News » 2007 » May » Tuesday the 22nd
Posted on May 22, 2007 @ 05:51 am
Albany Molecular Research, Inc. (AMRI) has signed anagreement to acquire two pharmaceutical manufacturing sites, along with additional land for future expansion, in Aurangabad and Navi Mumbai, India. AMRI will acquire the assets -- including facilities, employees, products and equipment-- of Ariane Orgachem Pvt. Ltd. in Aurangabad and Ferico Laboratories Ltd. in Navi Mumbai for approximately $11 million in cash. In fiscal 2006, the assets generated around $5 million in revenue.
All of the facilities are currently owned by the Runwal Group and manufacture a range of pharmaceutical intermediates and bulk active ingredients, including treatments for diabetes, heart disease and asthma. As part of the purchase, AMRI will obtain additional land in Aurangabad and plans to invest approximately $15 million to expand capabilities there during the next three years. The proposed expansion includes increasing capacity, as well as bringing these facilities into compliance with FDA regulations for manufacturing clinical trial materials and commercial drug substances.
AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D., remarked, "Initially, the purchase of these sites augments and provides a reliable and cost-effective supply chain for AMRI's U.S.-based manufacturing operations. It offers us the flexibility to produce raw materials and process intermediates to support our Rensselaer, NY plant. Longer-term, as we increase capabilities in India, we expect to leverage AMRI's small-scale / development resources on two continents, including our laboratory operations in Hyderabad, India."
He added, "This announcement culminates a multi-year search. Just as we have expanded our lab scale operations to include global facilities operating in a range of lower cost structure environments, we have continued to believe that globalization of our manufacturing operations was also critical to the survival and growth of this component. During our search for this facility, we evaluated a range of options, from large volume, existing large revenue-based operations, to several greenfield sites. While the purchase announced today is small in comparison to some of the options we evaluated, it gives us an immediate presence and base we can capitalize and build on; something that a greenfield location would have taken years to achieve. I am confident that, long term, this expansion of our business will provide our customers with increasing options and solutions, provide our business the opportunity to accelerate our future growth and expand our global market, and provide our shareholders increasing returns as AMRI becomes a larger, more successful competitor on the world stage."
"As we invest in additional capacity and ramp up production, we expect these facilities to add significantly to our Large Scale
Manufacturing contract revenue in future years," noted AMRI chief financial officer Mark T. Frost. "Ultimately, we expect to realize cost savings resulting from re-engineering our supply chain operations. That cost savings will be used to improve competitiveness and productivity in our Large Scale Manufacturing business component."
The size of the facilities, including both the Aurangabad and Navi Mumbai sites, is more than 9,100 square meters, with additional land available for expansion. To ensure a smooth transition, AMRI has established an integration team and plans to continue the employment of the approximately 200 people working at the facilities. Harold Meckler, Ph.D., vice president of science, technology and support services at AMRI, will lead the integration effort during the transition process.
The transaction is expected to close during the second or third quarter of 2007.
Posted on May 22, 2007 @ 05:50 am
Quintiles Transnational Corp. and Thermo Fisher Scientific has established Cenduit, a joint venture to provide Interactive Response Technology (IRT) services for pharmaceutical and biotechnology product development. IRT is a technology platform that integrates patient interaction systems through a combination of Interactive Voice Response (IVR) systems, Web interfaces and handheld electronic patient diaries. The use of IRT is expected to grow as pharmaceutical companies look to streamline and better control increasingly complex drug development processes, according to a joint statement by the companies.
Thermo Fisher will contribute to the JV with its Fisher Clinical Services IRT operations in three locations -- Horsham, U.K., Allentown, PA, and Basel, Switzerland. Quintiles will provide its IRT operations in Bangalore, India, and Research Triangle Park, NC. The RTP site will also serve as the venture's headquarters.
"Cenduit brings together best-in-class technology, exceptional customer service and global clinical trial expertise to give biotechnology and pharmaceutical companies a seamless, integrated 'one-stop' service for support of their clinical development programs," said Jogin Desai, chief executive officer of Cenduit. "Our efficiency and experience in IRT services and clinical project management offers the drug development industry a conduit to the broadest, most accurate, real-time view of every detail in the process -- and a very competitive solution." Dr. Desai previously served as executive director of Quintiles Cardiac Safety Services. A medical doctor, he has experience in clinical research in the U.S. He joined Quintiles India in 2002 and helped build and expand the global ECG business, which has staff in India, the UK, the U.S. and Japan.
Dr. Desai added, "IVR is used in an estimated 30% of all Phase II-III clinical trials, and this rate is expanding rapidly. With advances in technology leading to even broader application through IRT, we believe the market will grow at a rate of about 20% per year, and we plan to offer a service that can aggressively capitalize on this opportunity."
Cenduit will be guided by a joint venture board of directors, composed of representatives from each of the founder companies. The board will provide guidance on operational and strategic matters. "Our companies have been looking for an opportunity to leverage the particular service strengths we bring to the drug development process," said Marijn E. Dekkers, president and chief executive officer, Thermo Fisher Scientific.
"These are two businesses that know the complexity of clinical trials and the optimal cohesiveness and integration of their many work and data streams," said Oppel Greeff, Quintiles' Vice Chairman, Operations. "The joint venture that we have created through Cenduit offers the drug development industry the broadest, most accurate view of every detail in the process."
Posted on May 22, 2007 @ 05:34 am
Several Contract Research Organizations have formed a CRO Service Alliance (CROSA) in Shanghai's Zhangjiang HiTech Park. According to a press report, this is a first for China and is intended to take advantage of "specialized expertise from the three CRO companies to provide efficient and high quality CRO services in all related fields for drug discovery and development of clients worldwide."
The CROs that have formed the alliance are Sundia MediTech Co. Ltd., United PharmaTech Ltd. and HD Biosciences. The alliance will act as a single entity in the CRO market, and will explore ways to cooperate even closer in the future. "Allying with United PharmaTech and HD BioSciences is the best way to quickly and successfully expand our business into the complete range of CRO services to fit the increased demands from our clients world wide while maintaining high quality and efficiency and minimizing cost," said Sundia's chief executive officer Dr. Xiaochuan Wang. "It will change the landscape of China's pharmaceutical CRO industry.
The companies will provide services in new pharmaceuticals synthesis, lead optimization, molecular bio-assay development and tests, in vitro and in vivo PK/ADME research, and cGMP-required intermediates and API for clinical trials, according to HD Biosciences' chief executive officer and president Dr. Xuehai Tan.
"The current CRO industry in China is unique. Pharmaceutical companies in developed countries desperately need new drugs, but cannot afford the prohibitive cost of research in their home countries," said United PharmaTech's chief executive officer Dr. Xiongwei Shi. "Their best option is to outsource R&D work."
Sundia MediTech, United PharmaTech and HD BioSciences were all founded between 2002-04 in Shanghai by veterans of U.S. pharmaceutical companies to provide drug discovery and development CRO services in different stages and fields.
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