kidney disease

Pharmacopeia cuts 15% of workforce

Fri, 30 May 2008 06:59:57 -0400

In an effort to streamline its business and save cash, Pharmacopeia is laying off 15 percent of its workforce and decreasing "other expenses through improved operational efficiencies and increased financial discipline." The layoffs are part of the company's ongoing effort to focus resources on clinical and later-stage discovery programs.

Earlier this month Pharmacopeia announced positive trial results for PS433540, a hypertension drug. In a statement, interim CEO Joseph Mollica said it was the right time to put more resources towards the drug development. "In order to maximize shareholder value it is essential that we focus our efforts on the programs that can provide the greatest return," noted Mollica. The company is also testing PS433540 as a kidney disease treatment. Pharmacopeia expects the layoffs and other cost reduction efforts to save $10 million in 2009.

- see Pharmacopeia's release

Biotech CEO mixes business with vacation-home pleasure

Wed, 21 May 2008 06:59:54 -0400

If you've been pondering the best way to set up your biotech company's corporate retreat, consider the case of Dr. Brian Pereira, the CEO of Amag Pharmaceuticals, which is developing an iron replacement therapy for chronic kidney disease patients. He and his wife came across a two-acre island site off the coast of Maine 10 years that featured a World War II era bunker. They subsequently built a vacation house over the bunker, where execs can do some annual strategic thinking.

Exactly what they'll do to refurbish the 12,000-square-foot bunker, though, hasn't been decided. On the list: art gallery, heating and cooling plant for the house and a kind of storage shed for island wine enthusiasts.

"We do company executive retreats there," Pereira tells the Boston Globe. "The company saves money, and the team gets a good bonding experience at my home."

- read the report from the Boston Globe

Safety, efficacy problems sink Takeda drug

Fri, 28 Mar 2008 07:59:58 -0400

Japan's Takeda has walked away from development of its once-promising cholesterol drug TAK-475. The first sign of trouble came late in October, when the FDA recommended Takeda stop trials using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. Takeda discontinued TAK-475 development because, according to a release, the drug's profile was not superior to existing marketed drugs from both efficacy and safety standpoints. TAK-475 is a squalene synthase inhibitor which, had it been successful, would have been the first drug of its kind on the market. Takeda badly needs another blockbuster in its pipeline to make up for the loss of Actos patent protection in 2011.

In order to fill the gap, Takeda said it will aim for the "earliest possible launch of SYR-322 and TAK-390MR of which NDAs are now under review by the FDA, and for earliest possible NDA submission of the development projects in the late stage such as Hematide, a treatment for chronic kidney disease related anemia and cancer related anemia, and Lu AA21004, a treatment for mood and anxiety disorders."

- see Takeda's statement

Related Articles:
Safety questions cloud future of Takeda's TAK-475. Report
Takeda expands R&D budget, may look for buyout. Report
Takeda scraps licensing deals, inks $100M pact. Report

Keryx shares in meltdown after late-stage failure

Mon, 10 Mar 2008 07:59:58 -0400

Keryx Biopharmaceuticals' stock price wiped out this morning on the rocky shores of a failed late-stage trial of its lead drug, Sulonex, for diabetes. The news landed in a market that has little stomach for failure, and Keryx shares swiftly lost 81 percent of their value. Keryx shares were trading for $1 in after-market trading, down from $5.26 on Friday's close and a high of $11.70 last summer.

Researchers say the drug failed to hit its Phase III primary endpoint: therapeutic success at six months compared to placebo. But all is not lost, insists CEO Michael Weiss, who says Keryx will now focus on its experimental therapies for kidney disease and cancer--both in mid-stage development.

"While this represents the end of one chapter for Keryx, it is not the end of Keryx," said Chairman and Chief Executive Michael S. Weiss in a statement. "Drug development is inherently risky and, accordingly, we have spent the last several years building what we believe to be a promising product portfolio in the event our lead drug failed."

- see this release on the failure
- check out the AP report

Related Articles:
Keryx inks $100M deal with Japan Tobacco. Report
Keryx sells shares. Report
Keryx drug best at low dose. Report

Shire's Fosrenol flunks mid-stage trial for CKD

Tue, 06 Nov 2007 06:59:54 -0500

Researchers for Shire say that the chronic kidney disease drug Fosrenol failed to hit its primary endpoint in a mid-stage study. The primary endpoint focused on the control of serum phosphate to within normal levels. But the company highlighted the fact that the data indicates that the drug can effectively reduce serum phosphate levels in chronic kidney disease patients not on dialysis.

"This study provides valuable insights into the evolution of kidney disease and the development of the hyperphosphatemic state in patients with CKD," said Raymond Pratt, vice president and scientific leader for the Renal Business Unit of Shire Pharmaceuticals. "There is a paucity of data in this population and this study marks an important step toward learning more about the management of this patient population--and importantly, shows that a little bit of kidney function still goes a long way to maintain phosphate balance."

- read the release on the trial results

Related Articles:
Shire on lookout for acquisitions. Report
Who's next on the biotech buyout hit list? Report
More takeover targets for Big Pharma. Report
Should Pharma take the M&A cure? Report
Shire to Massachusetts: Pass incentive bill now. Report
FDA approves Shire's new ulcerative colitis drug. Report

ALSO NOTED: Schering-Plough touts trial; Novartis pain therapy wins approval; New study for HIV vaccine; and much more...

Mon, 22 Oct 2007 06:59:50 -0400

> Schering-Plough says that a mid-stage trial of its experimental oral thrombin receptor antagonist (TRA) demonstrated that the therapy was safe and did not increase major or minor bleeding in patients with acute coronary syndrome or prior ischemic stroke when added to standard antiplatelet therapy. Release

> Novartis' Voltaren Gel, a topical therapy developed for pain associated with osteoarthritis, has won FDA approval. Release

> Genzyme has won the FDA's approval of Renvela, a new version of its drug for chronic kidney disease. Release

> Inovio Biomedical and Ichor Medical Devices are planning the first human study to determine if Ichor's device can deliver an HIV vaccine into human cells. Report

> Raptor Pharmaceuticals has acquired its first clinical-stage product and launched a new subsidiary--Bennu Pharmaceuticals--to advance internally discovered drug candidates. Release

> Rockville MD-based Sequella says that the FDA and the EMEA have granted its lead drug program, SQ109, orphan drug status for the treatment of TB. Release

> The concerns about cough-and-cold meds for kids culminated Friday in an FDA advisory group vote against the products. Report

> Why should Medicare pay for Lucentis? Report

And Finally... Even as the overall cancer death rate is down, some cancers are killing more people. Article

Exelixis therapy fails in Phase II trial

Tue, 16 Oct 2007 06:59:58 -0400

Exelixis is reporting that one of its experimental therapies for diabetic nephropathy failed to hit its primary endpoint in Phase II. The kidney disease is brought on by chronic diabetes. Researchers had hoped to see statistically significant results for XL784 in reducing proteinuria, excess protein in urine, compared to a placebo. XL784 is described as a potent small molecule inhibitor of MMP2 and ADAM10, metalloprotease enzymes that may play a role in renal fibrosis and impairment.

Under the terms of its development pact with GlaxoSmithKline, Exelixis will submit the data to Glaxo to see if the pharma company wants to take the drug as one of three drug candidates it has options on. In the meantime, Exelixis plans to continue to analyze the data to see how, and whether, it wants to pursue more research.

- check out the release on the trial data

Read more on: Exelixis | Diabetes | GlaxoSmithKline

ALSO NOTED: Advanced Magnetics touts Phase III data; MicroIslet makes staffing changes; and much more...

Mon, 23 Jul 2007 06:59:50 -0400

> Advanced Magnetics has announced preliminary positive results from its fourth and final planned Phase III clinical trial of ferumoxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients. Release

> It's hard to decipher, but 'staffing changes' have been announced by MicroIslet in a new release. Release

> Depomed and Watson Pharmaceuticals have inked a deal to co-promote the extended-release version of Depomed's urinary tract infection treatment ProQuin. Release

And Finally… Roche's low-key recall of the AIDS drug Viracept has roiled the treatment of many of the world's poorest patients. Article

Press Release: Osprey Pharmaceuticals Limited Secures $9 Million In Financing

Maureen Martino — Tue, 30 Jan 2007 11:24:55 -0500

Osprey Pharmaceuticals Limited Secures $9 Million In Financing, Including $3 Million In Venture Debt From MMV Financial

MONTREAL, and TORONTO, Jan. 30 -- Osprey Pharmaceuticals Limited, a privately held biotechnology company focused on treating chronic diseases through a family of first-in-class therapeutic proteins, announced today that it has secured US $9.0 million (CA $10.5 million) in financing, including US $6.0 million (CA $7.0 million) in tranched convertible debt from existing investors and $3.0 million (CA $3.5 million) in venture debt from MMV Capital an arm of MMV Financial.

Osprey will use the proceeds from the financing to complete preclinical development work and fund early clinical trials of its lead product candidate, OPL-CCL2-LPM, for patients with chronic kidney disease. OPL-CCL2-LPM is a Leukocyte Population Modulator (LPM), one of 12 chemokine-based proprietary proteins developed by Osprey to selectively and systematically destroy disease-related leukocytes. The company plans to begin clinical trials of OPL-CCL2-LPM in the third quarter of 2007.

"Osprey has built an innovative technology platform for the development of drugs against a wide array of clinically important applications, including chronic kidney disease, multiple sclerosis and cancer," said Jacques Perreault, Senior Vice President, MMV Financial Inc. "We at MMV are excited about working with the company and our investment partners to build Osprey as a leading and innovative biotechnology company."

"This financing enables Osprey to enter the clinic with its lead compound this year, and to begin moving our portfolio of 12 preclinical candidates through the pipeline," said Phil Coggins, PhD., Chief Executive Officer and President of Osprey. "Support from prominent investors such as MMV is a great validation of our firm's technology and business model, and we are extremely pleased to have added MMV to our high caliber group of backers."

The convertible debt placement was led by GeneChem Therapeutics Venture Fund and included Series A shareholders Desjardins Capital Regional et Cooperatif, BDC Venture Capital and Western Technology Seed Investment Fund.

About Osprey Pharmaceuticals Ltd.

Osprey Pharmaceuticals Limited is a privately held biotechnology company focused on commercializing a unique family of therapeutic proteins capable of treating chronic diseases. Osprey's broad technology platform is based on the critical insight that many common diseases are propagated by overabundant and overactive leukocytes. The company's patented Leukocyte Population Modulators selectively and systematically destroy these disease-related leukocytes by infiltrating the chemokine system -- a complex network of small proteins and their receptors that regulate the movement and activity of leukocytes. The company expects to initiate a Phase I/II trial for chronic kidney disease in the second half of 2007.

Osprey has developed a portfolio of 12 preclinical product candidates addressing a variety of diseases including cancer, cardiovascular disease, and neurological disorders, and the company anticipates initiating at least one clinical trial annually over the next three years. Osprey minimizes the risks inherent to drug development and commercialization by using a technology that can rapidly generate new product candidates, and then uniformly applying standardized testing and manufacturing protocols across its portfolio. Osprey Pharmaceuticals is based in Montreal, Canada and can be found online at http://www.ospreypharma.com.

About MMV Financial

MMV Financial is a Toronto-based specialty finance company providing creative debt solutions directly to technology and life sciences companies across North America. MMV is backed by top U.S. and Canadian private equity firms and financial institutions including CCP Equity Partners, Caisse de depot et placement du Quebec, NewStar Financial Inc., and Wells Fargo Company. For more information please visit http://www.mmvf.com.

Contacts

MMV Financial Jacques Perreault Senior Vice President Tel: (514) 789-6425 Fax: (514) 396-4354 jperreault@mmvf.com

Osprey Pharmaceuticals Limited Phil Coggins, PhD President & CEO coggins@ospreypharma.com

Robert Wagstaff Vice President, Finance wagstaff@ospreypharma.com Tel: 514-336-3118

Or Susan Thomas or John Cummings from Burns McClellan on behalf of Osprey jcummings@burnsmc.com sthomas@burnsmc.com Tel: 415-352-6262

Ception Therapeutics pockets $63M in third round

Mon, 29 Jan 2007 19:01:37 -0500

Ception Therapeutics has rounded up $63 million in its third round of venture capital, with Essex Woodlands Health Ventures leading the way. Ception, which is based in Malvern Hill, PA, says that much of that money will be used to advance a late-stage biologic compound in clinical development for multiple inflammatory conditions, a small molecule anti-TNF program and other discovery programs. Investor Growth Capital, MDS Life Sciences Technology Fund II, New Science Ventures and Aperture Venture Partners all participated as investors.

- here's the release on the round

ALSO: Canada's Osprey Pharmaceuticals has garnered $9 million in financing, including $3 million in venture debt. Much of that is earmarked for early clinical trials of its lead product candidate, OPL-CCL2-LPM, for patients with chronic kidney disease. Release

PLUS: Abingworth has announced the closing of its $587 million life sciences fund, Abingworth Bioventures V. Company officials say the fund is the largest ever raised in Europe for the life sciences field. Release

Related Articles:
Athenagen acquires Osprey assets. Report

Clinical trial data disappoint Amgen investors

Thu, 25 Jan 2007 19:01:38 -0500

Amgen says that a new trial of its anemia drug Aranesp indicated a higher risk of death among patients with anemia caused by cancer. Aranesp is currently approved to treat anemia caused by chemotherapy and Amgen has been looking to broaden its approval for the drug. The new data raises new questions about the risks posed by Aranesp as well as two similar drugs--Epogen and Procrit--with a combined $10 billion market. Last November a separate study concluded that Procrit increased the risk of death among kidney disease patients by 34 percent.

In the Aranesp trial researchers were exploring whether the therapy could reduce the number of blood transfusions to combat anemia. The trial concluded that the drug did not reduce the number of transfusions but did increase the number of patients in the group by a statistically significant amount. Even though the drug is not approved to treat anemia from cancer, a company official estimated that up to 12 percent of the sales of Aranesp are for the off-label use of the drug for that indication.

In addition, Amgen said a new study of Vectibix as a front line therapy against advanced colon cancer failed to demonstrate any advantage over standard therapy. Vectibix is approved for patients who have failed to respond to chemotherapy. Several analysts said that the pair of disappointing results cast a significant pall over Amgen's ability to grow revenue.

- check out Amgen's press release on the data
- read the article on Aranesp from The New York Times

Related Articles:
FDA wants more data on new Aranesp doses. Report
Aranesp may work for heart failure. Report
Major challenges loom for Amgen. Report
Amgen launches price war on Vectibix OK. Report

Press Release: Neose Technologies Presents Positive NE-180 Phase I Clinical Trial Data

Maureen Martino — Mon, 01 Jan 2007 10:56:40 -0500

Neose Technologies Presents Positive NE-180 Phase I Clinical Trial Data at American Society of Hematology Annual Meeting

HORSHAM, Pa -- Neose Technologies, Inc. presented positive data from its NE-180 Phase I clinical trial during the American Society of Hematology 48th Annual Meeting and Exposition. The data were presented in a poster entitled, “NE-180, a Novel GlycoPEGylated™ Erythropoietin, Demonstrates Dose-Dependent Activity in a Phase 1, Single Dose, Dose Escalation Study in Normal Human Volunteers” on December 9, 2006. NE-180 is being developed for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Conclusions from the study are as follows:

> Single doses of NE-180, up to 1.5mcg/kg, were generally well-tolerated with no serious adverse events.
> Single doses of NE-180 demonstrated potent, dose-dependent erythropoietic activity.
> The results from the Phase I study support a Phase II program in patients with anemia associated with chronic kidney disease, dosed every four weeks, and in cancer patients receiving chemotherapy, dosed every three weeks.

The full poster presentation can be found on the Neose website via the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=60494&p=irol-presentations

“We are excited by the data generated in this Phase I trial, particularly the increases in reticulocytes and hemoglobin. These increases support further clinical development of our GlycoPEGylated erythropoietin candidate. We look forward to commencing our Phase II clinical trials in the near future,” said George J. Vergis, Ph.D., Neose president and chief executive officer.

About Neose Technologies, Inc.

Neose Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development of next-generation therapeutic proteins that are competitive with best-in-class protein drugs currently on the market, on its own and through strategic partnerships. The lead candidates in its pipeline, NE-180 for use in the treatment of chemotherapy-induced anemia and anemia associated with chronic renal failure and GlycoPEG-GCSF for chemotherapy-induced neutropenia, target markets with aggregate sales in excess of $14 billion.

For more information, please visit www.neose.com.

Neose “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are “forward-looking statements” that involve risks and uncertainties, including without limitation the risk that NE-180 could fail in clinical trials or never receive regulatory approval. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statement, see the section of Neose’s Annual Report on Form 10-K for the year ended December 31, 2005, entitled “Factors Affecting the Company’s Prospects” and discussions of potential risks and uncertainties in Neose’s subsequent filings with the SEC.

Press Release: Affymax Announces IPO

Maureen Martino — Thu, 14 Dec 2006 10:23:07 -0500

PALO ALTO, Calif., Dec. 14 -- Affymax, Inc. (Nasdaq: AFFY - News), a clinical-stage pharmaceutical company, today announced the pricing of its initial public offering of 3.7 million shares of common stock at $25.00 per share. All shares are being offered by Affymax. Affymax's common stock will trade on the Nasdaq Global Market under the trading symbol "AFFY."

Morgan Stanley & Co. Incorporated is acting as the sole book-running manager for this offering. Cowen and Company, LLC, Thomas Weisel Partners LLC and RBC Capital Markets are acting as co-managers for the offering. Affymax has granted the underwriters a 30-day option to purchase up to an additional 555,000 shares to cover over-allotments, if any.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any State in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such State. Any offer or sale will be made only by means of the written prospectus forming a part of the effective registration statement.

A copy of the prospectus relating to this offering may be obtained by contacting Morgan Stanley & Co. Incorporated, 180 Varick Street, New York, NY, 10014, Attention: Prospectus Department, by calling (866) 718-1649 or by emailing prospectus@morganstanley.com.

About Affymax, Inc.

Affymax, Inc. is a clinical-stage biopharmaceutical company developing novel peptide-based drugs to improve the treatment of serious and often life-threatening conditions. Affymax's lead product candidate, Hematide(TM), is currently in Phase 2 clinical trials for the treatment of anemia associated with chronic kidney disease and cancer.

Press Release: Amgen Announces $5 Billion Stock Repurchase Plan

Maureen Martino — Tue, 12 Dec 2006 13:05:34 -0500

Amgen Announces $5 Billion Stock Repurchase Plan

Amgen today announced that its board of directors has authorized additional repurchases of up to $5 billion in Amgen common stock. The company currently has $1.5 billion remaining under its previous stock repurchase authorization. This new authorization reflects Amgen's confidence in its long-term prospects.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statements

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2005, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing our products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of our products are affected by reimbursement policies imposed by first party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We, or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. Further, some raw materials, medical devices, and component parts for our products are supplied by sole first party suppliers.

Press Release: Adanced Magnetics Announces Positive Phase III Ferumoxytol Results

Maureen Martino — Sat, 18 Nov 2006 15:04:58 -0500

Adanced Magnetics Announces Positive Results from Phase III Study of Ferumoxytol as an Rntravenous Iron Replacement Therapeutic

CAMBRIDGE, MA, (November 17 , 2006) -- Advanced Magnetics (NASDAQ: AMAG) today announced positive results from a Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic that is being presented at the American Society of Nephrology’s Renal Week 2006 Annual Meeting in San Diego, CA. A poster entitled “Ferumoxytol as Intravenous Iron Replacement Therapy in Chronic Kidney Disease (CKD) Patients Not on Dialysis - Evaluation of Safety and Efficacy in Two Phase III Studies” is being presented today at 10:00 am PT. The study enrolled 304 non dialysis-dependent chronic kidney disease patients (NDD-CKD) who were randomized to receive either two 510 mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The study demonstrated a statistically significant achievement of all the primary and secondary endpoints. Additionally, all primary and secondary endpoints were statistically significant in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.

Efficacy results in the intent to treat (ITT) and efficacy evaluable (EE) populations were similar. In the ITT population, ferumoxytol significantly outperformed oral iron for the primary endpoint of change in hemoglobin at Day 35.

The results from the EE population analysis are as follows:
• At Day 35, patients receiving ferumoxytol had a significantly greater mean increase in hemoglobin compared to patients in the oral iron group
• Ferumoxytol was more likely to increase baseline hemoglobin by ≥ 1 g/dl compared to oral iron
• Increase in serum ferritin was significantly greater in the ferumoxytol group compared to the oral iron group at Day 21.
• Stratifying by ESP use, there was a significant difference in hemoglobin increase for ferumoxytol compared to oral iron in both patients who were on ESP and those who were not.
• At Day 35, mean hemoglobin increase in the group on a stable ESP dose was 1.20 ± 1.54 g/dl for ferumoxytol compared to -0.12 ± 1.27 g/dl for oral iron.
• Similarly, at Day 35, mean hemoglobin increase in the group not on ESPs was 0.70 ± 1.01 g/dl for ferumoxytol compared to 0.15 ± 0.99 g/dl for oral iron.
• ESP use in combination with ferumoxytol resulted in 61.0% of patients achieving an increase in hemoglobin of at least 1 g/dl compared to 16.7% of patients on ESP and oral iron.

Ferumoxytol was well tolerated with repeated dosing (2 x 510 mg). Adverse events occurred in 52.0% of oral iron patients compared to 35.5% of ferumoxytol patients. Similarly, drug-related adverse events occurred in 24.0% of oral iron patients compared to 10.6% of ferumoxytol patients. Serious adverse events were higher in the oral iron group compared to the ferumoxytol group (oral iron 9.3% vs. ferumoxytol 4.6%). There were no drug-related serious adverse events in either group.

A copy of the company’s poster presentation is available on the Investors section of the company’s web site.

“We are pleased with the results we are presenting today at this prestigious nephrology meeting,” stated Brian J.G. Pereira, MD, President and CEO of Advanced Magnetics. “This is an exciting milestone for the company. These early results are encouraging, and we will continue our efforts to successfully complete the Phase III development program for ferumoxytol.”

The company also announced today the completion of enrollment in its second multi-center study in NDD-CKD patients. With the completion of this study, three of the four pivotal Phase III clinical studies in the iron therapy program are done. The company currently expects to complete enrollment in its last remaining Phase III study, a multi-center study in hemodialysis-dependent chronic kidney disease (HD-CKD) patients, by the end of the first quarter of calendar 2007. Based on the company’s current estimates of the timing of completion of the HD-CKD study and its efforts to prepare and finalize the submission of the New Drug Application (NDA) for ferumoxytol, the company currently plans to submit the NDA during the second half of calendar 2007.

About Advanced Magnetics
Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in our field, we are dedicated to the development and commercialization of our proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. For more information about us, please visit our website at http://www.advancedmagnetics.com, the content of which is not part of this press release.

This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements regarding the expected date for completion of enrollment in the last remaining clinical trial for ferumoxytol, our efforts to successfully complete the Phase III development program for ferumoxytol, and the timing of the planned submission of the NDA for ferumoxytol are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to successfully complete the clinical development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, the timing of enrollment of patients in the Phase III studies, unexpected results from our clinical sites, inadequate performance by third-party service providers involved in the conduct of the clinical trials, deficiencies in the design or oversight by us of these trials, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) uncertainties surrounding the clinical development of ferumoxytol and our ability to obtain regulatory approval for ferumoxytol from the FDA; (3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) the fact that we lack sales and marketing expertise; (5) the possibility that we may not be able to raise additional capital on terms and on a timeframe acceptable to us, if at all; (6) uncertainties relating to our patents and proprietary rights; and (7) other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Advanced Magnetics reports positive data in Phase III

Thu, 16 Nov 2006 19:01:35 -0500

Cambridge, MA-based Advanced Magnetics is touting positive results from its late-stage therapy for chronic kidney disease. The Phase III trial for the intravenous iron replacement therapy hit primary and secondary endpoints. Patients taking ferumoxytol who were not dependent on dialysis demonstrated a significant increase in hemoglobin. The trial results are being released today at the American Society of Nephrology's Renal Week in San Diego. Advanced Magnetics says that it's on track to submit an NDA in the second half of 2007.

- here's the release on the trial data

FDA wants more data on new Aranesp doses

Sun, 15 Oct 2006 20:01:35 -0400

Shares of Amgen slipped slightly on Friday after the biotech giant announced that the FDA wants a new clinical trial of its monthly dose of the anemia drug Aranesp in patients with chronic kidney disease not on dialysis. The agency also asked for more data on a once-every-two-weeks dose of Aranesp. Amgen, though, countered that it would ask the FDA to consider additional data on the new doses that was not available when it filed for approval. Aranesp was originally approved for anemia five years ago. Amgen is also facing new competition from Roche, which has submitted its anemia drug for kidney disease--Mircera--for FDA approval. Amgen has sued Roche for allegedly violating its patent on Epogen, an earlier anemia drug.

- here's the release on Aranesp

Related Article:
Aranesp may work for heart failure. Report

Acologix files for $115 million IPO

Wed, 16 Aug 2006 20:01:36 -0400

Acologix has filed to go public with an IPO designed to raise $115 million. The drug developer has programs in renal diseases like chronic kidney disease and hard tissue ailments. The Hayward, CA-based biotech recently completed a Phase II feasibility study of AC-100 for the treatment of periodontal defects, which failed to hit its endpoint for significant regeneration of more periodontal bone versus a placebo. Researchers blamed the dosage used in the trial.

- here's the MarketWatch report

ALSO NOTED: Osiris files IPO; Amgen initiates kidney disease study; and much more...

Sun, 16 Jul 2006 20:00:50 -0400

> Baltimore-based stem cell therapeutic company Osiris Therapeutics announced an IPO at 3.5 million shares for about $11 to $13 each. Report

> Chutes & Ladders: Ann, Arbor, MI-based Aastrom Biosciences has named George W. Dunbar CEO and president. Release

> Melbourne-based CSL Limited will acquire biotech Zenyth Therapeutics for about $108 million. Release

> Amgen is initiating a 3,800-person study of Sensipar/Mimpara for kidney disease. Report

And Finally... The Senate will continue to debate three stem cell bills which President Bush has pledged to veto if passed. Article (WSJ sub. req.)

Takeda licenses Hematide in $535M deal

Mon, 26 Jun 2006 20:01:39 -0400

Japan's Takeda has agreed to pay Palo Alto, CA-based Affymax up to $535 million for the worldwide rights--excluding Japan--to Hematide. The therapy is used to treat anemia in cancer and kidney disease patients, a booming field in biologics. Affymax will net $105 million of that up front with commercial and regulatory milestones to run up to $430 million. Takeda had already licensed Hematide for Japan back in February. Affymax has co-development rights for the U.S. market and Takeda--which has inked a string of bullish licensing deals--will cover most of the costs. And Affymax will manufacture the drug.

"Takeda is an ideal global partner because they have the development experience, global commercial capabilities, and financial resources to assist us in our efforts to bring Hematide to market worldwide. Moreover, they have significantly grown their business in the U.S.," said Arlene M. Morris, Affymax's president and CEO.

- here's the release on Hematide