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Russia Reveals Renewed Commitment to Expand, Promote Biotechnology Sector

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Global Health Progress (GHP) released a new fact sheet highlighting Russia’s commitment to expanding and promoting its biotechnology sector. Although the biopharmaceutical sector in Russia is less developed than other markets, the sector is making progress by implementing public policies that support pharmaceutical research and development (R&D) for life-changing treatments, contribute high-quality, high wage jobs to the region and increase the number of clinical trials offered to the population to improve access to drugs and help reduce the overall burden of disease.

Currently, Russia accounts for approximately 0.5% of the world biotechnology market, two-thirds of which are biopharmaceuticals. In 2010, the value of the biopharmaceutical market in Russia was estimated to be approximately US $17.2 billion, compared with US $10.4 billion in 2006. According to analysts, the Russian market is predicted to expand at a compound annual growth rate of 8.3% over the next few years and approximately 53% of the biopharmaceuticals market in Russia is comprised of innovative medicines.

As part of a national 10-year plan to promote biotechnology, the government is enacting policies to strengthen Russia’s pharmaceutical research and development (R&D) areas that have been historically strong. For example, special economic zones will focus on attracting investors to commercialize biotechnology and related innovations. Additionally, the Russian government is investing in “bioparks,” R&D clusters of biotechnology and related sectors.

Russia is well-known for its highly skilled scientific workforce and the biopharmaceutical sector has emerged as an important source of high-quality, highly skilled jobs. As the presence of biopharmaceutical companies increases, so does the pool of highly skilled doctors, scientists and researchers. According to Burrill & Company, the biopharmaceutical sector currently employs approximately 12,000 people with the average salary for a PhD scientist in Russia approximately US $1,800.

Currently, Russia ranks 12 out of 25 in terms of active clinical trials with 1,084 sites with an average relative annual growth rate of 33%. However, as of February 2010, there were 304 medicines in development in Russia, making the country one of the fastest annual growth rates. The growth in share of global clinical trials can bring health benefits, including the diffusion of medical knowledge and effective medical practice, greater patient access to high quality care and improve access to drugs. Clinical trials can also help reduce the overall burden of disease on the Russian population.

Via EPR Network
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Brazil’s Biopharmaceutical Sector Contributes to Economic Growth, Expands Access to Healthcare

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Global Health Progress (GHP) released a new report that reveals how the biopharmaceutical sector in Brazil, the tenth largest biopharmaceutical market in the world and the largest in Latin America, is an important driver for its economy. For instance, Brazil’s biopharmaceutical sector develops high-quality, highly skilled jobs, which is a key factor in creating a stable economy. Currently, approximately 821 biotechnology companies in Brazil employ almost 100,000 people with an average annual salary of approximately US $4,457. Among those companies, six biopharmaceutical companies were featured in a 2003 list of the top 100 companies to work for in Brazil.

Not only does the biopharmaceutical sector produce valuable job opportunities for highly skilled workers, this emerging market plays a critical role in fostering public-private partnerships, which leads to more economic growth and greater access to healthcare for its citizens.

Investment in research and development (R&D) and promoting innovation are key ways the Brazilian government is helping drive future growth of the country’s biopharmaceutical sector. For instance, R&D investments in Brazil have increased to 1.5% of GDP in 2010 and there are more than 205 highly trained physicians per 100,000 of the population serving as investigators for clinical studies.

“In Brazil, promoting innovation is a public policy priority,” stated Rafael Oliva, Advisor to the Presidency at the Brazilian Development Bank. “The participation of the Brazilian government in research and development (R&D) is considerable, and the goal is to both increase innovative activities in Brazil on a systematic basis, and to consolidate the country’s culture of innovation.” GHP fact sheet shows how Brazil’s investment in research and development (R&D) will create positive effects throughout the economy, including improving access to healthcare for its citizens through the production of new medicines. The growing field of clinical trials is also a significant factor in improving access to healthcare. Brazil’s large population of 190 million people, with 8 out of every 10 residents living in or near a city, means clinical trial recruitment and participation is fairly robust.

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Non-corneal Tonometry Glaucoma Eye Test Independent of Central Corneal Thickness (CCT) and Biometric Properties Featured at ESCRS, Paris France

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Unique non-corneal Tonometer Diaton, which allows to measure intraocular pressure (IOP) through the eyelid and sclera, unlike others that obtain IOP through cornea was featured at The European Society of Cataract and Refractive Surgeons ESCRS meeting in Paris, France.

Unique non-corneal Tonometer Diaton, which allows to measure intraocular pressure (IOP) through the eyelid and sclera, unlike others that obtain IOP through cornea was featured at The European Society of Cataract and Refractive Surgeons ESCRS.

Diaton tonometry is a unique approach of measuring intraocular pressure without touching the surface of the eye, takes tonometry reading over the upper eyelid and over the sclera. This revolutionary tonometry method allows physicians to obtain intraocular pressure without influence of central corneal thickness (CCT) and other known and unknown biometric properties and parameters of the cornea.

Unlike Goldmann tonometry which is based on the Imbert–Fick law and is effected by CCT and other corneal parameters and corneal diseases, where small area of the membrane is flattened to measure pressure of the internal fluid. Evidence shows that variations in CCT may greatly influence Goldmann tonometry reading. Parameters such as membrane elasticity, rigidity and other biomechanical properties can influence the accuracy of the intraocular pressure readings.

Diaton tonometry solves most of the corneal issues by implementing Newton ‘s Second Law and a Ballistic principle to obtain IOP. Readings with Diaton Tonometer are taken over the upper eyelid, at the tarsus and over the sclera, not the cornea.

Recent clinical study “Comparison of Accuracy of Diaton Transpalpebral Tonometer Versus Goldmann Applanation Tonometer, Dynamic Contour Tonometer and Ocular Response Analyzer “ concluded: “Transpalpebral Tonometry is an accurate method of IOP measurement that is also independent from the biomechanical characteristics of cornea. It can be recommended for IOP measurements of patients diagnosed with glaucoma including those cases where cornea pathology or cornea characteristics have been altered”.

BiCOM Inc. ( New York , USA ) covers the full scope of customer service, which involves client training, follow ups, hotline support, sales support, etc. To get more information on the device or to make a purchase, visit the official website –http://www.TonometerDiaton.com, or call BiCOM at the toll free number 1-877-diatons (877-342-8667).

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Removing Intellectual Property Rights Will Only Worsen Africa’s Healthcare Crisis

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In recent commentary in the Wall Street Journal, Alec van Gelder, Project Director at the International Policy Network wrote that strong intellectual property rights are critical to strengthening Africa’s health care system. He criticized statements by the Head of the World Health Organization Essential Medicines Program, Hans Hogerzeil. Hoberzeil wrote that “Big Pharma” and intellectual property rights are preventing the world’s poorest countries from receiving access to healthcare. Contradicting these assertions, van Gelder pointed out that the region’s lack of health infrastructure and the diversion of aid money are the real culprits behind the crisis.

“Drug companies do make easy targets but that doesn’t make them villains,” said van Gelder, “The life-saving treatments they create remain Africa’s best hope. The misguided battle against pharmaceutical companies’ patent rights will only make Africa’s health crisis worse.”

van Gelder notes that the growing field of public-private partnerships have resulted in a twelve-fold increase in patients receiving treatment over the last decade and have created a program of voluntary patent licenses for lower-cost “generics” manufacturers. Furthermore, fewer than 5% of WHO’s 423 Essential Medicines are currently protected by patents and these are mostly advanced “second-line” anti-AIDS medicines.

Global Health Progress (GHP) is actively supporting public-private partnerships to help address the need for access to medicines. Strong patent protection and intellectual property rights are critical components of these efforts to treat the public health challenges that the world’s poorest countries face. As van Gelder aptly points out, “Trampling over intellectual property rights removes drug companies’ incentives to invest billions of dollars in the development of the next generation” of much-needed and sought after drugs.

Rather, GHP supports the continued development of public-private partnerships, research and development and protection for intellectual property rights. These policies ensure that developing countries continue to have drugs available at reasonable costs, that pharmaceutical companies continue to embrace innovations and that all organizations can work together to improve healthcare infrastructure worldwide.

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‘Drugging the Undruggable’ Symposium Highlights Advances in Treating Cancer, Diabetes and Other Major Diseases

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Scientists from government, industry, and academia presenting at the 240th National Meeting of the American Chemical Society released a new report highlighting advances in creating the next generation of medicines for treating cancer, diabetes, and other major diseases. The report, which was featured during the special symposium, “Drugging the Undruggable,” summarized progress in drug development for diseases that were once considered “untouchable.” These treatments specifically targeted conditions where previous efforts to develop a drug therapyhad failed.

However, after decades of a seemingly impossible search, scientists appear to be making a breakthrough in the area of drug development to treat cancers and other diseases. As Science Daily noted in their coverage of the report and symposium, scientists have identified “stapled peptides,” a new family of potential drugs capable of blocking a key protein that’s involved in the development of cancer.

Global Health Progress (GHP) supports symposium presenters’ statements regarding the importance of these type of drug developments. For instance, Gregory Verdine, a chemical biologist at Harvard University, explained:

“The entire pharmaceutical industry has been working on drug-design platforms that focus on this little sliver of human drug targets and this limits the drug arsenal available to doctors. What’s required is an entirely new class of drugs that overcome the shortcomings of drugs of the past.” Innovative research and development (R&D) of new drugs is critical in improving overall healthcare, combating epidemics and fighting diseases. Drug development is just one way research-based biopharmaceutical companies serve as active partners in some of the largest and boldest health initiatives that explore new and effective ways to provide treatment, care and education to millions of people both domestically and internationally.

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Medicines for Malaria Venture (MMV) Joins The Pool for Open Innovation Against Neglected Tropical Diseases

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Global Health Progress (GHP) is pleased to highlight the announcement that the not-for-profit public-private partnership Medicines for Malaria Venture (MMV) will became the first product development partnership (PDP) to contribute intellectual property to The Pool for Open Innovation against Neglected Tropical Diseases (The Pool).

MMV joined GlaxoSmithKline (GSK), Alnylam Pharmaceuticals, and the Massachusetts Institute of Technology (MIT) in providing intellectual property to The Pool. Discussing the decision, Professor Patrick Nef, Executive Vice President of Business Development at MMV, states, “In this way we hope to make fully available the know-how and technologies, assembled by MMV against malaria, for the research and development of innovative and efficacious treatments for other neglected diseases.”

By emphasizing a more accessible approach to intellectual property and know-how, The Pool facilitates access to patents and/or technologies for organizations that want to conduct research on treatments and motivates innovative and efficient drug discoveries and developments for neglected diseases.

The Pool is administered by BIO Ventures for Global Health (BVGH). It’s accessible to industry, non-profit institutions, and academic researchers who conduct research and drug development activities that deliver real benefits for patients in the least developed countries of the world.

Global Health Progress echoes the sentiment that MMV’s contribution of patents to The Pool, resulting from its research for new antimalarials, is an important milestone from an organization that plays a major role in leading the development of new therapeutics for malaria.

Global Health Progress supports the continuing partnership between not-for-profit public-private partnerships and research-based biopharmaceutical companies as a way to fight neglected tropical disease through targeted research and development (R&D), improving access to critical medicines and providing key intellectual property.

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Global Health Progress Stresses Importance of Product Development Partnerships

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Helen Coster’s recent commentary in her new Forbes blog Good Work addresses the issue of how product development partnerships (PDPs) can develop and improve treatments for neglected diseases like malaria, leishmaniasis, and Chagas disease.

Coster notes, “These diseases affect the world’s poorest people, and they often get ignored by pharmaceutical companies for a simple economic reason: there is no way that considerable investment in research will be recouped in drug sales.”

Coster’s entry highlights the work of some of the best-known PDPs, such as the Drugs for Neglected Disease Initiative, Global Alliance for Vaccines and Immunization, the International AIDS Vaccine Initiative and the Global Fund to Fight AIDS, Tuberculosis & Malaria. Coster also highlighted the significant funding of PDPs by The Bill and Melinda Gates Foundation.

In closing, Coster invites her readers to discuss the PDP approach to eradicating neglected diseases and what role, if any, the pharmaceutical industry, philanthropists and other global organizations should play in the fight.

Global Health Progress also believes that public-private product development partnerships are invaluable in expanding the capacity of research and development (R&D) on innovative drugs and vaccines for neglected diseases. These partnerships help by harnessing the technical expertise and resources of the private sector with the approach of universities, research institutes and other public organizations.

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Top Government Hospital for Stem Cell Treatments and Research Located in Beijing Launches English Website

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The Stem Cell Transplantation Department at the General Hospital of Chinese People’s Armed Police Forces has launched an English version of its website www.sinostemcells.com for its ever-growing international patients seeking Stem cell treatments. The new user-friendly site reflects the department’s vision of readily available, authentic, and relevant information and aims to supply its online visitors with up-to-date information on the department’s current stem cell therapies and research programs.

The Stem Cell Transplantation Department Director Dr. Yihua An, PhD, says “Access to relevant, quality information is becoming more important for international patients, their physicians, and families. We have met the ever-increasing need for English language updates on our current research direction and practices and have developed a modern English website especially designed for a Western audience.”

The department is located at the General Hospital of Chinese People’s Armed Police Forces in Beijing – a top Level 3A military institution that integrates healthcare services, scientific research, and medical education.

The Stem cell department is active in the field of stem cell treatments and research. The department primary focus is on Stem cell treatment for Spinal Cord Injury and Brain Injury apart from central nervous system -related diseases like Cerebral palsy and Stroke.

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Recent African Leaders Malaria Alliance Meeting Highlights Importance of Partnerships to Ensure Continued Progress on Malaria Vaccine

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During the recent African Union summit, the African Leaders Malaria Alliance (ALMA) gathered to discuss how to combat the threat of malaria in the continent. Inspired by this meeting, Madiké Seye, Vice-President for Africa – GlaxoSmithKline wrote a guest article on the Independent’s website calling for “new tools, such as a malaria vaccine, which could complement existing interventions.”

Seye wrote, “Vaccines and immunization services have been critical to improving Africa’s health over the last several decades. Anyone whose child has suffered f r o m malaria – and there are only few of us who have not directly been affected by the disease – can imagine what a malaria vaccine would mean.”

F r o m there, Seye highlighted the importance of partnerships between African leaders, policymakers, international groups and the pharmaceutical industry. These collaborations are required in order to move forward with making the dream of a malaria vaccine a reality, whether that’s through improving drug prices or investing in technology to fully develop the vaccine. Seye noted that the vaccine is already in the final phases of development and trial results have consistently shown an “acceptable safety profile.”

Global Health Progress supports the role of these public and private partnerships and the participation of the pharmaceutical industry, particularly when it comes to addressing issues involving drug prices, access to medicines, and the continued efforts to create innovative new drugs and vaccines. GHP believes research and development are especially critical components of improving health care and combating epidemics of neglected tropical diseases, such as malaria, in developing countries.

GHP echoes Seye’s call for countries, multilaterals, NGOs, the pharmaceutical industry and scientists to continue to work together to, “make sure Africa is ready for a vaccine. One day there may be the means to save many more lives and change the equation in the fight against malaria for good.”

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Global Health Progress Epitomizes Clinton, Gates’ Call for ‘Efficiency Savings’ In Regards to HIV/AIDS Prevention Treatments, Services

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During a recent international conference in Vienna for 20,000 AIDS scientists, health workers and activists, former U.S. President Bill Clinton and Microsoft founder Bill Gates urged AIDS activists to try to generate the most value possible out of funds set aside for HIV/AIDS prevention services and treatments, including securing access to drugs. Reuters Health and Science Correspondent Kate Kelland highlighted the leaders’ remarks in a recent article:

“The world is awash in troubles. It is easy to rail at a government and say … give us more money. But we also have to change the way we do what we do,” Clinton told the conference. “If we’re going to make this case, they (donor governments) have to believe that we are doing our job faster, better and cheaper. Then we have the moral standing to go ask people to give us more money.” Gates, a philanthropist whose Gates Foundation spends a large portion of its $34 billion fund on fighting AIDS, said efficiency was vital to be able to scale up access to AIDS drugs for the 15 million people who need them, “We can’t keep spending AIDS resources in exactly the same way we do today,” he said. “As we … advocate for more funding, we also need to make sure we’re getting the most benefit from each dollar of AIDS funding and every ounce of effort.”

In keeping with this message, Global Health Progress’ recent 3rd Annual African Health Delegation let African officials share experiences, expertise and insights about how they efficiently employ available resources when battling diseases in Africa. These conferences are just one way GHP helps advocacy groups meet Clinton and Gates’ plea for activists to employ “efficiency saving” tactics when delivering treatments and securing access to drugs for countries “hardest hit and at highest risk” by HIV/AIDs and other diseases.

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Global Health Progress Highlights ViiV Healthcare’s Announcement of New Initiatives

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Global Health Progress highlights ViiV Healthcare’s announcement of a new series of initiatives, including improving access to medicines, to support people living with HIV/AIDS in the poorest and most vulnerable countries.

To address the evolving treatment needs in these countries, ViiV Healthcare will now allow people living with HIV/AIDS to access the whole portfolio of ViiV Healthcare antiretroviral medicines, produced by generic companies. Additionally, ViiV Healthcare is implementing the groundbreaking step of making all patents available to generic manufacturers in these countries for all future pipeline developments, such as the novel integrase inhibitor jointly under development Shionogi – ViiVHealthcare, LLC.

ViiV Healthcare is also expanding the number of countries eligible for this expanded access to medicines to include all least developed countries, all low income countries and all of sub-Saharan Africa – that is 80% of all people currently living with HIV. “At ViiV Healthcare we wanted to go one step further in addressing the HIV/AIDS crisis and supporting access for people living with HIV in the worst affected countries. As a company totally focused and dedicated to tackling this epidemic we are passionately committed to thinking and acting differently and taking new steps to expand access,” said Dr Dominique Limet, CEO of ViiV Healthcare, “At present the numbers of people in the least developed countries moving onto second line therapy is very low compared to the developed world. However as more people have access to treatment, there is an increased need for second and third line treatment options once initial treatment failure occurs.”

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Global Health Progress Releases New Report that Features Innovative Solutions to Improve Access to Healthcare in India

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Global Health Progress’ recently released report, Innovative Solutions to Improving Health in India, summarizes how the organization is committed to building sustainable, innovative solutions to secure access to healthcare for all Indian communities.

The report notes that access to healthcare remains problematic in parts of India, especially in rural areas. For instance, forty percent of the country’s primary healthcare centers are understaffed and fewer than one in five have a telephone connection. Nearly one million Indians die every year due to inadequate healthcare facilities and lack of access to healthcare. Without qualified health care professionals and fully equipped health facilities, programs to assist patients with medicines (both patented and unpatented) are of little use.

Additionally, chronic diseases are on the rise in India and infectious diseases continue to afflict Indian patients. India has the highest prevalence of tuberculosis (TB) in the world, 60 percent of the world’s heart disease, and malaria has staged a comeback after its near eradication in the 1960s. An estimated 40.9 million Indian patients suffer from diabetes, the highest number in the world, and 30 million people are infected with Hepatitis B Virus (HBV).

Global Health Progress recognizes this serious situation and calls on joint action among local leaders and diverse global stakeholders to implement sustainable, innovative solutions. Fortunately, Indian communities have successful and long-standing collaborations with biopharmaceutical companies and other international partners.

The full report, which features examples of India’s successful and long-standing collaborations with international partners, is available here:
http://globalhealthprogress.org/mediacenter/index.php/global-health-progress-report…

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UIC Master of Science in Health Informatics: First in the Nation to Receive Prestigious CAHIIM Accreditation

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The University of Illinois at Chicago (UIC) is pleased to announce that the Commission on Accreditation for Health Informatics and Information Management Education (CAHIIM) has accredited its online Master of Science degree in Health Informatics. The UIC program is the first master level degree program to receive CAHIIM accreditation. Prior to receiving accreditation, UIC was one of only six master programs to be approved by CAHIIM.

“We are thrilled to receive CAHIIM accreditation for our online Master of Science in Health Informatics program,” says Department Head Dr. Larry Pawola. “The CAHIIM accreditation process requires our program to meet a very high educational standard; our accreditation status reflects both the overall quality of our online master’s program, and our ability to deliver valuable advanced education in an online format. We are pleased UIC is recognized as being the leader in health informatics education”

Students in the UIC online Master of Science in Health Informatics program (non-research track) can graduate after earning as few as 45 credits delivered through 14 courses. Since the master’s program started in fall 1999, student enrollment has grown to over 250 active students.

The online program is designed to appeal to working professionals. It offers a unique combination of academics, practical education and technology leadership skills that enables the effective utilization of information technologies to support the delivery of exceptional patient care.

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Unitaids Pool for HIV/AIDS Pharmaceutical Patents Appears Flawed

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Recently the International Policy Network (IPN), a nongovernmental educational organization focused on highlighting the role of free society institutions in social and economic development, released a report discussing Unitaid’s proposed pharmaceutical patent pool. Written by Alec van Gelder and Philip Stevens, this report examines the implications of creating a pharmaceutical patent pool for anti-retroviral medicines (ARVs) in order to improve treatments for HIV/AIDs.

The report examines the potential problems associated with this move, which would allow researchers to experiment on patented ARVs in order to create more effective “fixed dose combination” drugs (FDC) for subpopulations in Africa. Unitaid would distribute these new drugs on a non-profit basis, where royalties as determined by patent pool administrators would be paid to patent holders. The authors of the article point to several issues that could arise with this type of patent pool, including:

• Distribution barriers in Africa, where poor healthcare infrastructure and a shortage of trained personnel exists. These barriers could hinder the new
medications from reaching those that really need it.
• Uncertain need for a patent pool type of arrangement, when many companies already allow researchers to investigate patented material. The authors write, “Many companies have established programmes which give academic researchers free access to vast proprietary compound libraries.”
• Unclear incentive for patent holders to give up intellectual property rights to drugs, knowing that the royalties they could receive would be significantly less than what they are receiving now from the patent.

Stevens and van Gelder conclude that this type of patent pool needs a better focus before they would be able to garner support for it within the industry. If the patent pool was to become compulsory, “R&D, licensing production to existing and new FDCs along with access to medicines would be undermined and potentially crowded out of the marketplace altogether by an unwieldy and unworkable bureaucracy.” They add that this would be counter-productive to Unitaid’s efforts, and could slow access to medicines in the countries that most need them.

To learn more about Unitaid’s pool for pharmaceutical patents read the full article here.

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Pharmacy College Teacher And Students Write On A Common Blog To Share Quickly Pharmaceutical Industry Technology Developments

Dr.Martin a former teacher in pharmacy college and now a director in a worlds biggest pharmaceutical company, was favorite amongst his students and colleagues for his innovative ideas on research and development teaching subjects on pharmaceutical and biotechnology.

One day he and his students on their last day in the college after completing the examinations in course in pharmacy , decided to stay in touch with each other ,and share technical knowledge regularly with each other , they in this process started writing on a common blog whoguideline.blogspot.com on the subjects on their own profession of pharmaceutical industry and biotechnology

This blog is now updated by then students and now top pharmaceutical industry professionals they never knew that this platform will soon become a favorite world wide amongst worlds pharmaceutical industry and pharmacists.

In pharmaceutical industry technology is moving so fast and to keep one self updated day today is a difficult task unless one join a group of a pharmaceutical association or a forums , where one is required to attend meetings and seminars there & one can discuss the latest happening in pharmaceutical industry.

The students says advantage of writing on this blog is just like attending a seminar on pharmaceutical or biotechnology industry , we write on vivid topics and the technical articles are very informative.There is not a single topic on pharmaceutical technology which is left untouched on this blog , be it biotechnology , microbiology or novel drug delivery system or latest happening in pharmaceutical regulatory affairs and latest news in pharma industry is published regularly.

Dr.Martin the cheap author and editor of the blog said that we started writing on our blog to share our knowledge amongst under graduate and post graduate , and doctoral students and industry professionals , as it is best tool to publish and share the knowledge quickly and easily , in this process so far about 1161 pharmaceutical industry professionals and students and have successfully subscribed to the blog , and this blog is now one of the preferred resource of technical knowledge on all topics in pharmaceutical industry.

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Health Analytics, LLC Announces new Contract with Medtronic

Health Analytics, LLC announces today that it has signed a agreement with Medtronic to provide a study for Obstructive Sleep Apnea. The study will examine the effects of the Reposeâ„¢ System.

Health Analytics a healthcare intelligence firm that conducts and interprets scientific studies to improve healthcare outcomes, provide valuable business insights, and enhance business profitability. Health Analytics serves organizations large and small, from national managed care organizations to start-up medical technology, pharmaceutical manufacturers and biotech companies.

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NAICONS and NexThera Transfer Rights Of NAI-107, A New Anti-MRSA Antibiotic, To Sentinella Pharmaceuticals

NAICONS (New Anti-Infectives CONSortium) and NexThera Biosciences, Italian companies focusing on the discovery and development of novel anti-infective drugs, today announced that they have entered into an agreement with Sentinella Pharmaceuticals, Inc., a US-based pharmaceutical company established by Care Capital LLC, a leading life sciences venture capital firm. Under the terms of the agreement, Sentinella has acquired all rights to NAICONS’ proprietary lantibiotic technology, including its lead product candidate NAI-107, in exchange for an upfront cash payment, future development and commercialization milestones, royalties on future product sales and an equity stake in Sentinella. Lantibiotics represent a new class of natural products with potent bactericidal activity against gram positive bacteria including the multi-drug resistant pathogens MRSA and VRE.

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“This agreement represents an important recognition of NAICONS’s ability to discover and characterize innovative antibiotics with a novel mechanism of action”, stated Stefano Donadio, NAICONS’ Chief Scientific Officer. “Our technology is based on fermentation products and includes strong expertise in manipulating antibiotic-producing bacterial strains. This agreement further supports NAICONS’ mission of rebuilding the strong and successful Italian tradition in the antibiotic field.”

“Our partnership with a US-based pharmaceutical company represents the best opportunity to rapidly and successfully advance a potential life-saving drug into clinical development in its largest market. It also gives NexThera international visibility for developing additional anti-infective compounds”, said Daniela Jabes, NexThera’s Chief Executive Officer. “This agreement represents the first tangible result of the synergy between NAICONS’s discovery engine and NexThera’s development focus.”

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“We are delighted to be entering into this transaction with NAICONS and NexThera,” said David Ramsay, a Director of Sentinella. “The principals behind NAICONS and NexThera have a successful track record in the discovery and development of anti-infective products, including rifamycins, penems, dalbavancin and ramoplanin , and we hope to build on that success to develop and commercialize an important novel class of antibiotics for the treatment of multi-drug resistant nosocomial infections.”

Every year several million people worldwide acquire infections while in hospitals, with significant mortality rates. Continuing a trend that began several years ago, it is estimated that approximately seventy percent of hospital infections are currently caused by pathogens resistant to at least one class of existing antibiotics. Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) are among the most dangerous nosocomial pathogens.

According to the Infectious Diseases Society of America, drug resistant bacteria represent a significant economic burden because of the need for costly drugs, extended hospital stays and lost working days. The annual cost of infections by drug-resistant pathogens has been estimated as nearly $5 billion in the U.S. alone.

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Catalent Expands Capabilities In Testing For Melamine In Food And Medicinal Products

At a time when melamine-contamination has received global attention, Catalent Pharma Solutions continues its legacy of innovation by rapidly developing new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.

The current good manufacturing practice (CGMP) regulations require that all components (i.e. ingredients or raw materials) be tested before they are released for use in the manufacture or preparation of drug products (21 CFR 211.84). It is critical that all manufacturers determine whether they are using an at risk component for melamine contamination to manufacture or prepare a drug product.

In response to the FDA’s new guidance titled “Pharmaceutical Components at Risk for Melamine Contamination,” Catalent has successfully qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million. The method is based on that provided by the FDA (Laboratory Information Bulletin No. 4423 “GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide, and Cyanuric Acid”).

Catalent is now able to provide its customers successfully qualified and validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.

Melamine is a compound made of carbon, nitrogen and hydrogen and is typically combined with formaldehyde to produce a durable and moldable plastic that is fire and heat resistant. Trace amounts of melamine have recently been discovered to be toxic to dogs, cats, pigs, and chickens by veterinary scientists after kidney or renal failure occurred due to their food being contaminated with the chemical.

“Catalent is proud to have satisfied the demanding regulatory standards the US FDA has provided for detecting melamine,” said Kent Payne, Vice President and General Manager of Catalent’s Respiratory, Analytical and Biotechnology Services business. “Detecting trace levels of melamine in food and medicinal products at these levels is a challenging process, but is key to help avoid future public health crises. In order to support this critical public health need, Catalent can expedite this testing and provide results within 48 hours from receipt of samples

Fore more information on the US FDA guidelines, please visit:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176088.htm.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit www.catalent.com.

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Catalent To Present Webinar On Stabilities Studies In Pharmaceutical Development

Catalent Pharma Solutions will host a free Webinar featuring Senior Manager, Wei Pan, Ph.D. RAC and Kathy Waddle, Director, Stability QC Biology. The one-hour Webinar will cover stability studies as a critical part of the drug development process and the vital role they play for drug product marketing approval. The Webinar, titled “Stability Studies in Pharmaceutical Development,” will be held on Friday, November 20, 2009 at 2 p.m. (EST). To register for the Webinar please visit: https://www2.gotomeeting.com/register/280747146.

The presentation will address the principles and practices of stability studies in the drug development process. Pan and Waddle will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR211. Additionally, the Webinar will provide a comprehensive review of ICH and WHO stability guidelines by discussing the strategy used in stability protocols designed to support global registration.

Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market. During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs. At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration. After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Present Industry Conferences

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be delivering workshops this October at two industry conferences.

The first will be a pre-conference workshop at Cambridge Health Institute’s Immunogenicity Summit. The event will take place in Philadelphia on Monday, October 26, 2009. The interactive workshop, titled “Technical Advice on Assay Development,” will begin at 8:30 a.m. and will enable attendees to develop an immunogenicity pre-clinical and clinical testing protocol for a therapeutic protein.

The second presentation by Menendez will be a seminar at San Francisco’s Biologicals to Devices (B2G) conference on October 27. The workshop will be called “Effective transfer of Complex Biological Methods in the GMP Environment.”

As part of Catalent’s Development and Clinical Services Segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menenedez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent`s broad range of drug and biologic development services, go to www.catalent.com/development.

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