Features

Top Contract Service and Outsourcing Companies

Editor Gil Y. Roth continues our profiles of the top companies in pharma and biopharma outsourcing.

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association



Alpharma USPD, Inc.
Contract Manufacturing
7205 Windsor Blvd.
Baltimore, MD 21244
Phone: (410) 277-1301
Web Site: www.alpharmauspd.com

Revenues:
$260 million in 1999 for Alpharma U. S. pharmaceuticals division.

Key Personnel: Thomas L. Anderson, president; Emily D. Eldridge, account manager, business development; William J. Fournier, director, business development; Russell D. Gilbert, vice president, operations; Ronald L. Nedich, Ph.D., vice president, R&D; Arden Stoermer, vice president, quality affairs; Jane Williams, director, marketing.

Major Divisions: Liquids Facility, Semi-Solids Facility.

Capabilities/Capacities: Alpharma manufactures liquids, nasal sprays, semi-solids and suppositories. The company offers a full range of services from pre-formulation to commercial production. To maximize capacity and capability, Alpharma has dedicated both of its plants (Baltimore, MD and Lincolnton, NC) to specific dosage form technologies. The entire 268,000-sq.-ft. plant in Baltimore produces liquid and nasal spray products. Lincolnton has a 138,000-sq.-ft. state-of-the-art plant dedicated to semi-solids and suppositories.

Comments: Since 1997, when Alpharma began providing contract manufacturing activities, the company has partnered with some of the nations’ largest branded pharmaceutical companies.

In 1999, Alpharma made significant improvements at its manufacturing sites in Baltimore and Lincolnton by adding state-of-the-art high-speed equipment. Throughout 1999, Alpharma worked to improve product pipeline development activities. Its regulatory expertise helped to shorten FDA approval time and speed product approvals.

Also in 1999, Alpharma entered into a strategic alliance with Ascent Pediatrics, Inc., a company that provides pharmaceutical products to the $3.5 billion pediatric market.
In April 2000, Alpharma USPD was named one of the top generic pharmaceutical companies that best satisfy the overall needs of the long-term care industry in an audit conducted by Scott-Levin. The company recently opened a new nasal spray facility with a capacity of 14 million pump-in-place units in “clean room environment.”

BioReliance
19420 Broschart Rd.
Rockville, MD 20850-3349
Phone: (301) 762-5260
Web site: www.bioreliance.com

Revenues:
$47.2 million in 1999.

Key Personnel:
Capers W. McDonald, president and chief executive officer; Jonh L. Coker, vice president, finance and administration, chief financial officer and treasurer; Raymond F. Cosgrove, vice president, European testing and development; James N. Harris, vice president, marketing and client services; Michael E. Wiebe, vice president, regulatory affairs and quality assurance, vice president, R&D and chief scientific officer.

Major Divisions: Manufacturing; Testing and Development.

Capabilities/Capacities: BioReliance is a contract service or-ganization focused on the biologics sector of the pharmaceutical industry. The company serves more than 600 clients, providing testing, development and manufacturing services supporting the production of biologics and other biomedical products.

Comments: In the second quarter of this year, BioReliance commissioned its 58,000-sq.-ft. viral manufacturing facility in Rockville, MD. During 1999, the company expanded its testing and development facility in Scotland by 18,000 sq. ft, relocated its U.S. analytical services to new laboratories and began the first production of plasmid DNA in its German facility.

The company’s revenues dipped 6% in 1999, from $50 million to $47.2 million. President and chief executive officer Capers W. McDonald attributed this to client project delays and several cancellations. In his annual letter to stockholders, Mr. McDonald commented, “These setbacks had a notable impact at the start of 1999 and affected our financial performance for the entire year.” He added that the company had made sequential improvements since the first quarter of 1999 and has improved its results.

For the first half of 2000, revenues were up 23% to $27.3 million. Net income for the period was $.5 million, compared to a net loss of $1.5 million in the first half of 1999. Mr. McDonald recently said, “The revenue results for the quarter, our fifth quarter of sequential growth, are a further indicator that we are being rewarded for the focus we place on building strong client relationships and on achieving sustainable operating improvements.”

Last month, the company was selected by DynPort LLC as principal provider for development and manufacturing services supporting the U.S. Department of Defense (DoD) smallpox vaccine biodefense program. BioReliance will develop a production capability for an initial DoD stockpile, with the capacity to supply several million doses of the smallpox vaccine to support future requirements, if called for. The company will utilize the new facility in Rockville for the vaccine.

DPT Laboratories, Ltd.
318 McCullough
San Antonio, Texas 78215
Phone: (866) CALL DPT (225-5378)
Web site: www.dptlabs.com

Revenues:
$125 million.

Key Personnel: H. Paul Dorman, chairman of the board, chief executive officer; John W. Feik, president, chief operating officer.

Major Divisions: DPT Laboratories, Ltd.

Capabilities/Capacities: DPT offers formulation development, analytical development, scale-up, validation, stability and full-service commercial production of semisolids and oral liquids. Batch sizes range from 50 kg to 20,000 kg, giving DPT capability to compound most types of creams, lotions, ointments, gels and oral suspensions and solutions. Fourteen packaging lines offer flexibility in filling tubes and bottles. Compartmen-talized manufacturing areas allow DPT to produce safely products with hard-to-handle, flammable or explosive ingredients. The company’s regulatory compliance and technical know-how can help customers get products to market faster. DPT manages ANDA and NDA projects, including manufacturing site changes under SUPAC guidelines, and has developed and manufactured OTC products for its customers.

Comments: DPT’s heritage in semi-solids spans more than 60 years. The present year marks the 10th anniversary of DPT’s status as a private company and as a leading supplier of development and manufacturing services. DPT will record 30% revenue growth this year and forecasts strong double-digit growth for each of the next five years. DPT currently employs more than 650 people and anticipates a 38% increase in the number of employees during the next five years.

To best serve its growing customer base, DPT’s sales and marketing department has increased to almost 30 associates. Based on its current growth rate, the sales and marketing force will exceed 50 associates by 2004. Account managers serve as a single point of contact for DPT’s customers, holding responsibility for managing projects from initial development through commercialization and beyond.

DPT offers one of the world’s largest R&D departments dedicated to semisolids and oral liquids, with more than 60 people in the department. The company’s formulation scientists can transform a concept into a tangible, scalable prototype, optimize a formulation or scale-up existing formulae to a commercial batch size. Braham Shroot, Ph.D., a renowned scientist in the study of biochemistry and pharmacology of the skin, recently joined DPT as vice president of R&D. Dr. Shroot commented, “DPT has an ability to adapt to the changing market environment and uniquely blend the manufacturing discipline with the creativity of its formulation scientists.”

During the last five years, DPT has invested more that $30 million into an expansion of its facilities. Another $30 million is slated for investment during the next five years in order to ensure that DPT has the development and manufacturing capacity to meet the outsourcing needs of its customers. In addition, as part of its growth plan, DPT is assessing strategic acquisitions. Consolidation within the pharmaceutical industry has created a number of potential opportunities for acquisitions. DPT will evaluate these various opportunities and will likely acquire additional manufacturing space in the near future.

MDS Pharma Services
2350 Cohen St.
Saint-Laurent, Quebec
Canada H4R 2N6
Tel: (514) 333-0033
Web site: www.mdsintl.com

Revenues:
2000 total revenue (est) $337 million.

Key Personnel: Ian Lennox, president and chief executive officer; Doug Squires, president, global drug discovery and development; Susan Thornton, president, global clinical research; David Moszkowski, senior vice president and chief financial officer; Judith Nicholas, senior vice president, drug discovery services; Nigel Brown, senior vice president, preclinical drug development services; Bob Harris, senior vice president, early clinical research services; Jim Hulse, senior vice president, bioanalytical services; Claude Douetteau, vice president and general manager, central lab; Cinda Orr, vice president, global marketing; Jim McClurg, chairman, scientific advisory board; Jeff Spence, vice president, business development operations; John Capicchioni, vice president, business development, early clinical research; Randy Guthrie, vice president, business development, bioanalytical; Mark Crane, vice president, business development, discovery & preclinical; Jean Francois de Chermont, vice president, business development, central lab; Phyllis Duster, vice president, business development, global clinical research.

Major Divisions: Discovery, Preclinical, Early Clinical Research (Phases I-IIa), Bioanalytical, Global Clinical Research (Phases IIb-IV) and Central Lab.
Capabilities/Capacities: MDS Pharma Services offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotech industries.

Comments: MDS Pharma Services is the new organization integrating a number of MDS groups, including MDS Harris, MDS Panlabs, MDS Tricon, MDS Neo-Pharm, MDS Glarif, MDS Clinical Trial Laboratories and MDS Analytical Solutions. It also includes Phoenix International Life Services, which MDS International acquired in April, 2000. MDS Pharma Services employs nearly 4,000 people in 20 countries.
At the time of the acquisition, MDS, Inc. president and chief executive officer John A. Rogers commented, “We became interested in Phoenix International because we saw the synergies. This acquisition is all about growth. It would provide an impetus for more investment, increased research and development, and an expansion of knowledge-based jobs both in Canada and the rest of the world.”

In May, 2000, MDS Pharma Services debuted a new $56 million laboratory in Montreal. The 150,000-sq.-ft. facility houses 39 MDS Sciex LC-MS analytical instruments, bringing the company’s Montreal area total of the instruments to more than 50.

Approximately a year earlier, MDS acquired the clinical and bioanalytical operations of LAB, which comprise LAB Pharma-cological Research. That acquisition expanded the capabilities of MDS’s drug discovery and development sector, specifically its clinical pharmacology and bioanalytical capabilities. MDS assumed responsibility for LAB’s 130-bed clinical pharmacology unit in Montreal, which enabled MDS to broaden its global capacity for conducting Phase I and II clinical trials. The LAB acquisition also expanded recruiting capabilities for MDS Harris with several special population groups, including liver, renal, postmenopausal and surgically sterile women, and active asthmatics.

In May, 1999, MDS acquired Paris-based Glarif-Cerba S.A., a provider of central laboratory services throughout Europe. The ac-quisition doubled MDS’s central laboratory services and provided the company with a platform to support global clinical trials. The business was integrated with MDS Clinical Trial Labora-tories, with which Glarif-Cerba had worked under a joint marketing agreement for the previous year.

In April, 1999, MDS Har-ris (part of MDS Pharma Services) expanded its Site Management Organization (SMO) into Canada in a joint venture with London Health Sciences Centre (LHSC) of London, Ontario. This ena-bled MDS to conduct clinical research for pharmaceutical and biotechnology companies. The LHSC location marked the first MDS Harris SMO in Canada.

The company continued this initiative in October, 1999, with the acquisition of the Dallas, TX location of Research Across America (RAA), another SMO. The Dallas site is a multispecialty clinical research site with experience in the following areas: asthma and allergy, sinusitis and bronchitis, heartburn, hypertension, obesity, pediatrics, and OTC and OTC switch. “This acquisition is a continuation of our overall SMO growth strategy. We are proud to have the addition of such a talented team to our solid foundation,” said Matt Harris, vice president, site management organization, MDS Harris. “We look forward to more acquisitions of this caliber in the future.”

In May, 2000, MDS Pan-labs, another division of MDS Pharma Services, launched a new web site, www.panlabsexpress.com, which provides clients with immediate access to their pharmacology testing data reports. Said Doug Squires, Ph.D., president, global drug discovery & development for MDS Pharma Services, “When you consider that a pharmaceutical company will invest hundreds of millions of dollars in developing a single new drug, you can understand why they want to be able to see their research data on new drug candidates as quickly as possible.”

The site guards proprietary information through several layers of security, including file-level encryption, directory-level user authentication and separation of systems files and data files on separate drives. The site automatically e-mails clients when new data reports are posted on the site.

MOVA Pharmaceutical Corp.
P.O. Box 8639
Caguas, Puerto Rico 00726
Phone: (800) 468-5201
(787) 258-1661
Web site: www.movapharm.com

Revenues:
1999 revenues exceeded $80 million.
Key Personnel: Joaquin B. Viso, president and chief executive officer; Jack Van Hulst, executive vice president; Frank Ecock, senior vice president, strategic planning; Carlos H. del Rio, senior vice president, global development; Manuel Trillo, chief financial officer; Jose E. Casellas, vice president, business development; Blanca Melendez, vice president, operations R&D and Caguas site; Jose Garcia, vice president, engineering and logistics.

Capabilities/Capacities: Mova’s commercial contract manufacturing capabilities include solid dosage, parenteral and oral liquids manufacturing. In the solid dosage area, capabilities include cephalosporin and non-cephalosporin manufacturing, high shear granulation, fluid bed drying, solvent handling, controlled substances and bottle and blister packaging.

Comments: Established in 1986, Mova has more than 13 years’ experience in the field of contract manufacturing for the pharmaceutical industry. In 1998, the company acquired a site for cephalosporin solid dosage manufacturing from Eli Lilly. In 1999 Mova’s manufacturing plant network was significantly expanded to approximately a million square feet of space by acquiring a third manufacturing site from Marion Merrel International. The new 400,000-sq.-ft. manufacturing facility, dedicated to solid dosage manufacturing, is located on a 104-acre site offering potential for growth to support the growing outsourcing needs of clients. The company has more than 800 employees at its three manufacturing sites and development center.

As part of its strategic plan, Mova is currently evaluating manufacturing sites in Europe and in the U.S. mainland for potential acquisition and expansion of its services to the industry in both of those markets.

Pharm-Eco Laboratories, Inc.
25 Patton Road
Devens, MA 01432
Phone: (978) 772-1644
Web site: www.pharmeco.com

Revenues:
Approximately $22 million in 1999.

Key Personnel: David Wade, president and chief executive officer; Monica Tamborini, chief financial officer; Richard Gabriel, executive vice president, new ventures; Salah Zahr, Ph.D., executive vice president, scientific affairs; Lee Piver, vice president, marketing and business development; Robert Bondaryk, Ph.D., vice president, corporate development; Dick Einig, Ph.D., director of the quality unit; Tom Saulnier, senior director of engineering; Emile Bellott, Ph.D., director of medi-cinal chemistry; Adel Moussa, Ph.D., assistant director of medi-cinal chemistry; Yesh Sachdeva, Ph.D., director of government contracts and new products; Emile Al-Farhan, Ph.D., senior director of chemical development; Heather Taft, Ph.D., director of chemical development, laboratory operations

Capabilities/Capacities: PharmaSuite is Pharm-Eco’s suite of capabilities, expertise, services, technologies, scientists and chemists and customer-focused alliances. PharmaSuite provides outsourcing for discovery, process R&D and related support services. The company offers a wide array of value-added pharmaceutical services, including API Development, cGMP-compliant manufacturing, analytical services, discovery/medicinal/ combinatorial chemistry services, stability management under ICH guidelines and regulatory services.

Comments: Pharm-Eco re-cently moved into a new 20-acre world-class campus. The new location provides 160,000+ square feet, with capacity for 450+ professionals in three buildings. Pharm-Eco will expand from its 22 state-of-the-art, cGMP-compliant laboratories for API synthesis, re-search and development, to more than 50 labs during the next year. In the long-term, Pharm-Eco plans to expand the Devens campus to 60 acres during the next five years to provide one-stop shopping for API and drug product development and manufacturing. The company also plans to build eight reactor suites within a new cGMP-compliant Pilot Plant, housing up to 500 gallon glass-lined reactors.

In August, 1998, Pharm-Eco formed Universal Pharma Technologies (UPT), a joint venture with UOP. UPT offers a technology portfolio centered on its Simulated Moving Bed (SMB) technology, which provides pharma clients with an advanced tool for accelerating drug development with synthesis/separation process solutions.

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