MDS, the parent company of MDS Pharma Services, has entered into an agreement with INC Research to sell off MDS' phase II through IV contract research business for $50 million in order to focus on early-stage clinical development.

Under the terms of the acquisition agreement, Raleigh, N.C.-based INC Research will take ownership of approximately 100 active late-stage trials, as well as the 800 employees who work on these trials.

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U.S. Sites Rate Medpace, Kendle, ICON as Top CROs in 2009

Medpace, a private CRO on the rise, has been rated number one by U.S. investigative sites that it works with. Kendle, which came in second, has ranked in the top three in CenterWatch's survey the past three years, but was recently hit by a large number of project cancellations. Third place ICON returns to the top three for the first time since 2005.

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The Association for the Accreditation of Human Research Protection Programs (AAHRPP) released revised accreditation standards June 1--the first major revision since the organization established the standards in 2001.

The revised standards, used to measure the ethics and quality of research involving human participants, are available for public comment on AAHRPP's web site. AAHRPP released the proposed standards a month earlier than planned and hopes to publish the final standards by October 1, depending on the number of comments that the organization receives. If all goes as scheduled, organizations applying for accreditation will begin using the new standards in March 2010.

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Only days after BioClinica increased its purchase offer to acquire etrials Worldwide and the two companies agreed to proceed with their acquisition agreement, that agreement has been terminated.

BioClinica increased its purchase offer last week after eClinical vendor etrials received an unsolicited offer from another company. etrials has now entered into a new merger agreement with that company, now identified as Merge Healthcare, at a cost of $500,000, plus reasonable out-of-pocket expenses,  to terminate the agreement with BioClinica.

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Raleigh, N.C.-based contract research organization (CRO) INC Research entered into an agreement to acquire the phase II through IV operations of MDS Pharma Services, the clinical development division of MDS, for $50 million.

The deal is expected to close by the end of July, according to INC CEO James Ogle, and will complement INC's existing late-stage services and global footprint. As a result of the acquisition, INC Research will gain a stronghold in several countries where it previously had little to no presence, including China, Singapore, Malaysia, Peru, Argentina, Chile, Mexico, Brazil and South Africa, Ogle said.

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Palm Beach CRO in West Palm Beach, Fla., may be a new player in the clinical trial industry, but its founders and leadership are not.

The contract research organization (CRO), which opened in December, is an outgrowth of Palm Beach Research Center, a clinical research site headed by CEO David Scott. Although that business is a separate entity from Palm Beach CRO, it provided the funding for the new business and has conducted more than 500 clinical trials and worked with more than 110 pharmaceutical companies in its 15 years of operation.

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At a recent ACRP chapter meeting in India, industry leaders participated in a panel discussion on quality in clinical research in India. The panelists included: Larisa Nagra Singh, senior director, Asia Pacific ,ICON; Dr. Sacchidananda, dermatologist, registrar evaluation, Rajiv Gandhi University of Health Sciences, Bangalore; Suresh Ramu, vice president, Quintiles; Mitesh Patel, head, CTL Services,  Quintiles India and director, clinical operations, Bangalore; and Dr. Anil Shinde, clinical operations,  director, NovoNordisk. The discussion was moderated by Dr. Raman Shetty, director clinical research, Allergan, India. The following is an excerpt from that discussion prepared by Dr. Shetty of Allergan and Pratibha Nadig, M.D.; Medha Joshi, M.D.; and Santosh Hegde (all of the Bilcare Research Academy, Bangalore, India) .

Clinical Trials in India have increased exponentially in number over the last decade. The increased business has brought into sharp focus the need to manage quality while conducting clinical trials.

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Electronic data capture (EDC) company Nextrials is conducting a multisite trial that CEO James Rogers views as the future of clinical trials and possibly of his company.

The six-site trial, conducted with electronic health record (EHR) vendor Greenway Medical Technologies, is the first trial to collect data from the EHR systems of multiple sites and integrate them into one database using EDC software, according to Rogers.

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U.K.-based Quotient Bioresearch acquired an Edinburgh clinical research facility to supplement the company’s growing clinical research business.

The Cambridgeshire, England, company purchased the facility from Charles River Laboratories last week for an undisclosed sum. The new facility will combine with Pharmaceutical Profiles, a Nottingham, UKbased facility acquired by Quotient in December, to form Quotient Clinical, Quotient’s new strategic business unit. This is Quotient’s sixth acquisition in three years.

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Following Encorium Group’s announcement of plans to sell its assets, the Wayne, Pa.-based contract research organization (CRO) released its first quarter financial results earlier this week, reporting a significant decrease in net loss for Q1 2009 compared with the same period last year.

Encorium’s loss for the quarter was $195,220, or $(0.01) per diluted share, down from $2 million, or $(0.10) per diluted share, in the first quarter 2008. Encorium CEO David Ginsburg attributed the decrease to staff reductions and a reduction in overhead expenses.

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BioClinica, formerly Bio-Imaging Technologies, increased the value of its offer to acquire troubled eClinical vendor etrials Worldwide in response to an unsolicited offer received by etrials from an unrelated third party.

Under the terms of the amended acquisition agreement, the cash portion of the agreement increased to $0.62 in cash per share, up from $0.15 in the original offer. The remainder of the original agreement remains the same.

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Wilmington, N.C.-based PPD is promoting current CEO Fred Eshelman to the newly created position of executive chairman of the board of directors, effective July 1.

In this role, Eshelman will provide strategic direction to the company and oversee the implementation of the company’s strategic and business plans, including the company’s compound partnering business.

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Just a week after announcing plans to sell the assets of its U.S. business to a global based contract research organization (CRO), Wayne, Pa.-based Encorium Group has scrapped those original plans and signed a letter of intent with another international CRO.

Encorium has signed a non-binding letter of intent to sell its U.S. operations to Italy-based Pierrel SpA. Under the terms of the agreement, Pierrel has the right to purchase the U.S. line of business for a purchase price equal to a percentage of the company’s U.S. backlog calculated as of the closing or $1.35 million, whichever is greater. Pierrel also will pay Encorium a 10% commission on the value of any new contract executed between the closing date and December 31, 2009.

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In keeping with its strategic focus on expanding in Asia, Australia-based contract research organization (CRO) Novotech has entered into a joint venture with ETI Klinical, a CRO based in Bangalore, India, and part of the Karle Group.

Novotech already had, and will keep, its own office in Hyderabad, India. Together the two Indian offices have 25 employees. Novotech has 90 employees in its Australia office and five each in its New Zealand and South Korea offices.

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eClinical vendor etrials Worldwide cut its net loss for the first quarter 2009 in half from the same period 2008 by reducing operating expenses, the company said. Net loss for Q1 was $960,000, compared with $2 million in Q1 2008—and $5.5 million in the fourth quarter 2008.

Net service revenues for the first quarter 2009 held steady at $3.6 million, compared with $3.7 million for the first quarter 2008.

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Wayne, Pa.-based contract research organization (CRO) Encorium Group said yesterday that it has entered into two non-binding letters of intent to sell the assets of its U.S. business, Encorium Group, and its wholly owned European subsidiary, Encorium Oy.

The company did not release any specific information about the pending deals, other than to say that the potential buyers are a full-service internationally based CRO and a full-service clinical research organization based in the U.S. with operations globally.

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After warning investors two weeks ago that first quarter 2009 revenues would be significantly lower than expected, Cincinnati-based contract research organization (CRO) Kendle released its first quarter earnings late last week—reporting a 78% drop in profit compared with the same period last year.

The company’s net income for the first quarter 2009 was $886,000 or $0.06 per share, compared with net income of $4.1 million or $0.27 per diluted share for the same period last year. Net service revenues for the quarter fell 5% to $108.1 million, down from $114. 1 million in the first quarter 2008.

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Canadian contract research organization (CRO) ASKA Research entered into strategic partnerships with two CROs that will expand ASKA’s service offerings in North America and in Australia.

The first partnership, with Queensland, Australia-based Clinical Network Services (CNS), was made possible by the Economic Research Agreement between British Columbia and Queensland, which went into effect last June.  The agreement is designed to build international relations in key sectors, such as biotechnology and life sciences.

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Cincinnati-based contract research organization (CRO) Kendle warned investors earlier this month that first quarter 2009 profits would be down, and down they are.

The company reported net income of $886,000 or $0.06 per share for the first quarter 2009, compared with net income of $4.1 million or $0.27 per diluted share for the same period last year. Net service revenues for the quarter totaled $108.1 million, compared with $1.14 million in the first quarter 2008.

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BioClinica, the recently renamed and rebranded Bio-Imaging Technologies, reported a 31% drop in profit for the first quarter 2009 compared with the same period last year. Net income decreased from $1.14 million, or $0.09 per diluted share, in 2008, to $786,000, or $0.05 per diluted share, for Q1 2009.

The CRO’s first quarter 2009 revenues increased 31% over the same period last year, due in large part to the acquisition of Phoenix Data Systems in March 2008, which contributed $3.7 million to BioClinica’s Q1 2009 revenues.

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Only a week after Bio-Imaging Technologies announced a name change to BioClinica and alluded to future acquisitions, the contract research organization (CRO) announced this morning its intent to acquire troubled eClinical vendor etrials Worldwide.

Under the terms of the acquisition agreement, the sale will be consummated through a tender offer for all outstanding shares of etrials stock. For each share of etrials stock, shareholders will receive 0.124 shares of newly issued Bio-Imaging common stock, 0.076 shares of newly issued Bio-Imaging preferred stock, and $0.15 in cash, which equates to a value of $0.9068 per share for etrials, representing a 27% premium to the average closing price for the past 30 days. Stockholders with 33% of etrials outstanding shares have already agreed to tender their shares, and the tender offer is expected to expire on or about June 15, 2009.

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Contract research organizations (CROs) continue to feel the adverse effects of cancellations and negative foreign exchange, but their most recent earnings reports show some promise.

“To paraphrase the words of Mark Twain, ‘Reports of the death of the CRO industry have been greatly exaggerated,” ICON CEO Peter Gray told investors last week.

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U.S. Sites Rate Novo Nordisk, Novartis and Eisai as Top Sponsors in 2009

Results of the CenterWatch 2009 Survey of Investigative Sites in the U.S. are in. For the second time in a row, U.S. sites have rated Novo Nordisk and Novartis the top one and two sponsors to work with, respectively. Eisai was ranked third by U.S. sites, a very high ranking considering that it is the first time that the company has elicited a significant response.

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Covance's first quarter profit fell 18%, and the company reduced its 2009 profit guidance. In after hours trading, Covance's shares fell 8.2% to $37.

The contract research organization (CRO) recorded first quarter net income of $40.3 million, or 63 cents a share, down from $49.1 million, or 76 cents a share, a year ago.

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Waltham, Mass.-based eClinical company Phase Forward reported first quarter revenues jumped 28% to $48.8 million, compared with the first quarter of 2008.

In early morning trading, Phase Forward shares were up 31% to $15.70 a share.

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