The company’s first round of investment was oversubscribed, leading to a haul of $2.5 million, according to amended filings made with the Securities and Exchange Commission. Lumena’s investors are venture capital firms Pappas Ventures and  RiverVest Venture Partners. The new capital means the company can proceed to human tests for its novel type 2 diabetes treatment, which aims to develop a pill to help patients regulate their blood sugar.

Research Triangle Park, North Carolina-based Lumena was founded last year. The company is developing a new diabetes treatment based on the role bile acids play as signaling agents in the gastrointestinal tract. When Lumena launched its fundraising efforts last year, CEO Michael Grey explained that most gastric bypass surgery patients are type 2 diabetics. In 80 percent of those patients, blood glucose levels normalized within days — a change that’s not attributed to weight loss. What happened was that bile was diverted.

In normal gastrointestinal function, bile is recirculated. But gastric bypass surgery also bypasses that mechanism. The presence of bile in the GI tract triggers receptors that release Glucagon-like peptide 1, or GLP-1, a hormone that helps regulate blood sugar. Lumena’s treatment would work within the GI tract to stimulate the body’s production of GLP-1. Unlike other drugs that circulate through the bloodstream, the targeted action could offer fewer side and effects compared to other diabetes treatments.

Lumena’s technology comes from company co-founder Slava Gedulin, a former scientist at Amylin Pharmaceuticals (NASDAQ: AMLN), a San Diego, California biotechnology company that develops diabetes and obesity treatments. Gedulin’s discovery came after he left Amylin and the company has no claims on Lumena’s technology.

http://www.pappasventures.com/news-and-events/portfolio/2012/diabetes-drug-developer-lumena-raises-25m-compound-regulates-blood-sugar/

Under the terms of the agreement, Acorda made an upfront payment of $2 million to Neuronex and paid $500,000 of up to $1.2 million in research funding for a nasal application of epilepsy treatment diazepam.

Neuronex is preparing a new drug application for the proprietary nasal spray formulation of diazepam. Following the pre-NDA meeting, Acorda has an option to complete the acquisition by paying Neuronex an additional $6.8 million.

Neuronex is preparing a new drug application for the proprietary nasal spray formulation of diazepam. Following the pre-NDA meeting, Acorda has an option to complete the acquisition by paying Neuronex an additional $6.8 million.

If the acquisition is completed, Acorda will assume oversight and financial responsibility for all future development and regulatory programs for diazepam nasal spray. The company expects those expenses will not exceed $8 million in 2012.

There are potential payments to Neuronex and other parties of $1 million for the completion and acceptance of an NDA, and up to $25 million following regulatory approvals in the United States and Europe. Acorda will also pay Neuronex milestone payments and royalties based on net sales of the medication, if approved.

Neuronex, a startup drug development company, raised $1.5 million in a first round of funding back in 2010.

http://www.bizjournals.com/triangle/morning_call/2012/02/acorda-buying-morrisville-based-neuronex.html?ana=e_trig_rdup

BioCryst has successfully completed in vitro and in vivo studies in which BCX5191 exhibited potent and selective pan-genotypic antiviral activity against the hepatitis C polymerase enzyme. BCX5191 showed no inhibition of human RNA polymerase and no evidence of toxicity from standard in vitro screens.

Human liver cells rapidly and efficiently convert BCX5191 into its active triphosphate form. BCX5191 does not require prodrug technology to achieve bioavailability. BCX5191 inhibits the viral RNA polymerase enzyme across genotypes 1-4 at sub-micromolar concentrations (0.05-0.36 µM) and is active in replicon cell assays for genotypes 1a and 1b.

In preclinical models, BCX5191 demonstrates high oral bioavailability, and the drug is actively transported into the liver. Following a single oral dose in rats, liver BCX5191 triphosphate levels exceed the IC₅₀values for genotypes 1-4 through 24 hours. At C_max, the drug triphosphate level is more than 100 times the IC₅₀. This pharmacokinetic profile is expected to support once-daily dosing in clinical studies.

“BCX5191 has met stringent preclinical criteria to advance to IND-enabling studies. We expect this program to be ready to file for first-in-human studies during the fourth quarter of 2012,” said Dr. William P. Sheridan, Senior Vice President & Chief Medical Officer of BioCryst Pharmaceuticals. “Based on our internal comparative preclinical studies of BCX5191 with the most advanced nucleotide analog in clinical development, GS-7977, we believe BCX5191 has the potential to be the backbone of best-in-class oral treatment regimens for hepatitis C patients.”

Additional BCX5191 non-clinical experiments are ongoing or planned, including Good Laboratory Practices (GLP) non-clinical safety studies and in vitro evaluation of BCX5191 in combination with ribavirin.

http://www.businesswire.com/news/home/20120215005465/en/BioCryst-Announces-Promising-Results-Preclinical-Studies-BCX5191

Depending on potential milestones, the deal could be worth around $40 million. At closing, Aldagen shareholders received Cytomedix shares and will own 17 percent of that company.

As part of the transaction, some investors in Aldagen, which was backed by Durham-basedIntersouth Partners, bought $5 million of Cytomedix common stock in a private placement. That investment will help fund a Phase II clinical trial for a drug that could be used in the treatment of post-acute ischemic stroke – a drug for which Adagen estimates there is a $3.5 billion market.

Cytomedix has 22 employees and has grown “from nominal sales to $6 million per year in just over 18 months,” according to Martin P. Rosendale, the company CEO.

http://www.bizjournals.com/triangle/morning_call/2012/02/cytomedix-buys-durham-pharma-for-40m.html?ana=e_trig_rdup

Take Pfizer’s late 2010 deal with LPath: $14M up-front, plus shared expenses on Phase I and II, followed by an option to acquire the lead program for just under $500M in total if further milestones are met.

Sure, there are still a few acquisitions here and there more representative of the days of old.  Take Amira, for instance, acquired in 2011 by Bristol Myers Squibb for $325M up-front plus a potential earnout of $150M.  I can even accept some of the arguments that big pharma may be more willing to buy with up-front dollars in 2012:  patent cliffs loom even closer, the big pharma to big pharma merger dust is settling, R&D remains unproductive, and there is cash to be spent after having largely sat on the sidelines for the past couple of years.

But there are many reasons on both sides of the fence why option deals are becoming more popular.  Most of these reasons are underappreciated, and some are even surprising.

First, and most obvious, option-based deals diminish risk for the acquirer.  Why shell out $100M for a program that will fail in the next clinical trial?  Plain old milestone-based acquisitions may offset some risk, but unlike funded research deals, they don’t give the potential acquirer a flavor for the asset, or a flavor for the management team and style that brought the asset to where it is today.  Both could be important.  How many times have you had buyer’s remorse after finding out something bad that decides to reveal itself a day or two after the purchase instead of during the weeks or months you spent in diligence?  There’s a reason for this.  Once you start paying for research, you become part of the company in some way, and people tell you things you didn’t know before.

In many cases, the tiny option fees and often-shared research funding can come directly from the R&D budget of the big pharma, without having to draw down on business development reserves typically employed in larger deals.  This means that, in a sense, the money is already budgeted – it is already there if you will – and the deals can be done more quickly if senior management and boards of directors don’t have to weigh in heavily during the deal process.  Said another way, if only the big pharma R&D group buys in to the technology and agrees to share the R&D budget, that may be enough.

My suspicion is that it is easier for a big pharma to close on an acquisition via a research-funded buy-out option.  Imagine approaching your senior management telling them that you’ve worked together with this company for a couple of years, that the relationship is good, that the data has panned out well, and that you’ve done all this with small dollars.  Seems to me it would be harder to say no to this, whereas it would be easier to say no at the end of a fast-paced auction process that began two weeks ago.

In the heady days of healthcare venture capital, there were lots of venture capital funds willing to plunk down millions here and there in order to finance clinical trials.  But the number of such funds is dwindling fast, and those that remain are plunking down money for other things, like diagnostics, medical devices, and healthcare services and IT.  These days, the small biotech finds the big pharma research funding a more attainable source of capital than ever before, and in some cases much easier to close than VC money.  Because the pharmaceutical industry depends in part on biotech successes, big pharma are likely to partially cover for sources of funding that are drying up, and the option-based research deal is one way to do it.  (Check out the January 9, 2012 BioCentury article on page A11 regarding pharma stepping in to fund biotech IPOs for a similar take.)

The clincher is that, from a biotech investor standpoint, the risk-adjusted investment multiple of a research-funded option-based acquisition is actually higher than the risk-adjusted investment multiple from taking companies through Phase II and hoping for an all-upfront acquisition.  Here’s an example.  Let’s suppose you are a VC and you have invested $10M in a company at a valuation of $10M.  In the go-it-alone scenario, suppose that you get Phase I data and you then decide to invest (at a flat round) another $25M to get Phase II data.  Assume there is a 20% chance the Phase II will work (more or less the average these days) and that if it works, the company will be bought for $300M upfront.  Here, the VC would own about 78% of the company, reaping a risk-adjusted $47M at a 1.3x.  But assume instead that after Phase I, a large pharmaceutical company offers to pay for Phase II (the research-funding phase), and in the 20% chance that it is successful (possibly higher since you have the expertise of the big pharma), there is an agreement to purchase the company for $300M (the option).  In this case, you would own only 50% of the company, and you would receive a risk-adjusted $30M, but your multiple more than doubles to 3x.  In the end, VCs are in the multiples business, and the research-funded option-based acquisition should be more appealing than ponying up to shoulder risk alone, even if the meager to non-existent up-front won’t get you the Bentley SUV that you’ve been eyeing.

My own view is that risk sharing will continue to grow in popularity.  Sure, there are lots of reasons not to do these deals.  For example, what if you get good data but the option isn’t exercised?  (My response: if you really have good data, you will sell the company to some other big pharma notwithstanding the odd decision of your former partner.)  But all in all, these relationships are good for both parties, and I think the growth of such structures will go a long way to restoring the once-vibrant ecosystem of biotech-partnered-with-pharma successes that we all long to see return.

Todd Brady is a Principal at Domain Associates, LLC – www.domainvc.com

The new LipiFlow® console incorporates an enhanced graphical user interface by controlling pressure and displaying the treatment temperature, pressure sequence and treatment time remaining. The new LipiFlow® also allows physicians to store a record of the treatment on the device and on electronic medical record servers, eliminating the need to manually document the treatment in patient records.

LipiFlow®’s second generation product also allows physicians to treat two eyes simultaneously. Time savings achieved by performing a bilateral treatment is beneficial for both busy physicians and patients alike.

“We are pleased to have received FDA clearance for the second generation LipiFlow® to offer to our current and future customers,” said Tim Willis, chief executive officer and co-founder of TearScience. “The improvements in this next generation LipiFlow® reflect TearScience’s commitment to innovation. TearScience expects to provide many more enhancements that will assist physicians in treating dry eye sufferers efficiently, effectively and profitably.”

TearScience’s second generation LipiFlow® product will be commercially available in March 2012. Physicians currently using TearScience’s first generation LipiFlow® will be upgraded to the new system.

TearScience sells its LipiFlow® and LipiView® Ocular Surface Interferometer devices as a system for eye care practices. The LipiView® enables physicians to visualize the eye’s tear film. LipiView® won the 2011 Medical Design Excellence Award.

http://www.tearscience.com/en/tearscience-achieves-fda-clearance-for-second-generation-lipiflow-thermal-pulsation-system

Vipin K. Garg, president and CEO of Tranzyme, says the money will help Tranzyme take one of its drugs to a new drug application later this year.

Because of research and development costs, Tranzyme typically reports net operating losses. Through the first nine months of last year, it reported $13.1 million in losses.

http://www.bizjournals.com/triangle/blog/2012/02/tranzyme-pharma-lands-9m-in-debt.html

“This acquisition is an excellent strategic fit as OPKO expands its sales and distribution capabilities, particularly for its new pharmaceutical and diagnostic products.”

ALS started operations in 2009 as the exclusive product distributor of Arama Laboratorios y Compañía Limitada (“Arama”), a company with more than 20 years of experience in the pharmaceutical products market. In connection with the transaction, OPKO will also acquire all of the product registrations and trademarks previously owned by Arama, as well as the Arama name.

OPKO will acquire ALS for US $4 million in an all cash transaction from Inversiones SVJV Limitada, Inversiones BS Limitada, and Inversiones PYTT Limitada.

Phillip Frost, OPKO’s Chairman and Chief Executive Officer, commented, “This acquisition is an excellent strategic fit as OPKO expands its sales and distribution capabilities, particularly for its new pharmaceutical and diagnostic products.”

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsLang=en&newsId=20120123006190&div=928298533

Arthritis is the leading cause of disability in the United States with more than 46 million Americans having doctor‐diagnosed arthritis.¹ Local injections of corticosteroids and anesthetic agents are heavily relied on as early, effective interventions for pain relief.   The current standard of practice, ‘blind injection,’ depends on the expertise of the clinician and the accuracy with which the medications are injected into the affected joint space.  According to a recent study published in The American Journal of Sports Medicine, injection accuracy rates are significantly higher when imaging is used in conjunction with injection of the knee and shoulder.

The Navigator DS automates the preparation and delivery of injections using ultrasound to guide accurate needle positioning.   The automated system helps to ensure accurate dose preparation, while eliminating needle exposure to healthcare workers and minimizing the potential for contamination.   After the injection is delivered, the system records the treatment data and automatically creates a record for transfer to an electronic record management system.

“The support of our existing investors validates the investment community’s continued confidence in the vision of the company and the benefits of our product platform to improve the efficiency and accuracy of injection delivery,” said Timothy J. Patrick, president and chief executive officer of Carticept.  “With the completion of this financing, we are well positioned to launch the Navigator DS in leading orthopaedic and sports medicine centers across the United States.”

http://www.windwardmedical.com/press-release-011812.html

Apply now by downloading and completing the online form. No application fee is required! The application deadline is January 20, 2012. Companies will be notified on February 17, 2012.

Requirements: located in the Southeast, involved in the medical device field, seeking capital

Here’s why SEMDA represents the best value if your company is seeking funding:

• Medical Device Focus – companies will present to VCs, angels and companies specifically focused on medical devices.
• Affordable – no charge to apply and just $750 if you are selected and choose to present, which includes two conference admissions.
• Attendance – SEMDA’s annual conference has become known as the premier regional gathering for the medical device industry.
• Networking – Multiple opportunities to network with investors, business development professionals, researchers, medical device leaders and industry professionals.
• Education – When not presenting, attendees can take part in educational sessions geared towards the needs of medical device companies.
• 1:1 Partnering – meet with potential customers, partners and investors.
• Mentoring – each company will receive guidance and feedback prior to the conference from a team of seasoned investors and industry leaders.
• Marketing – all presenting companies will be promoted on the website, in e-mails and press releases, and in print materials, including the conference program.

SEMDA is a non-profit organization formed to promote medical device companies, provide a means for those companies and inventors to network and build a community, and support them with resources to grow.

Conference sponsorships available!

Email admin@semda.net to learn more or to have someone contact you!

Attached here is the Presenting Company Application SEMDA 2012 Presenting Company Application Form

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