Deals Of The Week Ponders Project Financing

GlaxoSmithKline has been out ahead of other big pharmas when it comes to investing in venture funds. Its deal with Avalon Ventures represents another flavor of the relationship – investing as a partner rather than as an LP and creating companies around a single drug. But in the rush to mint single-asset companies, are the stakeholders giving short shrift to innovation?

On April 22, GSK joined with Avalon Ventures to form up to 10 start-ups in one San Diego-area facility. Avalon will contribute up to $30 million from its Fund X, and GSK will provide up to $465 million in seed funding, based on development milestones, while retaining an option to swoop in and acquire a company if and when it produces a clinical candidate. Avalon will pick the early-stage prospects, and both companies jointly will approve the formation of new companies.

We’ve seen these deals before, motivated by the neediness of the two parties: big pharma needs low-risk access to external innovation as its own internal labs sputter; VCs need access to funding as their traditional sources dry up. GSK has been particularly active in teaming up with VCs, and seems to be trying out different flavors of collaboration. It invested last January in Sanderling Venture’s Fund VII; and in March 2012, it joined with Johnson & Johnson to invest in Index Ventures’ Index Life VI fund.

The Avalon deal is a new twist, however. GSK is not an LP in the venerable San Diego firm’s Fund X, which closed last year with $200 million in commitments. Rather, it is an investment partner, with the two sides forming syndicates of two for each company they create. They will not look to bring in more investors, officials from GSK and Avalon said this week.  And although GSK’s relationship to Index is as a limited partner, not a roll-up-the-sleeves, company-creation partner, it’s similar to the Avalon deal in one respect: the focus is on single-asset companies.

That’s also DOTW’s focus this week: project financing. Not from the perspective of the VCs who popularized the model and are investing in it like lemmings, but rather from the perspective of the scientists who do the daily work of inventing drugs. From the scientists’ point of view, the asset-centric model isn’t about lower risk and better returns. (After all, it’s an ongoing experiment whose benefits we won’t know for some time yet.) Scientists are asking a different question: is it the best route to innovation?

A single-asset company refers to a virtual start-up formed around a single drug. All staff, funding, planning and operations are geared to advancing that drug to an exit, whether it be the sale of the asset or the company that houses it. The leanness of the operation, and the need to outsource R&D, is thought to lead to capital efficiency. The exclusive focus on a single project is thought to offer operational efficiency and speed to proof-of-concept. The single-asset vehicle can make a clean, attractive package for a buyer, unencumbered with staff, infrastructure and overhead.

Here’s where the contrarian view comes in. Everything is outsourced these days, including synthesis and chemistry, in vitro and in vivo tox, ADME, pharmacokinetics, etc. But not so much target selection or lead optimization. Also, the outsourcing of R&D requires staff to oversee the tasks and manage the relationship – initiating the work, measuring performance and assuring quality, reviewing interpreted data, etc. Depending on the amount and complexity of the work, this can add bloat and cost.

Opinions about the capabilities and quality of CROs vary among scientists. Hermann Mucke PhD, founder of HM Pharma Consultancy, says he “would not trust a CRO's claims of its ability to identify any target, or optimize any lead structure.” He allows that a platform company with a sideline business could do specific target-related tasks quite well, likely better than most companies. But he adds that it’s sometimes difficult to achieve that narrow match. And it also requires more teamwork between internal staff and service provider than classical outsourcing.

Mucke’s last point about teamwork raises another potential problem with the virtual model. In his 1974 book “Lives of a Cell,” Lewis Thomas described the phenomenon of groups of ants, bees, fish, termites or people behaving like a thinking organism. It happens, like magic, when the group reaches critical mass. But does it happen in a virtual company with a handful of employees working from home, sometimes at a considerable remove from the operations? Thomas, who died in 1993, was the former Dean of Yale School of Medicine and New York University School of Medicine, and President of Memorial Sloan-Kettering Cancer Center. He knew something about scientists working in teams.

The short horizon to an exit  also could make it hard to attract top scientific talent. Scientists tend to like to dig deep into a project and are open to following leads thrown up by serendipity. Pfizer’s Xalkori (crizotinib) is a good example. The molecule was discovered at Sugen and came into Pfizer’s portfolio when it acquired Pharmacia, Sugen’s parent. Pfizer scientists at La Jolla, Calif., several of whom started at Sugen, spent seven years hitting crizotinib’s c-MET target before a chance publication in Nature magazine clued them into ALK and set them set them on the right path. Xalkori launched four years later.

Now, getting back to GSK – in siding with VCs, is the pharma seeking speed and cost-cutting advantages or is it hoping to get an innovative drug out of the investment? Are GSK’s interests aligned with its partners?

Beats us. We just thought the question needed to be aired. - Mike Goodman

We also think the following deals merit your patient attention:

Merck/Cerecor: In its second deal with Merck in the past month, on April 19 neuroscience specialist Cerecor acquired exclusive worldwide rights to develop and commercialize MK-0657, Merck’s NMDA (N-methyl-D-aspartate) receptor subunit 2B antagonist for all indications including depression.  The molecule was originally developed by Merck for Parkinson’s disease, but failed to show efficacy in an early study. However it did show a promising signal of antidepressant activity.  Dr. James Vornov, Cerecor’s SVP of clinical development, said his team was particularly interested in the oral drug’s “potential to rapidly reduce depressive symptoms, including suicidal ideation” in patients refractory to available therapies. Terms of the deal were not disclosed. Cerecor will immediately assume full development and commercialization responsibilities. The agreement includes milestone payments and royalties “consistent with clinical stage licenses in neuroscience.” Deals in the psychiatric space tend to feature low upfronts and moderate-large downstream payments, in keeping with the high-risk nature of neuropsychiatric drug development. In March, Cerecor received exclusive worldwide rights to develop and sell Merck’s catechol-O-methyltransferase (COMT) inhibitors, with potential applications in Parkinson’s disease, schizophrenia, and addictive behaviors. Financial terms were not disclosed. Founded in 2011, the start-up specializes in translating early stage neuroscience therapies into early human trials, and developing them for market. Merck’s mid and late-stage neuroscience pipeline shows no candidates for disorders of mood or behavior; but there are two for insomnia, two for neurodegenerative diseases, and one for neuromuscular blockade. - M.G.

AstraZeneca/Alchemia: In its ambition to transform the company through deal-making, AstraZeneca has signed yet another early-stage collaboration, this time a multi-target drug discovery deal with Australian oncology drug developer Alchemia. The agreement, announced April 23, gives AstraZeneca access to Alchemia’s Diversity Scanning Array (DSA) and associated Versatile Assembly on Stable Templates (VAST) chemistry platform to discover novel small-molecule drugs in a multitude of therapeutic areas, including oncology, respiratory and cardiovascular disease. Alchemia will receive an undisclosed upfront payment and is eligible for preclinical, clinical and commercial milestone payments of up to $240 million. The Alchemia’s DSA is a suite of 14,000 novel compounds that scan three dimensional molecular shapes and peptidomimetic functionality. It forms the basis of the VAST discovery platform which can identify the shape and binding elements required for target modulation. The deal is the fifth AstraZeneca has signed since unveiling its turnaround strategy to investors in March; the most recent was with Bind Therapeutics. - Jessica Merrill

Opko Health/Prolor Biotech: Opko Health announced April 24 that it will acquire Israel’s Prolor Biotech in an all-stock transaction valued at roughly $480 million. The stock-swap deal, expected to close during the second half of this year, is structured so that Prolor’s management and personnel will remain in place, serving as the biologics subsidiary of Opko, which already produces small-molecule drugs, vaccines and diagnostics. Prolor’s business focus is on developing longer-acting formulations of approved protein products, with a lead product for growth hormone deficiency, the Phase III human growth hormone hGH-CTP. Prolor intends to begin a Phase III trial in adults later this year, with a plan to position hGH-CTP as a weekly injectable more convenient for both adult and pediatric patients than the current daily-injection therapies. Opko Executive VP Steve Rubin said his firm placed a lot of value on acquiring the GHD product, which has orphan drug designation in both the U.S. and Europe in both adult and pediatric populations. The EU designation would protect the product, if approved, from direct competition for 10 years, he added. “This is the way we’re building Opko,” he said. “This gives us four products that will be in Phase III, which is very important to us. They’ll come on to the market at different times.” During an investor call, Prolor President Shai Novik spoke of how the deal structure – in which Prolor shareholders will receive 0.9951 shares of Opko stock for every full share in Prolor – will give his company’s investors the opportunity for lasting value by participating in Opko as long-term investors. The deal values shares in Opko at $7.03 a piece and Prolor shares at $7.00, a 20% premium over the Israeli firm’s closing price on April 23. - Joseph Haas

Bristol-Myers Squibb/Merck: Confident that its daclatasvir will prove the best-in-class NS5A replication complex inhibitor for hepatitis C, Bristol-Myers Squibb on April 22 signed its second non-exclusive partnership this month to test the compound in tandem with another company’s HCV candidate. The agreement to test Phase III daclatasvir in a Phase II combination trial with Merck’s MK-5172 follows on a similar arrangement signed with Vertex April 5 to test the NS5A inhibitor with nucleotide analog VX-135. The deal includes no financial considerations; Merck will fund the trial, with Bristol only contributing the volume of study drug needed, Doug Manion, Bristol’s senior VP of development, neuroscience, virology and Japan, said. The arrangement is open-ended, like other combo trial collaborations Bristol has entered – if the two companies want to move on to Phase III work with the combination being studied, they need to work out a new agreement. Manion said NS5A inhibition is a compelling pathway for treating HCV, in part because the exact function of the NS5A gene product in HCV is not fully understood. “It’s very complicated,” he said. “It does a large number of things and the virus can’t survive without it, we know that for sure. We were the first company to actually ‘crack the nut’ in terms of how to drug it.” Bristol plans to file the combination of daclatasvir and its proprietary Phase III protease inhibitor asunaprevir for Japanese approval later this year, specifically to treat genotype 1b of the virus, the version most prevalent in Japan. - J.A.H.

Achaogen/BARDA: The private anti-infectives company Achaogen secured $60 million from the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services, to advance its lead program. Disclosed on April 24, the funding is an extension of a 2010 contract with BARDA that brings the total to $103 million. The latest funding will go to conduct a global Phase III superiority study of plazomicin (ACHN-490) to treat patients with serious gram-negative bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE) infections. The trial is slated to start in the fourth quarter. Plazomicin is a next-generation aminoglycoside antibiotic; it’s also being developed against biothreat agents such as Yersinia pestis, which causes plague, and Francisella tularensis, which causes tularemia. Plazomicin is engineered to overcome known aminoglycoside resistance mechanisms. - Stacy Lawrence

Deals Of The Week: It's All About Access

One of the week's most interesting news events came from across the pond as the International Structural Genomics Consortium (SGC) made waves with news of $48.9 million in new funding and two new big pharma drug partners: Eli Lilly Canada and Pfizer.

Whether it's politics, invites to the cool parties, or the next potential blockbuster drug, what's important these days is access --especially when you are on a budget.

Recognizing that it costs a bundle to lock up rights to the next potential hot new drug (witness GSK's spend on Sirtris), big pharmas are devoting more resources to building relationships with academia and the venture community (whether it's through corporate venture efforts or as a strategic limited partner.) But they are also flirting with precompetitive alliances -- and the expanding pool of participants in the SGC consortium is a reminder of the growing importance of this trend.

Indeed, both SGC's newest consortium members have been active in other kinds of open innovation plays. Back in 2008 Pfizer and Lilly joined PureTech Ventures to stake Enlight Biosciences, an early-stage company developing new technologies --for instance novel drug delivery or imaging capabilities-- that could lead to better medicines. And in 2010, Pfizer also joined forces with four other pharmas to fund Ablexis, a next-generation antibody discovery play founded by ex-Abgenix execs.

Lilly, meanwhile, has spent the last two years building a web portal that allows outside researchers to submit compounds for interrogation using its proprietary drug-discovery assays. The project, which this week was expanded and rebranded the Open Innovation Drug Discovery initiative (OIDD), is part of an ongoing effort by Lilly to promote collaboration via providing biotechs and unis free access to nearly a dozen assays designed to measure cellular responses and mechanism of action data to potentially interesting compounds.

The SGC collaboration, like the Ablexis and Enlight efforts, is also focused on new tools that could be critical to drug discovery. As its name implies, one key element is the creation of three-dimensional protein structures for use in structure-based drug discovery. With the additional funding from Lilly and Pfizer, however, SGC is expanding its focus to epigenetics, a hot area of science that has been the focus of early-stage deal making and spawned the creation of two A-list biotechs, Epizyme and Constellation. SGC aims to use its protein structure and synthesis capabilities in this arena to create new chemical compounds and antibodies that block potential proteins that cause disease by epigenetic mechanisms. The findings, including the actual reagents, will be made available to the worldwide research community.

Why would Lilly and Pfizer, as well as existing SGC consortium members GlaxoSmithKline and Novartis, put money and in-kind med chem resources into an effort that will broadly disseminate its findings to the biopharma community at large? Because the companies are betting they will be more successful competing at the level of the compound rather than in the development of the technology itself. In other words, they have a better chance of creating the first-in-class or best-in-class version of compound X if they have access to better, more robust technologies, which by the way take time and are expensive to develop in-house.

Is such open access going to solve the industry's R&D productivity crisis as some have claimed? Probably not, given the redundancies of human biology and the reality that drug development is intrinsically hard. But a mindset that resources can be shared, thus obviating the need for duplicative infrastructure, is an important step forward and a trend likely to gain steam as successes mount from SGC and other public-private endeavors like the Innovative Medicine Initiative.

In the meantime, IVB is open 24 hours a day, seven days a week with an inside track to the week's deal making news in another edition of...

Karuna Pharmaceuticals/Vanderbilt: In the latest neuroscience-focused tie-up between Vanderbilt University researchers and a biopharmaceutical company, the Vanderbilt Center for Neuroscience Drug Discovery has licensed three preclinical compounds for schizophrenia to Boston-based start-up Karuna Pharmaceuticals. No financial terms were disclosed for the deal, which centers on glycine transporter one (GlyT1) inhibitors designed to address not only the hallucination and delusion associated with schizophrenia but also depression, ahnedonia, and memory loss, symptoms that can prevent patients from holding down jobs and living independently. VCNDD, which focuses on molecules that target the brain’s glutamate system, developed the GlyT1 compounds in part with $10 million in grant funding from the National Institute of Mental Health. VCNDD has been creating a lot of R&D buzz lately: in mid-September, it pulled in an undisclosed milestone payment after delivering preclinical candidates for fragile X syndrome to Seaside Therapeutics; thanks in part to grants from the Michael J. Fox Foundation, it's also advanced three mGluR4 agonists into the latter stages of preclinical development for Parkinson’s disease. Interestingly that latter arrangement allows VCNDD to retain all the intellectual property tied to the mGluR4 agonists. The next step could be another out-licensing, since VCNDD is looking for a biopharma partner to bring them into clinical development.—Joseph Haas

Ipsen/Photocure: Back in June, mid-sized Ipsen promised disgruntled investors it would shift to a specialty pharma strategy in its uro-oncology franchise, jettisoning R&D in favor of late-stage and commercial in-licensing. The company’s Sept. 27 in-licensing of worldwide ex-U.S and ex-Nordic rights to Photocure’s marketed bladder cancer diagnostic, Hexvix, suggests it’s doing what it said it would. There’s no technological or regulatory risk associated with Hexvix: it’s already approved in Europe (since 2006) and in the U.S. (since 2010). The product is designed to induce fluorescence only in malignant cells in the bladder during a cystoscopic procedure, thus improving the detection and resection of non-invasive bladder cancer.The risk is on commercial execution: Hexvix is a drug-device procedure that requires more sophisticated selling than a pill or even an injection.It’s reimbursed in ‘most major European markets’, according to the company, but sales have been patchy. Certainly GE Healthcare, which had held ex-Nordic rights to sell Hexvix since 2006, was apparently happy to give it up, citing a strategic shift away from urology. Hexvix sales are estimated to reach €14 million for 2011, giving an immediate, if small, boost to Ipsen’s revenues. And since the French group will give Hexvix to an existing sales force detailing prostate-cancer treatment Decapeptyl (a GnRh analog), incremental costs will be minimal. Ipsen pays €19 million up front, most of which goes to GE, which built up the current sales base in Europe. Photocure takes €1.5m at signing and €5m tied to some additional transition milestones in the next month, according to COO Kathleen Deardorff. More importantly, the Norwegian group is in line for double-digit sales royalties and manufacturing revenue. It also books top line revenue in the Nordic region, and retains US rights.--Melanie Senior

Lundbeck/Proximagen: Denmark's Lundbeck might be facing the imminent loss of patent protection on its blockbuster antidepressant, escitalopram (Cipralex/Lexapro), but it's still finding the time to look for early-stage product opportunities. It announced September 28 that it was going to work closely with the UK biotech, Proximagen, applying its clinical development expertise to three of that company's research programs in return for an opportunity to negotiate rights to interesting products. The areas of focus? Neuro-inflammation, neuropathic pain and epilepsy. Lundbeck will also make an equity investment of $16.1 million in Proximagen, giving it a 9% stake in the biotech. The companies have been working on setting up the strategic partnership for some time, and the alliance shows how in the competitive CNS space, players like Lundbeck, which is increasingly competing for high priority CNS assets with deeper pocketed pharmas, see an opportunity by aligning ever earlier in the drug development process. Proximagen raised more than $80 million two years ago, and is pursuing a risk-mitigating strategy of acquiring compounds at good-value prices and developing them with partners, while holding onto certain rights, usually for Europe.--John Davis

Biotie/Newron: In a deal weighty with balanced risk, Finland’s Biotie Therapies agreed to acquire Newron Pharmaceuticals of Italy in an all-stock deal. The agreement, which values Newron at €38 million ($52 million) plus €7 million in contingent value rights, gives it the potential upside of Newron’s Phase III Parkinson’s candidate safinamide, already partnered with Merck Serono. If the drug is approved, Biotie could receive milestone payments estimated at €48 million, plus sales milestones worth up to €60 million and royalties. But if the drug fails, Biotie will essentially be out €28 million, since Newron currently has €10 million in cash. It won’t cost Biotie much otherwise, since Merck Serono is funding safinamide’s late-stage trials. Further Phase III data are expected in the first half of 2012. The deal brings very weak returns to Newron’s stakeholders, who have invested about €200 million since 1999, but represents a 38% premium over its last closing price prior to the Sept. 27 deal. Biotie’s other drug candidate, nalmefene for alcohol dependence, is partnered with Lundbeck and is due to be filed for approval later this year; Newron withstood the failure of late-stage neuropathic pain candidate ralfinamide last year. – Paul Bonanos and Melanie Senior

Image: flickrer Ben Zvan / Creative Commons.

Vanda/Novartis: ... And the Circle of Life is Complete

The surprise approval of iloperidone (Fanapt) earned back in May by Vanda Pharmaceuticals had a lot of people (OK maybe just us?) scratching their heads to come up with comparable instances of molecules that were dumped by pharma and eventually made it to market. Like our lion king friends here, they also had to crane their necks to see where Vanda's stock price went.

Sure there are some ex-pharma molecules that wind up getting on the market (you helped us come up with half a dozen or so), but there aren't a lot. And that's a fact that biotechs eager to in-license discarded pharma assets needed to reckon with.

Vanda's unlikely success with iloperidone continues. Last night the biotech announced it was selling US/Canadian development and commercialization rights to Fanapt back to Novartis, for $200 million, plus milestones and royalties. It's the circle of life!

Novartis is now responsible for the drug's development in the US and Canada, "including the development and commercialization of a long-acting injectable (or depot) formulation of Fanapt," says the release. Vanda keeps rights to both formulations outside of those territories and will pay Novartis a royalty, though Novartis has an option to negotiate for those rights. Vanda investors like the deal--the company's stock is up again (this time only 35% or so).

As a reminder, here's the molecule's long and colorful business development history: In January 1997, Hoechst licensed the drug to now-tiny Titan Pharmaceuticals. Titan turned around later that year and licensed the drug to Novartis. Novartis and Titan ran into trouble in Phase III when the drug was shown to cause QT prolongation; Vanda took on development of the drug in 2004, and received the Not Approvable letter from FDA last July. The FDA's 180-degree shift to APPROVED came in May 2009.

Has Novartis pulled off the old don't-want-it-oh-wait-actually-we-do-want-it before? Yes, with Speedel Group's Tekturna renin inhibitor for hypertension. That deal was a little bit more straightforward, and certainly designed with the claw-back in mind (Novartis eventually bought out Speedel for nearly $900 million, so it was more expensive too).

Iloperidone may not be the kind of asset that pushes Novartis to snap up all of Vanda in the same way. But after this drug's twists and turns, you'd be crazy to rule it out.

WTF? Regulatory Victory for Vanda's Iloperidone after FDA U-Turn

Does the approval of Vanda's iloperidone (now given the 'just for you, crazy sportsfan!' name of Fanapt)--deemed Not Approvable by FDA only nine months ago--signal a shift at the agency around use of comparative effectiveness considerations in approval decisions?

The atypical antipsychotic was approved yesterday for acute treatment of adults with schizophrenia, and marks a significant turnaround from last July. As we wrote then:

The company and its rejected investigational atypical antipsychotic drug iloperidone appear to be a marker in the ongoing debate over whether FDA is increasingly using a comparative efficacy standard when considering new drug approvals.

There was plenty of reason to draw that conclusion. Though Vanda said FDA deemed the drug effective against placebo and having similar efficacy to Pfizer's Geodon, it was concerned about how the drug fared against other comparators, specifically Lilly's Zyprexa or J&J's Risperdal. It also wanted more safety data on the drug's higher, 24mg, dose. The agency was requiring further studies, Vanda said.

Remarks by FDA's 'dean of the drug approval process' Bob Temple at an Institute of Medicine meeting only days later seemed to support the notion that comparative effectiveness was becoming a standard hurdle in certain crowded drug classes. He clarified those remarks in an interview with RPM Report's Ramsey Baghdadi a few days later.

“At the IOM, I was explaining what I perceive drug companies to be perceiving and doing, not describing an FDA standard. That is what I was referring to when I said that ‘It’s getting harder to develop the third, fourth, fifth, and sixth member of a class of drugs because when there’s a generic available [within a class], people are inclined to use the cheap one. ...

"It seems apparent that in my statement I was referring to my impression of what companies are doing to have a commercially viable product when there is a generic available for the drug class, and was not referring to any FDA requirement. In most settings, especially for symptomatic treatments, we do not get or ask for comparative data and are perfectly willing to approve a drug that is shown effective."

And in the end, FDA didn't require the kind of large and expensive head-to-head trial that seemed on the cards for Vanda. In September 2008 Vanda reported it had met with FDA to make its case, and that it would file a complete response to FDA's letter. In November, the agency accepted the resubmitted NDA with a decision deadline of May 6, 2009.

It has been far from smooth sailing for Vanda in the meantime. The company did some December restructuring and earlier this year has spent time fending off activist shareholder and 15% Vanda owner Kevin Tang, who proposed back in February to install himself and a colleague at Tang Capital Management on Vanda's seven-member board, presumably to facilitate the liquidation of the company that he has been calling for. The situation escalated only a month ago (See The Pink Sheet Daily for details.).

And yesterday came the approval--hardly a nuisance for Tang, considering the biotech's shares were up more than 800% (yes, EIGHT HUNDRED, that's not a typo) in after-hours Nasdaq trading. Maybe he'll send flowers. (UPDATE: Vanda says Tang has formally withdrawn his proposal to replace the board and call for a shareholder vote on liquidation. Still no word on flowers.)

So what on earth has changed? Vanda's case to FDA must have been convincing. Today the company is trumpeting Fanapt's mild effects on weight in a space where weight gain is a significant issue, and the way patients often switch between antipsychotics--making any safe and effective option worth having.

Does that explain the U-turn? Given the stock's movement, clearly few investors were betting on a happy FDA outcome for Fanapt. Perhaps more complex, political forces are at work?

image from flickr user mag3737 used under a creative commons license.

While You Were Just Happy to Be Nominated

The Coen brothers didn't so much as provide the drama of a coin toss before slaughtering the competition last night, as their adaptation of Cormac McCarthy's No Country For Old Men took home four Oscars (including three for the Coens--best picture, best director, best adapted screenplay). Here are a few things you may have missed while being otherwise preoccupied by a psychopath with a cattlegun and a bad haircut:

• In a deal valued at up to $1.5 billion, Irish biopharmaco Elan may be spinning off its drug delivery technology unit, according to the Sunday Times (via Reuters).
  
• Theravance said on Saturday that FDA's planned advisory committee review of its antibiotic televancin was canceled. The meeting, scheduled for Wednesday, was to discuss Theravance's NDA for televancin in complicated skin and soft tissue infections; televancin was deemed 'approvable' by the agency last October. No word yet on the reason for the cancelation.
  
• The New York Times profiles the evolving science of schizophrenia treatment, focusing on Eli Lilly's development of the glutamate-modulating drug candidate LY2140023, led early on by neuroscientist Darryle Schoepp (who has since moved to Merck).
  
• The Boston Globe reveals the latest FDA insight: all employees must wash hands. Yes with soap!