Financings of the Fortnight Explores the Alternatives

With all the noise this year about IPOs in our little corner of the world, it’s been easy to forget that most biotechs out there are scrambling for any source of cash they can lay hands on. Assurances aside that traditional biotech VC is making relative bank, the overall pool of traditional venture capital available to invest will continue to dwindle, as respondents in START-UP’s 3rd annual life science VC survey were quite adamant about.

(The survey is now available, by the way.)

This week we got a taste of the post-VC world; or at least, a reminder of the various types of alternative funding out there for health care and biotech that, in a few years, could replace a significant chunk of traditional venture and interrupt for good the boom-and-bust cycle.

First, the elephant in the room: Google announced it would fund a new health care company, Calico, dedicated to anti-aging. The search-and-so-much-more giant is clearly obsessed with health, and doing something about the drastic – dare we say “tragic” – flaws in the care system. Our correspondent Paul Bonanos did a great job delving into Google Ventures’ health care investment strategy in this feature earlier this year, and we recommend reading it (non-subscribers can sign up for a free trial) as background to what might be going on with Calico.

Fly-on-wall fantasy: Page: How do we increase Google searches over a person's lifetime? Brin: What if we just increased the lifetime?
— Josh Berlin (@BioPharmaJosh) September 18, 2013

Paul also reminds us that the Googlers aren’t the only tech-heads with health-care ambitions: Peter Thiel, Yuri Milner and others are shifting their fortunes in small measures. And bully for them; we could certainly use fresh minds and tech-savvy strategies (Tech Tonics?), what with the data-intensive nature of health care these days.

But Silicon Valley’s libertarian streak is often at odds philosophically with another important source of biotech funding that we were reminded of this week. The National Institutes of Health announced the recipients of $45 million from the funds dedicated in 2012 to Alzheimer’s research. Those funds aren’t going directly to biotech companies, but the trials and other efforts they’re backing are much needed in an area that seems practically abandoned by industry – at least in proportion to the level of the dire medical need Alzheimer’s represents. So, indirectly, one can only hope the NIH funding can move the needle enough for biopharma, big and small, to see clearer pathways that deserve cash outlays from the private sector, as well.

Finally, we’re about to see a small but significant step toward equity crowdfunding. Title II of the JOBS Act, which loosens the rules for general solicitation of accredited investors, takes effect next week. It’s not quite crowdfunding nirvana – or the apocalypse, depending on your viewpoint – because we’re still a ways away from Mom and Pop, Joe Sixpack, and the Joneses being able to participate.  (That’s Title III.) But all manner of folks are lined up, ready to provide investment platforms for those with an eye on biotech, as our colleagues have written about here.

If you happen to be at PSA: The Pharmaceutical Strategy Conference in New York next week, you can ask Greg Simon, who’s running the equity crowdfunding site Polliwogg, all about the latest developments. (Or you can catch him on the panel “Funding Biotech: New Ways To Create Value.”)

Or, if you hate going anywhere near New York because you’re convinced it’s about to be overrun by giant drooling sea-dragon spiders, well, the people we write about have products that can help you. Until then, relax in the safety of your home or office, avoid the crowds (and their funds), and enjoy the latest edition of….



Civitas Therapeutics: From the ashes of the inhaled insulin efforts of the previous decade comes Civitas, which said September 11 it has raised a $38 million Series B financing to fund late-stage development of the company’s lead program, CVT-301, an inhaled formulation of levodopa (L-dopa) to treat debilitating motor fluctuations – known as “off episodes” -- associated with Parkinson’s disease. Civitas spun out of Alkermes' pulmonary business in 2010, then the latest casualty in Big Pharma’s complete retreat from several efforts to create inhaled insulin products. But Longitude Capital and Canaan Partners raised $20 million for a Series A, and in early 2011 new CEO Glenn Batchelder told FOTF he hoped to bring a Parkinson’s-related treatment to clinical proof of concept by the end of 2012. (Why an inhaled L-dopa for Parkinson’s? During acute “off periods,” characterized by halting or frozen movement, the Civitas technology aims to deliver drug even when it might be difficult for patients to draw a sustained breath.) CVT-301 is being positioned as an adjunct therapy to oral L-dopa. Bay City Capital led the round and was joined by crossover hedge fund RA Capital, an undisclosed blue chip public investment firm, and all returning shareholders including Alkermes, Canaan Partners, Fountain Healthcare Partners, and Longitude Capital. Partners from Bay City and RA Capital joined the company’s board. Civitas will also explore pipeline expansion with its ARCUS delivery platform for other diseases where what the company defines as a “large, precise” dose delivered from an inhalation device “would provide a significant clinical advantage.” – A.L.

DRI Capital: The Toronto health care royalty investor said September 9 it has raised a new $1.45 billion fund, its third following $240 million and $926 million vehicles, raised in 2006 and 2010 respectively. Investments under the first two funds followed a fairly straightforward set of criteria: drugs with FDA or EMA approval that offer strong efficacy and an attractive pharmacoeconomic profile and that are used to treat very serious, chronic conditions, DRI President and CEO Behzad Khosrowshahi told our “Pink Sheet” colleagues. For the third fund, however, DRI also plans to consider investments in Phase III assets and the higher returns that might come from higher-risk investments. It’s part of a larger but still subtle trend of royalty firms dipping toes into pre-commercial assets, even as traditional venture firms cross the other way and dabble in royalty investments. Khosrowshahi said that DRI has “a decent level of internal expertise” to evaluate pre-commercial risks. The drug royalty business has certainly attracted the capital to lure health care specialists, with DRI joined by competitors such as Capital Royalty L.P., Orbimed Advisors LLC and Healthcare Royalty Partners. Earlier this year, Capital Royalty raised more than $1 billion for its second fund, announcing a revised strategy under which it would emphasize debt instrument financing that would offer its deal partners a more concrete sense of the cost of capital. -- Joseph Haas

Five Prime Therapeutics: The protein therapeutic company notched on September 18 the first biotech IPO of the fall season. More than a dozen are waiting in registration, and an unknown number are also still under wraps with confidential filings. Five Prime raised $62 million by selling 4.8 million shares at $13 each, right within its projected range of $12 to $14 a share. Insiders bought about 408,000 shares. Five Prime was founded in 2001 and built at a time when VCs were more willing to wait for long-term payoffs for platforms. Five Prime’s platform consists in part of a library of 5,600 extracellular proteins to yield novel targets, and biotech or pharma partners have signed on with more than $220 million in partnership or licensing money. Its most advanced candidate FP-1039 is a selective FGF inhibitor that Five Prime and its partner GlaxoSmithKline put into a Phase Ib trial in July.  “If you were to tell a VC, ‘Give me four or five years and a chunk of money to develop this kind of platform,’ it might be a tough sell these days,” Five Prime VP of Biology Brian Wong told our sister publication START-UP earlier this year. Befitting a company that’s taken 12 years to reach the public markets, the pre-IPO ownership was spread rather widely. Only Pfizer had more than a 10% stake, with 13.7%. Venture or priate equity groups Advanced Technology Ventures, Domain Associates, Kleiner Perkins Caufield & Byers, HealthCap, Versant Ventures – from the firm’s very first fund -- and Texas Pacific Group all owned 9%. Founder and CEO Rusty Williams owned 6.8%. Jefferies led the underwriting team, which has the option to sell an additional 720,000 shares. – Alex Lash

Cubist Pharmaceuticals: The antibiotic maker said September 16 it bought $25 million in Series A preferred stock from Optimer Pharmaceuticals, a sale that was negotiated this summer as part of Cubist’s agreement to buy Optimer. That acquisition, not yet consummated, hasn’t gone over well with Optimer shareholders, who have filed suit to stop it because Optimer shares have actually been climbing since the company dumped its CEO and put itself up for sale in February. The $10.75-per-share offer, or $535 million, was at a 19% discount to Optimer’s July 30 closing price. Shareholders could earn more post-acquisition if Cubist hits sales milestones with Optimer’s Clostridium difficile treatment Dificid (fidaxomicin), a product it has been selling in the U.S. since 2011, when it signed an exclusive co-promotion deal with Optimer. The $25 million stock sale is essentially a bridge to help Optimer pay the bills – or as a Cubist spokeswoman told FOTF, “to address Optimer’s near-term cash needs” -- until the merger takes effect. The purchase repeats quarterly, so if the deal hasn’t closed in three months, Cubist will pay another $25 million, and another $25 million three months after that. As of June 30, Optimer had $73 million in cash on hand, down from $119 million at the end of 2012. Seeing how the deal was unusual for its discounted price, there certainly is a chance that the lawsuit will have legs and hold matters up for some time. The Cubist spokeswoman declined to comment on the suit. – A.L. and Jessica Merrill 

All The Rest: myoscience, developing Focused Cold Therapy devices for peripheral nerve conditions, closed on a $25M Series E round…Index Ventures is initially investing $10M into Egalet to support work on abuse-deterring pain meds, with the option for another $10M…Emmaus Life Sciences raised $7.5M to complete Phase III studies for its sickle cell candidate…to pay for its acquisition of CNS assets from Merck, Cerecor got $6.8M in Series A-1 financing…Taglich Brothers led a $3.2M round for screening and assay development services company Caldera Pharmaceuticals…Sanofi was an investor on Hadasit Bio-Holdings-portfolio company KAHR Medical’s $2.5M fundraise…BioMotiv and the NYU Innovation Fund launched autoimmune start-up Orca Pharmaceuticals…KV Pharmaceutical emerged from Chapter 11 bankruptcy, simultaneously closing on a $100M credit facility and $275M rights offering…Cell Therapeutics sold $15M in 15k Series 18 convertible preferred shares…Taiwanese biotech Amaran provided half of the $10M private investment in Stellar Biotechnologies…A $10M PIPE by NanoViricides gives the company a total of $22M in cash for the next two years to fund its FluCide and DengueCide candidates…A day after revealing positive outcomes in its Phase II glioblastoma multiforme vaccine study, Agenus raised $6.5M in an at-the-market registered direct offering…injectables developer Sagent Pharmaceuticals closed on a $75M FOPO…to continue work on ZFP Therapeutic candidates, Sangamo BioSciences completed a $64.5M secondary offering…Galena Biopharma’s $35M FOPO will help to commercialize its first product, Abstral…electroporation drug delivery company OncoSec publicly raised $12M…protein therapeutics company Acceleron priced its IPO at the top end of its range to gross $83.7M...glaucoma drug developer Aerie Pharmaceuticals filed for its IPO, while Bind Therapeutics, Ophthotech, and Enzymotec set terms for their offerings…Cubist offered $800M in two series of convertible senior unsecured notes…therapeutic protein maker Protalix BioTherapeutics closed on $69M in 4.5% convertible notes due in 2018…ProMetic Life Sciences’ $Cdn10M debt financing will help put its plasma purification facility into operations for manufacturing plasma-derived orphan drugs…Benu BioPharma established Benu BioVentures for investments in preclinical to proof-of-concept candidates…and Daiichi Sankyo teamed up with Mitsubishi UFJ Capital to launch a new fund for start-up creation; Daiichi gets rights to buy the companies and IP. -- Amanda Micklus 

Image courtesy of flickr use Kitschweb through a Creative Commons license. 

Financings of the Fortnight Says If It Floats Like A Duck...

The biotech IPO trickle continues, with Supernus Pharmaceuticals debuting its shares May 1 and raising $50 million for its drug reformulation programs. It was a third less than the company had hoped for when it freshened up its nearly forgotten S-1 and decided last month to make a lunge for the window. It’s the seventh biopharma to debut this year – five in the US, two in France (France? Mais oui) – and folks are wondering if the opening will expand.

We would never suggest that one deal, especially one as delayed and discounted, should stand for larger trends without putting it in context. Supernus raised $49 million from private investors (with well over $100 million more raised through non-dilutive royalty deals) and a $50 million IPO. Its immediate post-IPO valuation of $120 million translates into a 1.4x step-up, about in line with the typical biopharma IPO in the post-crash era – starting in 2009, that is.

In the same time period, we found pre-IPO terms for 44 US and foreign biopharmas that eventually went public. They wanted on average to sell shares at $14.50 each (we’ve used the midpoint of initial proposed price ranges, and we’ve converted foreign currencies to dollars). Their actual average IPO price: $11.69, or a 20% discount. (Supernus: A 62% discount, from $13 to $5.)

We found the proposed number of shares to sell for 39 companies. On average they wanted to sell 6.7 million. They actually sold an average of 8.2 million, or 22% more shares than first expected. (Supernus: twice as many shares sold than expected, from 5 million to 10 million.)

In other words, with a big haircut and dilution, Supernus is a lot like its post-recession peers, but more so. There’s another resemblance: It had to sell a good chunk of its IPO shares to existing shareholders. Lead VCs New Enterprise Associates, Abingworth, and OrbiMed Advisors ponied up $33 million – a whopping two thirds of the issue. (With insiders like that, who needs outsiders?) We noted it a couple months ago: insider participation isn’t necessarily a bad omen for post-IPO stock performance. And VCs taking companies public these days know the extra outlay is likely, even necessary to get the deal done.  As Clovis Oncology CEO Pat Mahaffy, who has now taken three biotechs public, said at a conference this week of Clovis’s late 2011 successful IPO, “It would have been hard to pull off without insider participation.” It’s now the new normal, says Mahaffy.

As of this writing Supernus is up $1.06 a few days past its debut, a 21% bump. Its backers, new and old, can only hope that over time it continues to resemble its 2012 peers in post-IPO performance. As a class, they’re up 15% post-IPO (as of the April 30 closing bell), and the class of 2011 is slightly better than that at 19%. For a lot more on IPO performance since 2009, look for START-UP Magazine’s next Valuation Watch. For the choicest biotech financing morsels, stick with…

Argos Therapeutics: Once a candidate for an IPO, Argos has turned to insiders for a $25 million Series D round to support Phase III trials on its treatment for metastatic renal cell carcinoma. It’s been an up-and-down year for Argos, which readied its story for retail investors last July but cancelled the offering in March, and instead returned to existing shareholders for cash. Like publicly traded Dendreon, Argos has a personalized cancer treatment in which tumor cells are modified and infused back into the patient to provoke a tumor-specific immune response. But Argos’ timing could hardly have been worse: Days after filing its prospectus, Dendreon shares lost almost two thirds of their value as questions about uptake, reimbursement and demand arose about Provenge (sipuleucel-T). With just $2 million in the bank at year’s end, Argos held hope for a $66 million listing until late winter before scuttling the offering eight weeks ago. “Public investors would like to put companies in boxes,” Argos CEO Jeff Abbey told our Pink Sheet colleagues. “It makes it hard to differentiate ourselves, although our technology is totally different.” Forbion Capital led the new round, and insiders TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group and Aurora Funds contributed the balance, bringing Argos’ total funding to $114 million since 1997. With $75 million budgeted to spend through 2015, Argos will need more capital from a partnership, private round or IPO during the interim. -- Paul Bonanos

Telstar Pharma: Astellas Pharma has gotten into the asset-financing game with Telstar, a virtual company formed around an ulcerative colitis treatment spun out by Astellas. The compound, ASP3291, was actually outlicensed to Drais Pharmaceuticals, a New Jersey firm whose cofounders, Donna Tempel and Robert Desjardins, were US senior management at one of Astellas’ predecessors. Tempel and Desjardins went on to form AkaRx with backing from Astellas Venture Management, an investment that brought one of the most lucrative returns in recent biotech memory. Drais is paying an undisclosed upfront fee and royalties on future sales to Astellas for ASP3291. Astellas’ venture arm has contributed a minor stake, less than 20%, of Telstar’s $14 million initial financing round, and parent company Astellas has various rights to the compound: the right of first refusal for the Japanese market, the right of first exclusive negotiation for any future partnering for the compound, and non-exclusive negotiations for ex-Japan markets. By depositing ASP3291 in a corporate entity separate from Drais, it should prove a cleaner exit – and faster return – if the compound succeeds in an upcoming Phase IIa trial. Telstar’s lead investors, InterWest Partners and Sutter Hill Ventures, are also investors in Drais. Astellas said it was considering a similar deal with Drais for a compound in a different, undisclosed therapeutic area. -- Daniel Poppy

Castlight Health: In its second large venture funding in two years, health care shopping pioneer Castlight Health has raised a $100 million Series D round that it says it will use to grow its commercial team and add features to its product. Announced May 1, the round was led by T. Rowe Price, Redmile Group and two major unnamed mutual funds, as well as prior investors. Founded in 2008 as Ventana Health Services, Castlight is a Web-based service that enables customers’ employees to compare out-of-pocket costs for procedures such as colonoscopies, X-rays and MRIs. In 2010, the company raised a $60 million Series C, led by non-venture backers the Cleveland Clinic and Wellcome Trust, as well as VCs such as Venrock Associates, Oak Investment Partners and Maverick Capital. The D round more than doubles Castlight’s total cash raised to $181 million. Last year, Castlight announced a 250% increase in revenue over 2010. Chief marketing officer Peter Isaacson would not detail the company’s 2011 performance, but noted that its customer base and revenue are growing “very quickly,” with many new clients being Fortune 100-sized firms. With so many companies still offering employees health care coverage, one of Castlight’s biggest challenges is determining which potential customers to target, he added. -- Joseph Haas

Transcept Pharmaceuticals: Five months after the eye-opening FDA approval of its sleep aid Intermezzo (a reformulated zolpidem, a.k.a. generic Ambien) Transcept has sold 9 million shares at $4.50 a piece in a public offering to raise $37.6 million net of expenses, not including a possible overallotment sale. Many observers had written off Transcept after the FDA gave the company a second thumbs-down in mid-2011, nearly three years after the firm originally submitted its NDA to the feds for Intermezzo, which is designed to help people fall back asleep after waking in the middle of the night. Transcept is relying on sales by US marketing partner Purdue Pharma to bring in revenue, and the marketer launched the drug last month. Transcept has earned a $10 million fee from Purdue and can draw an additional $80 million, plus royalties. The company, which went public in early 2009 through a reverse merger with Novacea, will use the new proceeds to help develop TO-2061, a low-dose version of ondansetron for obsessive-compulsive disorder. The compound has been used for twenty years to combat the nausea and vomiting caused by chemotherapy, radiation and surgery. The 4.5 million shares offered increase the outstanding share pool by 32%, with 675,000 reserved for the underwriter over-allotment. -- Alex Lash

Photo courtesy of flickrer jamiejohndavies.

Deals Of The Week's Tale of Two Drugs

It was the best of times (Vacation!). It was the worst of times (Market turmoil, London's riots, and unemployment; the Middle East.) It was the age of wisdom (Drug reprofiling! Warren Buffett. A new Muppets album); it was the age of foolishness (2012 Presidential election! Phone hacking scandals!).

We had everything before us -- with the waning of summer, the impending season of investor meetings ought to mean renewed opportunities for deal making, after all. Or maybe not. Big Pharma's aversion to take risk could well mean that for biotechs of a certain ilk, we had nothing before us.

Meantime, if regulators weren't exactly channeling a tale of two drugs this week, news of the extension of Eylea's PDUFA and the months-earlier than expected approval of Zelboraf, announced within 18 hours of each other, sure set up an interesting comparison. (The Friday announcement of an early nod for Seattle Genetics and Takeda's Adcetris means we could have written a tale of three drugs. Alas, it messes with my metaphor.)

On the one hand you have Eylea, a VEGF-inhibitor developed by Regeneron to treat the wet form of age-related macular degeneration, whose primary commercial advantage isn't improved efficacy but a more patient-friendly dosing regimen. Its new PDUFA data has been delayed three months from August 20 until mid-November. On the other hand, you have the small molecule BRAF inhibitor Zelboraf, a targeted therapy that is being co-launched with a companion diagnostic and becomes just the second new drug in decades to treat deadly metastatic melanoma. It's original regulatory action date was October 28.

Two different medicines both treating areas of high unmet medical need. But one is first-in-class and one is a essentially a convenience play, albeit an important one given the importance of sight and the potential to avoid onerous monthly eye injections. Still, it's tempting to wonder if stealth comparative effectiveness is at work by U.S. regulators.

That seems unlikely. No new safety or efficacy concerns are behind Eylea's regulatory extension; in a call with investors Wednesday August 17, the biotech's execs emphasized questions tied to the chemistry, manufacturing and controls portion of the drug's biologics license application were responsible for the postponement of the drug's approval. And if the recent advisory committee meeting vote is any guide -- the committee voted 10-0 in favor of the drug's approval -- there's no reason to think the drug won't make it to market later this year.

Still for Regeneron, which is leaning heavily on Eylea to catapult itself into the realm of commercially-focused biotechs, the news undoubtedly came as a psychic blow. The biotech is now in hurry-up-and-wait mode, having lined up a commercial team approximately 70-people strong to launch the product, according to this story in "The Pink Sheet" DAILY. On the August 17 conference call, the biotech revealed it will take a third quarter SG&A charge in part because of the estimated $70 million to $80 million associated with Eylea's launch. Unsurprisingly, investors reacted negatively, sending the company's stock price down about 8% as of the market's close August 18. (Though it could have been worse given the general market turmoil and the massive sell-off late in the week.)

Plexxikon, the biotech which originated Zelboraf, is in a completely different position entirely. Having exercised an option to co-promote the drug in the US, the VC-backed start-up was snatched up by Daiichi, which like so many other pharmas, is looking to double down in oncology. Roche's Genentech is leading the commercial efforts, and as our colleagues at "The Pink Sheet" DAILY report, has identified a crafty plan that puts the targeted therapy's value front-and center. At an estimated $60k for a course of therapy, the drug, which can only be prescribed for patients with a specific mutation, is significantly cheaper than Bristol-Myers Squibb's competitor Yervoy.

The dichotomy between the forces now steering Regeneron and the insulation Plexxikon now enjoys as a division of Daiichi show that for biotechs, the more things change, the more they stay the same. Or in the words of Charles Dickens,

in short, the period was so far like the present period, that some of its noisiest authorities insisted on its being received, for good or for evil, in the superlative degree of comparison only.

On one of the last Fridays of summer, perhaps it is a far, far better thing that I bring you another edition of...

General Dynamics/Vangent: Government contractor General Dynamics shored up its health care information technology division this week with the $960 million cash purchase of Vangent. The deal brings an exit to private equity fund operator Veritas Capital, which owned 90% of publicly traded Vangent prior to the sale. Veritas acquired Vangent’s predecessor, Pearson Government Solutions, for $600 million in 2007; Vangent has since expanded by acquiring two other companies, FDA and Medicare contractor Buccaneer Computer Systems and Service ($65 million) and the health care IT unit of Aptiv Technology Partners ($4 million). Vangent derives about 90% of its business from U.S. government agencies, including the Departments of Health & Human Services, Defense, State, Education and Labor. It provides IT services including electronic health records to military personnel and Federal employees, as well as informing Medicare recipients of health care options. Vangent will be integrated with Falls Church, Va.-based General Dynamics’ information technology division, which also recently grew by acquiring cloud computing company Network Connectivity Solutions. Arlington, Va.-based Vangent posted net income of $40 million on revenues of $762 million during 2010, and had $27 million in cash and equivalents at the end of the year. The deal comes as many government agencies seek to cut costs in anticipation of reduced budgets and buy-out firms as well as traditional venture groups see opportunity in the relatively nascent healthcare IT space. – Paul Bonanos

Paladin/Labopharm: Canadian drug formulator Labopharm had sought a suitor pour longtemps, and finally found one in acquisitive specialty pharma Paladin Labs. This week Montreal-based Paladin agreed to buy struggling Labopharm for CN 28.57 cents per share in cash, valuing the company at about CN$20 million ($20.4 million). Paladin, which markets a variety of drugs including pain relievers, contraceptives and injectable emergency treatments for hypoglycemia and allergic reactions, is already attempting to acquire cold remedy developer Afexa Life Sciences of Edmonton in a hostile bid. The offer for Labopharm is friendlier, however, and has already been accepted by its board. Labopharm, which brought in new management in March as part of a restructuring, develops drugs using its controlled-release and nano-delivery systems; in its earnings report earlier this month, Labopharm said its expenses and obligations would likely exceed its revenue and cash reserves in the coming months, and its ability to survive as a going concern was in question. While the deal seems likely to close without incident by the fall, Paladin has cause for concern elsewhere: Hours after the acquisition was announced on Aug. 17, Paladin CEO Jonathan Goodman was in a bicycle accident, and is currently hospitalized with what the company calls “serious injuries.”--PB

Human Genome Sciences/4-Antibody: Even as HGS's investors wonder what additional late-stage clinical assets the biotech will bring in to continue the revenue upsurge the biotech has enjoyed from the recent launch of its lupus biologic Benlysta, the Maryland-based biotech continues to ink early stage deals to ensure its continued access to innovative products. This week comes news that the firm is teaming up with the Switzerland-based 4-Antibody. Financial details of the tie-up weren't disclosed, but the licensing deal seems like a pretty standard early-stage R&D deal, giving HGS rights to use 4-Antibody's proprietary high through-put antibody discovery platform to produce two novel molecules. The technology is rooted in rapid flow cytometry and is designed to produce fully human antibodies that are "better behaved" (according to official 4-Antibody statements) than molecules produced via alternate methods. It's 4-Antibody's second deal; the start-up inked an alliance in 2010 with Boehringer Ingelheim worth more than $240 million in biobucks. (As with this week's HGS deal, the upfront in that collaboration was not disclosed.) HGS, meanwhile, continues to show its interest in large molecule therapeutics. Just one week after winning approval for Benlysta, it announced it would pay $50 million upfront for rights in the US, EU, and Canada to FivePrime Therapeutics' lead asset, a Phase II oncology medicine, FP1039. --EL

Pfizer/Qiagen: Is the biopharma industry finally getting real when it comes to companion diagnostics? It's hard to say given the economics of deals between biopharma and testing companies are rarely announced. But at least such tie-ups are happening with greater regularity, and this week we have another reminder (if Zelboraf's early approval wasn't already reminder enough) of the strategic importance of companion tests. On August 16, Qiagen and Pfizer revealed the two groups were teaming up to develop a molecular test to accompany the Big Pharma's Phase III dacomitinib, which works by blocking three related tyrosine kinases in the human epidermal growth factor receptor (HER) family. Details of the collaboration were undisclosed but it's a no brainer that Pfizer would align with Qiagen. The two have partnered before in the companion diagnostic realm and Qiagen has considerable expertise in developing FDA-approved tests to diagnose patients' KRAS genetic status. (Recall that mutations in the KRAS gene are commonly observed in human cancers and EGFR-inhibitors like dacomitinib are most effective in individuals who do not have these aberrations.) Indeed, Qiagen recently submitted a premarket approval application for KRAS companion tests associated with two separate drugs targeting metastatic colorectal cancer. While the Pfizer companion test is being adapted for specific use in lung cancer tissue, it uses the same core assay components as Qiagen's other KRAS diagnostics. Qiagen is a relative newcomer to the space of companion diagnostics, building its capabilities primarily through its 2009 acquisition of DxS; this additional Pfizer deal illustrates just how valuable that purchase has proved for a company whose historic strength has been as a purveyor of kits and reagents. That Pfizer is preemptively taking the step to pair dacomitinib with a companion test is a smart move; there are plenty of competing EGFR-inhibitors in development. Providing payers and physicians with a diagnostic that can help triage lung cancer patients helps provide an added level of differentiation.--EL

Bayer Healthcare/Pathway Medical: In the midst of the increased chatter about reviving the question of whether drug companies should also be in the medical device business, fueled by Endo Pharma’s recent $2.6 billion acquisition of American Medical Systems, at least one pharma company that is already in the device space appears to be quietly expanding its presence there. As reported by Xconomy, Bayer Healthcare’s Medrad device unit has reportedly reached an agreement to acquire atherectomy company Pathway Medical Technologies for $125 million, although the deal is not yet final.

Earlier this year, Medrad received CE Mark approval of its Cotavance drug-eluting balloon to treat peripheral artery disease and is selling that product in Europe, while also pursuing an IDE on the path to seeking US commercialization. Drug-eluting balloons hold great promise as the next major platform to treat vascular disease, particularly in areas where even drug-eluting stents have proven ineffective, with the peripheral vascular market representing the largest of those opportunities. Pathway’s atherectomy devices are also focused on clearing peripheral vessels. Medrad has long been a secondary player in this market, largely through its Angiojet thrombus removal system, which the company added in 2008 with its acquisition of Possis Medical. By adding atherectomy and drug-eluting balloons to their current product line, Medrad, which is located in the Pittsburgh suburb of Warrendale, PA, appears to be taking its cue from the hometown Pirates baseball team in looking to move up in the standings by assembling an armamentarium of endovascular devices for clinicians in the under-served and growing peripheral vascular market.

For Pathway, the deal appears to be a welcome exit, albeit one of uncertain return for its investors, for a company that has struggled for much of its 13 year history. The company was nearly out of business in 2004 but was able to revive its fortunes by switching its focus from the coronaries to the peripheral market. The reported $125 million acquisition price doesn’t quite match the $130 million that the company raised – and the Xconomy report suggested that only investors in the most recent Series D will see any benefit from the deal -- but $125 million is a strong acquisition price in the device space and in a glass-half-full kind of way represents something of victory for Pathway executives. --Steve Levin

Due to an editing error, the Anjojet device was inapprorpiately refered to as a drug eluting balloon. The post has been updated as of August 22, 9am ET.

Financings of the Fortnight Tries to Beat the Summer Heat

First, the good news. We had our favorite scrumptious local ice cream treat to finish off lunch today. You really should try one. (Not the one pictured above, but it's still good. Trust us.)

Wait, there's other good news: venture capitalists invested $1.24 billion in biotech in the second quarter of 2011, a 46% jump from the previous quarter. It's the highest quarter since... since....! Well, since the 2nd quarter last year ($1.37 billion). So, it "bounces back" from what, exactly? Even the dismal year of 2009 had a similar figure, $1.19 billion raised in the fourth quarter. It's a nice short-term bump, but not necessarily the breakthrough everyone's looking for.

[UPDATE: DowJones VentureWire released its VC numbers the day after this post went up. DJVW tallied $1.1 billion raised by biotech, up 36% from the first quarter. The different numbers are nothing new for the dueling data houses. FOTF tried to find an explanation last summer.]

Further clouding the picture (a.k.a. the bad news) is a second set of venture data released by the National Venture Capital Association: the previous quarter saw the lowest number of venture funds raising cash since 1995. Welcome to the shakeout. The number of venture dollars raised has decreased every year since 2007, down to last year's $13.3 billion, but larger inflows per firm this year have so far added up to $10.2 billion raised. The take-home lesson: VCs might be folding up shop, but those who remain are attracting more cash.

That's across all industries. NVCA and its survey partner Thomson Reuters don't break out fundraising by sector. For a little more color, though, we've got a treat for you. You can put it between oatmeal cookies and dip it in chocolate if you wish.

Our colleagues have recently updated what we call the "gas-tank" chart: Which life-science VCs are revving for a refill, and which are running on empty. It's coming soon to a START-UP magazine near you, but FOTF got a sneak peek. Since our last gas-tank update in July 2010, several firms have raised new funds (Advent Venture Partners, Avalon Ventures, Third Rock Ventures), while others listed as running low last summer are again pounding the hot pavement, stumping for cash. For example, Sofinnova Ventures is trying to match its vintage-2006 $375 million fund. Our European colleagues have noticed the stirrings, too.

But no matter how much we equate shoe leather with optimism, there's no getting around the shakeout. Everyone thinks the life-science VC sector will shrink in the next three years. Trust us, we've asked. (And you'll see the results in an upcoming issue of START-UP.)

As we love to remind you, not all venture capital is distributed equally. Call us bleeding-heart wasteful-spending underdogs, but we love to see the new ideas and emerging science get funded, so when we see a slight recovery in Series A rounds in the first half of 2011, as noted in our previous column, we think hey, maybe this time the good news outweighs the bad news. It might not be a massive hot fudge sundae, but it could be a little cherry on top. Or if you prefer, life is far from parfait, but once in a while you get your just desserts. Loosen your waistbands, everyone, it's time for a heaping helping of...


Essence Group: Healthcare services holding company Essence Group Holdings completed a $61 million round of funding that included contributions from private equity firm Camden Partners Holdings of Baltimore and blue-chip Silicon Valley VC Kleiner Perkins Caufield & Byers. It’s the latest large funding in the healthcare IT sector, an area that has attracted increased attention and investment since the passage of the Affordable Care Act last year. It also follows KPCB’s 2009 investment in employee health incentives start-up Red Brick Health. For Essence, it’s nominally a “Series 2” round, following a recapitalization of several previous rounds as a “Series 1." According to a company spokesman, the funding brings Essence’s private investment to more than $120 million. Previous rounds had included numerous individual investors, including KPCB partner John Doerr. Essence will use the funds largely to support marketing of its Lumeris subsidiary’s TackleBox software, a cloud-based collaborative communications system for accountable care organizations that includes clinical and financial outcomes management and decision support capabilities. St. Louis-based Essence also operates its own health plan, while a third subsidiary, ClearPractice, is a vendor of electronic medical records and revenue management software package for small physician groups. -- Paul Bonanos

Coronado Biosciences: Forgive us the easy pun, but Coronado, based in New York City, hopes to worm its way onto the public markets via a Form 10 filed on July 15, which effectively registers its private shares as common stock. The firm's lead therapy, not yet in the clinic, is made of the microscopic eggs of the parasitic pig whipworm and meant to treat autoimmune disorders. If the FDA allows the IND, the first test will be in Crohn's disease patients. The treatment is based on the "hygiene hypothesis" that modern humans, especially in developed countries, have cleansed their environments too well. Parasites like Trichuris suis -- which only briefly colonize humans before being flushed out-- are in fact necessary immune-system triggers. Without them, Coronado believes, we don't have the proper T-cell regulation, leading to autoimmune diseases, in the gut and elsewhere. Coronado says it plans to file an IND in the third quarter and complete a Phase I dose-escalation study by end of year. Its second candidate, slated for the clinic next year to test against acute myeloid leukemia, is a lysate that activates natural killer (NK) cells. Founded in 2006, the firm has racked up $43 million in losses. The Form 10 is the first step to making its shares tradeable, but there's no guarantee Coronado will win a listing on a major exchange. It does not intend to hold an underwritten IPO, according to its Form 10 filing. Coronado acquired regional rights to the worm treatment earlier this year as part of its acquisition of Asphelia Pharmaceuticals. That came on the heels of a management overhaul, in which its CEO and CFO were let go, but not before collecting $860,000 and $700,000 in compensation for 2010. -- Alex Lash

Merrimack Pharmaceuticals: Oncology drug developer Merrimack hopes to become the latest pharma to reach the public markets. The Cambridge, Mass.-based company filed paperwork with the SEC for an IPO potentially worth $172.5 million in the coming months, which would bring liquidity to a large and diverse investor group that has supported the start-up since its inception in the 1990s. The offering’s proceeds would support ongoing development of a pipeline whose most advanced drug is just reaching Phase III, a reformulation of the chemotherapy agent irinotecan dubbed MM-398, intended for use in metastatic pancreatic and gastric cancer patients who did not respond to Eli Lilly’s Gemzar (gemcitabine), the standard of care. MM-398 is slated to enter Phase III trials in the fourth quarter and will be compared to fluoruoracil and leucovorin. Merrimack already reaps licensing revenue from a partnership with Sanofi around its antibody MM-121, for which the pharma paid $60 million upfront for worldwide rights in 2009. Merrimack has raised more than $250 million to date, much of it in recent years. It now counts large funds affiliated with Fidelity Investments, Credit Suisse First Boston, and TPG-Axon among its top investors. The firm has four compounds total either in the clinic or soon to enter, and says it's also developing companion diagnostics for each compound. Despite near-record activity in IPOs in the month of July, the only biopharma firm slated to go public soon is Horizon Pharma, which has one pain-killing drug recently approved and another nearly ready for marketing application.-- P.B.

SARcode Biosciences: The San Francisco Bay Area ophthalmology company hopes there's not a dry eye in the house after its latest cash infusion, a $44 million B round led by Sofinnova Ventures. The firm plans to use the money to push forward development of its lead compound, a nonsteroidal anti-inflammatory small-molecule antagonist of the integrin lymphocyte function-associated antigen-1 (LFA-1) to treat dry eye. Dry eye is caused by a number of factors, including age, menopause, environmental factors, medications, certain diseases like diabetes, and even prolonged staring at a computer screen. (Uh-oh.) SARcode plans to begin the first of two Phase III trials later this year and to report data in June 2012, and CEO Quinton Oswald told "The Pink Sheet" this week that his troops might bring it to market and sell it without a partner. He said 100 to 120 sales reps could market it to ophthalmologists. Oswald was previously an executive at Roche Holding's Genentech, where he helped launch Lucentis (ranibizumab), a commercially successful macular degeneration drug with sales of $2.9 billion in 2010. The new round included new investor Rho Ventures, as well as returning investors Alta Partners and Clarus Ventures. The round closed July 14 and should fund the company through 2012.-- Lisa LaMotta

Image courtesy of flickrer infowidget via a Creative Commons license. Mmm.