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Posts Tagged ‘kidney-disease’

TODAY’S HEADLINES:

deltanoid-logo.gifDeltanoid Pharma raises $12M for kidney drugs — Deltanoid Pharmaceuticals, a Madison, Wis., drug developer focused on new forms of vitamin D for use against kidney disease, raised $12 million in a second funding round. The company’s PDF release is here.

Investors in the round included the Wisconsin Alumni Research Foundation (WARF), a tech-transfer organization associated with the University of Wisconsin, and two VC firms, Mason Wells and Venture Investors. Deltanoid is developing new “analogues” of the vitamin D molecule with possible utility in treating osteoporosis and kidney disease. The company has licensed one drug candidate to Pfizer, and so far has raised a total of $16 million.

covx-logo.gifCovX, cancer and diabetes-drug biotech, acquired by Pfizer — CovX, a La Jolla, Calif., biotech developing synthetic molecules with potential uses in treating cancer and diabetes, was acquired by Pfizer as part of the drugmaker’s expansion into biotech. Terms of the acquisition weren’t disclosed; the release is here.

CovX has been pursuing an interesting attempt to build new drugs out of the short protein fragments known as peptides. While peptides can have potent drug-like effects against various biological “target” molecules, they are often broken down quickly in the body. CovX has developed a new class of molecules that it calls — a bit too cutely — CovX-bodies, which purportedly combine the efficacy of peptides with the longer lasting effects of monoclonal antibodies, although of course it doesn’t specify exactly how.

The company’s pipeline includes two inhibitors of angiogenesis — or blood-vessel formation — which might be useful in treating cancer, as well as molecules that mimic metabolic processes that go awry in diabetes. None of its drug candidates have yet entered human testing.

(UPDATED: See below.)

relypsa-logo-1.jpgA common dilemma in biotech acquisitions is how to keep a startup’s entrepreneurial management happy and productive when they’ve just been assimilated by the Borg. The answer, often enough, is not to bother, and to let them spin out a new company with scientific “leftovers” that weren’t the point of the acquisition in the first place.

That’s more or less what Amgen has just done in launching Relypsa, a new Santa Clara, Calif., biotech just spun out of the big biotech’s Ilypsa unit. Relypsa is basically a full restart of Ilypsa — thus the name, I suppose — which Amgen acquired earlier this year for roughly $420 million (see our coverage here).

Of course, the new startup now lacks the kidney-disease drug (specifically, a treatment for hyperphosphatemia) that Amgen had shown particular interest in. But Relypsa is free to rev up its existing drug-discovery platform — one focused on making drugs out of long-lasting polymers that grab and eliminate excess molecules such as potassium or sodium — and also managed to keep a pipeline of promising candidates that might one day be useful in treating kidney and heart disease.

Such restarts of acquired biotechs aren’t unknown in the industry, although they’ve been growing in popularity. For instance, the former management of Eyetech Pharmaceuticals recently banded together to form Ophthotech with technology left over from Eyetech after it was swallowed by OSI Pharmaceuticals (our coverage here). This sort of strategy is likely to hold increasing relevance for Big Pharma as its companies fire up their biotech-acquisition machines.

The Relypsa deal, however, may set records for speed and continuity. The former CEO of Ilypsa, Jay Shepard, reprises that role at Relypsa; Ilypsa co-founder Garrett Klaerner returns as COO; and Ilypsa’s former chief medical officer Detlef Albrecht now resumes that position at Relypsa. (Honestly, props to whoever came up with the name “Relypsa,” because it’s really apropos here.) And so on down the line.

Relypsa raised $33 million in a first spinout round, with investors that included 5AM Ventures, New Leaf Venture Partners, the Sprout Group, Delphi Ventures, CMEA Ventures and Mediphase Venture Partners. Amgen, of course, retains a minority stake in Relypsa, and probably insisted on some form of right-of-first-refusal should Relypsa get interested in striking a partnership with — or selling itself to — another company. (I’ve asked Relypsa’s representatives about that, and will report back if I learn more.)

UPDATE: Relypsa’s external PR person got back to me on the right-of-first-refusal question, but kudos to you if you can make any sense of it. Here’s the response in its entirety: “Amgen retained certain rights related to transferred programs customary for spin outs at this stage. Relypsa will initiate partnering campaigns for certain indications and territories as appropriate.” Well, that was helpful. Sometimes I wonder why I bother asking.

UPDATE REDUX: In a later interview, Relypsa COO Gerrit Klaerner told me that “of course” Relypsa has an “entanglement” with Amgen, although he wouldn’t go much further than the official statement in describing Amgen’s particular rights. “There is enough skin in the game for Amgen to keep an interest in Relypsa,” he said. “If you see us doing a partnership, you will get an answer to your question.”

Klaerner added that the idea of recreating Ilypsa came up shortly after the acquisition. “We wanted to save a bunch of jobs and create a new home for the technology,” said Klaerner, who worked as an advisor to 5AM for the deal. “We had 38 people who, after the success of Ilypsa, had multiple job offers and asked them to stick with us, even though the company wasn’t really created.” What’s more, he said, Amgen’s backing of the deal didn’t waver despite the company’s recent woes (see, for instance, here). “Given what they were going through, to give this level of high-level support was really, really remarkable,” Klaerner said.

Oh, and the name Relypsa was apparently an internal placeholder that turned into the real thing when no one could think of anything better, Klaerner said.

FINAL UPDATE: I started thinking about other recent deals that resemble Ilypsa-Relypsa after an email correspondent planted the bug in my ear. The one that comes most immediately to mind would be the launch of Sequel Pharmaceuticals — another clever name — out of NovaCardia’s acquisition by Merck (our coverage here). Another example would be Cerexa Pharmaceuticals, which spun out of Peninsula Pharmaceuticals in 2005 after Peninsula was purchased by J&J. Cerexa was acquired by Forest Labs this past January, and doesn’t appear to have launched another spinout.

Have any other good examples? Sound off in comments.

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Cary, N.C.-based NephroGenex, a biotech developing personalized therapies for kidney disease, raised $3.3 million of an expected $26.8 million first funding round, VentureWire reports (subscription required), citing an SEC filing (no link available). There’s another report that cites PE Wire here.

Care Capital, BioStratum and Vanderbilt University are all 10 percent investors in the company, according to VentureWire.

NephroGenex’s aim is to tease apart a variety of different diseases that are generally lumped together as “kidney disease” by closely examining the activity of genes in the kidney’s filtration unit, the glomerulus. In so doing, the company hopes to figure out which of these conditions might be most responsive to drug treatment. In May, the company licensed commercial rights to BioStratum’s drug Pyridorin, and hopes to accelerate clinical trials of the drug by identifying patients whose kidney disease is progressing rapidly.

ilypsa-logo.JPGBiotech powerhouse Amgen agreed to acquire Santa Clara, Calif.-based Ilypsa, a developer of drugs to treat complications of kidney disease, for $420 million in cash, roughly ten times what the company had raised in venture capital. The company’s release is here.

The high price could mean Amgen had to win a bidding war for Ilypsa, since one of the startup’s main investors was none other than the venture arm of Amgen archrival Johnson & Johnson.

Ilypsa has focused on drugs that can help prevent mineral buildups in the blood that result when the kidneys’ filtering system starts to go awry. The company’s lead drug candidate, ILY101, is designed to prevent dangerously high blood levels of phosphorus, a condition known as hyperphosphatemia, by binding to phosphorous in the digestive tract and preventing its absorption into the body. ILY101 is currently in mid-stage human testing. Other candidates in Ilypsa’s pipeline include similar binders for potassium and sodium.

Amgen, whose best-selling drugs are a family of anemia treatments often used in place of blood transfusions in kidney patients, has shown off-and-on interest in treatments for other complications of kidney disease. In 2004 it launched Sensipar, a drug it licensed from NPS Pharmaceuticals in 1996 that treats elevated levels of parathyroid hormone and calcium in kidney patients. Annual sales of the drug, however, haven’t yet topped $100 million.

Ilypsa, formerly known as Symyx Therapeutics, had previously raised $46 million in venture capital, according to VentureWire (subscription required). That includes what the company originally described as an $8 million first round in 2003 and a $36 million second round in mid-2005.

From VentureWire:

Sprout invested in a $10 million Series A round in 2003 alongside 5AM Ventures. The company went on to raise a $36 million Series B round in 2005, that included Sprout, 5AM and new investors CMEA Ventures, Delphi Ventures, Johnson & Johnson Development Corp., Mediphase Venture Partners and U.S. Venture Partners.

100px-erythropoietin.jpgIs the bell tolling for EPO? – The news keeps going from bad to worse for the wonder drugs of biotech — the anemia treatments known as ESAs or EPO, shorthand for “erythropoiesis stimulating agents” and “erythropoietin,” respectively. Earlier today, an FDA advisory panel recommended new warnings for the drugs, which stimulate the production of oxygen-carrying red blood cells, as well as fresh clinical studies on their safety. Recent studies in kidney-dialysis patients linked higher doses of ESAs to heart problems and strokes, while studies in cancer patients treated for chemotherapy-related anemia have suggested that the treatments don’t improve patient survival, and may even cut lives short — possibly by encouraging tumor growth.

New restrictions, which the panel didn’t spell out, could put a serious crimp in ESA sales, which currently amount to billions of dollars for Amgen and Johnson & Johnson. The two companies have also been taking a public-relations battering in terms of how they promote the drugs. Yesterday, the NYT ran a front-page piece that detailed how rebates offered by Amgen and J&J encourage doctors to overuse the drugs, and today the WSJ followed with a look at whistleblower allegations that J&J boosted EPO sales by pushing higher-than-approved doses.

It’s worth remembering that while the storm is currently walloping industry giants like Amgen and J&J, plenty of smaller biotechs that have staked their hopes on getting into the anemia-treatment game could eventually be affected as well. These companies include Affymax, FibroGen and Neose. Only Affymax is public; another potential ESA competitor, GlycoFi, was acquired by Merck last year.

First embryonic stem-cell trial edges forward – By early next year, Geron plans to be injecting recent spinal-injury patients with nerve cells grown from embryonic stem cells, in hopes of regenerating damaged nerve pathways. This trial was supposed to be underway already, but last year the FDA requested more animal data for safety purposes. Geron CEO Thomas Okarma says the treatment will have been tested in 2,000 animals before it ever reaches humans. The FT’s Clive Cookson has the story.

Aggressive treatment leads to worse “quality of death” in cancer patients – File this one under things you already knew but didn’t want to think about. A study of 243 advanced cancer patients revealed that a greater number of aggressive treatments — including the use of ventilators and non-palliative chemotherapy — in the last week of life was associated with greater physical and psychological distress and a lower chance of dying in a preferred location (often home). Money quotes:

[Said study lead author Gabriel Silverman:] “These results suggest that when patients are actively dying, the use of aggressive treatments should be considered with caution and only pursued with the full understanding of patients or their surrogate decision makers.

[...]

“As a doctor, if I had a patient or family who wanted aggressive, life-sustaining care toward the end of their life, I would view it as a red flag warning of patient or caregiver distress,” Dr. [Robert] Arnold [of the University of Pittsburgh] concluded. “Often patients and their families are suffering, sad, or distressed at the end of life, and when dying occurs in medical settings they may hope that aggressive treatment will help the suffering, but often it doesn’t.”

Tau gets a little respect – For the past decade or so, Alzheimer’s researchers have concentrated their attention on beta amyloid, the protein that clumps around neurons in “tangles” visible in the autopsied brains of many — though not all — Alzheimer’s patients. Now comes evidence that a dark-horse protein called tau may also bear some responsibility for the disease. Researchers reported last week in Science that they reversed memory loss in mice by tinkering with their genes to produce lower levels of the tau protein. It’s heartening to see competing theories getting some attention in the Alzheimer’s community, which has had an unfortunate tendency to shun researchers who strayed from the majority opinion, but don’t expect beta-amyloid supporters to give much ground until they have to. That might be soon, as a new batch of drugs designed to block formation of beta-amyloid tangles should begin reporting data from human trials later this year.

New genetic heart-disease link – Another whole-genome association study has identified a new genetic variation that appears to increase heart-attack risk by 60 percent in European populations. The catch is that the variation doesn’t appear to be associated with any known gene, and instead exists in the long stretches of non-coding, or “junk,” DNA, meaning that no one has any idea why it should have any effect on heart-attack rates. The NYT has more.

Stem-cell researchers make like Willie Sutton – Near the end of this otherwise unremarkable account of a talk by James Thomson, the Wisconsin researcher who first isolated and grew human embryonic stem cells, comes this interesting nugget: Thomson will open a “satellite laboratory” on the UC Santa Barbara campus for stem-cell collaborations with UCSB researchers. Coincidentally enough, having a presence in the state might also qualify Thomson for funding by California’s $3 billion stem-cell program. Willie Sutton, you’ll recall, is the outlaw who once proclaimed that he robbed banks “because that’s where the money is.” Some sentiments, it seems, are universal.

Hypocrisy in the generic-biologics fight? – The prospect of legislation that clears a path for “generic” versions of expensive biotech drugs appears to have dimmed significantly. But biotech consultant and blogger David Williams — no fan himself of the push for “biogenerics” — notes that biotech companies and their lobbyists may be shooting themselves in the foot when they argue that biogenerics could never be “identical” to branded products now on the market. It’s worth reading his entire post — it’s not long — but the gist is that changing the manufacturing process for name-brand biotech drugs, which happens all the time, opens up the same “equivalence” issues that BIO and its allies find insurmountable where biogenerics are concerned. The main difference is that name-brand manufacturers can handle the issue with short, inexpensive “bioequivalence” trials — but they insist that biogenerics must undergo expensive, full-blown clinical testing to assure their efficacy and safety. If the biogenerics issue heats up again, don’t be surprised to see this argument make a comeback.

Surgical robots in space, stem cells in rodent eyes – These are just two interesting stories from the San Jose Mercury News I haven’t yet had a chance to mention. Last Sunday, the Merc ran this piece on efforts to automate surgery, with the ultimate goal of building robots that could operate on astronauts in space or soldiers on the battlefield. Far off and far out stuff. Similarly, this piece outlined the possibility of growing new blood vessels using an early and highly regenerative stem cell called a hemangioblast. Ultimately, these fast-growing cells could one day regrow blood vessels in the heart, eyes or limbs that were damaged by injury or disease.

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