09
Dec
2012
Wow … its been a long time since we last met. I hope you are well and thank u for sticking around LSDF.
Well, I am excited to inform you of a new application that I have been helping to develop, Collective IP. We are now seeking beta-testers for this novel innovation identification platform, please read on to understand our value proposition and to determine if you may qualify to participate.
Collective IP has built the world’s most comprehensive and accurate aggregation of innovators and technologies. No other opportunity identification, due diligence and competitive intelligence tool is more effective and efficient than Collective IP.
Our first module has organized the global Technology Transfer and Commercialization Office (TTO) ecosystem into an easy-to-navigate dashboard enabling the most comprehensive and accurate search of international TTO’s.
If your work includes interfacing with the TTO ecosystem and you are interested in having FREE beta access to the Collective IP vertical search platform simply in exchange for providing product feedback then click HERE and indicate how you interact with TTO’s in your workday and why you are interested in beta-testing our platform.
Click HERE to request access to Collective IP.
I look forward to hearing from you!
Happy Holidays.
Adam Rubenstein
CEO & Co-Founder
Collective IP
adam@collectiveip.com
About Collective IP is a premiere global information company focused on innovation identification. The Collective IP platform provides a revolutionary knowledge access point that aggregates technologies and their innovators across universities, research institutes, hospitals, government laboratories, foundations as well as public and private companies. The novel suite of Collective IP products compresses time and saves money for those engaged in opportunity identification, due diligence and competitive intelligence. For more information please visit http://collectiveip.com.
10
Oct
2011
OnBioVC continues to illuminate a deeply concerning financing trend observed over the last several years of aggregated data; one may term the resultant effect of this discernable development as an erosion in U.S.-based biomedical innovation. The metric invoked to quantify such bold nomenclature is simply the decline in first-time, Series A, institutional financings. With fewer and fewer early deals getting done (observed, 2H07-present) such a trend may yield, based upon industry standard probabilities, a marked reduction in the volume of potential products who can eventually make it to the steps of the FDA to submit their NDA (or equivalent regulatory approval process) for review. The input side of the biomedical innovation funnel is constricting – considering the diverse basket of risk factors faced by potential new biomedical products (be they therapeutics, devices, diagnostics and even IT-based healthcare products) – and given a reduction in risk capital (on a relative basis) allocated to first-time institutional financings is potentially quite alarming.
But don’t take OnBioVC’s word for it. While recently attending the Rocky Mountain Life Science Investor Conference (where over thirty managing directors representing corporate and venture funds were in attendance) one unnamed prolific investor bluntly stated, “We are not financing innovation, we are [instead] transaction oriented.” This sentiment is similarly echoed up and down the national conference hallways, from BIO to J.P. Morgan.
Granted there is a sort of perfect storm brewing occurring; with the near eradication of the public markets as a potential path to liquidity for equity investors, the IPO window is stuck closed and now with years of paint accumulated on the jam it is as difficult as ever to somehow unstick and wiggle open. It is always a confluence of variables that culminate in a perfect storm. Add to this list of variables the funds who have exhausted their resources who too are unable to reload their capital. When returns to limited partners are disappointing it comes as no surprise when the next vintage fund cannot be raised, closed and deployed, but when folks such as Prospect Venture Partners, who have been one of the largest (funds) and most successful bioscience investors (IRR), suddenly throws in the towel and gives up on fundraising and walks away from the near-term potential for any new investing in the sector, well that should certainly sound the concern alarm. Yes, Prospect is only an n of one, but with $150M already committed in their fundraising bag we may never really know the true cause for PVP to bail out on their fund close and thus give up on any new investing in the life sciences. Given some recent fund formation data one may present too that the rate of evaporation of funds is greater then the rate of new fund formations.
There are always three ways to look at the glass, friend, mentor-from-afar and Partner at Atlas Venture,Bruce Booth, D. Phil., digs into the data on his blog Life Sci VC (if you have not subscribed to his feed yet you certainly should!) in the recent post Early Stage Biotech Financing: Fewer, Leaner and Better? where he presents the glass half-full perspective.
More honey for the bioscience bears comes in an industry survey conducted by the Medical Innovation & Competitiveness Coalition who recently reported, in not so subtle language, in a joint press release with the National Venture Capital Association that U.S. Medical Innovation is at Risk: Fewer New Companies and Therapies Are Receiving Funding. Here is the link to the data from their survey of more than 150 VCs who identify a potpourri of factors, that have, and in their opinions shall continue to drive investment away from the early-stage entity (shoot me an email arubenstein@everettabbott.com if you have trouble accessing the slides).
The current investor climate then begs the question of who will finance innovation if private capital sources are waning? The funding mechanism du jour is a triage approach, where a one or more combination of governmental granting agencies, philanthropic donors, visionary angels and entities such as the Colorado Institute for Drug, Device and Diagnostic Development (CID4) are bearing more of the burden of catalyzing innovation and de-risking early-stage technologies. I am proud to be part of the CID4 team who continues to bring an innovative approach to aiding early-stage biomedical companies.
What innovative approaches can you derive to help ensure that novel approaches for the treatment and eradication of disease can be supported and developed? Do not all of us bear such a responsibility?
In memory of Steve Jobs, 1955-2011, I find this perspective to be rather timely and eloquently stated,
“I have looked in the mirror every morning and asked myself, ‘If today were the last day of my life, would I want to do what I am about to do today?’ And whenever the answer has been “No” for too many days in a row, I know I need to change something…almost everything – all external expectations, all pride, all fear of embarrassment or failure – these things just fall away in the face of death, leaving only what is truly important. Remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose.”
Note: Apologies if you received this post twice, it was due to a technology hiccup on Friday 7 Oct.
20
Jun
2011
Come meet and network with Life Science Deal Flow and OnBioVC at our Office Hours on 08 July in Cambridge, MA. For details on oHours (time/place) and to sign-up for a time slot visit HERE. We look forward to connecting with you! [Trouble with the oHours sign-up link? Then paste this url in your browser http://ohours.org/officehours/1578].
16
Jun
2011
Our Life Science Deal Flow PDUFA Trade Strategy is not applicable to just any approaching date. There are several dates this month; Celgene’s (Nasdaq: CELG) istodax®, for relapsed and refractory peripheral T-cell lymphoma, Acura Pharmaceutical’s (Nasdaq: ACUR) acurox®, an abuse-resistant pain med, and Fibrorcell Science’s (Nasdaq: FCSC) iaviv®, for the treatment of moderate to serve nasolabial folds and wrinkles. None of these entities have passed our filters to approve the trade. So though we have an itchy trigger finger and are eager to put some of our Optimer (Nasdaq: OPTR) winnings to work, patience is critical.
There are a number of gating elements that clear an entity to put on the PDUFA trade.
We are excited to now be queuing up the next deal. Our selection will be revealed in a separate post. In addition, a Profit.ly account will be turned on so that there will be third-party public validation of our performance.
01
Jun
2011
On a day when the markets were hammered, with the Dow, S&P and Nasdaq all down over 2%, it is pleasure to reveal that our Optimer Pharmaceuticals (Nasdaq: OPTR) trade worked out, just as we drew it up on the whiteboard!
Why did it work? Well it was not simply a function of the Company receiving FDA approval for its new antibacterial drug Dificid (fidaxomicin), believe it or not this trade may have made money even if the FDA had rejected the NDA.
So I am sitting here, telling you straight to your face, that we were positioned to capitalize on the stock regardless of the outcome at FDA and regardless if the stock price moved up or if the stock price moved down.
Perhaps more than just a few of you are wondering what the catch is here, maybe even thinking there is some sort of Madoff magic transpiring – well I assure you this is all on the up and up – nothing illegal, no smoke and no mirrors.
In fact, the only surefire way to lose money on this trade would have been if the stock price had failed to move, in either direction. It just so happened that OPTR, on the first day of trading post FDA ruling, rocketed skyward, and was up 11.8%. But again, just to emphasize our position no this trade … say the FDA rejected the NDA and the stock price subsequently plummeted on the bad news, well yes, we still would have made money on the trade!
But how say you? How do we make money if the price goes up or down? Okay so here is how we pulled off this trade [drumroll please…], we applied an advanced derivative strategy, and put on a long strangle with put and call options. And to add a little more gas to the fire we simultaneously applied a short straddle.
This might all sound a bit Greek, so depending upon the feedback from this post I may delve into some detail in subsequent posts with a primer on how options work and could follow this with additional option strategy posts covering such applications as our good friends the straddle and strangle. Any questions shoot me an email at arubenstein@rnaventures.com.
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Life Science Deal Flow is not a financial advisor, and does not recommend the purchase of any stock or advise on the suitability of any trade or investment. Stock trading and investing can cause loss of capital, and you should always consult with a professional financial advisor before trading or investing.
26
Apr
2011
Trade Prep – Optimer Pharma (OPTR)
Posted in CA Public: Optimer Pharma, Hedge Fund, Indication: C. diff, Trading
What follows is a mildly dense post … Sharing the details functions, in part, as a demonstration for the rationale behind the trade that we are going to put on; digest too the position of the entity relative to its development continuum and that shall additionally illuminate the Company selection for our trade. We will next follow this with a primer on the derivative strategy that we will put in place for Optimer Pharma, and on its heels will be the trade, in all its transparent glory to shine a light on whether we profit, or not, on the trade and this strategy in general.
Optimer Pharmaceuticals (NASDAQ: OPTR) is focused on discovering, developing, and commercializing innovative hospital specialty products that have a positive impact on society. The Company has two late-stage anti-infective product candidates, Fidaxomicin and Pruvel™ (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). In two Phase 3 trials, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. Most importantly, fidaxomicin reduced the risk of recurrence by 47% compared to vancomycin. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Optimer has also successfully completed two Phase 3 trials with Pruvel™.
Fidaxomicin, the lead product candidate, is a new antibiotic with a novel mechanism of action being developed for the treatment of Clostridium difficile infection or CDI, the most common nosocomial, or hospital acquired, diarrhea. OPTR believes that Fidaxomicin offers advantages over current treatments due to its demonstrated activity against C. difficile, low rates of recurrence, evidence of low C. difficile resistance, minimal systemic exposure, limited disruption of normally occurring gastrointestinal bacteria and convenient dosing regimen. Studies indicate that Fidaxomicin acts by inhibiting RNA polymerase, which results in the death of specific bacteria such as C. difficile. OPTR holds rights to fidaxomicin in all regions of the world except for Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States.
In February 2011, OPTR entered into an exclusive collaboration and license agreement with Astellas Pharma, to develop and commercialize fidaxomicin in Europe and certain other countries in the Middle East, Africa and the CIS. In return for an exclusive license to fidaxomicin in the Astellas territory, Astellas paid to OPTR an upfront cash payment of $69.2M, and OPTR is eligible to receive additional cash payments totaling up to $168M upon the achievement of certain regulatory and commercial milestones. Furthermore, OPTR will be entitled to receive escalating double-digit royalties ranging from the high teens to low twenties on net sales of fidaxomicin in the Astellas territory, if approved. Astellas will be responsible for all future costs associated with the development and commercialization of fidaxomicin in the Astellas territory including the costs associated with the Marketing Authorization Application for fidaxomicin in Europe. In connection with the collaboration and license agreement, OPTR also entered into a supply agreement with Astellas pursuant to which OPTR will be the exclusive supplier of fidaxomicin to Astellas in the Astellas territory and Astellas is obligated to pay OPTR an amount equal to cost plus an agreed mark-up for such supply.
In July 2010, OPTR filed, and in August 2010 the European Medicines Agency accepted for review an MAA to permit marketing of fidaxomicin in Europe. In September 2010, OPTR began a submission to the FDA a rolling New Drug Application, and in November 2010 completed submission of the NDA. In January 2011, the FDA accepted the NDA filing for the treatment of CDI and for reducing the risk of recurrence when used for treatment of initial CDI. The FDA has also granted a request for six-month priority review, and has assigned a Prescription Drug User Fee Act, or PDUFA, goal date of 30 May 2011 for its review of the NDA. The FDA also informed OPTR that it plans to discuss the NDA at a meeting of its Anti-Infective Drugs Advisory Committee currently scheduled for 5 April 2011.
OPTR completed two fidaxomicin Phase 3 trials which showed that fidaxomicin achieved the primary endpoint of clinical cure and demonstrated a significantly lower recurrence rate and significantly higher global cure rate (defined as cure with no recurrence within four weeks of completing therapy) compared to Vancocin, the only FDA-approved antibiotic for the treatment of CDI. In the two Phase 3 trials, among subjects who had experienced a prior CDI episode and recurred within three months of entering the study, treatment with fidaxomicin resulted in a 47% reduction in repeat CDI recurrence compared to Vancocin (p=0.045). The data also indicated that treatment with fidaxomicin significantly improved the recurrence rate and global cure rate in CDI patients requiring concomitant antibiotics compared to Vancocin. Fidaxomicin was also well-tolerated in the trials. In February 2011, the New England Journal of Medicine published results from the first Phase 3 trial. OPTR also reported additional data from the second Phase 3 trial showing a clinically meaningful reduction in recurrence rates and higher global cure rates compared to Vancocin in both the hyper-virulent BI/NAP1/027 and the non-BI strain type subgroups. Clinical cure rates for fidaxomicin and Vancocin were similar in these two strain type subgroups.
On 5 April 2011 OPRT announced that the FDA’s Anti-Infective Drugs Advisory Committee (AIDAC) recommended that the FDA approve Optimer’s investigational antibiotic DIFICID™ (fidaxomicin) for the treatment of patients with Clostridium difficile infection (CDI), a bacterial infection in the lining of the gut that can cause severe diarrhea, colitis and in some cases death. In a unanimous 13-0 decision, the AIDAC found that the clinical evidence submitted by Optimer demonstrated the safety and effectiveness of DIFICID for the treatment of CDI.
The FDA is not bound by the committee’s guidance but takes its advice into consideration.
“We view the vote of the FDA’s panel of expert advisors, with diverse backgrounds ranging from infectious disease to biostatistics, as a strong endorsement for approving DIFICID for the treatment of CDI. We are encouraged that the advisory committee recognizes the urgent need for new treatment options for CDI and the seriousness of the increasing incidence of these infections,” said Pedro Lichtinger, President and CEO of Optimer. “We are proud to be one step closer to providing patients, healthcare providers and physicians with a new treatment option for CDI, a serious and debilitating disease that can impact every aspect of a patient’s life.”
On 6 April 2011 OPTR and Cubist Pharmaceuticals (NASDAQ: CBST) an exclusive two-year co-promotion agreement to market DIFICID™ (fidaxomicin), in the United States. Under the terms of the agreement, OPTR and Cubist will co-promote DIFICID to physicians, hospitals, long-term care facilities and other healthcare institutions in the United States. OPTR and Cubist will also jointly provide medical affairs support for the product. Optimer plans to strategically build its sales force and medical affairs team. OPTR’s team will be complemented by Cubist’s existing U.S. hospital sales force and medical affairs team which is already dedicated to the antibiotic space for CUBICIN®, Cubist’s therapy for Staphylococcus aureus bacteremia, including right-sided endocarditis, and complicated skin infections caused by certain Gram-positive bacteria, including MRSA.
The agreement expires two years from the first commercial sale of DIFICID. The agreement can be renewed for additional terms upon agreement of the parties and can be terminated early by either party in certain defined situations. OPTR will be responsible for the manufacturing and distribution of DIFICID in the United States and for recording product revenue. OPTR will be responsible for obtaining FDA approval, and will retain ownership of the New Drug Application. For its efforts under the co-promotion agreement, including providing specified levels of resources and activities, Cubist will receive quarterly service fees of $3.75M ($15M/year) over the two years beginning with the first commercial sale of DIFICID. Cubist is also eligible to receive an additional $5M in the first year after first commercial sale and $12.5M in the second year of the agreement if mutually agreed upon annual sales targets are achieved, as well as a portion of OPTR’s gross profits from any sales above the specified annual sales target levels.
Life Science Deal Flow is not a financial advisor, and does not recommend the purchase of any stock or advise on the suitability of any trade or investment. Stock trading and investing can cause loss of capital, and you should always consult with a professional financial advisor before trading or investing.
18
Apr
2011
Clostridium difficile infection (CDI), commonly referred to as “C. difficile” or “c-diff”, has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S. It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.
Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.
Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. The increasing incidence of CDI, along with higher rates of both treatment failures and recurrences with current therapies have resulted in greater awareness and concern about CDI among medical professionals and public health officials.
If you have made it thus far perhaps you are curious about the motivation for the post. Well … I have been backtesting some trading strategies and it is time to put my money where my, err, uh … spreadsheet is. Perhaps if I make my performance public it may be of interest to some. Obviously CDI is where the first bet will be placed. Details to follow after the position(s) are put on…
Here goes nuthin’…
Life Science Deal Flow is not a financial advisor, and does not recommend the purchase of any stock or advise on the suitability of any trade or investment. Stock trading and investing can cause loss of capital, and you should always consult with a professional financial advisor before trading or investing.
21
Nov
2010
The Email MBA, Smarter, Faster.
Posted in Uncategorized
OnBioVC and Life Science Deal Flow are excited to announce our newest premium content site, The Email MBA, a resource to address simple to sophisticated business questions and quandaries; designed for those who are short on time and long on the desire to better understand critical concepts, from venture financings to IP management to term-sheet strategy, and much more.
For those seeking an advantage in the marketplace, at the office and in the lab & clinic, The Email MBA addresses business concepts, business strategy and business tactics designed specifically to empower those who are in need of having complicated information presented not only in an easy-to-understand way but also easy to tailor, implement and successfully execute for your own unique needs.
The Email MBA is ferociously focused, designed to aid entrepreneurs without the bandwidth to allocate time and/or resources to the pursuit of an MBA.
The Email MBA, smarter, faster.
Find a sample post from The Email MBA [HERE]
- Facebook | http://facebook.com/TheEmailMBA
- Twitter | http://twitter.com/TheEmailMBA
- LinkedIn | http://linkedin.com/TheEmailMBA
- Plancast | http://plancast.com/TheEmailMBA
10
Oct
2010
15
Sep
2010
Well then look no further than the Colorado Institute for Drug, Device and Diagnostic Development (aka CID4). CID4 has issued a Fall 2010 Statewide “Call for Proposals” from Colorado-based life science inventors, academics and private companies. Founded in 2009, CID4 is a not-for-profit entity whose mission is to drive Colorado bioscience company and job growth by helping bridge the gap between life science discovery and product commercialization. Note the deadline for response to the CID4 proposal solicitation is 15 October 2010. So…run, don’t walk on over to http://CID4.com!
02
Aug
2010
Hot off the press! The 2Q10 OnBioVC Trend Analysis study is available for download [HERE]; and now features OnBioIPO and OnBioM&A data too!
The 2Q10 OnBioVC Trend Analysis tracked, in aggregate, 81 biopharma, diagnostic, device, medical-IT and biofuel venture financings totaling $1,664.2M. Compared to 1Q10 OnBioVC data, this investment activity represents an increase in the number of quarter-versus-quarter financings by 7 (81 v. 74) and an increase in quarter-versus-quarter invested capital of $404.1M ($1,664.2M v. $1,260.0M).
Many thanks to our wonderful partners who make OnBioVC possible. Please show them your support!
Apredica – Preclinical ADME Tox Contract Research
BioWest – The Rocky Mountain Region’s Premiere Device & Biotech Conference
Denson Group – Executive Search Working Exclusively in Med Device Manufacturing
Colorado Bioscience Association – Advocacy. Representation. Service.
San Jose BioCenter – Giving emerging companies that Big Company Advantage…
Faegre & Benson – Effective legal representation
Headwaters | MB – Independent middle market investment bank
DitchmanWest – National life science commercial real estate advisory
Freestone Group – Integrated Solutions for Emerging Life Science
Lockton – Lifescience Industry Specific Insurance Needs
Regulus – A Full Spectrum of Regulatory Affairs and Quality Assurance Solutions
BioBeers – Where Great Minds Drink Alike…
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Sign up [HERE] for FREE Subscriptions to ‘Pharmaceutical Executive’ and ‘Life Science Leader’ Magazines (and other journals too!)
24
Jul
2010
Good stuff here. The first ~seven minutes are intro, then comes a variety of introductory concepts related to Terms in the Term Sheet. Considering these are tech investors I thought they could do a better job with displaying the spreadsheet, but that is being knit-picky. Grab a cup of yerba mate and enjoy…
Click [HERE] to view the video if reading in email or RSS.
06
May
2010
If you have not been paying attention lately, perhaps this will jar something loose…$1BILLION IN CASH GRANTS AVAILABLE FOR EMERGING LIFE SCIENCE COMPANIES aka Section 48D of the IRS code “The Qualifying Therapeutic Discovery Project Credit”. That get your attention? Good. The recently enacted healthcare reform legislation provides up to $1 billion in tax credits and cash grants for life sciences companies with 250 or fewer employees that have made or will make “qualified investments” in “qualifying therapeutic discovery projects” during 2009 and 2010. Credits and grants will be awarded through a competitive application process which is expected to commence on or before May 21, 2010.
A “qualifying therapeutic discovery project” is a project which is designed to develop a product, process or therapy to diagnose, treat or prevent diseases and afflictions by:
1. Conducting pre-clinical activities, clinical trials, clinical studies and research protocols, or
2. Developing technology or products designed to diagnose diseases and conditions, including molecular and companion drugs and diagnostics, or to further the delivery or administration of therapeutics.
A “qualified investment” is the aggregate amount of the costs paid or incurred in 2009 or 2010 for expenses necessary for and directly related to the conduct of a qualifying therapeutic discovery project, subject to certain limitations and exclusions. The tax credits are equal to 50 percent of the qualified investment, and taxpayers may elect to receive the credits in the form of a cash grant. Any such grant is not includable in the taxpayer’s gross income. The availability of a cash grant significantly increases the appeal of the program to companies in a loss position who may not otherwise be able to immediately utilize the credits. Furthermore, unlike the grants available under the Small Business Innovation Research (SBIR) program, corporations that are majority owned by venture capital funds should be eligible for cash grants based on their qualified investments.
Companies must apply to the Secretary of the Treasury in order to obtain certification for qualified investments.
Guidance on the application process is expected to be published by the Secretary on or prior to May 21, 2010. Applications should be prepared in advance of the guidance since the aggregate amount of credits and grants available under the program is limited to $1 billion, and it is expected that the Secretary may approve eligible applications on a first-come, first-served basis. Once applications are accepted, they will be approved or denied within 30 days of submission.
For questions or assistance with the application process contact:
Michael Weiner, Partner, Dorsey & Whitney, weiner.michael@dorsey.com or
Evan Ng, Partner, Dorsey & Whitney, ng.evan@dorsey.com
Life Science Deal Flow PARTNERS
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