With most of the pharmaceutical companies establishing biotechnology as an [...]]]>

Fleming Gulf announced its BioProcess Asia Pacific Conference, scheduled to take place from 26th to 28th July 2010 in Singapore. Because there is growing at a very high rate more than other regions, though Asia Pacific profit share of Biopharmaceutical Industry accounts to 3.3% by share.

With most of the pharmaceutical companies establishing biotechnology as an integral part of their business strategy in the near future, and acquiring or developing expertise in select technologies such as recombinant DNA, the country is a strong contender for the biopharmaceutical / biogenerics market.

Forming of strategic alliances and increase in international collaboration lead to the high growth of biopharmaceutical market in Asia Pacific. This is creating a strong need for production of biopharmaceuticals at higher Qualities and Volumes as well as developing an effective and efficient bioprocess.

The Biopharma manufacturing is supported by Government Initiatives and the up-to-date trend – Outsourcing of the production of Biopharmaceutical companies to Asia Pacific – minimize the costs of the whole Biopharmaceutical process.

Based on this emerges some crucial topics which needs to be discussed on the top level platform. The understanding of the strategies to create flexible facility and forecasting future requirements as well as exploring Biosimilars challenges and regulatory models and operational excellence will be discussed by world wide experts at the BioProcess Asia Conference.

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The deal is an extension to an earlier programme agreed in October 2003 between Crucell, GSK and the Walter Reed Army Institute of Research to evaluate Crucell’s malaria vaccine candidate in pre-clinical studies.

Crucell said pre-clinical data indicated greatly enhanced immune responses [...]]]>

Dutch biotechnology firm, Crucell agreed with Britain’s GlaxoSmithKline to jointly develop a malaria vaccine candidate.

The deal is an extension to an earlier programme agreed in October 2003 between Crucell, GSK and the Walter Reed Army Institute of Research to evaluate Crucell’s malaria vaccine candidate in pre-clinical studies.

Crucell said pre-clinical data indicated greatly enhanced immune responses against the malaria parasite when Crucell’s Adenovirus technology and GSK’s RTS,S/AS technology are used in combination, versus either component alone.

The companies aim to start human clinical studies and seek third-party funding to advance the programme into a phase I/IIa clinical challenge trial in the United States.

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Held at the Polaris Science and Technology Park in Pula in the Cagliari province, the international event that [...]]]>

Dubai Biotechnology and Research Park(DuBiotech), the major life sciences hub in the Middle East and a member of TECOM Investments, today announced its successful participation at the Investing and Partnering Forum on Biomedicine and ICT in Sardinia, Italy.

Held at the Polaris Science and Technology Park in Pula in the Cagliari province, the international event that was organized by the Italian Trade Commission (ICE) for investors in biomedicine and information and communication technology (ICT), attracted more than 80 industry professionals from 17 countries around the world, who met around 100 managers of Italian biotech companies.

Dr Amin Al Amiri, CEO Medical Practice and license and Chairman of supreme national Blood Transfusion committee UAE, UAE Ministry of Health, and Dr Marco Baccanti, Executive Director, DuBiotech, led the team of officials from the UAE. Dr Al Amiri met with Andreina Farris, Italian Regional Minister of Industry, as well as Dr. Antonello Liori, Sardinian Minister of Health, and extended an invitation to visit Arab Health 2010, the largest healthcare exhibition in the Middle East, held annually in Dubai.

Dr Amiri met with 14 managers and researchers of Italian companies and visited the bone marrow transplant facilities and the high-tech infrastructure in hospitals in the Cagliari province.

Dr. Marco Baccanti held discussions with 16 Italian and international companies that exhibited substantial interest in DuBiotech, willing to set up their operations in the Middle East under the license of the life sciences free zone. He highlighted the range of business incentives the cluster offers to companies keen for establishing their regional base in Dubai, as well as the important critical mass of 65 companies that the growing cluster has recently reached.

Dr Baccanti said: “The event provided an important opportunity to meet Italian and international companies interested in DuBiotech The leading life sciences cluster offers a unique business environment through a mixture of incentives such as advanced infrastructure, support services, freedom of capital movement, tax-free income and easy access to different markets. All these factors together position DuBiotech as the strategic and ideal location for life sciences companies.”

The Investing and Partnering Forum on Biomedicine and ICT serves as a platform to foster science-business links and promote science and technology partnerships among local enterprises and research centres as well as foreign investors and operators.

Currently, DuBiotech hosts some of the world’s top pharmaceutical/biotechnology leaders such as Pfizer, Genzyme and Merck Serono, and has firmly established itself as a globally recognized centre for the life sciences industries.

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Dr Mohammad Naveed, director of UAE Genetic Disease Association, said Mediterranean countries such as Cyprus and Sardinia, where this disease was common, have already [...]]]>

The UAE hopes to make 2012 the year when all children born in the country will be free of thalassaemia, a genetic disorder which is deadly, a senior consultant geneticist said here.

Dr Mohammad Naveed, director of UAE Genetic Disease Association, said Mediterranean countries such as Cyprus and Sardinia, where this disease was common, have already achieved the target.

He said pre-marital screening, which has been mandatory in the UAE, is often a stressful experience for both parties in the marriage. The association is now focusing on screening university students across the country.

Thalassaemia affects one in 12 people in the country, according to Ministry of Health data.

He was speaking to Gulf News during UAE’s first genetic and biotechnology conference held at Zayed University, Academic City.

The conference is looking at common genetic blood disorders such as thalassaemia, sickle-cell disease and anaemia.

The association has tied up with Yamaguchi University, Japan, DuBiotech and Zayed University for this conference and future research.

Visiting Professor Dr Yukio Hattori from the Yamaguchi University School of Medicine, Japan, said the association has given them DNA samples to study.

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FABA is a non-profit international organization established in 2005. Founded with the objective of creating a common [...]]]>

Dubai Biotechnology and Research ParkDubai Biotechnology and Research Park, a major life sciences hub in the Middle East and a member of TECOM Investments, today announced it has become a member of the Federation of Asian Biotech Associations (FABA).

FABA is a non-profit international organization established in 2005. Founded with the objective of creating a common platform for the development of biotechnology, it also aims to promote and safeguard the overall interests of biotechnology as a science and profession, as well as that of industry professionals, entrepreneurs, industries and academic institutions of Asian countries.

The FABA membership will help DuBiotech explore fresh business opportunities, as well as cooperate and collaborate with biotechnology companies and institutions across Asia.

The UAE, through DuBiotech, has become the 19th member state of FABA. Other major Asiatic countries that have their biotechnology industry represented in FABA are China, India, Japan, Saudi Arabia, Turkey and Malaysia.

FABA also enjoys the support of several Asian and non-Asian biotech organizations such as Biocat (Catalonia – Spain), European Federation of Biotechnology, Bioindustry Park Canavese – Italy, The Federation of Andhra Pradesh Chambers of Commerce and Industry (FAPCCI) in India, the Confederation of Indian Industry (CII), the Russian Biotechnology Society, Maryland-India Business Round Table (MIBRT) and the Association of German Biotechnology Companies (DECHEMA).

Dr Marco Baccanti, Executive Director of DuBiotech, said: “The membership of the Federation of Asian Biotech Associations will help us explore collaborations in the region and increase awareness of the advantages that emerging Asian biotech companies can gain from the access to the wide range of services and assets offered by the DuBiotech cluster.

“DuBiotech has firmly established itself as a globally recognized centre for the life sciences industries, and joining prestigious organizations such as FABA will further strengthen its role as an industry pioneer in the region.”

Dr. B. S. Bajaj, Secretary General, FABA, said: “We are extremely happy that the Federation of Asian Biotech Associations and Dubai Biotechnology and Research ParkDubai Biotechnology and Research Park have entered into an agreement to work together for the development of the industry in Asia. We believe this will lead to an Asian biocluster and result in closer networking, particularly between the UAE and India.

“The establishment of FABA chapter in the UAE will help facilitate the continuous exchange of information on biotechnology development that will eventually bring enormous benefits for both the countries.”

According to recent research, the GCC healthcare services sector will witness major improvements in the quality of deliverables and in achieving competitiveness on a global scale. The region’s endeavour to set up integrated healthcare facilities in the form of medical cities and hubs, coupled with continuous improvement in technology and infrastructure, are expected to significantly improve the availability and quality of healthcare services in the region.

Biotechnology, which took off as a highly specialized scientific stream, is now at the heart of all biology and clinical therapy. With prestigious partners, including some of the world’s top pharmaceutical/biotechnology companies such as Pfizer, Genzyme and Merck Serono, DuBiotech is positioned to significantly transform biomedical research and clinical therapy in the Middle East.

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DuBiotech, a member of Tecom Investments, hosts some of the world’s top pharmaceutical/biotechnology companies such as Pfizer, Genzyme and Merck Serono, and has firmly established [...]]]>

Dubai Biotechnology and Research Park (DuBiotech), a major life sciences hub in the Middle East, has signed an agreement with the Swiss Biotech Association to promote collaboration between the two organisations.

DuBiotech, a member of Tecom Investments, hosts some of the world’s top pharmaceutical/biotechnology companies such as Pfizer, Genzyme and Merck Serono, and has firmly established itself as a globally recognised centre for the life science industries.

The agreement was signed by Dr Marco Baccanti, executive director of DuBiotech, and Domenico P. Alexakis, CEO of the Swiss Biotech Association, at an event hosted by Christian D. Watts, Diplomatic counsellor and regional director for the Swiss Trade and Investment Promotion – IMEA.

The event was also attended by Peter Harradine, president of Swiss Business Council, and representatives of the major biotechnology companies at the life sciences cluster in Dubai.

In addition to collaboration between the two biotechnology organisations, one of the initiatives under the agreement includes a campaign to raise awareness among the Swiss biotechnology and medical technology companies about the Middle East’s growing healthcare market and the benefits offered by DuBiotech as a life sciences free zone.

Dr Baccanti, executive director, DuBiotech, said: “Considering the strategic importance and the technology advancement of the Swiss biotechnology and medical technology sectors, and the benefits the DuBiotech platform offers to these industries, the agreement is an ideal move to ensure mutual advantages to the UAE and Swiss biotechnology companies.”

Domenico P. Alexakis, CEO of Swiss Biotech Association, said: “We are actively supporting all our 183 members to develop their business opportunities. With the collaboration between DuBiotech and the national industry association, the awareness level will increase and generate additional value for the industry.”

The Swiss Biotech Association’s members are well connected to a cluster of 400 Swiss medical technology companies. The association will offer all these companies an opportunity to participate in seminars in the Middle East that will be co-organised by DuBiotech and the Swiss Biotech Association.

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“PhRMA, along with research universities, patients, healthcare providers, and elected leaders at the state and federal levels, supports the development of a responsible, abbreviated approval pathway for biosimilars that includes a fair [...]]]>

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding appropriate incentives for continued biotechnology innovation:

“PhRMA, along with research universities, patients, healthcare providers, and elected leaders at the state and federal levels, supports the development of a responsible, abbreviated approval pathway for biosimilars that includes a fair period of data protection that is critical for the future of medical progress.

“Legislation moving forward in the U.S. House and Senate provides for patient safety and strikes the appropriate balance between the desire for enhanced competition for biologics, and the need to provide meaningful incentives for innovation.

“Such incentives are vital for ensuring continued development of new biologics that are needed to provide future treatments and cures for such serious ailments as Alzheimer’s disease, Parkinson’s and cancer. Already, biologic medicines have revolutionized patient care. In fact, these cutting-edge therapies are among the reasons why American patients with life-threatening diseases, like cancer, are living longer.

“The pathway endorsed through strong bipartisan Congressional votes would allow onto the market biosimilars — medicines that are similar to, but will never be exactly the same as, the original biologic.

“That key element — similarity — factors into investment decisions, because the nature of patent protection for biologics is uncertain in the context of biosimilars. Because biologics are extremely complex, patents may cover just part of the molecule or simply cover the process for its manufacture.

“In the future, should this legislation become law, a biosimilar manufacturer using its own manufacturing process to create a biosimilar that differs slightly from an innovator biologic would have the potential to circumvent patents — while qualifying for an abbreviated application.

“Economists and the venture capitalists whose private investments shore up this vital, yet vulnerable sector agree: 12 years of data protection, at a bare minimum, are needed to help recoup the significant development costs for biologic innovators. That, however, does not constitute market exclusivity. Companies could still seek approval of competing biologics using their own data, but for those 12 years no biosimilar competitor could rely on innovators’ hard-earned data, collected during development that may span a decade, or more, to seek approval.

“For many biologics on the market right now, the 12-year data protection clock began ticking long ago, when federal regulators approved the therapy. In addition to the brand-to-brand competition that already occurs for biologics, those biologic medicines could face biosimilar competitors relatively soon; multiple biosimilars are already on the market in Europe.

“Biosimilar versions of current biologics may well be approved before 12 years have elapsed after the law’s enactment, but 12 years of data protection is important to provide incentives for manufacturers to create the next wave of innovative biologics.

“Giving short shrift to incentives for innovation would grind to a halt uniquely American innovation, moving critically important R&D — and tens of thousands of U.S. jobs — overseas. Right now, 80 percent of the world’s biotech research occurs in the U.S.

“A diverse group of supporters agree with the need for adequate data protection, from patients eagerly awaiting new therapies to elected officials who understand how tenuous U.S. leadership in biologics research could become if incentives for innovation are weakened:

• ‘Many of these biologics will be developed from early-stage discoveries arising from basic research conducted by universities. … [I]t will be important to preserve sufficient incentives for innovator companies and venture capitalists to commit the substantial investments necessary to develop such discoveries into new biologic treatments…’ — Association of American Universities
• ‘[W]e must avoid excessive damage to the system that produces the majority of revolutionary and innovative new biologic drugs. NVCA believes a data exclusivity period of at least 12 years for innovator products is a critical fulcrum in the effort to balance cost with the preservation of biotech innovation.’ — National Venture Capital Association
• ‘This critically important issue has a direct economic impact on our states, our nation’s public health, our economic success, and our global leadership in biomedical research. … 12 years of data exclusivity for biologics represents a critical element needed to ensure appropriate incentives for continued biomedical innovation.’ — Joint letter signed by the Governors of Massachusetts, Connecticut, Colorado, Delaware, Maryland, North Carolina, Oregon, Rhode Island, Puerto Rico and Washington
• ‘[I]t would be neither fair nor sound public policy to demand that one company spend millions of dollars to generate expensive data, and then allow another company to use that data for free before the first company has had the chance to recoup its investment. This would mean fewer new biologics for patients and fewer future competitive opportunities for both innovative and biosimilar companies.’ — Dr. Henry Grabowski, Duke University
• ‘Saving money is a hollow victory if it costs lives, and elderly Americans are at the greatest risk. … 12-year data exclusivity [is] needed to incentivize the development of new medical breakthroughs that our seniors are counting on.’ — RetireSafe
• ‘We strongly believe that the treatments developed through biotechnology will enable better care for a host of debilitating age-associated infirmities … [A] well-defined process for approving biosimilars will help sustain investment in this vital area of therapy development and allow for these treatments to one day be made widely available to patients who otherwise could not have access to them.’ — Alliance for Aging Research

“Creating a new biologic medicine is a complex, long-term endeavor that is costly, takes years of research, and has an uncertain chance of success. Development costs for innovative biologics alone can exceed $1.2 billion, plus up to an additional $450 million to build specialized manufacturing facilities.

“Already, many biotechnology companies that are the birthplace for many cutting-edge therapies face a bleak outlook. The recent financial crisis, for some, represented a deadly blow. Twenty-two biotechs have already been delisted from NASDAQ. This week, NVCA and Thomson Reuters reported that venture capital funds raised in the third quarter of 2009 plummeted to the lowest level in 15 years.

“R&D is the engine that drives continued medical advances that save lives and improve patients’ quality of life, but few would tackle biologic medicines without a fighting chance to recoup their significant investments.

“Importantly, if we’re going to cure cancer in our lifetime, as President Obama has challenged America to do, new innovative biologics, undoubtedly, will play an instrumental role.”

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The announcement came at a press conference held concurrently with the groundbreaking ceremony for the new facilities. The events were held under the patronage and in the presence of His Highness Sheikh Nahyan bin [...]]]>

Neopharma, the Abu Dhabi-based pharmaceuticals manufacturer, announced a large scale expansion program to enter into biotechnology and nanotechnology-based research and manufacturing capabilities.

The announcement came at a press conference held concurrently with the groundbreaking ceremony for the new facilities. The events were held under the patronage and in the presence of His Highness Sheikh Nahyan bin Mubarak Al Nahyan, UAE Minister for Higher Education and Scientific Research, and Chairman of Neopharma.

Elaborating on the series of new expansions, His Excellency Abdullah Humaid Al Mazroei, Vice-Chairman, and Dr. B R Shetty, Managing Director and CEO, Neopharma, said the new facilities will form an integral part of the company’s horizontal integration process to produce additional pharmaceutical dosage forms and mark its foray into high-technology based research and development (R&D).

Neopharma’s new plants will facilitate the manufacture of nutraceuticals, injectable preparations, topical applications, ophthalmic products and aerosols. In addition, manufacturing lines are being set up for an important group of antibiotic drugs called ‘cephalosporins’. Such plants call for dedicated facilities and Neopharma has allocated separate areas for both oral and injectable variations.

With an investment outlay of AED250 million, the new facilities will be designed on the guidelines recommended by the US FDA. Equipments for the expansion are being sourced from the best-in-class companies worldwide and commercial production is expected to begin within 14 months.

Dr. B. R. Shetty said:

“Companies across the globe are reluctant to start new initiatives due to the impact of recession. Yet, at Neopharma, we have been aggressively pressing ahead with our organic growth initiatives that remain crucial to the future of the company. The immense support of Bank of Baroda, the lead financing partner in this project, is a significant stimulus that complements our efforts.”

“The success of pharmaceutical companies depends to a large extent on the ability to introduce new and novel therapies. We believe our investments in this area will provide the necessary impetus for sustainable growth.”

Dr. Shetty added: “Businesses must adopt the organic route to improve and sustain the nation’s manufacturing capabilities. This is our social responsibility – to create, develop and sustain the economic foundation for the good of future generations.”

Operating in a competitive generic marketing space, Neopharma has differentiated itself by offering innovative drugs through the in-house research for formulations or through landmark joint venture partnerships that have propelled the company to new heights.

Neopharma’s in-house R&D efforts saw the introduction of products in sustained release formats and includes medications for diabetes and the management of angina. The joint venture with biotechnology major Biocon heralded the introduction of a novel nanotech-based oncology product Abraxane that is used in the treatment of breast cancer.

Last week, the company received approval for the manufacture of BR Flu – Oseltamivir for the treatment of H1N1 infections. The product is an outcome of its joint venture with the pharma major Hetero Drugs and the entire range of formulations are expected to be ready shortly.

The new initiatives are expected to help the company obtain an early lead in nanotechnology based devices. With parallel work already initiated, Neopharma will be the first company to start filing patents for such devices.

In addition, Neopharma’s state-of-the-art facilities are designed to provide the right training opportunities for students in the country and help create a professional talent pool.

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