Quintiles officially opened its expanded regional headquarters facility in Singapore’s Science Park I. The new facility doubles the size of the company’s previous space in Singapore and provides additional room for future expansion.

Quintiles is leasing a total of 79,000 sq.-ft. of space in the new Cintech IV building, which is capable of accommodating approximately 550 employees when fully occupied.

The new, 13,000-sq.-ft. central lab facility doubles the size of the previous Singapore lab, providing the additional space necessary to accommodate the demand for central lab services in the region. The lab facility provides globally harmonized lab services and plans are underway to expand these capabilities to include an assay development lab (ADL) and an anatomic pathology lab.

“Quintiles’ expansion today, to make Singapore its strategic home-base in Asia to drive regional expansion, represents a strong endorsement of Singapore’s capabilities in regional clinical trial coordination and research. Coupled with our capabilities in translational research, pharmaceutical and biotech companies can leverage Singapore as a one-stop location to carry out through-train drug discovery and development,” said Gan Kim Yong, Minister for Manpower, Singapore.

Gloucester Pharmaceuticals received approval from the FDA for Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

The approval was based on disease response defined as the number of patients with confirmed complete response or partial response. The NDA included efficacy data from two studies involving 167 patients. Istodax is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and is expected to be commercially available in January 2010.

“The approval of Istodax is the result of an extraordinary commitment by our clinical investigators and the patients and their families who volunteered to participate in the Istodax clinical trials,” said Jean Nichols, Ph.D., president and chief operating officer of Gloucester Pharmaceuticals. “Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of Istodax.”

Ziopharm Oncology, Inc. achieved positive data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) in patients with unresectable or metastatic soft tissue sarcoma.

Having achieved the study’s efficacy milestone following safety and efficacy review, it was determined that the data is sufficient to proceed to a pivotal study in support of product registration and to conclude enrollment in the trial.

In the Phase II trial, patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. As of the October 5th cut-off date, there were 67 patients randomized to the trial, with 65 treated and 61 eligible for analysis. The 61 patients were evaluated for progression-free survival (PFS).

The median (PFS) for doxorubicin is 4.4 months, the median PFS for palifosfamide + doxorubicin has not yet been reached; the 1st PFS was 1.5 months for doxorubicin vs. 3.5 months for palifosfamide + doxorubicin. PFS is a biologically important end point in sarcoma, and has been well demonstrated to be a relevant measurement of the effect of treatment on outcome.

The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The company is in the process of finalizing a registration trial plan in soft tissue sarcoma for review by regulatory authorities.

Ligand Pharmaceuticals and Pfizer have extended their JAK3 research collaboration for another year. Ligand will receive $3.1 million in research payments to continue drug discovery and lead candidate optimization. Under the original agreement, Ligand is entitled to receive as much as $175 million in success-based milestones for the development and commercialization of multiple products. In addition, Ligand will receive royalties on product sales.

“We are very pleased to learn that Pfizer has elected to extend the JAK3 research collaboration with Ligand,” said John L. Higgins, President and chief executive officer of Ligand. “We view JAK3 inhibitors as a very promising market opportunity, and given Pfizer's clinical success with its own internal program we are convinced that they are highly committed to this category. Ligand has an exceptional record of drug discovery while serving major pharmaceutical companies in a number of research collaborations. We are pleased with the team’s progress and look forward to continued success as we drive the program forward for Pfizer.”

Kendle 3Q09

3Q Revenues: $133.8 million (-26%)

3Q Earnings: $8.8 million (-6%)

YTD Revenues: $421.0 million (-19%)

YTD Earnings: $12.9 million (-35%)

Comments: Early Stage revenue was $10.8 million (-4%) and YTD was $27.2 million (+7%). Late Stage revenue was down 17% to $91.5 million in the quarter and down 14% to $284.7 million YTD. New business awards for the quarter totaled $137.2 million, up from $132 million in 2Q09. Contract cancellations for the quarter were $53.8 million or 6% of the company's backlog at June 30, 2009.

Omnicare 3Q09

3Q Revenues: $1.5 billion (-6%)

3Q Earnings: $72.5 million (+35%)

YTD Revenues: $4.6 billion (flat)

YTD Earnings: $132.1 million (+17%)

Comments: CRO business revenues were $36.9 million in the quarter (-28%). Backlog at September 30, 2009 was $235.7 million. The Pharmacy services business generated sales of $1.5 million in the quarter (-1%). Results in 3Q08 include the impact of special items and an accounting change totaling $28.8 million.

Stelmi (Booth 1000) will host a seminar at 9:30 a.m. on Tuesday, Nov. 10, covering the mastery of microbiological and particulate cleanliness in the production RTS and RTU elastomeric closures for pre-filled syringes and vials.

Drawing on Stelmi's experience as a specialist in rubber components for pharmaceutical primary packaging, the seminar will feature targeted presentations on the reduction of microbiological and particulate contamination in the production of rubber closures, with special emphasis on sterile components and visual quality.

This event will also be the cover Stelmi’s newly in-line production concept, PremiumFill. In a globally controlled area, this concept is aimed at optimizing the microbiological and particulate cleanliness levels in the production of sterile (ready-to-use) and cosmetic quality components (visual aspect).

For an invitation, e-mail contact@stelmi.com or visit Booth 1000.

Addressing the continuing pharmaceutical market trend of manufacturing medication in smaller but more potent doses, Almac (Booth #2600) has successfully completed the design, manufacture and installation of state-of-the-art containment technology to facilitate the processing of potent compounds in its Product Development facility.

The company says that its in-house engineered containment solutions employ rigid and flexible film Isolator technology around the processing zones of equipment that require containment of airborne particulates. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions; and demonstrate Almac can process compounds with an OEL as low as 30 ng per m3.

Almac has the capability to process batch sizes ranging from 0.1Kg to 100Kg, manufacturing development, clinical & small-scale commercial solid, oral dose products.

Phase Forward (Booth 702) has signed a multi-year agreement with Quotient Clinical (Booth 2446) to implement Phase Forward’s InForm Global Trial Management (GTM) electronic data capture (EDC) solution to support data collection, management and analysis for its clinical trials. Quotient Clinical will use Phase Forward’s Central Designer™ module to enhance eCRF design efficiency and improve workflow in the study development process for EDC trials.

“As an innovative provider of early drug development services, we want to ensure that our customers can take advantage of the benefits inherent in using EDC in Phase I trials, including access to high quality data within hours of collection, streamlined process efficiencies and rapid qualification of data,” said David Chalmers, Quotient’s vice president, Biometrics. “We selected InForm because of Phase Forward’s strong position in the marketplace and the company’s experience with Phase I trials.”

By supporting faster accessibility and greater visibility into trial data, the EDC implementation will help Quotient to expand its full-service, in-house Biometrics offering, according to the company. In addition, Quotient plans to offer customers on-line access to trial data, making it easier for them to track progress to date or to review summary reports.

“Quotient’s team is committed to continual expansion of its technical infrastructure to provide advanced services that help customers speed the development process,” said Steve Powell, senior vice president, Phase Forward. “The organization joins the growing number of CROs adopting our InForm product as part of a broader initiative to automate and streamline their Clinical Research Units.”

Vetter (Booth 839) will open Vetter Development Service (VDS), a technologically advanced customer service facility located in Chicago, IL. The site will allow the company to provide greater commitment and support toward the product needs of its North American customers, according to a Vetter statement. Vetter will be capable of aseptically filling very small quantities of products in the new facility, providing faster and more streamlined product delivery and customer service. Headquartered in Ravensburg, Germany, Vetter sees the new facility as a significant investment in Vetter Pharma International GmbH. The 25,000-sq.-ft. facility will open end of 2009.

With its new location in the heart of the U.S., Vetter can now process and test small quantities of materials by bringing the development process closer to key customers, enabling greater cooperation at the earliest stages of development and minimizing the need to transport products, according to the company.

The site is intended to facilitate a shorter time to market for Vetter's North American customers. Peter Soelkner, managing director at Vetter, remarked, “The opening of this new cutting-edge VDS facility shows Vetter’s firm, strategic commitment to the North American market by bringing the state-of-the-art technology to the heart of the U.S.,” said Peter Soelkner. “The support VDS delivers throughout the entire product development cycle can now start earlier, and the proximity to our customers will contribute to streamlining the process and delivering the final product faster.”

Toxikon Corporation (Booth 1161) has expanded the offerings in its immunotoxicology department. To meet increased demand for biologics research, Toxikon has added flow cyctometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.

Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, remarked, “This is an opportunity for Toxikon to promote the development of our sponsors’ drugs and medical devices,” said Dr. Brynczka. “If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary.”

Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function. “The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell,” said Dr. Brynczka.

A study published last fall by the Journal of the American Medical Association stated that almost 25% of biologic drugs approved in the U.S. and Europe since 1995 have been at the forefront of at least one safety-related regulatory action in the decade since initial market approval, while 11% of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.

While all newly developed drugs carry risks, said a Toxikon statement, biologics are in a special class because they are derived from biological sources, including antibodies, enzymes and hormones.

The new equipment is just one of several additions Toxikon has added to its immunotoxicology department, offering everything from quantitation of splenic B and T cells to a full battery of host resistance models.

Norwich Pharmaceuticals (Booth 2639) has a newly built and commissioned pilot scale development facility. The new area's features state-of-the-art equipment, according to Norwich, and a company statement said the facility "offers greatly expanded contract outsourcing capabilities enabling them to work with customers earlier on in the development cycle, continuing right through scale up and commercial launch."

With the addition of compatible bench scale equipment, the facility has significantly increased its capabilities. The new equipment includes a four, eight, sixteen quart PK Blend Master with intensifier bar, an Aeromatic MP1 Fluid Bed Dryer, a Vector GMX-10 and GMX-25 Hi-Shear Mixer and a Vector FL-M-1 Flo-Coater. These new additions provide a working range of one to 25 Kgs.

Norwich also recently added new commercial large scale facility capabilities, including a Niro precision coater for the Niro MP5 commercial scale fluid bed to support customer product scale up from the development suite. This three-column coater has a volume range of 30 to 245 liters.

Merck has completed its merger with Schering-Plough Corp. and has outlined its new global strategy. The new Merck will operate as MSD outside the U.S. and Canada, and according to the company, is a global health care leader “aimed at providing innovative, distinctive products and services that save and improve lives, while satisfying customer needs and creating long-term shareholder value,” according to a statement from the new company.

Merck now has approximately 106,000 employees, and operations in more than 140 countries around the world. The company expects to generate more than 50% of its revenue outside the U.S.

Merck will now market more than 530 pharmaceutical, consumer and animal health products, employ approximately 1,800 people, and invest more than $121 million in R&D in Canada, as part of the company's expanded global presence. Merck operations in Canada include research, manufacturing, and sales.

"This is an exciting time for our company as we advance our position as a strong, global health care leader that will make a substantial difference to patients around the world," commented Carlos Dourado, president, Merck Canada. "Thanks to the talent and dedication of our scientists and employees, the company will offer an outstanding clinical development pipeline that will greatly increase our ability to deliver important new medicines to patients. We look forward to continuing to meet and exceed the needs of our customers and providing them with the high-quality products and service they have come to expect."

Pramod Gupta, Ph.D. has been appointed vice president of quality and chief scientific officer, Coldstream Laboratories, Inc. (CLI). In his new role, Dr. Gupta will focus on strengthening the company’s quality systems, R&D capabilities and overall project execution.

Dr. Gupta has more than 20 years of experience in the pharmaceutical and medical device industries. Most recently, he served as vice president of R&D at Bausch & Lomb with focus on the global development of drugs and devices. Previously, he held leadership positions at Baxter Healthcare Corp., TAP Pharmaceuticals and Abbott Laboratories. He has been involved with the development, approval and commercialization of more than 30 drug and medical products.

Joe Wyse, president and chief executive officer of CLI, said, “I am pleased to have recruited Dr. Gupta at this critical stage of Coldstream’s growth. His extensive industry experience and successful track record will be key to achieving our goal of becoming a leader in research, development and manufacture of clinical and commercial healthcare products.His record of excellence in R&D, technology transfer and regulatory interactions will greatly benefit our organization and our partners.”

Emerson Resources, Inc. has formed a strategic partnership with Bio Research, a CRO specializing in agrichemical and related industries, to extend its business development capabilities. Robert Westbrook, chief executive officer of Bio Research, will spearhead Emerson's business development and sales efforts in an effort to establish a greater footprint in the pharmaceutical and biotech sectors.

Currently, Emerson serves global organizations including branded, generic and OTC pharmaceutical companies, virtual and emerging pharmaceutical research organizations, raw material suppliers, equipment manufacturers, and intellectual property attorneys.

"Our partnership with Bio Research will strengthen our position as the leader in value-added service, ingredients and expertise," said Adolfo Gomez, president of Emerson Resources. "Robert brings a strong combination of business development skills and diverse industry insight to Emerson and I am confident that he and his team will vastly expand our industry presence — particularly on the West Coast, an area that is ripe with opportunity."

Bio Research, based in Fresno, CA, and its subsidiary, Bio Research Services, represents select products and services related to clinical diagnostics, drug discovery, drug development, and agrichemicals.

As Emerson Resources' new business development executive, Mr. Westbrook will focus on creating new sales channels and building client and industry relationships in support of the Emerson's strategic growth objectives.

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