PHARMACEUTICAL / BIOTECHNOLOGY

UPDATE

 

December 2007

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

Bilcare Inaugurates R&D Center

Orchid Biotech Park, University Forge Ties

New Facilities for PA Universities

Haemacure Starts Construction on New State-of-the-Art Biologics Facility

Eisai Building a 65,000 sq. ft. Facility

Brazil and Cuba Cooperation

CMC Expands Bio-CMO Footprint with Icos Purchase

Skystar Bio-Pharmaceutical Establishes R&D Center in Shanghai

Traditional Chinese Medicine Research JV Sets Up in the Babraham Bioincubator; First in UK

Joslin Diabetes Center Completes Sale of Land, Development Rights to Alexandria, National Development and Charles River

Merck to Build $297 Million Vaccine Plant in Ireland

Covance Plans a 410,000 sq. ft. Facility

MEDICAL DEVICE

Turner to Construct General Electric Healthcare Facility

 

 

 

 

Bilcare Inaugurates R&D Center

Bilcare recently inaugurated its Centre of Excellence in Pune, India. The site has dedicated R&D sections for Packaging Research, Material Research, Analytical Research, Drug Sensitivity Studies and Package Design. Bilcare has developed an anti-counterfeiting product to increase product warrant and traceability.

 

The Centre is also equipped with Asia's first integrated Flexo Printing machine, as well as a state-of-the art pilot plant.

 

Orchid Biotech Park, University Forge Ties

The National University of Kaohsiung (NUK) forged cooperative ties yesterday with the Taiwan Orchid Plantation, an orchid biotech park located in Tainan County, southern Taiwan, in an effort to breed high-quality orchid seedlings and boost the competitiveness of Taiwanese orchids on the international market.

 

A greenhouse will be built for the use of academia-industry cooperative research projects.

 

The NUK will also install a laboratory in the park to engage in virus tests on orchids in a drive to breed healthy and high quality seedlings, according to the agreement.

 

The cooperation is part of the government's national high-tech development program in agricultural biotechnology being carried out by NUK, National Tsinghua University, National Cheng Kung University, National Pingtung University of Science and Technology and the Taichung-based National Museum of Natural Science.

 

The plantation, located in Hobi township and inaugurated at the end of 2004, covered 23 hectares in the first stage of its five-stage construction plan, and is now at the third stage.

 

When all five stages of the plan are completed, the total area of the plantation will cover some 170 hectares.

 

New Facilities for PA Universities

James Madison University will collect $96 million: $44.8 million to build a new biotechnology building, $43.4 million to renovate and expand Duke Hall and $8.6 million to finish acquiring the existing Rockingham Memorial Hospital site on Cantrell Avenue. RMH is building a new $280 million complex at Reservoir Street and Port Republic Road that's expected to open in 2010.

 

Blue Ridge Community College, on the other hand, will take in $5.6 million to renovate and expand an administration/classroom building.

 

Haemacure Starts Construction on New State-of-the-Art Biologics Facility

Haemacure Corporation, a Montreal-based specialty bio-therapeutics company, announces the start of construction of its manufacturing facility, the production of laboratory samples of fibrin sealant, the hiring of two senior scientists and share purchases by insiders.]

 

Construction is underway at the facility to prepare for the installation of the clean room. Haemacure is on plan to have an operational facility by mid-2008. Construction of a state-of-the-art facility incorporating the latest proven manufacturing components is a major milestone that will require significantly lower capital investment than originally planned. The facility will also allow lower operating costs and higher final product safety standards. Haemacure has produced in its laboratory samples of its proprietary fibrin sealant for delivery to potential partners for evaluation as a part of a collaboration program. This will enable these partners to evaluate the product in their labs and see how it can enhance the performance of their own products, in wound management, regenerative medicine, drug delivery and combination with biomaterials applications.

 

Haemacure operates offices in Sarasota, Florida through a wholly-owned subsidiary.

 

Eisai Building a 65,000 sq. ft. Facility

Eisai is willing to shell out $3.9 billion to buy MGI Pharma. The transaction will significantly pad the company’s oncology business as well as its position in the U.S. market.

 

Under the all-cash definitive merger agreement, Eisai will pay $41 per MGI share. The price represents a 25.5 percent premium over MGI’s closing price on Friday, December 7.

 

Faced with patent expiration of its cash cow, the purchase of MGI Pharma bolsters Japan-based Eisai’s position in the U.S. market. The company’s lead product, Aricept, an Alzheimer’s treatment, is expected to lose patent protection in 2010. MGI brings with it five approved therapies, which together had sales of $283.34 million during the nine-month period ended September 30.

 

MGI also has an end-stage heavy cancer pipeline. It has one product under regulatory review for the treatment of post-operation nausea and vomiting, five candidates in Phase III trials, one in Phase II, and one in Phase I. The deal thus gives Eisai plenty of R&D potential in the U.S., where it is currently building a 65,000 sq. ft. facility.

 

In fact, this is the third transaction Eisai has entered to reinforce its pipeline and international foothold. In March, the company paid $325 million to take over Morphotek, thus adding biologics to its pipeline. Last year, Eisai bought four oncology products from Ligand Pharmaceuticals for $205 million.

 

The acquisition is expected to be completed during the first quarter of 2008. Eisai anticipates that the transaction will then be accretive to its cash EPS in fiscal year 2008 and GAAP EPS in fiscal 2009.

 

Brazil and Cuba Cooperation

Brasilia, Brazil is interested in enhancing scientific-technical collaboration with Cuba in all sectors, the island's Foreign Trade Minister Raul de la Nuez told Prensa Latina.

 

In an interview, the Cuban minister referred to the work of the Intergovernmental Joint Commission started. The minister met with Health Minister Jose Gomes Temporao and "Banco do Brasil" president Antonio Francisco de Lima Neto, analyzed the state of exports of biotechnology products this year and the homologation of titles, and visited the Federal Confederation of Companies.

 

The agenda included talks with authorities from Tourism and Finance Ministries, and the closing ceremony and signing of the act of the Second Bilateral Joint Commission.

 

CMC Expands Bio-CMO Footprint with Icos Purchase

CMC Biopharmaceuticals A/S has reached an agreement with Lilly to buy the biologics development and manufacturing operation of ICOS Corp., which Lilly bought on in January 2007. CMC, a Copenhagen, Denmark-based bio-CMO, will purchase the biologics facility in Bothell, WA. The new operation, CMC ICOS Biologics Inc., will develop and manufacture therapeutic proteins for early clinical trials.

 

The company said that it is planning "significant investment in the facility to enable production of late-stage clinical trial and commercial biopharmaceuticals." CMC plans to retain the 127 employees currently working at the Bothell facility.

 

Skystar Bio-Pharmaceutical Establishes R&D Center in Shanghai

XI'AN, China, Skystar Bio- Pharmaceutical Co., Ltd., a leading bio-pharmaceutical company in the People's Republic of China ("PRC"), today announced that it recently established a new research and development center ("R&D Center") in Shanghai.

 

The R&D Center, registered as Shanghai Siqiang Biotechnology Co., Ltd., utilizes advanced professional equipment such as liquid chromatography and infrared dissolution and infiltration equipment. The 200-square-meter (2,152 sq. ft.) facility is staffed with six chief researchers, four of whom are from the Chinese Academy of Agricultural Sciences ("CAAS"). The CAAS researchers have participated in national key science and technology projects, and have published numerous academic papers in Chinese and

 

Traditional Chinese Medicine Research JV Sets Up in the Babraham Bioincubator; First in UK

China's Ambassador to the UK Madame Fu Ying, opened Meditrina, the newest Bioincubator building at the Babraham Research Campus, and welcomed the first Chinese company - Guangzhou Xiangxue Pharmaceuticals - to the campus, near Cambridge.

 

The XiangCam TCM Research Centre is a pioneering collaboration between Chinese enterprise and academic institutions in China and the UK. It aims to illuminate the science underpinning Traditional Chinese Medicine (TCM) theories and practice, facilitating interaction between Eastern and Western practices, and ultimately to deliver solutions to the unmet needs of global healthcare in the 21st century.

 

Dr David Hardman, CEO of Babraham Biosciences Technologies (BBT) said, “Not only is Xiangxue the first overseas bioventure in our facilities, it is also the 50th biomedical company to locate to the Babraham Research Campus since the Bioincubator opened in 1999.”

 

This is the first Chinese Pharma investment in a TCM research organization in the UK, fostering collaborative research across the academic and commercial divide between East and West.

 

Cambridge University spear-headed the initiative with China's Tsinghua University.

Professor Peter McNaughton, Head of the Department of Pharmacology at the University of Cambridge said, "In these days of huge international pharmaceutical companies and modern high-powered methods of drug development it is worth recalling how much we owe to compounds discovered in the natural world through folk medicine. As an example, aspirin, one of the most successful pharmaceutical compounds of all time, was discovered as a minor chemical modification of salicylic acid, isolated from willow bark, whose analgesic properties had been known by folk healers for millennia.”

 

Other UK partners include the Royal Botanic Gardens, Kew, which will authenticate a selection of TCM herbs prior to chemical, pharmaceutical and toxicological analysis by teams at Brunel University, Bradford University, the London School of Pharmacy, Guy’s & St Thomas’ Hospital. In addition to elucidating the cellular and molecular mechanisms behind the actions of single TCM herbs, or formulas including several different herbs, a further outcome will be a reference library for TCM standards.

 

“Leads” identified through the Anglo-Chinese collaborative research projects will then undergo clinical research in China. This may also pave the way for new blends of Chinese medicine or plant extracts, as well as synthetic derivatives, yielding a new generation of safer and more efficacious TCM products.

 

Meditrina, named after the Roman goddess of medicine, was part-funded by a capital grant of £2m from the East of England Development Agency (EEDA) in partnership with the Biotechnology and Biological Sciences Research Council (BBSRC) enabling the construction of this state-of-the-art £7m Bioincubator.

 

Joslin Diabetes Center Completes Sale of Land, Development Rights to Alexandria, National Development and Charles River

Joslin Diabetes Center announced it has completed the sale of a prime development parcel in the Longwood Medical Area (LMA) to a joint venture of Alexandria Real Estate Equities, Inc., National Development, and Charles River Realty Investors.

 

The joint venture partners plan to build an approximately 350,000 square foot life science research building on the parcel, an approximately 1.1 acre site for which development rights were approved by the BRA in 2003. Joslin will secure expansion research space in a portion of the new building, with the remainder of the building expected to be leased to other institutions and life sciences companies. Construction on the new building is expected to begin in 2008.

 

Merck to Build $297 Million Vaccine Plant in Ireland

Merck & Co will build a new 200 million euro ($297 million) plant in Ireland to develop and manufacture human vaccines. The 65-acre site in the southeastern town of Carlow will create 170 new jobs.

 

The new Carlow facility, which will be the first stand-alone human vaccine project in Ireland, will involve a formulation and sterile filling operation and an R&D (research and development) team to support a number of recently launched vaccines and new products in the future. A Merck spokesman said it expected to begin construction next year.

 

Merck already has a production facility in the south of the country which employs 360 people and makes active pharmaceutical ingredients for Merck subsidiaries globally.

 

It is currently building a 100 million euro research and manufacturing facility at the site, in the town of Clonmel, which is expected to be completed by 2010.

 

Merck has two existing operations in Ireland employing a total of 460 people - Merck, Sharp & Dohme (Ireland) Ltd, at Ballydine, Co. Tipperary, producing active pharmaceutical ingredients; and Merck, Sharp & Dohme Ireland (Human Health) Ltd, at Leopardstown, Co. Dublin, which is the corporate platform for a number of strategic activities for the company in Ireland.

 

Merck is Not Alone in Choosing Sites in Ireland, with several pharma firms operating multiple sites in the region in response to considerable time and effort spent by the IDA and its counterparts to create an attractive environment for the sector.

Abbott, for example, operates seven sites in Ireland, Johnson & Johnson has six, Pfizer currently has five and Schering Plough and GlaxoSmithKline both have four.

Ireland has in fact become a real focal point for the industry, establishing itself as the most popular destination for development and manufacture outside the US, according to the IDA.

 

With considerable expertise, an attractive infrastructure and all-important tax breaks, the life sciences are the biggest source of foreign investment in Ireland, with the pharmaceutical and biotech industries bringing in the bulk of the €2.6bn the region saw in capital investment projects over 2006.

 

Covance Plans a 410,000 sq. ft. Facility

Covance, Inc. purchased a partially constructed manufacturing facility in Prince William County's Technology Park from Eli Lilly. The company intends to transform the current facility into a 410,000-sq.-ft. state-of-the-art early drug development lab offering safety testing and chemistry analysis services.

 

For 60 years, Covance operations in Northern Virginia have made significant contributions to the development of new medicines for HIV/AIDS, breast cancer, heart disease, leukemia, diabetes, Alzheimer's, multiple sclerosis, cystic fibrosis, deadly infections, and many other debilitating diseases.

 

Covance plans to relocate approximately 450 current employees from its existing operations in Vienna, VA and Chantilly, VA by 2011, and hire an additional 100 employees by 2014. The company plans to invest approximately $175 million in the project. Covance expects to receive approximately $3.7 million in financial incentives from the Commonwealth of Virginia and Prince William County.

 

MEDICAL DEVICE

 

Turner to Construct General Electric Healthcare Facility

Turner Construction Company has been selected to serve as the construction manager and provide preconstruction services for a $165 million digital x-ray detector production facility for General Electric Healthcare in the Rensselaer Technology Park in North Greenbush, NY Completion is scheduled for December 2008.

 

The facility will produce state of the art digital x-ray mammography machines. The building will consist of a total area of 150,000 square feet, of which 60,000 square feet will be clean room space.

 

McIlvaine Company,

Northfield, IL 60093-2743

Tel:  847-784-0012; Fax:  847-784-0061;

E-mail:  editor@mcilvainecompany.com;

Web site:  www.mcilvainecompany.com