infectious diseases

Rheumatology: fastest growing subject of trials

John Carroll — Wed, 20 Aug 2008 10:24:13 -0400

New analysis from Nature on the Phase II-IV clinical trials registered with ClinicalTrials.gov shows that oncology studies led all therapeutic areas, followed by central nervous system disorders, cardiology, infectious diseases, endocrinology, and respiratory diseases. Those six areas accounted for two thirds of all protocols and two thirds of all sites. The highest growth in trials was in rheumatology, at 157 percent, and rheumatoid arthritis became the third most common disease being studied.

--read the analysis from Nature

Breakthrough reported in flu vaccine research

Mon, 10 Mar 2008 07:59:57 -0400

A Japanese chemical company saw its stock shoot up 20 percent this morning, the maximum allowed on the Japanese market, after researchers for NOF and Japan's National Institute of Infectious Diseases announced that they had found a way to create a new vaccine that could protect people from all types of bird flu viruses. One of the researchers said that the new approach targets the inside of the virus, preventing it from replicating. Current vaccines rely on alerting the immune system to attack the virus and become ineffective when the virus mutates.

"We are continuing the joint study in the hope that it will have universal effect on human influenza as well as a variety of other influenza viruses," said NOF. Any vaccine for human use is still far off, though. Researchers plan to start testing the vaccine in biotech mice in April.

- read the AFP report

Related Articles:
Breakthrough in understanding mechanism of bird flu. Report
Antibodies used to protect against bird flu. Report
Bird flu scientist says annual mutations likely. Report
Experimental vaccines show efficacy against H5N1 viruses. Report

ALSO NOTED: Rituxan aces RA, leukemia trials; Two die after Gardasil jab; Galapagos earns milestone; and much more...

Fri, 25 Jan 2008 06:59:50 -0500

> Roche's antibody med MabThera (Rituxan) just aced two trials aimed at expanding uses for the drug: one that pitted MabThera against rheumatoid arthritis and another that used it against adult leukemia. Release

> Two young women died suddenly and mysteriously after getting the Gardasil vaccine, European regulators announced yesterday. Did the vaccine precipitate their deaths? No one knows. Report

> Galapagos has achieved a milestone under its alliance agreement in rheumatoid arthritis with Johnson & Johnson's Janssen Pharmaceutica. The milestone triggered a cash payment of €3.4 million to Galapagos. Release

> Lawyers, Congressional reps, and now Senators are circling around Merck and Schering-Plough as the Vytorin brouhaha escalates into a full-blown scandal. Report

> A small clinical trial of a malaria vaccine funded by the National Institute of Allergy and Infectious Diseases has delivered positive data, triggering a move to expand the research into a second trial that enlisted 400 children in Mali. Report

> Health plans are drawing scrutiny for paying physicians to prescribe cheaper generics rather than brand-name drugs. Report

And Finally... American adults are largely ignoring a slate of important new vaccines that can prevent serious illness, according to a new survey from the National Foundation for Infectious Diseases. Report

Idera shares surge on Merck KGaA pact

Wed, 19 Dec 2007 06:59:58 -0500

Idera is pocketing a $40 million up front fee from Merck KGaA and hopes to make an additional $381 million in milestones from licensing its technology for cancer therapies. The German Merck gains exclusive rights to Idera's two most advanced Toll-like Receptor 9 (TLR9) agonists for cancer--IMO-2055 and IMO-2125--for all uses with the exception of cancer vaccines. These Toll-like receptors are sentinels for chemicals in pathogens for cancer, infectious diseases, respiratory and autoimmune disorders. IMO-2055 has been involved in Phase I studies for solid tumors that have been unresponsive to standard therapy. Shares of Idera surged on the news.

- see the release
- here's the AP's report on the deal

Related Articles:
Idera inks $455M pact for Merck vaccines. Report
Merck KGaA CEO eyes new acquisitions. Report
Mylan inks $6.6B deal for Merck's generic drug biz. Report
Merck KGaA buying control of Serono. Report

Sanaria takes new approach for malaria vaccine

Tue, 11 Dec 2007 06:59:55 -0500

The New York Times profiles Sanaria, a Maryland vaccines company that is taking a cue from Louis Pasteur in developing a new way to combat malaria. Instead of relying on fragments of the parasite's protein to trigger an immune response--the common approach for vaccine development--Sanaria takes the whole parasite and weakens it with gamma rays so it can't multiply, an advance on Pasteur's method of weakening rabies bacilli by air drying them. This vaccine program is one of dozens being tested around the world. The Malaria Vaccine Initiative, funded by the Bill and Melinda Gates Foundation, is bankrolling eight development projects. At Sanaria, researchers have demonstrated their new vaccine can protect lab mice and a small number of humans. But the big challenge they face is manufacturing the vaccine in bulk. The company has already won the endorsement of Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

- see the profile on Sanaria from The New York Times

Related Articles:
New malaria vaccine offers better protection. Report
Gates Foundation readies $258M for new malaria programs. Report
New tech drives huge growth in vaccine business. Report
Genome map completed on malaria parasite. Report

Pfizer buys Coley for $164M

Fri, 16 Nov 2007 06:59:58 -0500

In what is sure to be one of many acquisitions to come, Pfizer has agreed to purchase Wellesley, MA-based Coley Pharmaceuticals for $8 per share, bringing the total deal to $164 million. Pfizer will gain access to Coley's vaccine adjuvant technology. Coley also has a new class of immunomodulatory drug candidates--TLR Therapeutics--which work by stimulating or blocking important immune system receptors.

"This acquisition is an important component of Pfizer's vaccine strategy and reflects our commitment to research new and more effective vaccines to prevent infectious diseases and to treat cancers and other debilitating conditions. Coley's innovative product candidate portfolio and technology have the potential to significantly enhance future vaccine and immunotherapeutic approaches to a broad range of diseases..." said Jeffrey B. Kindler, chairman and CEO of Pfizer.

- see Pfizer's release for more

Related Articles:
Who should Pfizer buy? Report
Pfizer hires new R&D chief, launches biotech center. Report

Lead Therapeutics banks $17M in VC

Mon, 05 Nov 2007 06:59:54 -0500

Lead Therapeutics has pocketed $17 million in its first venture round. Much of that money will go to advance its two candidates for infectious diseases and oncology. Pappas Ventures and ProQuest Investments led the round for Lead, which plans to do most of its research in China.

"Lead Therapeutics' business strategy is designed to capitalize on the best scientific and technical resources of both China and the United States, enabling the company to more cost efficiently deliver high quality IND candidates that can currently be achieved in the West alone," said Alain Schreiber, MD, Partner at ProQuest Investments. "Moreover, by establishing R&D capabilities within China, the company will be well-positioned over time to benefit from increasing demand for China capabilities from Western pharmaceutical companies."

- check out the release for more information

Ranbaxy spins off R&D unit

Fri, 19 Oct 2007 06:59:57 -0400

Ranbaxy, one of India's largest drug makers and a dominant force in the generic drugs business, is spinning off its R&D unit that will develop new medicines. The move will allow the drugmaker to expand beyond the generic drug market, and will remove millions of dollars from Ranbaxy's annual expenses. It will also mean Ranbaxy can compete on a global scale by making more profitable, brand-name drugs. And Ranbaxy certainly has a leg up with it comes to R&D costs. Developing new drugs in India is much cheaper, as the country has a large, inexpensive pool of biotech talent.

Ranbaxy already has programs for an original anti-malarial drug and treatments for oncology, respiratory, metabolic and infectious diseases. Details on the new company's structure will be ironed out by the end of this year and it will be listed some time in 2008. The planned spinoff will have an annual budget of $20 million to $25 million.

- see this release for more
- read the Financial Times article

Related Articles:
Ranbaxy touts R&D abilities in new discovery pact. Report
Ranbaxy reportedly near $100M generics deal. Report
Ranbaxy buys new European manufacturing hub. Report
Ranbaxy acquires GSK generic business in Spain. Report

Eli Lilly forges $1B diabetes deal

Thu, 18 Oct 2007 06:59:58 -0400

Eli Lilly is putting down a $41 million payment to acquire exclusive rights to MacroGenics' diabetes drug teplizumab in a deal that could be worth more than a billion dollars in total. MacroGenics also gets a $10 million financing arrangement, up to $200 million in development milestones for diabetes, sales milestones of $250 million and up to $600 million for other approvals of molecules developed by the two companies. For MacroGenics, the deal with Lilly marks a key turning point as it develops new therapies for cancer, autoimmune diseases and infectious diseases. Teplizumab is its lead therapy and marks Eli Lilly's continued interest in acquiring more biotech drugs for development.

"The additional capital brought into the company will give us the ability to expand our portfolio and work in other areas," MacroGenics chief executive Dr. Scott Koenig told the Baltimore Sun said in an interview.

- take a look at the release on the deal
- read the Baltimore Sun's report

Related Articles:
Lilly diabetes med linked to pancreatitis. Report
MacroGenics garners $45M in third round. Report
In speech, Lilly CEO calls for drug monitoring. Report
Lilly developing biotech drugs the old-fashioned way. Report
Diabetes epidemic triggers soaring drug market. Report

Read more on: Eli Lilly | Diabetes

Emerging Drug Developer: Argos Therapeutics

Fri, 05 Oct 2007 06:59:59 -0400

Emerging Drug Developer: Argos Therapeutics

Immunology is a hot topic in biotechnology these days, and Argos Therapeutics is gambling on its dendritic cell technology to get it past Phase II and into a new stage of development. With a drug platform aimed at cancer and infectious diseases, the Durham, NC-based developer is touting some early successes and some great expectations for the next two years. It's already managed to win over some of the leading names in global biotechnology as partners. And data due by mid-2009 will be crucial to its long-term success. Article

WHO: Infectious disease a growing threat

Fri, 24 Aug 2007 06:59:54 -0400

A new report from the World Health Organization is sounding the alarm on the serious threat the world faces from rapidly spreading infectious disease. New disease are emerging--such as AIDS, Ebola and SARS--and the prevalence of air travel means that localized diseases can be easily transported around the globe within hours. In addition, infectious diseases are becoming more difficult to treat and drug resistance in particular poses a serious threat to world health. "Since 1967, at least 39 new pathogens have been identified, including HIV, Ebola hemorrhagic fever, Marburg fever and SARS. Other centuries-old threats, such as pandemic influenza, malaria and tuberculosis, continue to pose a threat to health through a combination of mutation, rising resistance to antimicrobial medicines and weak health systems," warns the WHO.

- see the WHO report

Related Articles:
The challenges of infectious disease. Report
Study finds alarming spread of MRSA. Report

Ventana spurns Roche's $3B hostile takeover bid

Wed, 11 Jul 2007 06:59:58 -0400

Ventana Medical Systems has once again turned its nose up at Roche's avid pursuit of the company, rejecting the pharma giant's $75 per share bid as inadequate in several respects. Roche has been rapidly building up a new diagnostics division with its acquisition of several small and medium-sized biotechs. Ventana specializes in the analysis of human tissue in diagnosing cancer and infectious diseases. Ventana says it will "vigorously resist" Roche's bear hug as it shrugs off the 44 percent premium being offered shareholders. More money may help turn resistance into acceptance, but there's no word yet from Roche over its willingness to sweeten the bid. Roche took the hostile path after Ventana declined overtures to discuss an acquisition.

- see the announcement from Ventana's board
- here's the report from The Wall Street Journal (sub. req.)

Related Articles:
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Roche shakes up R&D, eyes new buyouts. Report
Roche to boost R&D spend, reorganize research. Report

BioVex raises $22M for ongoing cancer trial

Mon, 09 Jul 2007 00:01:35 -0400

Woburn, MA-based BioVex--which is working to develop new therapies for cancer and infectious diseases--has raised $22 million in the first close of its fifth round. Medical Ventures led the round. New Science Ventures joined as a new investor along with existing investors such as ABN Amro (Forbion), Avalon Ventures, Credit Agricole Private Equity, GeneChem Management of Montreal, Innoven Partners and Scottish Equity Partners.

"Building on the impressive data that has recently been generated with our lead cancer product, OncoVEX GM-CSF, in the clinic, the funds raised in this round will allow us to complete our Phase II program and to complete preparations to advance OncoVEX GM-CSF into a registration study in metastatic melanoma," said BioVex CEO Philip Astley-Sparke. "The funds will also be used to progress our lead infectious disease candidate, a vaccine for genital herpes, through to Phase II. "

- see the release on the new round

Related Article:
BioVex moving HQ to Mass. Report

Press Release: AstraZeneca Makes $100M Research Investment In Boston

Maureen Martino — Mon, 22 Jan 2007 12:12:36 -0500

AstraZeneca Makes $100M Research Investment In Boston

Expansion Of R&D Boston To Create Up To 100 New Scientific Jobs

WILMINGTON, Del., Jan. 22 -- AstraZeneca today announced a $100 million research investment to strategically boost work in the infectious disease area and continue its incremental growth in cancer research at its R&D center near Boston, Massachusetts.

The expansion of AstraZeneca's research facility will accommodate up to 100 additional researchers. They would join the more than 400 existing employees who are focused on discovering treatments for infectious diseases and cancer.

"This investment will significantly boost our research capabilities in two critical areas of medical need, and two areas where we have tremendous heritage," said David Brennan, Chief Executive Officer of AstraZeneca. "It will provide additional resources for our scientists who are tackling more complex diseases than ever before, as they work towards our ultimate goal of giving people hope for a healthier future."

Adds Jan Lundberg, Executive Vice President, AstraZeneca Global Discovery Research, "Infectious disease is becoming more prevalent and problematic to patients and healthcare providers, placing a heavy burden on our healthcare systems. With our expanded presence in Boston, our scientists will be better equipped to discover and develop novel medicines to address important areas of unmet need."

The World Health Organization figures show that 41 percent of the global disease burden is due to infection. Outside the European Union and US, the infectious disease burden is greater than the total of all other therapy areas combined. Meanwhile, there has been a worldwide decline in the delivery of new antibiotics -- only 10 new antibacterials have been introduced since 1998, of which two were truly novel. Resistance to currently available antibacterials continues to increase and represents a clear danger to patients and public health globally. AstraZeneca is committed to providing much needed new antibacterial agents for worldwide use.

Construction of the 132,000 square foot facility will begin at the Waltham, Mass. site during the first quarter of 2007 with scheduled completion by mid 2009. Upon completion, the total size of the AstraZeneca research facility will be 382,000 square feet. AstraZeneca first established a research presence in Boston in 1995, ahead of many competitors. In 2000, the company opened their state-of-the-art research facility in Waltham where it has continued to invest and expand, growing from 170,000 square feet to the current 250,000 square foot facility.

Since the opening of AstraZeneca R&D Boston, scientists there have discovered three potential drugs that are under development to treat different cancers including breast, ovarian, thyroid and prostate cancer, and two novel- class candidate drugs to potentially treat serious skin infections, serious cases of chronic bronchitis and serious pneumonias.

AstraZeneca believes Boston gives the company access to the leading scientific talent, potential partners and collaborators, and emerging science in a worldwide biotechnology hub.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

Press Release: Sequoia Pharmaceuticals Raises $35M In Series C Financing

Maureen Martino — Tue, 09 Jan 2007 11:11:42 -0500

Sequoia Pharmaceuticals Raises $35M In Series C Financing

GAITHERSBURG, Md., Jan. 8 -- Sequoia Pharmaceuticals, Inc. announced today that it has raised $35 million in a Series C financing that will be used to further develop its pipeline candidates for the treatment of drug-resistant HIV infections, including the company's two lead clinical candidates, an HIV protease inhibitor as well as a novel therapeutic agent: a Pharmacokinetic Enhancer. The Wellcome Trust led the round of financing and was joined by other existing investors including Healthcare Venture, Sofinnova Partners, and Aberdare Ventures as well as new investor, MedImmune Ventures, Inc. As a result, Julie Eskay-Eagle of Wellcome Trust and Wayne T. Hockmeyer, Ph.D., President of MedImmune Ventures and Chairman of the Board, former CEO and founder of MedImmune, Inc., join the Sequoia board.

"We are delighted to have the continued endorsement of our current investors, led by Wellcome Trust, as well as to have a new investor in MedImmune Ventures in this round of financing," said Cindy Collins, President & CEO, Sequoia Pharmaceuticals. "The proceeds from this Series C financing enable us to further advance the development of our drug candidates. Sequoia is anticipating sponsoring two clinical trials beginning in early 2007." Julie Eskay-Eagle, who represents The Wellcome Trust, says, "Wellcome is very pleased to continue supporting Sequoia's breakthrough discoveries in HIV therapy and other viral diseases as these are aligned with the Trust's mission to improve human health, as well as its commitment to fund outstanding health care investment opportunities."

About Sequoia:

Sequoia Pharmaceuticals discovers and develops revolutionary new treatments, primarily for viral diseases including HIV/AIDS and HCV-induced hepatitis with a focus on the growing global problem of drug-resistant infectious diseases. Although most drugs are likely to become less effective over time due to the emergence of drug-resistant mutations, Sequoia's drugs are expected to overcome that critical deficiency.

Sequoia Pharmaceuticals, Inc.
CONTACT: Gary Altman, PhD, of Sequoia Pharmaceuticals, Inc.,+1-301-514-5286 or gary@sequoiapharma.com

Press Release: pSivida Limited Signs Drug Delivery Licensing Agreement With Faber Research

Maureen Martino — Tue, 09 Jan 2007 11:04:08 -0500

pSivida Limited Signs Drug Delivery Licensing Agreement With Faber Research; Payments Totalling US $990K

BOSTON & PERTH, Australia -- Global bio-nanotech company pSivida Limited today announced it has entered into a licensing agreement with US-based Faber Research LLC (Faber) to develop pSivida's proprietary Durasert(TM), Zanisert(TM) and Co-Drug(TM) drug delivery technologies for infectious diseases and diseases of the ear.

This announcement follows an announcement on December 26, 2006 that pSivida entered into an exclusive negotiation period with a major global pharmaceutical company to acquire a worldwide, royalty bearing license to make, use and sell products using pSivida's drug delivery technologies. The pharmaceutical company will make payments totalling US$990k (AU$1.3m) to pSivida for the right to exclusively negotiate a licensing agreement with the Company for a period of three months and to fund the cost of a preclinical study. The commencement of licensing negotiations follows a 12 month evaluation of pSivida's technologies by the large global pharmaceutical company.

Under the terms of the Faber license, Faber receives exclusive rights to pSivida's technologies for diseases of the ear and for five specific infectious diseases, namely malaria, HIV/AIDS, influenza, tuberculosis, and osteomyelitis. All costs of development will be born by Faber and its operating company Auritec Pharmaceuticals Inc (Auritec) and pSivida will receive royalties and milestone payments.

In addition, pSivida has granted Faber co-exclusive rights to the Durasert(TM), Zanisert(TM) and Co-Drug(TM) drug delivery technologies for other infectious diseases. Under this arrangement pSivida and Faber can elect to convert their co-exclusive rights to exclusive rights for a specific infectious disease indication(s). pSivida believes this maximizes the potential to commercialize these technologies in the development of novel anti-infective drugs, a market that reached (a)US$44 billion in 2005.

pSivida's Durasert(TM) controlled release technology is already validated in that it forms the basis of the company's ophthalmic drug delivery products, Retisert(TM), which is FDA approved, and Medidur(TM), which is currently in Phase III clinical trials.

Auritec has developed novel approaches to extended release drug delivery with implications for indications including: HIV microbicides, the treatment of malaria and the prevention of pandemic influenza. Auritec also has an active program for the delivery of drugs to the inner ear.

Dr. Roger Brimblecombe, Chairman and CEO at pSivida said, "We believe this represents a significant opportunity for our drug delivery technologies to be exploited in another therapeutic area - that of infectious diseases and it will be done at no direct cost to us."

Dr. Thomas J Smith, MD, Chairman and Chief Executive Officer at Auritec said, "We look forward to the opportunities for synergies between our companies in the treatment of infectious diseases."

Dr William H. Slattery, MD, Clinical Professor of Otolaryngology at the University of Southern California, and Director of Otology Research at Auritec said, "The ability to utilize pSivida's drug delivery technologies will accelerate our otology program significantly."

Faber Research LLC and Auritec Pharmaceuticals

Faber is the intellectual property holding company for Auritec, a private company based in Pasadena, California, specializing in innovative, extended release drug delivery systems. Auritec was co-founded by Dr. Thomas J Smith, MD, who was previously Chairman and co-founder of Control Delivery Systems, Inc., the Boston, MA. based drug delivery company pSivida acquired in January 2006.

(a) CHA Advances Reports, 2006

NOTES TO EDITORS:

pSivida is a global bio-nanotech company committed to the biomedical sector and the development of drug delivery products. pSivida has developed proprietary drug delivery technology which it had previously referred to as its AEON technology. pSivida now has identified two somewhat distinct avenues for such technology: non-biodegradable implants for focused drug delivery (Durasert(TM)) and biodegradable implants for focused drug delivery (Zanisert(TM)).

Retisert(TM) is FDA approved for the treatment of uveitis. Vitrasert® is FDA approved for the treatment of AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks Vitrasert® and Retisert(TM). pSivida has licensed the technologies underlying both of these products to Bausch & Lomb. The technology underlying Medidur(TM) for diabetic macular edema is licensed to Alimera Sciences and is in Phase III clinical trials.

pSivida owns the rights to develop and commercialize a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon(TM), which has applications in drug delivery, wound healing, orthopedics, and tissue engineering. pSivida's subsidiary, AION Diagnostics Limited is developing diagnostic products and the subsidiary pSiNutria is developing food technology products both using BioSilicon(TM).

pSivida's intellectual property portfolio consists of 76 patent families, 95 granted patents, including patents accepted for issuance, and over 300 patent applications. pSivida conducts its operations from offices and facilities near Boston in the United States, Malvern in the United Kingdom, Perth in Australia and Singapore.

pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and on the Frankfurt Stock Exchange on the XETRA system (German Symbol: PSI. Securities Code (WKN) 358705). pSivida is a founding member of the NASDAQ Health Care Index and the Merrill Lynch Nanotechnology Index.

This document contains forward-looking statements that involve risks and uncertainties including with respect to Faber's development of pSivida's technologies for infectious diseases and disease of the ear; the major global pharma's acquiring a license to pSivida's drug delivery technology; the potential signing of definitive agreements with Nordic on the terms described; the amount of pSivida's portion of the costs to develop Medidur(TM) for DME; the potential size of certain markets; and potential products, applications and regulatory approvals. Although we believe that the expectations reflected in such forward-looking statements are reasonable at this time, we can give no assurance that such expectations will prove to be correct. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Actual results could differ materially from those anticipated in these forward-looking statements due to many important factors including:

The failure of Faber to develop pSivida's drug delivery technologies for infectious diseases and diseases of the ear; failure of the election to convert co-exclusive rights to exclusive rights to maximize the potential to commercialize pSivida's technologies in the development of novel anti-infective drugs; inability of any products developed under the license to Faber to penetrate the novel anti-infective drug market; failure of novel anti-infective drug market to continue to remain at US$44 billion; failure of Auritec's novel approaches to extended release drug delivery to have implications for indications including; HIV microbicides, the treatment of malaria and the prevention of pandemic influenza; failure of Auritec to continue its active program for the delivery of drugs to the inner ear; the failure of the company to successfully negotiate and sign a license agreement with the major global pharma on advantageous terms or at all; failure of the ongoing evaluation with the major global pharma to produce favorable results; failure of the focus of the preclinical study to be in a very significant product opportunity; failure of the company to successfully close the transaction with Nordic contemplated by the MOUs with Nordic; the failure of the Company to obtain the requisite shareholder approvals to complete the Nordic transactions; failure of pSivida's share of Medidur(TM) development costs to be no more than US$22m; failure of the results of the Retisert(TM) for DME trial to be a good indicator of the results of pSivida's ongoing Phase III Medidur(TM) for DME trial; failure of the Medidur(TM) trials in DME to show a very similar improvement in visual acuity and diabetic retinopathy severity score as Retisert(TM) for DME; failure of Medidur(TM) to release fluocinolone acetonide at the same rate as Retisert(TM); our inability to recruit patients for the Phase III Medidur(TM) for DME trial; our inability to raise additional funds at favorable terms or any terms; our inability to repay the amended notes and new convertible notes; our inability to develop proposed products, including without limitation, in the drug delivery, wound healing, orthopaedics, and tissue engineering, diagnostics and food technology fields; failure of our evaluation agreements to produce favorable results and/or result in license agreements; failure to develop applications for BioSilicon(TM) due to regulatory, scientific or other issues; failure to complete negotiations for new centers for the BrachySil(TM) Phase IIb clinical trial for inoperable primary liver cancer; failure of our discussions with the FDA for BrachySil(TM) to continue or to lead to FDA approval; failure of the BrachySil(TM) Phase IIb clinical trial for inoperable primary liver cancer to determine the optimal dose, provide key safety data or support future pivotal efficacy trials or product registration or approval; failure of the BrachySil(TM) primary liver program that is in Phase IIb clinical trials to provide a valuable platform for the development and commercialization of BrachySil(TM) for pancreatic cancer and other indications; failure of the findings of the pancreatic cancer Phase IIa trial to provide a platform for further multicenter efficacy and safety trials; and failure of there to be optimization and standardization between our two pancreatic cancer study centers. Other reasons are contained in cautionary statements in the Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission, including, without limitation, under Item 3.D, "Risk Factors" therein. We do not undertake to update any oral or written forward-looking statements that may be made by or on behalf of pSivida.

Contact: pSivida Limited Brian Leedman, + 61 412 281 780 Director of Investor Relations brianl@psivida.com or Martin E. Janis & Company, Inc US Public Relations Beverly Jedynak, 312-943-1100 ext. 12 President bjedynak@janispr.com or Accent Marketing Limited European Public Relations Eva Reuter, +49 (254) 393 0740 e.reuter@e-reuter-ir.com or For Auritec Auritec Pharmaceuticals Gary Ransom, 626-376-4070 Vice-President Corporate Development gransom@auriecpharma.com www.auritecpharma.com or Oak Crest Institute of Science US Public Relations Sayuri D. Hanna, 626-817-0886 s.hanna@oak-crest.org

ALSO NOTED: Medicines Company gets positive safety data; InterMune gains $10M payday; and much more...

Mon, 08 Jan 2007 19:01:30 -0500

> The Medicines Company announced that three late-stage safety trials of Cleviprex, an experimental drug for severe high blood pressure, met their specified objectives. Release

> InterMune has pocketed a $10 million milestone payment from its pact with Roche on an experimental hepatitis C therapy. Release

> Genentech has agreed to pay an unspecified amount for an entire oncology program for a target run by Amphora. Release

> Australia's pSivida has struck a licensing deal with Faber Research to develop pSivida's drug delivery technologies for infectious diseases and diseases of the ear. Faber receives exclusive rights to pSivida's technologies for diseases of the ear and for five specific infectious diseases. All costs of development will be born by Faber and its operating company Auritec Pharmaceuticals. Release

> Osiris Therapeutics has won the FDA's fast track status for its stem cell treatment for Crohn's Disease. Release

> India's Ranbaxy expressed an interest in bidding for Merck KGaA's generic drug unit. Report (WSJ sub. req.)

And Finally... Japanese scientists have developed a technique to gauge a person's thoughts by changes in the blood flow of his brain. Report

Press Release: Elusys Announces Collaborative Research and License Agreement with Pfizer

Maureen Martino — Thu, 04 Jan 2007 11:58:32 -0500

Elusys Announces Collaborative Research and License Agreement with Pfizer

Developing Therapeutics for Serious Infectious Disease Targets Including MRSA

PINE BROOK, N.J., Jan. 4 /PRNewswire/ -- Elusys Therapeutics, Inc., a biotechnology company developing targeted anti-infective antibodies to fight life-threatening infections, today announced that it has entered into an exclusive collaborative research and license agreement with Pfizer Inc. to develop new therapeutics for select infectious diseases using Elusys' HP Antibody(TM) technology. The research collaboration will include ETI-211, an HP Antibody for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections, in addition to research into other indications.

Under the terms of the agreement, Elusys and Pfizer will collaborate on determining the full product profile of ETI-211 and perform research on other indications of the HP Antibody technology. Elusys will receive an upfront equity investment, research and development funding plus near-term research milestones. Elusys has also granted Pfizer an option to acquire an exclusive worldwide license to products developed under the agreement, and upon exercise, the company will receive significant clinical and sales
milestones, as well as royalties on future sales of products resulting from the collaboration.

HP Antibodies represent a unique approach to the treatment of a variety of infectious diseases by enhancing the effectiveness of the body's natural defense mechanisms to remove and destroy life-threatening pathogens. An HP Antibody drug consists of a monoclonal antibody specific to an immune receptor (CR1) that is chemically linked to a second antibody that binds a particular pathogen. By targeting CR1, HP Antibodies enhance a natural clearance mechanism and direct the rapid removal of pathogens into liver macrophages, where they are destroyed and removed from the body.

Elizabeth Posillico, Ph.D., President & CEO of Elusys Therapeutics commented, "We are delighted that Pfizer has recognized the potential value of our HP Antibody technology as a novel approach for the treatment of life- threatening infections. Pfizer's impressive scientific team and expertise in infectious diseases provides Elusys with a strong partner to advance HP Antibody products into human clinical trials." Dr. Posillico added, "In parallel with the collaborative research on ETI-211, Elusys will continue to advance its other internal clinical development programs. These include Anthim(TM), our Phase I therapeutic for anthrax infection and our HIV HP Antibody and CR1 Vaccine programs."

About ETI-211

ETI-211 is a proprietary HP Antibody drug being developed to treat MRSA infections. In previously reported studies by Elusys, mice given ETI-211 prophylactically were completely protected against a lethal MRSA challenge. Further, all ETI-211 treated animals survived a second lethal challenge of either MRSA or S. epidermidis months later, with no additional drug treatment.

About MRSA

MRSA is a type of bacteria that is resistant to almost all antibiotics. MRSA accounts for over half of the infections in intensive care units in the US alone, with an estimated 300,000 people contracting MRSA infections each year, resulting in approximately 12,000 deaths. MRSA infections incur significant treatment and hospitalization costs versus other infections, exceeding $48,000 per patient on average.

About Elusys

Elusys Therapeutics is a privately-held biopharmaceutical company focused on the development of targeted anti-infective therapeutics using its proprietary HP Antibodies(TM) for the treatment of life-threatening infectious diseases. Pfizer joins current venture investors including Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures, and MedImmune Ventures. For more information on Elusys, please visit http://www.elusys.com.

Press Release: Bill & Melinda Gates Foundation gives $47M to fight tropiacl diseases

Maureen Martino — Wed, 20 Dec 2006 13:21:50 -0500

Leading Global Health Organizations Receive $46.7 Million from Gates Foundation to Integrate Programs Fighting Neglected Tropical Diseases

The fight against neglected tropical diseases (NTDs) received a major boost today with the announcement of five grants from the Bill & Melinda Gates Foundation totaling $46.7 million. The grants will support efforts to coordinate and integrate programs to fight key neglected diseases in developing countries.

NTDs such as trachoma and hookworm cause severe disability among the world’s poorest people and keep generations in a cycle of poverty. In Africa, more than 500 million people are affected by NTDs, and globally, more than two billion individuals are infected with one or more of the parasites or bacteria that cause NTDs.

“Today, most control and treatment programs for neglected tropical diseases focus on a single disease, but people in tropical regions usually face more than one serious disease threat,” said Dr. Regina Rabinovich, director of Infectious Diseases at the Bill & Melinda Gates Foundation. “An integrated approach that addresses multiple diseases at once could reach those in need more efficiently and help save more lives.”

The overall goal of the new grants is to develop evidence that controlling NTDs in an integrated way has a greater impact on these diseases than the disease-specific strategies currently in use. The five projects aim to demonstrate that an integrated approach improves the performance and efficiency of programs, enhances their coverage, promotes sustainability, and reduces the burden caused by NTDs in Africa. This integrated approach is expected to improve the health of hundreds of thousands of people.

Purchasing and delivering drugs to control five of the most devastating NTDs could cost as little as $0.50 per person per year if existing drug delivery programs are brought together. The diseases are trachoma (blinding eye infection), soil-transmitted helminths (hookworm, ascaris, trichuris), onchocerciasis (river blindness), schistosomiasis (snail fever), and lymphatic filariasis (elephantiasis).

These diseases can be treated safely and effectively with single-dose drugs, given once or twice a year to populations at risk. Studies during the past decade have shown that such low-cost interventions can greatly reduce the burden of NTDs, especially when introduced alongside measures to improve water and sanitation and to control the organisms that transmit disease. The new grants address the greatest remaining challenge—to bring together all the different disease-specific interventions already underway and expand programs to reach all who are in need.

The organizations receiving the new funds are: the Task Force for Child Survival and Development, Atlanta, Georgia ($11.7 million); the International Trachoma Initiative, New York ($10 million); The Carter Center, Atlanta, Georgia ($10 million); the Schistosomiasis Control Initiative at Imperial College London ($10 million); and the World Health Organization ($5 million).

The five projects are the result of two years of work by the grantees to ensure that each produces the best possible evidence about integration, and that they work together in close coordination.

Details of the grants are as follows:

The Schistosomiasis Control Initiative will use its $10 million grant to support its core activities at Imperial College London, and to develop and implement a health package that can deliver NTD drugs in Tanzania in the best possible regime. The grant will also be used to co-fund the USAID/NTD control project which will encourage integration of measures to combat NTDs in Burkina Faso, Ghana, Mali, Niger, and Uganda. Up to 40 million people will receive the package of drugs over the next few years, improving their quality of life.

The Task Force for Child Survival and Development will use its $11.7 million grant to coordinate operational research aimed at ensuring the success of the ongoing Global Program to Eliminate Lymphatic Filariasis (LF). Currently delivering anti-parasite drugs donated by the pharmaceutical industry to over 500 million people yearly in 46 of the 83 LF-endemic countries, this 6-year old Program faces important challenges to assuring long-term program success and LF elimination. Grant funds will support coordinated research initiatives in more than 20 countries to refine epidemiologic and immunologic tools for enhancing programmatic decision-making, to evaluate potential supplementary vector control and therapeutic strategies for use in especially difficult areas, and to identify innovative, sustainable financing strategies for LF- and NTD-focused global health programs.

The International Trachoma Initiative will use its $10 million grant to increase the sustainability and scalability of national neglected disease control programs on a country and global level. ITI and its partners will conduct a study to determine the efficacy of an integrated disease treatment program in Mali for trachoma and lymphatic filariasis (LF) compared to single disease initiatives. This aim of this project is to provide evidence of the effectiveness of combined interventions, as well as the costs, benefits, and impact of integration on the health system and target population. It will benefit other health initiatives by providing a model for future integration efforts. Concurrently, ITI will strengthen advocacy and resource development efforts on behalf of trachoma and other core neglected diseases

The Carter Center will use its $10 million grant to expand its integrated disease prevention assistance in central Nigeria, which currently includes four neglected tropical diseases: river blindness, lymphatic filariasis, schistosomiasis, and trachoma, all of which can be controlled or eliminated by safe and effective medicines combined with health education. The Center will expand the scope of its activities to add Vitamin A supplementation for young children to the distribution system, as well as further pioneer distribution of long-lasting insecticide-treated bed nets to prevent both lymphatic filariasis and malaria. In southeastern Nigeria, where infection with the parasite Loa loa limits treatment options for lymphatic filariasis, the Center will study the feasibility of eliminating lymphatic filariasis with long-lasting insecticide-treated bed nets, and integrating with the malaria program. The Center plans to measure the sustainability, cost-effectiveness, and impact of its disease integration efforts, while promoting expansion of integrated efforts throughout Nigeria. The Center will work in collaboration with the Nigeria Ministry of Health, Emory University’s Rollins School of Public Health, and the Centers for Disease Control and Prevention.

The World Health Organization will use its $5 million grant to support and coordinate integration of NTD programs on a global level. It aims to set standards and provide support for integration globally, including a global platform to assess progress, an integrated data management, monitoring and evaluation system, a renewed effort to improve access to currently non-donated drugs, and the development of common tools such as the recently released guide Preventive Chemotherapy in Human Helminthiasis.

Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to reduce inequities and improve lives around the world. In developing countries, it focuses on improving health, reducing extreme poverty, and increasing access to technology in public libraries. In the United States, the foundation seeks to ensure that all people have access to a great education and to technology in public libraries. In its local region, it focuses on improving the lives of low-income families. Based in Seattle, the foundation is led by CEO Patty Stonesifer and Co-chairs William H. Gates Sr., Bill Gates, and Melinda French Gates.

Idera inks $455M pact for Merck vaccines

Sun, 10 Dec 2006 19:01:36 -0500

Merck has struck a deal to put Idera's toll-like receptor agonists to work in its new vaccine programs for oncology, Alzheimer's and infectious diseases. Idera gains $20 million up front for the development pact along with another $10 million equity investment at $5.50 a share. The big payoff would come if Merck can develop vaccines in all three fields, with $165 million in scheduled milestones. Another $260 million in milestones will be paid for successful development of follow-on therapies. Toll-like receptors recognize different microbial products present in pathogens such as bacteria, viruses and parasites, and mount an appropriate immune response against the foreign invaders.

"We believe that vaccines combined with TLR-targeted compounds offer great promise in treating and preventing serious diseases, and look forward to integrating Idera's TLR agonists into our vaccine development programs," said Peter S. Kim, president of Merck Research Laboratories.

- read the AFX report on the deal