Deals of the Week Mulls The Wild Frontier

Sometimes, it's said, the pioneers are the ones that end up with arrows in their backs. It's a tech-industry cliché, one designed as a reminder that first-mover advantage isn't everything. There are those whose innovations turn into category winners, and then there are those whose inspired inventions become part of someone else's best-selling product.

While it's rarely quite that way in the pharma business, drug-developing pioneers can still face challenges that benefit their competitors but backfire on their own ambitions. Among the Davy Crocketts struggling to translate a novel product into a sales juggernaut is Seattle's Dendreon, which was thought to be sitting on a goldmine when its Provenge (sipuleucel-T) became the first cancer immunotherapy to be approved by FDA in April 2010. Now, however, the company has more muted expectations for Provenge -- and accordingly, will go through a painful restructuring that will cost a quarter of its employees their jobs.

Many estimates pegged Dendreon to bring in well over $1 billion annually at its peak, given its survival benefit for prostate cancer patients, and Dendreon staffed up accordingly to meet anticipated demand. During a Sept. 8 conference call, CFO Greg Schiffman acknowledged that it had overreached in projecting $350 to $400 million in annual sales, including $175 to $200 million in the fourth quarter alone.

Many doctors are loath to prescribe the expensive buy-and-bill drug, reportedly due to concerns about reimbursement; thus, it's been difficult for Dendreon to reach Provenge's target patient population. While the company ultimately made the decision not to close its three manufacturing plants, it has scaled back production -- and one commercial relationship didn't survive the cut: Dendreon canceled its antigen supplier contract with GlaxoSmithKline, which company officials described as a "second-source" contract rendered unnecessary by the slow sales.

With 500 staff set to be laid off, Dendreon says it can save $120 million annually, and now expects to break even on Provenge if it can generate $500 million in annual sales. A fraction of what they'd hoped for, sure, but sometimes that's the price of being first-to-market with a category-defining product. "We are scientific pioneers," said Gold during the conference call, "and also commercial pioneers."

With that in mind, it's Friday afternoon. Sure, it was a short work week for most of us, but we all deserve a break. So please ride off into the sunset with...

GlaxoSmithKline/BARDA: GlaxoSmithKline has received a two-year $38.5 million grant from HHS’ Biomedical Advanced Research and Development Authority to support the pharma’s development of an experimental antibiotic against biothreat pathogens such as Yersinia pestis, which causes bubonic plague, and Bacillus anthracis, which causes anthrax. GSK could receive additional financing from BARDA if the research agreement is extended, bringing the potential total funding to $94.5 million. The work centers around development of GSK2251052, an antibiotic targeted at the bacterial enzyme leucyl tRNA synthetase (LeuRS), which is moving into Phase II in ventilator-associated pneumonia and Phase III for complicated intra-abdominal infections. GSK ‘052, previously known as AN3665, is a boron-based Gram-negative systemic antibiotic that GSK licensed from Anacor Pharmaceuticals under their 2007 platform technology collaboration around four targets. On Sept. 6, GSK and Anacor agreed to extend that research partnership around LeuRS candidates, with the pharma returning all intellectual property related to the other three targets included in the original deal. — Joseph Haas

Evotec/Roche: German drug discovery company Evotec appeared at first blush to have pulled off a coup on Sept. 5, when it announced it was licensing back to Roche a potential Alzheimer's therapy, EVT-302, first inlicensed from the Swiss multinational more than five years ago. A great piece of business for Evotec, apparently, with Roche paying it an upfront of $10 million and potentially over $800 million in future development and commercial milestones. But on closer inspection the ownership of the asset had as many switchbacks as an alpine pass: a predecessor company, Evotec Neurosciences, owned EVT-302 when it was first spun out of Roche, and these rights came with the company when it was later acquired by Evotec. Under the all-new deal, Roche benefits from a package of preclinical and clinical data, collected by Evotec when it tried, and failed, to develop EVT-302, a highly selective MAO-B inhibitor, as an aid to smoking cessation. EVT-302 complements the other approaches Roche is pursuing for the treatment of Alzheimer's, including MAbs against beta-amyloid. With Roche now shouldering all costs of development, the deal works well for Evotec: over the past two years, it has restructured its business and is focused on developing drug discovery partnerships with partners, rather than developing its own R&D pipeline. MAO-B is up-regulated in the brains of Alzheimer's disease patients, and as well as breaking down monoamines like the neurotransmitter dopamine, it also produces oxygen free radicals, which contribute to oxidative stress and could possibly accelerate the disease process. An inhibitor might slow down disease progression, and Roche is to conduct a Phase II trial in 2012 to prove this concept. - John Davis

F-Star/Merck Serono: F-Star, an antibody engineering company based in Vienna, Austria, saw its relationship with one of its pharmaceutical corporate investors blossom this week when it announced a discovery and development agreement with Merck Serono, the pharmaceuticals arm of Merck KGaA. The German company's VC arm, Merck Serono Ventures, has only been an investor in F-Star since January 2010, when it co-led an €8 million extended Series A financing, but its parent company obviously liked what it saw. Merck Serono and F-Star will now build on their relationship by collaborating on the discovery and development of antibody-derived therapeutics against inflammatory disease targets in a deal valued at €492 million ($683 million). Merck Serono will nominate three therapeutic targets and the companies will collaborate on developing targeted and bispecific biologics against these molecules. Merck Serono will have exclusive commercialization and development rights, with F-Star receiving an initial technology access fee, research-based funding, and development and commercialization milestones, as well as tiered royalties on sales. Accessing bispecific antibody capabilities has been a hot topic lately, with this week's F-Star/Merck Serono tie up reminiscent of last week's Zymeworks/Merck collaboration, although the technology access fee and committed R&D dollars make F-star's tie-up richer. - J. D.

Astellas/Evec: Japan’s Astellas Pharma has in-licensed the worldwide development and commercialization rights to a fully-human antibody targeting infectious disease from Japan’s Evec. Specific details regarding the program weren’t provided. While Astellas’ upfront payment for the pre-clinical program is modest at ¥600 million ($7.75 million), development and sales milestone payments could add as much as ¥13 billion ($168 million) to the deal, which also includes royalties. Founded to commercialize research conducted at the University of Hokkaido and based in Sapporo, eight-year-old Evec is developing antibodies for cancer and inflammatory disease as well as infectious disease. Evec previously licensed an antibody to Boehringer Ingelheim in a 2008 deal that could be worth up to €55 million ($75 million). In August, Astellas appointed a new CEO, promoting Yoshihiko Hatanaka, the head of the U.S. Astellas unit, to the top post. – Lisa LaMotta

Eisai/SFJ Pharma: It's a deal -- and a financing! This week's DOTW two-fer illustrates the heightened risk-hedging protocols at work as big pharmas try and limit their cash R&D burn, while still retaining access to a product a la project finance. And based on the press release, there ain't a whole lot for Eisai -- or its shareholders -- NOT to like about the SFJ arrangement. Essentially Eisai has partnered late-stage clinical development of its Phase III tyrosine kinase inhibitor, lenvatinib, in thyroid cancer. Under the agreement, the studies will be conducted by Eisai (so it keeps control!), BUT they will be completely funded by SFJ. That's right --SFJ is picking up the tab, and in return stands to earn milestone payments, but only if the compound wins regulatory approval. In addition, if and when the compound is approved, all commercial rights remain with Eisai. With so many of the financial details of the relationship undisclosed, one has to assume that the future milestone payments owed to SFJ, which is backed by VCs including Clarus and Abingworth, are lucrative. This isn't the first time Eisai has sought a partner to hedge its development risk: back in 2009 Eisai teamed up with the CRO Quintiles to develop multiple oncologics. That particular alliance called for Eisai and Quintiles to share development costs, with Quintiles' cancer specialists conducting the proof-of-concept trials and Eisai paying milestones for compounds that meet predefined POC criteria.--Ellen Licking

Image of Davy Crockett, painted by Chester Harding, reproduced courtesy of Wikimedia Commons.

Deals of the Week Hopes Its Labors Aren’t Lost

When bidding for a union contract, it’s essential that one’s proposals wind up in the right hands. That’s one lesson that can be taken from Shakespeare’s Love’s Labour’s Lost, which draws much of its comedy from a series of letters whose private content ends up in more public hands. As the characters’ secrets are revealed in a sort of 16^th Century version of a botched reply-to-all, hilarity ensues. All’s well that ends well in this one, because everyone wants to get together as the curtain falls.

But unwanted and misdirected proposals are a lot less funny. In matters of love, they break hearts. In other realms, the results can be disastrous as well – like, say, the realm of biopharma deals. (Ham-fisted a transition as that may be, you knew I’d get there somehow, didn’t you?) For example, if you’re Canada’s Paladin Labs – last spotted in another recent literary-minded installment of this column, complete with dusty Brit – you’ve laid down a glove for cold medicine maker Afexa Life Sciences, only to witness the gallant entry of a white knight from stage left, Valeant Pharmaceuticals, ready to exeunt with its prize. (More on that later.)

Sometimes, though, all it takes a little persistence to be appreciated. Pfizer, for example, has been courting pain drug developer Icagen for years – their partnership was initiated in 2007 – but only recently expressed a desire to put a ring on it and acquire the company outright. But although its $6-per-share offer for the portion of the company it does not already own has garnered the support of Icagen’s board, it hasn’t yet won over all the necessary shareholders, some of whom are holding out for what they perceive as fair value for the company’s assets.

As of this writing on Friday morning, the deal is very close to being done, with just a few thousand shares standing between rejection and betrothal. Pfizer has extended its tender (trap) offer twice, with Icagen’s decision expected by late Friday afternoon.

With that in mind, perhaps we’ve got a rarity for this Labor Day weekend: a cliffhanger episode of…


Valeant/Afexa: With two highly acquisitive companies bidding for Afexa Life Sciences, the maker of Cold-FX flu medicines, only one could win its heart. Already in the midst of a buying spree, Canada’s Valeant Pharmaceuticals proposed a sweeter -- and friendlier -- deal than rival bidder Paladin Labs for Afexa, swooping in with a white-knight offer on Aug. 30. Valeant’s cash bid is worth 71 cents per share, or about $76 million, a 29% premium to Paladin’s hostile bid of 55 cents per share, or $56.7 million. The new offer from Valeant will give Afexa another 30 days to weigh any other better offers. Valeant has the option to match any higher offers or opt for a $3.75 million termination fee. Valeant has made several acquisitions this year, largely adding to its dermatology business. Afexa, however, is destined to be slotted in with Valeant's over-the-counter products portfolio, according to CEO Michael Pearson. Paladin, meanwhile, has been on a spree of its own, most recently acquiring drug formulator Labopharm last month; it hasn't yet decided whether it will improve its offer. – Lisa LaMotta

Merck/ZymeWorks: Privately-held ZymeWorks of Canada inked its first Big Pharma partnership this week, worth an undisclosed upfront plus research, development, and regulatory milestones totalling up to $187 million (that’s US dollars). As early stage research collaborations go, the Merk/ZymeWorks deal is pretty standard. There’s no yearly R&D support in addition to the upfront; the relationship is also target specific, meaning it doesn’t preclude the start-up from partnering its technology, which creates so-called bi-specific antibodies, with other interested parties. Because it raises the 8 year-old company’s profile far higher than the biotech’s prior deals (which in terms of industry have been limited to Xoma) and therefore could be the springboard to larger, more lucrative alliances, the Merck tie-up is an important landmark. That’s undoubtedly what CTI Life Sciences, ZymeWorks’ main backer is hoping. Whether an acquisition eventually transpires will likely depend on how well molecules derived from the biotech’s proprietary Azymetric platform perform in the clinic. Back in the 2006 to 2007 time frame, biopharma rushed to lock up next-generation antibody capabilities, as companies like Bristol-Myers Squibb (Adnexus), GlaxoSmithKline (Domantis) and Merck (GlycoFi) tried to bolster their in-house biologics expertise while accessing validated targets locked up by first generation technologies. That trend has largely switched to licensing – most next-gen antibody players are still so early that risk averse pharma doesn’t want to spend the money acquiring platforms that may only be useful in the creation of specific compounds. – Ellen Licking

Adimab/Novo Nordisk and Adimab/Biogen Idec: Adimab, a purveyor of yeast-based antibody discovery technology, this week announced separate two-program discovery deals with Novo Nordisk and Biogen Idec (pdf), and said it was on pace to double its number of partnered candidate programs for the second straight year. Adimab CEO Tillman Gerngross said the privately held company now has 24 partnered programs and is aiming to finish the year with 35 - five in 2009, 10 in 2010, and 20 this year. Two programs might not sound like a lot, but unless either of those companies -- or any of Adimab’s eight other biotech or Big Pharma partners – wants to ante up some serious cash to bring Adimab’s technology in-house, that’s all they’ll get. Currently, explained Gerngross, Adimab limits partners to two programs apiece. Biogen and Novo, for example, each have selected two undisclosed targets against which Adimab will deliver fully human antibodies. The big biotechs get options to commercialize antibodies generated through their collaborations and Adimab gets upfront payments and preclinical and clinical milestone payments and royalties. Those and other existing deals are structured as project-based research licenses and companies later can opt for a commercial license around a program (so far only Merrimack Pharmaceuticals has done so, around MM-151, a three- antibody cocktail designed to bind three distinct epitopes of the epidermal growth factor receptor). Gerngross says the company typically commands $10 million to $20 million in total pre-commercial milestones and a mid-single-digit royalty per program, a price he describes as "in-line with competing technologies." Adimab's involvement in the programs begins and ends with antibody discovery, a process that typically takes eight weeks. So far Adimab has built a successful business on discovery, on the cusp of positive cash flow and no need to raise additional cash. Time will tell if it can sign the kind of big-money partnerships that would give its venture investors a successful return. - Chris Morrison

Teva/Sinclair IS Pharma: As part of its gradual transformation from a generic drug company to a full-fledged pharma with its own branded products, Teva Pharmaceutical Industries Ltd. licensed commercialization rights in specified EU markets to oncology supportive product Episil from Sinclair IS Pharma on Aug. 31. Terms of the licensing deal were not disclosed. Teva obtains commercial rights to the drug in Germany, Spain, Poland, Switzerland and the Czech Republic, while Sinclair IS Pharma, a U.K. specialty firm formed by the April 2011 merger of Sinclair Pharma PLC and IS Pharma PCL, will retain rights to co-market the product in Spain and Germany, where it has an existing sales force. Episil is an oral spray to treat pain associated with oral mucositis, a side effect of chemotherapy and radiotherapy during cancer treatment. Sinclair IS Pharma was created through a stock-for-stock transaction valued at €53.2 million ($85.3 million) with the intention of establishing a specialty pharma with pan-European exposure. In a statement, the firm’s CEO Chris Spooner said the rationale behind the merger was to broaden the sales reach of IS’ portfolio through Sinclair’s commercialization operations. “This is the first in what we expect to be a number of marketing and co-marketing partnerships,” he said. — Joseph Haas



Merck/Addex: Addex Pharmaceuticals said on Sept. 2 that Merck was returning rights to the companies’ programs targeting metabotropic glutamate receptor 4 (mGluR4). Addex pledges to push forward with development of the small molecule positive allosteric modulators in CNS diseases, namely Parkinson’s disease. The companies have been working together on mGLuR4 programs since the research collaboration began in 2007. Merck took sole responsibility for the programs about a year ago, and now returns the rights just about the time it would be expected to pick a clinical candidate (Addex’s pipeline chart shows the programs nearing the end of the lead-optimization stage); not only would that likely trigger a milestone to Addex, but it also represents a point when development costs increase. The mGluR4 deal may be a delayed casualty of the Merck/Schering-Plough megamerger which added Schering’s now-Phase III preladenant (MK 3814, nee SCH420814) to the mix in 2009. That adenosine 2A receptor antagonist is jockeying with a similarly late-stage molecule from Kyowa Hakko for the lead in the class. But the mGluR4 space has seen its share of attention too – albeit earlier stage – with investments from the likes of the Michael J. Fox Foundation, Novartis and Merck-Serono, the last of which is teamed up with Domain Therapeutics. With CHF 50 million in the bank as of the last quarterly statement but later-stage fish to fry, Addex is likely to look for a new partner to fund development of the program, sooner rather than later. – C.M.

Genzyme/PTC Therapeutics – As part of its portfolio review following its acquisition earlier this year by Sanofi SA, Genzyme has decided to restructure its partnership with PTC Therapeutics around ataluren, a small molecule in development for genetic disorders caused by nonsense mutations. In 2008, Genzyme paid $100 million upfront, with potential for as much as $337 million in development, approval and sales milestones, for commercial rights to the protein restoration therapy in all territories outside the U.S. and Canada. In 2010, however, ataluren failed to demonstrate a statistically significant effect, as measured by distance improvement in the six-minute walk test, in nonsense mutation Duchenne/Becker muscular dystrophy. On Sept. 2, PTC announced that Genzyme had returned its commercial rights to ataluren in that indication, but would retain an option to commercialize the drug outside the U.S. and Canada in other indications. PTC said it would continue development of the compound in both nmDBMD and nonsense mutation cystic fibrosis. Citing its portfolio assessment, Genzyme Chief Operating Officer David Meeker said, “our option to reengage the collaboration reflects our belief in the potential of this approach for the treatment of nonsense mutation genetic disorders.—J.H.

Image courtesy of Flickr user UMTAD, the University of Minnesota's Theatre Arts & Dance program, reproduced under Creative Commons license.

Financings of the Fortnight Hops Across the Pond

The United Kingdom isn't really Europe, as any Euroskeptic worth his warm pint would tell you. But we were still surprised to see a flurry of financing news coming from the Isles in August, when, famously, everyone across the pond and beyond is supposed to be off catching a few rays.

Biotech doesn't take a summer holiday, apparently. Still, three newly-minted UK firms announcing Series A fundraisings within the same week at the end of August is reason enough for a double-take. Life-science venture in Europe (and yes, we include the UK) has been weak-kneed, as our London-based colleagues wrote a few days ago. That's not surprising, with the austerity measures in the UK and a continent-wide debt crisis adding to an investment attitude already more cautious than what's found in the US. Nearly half the 27 fundraisings by private European biotech companies so far this year have been for sums totaling $10 million or less, a "drip-feed" mentality that some argue can be counter-productive as start-up managers constantly scramble for the next meager slice of humble pie. (Then again, some say hungry executives are the best kind.)

Whatever your views on human motivation, there's no denying this year's frugality, which becomes more pronounced if we weed out the two massive rounds at the start of the year that went to Danish firm Symphogen for €100 million ($131 million) and Circassia for £60 million ($98 million).

One bright spot has been Series A financings, which in Europe have averaged just over $12 million each this year, thanks in part to the debuts of several Swiss firms firms such as Shield Therapeutics. (See here and here for more.) Duly noted that Switzerland, while smack-dab in the middle of Europe, doesn't play in the euro-zone and, thus, isn't subject to the same economic vicissitudes.

Economic Darwinians like to talk about creative destruction: tear down an old structure to give breathing room to new ones. The UK has historically been dominated by large drug firms, so the crumbling of these monoliths around the edges -- such as the recent shuttering of Pfizer's Sandwich labs, though nothing to cheer about when announced this past February -- might eventually generate start-ups.

But such gestation needs time. Take for example Autifony Therapeutics. It's the second newco born from the dissolution of GlaxoSmithKline's neuroscience division, which the London-based Big Pharma announced in February 2010. Autifony is the first of the week's trifecta of UK start-ups that caught our attention, and unlike the first GSK neuro-spinout, last year's Convergence Pharmaceuticals, Autifony is still preclinical, with a pipeline of small molecules targeting voltage-gated ion channels to address hearing loss. GSK still holds about 25% of the company. SV Life Sciences and Imperial Innovations, the tech-transfer-plus arm of London's Imperial College, are each in for up to £5 million. (Read more about Imperial's new fund and aggressive investment plans here.) Only a £3 million tranche is currently in play, however -- drip, drip, drip -- until the firm can complete a toxicity package in about a year, its co-founder told our Pink Sheet colleagues. If the full £10 million goes in, GSK's current stake would drop to 13.2%, and GSK has no future rights to any of Autifony's programs.

The other two brand-new UK startups, KalVista Pharmaceuticals and Mission Therapeutics, are detailed below in our roundup. There were venture fundings in other parts of the world, too: Ardelyx in California, highlighted below, Affinium Pharmaceuticals in Texas and Toronto, and Spinifex Pharmaceuticals down under.

Alas, we can only choose four. As experienced globetrotters, we know the importance of traveling light. Take just the essentials: Pepto-Bismol, a featherweight rain slicker, a hidden wad of $20 bills to bribe the border guards, and of course...



Mission Therapeutics: Spun out of labs at the University of Cambridge, Mission's ubiquitin-based research is still in early days, prompting acting CEO Niall Martin to call the £6 million ($10 million) Series A funding "a bold move by our investors to take on a company like ours." Announced Aug. 25, the round was led by Sofinnova Partners and included corporate venture from GlaxoSmithKline's SROne and the Roche Venture Fund, as well as £1.3 million from Imperial Innovations. It's Imperial's first bet on a Cambridge spin-out and more evidence, along with the Autifony deal described above, that its new mandate to invest beyond the alumni of Imperial College is no window dressing. Mission is focused on cancer, but beyond that, it's too early to talk about indications of interest. They're quite specific about their targets, however: ubiquitin enzymes E2, E3 and de-ubiquitylating enzymes (DUBs) involved in the DNA Damage Repair (DDR) signaling pathway, which cells use to monitor their genomes for damage. The Series A funds should last two-and-a-half to three years, according to Martin, enough to get the new company to, or close to, pre-clinical validation with one or two of its main target/protein areas. Mission joins start-ups such as CellCentric and ProGenra in the race to target the ubiquitin pathway. -- Melanie Senior

KalVista Pharmaceuticals: Big Pharma isn't the only storehouse of compounds worth mining as sources for new companies. To create KalVista, SV Life Sciences and Novo A/S have spun out a basket of potential eye disease treatments from a small specialty shop in their portfolios. Each investor has put £4 million into KalVista, which now holds small molecule kallikrein inhibitors targeting the eye disease diabetic macular edema (DME). KalVista got the assets from Vantia Therapeutics, a urology specialty firm that itself was spun out of Ferring Pharmaceuticals in 2008. Crockett says KalVista's compounds could be useful for DME patients who don't respond to Roche/Genentech's Lucentis (ranibizumab), especially if the firm is ultimately successful developing an oral formulation. For now, though, it's pushing an injectable that could reach the clinic by the end of 2012. DME is becoming a competitive space, and KalVista will likely need some differentiation. Through its acquisition of Fovea Pharmaceuticals in 2009, Sanofi is working on both a plasma kallikrein inhibitor for retinal-vein-occlusion induced macular edema and a DME-specific compound. For a therapeutic area nearly abandoned by Big Pharma in the previous decade, eye disease is driving a lot of deal flow. SV Life Sciences wants to do with KalVista what it did with Swiss biotech ESBATech, reorganizing it around ophthalmology and selling it to Alcon in 2009 for up to $590 million, with the non-ophtho assets spun out into yet another newco, Delenex Therapeutics. -- M.S.

OrbiMed Advisors: As promised, the prominent New York-based health care investment firm is moving into royalties. It already has venture capital funds, hedge funds, and mutual funds under its auspices. In the spring of 2010, it closed a $550 million fund, dubbed Caduceus IV, that was slightly larger than its predecessor but aimed for roughly the same allocation mix: 60% biopharma, 25% devices, and the rest diagnostics. At that time, its partners told our friends at START-UP that the royalty fund was in the works but wouldn't discuss potential fund size. Now we know: The $600 million "Royalty Opportunities" fund will be domiciled in Luxembourg and follows established firms such as Paul Capital, Royalty Pharma, and Cowen Healthcare Royalty Partners into the arena. (OrbiMed also turned to those firms to find some of its new royalty team.) Royalty deals can be quite nuanced with complex structures, but two frequent templates are upfront payouts to drug makers in exchange for all future rights to downstream sales royalties; and debt structures that use royalties as collateral. Orbimed says it'll lean heavily toward the latter. It has pursued royalty-related deals from its other funds, with about 25 already on the books, but wanted to create a dedicated fund to give its limited partners an avenue to lower but less risky returns, targeting 2x over five to seven years instead of the minimum threshold of 3x of typical venture funds, said OrbiMed partner Carter Neild. -- Paul Bonanos and Alex Lash

Ardelyx: In another showing of corporate venture backing this fortnight, Amgen Ventures has joined the investor syndicate for Ardelyx, which completed a $30 million Series B preferred stock financing on August 31. The cash will help complete a Phase II trial of its lead compound, RDX5791, for constipation-predominant irritable bowel syndrome. The funding is a significant jump from the $22.3 million Ardelyx reported as the total for the round in this July Form D filing. Existing shareholders New Enterprise Associates, CMEA Capital, and individuals were also involved. The 2007 start-up focuses on mineral metabolism imbalance and metabolic disorders says it now expects to finish a Phase II trial by early next year and provide the first efficacy data for RDX5791, an NHE3 sodium transport inhibitor. At a different dose or regimen, RDX5791 also has potential in preventing excess dietary sodium absorption to help control hypertension, the company said. Its other two agents are in preclinical testing: RDX002 (an NaP2b phosphate transport inhibitor for chronic kidney disease) and RDX009 (TGR5 agonist for Type II diabetes). All three molecules have restricted systemic absorption and primarily target transporters and receptors in the intestines to affect only cardio-renal, metabolic, and gastrointestinal functions. Because of their minimal systemic nature, Ardelyx believes its drugs will avoid the side effects and thus be safer than current systemic treatments on the market. -- Amanda Micklus

Many thanks to Melanie Senior for her help this week.

Photo of the world's most adorable frog is courtesy flickr user Benimoto via a Creative Commons license.