PharmaNet 2008 Outlook Cut Amid Strong CRO Growth

Contract research organizations (CROs) had a great run in the past year, but PharmaNet Development Group’s weak guidance for 2008, issued on Feb. 28, sent its shares tumbling more than 30%. That raises concerns about a possible pullback for the clinical trials industry following a strong year.

PharmaNet’s shares closed down 31% at $28.62 on Feb. 28 after the company said its direct revenue for 2008 would be in a range of $401 million to $409 million with earnings of $1.42 to $1.57 a share.

Both fell short of analysts’ expectations of $1.76 in earnings on sales of $414.8 million.

Princeton, N.J.-based PharmaNet’s quarterly financials were positive and the company continues its turnaround story after going through a tough transition in 2006.

The company reported it returned to profitability with net earnings for its fourth quarter of $4 million, or 21 cents a share, compared with a $11.9 million loss for the same period last year. Revenue for the quarter increased 16.7% to $92.3 million compared with $79.1 million during the same period in 2006.  PharmaNet doubled its full year net earnings in 2007, reporting $12.1 million, or $0.63 per diluted share compared with $6.1 million or $0.33 per diluted share, the year prior.

“Since the end of 2006, we have made significant strides in improving our financial metrics with respect to earnings, direct revenues, backlog and the balance sheet," Jeffrey McMullen, PharmaNet’s president and chief executive officer, said in a conference call.

PharmaNet, which was acquired by SFBC in late 2004, took the company lead after a series of serious legal and financial issues engulfed the company in 2005 and 2006. It shed its early phase I operations in Florida – once one of the industry's largest – and now offers early stage work through its Anapharm subsidiary in Canada. Its been slowly, but successfully, rebuilding its operations.

Yet other companies across the clinical trials industry continue to report strong financial gains in early 2008, including CROs and eClinical firms.

Fourth quarter revenue for Cincinnati-based CRO Kendle rose 31% to $154.6 million from $118.1 million a year earlier. Analysts had estimated revenue of $102.9 million. Profit was reported at $6.4 million, or 43 cents a share, from a year-earlier loss of $4.7 million, or 32 cents a share.

Dublin-based ICON reported nearly a 40% increase in year-over-year net revenue for its fourth quarter. Income from operations was $19.8 million compared with $13.8 million last year. In January, ICON expanded its presence in Central and Eastern Europe with the addition of three offices located in Prague, Czech Republic; Kiev, Ukraine; and Bucharest, Romania. The offices were sized to staff 75, 60 and 75 employees respectively.

In its second quarter reported Jan. 23, Waltham, Mass-based Parexel said net income jumped 27% to $11.5 million, or 40 cents a share, from $9.08 million, or 32 cents a share, in the year ago period. Revenue increased 29% to $284.3 million. For its fiscal 2008, Parexel boosted guidance to $1.78 to $1.83 a share from $1.75 to $1.81 a share and its revenue range to $935 million to $955 million, from $890 million to $920 million. In February, Parexel made a surprise bid for eClinical company ClinPhone. ClinPhone rejected that preliminary takeover offer saying it considered it too low.

Princeton, N.J.-based CRO Covance reported a nearly 20% jump in fourth quarter net revenue to $411 million compared with $343 million in the prior year. Net income jumped 22% to $47 million. Within the CRO’s early development services, its central lab business saw fourth quarter revenue jump by 11%. For the full year 2007, Covance’s total revenues were $1.55 billion, up 15.4% compared with 2006.
Wilmington, N.C.-based PPD has had a solid run. For its fourth quarter, PPD reported revenue of $375 million, an increase of 15% compared with the same period in 2007. Income from operations was up slightly for the quarter at $56 million.

CROs weren’t the only companies to report strong numbers.

Waltham, Mass.-based electronic data capture company Phase Forward reported stellar results as well. Revenue was up 25% for the fourth quarter at $37.8 million compared with $30.2 million during the same period last year. Net income nearly tripled to $15.7 million, or 36 cents a share, from $5.48 million. Revenues for the full year were $134.3 million, a 26% increase from $106.6 million in the previous year.

And eResearch Technology recorded a 45% gain in its fourth quarter revenue, with $28.9 million reported. Its net income rose 129.9% to $5.2 million compared with $2.2 million the year prior. In November, eRT entered into a deal worth potentially $50 million, with the acquisition of the cardiac safety business unit of Princeton, N.J.,-based CRO and central laboratory Covance. The newly acquired unit is expected to generate $20 million in additional revenue in 2008.  In February, Datatrak inked an enterprise agreement for at least $800,000, depending on the extent of services required by the client. The agreement is a three-year subscription license with an unnamed pharmaceutical company in Europe.

Datatrak was one glaring exception this cycle with reported quarterly revenues of $1.8 million, down 54% from last year and a net loss of $2.48 million. The company is taking a number of cost cutting initiatives and plans to bolster sales operations this year.

GVAX Show Antibody Respone in Prostate Cancer

Cell Genesys reported positive results from a phase II trial of GVAX for the treatment of prostate cancer. GVAX is a cell vaccine that is also being evaluated for the treatment of leukemia and pancreatic cancer.  The autologous vaccine is made by removing a sample of the patient's own tumor and coaxing it into producing granulocyte-macrophage colony stimulating factor (GM-CSF). The vaccine is then re-administered into the patient via injection, which initiates a potent immune response against the tumor.

The trial analysis was designed to evaluate the potential association between immune responses to GVAX and increased survival. The study enrolled 80 subjects, including 65 who had their serum evaluated to determine each subjects' immune response to two specific antigens, HLA-A24 and FLJ14668, following GVAX treatment. Of the 65 subjects, 34 demonstrated FLJ14668-specific antibody immune response and had a median survival of 43 months. 

The median survival of subjects who did not generate the anti-FLJ14668 antibodies was 21 months (p=0.002). Twenty-two of the 65 subjects received a dose of GVAX comparable to that being evaluated in ongoing phase III prostate cancer trials. Of the 22 subjects, 16 (73%) mounted an immune response to FLJ14668.

These 16 subjects achieved a median survival of 44.9 months. The median survival for all 22 subjects in this treatment group was 35 months. Of the 58 subjects who were HLA-A24 genotype negative and therefore potentially able to mount anti-HLA-A24 specific antibody responses, 30 subjects were found to be anti-HLA-A24 antibody positive. These 30 had a median survival of 43 months, compared with a median survival of 18 months in the subjects who did not generate anti-HLA-A24 antibodies (p=0.05).

"The findings being reported today indicate a potential association between two specific GVAX-induced antibody responses and patient survival, an association consistent with the proposed mechanism of action for this product. We look forward to expanding these findings in a prospective analysis of the sera of patients treated in our two randomized controlled phase III trials," stated Peter Working, Ph.D., senior vice president of research and development at Cell Genesys.

The results will be presented by Thomas Harding, Ph.D, and colleagues from Cell Genesys at the American Society of Clinical Oncology's Genitourinary Cancer Symposium held in San Francisco. Phase III trials are currently underway.

Encorium Appoints New CEO, Replaces Borow

Wayne, Pa.-based Encorium Group has appointed Kai Lindevall, M.D., Ph.D., as chief executive officer, replacing president and CEO, Kenneth Borow, M.D.

Borow, who ran the company for seven years, will assume the role of chief medical officer and strategic development officer.

Lindevall was Encorium’s president of operations for the company’s Europe and Asia business. He was the founder and former CEO of Remedium Oy, and joined Encorium when it acquired that company in November 2006. The company stated it made the changes to allow Borow to focus on expanding its consultancy business and international business development.

"In my position as CEO I shall oversee the implementation of the strategy that our entire senior management team anticipates will lead to success in terms of predictable growth and improved financial results.  With Ken now able to focus more of his time on building our consultancy services and delivering on new business development opportunities, the team should be well positioned to achieve our targets for global growth and profitability,"stated Lindevall.

Encorium also stated it plans to expand into the emerging markets of China, India, and Latin America.

"Expansion into new therapeutic and geographic areas through both organic growth and acquisitions will be essential in achieving our strategic targets. My expertise bringing CRO services into emerging markets will be very helpful in accomplishing our goals," said Lindevall.

CWWeekly February 18th 2008 Issue

Top News

ICON Acquires Phase I Unit in Texas

Dublin, Ireland-based ICON made its move into the U.S. phase I market with its acquisition of Healthcare Discoveries, a San Antonio, Texas-based 40,000-square-foot, 85-bed clinical pharmacology unit. The company, owned by Catalyst Pharma Group, was purchased by ICON for $12 million in cash and performance payments of up to $10 million to be paid by the end of 2008. The buy will more than double ICON’s total phase I capability and expand its services across the Atlantic. ICON already operates an 80-bed, full-service pharmacology unit in Manchester, England.

Chiltern Buys Second Phase I Unit in UK

London-based contract research organization (CRO) Chiltern acquired Drug Development Solutions (DDS), a phase I facility based in Dundee, Scotland. The 45-bed unit is located at the Hospital and Medical School. Including the company’s facility in Slough, Chiltern now has a total of 72 beds in its phase I division.

Other breaking news...      

• KCR acquires Dux Consulting...
• Quintiles central laboratory in India receives CAP certification...

Company Profile: An interview with Vijai Kumar, M.D., president and chief medical officer, Excel Life Sciences

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

eClinical Technology News

• Cleveland, Ohio-based Datatrak inked an enterprise agreement for at least $800,000, depending on the extent of services required by the client. The agreement is a three-year subscription license with an unnamed pharmaceutical company in Europe. The model is a contracting mechanism for the company’s platform is a separate option to its “trial by trial” model. Datatrak stated its typical “revenue composition” has been 25% for the technology element of an eClinical implementation and 75% for services. “We believe that we will always have the trial-by-trial business model, because this is more appropriate for clients with smaller pipelines. However, for clients with more predictable and larger pipelines, this model provides very predictable research and development costs and eliminates wasted time involved with negotiation and contracting under the trial-by-trial mode,” stated Jeffery Green, Pharm.D., chief executive officer of Datatrak.

• Seattle, Wash.-based Advanced Clinical Software (ACS) has launched a new version of its clinical trial management software (CTMS) product StudyManager, called StudyManager Sponsor Edition. The product is gear towards smaller sponsors, which may not have internal CTMS platforms. The new edition provides data collection, study management and real-time site/monitor interaction. “I root for the underdog,” said Bruce Schatzman, ACS’s founder and chief executive officer. “Most middle-tier research sponsors we’re addressing with our new product have been dwarfed for years by Big Pharma, which has the resources to purchase high-priced CTMS and electronic data capture (EDC) programs,” he said.

• Research Triangle Park, N.C.-based contract research organization (CRO) StatWorks has selected Akaza Research’s Open Clinica Enterprise for its EDC needs. Open Clinica is an open source, web-based, EDC software system that can be integrated into any existing infrastructure with internal client coding.

• India-based CRO SIRO Clinpharm (SIRO) is implementing a new IT framework using Oracle’s Life Sciences Applications and will use Sun Microsystems’ (Sun) hardware platform. This IT infrastructure will be implemented by DBMS Consulting, an Oracle partner network company.

• Waltham, Mass.-based Phase Forward will be moving to a 165,000 square-foot headquarters housed in a new state-of-the-art, green certified business center. The office is approximately five miles from the eClinical company’s current headquarters at 880 Winter St. The building has been certified by the U.S. Green Building Council (USGBC). A “Green” certification requires specific standards to be met in sustainability, water efficiency, energy, materials and resource, and indoor environmental quality. Phase Forward stated its accelerated growth, and anticipated new growth, created the need for a much larger office space. “Our high-caliber workforce has been key to our strong growth, so remaining in the Waltham area was a critical factor in recruiting and retaining employees and minimizing commute times,” said Bob Weiler, president and chief executive officer of Phase Forward.

Parexel Courts ClinPhone with Takeover Bid

UK-based eClinical company ClinPhone rejected a preliminary takeover offer from Parexel International,  a contract research organization (CRO) based in Waltham, Mass.

Although financial details were not disclosed, ClinPhone said it considered the offer too low.

“The board believes the indicated value materially undervalues the company and its prospects and the board therefore rejected this approach,” ClinPhone said in a statement.

Shares of the eClinical company’s stock, listed on the London Stock Exchange, shot up 16% to $1.93 immediately on the news. Parexel’s shares closed up 3.7% on Feb. 19 at $57.88.

In a statement, Parexel confirmed that it had made the initial offer for all of the shares issued by ClinPhone to be paid in cash. With its initial offer rejected, the company must now decide its next move. 

“Parexel is currently evaluating its options in relation to ClinPhone. A further announcement will be made in due course. However, there can be no certainty that an offer for ClinPhone will be forthcoming,” Parexel's statement said.

ClinPhone has about 730 employees. The company is valued at about $127 million. Parexel had 2007 revenues of more than $900 million.

In an interview with Reuter’s John Bowker, ClinPhone chief executive Steve Kent stated: "We are extremely confident about it (rejecting the bid),” adding that the firm had not consulted shareholders about the approach. We have very substantial plans (for growth). We have a clear business plan," he said. According to Kent, ClinPhone’s directors have not yet consulted with shareholders regarding the offer.

In September 2007, UK-based clinical trials technology company ClinPhone was forced to reduce its estimated 2007 revenue by roughly $20 million and its earnings by $1.98 million. The company blamed the drop in estimated financials to an increase in sales of its electronic data capture (EDC ) software at the expense of licensing the product, telephone outages and a weak U.S. dollar.

ClinPhone said it had an “exceptionally high rate” of contract cancellations during June and July, primarily due to “operational” issues.

CenterWatch Monthly February 2008 Issue

Site Training on EDC Improves

According to a new Center-Watch training survey, more than half of investigative site staff indicated that the effectiveness of training on electronic data capture (EDC) software has improved during their career. Though training has im-proved, complexities remain. Nearly half of CenterWatch training survey respondents indicated they must learn to use at least five different EDC programs.

The Ethics of Subject Payment

Offering subjects money to participate in studies is a common practice in biomedical research. Payments can enhance recruitment but they can also generate ethical controversy. The chief ethical concern with offering subjects money is that this may be an undue influence that compromises their ability to assess the benefits and risks of participation. Phase I trials offer the highest payment, with an average of nearly $500 per trial, but payments per healthy volunteer can total thousands of dollars.

Revolutionary Public-Private Partnership for Early Phase Trials Established in France

The Centre Hospitalier Universitaire (CHU) de Caen, a university teaching hospital and the largest hospital in the West of France, and Therapharm, a large, private contract research organization founded in 1980, have joined forces to form the first public-private partnership to conduct early phase clinical research in France. The clinical research center is called Centre de Recherche Clinique-Basse Normandie (CRC-BN). The center conducts phase I and II clinical trials that are industry-sponsored, investigator-initiated and government-sponsored.

Eye On: Tropical Diseases

Tropical diseases run the gamut of bacterial, viral and parasitic infections from those commonly encountered, such as travelers’ diarrhea, to those endemic in underdeveloped nations with primitive living conditions, to rare but lethal infections potentially employed as bioterror agents. CenterWatch has identified a pipeline of 19 drugs in various stages of development against tropical diseases related to bacterial, viral and parasitic infections. Some of these drugs are vaccines and prophylactic agents, whereas others address treatment of active infections.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

CWWeekly February 11th 2008 Issue

Top News

Veritas Medicine Restructures Business and Drops Trial Listing Service

Cambridge, Mass.-based Veritas Medicine, a clinical trial services company, has discontinued its patient recruitment services and laid off a number of employees. According to Veritas, it is restructuring the company to focus solely on its clinical trial disclosure business. The company’s clinical trial listing service and patient screening business will be terminated. Veritas stated it ceased providing patient recruitment services on Feb. 8.

PPD Buys Russian CRO InnoPharm

Wilmington, N.C.-based PPD acquired contract research organization (CRO) InnoPharm, based in Smolensk, Russia. InnoPharm has a staff of 300 and has additional offices in Moscow, St. Petersburg and Kiev, Ukraine. It offers late-stage services in clinical monitoring, data management and biostatistics. No financial details of the transaction were given.

Other breaking news...      

• Covance reports jump in fourth quarter revenue...
• Medidata wins a contract with Eliassen Group...

Company Profile: An interview with William Cooney, president and chief executive officer, MedPoint Communications

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

Ketek Hearing Winners and Losers

By Steve Zisson

After listening to the Feb. 12th hearing by the House Energy and Commerce’s Subcommittee on Oversight and Investigations probing study fraud and the antibiotic Ketek, one thing is clear: PPD, which monitored the study in question sponsored by Aventis (now Sanofi-Aventis), took the least hits from Congress. And it is also quite clear that many in Congress, including committee staff, don’t seem to understand much about the research process.

Outside of the FDA—which the committee would like to hold in contempt of Congress for failing to respond to a subpoena— taking the toughest criticism from the committee was Sharon Hill Price, founder and chief executive officer of Copernicus Group, the institutional review board (IRB) which oversaw the study.

Price, who admitted to being a bit nervous, was hammered by Michigan Democratic Rep. Bart Stupak, chairman of the oversight and investigations subcommittee, and House Energy and Commerce Committee Chairman John Dingell.

Stupak was upset that Copernicus didn’t provide in a timely fashion a call log of a phone call from Ann Marie Cisnernos, the former PPD study monitor and whistleblower, who reported the fraud that led to the conviction of Anne Kirkman-Campbell, a clinical investigator on Study 3014. Price told committee members she doesn’t recall talking to Cisneros.

Visibly frustrated with Price’s answers, Stupak at one point asked Price, “Why do you exist?” Presumably Stupak was referring to the IRB and not Price herself. Many of Stupak’s and Dingell’s questions showed a clear lack of understanding of clinical research. At one point Stupak was baffled at what “GCP” stood for. He was told Good Clinical Practices, the research standard. Ouch.  Dingell seemed lost when trying to figure out where in the research process an IRB figured in.

Trial Results for Psoriasis Drug Ustekinumab Hit Mark

Centocor reported one year data from a phase III trial of ustekinumab (CNTO-1275), a monoclonal antibody against the p40 subunit of IL-12 and IL-23 for the treatment of moderate to severe plaque psoriasis. This randomized, double-blind, placebo-controlled trial, dubbed PHOENIX-1, enrolled 766 subjects.

The subjects received subcutaneously administered ustekinumab (45 mg or 90 mg) at Weeks 0 and 4 followed by the same dose every 12 weeks, or placebo. Following the double blind phase, the subjects in the placebo group crossed over to receive either 45 mg or 90 mg doses of ustekinumab at Weeks 12 and 16 and every 12 weeks thereafter.

The primary endpoint was the proportion of subjects achieving at least a 75% improvement on the Psoriasis Area and Severity Index (PASI 75) at Week 12. The endpoint was reached; after two doses of ustekinumab 67% of subjects receiving the 45 mg dose and 66% of subjects receiving the 90 mg dose achieved PASI 75 compared with 3% of subjects receiving placebo (p<0.001).

In addition, 42% of subjects in the 45 mg ustekinumab dosing group and 37% of subjects in the 90 mg ustekinumab dosing group achieved PASI 90, compared with 2% of subjects receiving placebo (p<0.001). The subjects who received 45 mg or 90 mg of ustekinumab and consistently achieved a 75% improvement from baseline were randomized at Week 40 to either continue treatment or switch to placebo, with levels of response to maintenance therapy measured at Week 52.

Of those subjects who continued treatment with ustekinumab 45 mg and 90 mg, 87% and 91%, respectively, had a sustained PASI 75 response compared with 64% and 62% of subjects switched to placebo (p less than or equal to 0.001 for 45 mg comparison; <0.001 for 90 mg comparison).

Also at Week 40, 66% and 73% of subjects achieved PASI 90 after receiving either 45 mg ustekinumab or 90 mg ustekinumab, respectively, and response rates remained stable through Week 52 with continued treatment, compared with 37% and 38% of subjects switched to placebo. The adverse events profile was comparable between the treatment arms.

Johnson & Johnson subsidiary Centocor and Janssen-Cilag are developing ustekinumab. A Biologic License Application (BLA) is currently under review by the U.S. Food and Drug Administration (FDA).

Revolutionary Public-Private Partnership for Early Phase Trials Established in France

By Sara Gambrill

The Centre Hospitalier Universitaire (CHU) de Caen, a university teaching hospital and the largest hospital in the West of France, and Therapharm, a large, private contract research organization founded in 1980, have joined forces to form the first public-private partnership to conduct early phase clinical research in France. The clinical research center is called Centre de Recherche Clinique-Basse Normandie (CRC-BN). The center conducts phase I and II clinical trials that are industry-sponsored, investigator-initiated and government-sponsored.

Antoine Cournot, who is president of Therapharm and spearheaded the partnership, said, “The objective of the clinical research center is to be able to perform early phases, phase I and II, with a high level of international quality but with a professional approach.”

The impetus for the unique partnership was to attract more industry-sponsored clinical research to France. Creating a public-private partnership clinical research center in a large hospital has been a dream of Cournot’s for 20 years, when he first attempted to establish one in Paris, where Therapharm’s headquarters are. Ten years ago, when Therapharm moved its phase I unit from Paris to Caen—in close proximity to CHU de Caen—Cournot approached the hospital about his idea.

But, it wasn’t until 18 months ago that the hospital and Therapharm met for a serious discussion about plans for building CRC-BN...

Veritas Medicine Restructures Business, Drops Trial Listing Service

By Stephen DeSantis

Cambridge, Mass.-based Veritas Medicine, a clinical trial services company, has discontinued its patient recruitment services and laid off a number of employees.

According to Veritas, it is restructuring the company to focus solely on its clinical trial disclosure business. The company’s clinical trial listing service and patient screening business will be terminated.

Veritas stated it ceased providing patient recruitment services on Feb. 8.

The company’s clinical trial listings service had been a major part of its business since its inception. One of its main patient recruitment services asked for potential subjects looking to enroll in trials to fill out medical and geographic information, which could then be matched with studies posted by sponsors. That service also contained a trial notification message to be sent to potential subjects via email.

“There have been reductions of staff who were directly related to the patient recruitment business, but the clinical data disclosure team is intact,” said Andrew O’Brien, Veritas’ president and chief executive officer, in a statement to CWWeekly.

The company is responding to the evolving landscape of the industry’s transparency requirements. That business consists of Veritas’ clinical trial registry system, its sponsor registry web site development and its patient response service.

“Historically, this has been a smaller part of our business, but it certainly is where we see the best growth prospects today,” said O’Brien.

The company’s web-based platform allows clients to post trial listings and results to different registries. Veritas’ web site development service helps its clients develop their own corporate registry sites in a branded environment.

“We’re focusing Veritas Medicine on the clinical data disclosure business because there is a terrific market opportunity and we are very well positioned there...the disclosure requirements for our biopharmaceutical customers are growing more complex,” said O’Brien.

In the last year, Veritas has been through some significant changes. After seven years as Veritas’ chief executive officer, Joe Avellone, M.D., left. In May 2007, Parexel, a Waltham, Mass.-based contract research organization, named Avellone to the position of corporate vice president of clinical research operations for both North and Latin America. Avellone remains on the company’s board of directors. He previously served as chief operating officer for BlueCross BlueShield of Massachusetts.

Veritas was founded in 1999 with an initial investment of $8 million from Burrill & Company, BioAsia’s Biotechnology Development Fund II, Cambridge Incubator and Seaflower Ventures. Three years after launch, Veritas had raised a total of $16 million in funding. Its current list of investors includes Burrill & Company, Vivo Cambridge Innovations, Seaflower Ventures and MDS Capital.

Stephen DeSantis is the Senior Associate Editor at CenterWatch.

CWWeekly Feb. 4th 2008 Issue

Top News

Synarc Adds Hong Kong to List of Global Research Centers

San Francisco, Calif.-based contract research organization (CRO) Synarc launched a dedicated clinical research center in Hong Kong’s central district. The unit is more than 3,000 square-feet and operated by a dozen local staff members. A typical Synarc clinic is about 20,000 to 30,000 square-feet. Synarc conducts all its clinical trials at either its own sites or at sites run by partners. The company now owns 11 sites in Denmark, Estonia, Lithuania, Brazil, Romania, Poland, Czech Republic and mainland China.

PPD Breaks into China Central Lab Business

Wilmington, N.C.-based contract research organization (CRO) PPD made its first foray into the rapidly growing Chinese central laboratory market with the launch of its own unit, in cooperation with Peking Union Lawke Biomedical Development Limited (PUL). The exclusive agreement allows PPD to establish a commercial entity located on a separate campus near Peking Union Medical College Hospital (PUMCH). The facility is headed by Mayo Clinic–educated Jian Ho, M.D, Ph.D. The PUL has 60 highly trained local personnel.

Other breaking news...

Clinical Data signs agreement with Affymetrix...
Phase Forward reports strong growth...

Company Profile: An interview with Ibrahim Farr, MD, PhD, chief executive officer, Pivotal

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

Covance Reports Jump in Fourth Quarter Revenue

Princeton, N.J.-based CRO Covance reported a nearly 20% jump in fourth quarter net revenue to $411 million compared with $343 million in 2006. Net income was also impressive, $47 million, a 22% increase compared with the fourth quarter of 2006. Earnings per share were $0.72 in the quarter, up 21.8% compared with the fourth quarter of 2006. Fourth quarter revenues were split evenly between Covance’s early development and late-stage development business units.

Within the CRO’s early development services, its central lab business saw fourth quarter revenue increase by 11% and year-on-year revenue by 21%. Covance’s phase II-III business also saw revenue growth in excess of 20% both for the fourth quarter and the full year. For the full year 2007, Covance’s total revenues were $1.55 billion, up 15.4% compared with 2006. Full year operating income increased 18.3% to $229 million. Net income grew to $172 million in 2007, up 20.5%. Full year EPS was 265, up 20.5% over the year prior.

“These results topped our internal budget helping us drive at 21% growth in backlog to $2.7 billion and a strong net book-to-bill of 1.28:1 for the full year. Increasing levels of client satisfaction led to strong repeat work resulting in more than $500 million in net orders for the quarter and a 20.6% growth in our backlog to $2.7 billion,” said Joe Herring, chief executive officer of Covance.

Rapid Growth of Asia-Pacific Clinical Trials Market Focus of New CenterWatch Report

BOSTON, Feb. 6 -- CenterWatch, a publishing and information services company focused on market research about clinical trials, finds in a new report that the Asia-Pacific region is grabbing an increasing share of the global clinical trial market, and with new regulatory changes across the region, has already been growing at more than 50% in recent years.

According to the new 160-plus page report from CenterWatch entitled, Asia- Pacific's Growing Role in Global Clinical Trials, Asia Pacific countries are tapping into their power as a bloc to boost their role in the expanding global clinical trials market.

An important part of the report contains the results from CenterWatch's first-ever survey of clinical researchers in the region. CenterWatch surveyed more than 156 investigative sites from more than a dozen countries in Asia Pacific. The survey revealed, among other results, the key role of electronic data capture (EDC) of clinical trial information in this region.

Rituximab Hits Endpoints for New Indication

Roche issued positive results from a phase III trial of MabThera (Rituxan, rituximab) as a first-line therapy for rheumatoid arthritis. This international, randomized, placebo controlled, double blind, parallel group study was dubbed SERENE (Study Evaluating Rituximab’s Efficacy in methotrexate iNadequate rEsponders).

The trial enrolled five hundred and nine subjects who received either MabThera (500 mg or 1000 mg) or placebo by intravenous infusion on days one and fifteen, plus weekly methotrexate (MTX).

The primary endpoint was the percentage of subjects who had at least a 20% reduction in a number of symptoms and measures of disease, measured via the American College of Rheumatology assessment (ACR20) at week twenty four.  The primary endpoint was reached; a significantly greater proportion of subjects treated with MabThera/MTX achieved an improvement in disease signs and symptoms compared to those treated with MTX alone. Treatment was well tolerated, with a profile consistent with previous studies.

“These data support the potential for MabThera to be used earlier in the course of treatment for RA. The results are encouraging and show that MabThera represents a promising alternative to current treatment options in patients who have an inadequate response to traditional therapy”, said William Burns, chief executive officer of Roche's pharmaceuticals division.

Rituximab is already approved rheumatoid arthritis in combination with methotrexate. It is also approved certain forms of B-cell non-Hodgkin's lymphoma (NHL).

Based on the results, Roche intends to file for FDA approval of MabThera as a first-line therapy.

Rituximab is a (mouse/human chimeric) anti-CD20 monoclonal antibody developed and launched by IDEC Pharmaceuticals (now Biogen Idec), Genentech, Roche Holding and Zenyaku Kogyo.

Phase Forward Delivers Strong 4Q, 2007

Waltham, Mass.-based eClinical company Phase Forward reported strong fourth quarter and full 2007 annual results on Jan. 31. Revenues for the full year 2007 were $134.3 million, a 26% increase from $106.6 million in the previous year. More than 70%, or $96.9 million, of its total revenue stemmed from its electronic data capture product (EDC) product InForm.

"We believe Phase Forward's proven track record of delivering highly scalable and complex deployments for companies of all sizes serves as a strong motivating factor that influences customers to adopt Phase Forward and has made us a strategic partner of choice for many of our customers. Our strong business momentum and solid industry fundamentals make us optimistic about our outlook heading into 2008," said Bob Weiler, chief executive officer and president of Phase Forward.

Phase Forward’s operating income was $19.7 million for the year, an increase of 50% from 2006. Its full year operating margin of 14.7%. Revenue was up 25% for the fourth quarter of 2007 at $37.8 million compared with $30.2 million during the same period last year 2006. Net income nearly tripled to $15.7 million or 36 cents a share, from $5.48 million.

During the year, Phase Forward acquired the Montpelier, Vt.-based phase I software management company Green Mountain Logic for $5.2 million in cash.

"During 2007, we added over 50 new direct customers. These included clients spanning the global pharmaceutical, biotech, medical devices, CROs and academic sectors and range from the smallest to some of the largest life science companies in the world," said Weiler.

For 2008, the company stated it expects revenues to be between $165 and $169 million.

CWWeekly January 28th 2008 Issue

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MDS Pharma Opens Large Phase I Unit in Arizona

King of Prussia, Pa.-based contract research organization (CRO) MDS Pharma Services launched a 300-bed phase I facility just outside Phoenix in Tempe, Arizona. The unit cost about $25 million and took more than two years to complete. According to MDS, the new unit is the largest phase I clinic on the West Coast. By building the unit specifically for phase I services, MDS stated it was able to include specialized features such as thorough QT cardiac safety trial areas and improved security for conducting controlled trials. The facility also has its own clinical lab and pharmacy.

ICON Expands in Eastern Europe

Contract research organization (CRO) ICON Clinical Research expanded its presence in Central and Eastern Europe with the addition of three offices located in Prague, Czech Republic; Kiev, Ukraine; and Bucharest, Romania. Each office will be staffed with 60 to 75 employees. In the region, the CRO already has offices in Russia, Latvia, Lithuania, Poland and Hungary. According to Alan Morgan, president of ICON Clinical Research Europe, clients drive office expansion into these areas.

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