has grown 3.8% from 2005 to 2009. The US PTCL market is growing at an estimated incidence rate of 5% due, in part, to increased PTCL awareness; the addressable market is approximately 80-90% of estimated first-line patients treated (according to Allos), or more specifically of ~6,800 patients forecasted in 2013, ~6,200 are treatable. It has been reported that single agent treatments prescribed off label for PTCL average approximately $76,000 per patient per therapeutic and therefore one may calc the total addressable market at ~$516M to $471M per year – NOTE: this is not a market forecast for Folotyn™.

Allos maintains exclusive worldwide commercial rights to Folotyn™ for all indications and their exists the potential for co-promotion or out-licensing to reach EX-US markets. The composition of matter patent protection is in place till 2017 in the US and EU with the potential for an additional 5-year extension under Hatch-Waxman. Additional potential hematological malignancy indications for Folotyn™ that are under clinical investigation include B-cell non-Hodgkin’s lymphoma, non-Hodgkin’s lymphoma and cutaneous T-cell lymphoma, and in solid tumor indications for bladder cancer and non-small cell lung cancer.

Folotyn™, a next generation chemotherapy, is a rationally designed, for improved cancer cell uptake and retention, anti-folate. The mechanism of action of Folotyn™ is a folate analog that inhibits folate metabolism by binding to and inhibiting the enzyme DHFR. Folotyn™ has high affinity for the RFC-1 protein and is an efficient substrate for polyglutamation by the enzyme FPGS. Polyglutamated Folotyn™ has a prolonged intracellular half-life, which allows for prolonged action in malignant cells. The relative increase in cellular uptake by RFC-1 and differences in polyglutamate formation may account for the enhanced activity of Folotyn™.


Some additional players in the hematological malignancy market include Biogen Idec (NASDAQ: BIIB) who markets with Roche (VTX: ROG.VX) Rituxan® for non-Hodgkin’s lymphoma; Novartis (NYSE: NVS) who markets Gleevec® for chronic myeloid leukemia, and; Wyeth (Pfizer) (NYSE: WYE) who markets Mylotarq® for acute myeloid leukemia.

It will be fascinating to observe Allos evolve from a development-stage company to a commercial-stage entity. Needless to say this is an incredible achievement – bringing a new treatment option to market for patients with relapsed or refractory PTCL.

FDA Allos pic courtesy of http://topnews.us

Tape-Delay from the RMLSIC | 3 of 4

Today’s third of four installments covering the Rocky Mountain Life Science Investor Conference focuses on the medical device presenting companies. In addition, here are some links to the additional coverage:

Part I – The Dx companies [HERE]
Part II – The Biopharma companies [HERE]
Part iV – Summary [In the Works]

BiOptix – Boulder, CO-based BO has developed a highly sensitive biosensor for real-time detection of trace amounts (~pg/mm^2) of bacteria, viruses, proteins, miRNA and other nucleic acids, and antibodies. The patented biosensor design relies upon common path interferometric detection in combination with non-resonant surface Plasmon excitation – the design of which was conceived by University Colorado 2005 Physics Nobel Prize Laureate and BO Chief Scientific Advisor John Hall.

Coherex – Salt Lake City, UT-based commercial-stage CH is focused on catheter-based technologies for the treatment of certain structural heart defects. The initial focus is on a minimally invasive device to treat a common defect called Patent Foramen Ovale (PFO). The FlatStent™ PFO Closure System includes an implantable, self-expanding Nitinol stent with a polymer substrate designed to stimulate tissue growth within the PFO. AN exclusive multi-year distribution agreement with Abott Laboratories (NYSE: ABT) was recently announced.

Kinetic Muscles – Tempe, AZ-based KM is a preclinical-stage medical tehnology company focusing on recovery for victims of stroke, traumatic brain injury and other neurological injury via the combination of robotic therapy technology and telemedicine to create a ‘virtual clinic’ that delivers therapy to the patients home. The company recently signed a supplier contract with Healthsouth (NYSE: HLS), the largest provider of rehabilitation services in the US.

Leap Frogg – Grand Junction, CO-based LF is a clinical-stage company developing the Frogg Dynamic Compression System, a venous augmentation system for the prevention of deep vein thrombosis prevention, pulmonary embolus prevention and edema therapy.

Medipacs – Tuscon, AZ-based MP is developing the Mini-Infuser™ a disposable infusion pump drug delivery system whose pumps utilize a polymer actuator that enables precise programmed delivery. The technology lowers manufacturing costs and enables the creation of small infusion devices that may be worn by patients.

Medivance – Louisville, CO-based MV is a commercial-stage company focused on the Actic Sun™ product, a therapeutic temperature management designed to improve patient outcomes through precise control of core body temperature after traumatic events such as cardiac arrest, traumatic brain injury and hemorrhagic stroke.

Micro-Imaging Solutions – Greenwood Village, CO-based MIS has developed a technology enabling miniaturization of CMOS disposable micro-digital cameras that are low cost, high resolution and enable extreme product design flexibility in a variety of medical device applications that do or may not have previously incorporated imaging.

Numira Biosciences – Salt Lake City, UT-based NB is a specialty Contract Research Organization focusing on Virtual Histology™, a new technology for soft tissue nas skeletal imaging combining proprietary contrast agents and software with microCT imaging; and, high performance visual analytics via the graphic processing unit for accelerated image processing and analysis techniques.

Regenesis Biomedical – Scottsdale, AZ-based RB is a commercial-stage company marketing the Provant Therapy System® which delivers Cell Proliferation Induction® therapy into post-operative skin tissues to reduce pain and edema in the inflammatory phase of wound healing via triggering mitosis and gene expression of various growth factors, extracellular matrix proteins and enzymes involved in tissue repair and regenerations.

ThermImage – Salt Lake City, UT-based TI is a preclinical-stage company developing Thermaflux Scan™ for the safe and noninvasive detection of pediatric Vesicoureteral Reflux, a common and under-diagnosed condition where urine flows back to the kidneys from the bladder, exposing them to infection.

Valve Xchange – Aurora, CO-based VX is a preclinical-stage company developing the Vitality™ Exchangeable Heart Valve for adult and pediatric/congenital heart valve disease – an permanently implanted docking station and exchangeable leaflet set, when needed, using minimally invasive techniques – offering a lifetimes tissue valve alternative to mainstream heart valve patients.

Vital Access – Salt Lake City, UT-based VA a developmental-stage company focused on Vital Access Venous Window™ a fully-interventional vessel anastomosis device enabling interventionalists to percutaneously create anastomoses (connecting two different vessels) without using sutures or the need for invasive surgery. The Venous Window™ may provide quicker, easier and more reliable cannulation access to hemodialysis patient’s fistula while also potentially improving fistula longevity and patient quality of life.

Snoasis Medical | Born to Smile!

Commercial-stage Snoasis Medical (Denver, CO) is focused on the development and commercialization of products which redefine the way clinicians perform perioplastic surgery. The core technology behind Snoasis Medical’s current product offering is placental tissue. These placental tissue products are believed to be the first of its kind for dental applications and possess features and benefits which may lead to improved satisfaction for the patient and the clinician. BioCover™, the initial Snoasis product to reach the market, represents possibly the first allograft composed of amnion tissue for use as a wound covering for the treatment of gingival recession.

This novel solution to gingival recession is a processed, dehydrated graft containing multiple layers of human amnion tissue. BioCover™ technology leverages the basement membrane architecture of oral mucosal tissue and the high concentration of the adhesion factor, laminin-5. The product does not require hydration prior to use – it rehydrates upon placement and naturally self-adheres to the exposed root surface and proximal bone, this unique attribute eliminates the need to suture the graft into place – and therefore BioCover™ may become the preferred procedure to the current standard-of-care where patient tissue is first harvested from the palate and then sutured in place.

Greg Gumbel, host of the business news program, The Economic Report takes his camera and staff on a journey exploring the large market of gingival recession, or receding gum lines, (>25% of US adults, Company data) and details how and why the BioCover™ solution brought to market by Snoasis Medical is positioned to potentially transform the use of amniotic tissue and the incorporation of regenerative medicine in the dentistry market. Watch the video below, or if reading this via email or RSS-reader click [HERE] to view. Finally read the coverage of Snoasis Medical in the July 2009 issue of Orthopedics This Week [HERE].

The Program You Are Watching is a Paid Advertisement for Snoasis Medical

Anthera | Working to Thaw the Markets

CLSDF continues to maintain keen watch on the thawing of the public equity markets, calibrated in a semi-quantitative approach via the life science IPO pricings. If all three of the current filings get out priced ‘as-is’ I would then call the score FINANCING EVENT 3 & LIQUIDITY OPPORTUNITY 2. A nice balance and it makes sense as the three clinical-stage pre-revenue companies (Cumberland, Omeros and Anthera) appear to intend to use the public offering as a capital source to finance the phase III to commercialization processes.

Anthera Pharmaceuticals is the newest name to be added to the CLSDF-IPO Watch List. Hayward, CA-based Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly (NYSE: LLY) and Shionogi & Co. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase family - a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases.

Tape-Delay from the RMLSIC | Part Deux

Continuing here with Part Deux of the Rocky Mountain Life Science Investor Conference presenting companies. Yesterday CLSDF posted the Diagnostic oriented entities, today we feature the biopharma folks.

ApopLogic – Aurora, CO-based AL is a biopharmaceutical company focused on the discovery, and development of therapeutic products that target apoptotic cell death pathways found in cancers, leukemias and lymphomas. The lead compound is Breceptin, a novel anti-cancer technology that antagonizes neuropeptide growth-factor receptors, targeting a broad range of cancers. The pipeline also includes Fasaret a proprietary therapy based on Fas ligand, an apoptotic cell death-inducing molecule with unique pro- inflammatory properties and Cytonil a proprietary combination of a cell-type specific growth factor and a cell signaling agonist to treat Sezary leukemia, cutaneous T cell lymphoma and psoriasis.

Allogenesis – Denver, CO-based AG is focused on pHPM, a ‘humanized’ purification of blood extracts for expansion of stem cells used for research & clinical applicications as well as wound healing in the dermal, orthopedic and additional soft tissue applications. The pHPM product is engineered to replace animal proteins in stem cell culture applications and augment existing in vitro culture media.

BioAmps – Aurora, CO-based BA is focused on focused on the discovery and development of proprietary antimicrobial peptide therapeutic solutions for the treatment of systemic infectious diseases, including methicillin-resistant Staphylococcus aureus (MRSA) and other resistant gram-negative and gram-positive bacteria. A rational design platform has produced a large portfolio of D-confirmation, alpha-helical antimocrobial peptides that are structurally manipulated to alter their hydrophobicity and amphipathicity properties. The charge substitutions and structure alterations on both the polar and non-polar faces of the peptides produce a unique “carpeted model” mechanism of action, broad spectrum of activity, and low level of toxicity to human cells.

GlobeImmune – Louisville, CO-based GI develops active immunotherapies called Tarmogens® for the treatment of cancer and infectious diseases. Tarmogens are recombinant yeast engineered to express disease antigens. Lead products include GI4000 and GI5005 both in Phase II for cancer and hepatitis C. The Tarmogen™ manufacturing process is simple and scalable with small molecule-like margins.

Inviragen – Ft. Collins, CO-based IV is focused on vaccines against emerging worldwide infectious diseases. Compounds queued up for clinical trials includes DENVax against dengue, HFMDVax against hand, foot and mouth disease and JEVax for Japanese encephalitis. In addition, are a number of ongoing vaccine research programs in chikungunya, HPV, influenza and plague vaccines.

LigoCyte Pharmaceuticals – Bozeman, MT-based LCP is a clinical-stage biologic drug development company focused on respiratory and gastrointestinal indications. The company’s virus-like particle (VLP) vaccine technologies support products that induce robust immune responses to prevent serious infections. The lead product is Norovirus VLP Vax in Phase I and the pipeline includes the biodefense vaccines against influenza and anthrax and the monoclonal antibodies Anti-CD103 partnered with Biogen Idec (NASDAQ: BIIB) and Anti-CD62 partnered with NIH.

miRagen – Boulder, CO-based MR is developing innovative microRNA (miRNA) based therapeutics for cardiovascular and muscle disease. The lead optimization pre-clinical pipeline candidates are focused on heart failure with indications of post-MI remodeling, chronic heart failure and refractory angina; broader cardiovascular disease including cardiac fibrosis, angioplasty/restenosis and arrhythmia; and, general fibrosis, muscular atrophy and amyotrophic lateral sclerosis.

Myocept – Lafayette, CO-based MC is a pre-clinical stage biopharmaceutical company focused on biotherapeutics designed to modulate signal transduction through subtypes of the cholinergic receptor family (AChR). The receptors targeted control contraction of skeletal and smooth muscle fibers, while other members of the AChR family are involved in angiogenesis, pain, additiction, down-regulation of inflammatory immune responses and progression of certain cancers.

Western States Biopharma – Aurora, CO-based WSB is a pre-clinical stage biopharmaceutical company developing novel therapies that selectively modulate adaptive immunity to treat inflammatory diseases while concurrently affecting the immune system’s natural ability to fight disease. Potential lead indications under consideration for WSBI19711A include rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis, and anklyosing spondylitis.

FDA 2.0…Really?

Now this is interesting! The Food and Drug Administration's Center for Drug Evaluation and Research, in collaboration with FDA's Center for Biologics Evaluation and Research, Center for Veterinary Medicine, and Center for Devices and Radiological Health, has announced a public hearing (scheduled for 12 & 13 November in Washington DC) to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools (can you say Twitter, Facebook, YouTube and the blogosphere, etc.?). FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share. From my understanding the last discourse FDA held on the matter was in October of 1996. For a blast from the (Web 1.0) past to a look at the transcript [HERE].

Tape-Delay from the RMLSIC | Part I

I had the best intentions of bringing up to the minute information flowing through CLSDF from the content rich Rocky Mountain Life Science Investor Conference however, during the first company presentation slot it quickly became apparent that due to the richness of the subject matter in order to keep up I had to turn off the laptop and turn on my brain. So with that said here is an overview recap of the presenting entities broken out by biopharma, device and diagnostic companies. So without further adieu here are the Dx entities who presented:

Applied Microarrays – In 2007 Tempe, AZ-based AM acquired the microarray assets of GE Healthcare (NYSE: GE); the core technology capabilities include design and production of DNA and protein microarrays, circulating tumor cell capture microarrays and, expertise in surface chemistries, capture probe design, precision piezoelectric printing, assay optimization and reagent formulation.

Axial Biotech – Salt Lake City, UT-based AB ScolioScore™ AIS prognostic test is the first molecular Dx DNA-based assay for spinal disorders. The prognostic is a clinically validated test with a 99% negative predictive value that determines the likelihood of severe spine curve progression for children diagnosed with Adolescent Idiopathic Scoliosis. The product is being marketed by DePuy Spine, a Johnson & Johnson (NYSE: JNJ) company.

Beacon Biotechnology – Aurora, CO-based BB BrightSPOT System™ point-of-care diagnostic microarray chip enables up to 100 simultaneous diagnostic assays to be performed simultaneously with a single blood or other fluid sample. The handheld reader instrument moves the laboratory to the bedside. Initial therapeutic foci is on infectious diseases and diabetes.

Biodesix – Broomfield, CO-based BD is a developer of Dx tests using their proprietary platform based upon mass spectrometry. The company is advancing the revolution in personalized medicine, providing physicians with clinical information that assists with the diagnosis of disease and selecting appropriate and effective therapeutic treatments. The first product, VeriStrat®, a simple blood test used by oncologists to assist in decision making while treating non-small cell lung cancer, was marketed in 2008.

Castle Biosciences – Friendswood, TX-based CB is a biomarker-based oncology multivariate molecular Dx company focusing on orphan cancers. Their first product, DecisionDx-GBM, was taken to market in 1Q09 and targets glioblastoma multiforme, the most common form of primary brain cancer. The DecisionDx-LEA product is currently in clinical development.

High Throughput Genomics – Tuscon, AZ-based HTG is a commercial stage diagnostic company offering the quantitative Nuclease Protection Assay (qNPA™) Gene Expression Platform, a multiplexed, lysis-only assay of mRNA and miRNA with no RNA extraction, no labeling and no amplification required.

LineaGen – Salt Lake City, UT-based LG is target validation stage specialty Dx company offering tests for Autism, Osteoporosis, COPD and Multiple Sclerosis that leverage its access to the biomarker discovery research platform provided by the Utah Genetic Research Project and the Utah Population Database.

nanoMR – Albuquerque, NM-based NMR is developing a Dx for the detection and identification of bacteria and fungi in blood, the primary cause of sepsis. The assay, promising results in as little as one hour uses immune-labeling to attach magnetic beads to the blood borne pathogens that are then detected via nuclear magnetic resonance imaging.