Novartis has discontinued development of Aurograb, an add-on therapy to antibiotics that was being assessed for use in treating deep-seated staphylococcal infections, following a review of recent Phase II results showing a lack of efficacy.
   
Novartis gained rights to the compound in 2006 through the acquisition of NeuTec Pharma. An intangible asset impairment charge of approximately $235 million, which is the full amount allocated to this project, will be taken in the 3Q08 in the Pharmaceuticals Division.
   
Phase III trials and submission preparations continue for Mycograb, another development compound acquired with NeuTec that is being studied as an add-on therapy to antifungal agents in treating invasive candidiasis and other severe fungal infections.

Pharmos Corp. will cease operations in Rehovot, Israel, effective October 31, 2008. The company plans to manage the activities currently based in Rehovot out of its U.S. headquarters in Iselin, NJ.
   
The research programs in Israel include the CB2 receptor selective library of compounds, including preclinical development of PRS-639,058 for neuropathic pain. The company is also working on finishing up a Phase IIa trial for its 3% diclofenac NanoEmulsion cream for use as a topical treatment for osteoarthritis pain.
   
The company is seeking a partner to lead both operating and funding of the research programs in Israel. The Rehovot senior management team of Iris Alroy, Ph.D. and Arnon Aharon, M.D. will remain available to support ongoing business development and existing collaborations as consultants.

Valeant Pharmaceuticals and GlaxoSmithKline have entered into an exclusive worldwide collaboration for the investigational drug retigabine, a neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures. Retigabine has shown efficacy and safety in two Phase III trials in patients with refractory epilepsy receiving treatment with as many as three antiepileptic drugs (AEDs). The two companies plan to file a NDA in the U.S. and a MAA in Europe by early 2009. The drug is also being studied in patients with post-herpetic neuralgia (PHN), a painful and common complication of shingles.
   
Under the terms of the agreement, Valeant will grant GSK worldwide development and commercialization rights to retigabine, VRX698 and the other compounds from the potassium channel opener discovery program in exchange for an upfront payment of $125 million. Valeant is eligible to receive as much as $545 million based on certain regulatory, development and commercialization milestones, as well as the development of additional indications for retigabine. Valeant will co-commercialize and share as much as half of the profits in the U.S., Canada, Australia, New Zealand and PR, and will receive as much as a 20% royalty on sales outside those regions. The two companies will share global R&D expenses for retigabine, and GSK will fund the development of VRX698 and the other back-up compounds from the program. Valeant could receive an additional $150 million based on the achievement of certain milestones for VRX698 and the back-up compounds, and double-digit royalties on worldwide sales.
   
“We were pleased with the significant interest shown in retigabine and we have selected GSK as a collaborator because we believe they are ideally suited and strongly committed to the continued development of this important compound,” stated J. Michael Pearson, chairman and chief executive officer of Valeant. “GSK’s development expertise and strong commercial infrastructure will be critical to maximizing the worldwide potential of retigabine. We believe this collaboration will strengthen our ability to bring this medicine to patients suffering from epilepsy and a variety of other conditions.”
   
“GSK is looking forward to working with Valeant to provide important medicines like retigabine to the medical community and to the patients we serve,” commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. “There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications. We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK’s portfolio.”

Genentech, Inc. will initiate a Phase II trial of GDC-0449, an orally administered small molecule Hedgehog antagonist, as a maintenance therapy for ovarian cancer patients in second or third complete remission. Genentech is developing the drug in collaboration with Curis, Inc. and will be the sponsor of this study.
   
GDC-0449 will be evaluated in approximately 100 patients in a randomized, placebo-controlled, double-blind, multi-center Phase II trial. Patients will be randomized to receive either GDC-0449 or a placebo comparator and will be separated based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival, and secondary outcome measures include overall survival, the amount of Hedgehog protein expression in archival tissue and tracking of adverse events.    
   
“We believe that the dysregulation of developmental pathways such as Hedgehog may play a role in the formation or recurrence of cancer. Therefore, we are hopeful that a Hedgehog inhibitor, such as GDC-0449, may be a useful therapeutic tool in preventing cancer from returning in these ovarian cancer patients and may prove useful as a maintenance therapy,” said Curis president and chief executive officer Dan Passeri. “GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech has indicated that it expects to initiate an additional Phase II clinical trial in advanced basal cell carcinoma in the second half of 2008.”

David Blumberg has joined KPMG LLP as a principal and advisory sector leader for the Pharmaceutical Industry practice, based in the firm’s Philadelphia office.
   
In his new role, Mr. Blumberg provides a full array of advisory services to pharmaceutical and life sciences clients. He has significant experience working in the global pharmaceutical space, including market evaluations, launch/entry strategy, product strategy, business transformation, performance improvement, strategic planning and merger integration.
   
Prior to joining the company, Mr. Blumberg served as executive vice president at I-Many, a provider of advanced Enterprise Contract Management (ECM) solutions, where he was responsible for all professional services, customer support, sustaining engineering functions, as well as formulating and directing marketing strategies in the Life Sciences and Healthcare business line.
   
He also served as global pharmaceutical and medical products industry leader for Accenture, where he serviced client accounts and led the industry team in developing strategy, positioning, awareness, thought capital, alliances and media/marketing programs.   

Chiltern has fully integrated its two early Phase units into a single operation branded as Chiltern Early Phase. This follows the acquisition of Drug Development Solutions (DDS) in February.
   
Chiltern Early Phase provides early phase services for the pharmaceutical industry through its two units in Slough (just outside of London) and Dundee, Scotland. Chiltern Early Phase has a total of 72 beds, 42 of which are based at Ninewells Hospital in Dundee and can cover all therapeutic areas and all types of clinical pharmacology studies, with specialization in first in man, drug photosensitivity, drug-drug interaction, Japanese bridging and vaccine studies.
   
Glenn Kerkhof, Chiltern's chief executive officer, said, "When we created Chiltern Early Phase, our vision was to develop a brand that would be synonymous with quality and service excellence. We now have the team, organization and facilities to deliver on this vision and provide a truly expert Early Phase service at reasonable cost."
   
Dr. Brian Sanderson, medical director of Chiltern Early Phase commented, "I am delighted to see the integration completed so thoroughly and ahead of schedule. We are now looking to build on our units' long histories of good science and medicine, both in the areas where we have traditionally been strong but also in new areas of specialization such as diabetes and cardiovascular medicine. We are also looking forward to forging academic links to provide specialist studies involving new biomarkers."

Timothy C. Tyson has been appointed executive chairman and acting chief executive officer of Aptuit, Inc. Michael A. Griffith, the company’s founder and chief executive officer since 2005, has resigned to pursue other opportunities.
    
“The board wishes to thank Mike for his outstanding success in creating a world-class organization that is a trusted partner to hundreds of innovative clients throughout the world,” said Tony Ecock, outgoing chairman of Aptuit’s board of managers. “With 2,700 employees working with more than 800 clients throughout the world, Aptuit has established a solid foundation for continued growth and success.”
   
Tim Tyson is the former chief operating officer, president and chief executive officer of Valeant Pharmaceuticals International, where he served from 2002-2008. Prior to Valeant, Mr. Tyson spent 14 years at GlaxoSmithKline, where he was president of global manufacturing and supply and ran Glaxo Dermatology and Cerenex Pharmaceuticals. He managed all sales and marketing for GlaxoWellcome’s U.S. operations. Mr. Tyson has also held executive positions at Bristol-Myers in commercial and technical operations and R&D. Previously he was a manufacturing manager for Procter & Gamble.

Bristol-Myers Squibb and Pfizer reported that an interim analysis of results from a Phase III study of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement indicate that the primary endpoint of this study was not met.
   
The Phase III VTE prevention study known as ADVANCE-1 compared apixaban, an oral Factor Xa inhibitor given at a dose of 2.5 mg, twice daily, to the FDA-approved dose of Sanofi-Aventis' enoxaparin, 30 mg given twice daily. The primary efficacy outcome was the total of symptomatic or asymptomatic deep vein thrombosis, pulmonary embolism, and death by any cause. The rate of the primary efficacy endpoint on apixaban was similar to enoxaparin (9.0% vs. 8.9%), but did not meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin, which was expected to be 16%, based on previous trials.
   
The companies are considering further studies with different protocols in preventing VTE in knee surgery and will not submit the U.S. filing for VTE prevention in 2009 as planned. Programs directed towards VTE prevention including EMEA registrational studies, treatment of VTE, and the prevention of stroke in atrial fibrillation continue as planned.
   
Full results of the ADVANCE-1 trial will be presented in December. Also, new Phase II data of apixaban in acute coronary syndrome patients (ACS) will be presented at the upcoming meeting of the European Society of Cardiology (ESC).
   
“Bristol-Myers Squibb and Pfizer remain enthusiastic and committed to the clinical development program for apixaban,” said Jack Lawrence, vice president, R&D, Bristol-Myers Squibb. “[The companies] anticipate that the results of APPRAISE-1 being presented at ESC will provide important insight into the potential use of apixaban for the secondary prevention of cardiovascular events in patients with acute coronary syndrome, which affects an estimated 2.7 million people around the world every year.”

James J. Kramer, Ph.D., has been appointed vice president, Global Biologics Operations, a newly created position at BioReliance Corp. Dr. Kramer joined the company in December 2007 as vice president, operations, U.S. Biologics. In his new position, his responsibilities will be expanded to include all operations at the company’s three facilities in Scotland, located in Glasgow, Stirling and Edinburgh, Scotland. He will continue to report to president, chief executive officer and chairman David A. Dodd, and will be based at the company’s headquarters in Rockville, MD.

“Jim is an excellent choice to lead our global biologics operations as we aggressively proceed in developing our organization to more effectively serve our clients. His leadership will ensure that BioReliance remains highly competitive as we develop and expand our customer base globally,” said Mr. Dodd. “Since joining the organization, Jim has consistently demonstrated expertise in creating and leading a highly customer-oriented management team. Our focus is to provide the highest levels of client support and service through operational excellence, and I am confident that under Jim’s direction we will achieve that goal.”

Prior to joining BioReliance, Dr. Kramer served as senior vice president/general manager, Talecris Plasma Resources, Talecris Biotherapeutics. Previously, he served as vice president, Global Manufacturing Operations at Serologicals Corporation, and held management positions at Ortho-Clinical Diagnostics, Inc. (a Johnson & Johnson Company), and Pacific Hemostasis Division of Curtin Matheson Scientific.

BioReliance provides biologics safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services.

Morphotek, Inc., a subsidiary of Eisai Corp. of North America, has opened clinical sites in the EU as part of its Phase II study of MORAb-009. A monoclonal antibody to mesothelin, MORAb-009 is being studied as a first-line treatment for patients with pancreatic cancer. The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine.

Morphotek has currently qualified 33 clinical sites in the U.S. and Canada to conduct its Phase II study that started earlier this year. The company has opened four clinical sites in Spain and received regulatory approval in Spain, Belgium and Germany and 17 sites have been qualified in these countries. Regulatory approval for this study is also pending in Argentina. These approvals expand the ability to evaluate the efficacy of this compound in patients outside of the U.S.

“We are extremely pleased to receive approval for the MORAb-009 Phase II trial sites in the EU,” said Martin D. Phillips, M.D., chief medical officer of Morphotek. “A distinguished group of clinical investigators treating pancreatic cancer patients throughout the EU have expressed an interest in novel biologic therapies for this typically fatal disease. We look forward to the possible involvement of additional European clinical sites for this compound as well as others in our pipeline.”

MORAb-009 is an IgG1 antibody that recognizes a cell surface glycoprotein called mesothelin, which is over-expressed on a number of epithelial-derived cancers. The antibody has been found to elicit anti-tumor effects via blockade of mesothelin to bind to its ligand present on neighboring cells and immune-effector responses. Phase I studies of the antibody in patients found the molecule to be well tolerated at, or below, the maximum tolerated dose and clinical observations from those studies suggested anti-tumor responses in a number of patients.

Algorithme Pharma has acquired Simbec Research in Merthyr Tydfil, Wales. The move gives the Laval, Quebec-based clinical research and bioanalysis provider, a foothold in Europe, and comes six weeks after the company's acquisition of a Baltimore, MD-based CRO.

Simbec has provided contract clinical research services to large pharmaceutical R&D companies for more than 30 years. The staff of the new Algorithme Pharma division in the UK is composed of a core team of approximately 100 employees who will join those already working at company locations in Montreal, Laval and Baltimore.

"Given the considerable growth of our 'international' clientele, it became necessary to acquire a location in Europe in order to better serve our fast-growing market once we had expanded to the U.S. The acquisition of this strategically-located and highly-respected clinical research centre is the first step in our European expansion strategy and provides us with an important base for future growth in the European market," explained Algorithme president and chief executive officer, Louis Caillé.

The Phase I and IIa UK location for clinical research includes a 38,000-sq.-ft. facility with 48 beds, all used by the Intensive Monitoring Unit. With this addition, Algorithme will increase its production capacity in Phase I and IIa drug development clinical trials.

Dr. Michael D. Ruff has recently been appointed vice president of pharmaceutical development at Metrics, Inc. He recently received his clinical doctor of pharmacy degree from the Shenandoah University Bernard J. Dunn College of Pharmacy.

Dr. Ruff completed his Pharm.D. degree shortly after becoming the ninth person in the world to earn the new Certified Pharmaceutical Industry Professional (CPIP) credential, awarded by the International Society for Pharmaceutical Engineering’s Professional Certification Commission and is the first competency-based international certification for pharmaceutical professionals. Those who qualify for the credential demonstrate global competency through education, experience and rigorous examination.

Dr. Ruff has been with Metrics for 11 years, where his responsibilities have included providing formulation development, clinical trial material manufacture and consultation services to clients. “In his many years here at Metrics, Mike has consistently demonstrated a personal commitment to excellence, including his pursuit of continuing education that allows him to remain at the forefront of industry knowledge and technology,” said Phil Hodges, president. “We congratulate Mike on earning his doctorate.”

Dr. Ruff has been a member of ISPE since 2005 and is a registered pharmacist with more than 20 years’ experience in developing new chemical entities with a focus on oncology, central nervous system and anti-viral drugs. He holds several U.S. patents for pharmaceutical applications and has authored numerous technical papers. He also is a member of the American Association of Pharmaceutical Scientists.

The FDA has approved Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.

The FDA approval of Nplate was based on efficacy and safety results from two Phase III studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83% of treated patients, and platelet counts were raised and sustained in these six-month studies. Additionally, patients treated with Nplate were able to reduce or discontinue their use of concomitant ITP medications and emergency medications.

Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Recognized as an orphan disease, chronic ITP affects an estimated 60,000 adult patients in the U.S. and is considered an unmet need by the FDA.

“Until now, patients suffering from chronic ITP have had limited available treatment options, many of which are often unsuitable for long-term use due to side effects and tolerability issues,” said David J. Kuter, M.D., Chief of Hematology, Massachusetts General Hospital, Boston. “Nplate represents the first long-term treatment for adult chronic ITP patients, providing a new treatment approach for this chronic disease.”

Said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president of R&D, “The FDA approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first FDA-approved peptibody protein, an innovative platform for delivering targeted therapies.”

Nplate was also approved for ITP by Australia’s Therapeutic Goods Administration (TGA) in July 2008. Amgen has filed for regulatory approval of Nplate in the European Union (EU), Canada, and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the EU (2005), Switzerland (2005) and Japan (2006).

Amgen is continuing to study the long-term efficacy and safety of Nplate for which there is more than three years of follow up safety and efficacy data.

Scott Neilson has been appointed to the position of chief operating officer of AAIPharma. Mr. Neilson will be responsible for the company's global drug development services operations, reporting to chief executive officer and president Dr. Ludo Reynders.
 
Mr. Neilson is an accomplished leader with over 25 years multi-functional experience in all phases of drug development on a global basis. During the past 10 years he has led the turnaround of two of the top six Global Central Laboratories, dramatically improving market share, revenues and profitability, according to an AAIPharma statement. He has also held senior operations positions in clinical research and has a broad spectrum of functional experience including finance, regulatory affairs, human resources and business development. His experience spans pharmaceuticals and CROs, having worked at MDS Pharma Services, LabCorp, Covance and SmithKline Beecham (now GlaxoSmithKline).
 
“As a company, we have made significant progress across the major lines of business over the last three years,” said Dr. Reynders. “Scott’s appointment underscores our commitment to continuing this progress and our goal of a global leadership position in the markets we serve."

Sancilio & Company, Inc. (SCI) opened its newly expanded 2,000-sq.-ft. contract manufacturing facility. The GMP facility specializes in small batch manufacturing of tablets and capsules as well as packaging and labeling services.
   
The facility is adjacent to the company’s pharmaceutical laboratory, a climate-controlled facility for pharmaceutical, biotechnology and nutraceutical clients providing analytical services, which include formulation development, quality control, quality assurance and regulatory affairs.
   
According to Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of SCI, “The new, fully cGMP compliant combined operation is FDA registered, and licensed for DEA Schedule 2, 3 and 4. The key attributes of both the manufacturing facility and the laboratory are rapid turnaround and competitive pricing.”
   
Nealie Newberger, Ph.D., vice president of laboratory services, said, “We anticipate that the addition of small batch contract manufacturing to our roster of services strategically positions the company as a full-service pharmaceutical and nutritional enterprise.”

The Centers for Disease Control and Prevention (CDC) will implement Pilgrim Software's automated platform for document control, complaints and corrective and preventive action (CAPA) systems management throughout the Laboratory Response Network (LRN) under the Division of Bioterrorism Preparedness & Response.
   
Pilgrim's SmartCAPA solution is a web-based, closed-loop system that allows users to investigate and resolve an issue and prevent recurrence. SmartCAPA will be integrated with the CDC’s internal LRN Website where complaints and product deviations are currently recorded. The complaints will then funnel into the SmartCAPA solution where they will automatically be routed through a closed-loop Investigation and CAPA process for follow-up and resolution.
   
The SmartDoc™ Solution helps organizations create, manage and share critical documents and best practices. SmartDoc will automate the review, approval and change management of controlled documents used throughout the LRN, and all current documents will be made available through the LRN Website.
   
“In selecting Pilgrim’s SmartSolve system, the LRN will elevate the harmonization and streamlining of processes that increase efficiency and enable quicker response to internal and external needs and expectations,” said Prashanth Rajendran, Pilgrim’s chief operating officer. “With the efficiencies it gains, the LRN will further solidify its reputation as a responsive division of the CDC.”

Biogen Idec initiated a Phase III trial of intravenous (IV) Adentri (BG9928), an adenosine A1 receptor antagonist for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate Adentri — developed under a licensing agreement with CV Therapeutics — against placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the U.S.
   
The TRIDENT-1 (TReatment with Intravenous BG9928 for patients with acutely DEcompensated heart failure and reNal insufficiency Trial) study is a randomized, multi-center, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of IV ADENTRI dosed as many as five days on body weight in ADHF patients with impaired renal function. Body weight is a measure of fluid accumulation, which is considered an important cause of symptoms experienced by heart failure patients.
   
“In previous clinical studies, ADENTRI has exhibited the potential to optimize fluid management without harmful effects on renal function. Heart failure patients with renal insufficiency are at risk for poor clinical outcomes and are among the most difficult to treat, as currently available therapies negatively impact renal function,” said lead investigator William Abraham, M.D., Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine, The Ohio State University Medical Center.

Boehringer Ingelheim has extended research funding for another year in its Alzheimer's disease collaboration with Ablynx. In January 2007 the companies entered into a $265 million worldwide research and licensing agreement to discover and develop new therapies for Alzheimer's disease using Ablynx's Nanobodies, a class of therapeutic proteins. The agreement included a joint research program with Ablynx scientists.

BI will be responsible for the development, manufacture and commercialization of any products resulting from the collaboration. As part of the collaboration, Ablynx received an upfront fee and will receive development and commercial milestones as well as undisclosed royalties based on net sales.
   
Dr. Edwin Moses, chief executive officer and chairman of Ablynx, commented, "We are very pleased with the progress that has been made in our joint Alzheimer's disease program with BI. We look forward to continue working together with BI in this medical area which urgently requires an innovative approach."

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals began enrolling patients in the STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial. The randomized, double-blind, placebo-controlled Phase III study is evaluating Nexavar (sorafenib) tablets as adjuvant treatment for patients with hepatocellular carcinoma (HCC), or primary liver cancer.
   
"Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, M.D., vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "Liver cancer is the third largest global cancer killer worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay disease progression and prolong life."
   
In addition, the FDA has completed a SPA for the STORM trial. An SPA is a written agreement on the design and size of a trial intended to form the basis for a new drug application.
   
The trial is expected to enroll approximately 1,100 patients and will include patients who have received surgical resection or local ablation. The study will look at whether oral Nexavar delays the time to recurrence and increases overall survival. The primary endpoint of the study is recurrence free survival. Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.

Bristol-Myers Squibb and PDL BioPharma, Inc. entered an agreement for the global development and commercialization of PDL’s anti-CS1 antibody, elotuzumab, currently in Phase I development for multiple myeloma.
   
Elotuzumab offers a new approach to treating multiple myeloma in that it binds to the CS1 glycoprotein, allowing the immune system to selectively kill myeloma cells with minimal effects on other cell types. CS1 is a cell surface glycoprotein found on multiple myeloma cells but is minimally expressed on normal cells. Elotuzumab is currently being investigated in Phase I studies as a monotherapy and in combination with other therapies. There are currently no approved monoclonal antibodies on the market to treat multiple myeloma.
   
Under the terms of the collaboration, PDL will receive an upfront cash payment of $30 million for the development and marketing rights to the drug and for an option to expand the collaboration to include PDL241, another anti-CS1 antibody. PDL could receive additional payments of as much as $480 million in development milestones and as much as $200 million in sale-based milestones, in addition to royalties.
   
BMS will cover 80% of development costs and will lead global development activities, while PDL will complete the ongoing Phase I program and provide support for Phase II studies. The companies would share profits on sales of elozutumab in the U.S. PDL would receive royalties on sales outside the U.S.
   
If BMS opts to expand the collaboration to include PDL241, PDL would receive an additional payment of $15 million and could receive as much as $230 million in development milestones, and another $200 million in sales-based milestones. The same division of development costs would apply to that drug.

Richard Ranieri has been appointed to the newly created position of executive vice president, Human Resources and Administration, and Julio Casoy, M.D. has been appointed senior vice president, Medical Affairs, at Sepracor.
   
Mr. Ranieri joins the company from Neurocrine Biosciences, where he was senior vice president and chief administrative officer. Mr. Ranieri managed and directed the company’s human resources function and its corporate communications, operations and purchasing. He also served as a corporate officer and was a member of the senior management team as well as secretary to the compensation committee of the board of directors. Prior to Neurocrine, he served as senior vice president, Human Resources at Genencor International for 12 years. Prior to joining Genencor, Mr. Ranieri spent more than 15 years with GlaxoSmithKline where he held a variety of human resources and sales management positions.
   
Dr. Casoy joins the company from Shire Pharmaceuticals where he served as senior vice president, Global Medical Affairs since 2005. Dr. Casoy was responsible for providing direction and oversight for all medical affairs activities supporting Shire’s drug development programs and marketed products worldwide. In addition, he was responsible for developing and directing objectives, policies and programs pertaining to global medical affairs activities and responsibilities and was a member of the R&D leadership team. Prior to Shire, he served as vice president of Global Medical Affairs, Compliance and intercontinental medical director at Wyeth.
   
“I am pleased to announce the addition of such accomplished professionals to Sepracor’s human resource and research and development teams,” said Adrian Adams, president and chief executive officer. “Richard brings with him a wealth of successful human resource, operational and general management experience, and his leadership skills will be integral to our plan and vision for continued organizational growth. Julio’s appointment to lead our medical affairs organization supports our focus on deepening and broadening our management team’s strength and capabilities and reinforces our objective of delivering enhanced performance and productivity across our commercial and research and development organizations.”

United Drug plc, an Ireland-based distributor, wholesaler and contract packager, has acquired Allentown, PA-based Sharp Corporation for $99 million. The acquisition is intended to complement UD's contract packaging operations in Europe with Sharp's U.S. presence.

Sharp will combine with UD’s existing U.S. operations to broaden its range of outsourced services for U.S. pharmaceutical and healthcare manufacturers. In contract packaging, which forms part of UD’s Supply Chain Services division, UD now combines the leading independent contract packaging business in the U.S. with UD’s existing European operations located in the UK, Belgium and Holland, according to a UD statement.

UD chief executive officer Liam FitzGerald commented, “We are delighted to announce the acquisition of Sharp. Sharp is a quality and compliance leader in pharmaceutical contract packaging in the U.S. and will fit extremely well with our existing packaging operations that provide services to the same client base in most major markets in Europe. The acquisition will also provide a major platform for our ongoing development as an international healthcare services company.”

The $99 million purchase price is equal to Sharp's reported 2007 revenues. Sharp employs 600 people, all of whom are expected to remain with the company after the acquisition.

Peter C. Gonze has been appointed executive vice president of Global Business Development at Averion International Corp. In this role, he will oversee the company’s global business development and marketing activities, and will serve on the company’s executive management team.
   
“Peter brings the necessary sales, marketing and operational management experience to grow Averion’s global sales. We will continue to pursue new business opportunities in North America and Europe, and plan to expand our geographic and therapeutic capabilities in emerging regions of the world,” said Dr. Markus H. Weissbach, chief executive officer of Averion International. “I welcome Peter to our senior management team and look to him to lead our sales growth and position Averion as a top-tier international CRO.”
   
Mr. Gonze has more than 35 years of pharmaceutical sales, marketing and development experience. He also has extensive leadership experience developing and commercializing products at biotech, pharmaceutical, device and consumer healthcare companies. Most recently, Mr. Gonze was the chief operating officer at Unither Pharmacueticals, a company focused on immunotherapeutic vaccines for oncology indications. He has broad experience in all aspects of commercial operations having held senior level positions in business development, commercial operations and general management with pharmaceutical and biotech companies including: GlaxoSmithKline, Rhône-Poulenc Rorer (now Sanofi-Aventis), Johnson & Johnson, Abbott Diagnostics-Medisense, and AltaRex.

Cellumen, Inc., a discovery toxicology company, entered an agreement with Mitsubishi Tanabe Pharma Corp. (MTPC), to develop panels of biomarkers that identify toxicity early in the drug development process.
   
“We’re pleased to announce this collaboration with MTPC,” says D. Lansing Taylor, Ph.D., chief executive of Cellumen. “By working together to develop biomarker panels, we hope to identify toxic liabilities much earlier in the drug development process than currently exists in the marketplace. Our ultimate goal is to enable MTPC to prioritize its lead drug series.”
   
Cellumen’s CellCiphr CSB Toxicity Profiling Services can identify toxic compounds in late primary screening through early preclinical phases, before entering expensive pre-clinical testing. By integrating optimal cells, panels of functional biomarkers and classifier software, CellCiphr is able to create a Safety Risk Index for compounds, and help researchers predict potential rodent or human toxicity earlier in the process.

Nicholas J. Hart has joined Emisphere Technologies, Inc. as vice president of strategy and development. In this capacity, Mr. Hart will be responsible for the planning and commercial development aspects of the company's Eligen technology.
   
Mr. Hart joins the company with more than 16 years of commercial experience in the pharmaceutical industry. Most recently, he was leader of the Contraception Therapy Area and a member of the corporate executive leadership team for Organon, recently acquired by Schering Plough. Also at Organon, he served as senior director/executive director of marketing of the Women's Healthcare Franchise; director of CNS marketing, and associate director of Specialty Products. Prior to Organon, Mr. Hart held various marketing and sales positions with Novartis, Sankyo Parke Davis Pharmaceuticals, and Bristol-Myers Squibb.
   
"I am delighted Nick Hart has joined our team at Emisphere to help us commercialize our Eligen Technology, including Eligen B12," said Michael V. Novinski, president and chief executive officer of Emisphere. "He brings a tremendous wealth of experience and a successful track record of accomplishment in the pharmaceutical industry. He has a demonstrated skill set both strategically and operationally, and I am confident that this track record will be continued at Emisphere."

Lou Panini has been named director, business development, Keata Pharma, Inc.  Mr. Panini has many years of experience in the pharmaceutical industry, having spent most of his career with Pfizer in Canada and Belgium. Mr. Panini began his career with Pfizer in Montreal and held responsibilities in finance, IT and operation management in the Animal Health, Pharmaceutical and Manufacturing divisions. In 1998, Mr. Panini was assigned to Belgium where he was general manager and site leader for the Global Logistics Center in Brussels. He returned to Pfizer Canada in 2006 as director of operations planning for Global Logistics.
   
Jocelyn Larose has been named associate director, business development at Keata. Mr. Larose has more than five years of experience in the pharmaceutical industry, working for a privately owned CMO in the greater Montreal area in Quebec, Canada. Mr. Larose was responsible for managing and assisting clients in the U.S. market for a portfolio of products that included oral solids, semi-solids and liquid doses handled from development through commercial operations.
   
John Durham, Keata's corporate vice president, business development, commented, “The Business Development Team is responsible for managing existing accounts and generating new business opportunities that will transform into additional revenue for Keata. Mr. Panini and Mr. Larose collectively bring a wealth of knowledge and experience to the organization and will make a significant contribution in positioning Keata as a contract manufacturer of choice by servicing our existing and new clients for our two manufacturing facilities.”

Garry Takle, Ph.D. has been appointed vice president of operations at WuXi AppTec, Inc., and Joseph Hughes, Ph.D. has been appointed vice president of testing services for the company's Philadelphia facility. Both Dr. Takle and Dr. Hughes will report directly to Edward Hu, chief operating officer of WuXi PharmaTech.
   
Dr. Takle has been with the company for nine years in roles of increasing responsibility at the Philadelphia site, most recently as vice president of R&D testing. He has more than 20 years of experience in the biopharm/biotech industry and previously worked at Wellcome (now GSK UK), the Rockefeller University and Innovir. In his new position, Dr. Takle will focus on continuous improvements in operations at the Philadelphia facility and will have overall responsibility for biologics manufacturing services.
   
Dr. Hughes has been with the company for more than 10 years in various leadership capacities. He has more than 29 years of experience in the industry, including previous positions at Merck Sharp and Dohme Research Laboratories and at Sterling Winthrop. In his new position, Dr. Hughes will take on direct management of all of the testing laboratories at the Philadelphia facility and also work to expand the company's biologics services and client base.
   
"WuXi AppTec is fortunate to have two such experienced and talented managers within our organization to tap for these important roles," said Mr. Hu. "Their deep understanding of the industry, their many years with the company and their proven track record as leaders will be tremendous assets as the Philadelphia facility continues to grow and strengthen its services for the biologics industry."

   
In preclinical testing, the compound has been shown to demonstrate improved and potentially superior efficacy over existing members of its class, which are currently used extensively in anticancer chemotherapy. Significant tumor growth delay was seen against human colon, lung and prostate solid tumors (as xenografts in mice) and against leukemia in mice.  
   
“We are pleased to begin the process of enrolling patients and commencing Phase I clinical trials of our compound and are hopeful that this first clinical step will ultimately lead to a new weapon in the fight against cancer,” said AMRI chairman, president and chief executive officer, Thomas E. D’Ambra. “The initiation of this study demonstrates the company’s ability to leverage its full spectrum of scientific capabilities to generate new products with commercial potential and to execute on the R&D portion of our strategic plan to provide value to stakeholders.”

Azopharma Product Development Group plans to expand its clinical research management services through its newly formed company, Acromon Clinical Research Organization. This company adds to the services provided by the human clinical dosing unit, AvivoClin, and the bioanalytical services unit, ADMEQuant.
    
The new organization will provide clinical management services for human clinical trials. Acromon will operate independently from other Azopharma companies in order to design and monitor trials in an unbiased manner, whether the study is performed at the AvivoClin site or another clinical facility. The staff will provide the designing, monitoring and technical writing aspects of clinical studies with a focus on regulatory compliance.  
   
Phil Meeks, Azopharma’s chief executive officer, said, “This expansion will help us to meet the growing needs of the clinical design and execution market which has seen steady growth for the past few years. This expansion will also help us more fully serve our clients’ needs for total product development.”
   
Acromon’s services include clinical study development, protocol design, clinical monitoring, data management, biostatistical analysis and reporting, and final clinical study report writing.

Dr. Juergen Lasowski has been appointed senior vice president of corporate development, Onyx Pharmaceuticals. In this role, Dr. Lasowski will lead business development activities for the company, assessing opportunities to potentially expand and diversify the company's portfolio.
   
"Juergen has a proven track record of success in corporate development and, under his leadership, we will remain poised on the business development front in order to move forward opportunistically," said Tony Coles, M.D., president and chief executive officer of Onyx. "While Nexavar remains the core asset for Onyx and the engine for growth for our business, over time we expect to expand our portfolio as the means to build a sustainable profitable company."
   
Most recently, Dr. Lasowski was the senior vice president of corporate development at NPS Pharmaceuticals. Previously, Dr. Lasowski held several positions at Sanofi-Aventis, in both business development and corporate strategy positions. Dr. Lasowski has completed more than 25 different business transactions and worked on three continents including North America, Europe and Asia.  

Abbott and AstraZeneca have entered into an agreement for Abbott to promote AZ's cholesterol drug Crestor. Under the terms of the agreement, Abbott will obtain the non-exclusive right to promote the drug alongside AZ in the U.S., excluding Puerto Rico. Financial terms were not disclosed.
   
This agreement is the second collaboration between the two companies. In 2006, they announced an agreement to develop a fixed-dose combination of the active ingredients in Abbott's investigational TriLipix and AZ's Crestor, with plans to submit a NDA to FDA in 2009. An NDA for TriLipix for use as monotherapy and in combination with statins has been submitted to the FDA and is currently under review.
   
"This agreement will allow AstraZeneca to increase share of voice for Crestor among physicians whose patients may benefit from this therapy. We see this as a good fit for both companies as this agreement allows us to leverage Abbott's established presence in the dyslipidemia space," said Mike Tilton, vice president of Primary Care, AstraZeneca.

Tekmira Pharmaceuticals Corp. has entered into a research collaboration with Bristol-Myers Squibb using Tekmira's SNALP technology to deliver small interfering RNAs (siRNAs) to specific organs and tissues outside of the liver.
   
The two companies previously worked together using siRNA delivery technology provided by Protiva Biotherapeutics. In May, Protiva and Tekmira combined their businesses. The collaboration between BMS and Protiva focused on validating certain gene targets using small interfering RNAs provided by BMS and employed a number of different stable nucleic-acid lipid particle (SNALP) formulations. SNALP is Tekmira's proprietary lipid nanoparticle technology for the delivery of RNAi drugs, including siRNAs.
   
Dr. Mark J. Murray, Tekmira's president and chief executive officer, said, "Our relationship with Bristol-Myers Squibb is consistent with our strategy to work with global pharmaceutical leaders to expand the therapeutic potential of our leading RNAi delivery technology. At the same time, this work compliments our internal product development initiatives as we advance our own RNAi therapeutics to treat serious human diseases."

Stora Enso has signed the first Pharma DDS packaging license agreements in the U.S. and in Europe. The company will partner with Sharp Corp. to package pharmaceutical products into Pharma DDS cartons. An agreement has also been reached with Cadmus Whitehall Group and with RLC Packaging Group to produce printed and converted components of the Pharma DDS carton. Pharma DDS is targeted for prescription drugs, OTC products, and nutraceuticals.  
    
"These three agreements only eight months after the launch of Pharma DDS in the market demonstrate the great interest in the product. We are especially excited about the cooperation with Sharp Corporation and the possibility to produce Pharma DDS on their new high speed MGS Stealth cartoner," says Ismo Saarinen, director, Stora Enso Pharmaceutical Solutions. The Pharma DDS carton is designed to be convenient and discreet to use, yet it has reached the highest F=1 child resistance testing result.
    
Sharp has recently finalized the installation of the new MGS Stealth cartoner at its facilities in Conshohocken, PA. "MGS Stealth is a high speed cartoner that can effectively produce such a specialized product as Pharma DDS. The speed of the line is up to 220 cartons per minute," said Rick Seibert, vice president of New Business Development, Sharp.

CSL Ltd. has signed an agreement to acquire Talecris Biotherapeutics Holdings Corp. for $3.1 billion, enhancing its position in the global plasma market. Talecris produces plasma medicines in the U.S. and operates 56 plasma collection centers and two manufacturing facilities. For the year ended June 30, Talecris had sales of $1.2 billion and earnings of $258 million. The company also operates a sterile CMO business.
   
CSL managing director Brian McNamee commented, "Talecris is highly complementary with CSL's business and the deal will increase output and profitability and diversify CSL's product range. " Mr. McNamee added that the purchase of Talecris would add 10% to earnings per share in its first year of acquisition.
   
According to the company, CSL expects to reduce costs by approximately $220 million over three years, with the majority of the synergies appearing in the second and third year. The acquisition, subject to regulatory approvals, will give CSL access to key plasma products such as Gamunex and Prolastin and expand its geographical presence. The deal would also add to CSL's position against rivals Baxter International, Grifols and Octapharma.
   
"We continue to anticipate stable market conditions for our plasma therapies business," which is growing at 8% to 10% a year, Mr. McNamee said.

Desmond Cave has been named business development director in Europe for Ricerca Biosciences. Mr. Cave will be based in the UK and will focus on selling Ricerca’s discovery and preclinical services to the pharmaceutical and biotechnology industries, along with its environmental and industrial toxicology services. He will be responsible for developing contacts and building relationships with prospective and current clients, as well as implementing strategies that will generate revenue growth.

Prior to joining the company, Mr. Cave was responsible for managing a business development team for a CRO, requiring coordination for activities in Europe, India, and Australia. He has more than 25 years of experience in the pharmaceutical research industry primarily focused on preclinical and toxicology. Mr. Cave also has expertise in developing proposals and streamlining processes for clients.

Ronald Kershner has been appointed to lead AAIPharma's North American Biostatistics and Data Management Services groups. Mr. Kershner has more than 25 years of industry experience at several large pharmaceutical, biotechnology and contract research companies. His previous roles include oversight of biostatistics and data management across a variety of therapeutic areas at inVentiv, Inveresk and Omnicare. Mr. Kershner has experience with regulatory submissions and has been involved in more than 20 NDA submissions. He also has experience with the implementation of EDC and eClinical technologies.
    
Mr. Kershner will be responsible for functional and financial oversight of all biostatistics and data management activities for AAI in North America. In this role, he will work closely with clients to insure on-time, on-budget quality deliverables. He will also be involved in new global technology initiatives to provide clients with technological solutions for implementing and managing clinical trials.

Schering-Plough has expanded its presence in China by establishing Shanghai Schering-Plough Pharmaceutical Co. Ltd. A wholly-owned operation based in Shanghai, the unit was formed through the acquisition of shares of its former joint venture partners. SP entered into an agreement in 1994 with Shanghai Pharmaceutical Industry Co., Ltd. and Shanghai Pharmaceutical Group Co., Ltd., to manufacture, market and distribute allergy and skincare products.
   
"The actions announced today are part of Schering-Plough's long-term global geographic expansion strategy," said Fred Hassan, chairman and chief executive officer of SP. "Investing in the Asia-Pacific Region, and especially China, represents another step in our journey to transform Schering-Plough into a global high-performance health care company. With a long-term presence in China, Schering-Plough now takes a significant step forward in its strategic development to further build growth and strength in this important market."
   
SP in China serves Chinese health care professionals, customers and other stakeholders in the areas of allergy/respiratory, cardiovascular, central nervous system, skin care, oncology, infectious diseases, and women's health.

DSM Biologics and MorphoSys AG signed a biopharmaceutical manufacturing agreement covering process development and cGMP manufacturing of MOR202, a fully human HuCAL antibody being studied for the treatment of multiple myeloma. DSM will manufacture MOR202 in its cGMP facilities in Groningen, the Netherlands. Financial details were not disclosed.
   
"Based on the positive experiences we have gained with the PER.C6 cell line and DSM's manufacturing capabilities within our MOR103 lead program, we have chosen to continue to use this platform for MOR202," commented Dr. Marlies Sproll, chief scientific officer of MorphoSys.
   
"We are very pleased that MorphoSys is extending its business partnership with DSM Biologics as their preferred manufacturing partner after our highly successful collaboration on the MOR103 program," says Marcel Lubben, vice president marketing and sales at DSM Biologics. "It is exciting how well the combination of our two strong platforms works for fully human antibodies."

BioFocus DPI, Galapagos' service division, has signed a contract with UCB to supply chemistry services in the UK for one of UCB's medicinal chemistry programs. The total contract value for Galapagos could potentially exceed $6 million. Galapagos is also eligible to receive as much as $749,000 in success-based payments.
    
UCB will transfer a team of chemists to BioFocus DPI from UCB's recently closed Cambridge research site and BioFocus DPI will continue UCB's chemistry work for the program towards candidate selection stage. Under the contract, UCB will provide biology support for the program.
   
"This agreement demonstrates BioFocus DPI's flexibility in meeting client needs," said Chris Newton, senior vice president of BioFocus DPI. "This innovative deal structure allows UCB to progress their program externally while applying the specific project expertise that UCB has already built internally."
   
"UCB is delighted to be able to work with BioFocus DPI in this way, combining our expertise to advance this program towards development," said Dr. Neil Weir, senior vice president research, UCB.

Enzon Pharmaceuticals is exploring strategic options for its specialty pharmaceuticals business. These options include selling the entire specialty business or selling one or more of Enzon's marketed products, Oncaspar, DepoCyt, Abelcet and Adagen, as well as the company's Indianapolis, IN manufacturing facility.
   
Enzon reported that it's received "confidential, non-binding interest for the purchase of all or a portion" of the specialty pharma business. The company intends to continue evaluating the sale process, while continuing to move forward with the previously announced spin-off of its biotechnology business. On July 31, 2008 Enzon filed a registration statement on Form 10 and related information statement with the SEC under the name Evivrus, Inc.
   
"We are committed to delivering value to our shareholders in the most efficient manner possible," said Jeffrey H. Buchalter, Enzon's chairman, president and chief executive officer. "During our efforts to spin-off our biotechnology business, it became clear that we should also explore attractive opportunities for Enzon's other businesses. Our decision to explore alternatives for our specialty pharmaceuticals business is an outgrowth of that thinking and has the potential to allow Enzon to focus exclusively on our novel biotechnology business as an alternative to our previously announced spin-off."

Alnylam Pharmaceuticals has formed an exclusive research agreement with the Max Planck Institute of Molecular Cell Biology and Genetics in Dresden, Germany, to investigate the molecular mechanisms of small interfering RNA (siRNA), the molecules that mediate RNAi.
   
Alnylam scientists will work with the lab of Marino Zerial, Ph.D., a team that specializes in intracellular trafficking, to investigate cellular uptake pathways in a high-throughput manner. Alnylam will have an option on any intellectual property that results from this agreement.
   
“Alnylam has a long-standing commitment to scientific excellence in the field of RNAi therapeutics and our new collaboration with Professor Zerial and his team is representative of the collaborations we have and will continue to form as we seek to increase our understanding of the underlying mechanism of cellular delivery of RNAi therapeutics,” said Victor Kotelianski, M.D., Ph.D., vice president for research at Alnylam. “This agreement complements our existing delivery collaborations and will provide deep insights into the cellular uptake of siRNAs and the pathways by which they function. We believe the findings from this effort will allow us to further optimize and expand our broad range of delivery approaches for RNAi therapeutics.”

Merck is reevaluating the design of its Phase IIb trial for I-vation TA that it's conducting with SurModics, Inc. and therefore suspending enrollment of new patients in the trial. The decision follows recent study results comparing laser treatment and intravitreal injections of triamcinolone acetonide (TA) in patients with diabetic macular edema (DME).
   
Merck’s Phase IIb trial is intended to evaluate the safety and efficacy of SurModics’ I-vation TA in patients with DME. The trial suspension follows the publication of a study sponsored by the National Eye Institute suggesting a benefit for laser treatment over intravitreal injections of TA. This report does not discuss I-vation TA or the safety or efficacy of sustained drug delivery systems.
   
"The decision to suspend enrollment in this clinical trial is based solely on the results reported in a recently published study comparing laser treatment and intravitreal injections of TA," said Bruce Barclay, president and chief executive officer of SurModics. "We believe the data from the Phase I and Phase IIb clinical trials generated to date provide support for the tolerability profile of I-vation TA, and more generally, that of the I-vation sustained delivery platform.”

Michael Mallon has been appointed business development manager, DPT Laboratories. Mr. Mallon was most recently with Catalent Pharma Solutions, where he was responsible for managing selected accounts in the northeastern U.S. The contract service portfolio included oral solids, sterile fill and packaging services ranging from clinical development to commercial operations.
   
Mr. Mallon began his pharmaceutical career with Sterling Winthrop (now Sanofi), where he held positions in contract manufacturing, new product development and product management during eight years with that organization. He also has national and international account management experience working for Phoqus Pharmaceuticals based in Kent, England, and Penwest Pharmaceuticals in Patterson, NY.
   
"Michael's understanding of the industry and wealth of experience will certainly be an asset to DPT," said Paul Josephs, DPT's vice president of sales and commercial operations. "With his level of expertise, accomplishments and enthusiasm, we are confident that he will have a positive impact early in his career at DPT."

CMC Biologics has entered into an agreement with Symphogen for process development and cGMP manufacture of an undisclosed polyclonal antibody product candidate from Symphogen’s development pipeline. Terms of the agreement were not disclosed.
   
“We are pleased to establish such a partnership with Symphogen and are excited to be involved in this unique field of recombinant polyclonal antibody technology,” said Mads Laustsen, chief executive officer of CMC Biologics.

Centocor's BLA for ustekinumab for the treatment of plaque psoriasis has been delayed by three months to December 2008. Centocor filed the BLA late in 2007.
   
The FDA extended the review period in order to review amendments to the application provided by Centocor within the last three months. The FDA has not requested additional clinical trials.
   
In June, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended ustekinumab for approval. The committee provides recommendations based on its evaluation but the FDA has the final say on approval. Ustekinumab is also under review by the EMEA.

Valeant Pharmaceuticals and Meda AB have agreed to form joint ventures in Australia, Canada and Mexico to develop, market and commercialize certain current and future products. The joint ventures will be majority-owned by Meda; Valeant will own a minority interest. The joint ventures will initially include insomnia drug Sublinox and pain drug flupertine, with the option to include additional products in the future.
    
“I am delighted to join Meda in a strategic partnership that will provide new opportunities for both companies,” said J. Michael Pearson, chairman and chief executive officer. “Through these joint ventures, Valeant will be able to increase the leverage of our business operations in Canada, Mexico and Australia, while opening up new market opportunities for Meda.”
   
“We are very pleased to be able to join Valeant in the creation of these three joint ventures,” said Anders Lonner, chief executive officer of Meda. “Long-term partnerships are a fundamental cornerstone of Meda’s strategy and I believe that this collaboration will yield long-term benefits for both companies.”
   
Meda recently agreed to acquire Valeant’s pharmaceutical business in western and eastern Europe for $181 million. The majority of the acquired products are within Meda’s key therapy areas; neurology and dermatology. The major markets are Germany, UK, Italy, Spain and Russia.  

Parexel

4Q Revenues: $331.9 million (+31%)

4Q Earnings: $25.0 million (+140%)

FY Revenues: $1.2 billion (+27%)

FY Earnings: $64.6 million (+73%)

Comments: Record quarterly and FY service revenue was $272.2 million (+33%) and $964.3 million (+30%), respectively. The company had a record backlog of  $2.1 billion (+37%) for the year. Consolidated service revenue in the quarter was $212.0 million in Clinical Research Services (CRS), $33.3 million in Parexel Consulting and Medical Communications Services (PCMS), and $26.9 million in Perceptive Informatics, Inc. FY08 service revenue was $964.3 million (+30%). Consolidated service revenue was $745.7 million in CRS, $129.8 million in PCMS, and $88.8 million in Perceptive Informatics, Inc. Earnings in 4Q08 include a favorable impact of $8.7 million in net tax adjustments.

Dr. Sue Price has been appointed head of Clinical Trial Supplies (CTS), Penn Pharmaceutical Services. Dr. Price has experience working with major pharmaceutical companies including Sanofi-Winthrop and Brecon Pharmaceuticals. Most recently she has worked as an independent clinical suppliers consultant for a number of pharmaceutical companies.
    
Also, Pedro Pala has joined the company as a CTS project Manager, following a five-year appointment with Simbec Research.   

John J. Gilroy, P.E. has been promoted to general manager, construction at Integrated Project Services (IPS). Mr. Gilroy previously served as senior director, engineering. He will assume responsibility for the strategic direction and overall management of IPS’ construction division including construction management, program management, pre-construction and design/build services. Also, Edward J. Tannebaum, AIA assumes the role of president, for the new Strategic Planning Initiatives (SPI) entity, providing facilities management consulting services for technology-intense customers. SPI also offers owner representation, related program development and expert management consultation services.
   
“A key contributor for a number of years, John’s promotion is the result of his ability to think strategically and his track record of successfully delivering large, technically complex facilities on a global scale,” said Dave Goswami, P.E., president and chief operating officer, IPS. “John understands all aspects of a project, from concept development and engineering through construction and validation; offering creative and innovative solutions to help our clients succeed.”
   
Mr. Gilroy has more than 20 years of technical experience in providing project management, engineering and construction for the pharmaceutical, biotechnology, petrochemical and semi-conductor industries. He has expertise and focus within pharmaceutical manufacturing including oral solid dosage, sterile, aseptic, potent and cytotoxic projects.
   
Mr. Tannebaum has more than 35 years of design, facility management and construction experience. He has served in senior management roles at several major construction service firms and large pharmaceutical companies. Mr. Tannebaum has completed manufacturing, R&D and corporate headquarters projects ranging from Internationally Compliant Aseptic Filling, GMP solid dosage manufacturing and packaging, pilot plants, potent compound facilities, and critical support operations to major R&D labs, facilities, and upgrades.

Enzon

2Q Revenues: $51.0 million (+4%)

2Q Loss: $1.7 million (loss of $2.0 million in 2Q07)

Comments: Contract manufacturing revenue was $6.7 million in the quarter, up 14% due to deliverables. The company warned that it likely will not maintain contract revenues at that level during the rest of the year. Product sales were $29.2 million (+17%), driven by Oncaspar sales up 36% to 13.2 million, DepoCyt sales up 14% to $2.4 million, and Adagen sales up 7% to $7.0 million. Royalties were $15.0 million in the quarter (-18%), impacted by the sale of its royalty interest in Peg-Intron in August 2007.

Kendle

2Q Revenues: $177.4 million (+27%)

2Q Earnings: $7.8 million (+81%)

YTD Revenues: $336.2 million (+24%)

YTD Earnings: $13.5 million (+59%)

Comments: The company achieved record service revenues of $127.0 million in the quarter (+30%), as well as record new business awards of $204 million (+24%), and record business authorizations of $979 million (+13%). Service revenues were 45% in North America, 44% in Europe, 8% in Latin America and 3% in the Asia/Pacific region. Early-stage revenues were up 54% in the quarter to $8.6 million and late-stage revenues were $116.1 million (+29%).  

Covance has signed a definitive agreement with Lilly to help transform Lilly’s R&D model. Under the agreement, Covance will acquire Lilly’s 450-acre early drug development campus in Greenfield, IN for $50 million and will offer employment to about 260 Lilly employees.  In addition, Covance will provide Lilly with a broad-range of drug development services during the next 10 years for a contract value of $1.6 billion. Covance will assume ownership of the site and operations in October.
 
Lilly will transfer responsibility to Covance for its non-GLP toxicology, in vivo pharmacology, quality control laboratory, and imaging services.  In addition, the contract includes a committed level of clinical pharmacology, central laboratory, GLP toxicology studies, and clinical Phase II-IV services.

“This announcement represents an innovative approach to the R&D productivity challenges our pharmaceutical clients are facing,” said Joe Herring, Covance's chairman and chief executive officer. “We are very excited to welcome world-class Lilly scientific talent to Covance, and to take possession of valuable state-of-the-art assets, including more than 600,000 sq. ft. of laboratory space, and acquire new service lines that will help us accelerate our long-term, strategic growth plans. Covance will invest in this facility and maximize its capacity utilization by conducting substantial work with Lilly and bring in new work from other pharmaceutical and biotechnology clients. We expect the Greenfield site to be a key contributor to the future growth and success of Covance.”

“This strategic agreement is a result of a long-term trust-based relationship between our two companies.  Covance has proven they can help accelerate drug development timelines and improve efficiencies with Lilly, which will enable us to further focus on our core competencies in delivering better patient outcomes over the longer-term,” said John Lechleiter, chief executive officer of Lilly. “This industry-pioneering alliance will provide Lilly access to Covance’s broad and efficient drug development platforms. In addition, this collaboration will help us make our fixed cost infrastructure more flexible and continue to grow our portfolio of best-in-class and first-in-class pharmaceutical products.”

Covance has been in Indiana for more than 20 years with a global central laboratory facility in Indianapolis and a Phase I clinic in Evansville. The company has more than 1,000 employees based in that state.

Tolerx reached a clinical milestone in its collaboration with Genentech, as that company recently moved a modified version of TRX1, MTRX1011A, an anti-CD4 monoclonal antibody, into a Phase I clinical trial. The trial is evaluating the safety and tolerability of both single and multiple doses of MTRX1011A.

Under the terms of the collaboration agreement between Tolerx and Genentech, Tolerx realized milestones in the first quarter of this year upon selection of the antibody for further development within Genentech's clinical pipeline and upon IND filing. The initiation of the clinical trial resulted in the realization of an additional milestone by Tolerx.

Dr. Douglas J. Ringler, president and chief executive officer of Tolerx, commented, "We are extremely pleased that our collaboration with Genentech has resulted in the continued advancement of the program, and we look forward to continued progress."

Tolerx and Genentech entered into a collaboration in 2002 to develop and commercialize anti-CD4 monoclonal antibodies. Genentech has the right in all indications to develop, manufacture and commercialize such anti-CD4 monoclonal antibodies. Tolerx will receive additional milestone payments upon further successful development by Genentech of the anti-CD4 monoclonal antibodies in autoimmune or other indications. Tolerx may receive royalties on worldwide net sales of the anti-CD4 monoclonal antibodies that Genentech successfully develops. In lieu of receiving royalties on product sales in the U.S., Tolerx has the option to participate in a loss- and profit-sharing arrangement with Genentech.

Tom Beil has been named vice president of Quality and Regulatory Affairs at SAFC, a member of the Sigma-Aldrich Group. Mr. Beil, a quality systems and operations professional with nearly 25 years of experience, will lead SAFC's quality assurance team and oversee all aspects of the company's regulatory and quality assurance programs. He will report to SAFC president Dr. Frank Wicks and to Rich Keffer, general counsel and secretary for Sigma-Aldrich Corp. This appointment is Mr. Beil's second go-'round with Sigma-Aldrich; he spent 13 years as Quality Systems Manager from 1986 to 1999.

Said Dr. Wicks, "We are pleased to welcome Tom back to SAFC. He brings a wealth of knowledge and experience that is expected to help us continue to build upon our industry-leading regulatory compliance position. His addition to our senior management team will be focused on helping us support risk mitigation, quality assurance and regulatory initiatives across our product and service lines and will enhance the regulatory partnerships we intend to build with our customers to guide them through the challenges they face in procuring materials with the proper compliance profiles."

Mr. Beil rejoined SAFC from Centocor/GBSC, where he was senior director of Site Quality with responsibilities for quality assurance, quality control and quality systems. Prior to that appointment, Mr. Beil worked as associate director of Quality Assurance for Wyeth.

Abingdon Life Sciences has entered into an agreement with Stason Pharmaceuticals to provide clinical and regulatory support for Stason’s drug development programs. As part of the agreement, Abingdon will provide clinical and regulatory services for Stason’s pipeline of potential drug candidates and devices in the areas of cancer and inflammation.  

“We are extremely happy to have formalized our relationship with Stason, and believe that this represents a synergistic opportunity for both our companies to leverage our respective core competencies in drug development and manufacturing,” said Richard Lebovitz, Abingdon's chief executive officer.

Harry Fan, chief executive officer of Stason, added, “Stason is pleased to have agreed to this strategic partnership with Abingdon. It is a mutually beneficial relationship bringing expertise in many areas to our clients, both here in the US and in our overseas markets.”

Scott Watson has joined Girindus to lead its sales and marketing efforts. Mr. Watson has more than 25 years of experience in general management, operations, business development and sales. Prior to joining Girindus he was senior director, North American Sales for Aptuit and director, Business Development for DSM. A 1983 graduate of the U.S. Naval Academy, Mr. Watson served as a submarine officer before entering the pharmaceutical industry in 1991.

"Scott has a demonstrated track record in sales and leadership. We are looking forward to the energy and passion for excellent customer service that he brings to the table,” commented M. Laskovics, Ph.D., president and chief operating officer of Girindus America Inc., a service provider to the pharmaceutical industry and a manufacturer of therapeutic oligonucleotides.

"I am excited about the opportunity to join the Girindus team. Girindus’ technical strengths, combined with the strong financial backing and commitment of Solvay offer a unique and compelling opportunity to support companies developing oligonucleotide medicines." said Watson.

Meda has signed an agreement to acquire Valeant’s pharmaceutical business in western and eastern Europe. The acquisition will give Meda an entry into the Russian market. In Eastern Europe, it means a potential for significant market synergies with products in Meda’s existing pipeline, according to the company. In western Europe, Meda’s position will be strengthened, especially in the UK. The majority of the acquired products are also within Meda’s key therapy areas; neurology and dermatology, in line with the company’s focused approach.

The total sales of the acquired business is $181 million, of which Eastern Europe account for $33 million. The major markets are Germany, UK, Italy, Spain and Russia. Total headcount is 380 employees, of which 230 employees in marketing and sales primarily visit specialists within dermatology and neurology.

“I’m really glad that we have reached this deal with Valeant. This acquisition has a perfect fit with our operations in Europe. It also makes a very important contribution to our strategy to become stronger in eastern Europe. We now get a foothold in Russia and we will use that platform to introduce many of our pipeline products. We also look forward to a long term collaboration in other areas with Valeant,” said Anders Lonner, Meda's chief executive officer.

George L. Fotiades has been appointed interim president and chief executive officer of Catalent Pharma Solutions, effective immediately. John W. Lowry, the incumbent in this role, is leaving Catalent to pursue other opportunities. The search for Mr. Lowry's replacement is ongoing.

Mr. Fotiades has served as chairman since Catalent’s creation in 2007 and will continue to serve in that capacity. He brings strong experience to this role, having led the business from 2000 through 2004. Mr. Lowry will  assist Mr. Fotiades during the leadership transition.

Mr Fotiades said, “I would like to recognize John Lowry’s important contributions to Catalent over the last seven years, and particularly the leadership continuity and focus he brought during our transition to a standalone company. I am also pleased to assume an even more active role during this transition to help drive Catalent’s future success.”

Amgen has licensed a clinical stage molecule for the treatment of chronic and neuropathic pain to Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company. The terms of the agreement include a $50 million upfront payment, $385 million in success-based milestones and additional sales based milestones and royalties on sales.

The agreement provides OMJPI with global rights to the product, but excludes Japan, where Amgen has entered into a previous license agreement with respect to the compound. OMJPI and its affiliates will be responsible for future development and commercialization of the compound, a fully human anti-nerve growth factor (NGF) antibody.

“OMJPI’s proven capabilities in developing and marketing pain therapeutics make them an ideal partner to bring this potentially important molecule to patients who suffer chronic pain,” said Roger M. Perlmutter, M.D., Ph.D., Amgen’s executive vice president of R&D.

Steven M. Hutchins has been named vice president of business development at WuXi PharmaTech. Mr. Hutchins will be responsible for leading the company's global business development and reinforcing WuXi's brand value and market leadership. He will report directly to Dr. Ge Li, Chairman and CEO of WuXi PharmaTech.

Prior to joining the company, Mr. Hutchins was vice president of business development & collaboration management at BioDuro, a U.S.-based life science outsourcing service company, and also served as  senior director of global basic and preclinical sourcing at Merck.

"It was a great pleasure that I had the opportunity to manage the collaboration between WuXi and Merck in the past six years, and help to grow the relationship into a strategic long-term partnership." said Mr. Hutchins.

Bilcare Global Clinical Supplies has opened its new global U.S. headquarters in San Francisco, CA. The headquarters, which will be led by chief executive officer Vito Mangiardi, operates as the company's corporate hub to drive growth in Bilcare's American, European, and Asian regions.

"This year has been one of substantial growth in every area of our global business, from staffing and facilities to equipment and services," said Mr. Mangiardi. "While our U.S., India, and Wales-based facilities manage the increased demand for research and packaging services, our headquarters will dedicate itself to furthering global integration and growing the company as a full-service solutions provider that can take customers from research and development, to Phase I and II trials, and through longer-term Phase III trials."

Bilcare GCS nearly doubled its global workforce during the 2007-2008 fiscal year, and also completed a $2.3 million capital investment program in the U.S., expanded its facility in Rajgurunagar, near Pune, India, and made plans for a new clinical supplies facility in South Wales during that period.

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