Ownership Change For Consumer Health
Corrections or additions?
These articles by Barbara Fox, Kathy Spring, and Fran Ianacone were
prepared for the May 25, 2005 issue of U.S. 1 Newspaper. All rights
reserved.
Life in the Fast Lane: Able Laboratories Shuts Down
Able Laboratories, a generic drug developer and manufacturer that
expanded to a former Squibb facility near Exit 8A of the New Jersey
Turnpike, has suspended all shipments of products until further notice
and has begun a mass recall of all products.
On May 19 Able announced that an ongoing review into its manufacturing
procedures had uncovered quality control problems involving the
company’s testing practices. In the wake of the news, Dhananjay
Wadekar, CEO, resigned, and Robert Mauro, president and COO, is in
charge.
The company is at a standstill.
“I have no idea when we can resume shipping,” said George Sager, the
company’s controller, last week. “But we hope to rectify the problem
soon.”
Able manufactures and sells a range of prescription pharmaceutical
products in solid oral dosage and suppository forms under its own
label as well as under private label agreements. Its products include
Ritalin for attention deficit disorder, Vicodin for pain, and
antibiotic metronidazole capsules and drugs to treat nausea while
undergoing chemotherapy. Its products are sold primarily through
direct sales efforts to drug wholesalers, distributors, and retail
drug chains. Able had six Abbreviated New Drug Applications (ANDAs) in
line at the FDA, but it has just withdrawn those applications.
Able leased the former 1 Squibb Drive building, last used as a
distribution facility, from Matrix Development in September 2003. Not
wanting to operate from a street named for a competitor, Able obtained
permission from the town of Cranbury to rechristen its address “1 Able
Drive.”
With this expansion, Able aimed to quadruple its manufacturing
capacity and has invested nearly $35 million in retrofitting the
building for manufacturing. Sager says that many departments,
including administration, R&D, shipping, and receiving have already
moved in. Current manufacturing operations are in South Plainfield in
a facility Able plans to retain.
Able plans to move another 240 employees, many of them to be involved
in manufacturing, into its new 1 Able Drive facility late in the
second quarter or early in the third quarter. Meanwhile, said Sager on
Friday, May 20, there have been no lay-offs, either permanent or
temporary, as a result of the halt in shipping.
Problems leading up to this suspension include several recalls,
including one for batches of atenalol, a blood pressure drug, for lack
of potency. In a press release dated May 19, Able states that “the
company’s comprehensive review is proceeding based on protocols
established by outside consultants retained by Able.” It goes on to
say that these reviews are time consuming and that, therefore, the
company is unable to determine the extent to which production deviated
from standard manufacturing practices.
The company ran afoul of the FDA on at least one other occasion. It
received a warning in April, 2004, citing failure to report adverse
drug experience reports on at least 27 occasions. The adverse
reactions, many of them to lithium caps – but also to phentermine
caps, carisoprodol, and methylphenidate – included chest pains,
difficulty breathing, elevated blood levels, minor strokes, and
irritability. In its warning letter, the FDA states that “the specific
violations noted in this letter are serious and may be symptomatic of
serious underlying problems.”
Able, enmeshed in new problems now, has seen its stock torpedo. It
plummeted 75 percent on the news that all shipments had been halted,
falling to $6.26 before trading was suspended on May 19. Trading has
resumed and, on Monday, May 23, it closed at $5.05. This set-back
occurred shortly after the company announced that first quarter
revenues, for the period ended on March 31, had risen 43 percent, to
$30.7 million.
A Manhattan-based law firm, Lasky & Rifkind, is filing a class action
lawsuit on behalf of those who took Able’s products after October 30,
2002, and Radnor, Pennsylvania-based Shiffrin & Barroway has filed a
shareholders’ lawsuit.
Able Laboratories (ABRX), 1 Able Drive, Cranbury 08512-3609.
609-495-2800; fax, 609-495-2705. Home page: www.ablelabs.com
Top Of PageExpansions: Bullrun
Bullrun Financial, 134 Franklin Corner Road, Suite 106, Lawrenceville
08648. John Coscia, managing director. 609-838-6000; fax,
609-838-6014. Home page: www.bullrunfinancial.com
Bullrun Financial, which provides a web-based portfolio-management
service to institutional portfolio managers and high net-worth wealth
advisors, has moved from 134 Franklin Corner Road to the American
Metro Center in Hamilton.
The company uses proprietary software hosted on the Internet to
analyze and compare different investment options, and to provide
real-time information to financial advisors on the status of their
clients’ investments.
CEO John Michel, a 1980 graduate of West Point, says he chose the
location for its proximity to I-295, Route 1, and the northeast
corridor train line. “The new location is advantageous to attracting
talent from various areas in Bucks County and both central and south
Jersey. Being next to the Hamilton train station allows employees to
come from North Brunswick and points north and walk right up to our
office.”
According to Michel, Bullrun’s software has enabled it to expand its
focus from institutional investing to high-net worth individuals.
During the first quarter of 2005, the company doubled the amount of
business realized during its entire fiscal year in 2004. It projects
revenue of $9 million by year-end.
After five years at the Technology Center of New Jersey, Celgro has
moved from 661 Route 1 South to consolidate with its parent company,
Celgene, at a new headquarters in Summit.
Celgene is known for having found good uses for the drug thalidomide;
it discovers, develops, and commercializes therapies to treat cancer
and inflammatory diseases through gene and protein regulation. Celgro,
its wholly owned subsidiary, is an agrochemical company working in
pesticides; it does enzyme and protein engineering, custom biocatalyst
development, chiral product applications, and enzyme and biocatalyst
production (U.S. 1, January 19, 2000).
Celgene moved its headquarters from Warren to the former 45-acre
campus of Celanese. The campus started out as a junior high school in
the 1930s. Celanese bought that building after World War II and added
to it; now it has 15 buildings (including a cafeteria, tennis courts,
and a small pilot plant) and more than 414,000 square feet. The
Garibaldi Group/CORFAC International of Chatham represented the
sellers, and Murray Hill-based Staubach Company represented the
buyers.
Celgro Corporation (CELG), 86 Morris Avenue, Summit 07901. George W.
Matcham, senior vice president, Celgro. 908-673-9000. Home page:
Top Of PageOwnership Change For Consumer Health
Princeton-based Consumer Health Sciences, formerly part of Grey
Healthcare, has formed a new division within another Grey-owned
company, The Ziment Group. According to vice president of sales, Len
Force, the company’s name will remain unchanged although it is now
affiliated with a different parent company.
Consumer Health Sciences became part of Grey Advertising when it was
acquired by Grey Global Group in 1999. When Grey itself was acquired
by WWP, CHS became a separate operating division of the Ziment Group,
a New York-based market research consultancy, and operating unit
within the Kantar divison of WWP. “CHS will continue to be a
standalone operating unit in the Ziment Group,” says Force,”focused on
syndicated patient medical research.”
Established in 1998 by founder and CEO Jane A. Donahue, CHS is a
20-person health information and market research company that provides
disease-specific, self-reported consumer data to pharmaceutical and
life science companies, to help close the gap between the doctor and
consumer. Its flagship offering is its National Health and Wellness
Survey (NHWS) which annually compiles information from 45,000 adult
U.S. consumers and 20,000 European respondents.
Donahue grew up in Chicago, where her father was a marketing executive
at Readers Digest. She graduated with a BS in Psychology from St.
Lawrence College, in 1974, and earned a Ph.D. in social research from
Bryn Mawr. Formerly, she was the director of outcomes research for
Janssen.
Her firm employs researchers with master’s and doctor’s degrees who
design the questionnaires. The field work is done in the U.S.,
Germany, Italy, France, and Spain, with the cleaning, coding and
scoring of the data performed in Princeton. Though the studies are
sold to pharmaceutical and managed care companies, the firm maintains
ownership of the data.
Consumer Health Sciences LLC, 165 Wall Street, Princeton 08540. Jane
A. Donohue CEO. 609-924-4455; fax, 609-924-7794. Home page:
Dianet Communications, 3 Cedar Brook Drive, Cranbury 08512. Jeff Just,
president. 609-655-2856; fax, 609-409-1927. Home page:
Dianet Communications, which designs, finances, builds, manages and
maintains share networks for wireless carriers, moved last year from
Park Avenue to 3 Cedar Brook Drive. The five-person office is
currently conducting a project at 30 Rockefeller Center.
Blue Star Infotech America Inc., 666 Plainsboro Road, Suite 1010,
Plainsboro 08536. Sanjeev Sethi, director. 609-799-5454; fax,
609-799-5486. Home page: www.bsil.com
Blue Star Infotech, a software consulting firm, moved within Princeton
Meadows Office Center from Suite 1116 to 2,000 square feet in Suite
1010. Founded 20 years ago, it is headquartered in Mumbai, India, and
has 1,000 employees worldwide, 10 in this office. Another U.S. office
is in Santa Clara. A spokesperson says that the company offers design
and development services on all platforms and focuses on four
industries – technology, retail, travel, and manufacturing.
Forums Institute for Public Policy, 315-316 Commons Way, Princeton
08540-3906. Linda Mather, president. 609-688-0100; fax, 609-688-0855.
Forums Institute for Public Policy has moved from 101 Campus Drive and
has a new phone and fax. A nonprofit corporation, it promotes sound
public policy through education, communication, and research, and it
is partially funded by the RWJ Foundation.
Robert A. Obler, 3131 Princeton Pike, Building 3D, Suite 200,
Lawrenceville 08648. 609-896-1321; fax, 609-896-3184.
Criminal trial attorney Robert A. Obler has left his old office and is
now leasing space in the offices of Markowitz, Gravelle at 3131
Princeton Pike, Building 3D, Suite 200. He has a new phone number.
Top Of PageManagement Moves: Countrywide
Countrywide Home Loans (CWD), 1 Nami Lane, Quakerbridge Business Park,
Suite 2, Mercerville 08619. Daniel Guest, branch manager.
609-584-7644; fax, 609-584-8151. Home page: www.countrywide.com
Daniel Guest is the new manager at Countrywide Home Loans, a national
mortgage company. After graduating from York College, Class of 1988,
and obtaining his Wharton MBA, he worked in telecommunications, most
recently as director of sales for Nextel.
When Green moved to the mortgage banking business, he worked at
Washington Mutual in Cleveland and Princeton before joining
Countrywide.
Ryder Logistics, 112 Melrich Road, South Brunswick Industrial Park,
Monmouth Junction 08852. 609-409-0077; fax, 609-409-4496.
FNS Logistics had the contract to manage the LG Electronics warehouse,
but Ryder Logistics has taken over the role of distribution here. The
company did not return calls asking for information.
Stephen W. Koontz, 57, on May 20. He was a director at Johnson &
Johnson in Montgomery.
Donald P. Albury, 54, on May 22. At Princeton University he was
manager of media services. A memorial service is Saturday, May 28, at
10 a.m. at Princeton United Methodist Church, Nassau Street.
Corrections or additions?
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