Professor Tim Walsh, from UQ’s Centre for Clinical Research, suggests that bacteria is more widespread than previously thought, with his research published in today’s issue of The Lancet.

The research indicates NDM-1 is present in New Delhi’s drinking water and seepage, and thus is widely prevalent in the Indian environment.

Professor Walsh said international efforts were crucial to stem the tide of antibiotic resistant bacteria (known as NDM-1 positive bacteria).

“Along with the fact that some people infected with the new multi-resistant NDM-1 super bugs did not have a hospital stay in India, this research indicates that NDM-1 positive bacteria are occurring on the streets of New Delhi.”

Professor Walsh said the research highlighted the urgent need for action to limit the global spread of NDM-1 producing bacteria.

“The potential for the spread of superbugs is real and it is time for an unequivocal international commitment to combat the growing threat,” he said.

Only a small number of infections caused by NDM-1 bugs have been detected in Australia, in travellers returning from India.

“At the moment there are five known cases in Australia and at least two in Queensland. Without exception all have been linked to Southern Asia,” Professor Walsh said.

Professor Walsh said the study showed there was an urgent need for broad epidemiological and environmental studies to be done, not just in India, but also in Pakistan and Bangladesh, which are source countries for other exported cases of infection.

“There are many good documents written, not least by the WHO, listing key points to curb antibiotic resistance,” he said.

“The trouble is that these are merely recommendations which can be adhered to or totally ignored ??” sadly it is easy to ignore them.

“But we have now reached a point where we can no longer ignore these recommendations and effective measures now need to be enforced.

“A holistic approach and a change of social priorities in various countries is needed, however, it may well be too late to save one of medicine’s most precious and long standing resources ??” antibiotics.”

Professor Walsh said screening of hospital transfer patients from India has already been initiated by French, Chinese and Korean health authorities and is being considered in the UK.

The Lancet article – “Dissemination of NDM-1 positive bacteria in the New Delhi
environment and its implications for human health: an environmental point prevalence study”- is the first molecular study to look at superbugs in the general environment, rather than a hospital environment.

A group of journalists from Channel 4 News in the UK were central to the research.

They helped collect the seepage and water samples in India for analysis by researchers at Cardiff University, where Professor Walsh was based.

Professor Walsh said he and his colleagues, many based in India, were very keen to facilitate further studies in Southern Asia to help establish key risk factors for acquisition and spread of NDM-1 positive bugs and to identify intervention measures to curb their spread.

Professor Walsh’s previous NDM-1 research (also published in The Lancet) revealed the presence of super bugs in hospitals in India, Afghanistan, Bangladesh and their subsequent import into the UK. It influenced international trade, caused a mini-run on Chinese markets and attracted a significant reaction from the Indian government and surgeons.

Source:

University of Queensland

This Phase III trial is a three-arm, double-blind study to be conducted in approximately 40 centers around the world. It is powered to provide potentially registrational data on the efficacy, tolerability and safety of topically applied terbinafine delivered through the Transfersome® targeted delivery technology over 48 weeks. PPD Inc., a leading global contract research organization, has been appointed to conduct the study.

Dr. Phoebe Rich of Oregon Dermatology and Research Center, Oregon Health and Sciences University, the Principal Investigator for North America said, “This important trial uses exciting new technology to deliver antifungal drug deep into the site of infection in the nail. This drug could potentially address the huge unmet need for topical therapy for onychomycosis.”

Dr. Bardur Sigurgeirsson, Department of Dermatology, University of Iceland, the Principal Investigator for Europe added, “I am delighted to be involved in the trial of this innovative new product, which I believe to be an important advance in this therapy area. There is a huge demand for a safe and effective treatment for onychomycosis. Whilst oral therapies can be successful in treating the disease, they carry the risk of side-effects, notably hepatotoxicity. This results in physicians not being able to treat a large percentage of the people suffering from this disease. There is a great opportunity for a safe and effective topical treatment and I believe that TDT 067 could be just that.”

John Mayo and Stephen Evans Freke, Managing General Partners, Celtic Pharma said: “We are delighted to progress to Phase III clinical development of TDT 067, where we anticipate confirmation that this is a medically and commercially important advance in the treatment of this common disease. Based on what we have seen in Phase II development, we believe that we have a product candidate that is comparable in efficacy to currently available oral therapy but without the potential for serious safety issues.”

During Phase II development, TDT 067 achieved two orders of magnitude lower plasma terbinafine concentrations compared to oral terbinafine in a pharmacokinetic study conducted under conditions of maximal use. In contrast, terbinafine levels measured in affected nails were three orders of magnitude higher than those reported for oral terbinafine. This illustrates the targeted delivery of terbinafine. In a Phase II efficacy and safety study, patients treated for only 12 weeks with a primary endpoint of mycological cure at 14 weeks and follow up to 48 weeks, a 90% mycological cure rate (as defined by negative culture and negative microscopic examination) was observed at 14 weeks. At 48 weeks the mycological cure rate was still 38% despite no active treatment for the preceding 36 weeks. TDT 067 was well tolerated with negligible systemic exposure and no serious local side effects, confirming the maximal use study findings, suggesting that patients can be treated for longer durations which should enable improved efficacy.

About Onychomycosis (Fungal Nail Infection)

Onychomycosis is a fungal infection, generally of the toenails, that results in thickening, discoloration, splitting of the nails and lifting of the nail from the nail bed. The disease has a high incidence within the general population — estimated to be as high as 13% in the US — especially among older individuals, with only a small percentage of patients being treated. Present treatment options include both oral and topical drugs, with oral therapies giving better outcomes. However, these oral therapies have a black box warning and carry the risk of systemic side-effects, notably hepatotoxicity, that may be considered disproportionate to the disease being treated. This results in a large percentage of those affected by the condition not being given the most effective treatments available.

Innovative drug carriers called Transfersomes® have been developed for the noninvasive delivery of agents into or through the skin. Transfersome® preparations consist of complex lipid vesicles, which are able to cross the skin permeability barrier, the stratum corneum, driven by the transcutaneous water gradient. TDT 067 (terbinafine in Transfersomes®) is a novel, epicutaneously applied carrier-based dosage form of terbinafine for the treatment of onychomycosis of the toenail and fingernail. Celtic Pharma acquired an exclusive global licence to IDEA AG’s Transfersome® technology in February 2006. ‘Transfersome’ is a registered trademark owned by IDEA AG.

About Celtic Pharmaceutical Holdings L.P.

Celtic Pharmaceutical Holdings L.P. is a global private equity investment firm focused on the biotechnology and pharmaceutical industries. Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE, and is based in Bermuda, with offices in New York and London. Celtic Pharma acquires and invests in late stage pharmaceutical programs and drives these programs through the final stages of regulatory approval. Celtic Pharma’s aim is to bridge the gap between the established pharmaceutical companies’ new product pipeline crisis and the biotech industry’s capital drought.

Forward-Looking Statements

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Celtic Pharma disclaims any intent or obligation to update these forward-looking statements.

Source: Celtic Pharmaceutical Holdings

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Effective interventions can still prevent HIV from turning into a health catastrophe, as has occurred elsewhere in the world and even in some Caribbean islands. This analysis is the central theme of the Spanish version of HIV/AIDS in Latin American Countries: The Challenges Ahead, published by the Pan American Health Organization (PAHO) and the World Bank.

The study, conducted in 17 Latin American countries encompasses all parts of the AIDS problem: epidemiological surveillance, effective interventions, persistent problems, and national and international responses to the epidemic.

“The most recent studies indicate that the prevalence of HIV among pregnant women is 2 percent or higher in six countries: Bahamas, Belize, Guyana, Haiti, Dominican Republic, and Trinidad and Tobago. In contrast, the majority of the other countries of the region show a concentrated epidemic, particularly in the Southern Cone, where Brazil has the greatest number of people who live with HIV/AIDS”, says the prologue by Dr. Mirta Roses, director of PAHO.

Although the book notes that there is significant underreporting of cases, the best estimates of PAHO, UNAIDS and WHO indicate that in Latin America there are some 1.4 million people living with HIV/AIDS. During 2001, 130,000 adults and children contracted the infection and 80,000 people died because of AIDS.

The so-called feminization of the epidemic is shown by the increasingly equal proportion of men and women with AIDS, and by the growing rates of HIV infection in pregnant women and children, the book notes. The ever-growing numbers of cases of AIDS and HIV infection among women 20 to 29 years old indicate that adolescents are at high risk, it says.

“In most countries we see all the mechanisms of transmission, as well as risk behaviors such as early sexual initiation, unprotected sex with multiple partners, and injectable drugs used with contaminated syringes,” according to Roses.

“Many countries have substantially improved the resources allocated to the struggle against HIV/AIDS. Alliances and successful projects with access to the Global Fund against AIDS have tripled existing resources. However, stigma, discrimination and gender inequalities that weaken women’s ability to negotiate continue to be the greatest impediments,” Roses said.

Research shows that the level of knowledge and information is sufficiently appropriate, but, “We are not seeing behavioral change toward sexual practices of lower risk,” she said. The challenge is to ensure that AIDS does not continue to devastate generations in the most productive stages of the life cycle, which could threaten the important achievements in life expectancy and quality of life that have been hit in recent decades in the region, she added.

The authors of the book, Anabela Garc?a Abreu, Isabel Noguer, and Karen Cogwill conclude that Latin America has the infrastructure and the knowledge necessary for coping with the epidemic efficiently and effectively, if the required resources are provided. “The needs vary and, as a result, it is important to adapt the interventions to respond to the profile and the capacity of each country,” they say.

International organizations and programs are in position to increase regional or subregional interventions in concrete areas, and “Cooperation will lead to multiple benefits from effective interventions, as well as positive costs-benefits, ” they conclude.

The XV International AIDS Conference in Bangkok highlighted the need for joining efforts globally to fight the epidemic. Latin America, with PAHO at the forefront, has been leading efforts to expand access to antiretroviral therapy for the people who live with the virus, in line with global initiatives.

PAHO was established in 1902 and is the oldest public health organization in the world. It serves as the Regional Office of the World Health Organization and works on with all the countries of the Americas to improve the health and quality of life of their inhabitants.

For additional information, contact Daniel Epstein, PAHO, Public Information, 202-974-3459.

paho/English/DD/PIN/pr040723.htm

Thursday’s Hearing
Before the hearing was adjourned, Rath’s attorney, John van der Berg, said that an injunction would “depriv[e]” Rath of his “chance to join in a free debate,” even if Rath “hits under the belt,” according to the Associated Press (Nullis, Associated Press, 5/26). Van der Berg said, “Debate should not and cannot be restrained,” adding, “There will be some who are wounded in the process, but as long as that happens within the ambit of the law, all is in order” (Bell, Reuters, 5/26). Dumisa Ntsebeza, an attorney for the Traditional Healers’ Organisation, which is supporting Rath, said TAC cannot ask for defamation protection when it has called South African cabinet ministers “murderers,” according to the Times. “If you want to go into the arena and dirty your hands and fight, then you cannot come to a court of law when you get a response in kind,” Ntsebeza said (Cape Times, 5/27).

The Long Island Newsday on Sunday profiled South African Health Minister Manto Tshabalala-Msimang and her involvement in the Rath case (Holm, Long Island Newsday, 5/29).

“Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/hiv.. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

“Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/hiv.. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Viread.

Sterile Vancomycin HCl is an antibiotic indicated for the treatment of potentially life-threatening infections which cannot be treated with other effective antimicrobial drugs, including the penicillins and cephalosporins. Recent IMS data estimates an annual market size for Sterile Vancomycin HCl of approximately $150 million. The expected launch date for these two new products is the first half of 2009.

The current product portfolio of the Joint Venture, which is funded equally by Akorn and Strides Arcolab, was recently expanded and now includes 29 ANDA’s with a total of 53 SKU’s, or product line offerings. To date, the Joint Venture has filed for 18 ANDA’s and received 14 ANDA approvals. The Joint Venture generated its initial product revenues in the third quarter of 2008, from the launch of Rifampin for Injection.

Arthur S. Przybyl, Akorn’s President and CEO and Member Manager of Akorn-Strides, LLC stated, “These two important product approvals represent the largest market size opportunity for the Joint Venture to date. I would like to personally thank Arun Kumar, co-founder of the Akorn-Strides Joint Venture, for having built the necessary manufacturing infrastructure to allow the Joint Venture to effectively compete for market share.”

About Akorn, Inc.

Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company’s website at akorn.

About Strides Arcolab Limited

Strides, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is one of India’s largest exporters of branded generic pharmaceutical products. Strides manufactures pharmaceutical formulations in various dosage forms, including capsules, tablets and liquid injectables and is one of the world’s top five manufacturers of softgel capsules. Strides also has the only globally dedicated softgel facility for hormones. In addition, Strides undertakes contract research and the manufacturing of specialty chemicals for various multinational companies. Strides has a major presence in various developing countries such as Africa, Latin America and Asia as well as in developed markets such as the U.S., Canada and part of Europe. Strides is one of the largest Indian suppliers of institutionally funded aid projects and is an approved supplier to the Global Drug Facility, UNICEF, and MSF amongst others.

Strides has 14 manufacturing plants spread across the U.S., Brazil, Mexico, Italy, Poland, Singapore and India. This broad manufacturing network facilitates partnering with global organizations ranging from UNICEF and WHO-Global Drug Facility to European and American pharmaceutical multinationals, private labelers and distribution chains. Strides has product registrations in over 37 countries around the world and has earned ISO 9001, ISO 14001 and GMP accreditations including USFDA. Strides employs approximately 1,700 people across the globe. Strides also has a marketing presence in over 50 countries.

Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.

Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.

Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled “Cautionary Statement Regarding Forward-Looking Statements” in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.

Akorn, Inc.

According to Lytix Biopharma CEO Gunnar S?¦lid, “We are delighted to announce the approvals by the Hungarian Regulatory Authorities and appropriate Ethics Committee to test our novel antimicrobial drug LytixarTM (LTX-109) in patients whom have skin infections caused by Gram positive bacteria. Skin infections caused by Gram positive bacteria are an ideal patient group in which to test our antimicrobial drug. Standard of care for these types of infections is generally topical drugs, representing a significant market. Since bacteria such as Staphylococcus aureus are often resistant to the exisiting drugs including methicillin-resistance (methicillin-resistant Staphylococcus aureus – MRSA), there is a clear need for a novel drug such as LytixarTM. For the Company this is an important study, validating the clinical utility of our novel, broad-spectrum, antimicrobial drug LytixarTM.”

Preclinical models have demonstrated that LytixarTM is strongly bactericidal, being equally effective against wild-type as well as drug-resistant bacteria such as MRSA. Because of its unique membrane-lysing mechanism of action, there is no cross-resistance to other drugs. It has also proven highly unlikely for bacteria to develop new resistance to the drug.

“The current study will be run at four hospital dermatology clinics in Hungary. Patients with confirmed Gram positive skin infections will be included in the study and randomized to receive either active drug or placebo in cohorts at ascending dose levels. LytixarTM (LTX-109) has the potential to become a valuable new antimicrobial agent for Gram positive skin infections as well as in a range of other indications”, concludes Dr. Wenche Marie Olsen, COO and Director of Product Development, Infectious diseases, at Lytix Biopharma AS.

Source:

Lytix Biopharma AS

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.