d center

Novartis' China plans grew from science roundtables

Wed, 07 May 2008 06:59:55 -0400

PharmAsia News sat down with Paul Herrling, head of corporate research at Novartis, and En Li, VP and head of research for Novartis Institutes for BioMedical Research Shanghai, to discuss the massive R&D efforts the company now has underway in China.

Novartis began its involvement in China 10 years ago with discussions with Chinese scientists about traditional Chinese therapeutics and how that fit in with Novartis' effort to develop new compounds using natural ingredients. Now Novartis is budgeting $96 million for a new R&D center in China and plans to make the Chinese market one of its top 10 globally.

- read the story from In Vivo

Genzyme gets biosimilar rejection, builds R&D plant

Tue, 22 Apr 2008 06:59:58 -0400

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This rejection underscores the difficulty biosimilars face in the United States. "The FDA decision...suggests that regulators may be reluctant to approve any generic versions of biologic drugs...without clinical data proving the drugs are at least as safe and effective as the originals if there are even slight differences in the compounds," observes the Boston Globe. Currently, the U.S. has no pathway to quickly approve biosimilar drugs.

As Genzyme points out, Myozyme production has already been scaled up in 40 other countries. "Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale...Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe," the company said in a statement. The company expects the FDA to act on the application by the end of the year.

- see this release from Genzyme
- read the Boston Globe article

ALSO: Genzyme is opening a major new R&D center in Beijing. The facility will house 350 employees and will cost an estimated $90 million. Researchers in the Beijing plant will develop drugs in four focused areas: orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. According the the release, the R&D facility "is part of Genzyme's ongoing global expansion and commitment to establishing a long-term presence in China." Report

Arizona gets its own early-stage venture fund

Mon, 10 Mar 2008 07:59:55 -0400

The Translational Accelerator has opened its doors to all biotech companies in Arizona--or any life sciences company thinking about moving there. And it has $20 million in venture funds to welcome the industry with, according to the Business Journal of Phoenix. Richard Love, a former senior executive with the Translational Genomics Research Institute, helped organize the fund, bringing some of the top names in the state's biotech business together to help spur the industry along. Their niche will be investments of $500,000 to $2 million for early-stage ventures.

Arizona officials heralded the move, saying it represents the growing role that biotech will play in the state.

"We are already seeing great results from the additional funding we gave to the research and development institutions at the universities," says Arizona Gov. Janet Napolitano. "We are also seeing more and more biomedical companies relocate or expand to Arizona because of the business climate and the workforce we are turning our of our universities."

- read the article in the Phoenix Business Journal

Related Articles:
Arizona expands biotech hub plans. Report
Sanofi breaks ground on Arizona R&D center. Report
Sanofi plans Arizona expansion. Report

GSK blueprints $100M Chinese R&D center

Thu, 13 Dec 2007 06:59:56 -0500

GlaxoSmithKline is sinking $100 million into a neuroscience research center in China that will play a pivotal role in its ongoing drug discovery work. R&D chief Moncef Slaoui says that Glaxo's new center in Shanghai will be primarily responsible for work on new therapies for neurodegenerative diseases like Alzheimer's and Parkinson's. But don't think of this as an outsourcing deal, he adds. "It's about different science," he tells the Financial Times. "We will link our fate to their fate. Within five to ten years we will be moving from 'made in China' to 'discovered in China'."

Glaxo isn't alone in changing the stamp on drugs to 'discovered in China'. Roche, Novartis, Sanofi and many other pharma giants are clustering their research efforts in China, with most flocking to Shanghai.

- see GSK's release on the R&D center
- read the Financial Times report for more

Related Articles:
GSK shakes up R&D. Report
R&D spending going gangbusters in China. Report
GSK plant closure begins 5,000 job cuts. Report
Behind the scenes of GSK's overhaul. Report

Sanofi breaks ground on Arizona R&D center

Wed, 28 Nov 2007 06:59:55 -0500

Pima County, Arizona has scored a big win on the economic development front with the newly begun construction of a new, $60 million research facility for Sanofi-Aventis. The R&D center sits in a 300-acre park that is being developed as a biotech hub. Construction on the 110,350-square-feet facility should be completed next summer.

"The Oro Valley center plays an important role in Sanofi-Aventis' future research oals," says Jean-Marc Herbert, senior vice president of Discovery Research for the company.

- read the report from Expansion Management

Related Articles:
Sanofi plans Arizona expansion. Report
Arizona expands biotech hub plans. Report
Sanofi underscores pipeline advances, setbacks. Report
Mayo teams with Arizona State on cancer vaccines. Report

Press Release: DuPont Plans New R&D Center in Hyderabad, India

Maureen Martino — Thu, 01 Feb 2007 12:35:28 -0500

DuPont Plans New R&D Center in Hyderabad, India

NEW DELHI, India, HYDERABAD, India and WILMINGTON, Del., Feb. 1 -- DuPont today announced plans to invest over Rs 100 crores ($22.5 million) to construct its first research and development center in India. The DuPont Knowledge Center will be located in Hyderabad and is expected to accommodate more than 300 scientists and other employees.

"The DuPont Knowledge Center in India will focus on discovery research as well as applications development in a variety of areas," said DuPont Senior Vice President and Chief Science&Technology Officer Dr. Uma Chowdhry. "This location will allow us to engage some of the world's top scientific talent in bringing better innovation to both global and local DuPont customers faster."

DuPont has signed a Memorandum of Understanding (MoU) with ICICI Knowledge Park for a long-term lease that will allow DuPont to construct its own R&D facility on 15 acres of land in the park. The groundbreaking is slated for March and is expected to be fully operational in early 2008.

The DuPont Knowledge Center will provide the needed research and development capabilities for DuPont to assist in business growth in India and surrounding countries. It will be the seventh major DuPont R&D facility outside the United States. Other major DuPont R&D facilities are located in Shanghai, China; Utsunomiya, Japan; Hsinchu, Taiwan; Wuppertal, Germany; Meyrin, Switzerland and Kingston, Canada.

Research at the site will focus on "integrated science" -- the addition of biology to traditional strengths in chemistry and materials science -- to develop the company's application pipeline in India and other emerging markets. The site initially will focus on molecular biology, bio-informatics and polymer synthesis, with further R&D in the company's application pipeline across all five of its business growth platforms.

"The establishment of the DuPont Knowledge Center in India is consistent with our company's strategy of going where the growth is," said Balvinder Singh Kalsi, president, DuPont India. "Our intent is to leverage Indian science and engineering talent for the benefit of DuPont customers and shareholders."

DuPont has appointed Homi Bhedwar as director of the Knowledge Center. Prior to relocating to Hyderabad, Dr. Bhedwar held R&D leadership positions in DuPont Electronic&Communication Technologies at the company's headquarters in Wilmington, Del. Most recently, he led a range of initiatives designed to support high-growth DuPont businesses.

The DuPont Knowledge Center is expected to house research programs for several businesses in addition to molecular biology research for DuPont subsidiary Pioneer Hi-Bred International, Inc. Other DuPont businesses include Crop Protection; Chemical Solutions Enterprise; Electronic Technologies; Surfaces; Building Innovations; Titanium Technologies and Performance Coatings.

Globally, DuPont has more than 75 R&D facilities with over 40 in the United States and more than 35 in 11 other nations. DuPont invests an average of $1.3 billion annually on global research and development in a diverse range of technologies for many markets including agriculture, automotive, construction, electronics, chemicals and industrial materials. Today, DuPont has more than 4,400 scientists and engineers around the world.

DuPont India is a subsidiary of its American parent. DuPont's relationship with India began in 1802 when it received its first shipment of raw materials from India to produce black powder for explosives. Today, DuPont India markets a wide range of products in varied market segments. With close to 700 employees, DuPont India is growing at a rate of more than 25 percent annually. DuPont India has seven production facilities in three locations representing Crop Protection, Engineering Polymers, Liquid Packaging Systems, Refinish automotive paints and Pioneer businesses.

DuPont is a science-based products and services company. Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.

DuPont blueprints $23M Indian R&D center

Wed, 31 Jan 2007 19:01:35 -0500

DuPont has unveiled plans to invest almost $23 million in a new R&D center in Hyderabad, India. The site initially will focus on molecular biology, bio-informatics and polymer synthesis, according to DuPont. DuPont has appointed Homi Bhedwar as director of the Knowledge Center.

- here's the release on the new R&D facility

Related Articles:
Novartis patent challenge spurs protests in India. Report
Looking to India, China et al. Report
Price controls outrage India's pharma industry. Report

Press Release: AstraZeneca Makes $100M Research Investment In Boston

Maureen Martino — Mon, 22 Jan 2007 12:12:36 -0500

AstraZeneca Makes $100M Research Investment In Boston

Expansion Of R&D Boston To Create Up To 100 New Scientific Jobs

WILMINGTON, Del., Jan. 22 -- AstraZeneca today announced a $100 million research investment to strategically boost work in the infectious disease area and continue its incremental growth in cancer research at its R&D center near Boston, Massachusetts.

The expansion of AstraZeneca's research facility will accommodate up to 100 additional researchers. They would join the more than 400 existing employees who are focused on discovering treatments for infectious diseases and cancer.

"This investment will significantly boost our research capabilities in two critical areas of medical need, and two areas where we have tremendous heritage," said David Brennan, Chief Executive Officer of AstraZeneca. "It will provide additional resources for our scientists who are tackling more complex diseases than ever before, as they work towards our ultimate goal of giving people hope for a healthier future."

Adds Jan Lundberg, Executive Vice President, AstraZeneca Global Discovery Research, "Infectious disease is becoming more prevalent and problematic to patients and healthcare providers, placing a heavy burden on our healthcare systems. With our expanded presence in Boston, our scientists will be better equipped to discover and develop novel medicines to address important areas of unmet need."

The World Health Organization figures show that 41 percent of the global disease burden is due to infection. Outside the European Union and US, the infectious disease burden is greater than the total of all other therapy areas combined. Meanwhile, there has been a worldwide decline in the delivery of new antibiotics -- only 10 new antibacterials have been introduced since 1998, of which two were truly novel. Resistance to currently available antibacterials continues to increase and represents a clear danger to patients and public health globally. AstraZeneca is committed to providing much needed new antibacterial agents for worldwide use.

Construction of the 132,000 square foot facility will begin at the Waltham, Mass. site during the first quarter of 2007 with scheduled completion by mid 2009. Upon completion, the total size of the AstraZeneca research facility will be 382,000 square feet. AstraZeneca first established a research presence in Boston in 1995, ahead of many competitors. In 2000, the company opened their state-of-the-art research facility in Waltham where it has continued to invest and expand, growing from 170,000 square feet to the current 250,000 square foot facility.

Since the opening of AstraZeneca R&D Boston, scientists there have discovered three potential drugs that are under development to treat different cancers including breast, ovarian, thyroid and prostate cancer, and two novel- class candidate drugs to potentially treat serious skin infections, serious cases of chronic bronchitis and serious pneumonias.

AstraZeneca believes Boston gives the company access to the leading scientific talent, potential partners and collaborators, and emerging science in a worldwide biotechnology hub.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

ALSO NOTED: Semaphore closes $9.5M round; VaxGen looks to refocus; BioCryst wins $102M contract; and much more...

Thu, 04 Jan 2007 19:01:30 -0500

> Indianapolis-based Semafore Pharmaceuticals has completed a $9.5 million second round of venture financing. Much of the money will be used to advance Semafore's clinical program for SF1126, its lead PI3 Kinase inhibitor for the treatment of cancer. "This is an exciting time for Semafore, as we prepare to initiate Phase l clinical trials of our lead PI3 Kinase inhibitor SF1126 and transition into a clinical stage company," said John Sima, interim CEO and COO of Semafore. Release

> Fresh from losing a big contract for an anthrax vaccine, speculation is heating up about how VaxGen will restructure. The company got a $51 million boost from the sale of its Celltrion stock. Report

> BioCryst has won a $102 million contract from the U.S. government to develop peramivir as a therapy against seasonal and avian flu. Report

> A new study has provided data that shows that Herceptin combined with chemotherapy after surgery for breast cancer improves the chance of surviving three years after treatment. Report

> Enzon Pharmaceuticals has submitted an INDA to the FDA for its HIF-1alpha (hypoxia-inducible factor 1alpha) antagonist. Release

> Software-maker Accelrys is closing its R&D center in Bangalore, India and laying off 60 workers. Report

> MediciNova has established a subsidiary in Japan. Release

> Chutes & Ladders: Xytis Pharmaceuticals has named Vincent F. Simmon, Ph.D., president and CEO. Release

> Scientists at Taiwan University have developed a five-gene test that can help illuminate which lung cancer patients are likely to benefit from chemotherapy. Report

And Finally... Government plans to prevent the creation for animal-human embryos has attracted criticism from the country's scientific community. Article

Bayer Schering outlines global R&D restructuring

Thu, 09 Nov 2006 19:01:37 -0500

Bayer will slash hundreds of jobs as it shutters its research facility in West Haven, CN, as part of a global restructuring triggered by its takeover of Schering. About 600 research jobs will be cut in the U.S. with another 200 layoffs to come. In the future, Bayer Schering Pharma will concentrate R&D activities in Berlin and Wuppertal in Germany, and Berkeley, CA. By the end of 2008 the company expects to reduce its R&D costs by $210 million a year.

"The productivity of our oncology research group in Berlin is enhanced by its close working relationships with other co-located R&D functions, and the proximity of this group to our center of excellence for lead discovery in Wuppertal will further enhance productivity," said Marc Rubin, member of the board of management of Bayer Schering Pharma and head of the company's Research and Development organization. Berkeley will remain the R&D center for protein-based biologics drug discovery and development and will continue to be home to the company's Global Hematology/Cardiology business unit.

- here's a report on the restructuring from the International Herald Tribune
- see the company press release for more

Related Article:
Bayer outbids Merck KGaA for Schering. Report

ALSO NOTED: Alantos Pharmaceuticals inks deal with Servier; Millipore opens $50M R&D center; and much more...

Mon, 23 Oct 2006 20:01:30 -0400

> Alantos Pharmaceuticals of Cambridge, MA has signed a collaboration deal for its lead compound, ALS 2-0426 for Type 2 diabetes, with France's Servier. Alantos stands to gain $75 million in up front fees and milestones. Release

> Millipore has opened its $50 million R&D center in Bedford, MA. Release

> Chutes & Ladders: Threshold Pharmaceuticals CFO and COO Michael Ostrach is resigning his posts. Report

> Organon and BrainCells say they will collaborate on the development of new CNS drugs. Report

> ProNAi Therapeutics has arranged $6.65 million in bridge financing. Report

> Axial Biotech has raised a small round of venture capital. Report

> Wyeth has extended a deal that gives it access to Affymetrix's GeneChip microarray technology by three years. Report

And Finally… Inspired by a website, a rush of patients complaining of the same mysterious symptoms has spurred the CDC to see if two clusters are indeed the result of Morgellons disease. Article

Eli Lilly to shutter European facilities

Tue, 27 Jun 2006 20:01:39 -0400

Eli Lilly plans to shutter two research sites and a manufacturing facility in Europe, including one R&D center in Belgium that employs 330 staffers. Altogether, most of the 900 workers employed at the facilities will be affected by the restructuring. The manufacturing center is at Basingstoke. Lilly said the move was prompted by what it called an increasingly difficult global environment hampered by price pressures.

- here's the AFX report on Lilly

Eisai plans $105M expansion in NC

Mon, 27 Feb 2006 19:01:39 -0500

Eisai has blueprinted a $105 million expansion project in Durham, NC, with plans to add 84 jobs and a 65,000-square-foot R&D center for intravenous cancer therapies. Durham County officials voted a $1 million incentive package for the project at Research Triangle Park. Eisai says it will break ground this fall and plans to open the facility in 2009. Eisai was also considering sites in Japan and Italy before settling on RTP, where it already has facilities for manufacturing Aricept.

- read this report from the Durham Herald-Sun for more information

FDA says Aclasta "approvable" for Paget's

Sun, 26 Feb 2006 19:01:36 -0500

Switzerland's Novartis says it received an FDA "approvable" letter for Aclasta to treat Paget's disease of the bone. The FDA has requested additional data from an ongoing trial of the drug for osteoporosis. Novartis added that it believes it can win final approval this year. Novartis is pursuing EU and FDA approval for Aclasta as a therapy for osteoporosis in 2007.

- here's the report from AFX

PLUS: Novartis is investing $83 million in a manufacturing and R&D center in China's Jiangsu Province. Report

ALSO NOTED: Azidex gains seed funds; Wyeth opens $2B hub; Sepracor vows patent fight; and much more...

Wed, 07 Sep 2005 20:00:50 -0400

> PA Early Stage Ventures has injected seed capital into a Pittsburgh-based biotech start-up, Azidex Pharmaceuticals. Azidex is a spin-out from the University of Pittsburgh Medical Center and is developing new therapies to fight drug-resistant HIV. Release

> Wyeth has opened a $2 billion manufacturing and R&D center in Ireland. Wyeth officials say that the new center is intended to be a major production and distribution hub designed to complement its facilities in Andover, Massachusetts. Story

> Sepracor of Marlborough, Massachusetts, said it has learned that a generic drug maker has filed an ANDA for a copycat version of Xopenex and plans to fight to protect its patent on the drug. Release

And Finally... New federal regulations would bar children and pregnant women from being included in studies on the health effects of pesticides. Article