Genentech and Biogen Idec have submitted an sBLA to the FDA for the use of Rituxan as first-line treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisone) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy.

The sBLA submission is primarily based on efficacy and safety data from two randomized, controlled studies of Rituxan in 644 previously untreated patients. The first study was a Phase III trial in 322 patients with follicular, CD20-positive, B-cell NHL that met its primary endpoint of an improvement in progression-free survival when Rituxan was used in combination with CVP chemotherapy as compared to CVP chemotherapy alone. Also, data from a Phase III trial of Rituxan given in a series of infusions over a two year period of time designed to evaluate efficacy and safety in 322 patients who had achieved a response or demonstrated stable disease to first-line CVP chemotherapy and who were then randomized either to receive Rituxan or observation. This study, E1496, met its primary endpoint of an improvement in progression-free survival.

Rituxan is approved as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL; Rituxan in combination with CHOP or other anthracycline-based chemotherapy was approved in February as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). Also in February, Rituxan was approved in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Amgen has completed the BLA submission to the FDA for panitumumab for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. The rolling BLA submission was initiated in December 2005.

Amgen and Abgenix's data from a randomized Phase III trial of 463 patients showed that those who received the drug every two weeks showed a 46% decrease in tumor progression rate versus those who received best supportive care alone. The most common side effect was acneiform rash. Other side effects less commonly observed were fatigue, nausea and mild diarrhea.

Panitumumab is an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), a protein that plays an important role in cancer cell signaling. Panitumumab received Fast Track designation from the FDA in July 2005 for patients with metastatic colorectal cancer who have failed standard chemotherapy treatment. It is being evaluated as both a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung and head and neck.

Oakwood Laboratories, L.L.C. and Santen Pharmaceutical Co., Ltd., of Osaka, Japan, have entered into an agreement for the licensing of Oakwood’s drug delivery technology for use with Santen’s steroidal product (DE-102) to treat Diabetic Macular Edema (DME). Under the agreement, Oakwood will provide formulation and dosage form development, and manufacturing of clinical and commercial scale supplies of DE-102, using Oakwood’s Chroniject microsphere-based sustained release injectable technology.

DME is an ophthalmic disorder associated with swelling of the retina in diabetes mellitus due to leaking of fluid from blood vessels within the macula, which is in the central portion of the retina. The severe deterioration of DME can cause failing vision or vision loss. Currently, the major treatments for DME are endophotocoagulation or surgery.

“Santen is committed to improving the effectiveness of drugs to treat DME, utilizing enhanced drug delivery,” said Toshiaki Nishihata, Ph.D., Santen’s head of R&D. “DE-102 has demonstrated sustained efficacy when injected around the affected area. Producing sterile microspheres in commercial scale requires the technology and facilities that Oakwood will provide.”

“We are pleased to be entering into this important relationship with Japan’s premier ophthalmic company,” said Mark T. Smith, president and chief executive officer of Oakwood. “ It is a tribute to both the expertise of our personnel and the strength of our Chroniject drug delivery technology. Oakwood’s feasibility study provided Santen with robust proof-of-concept, and the confidence to move forward with us on the development of this exciting product.”

Cheryl L. White has been promoted to the position of corporate vice president of quality at Baxter. Ms. White, who had been serving in an interim capacity in the role since November of last year, will report to chairman and chief executive officer, Robert L. Parkinson, Jr.

Ms. White has been with the company for eight years, most recently as vice president, BioScience Quality Management in Westlake, CA. She has held senior positions within the BioScience business with direct supervision over global manufacturing facilities and product development for biopharmaceutical products, biosurgery and vaccines. She played a vital leadership position in the successful validation, staffing and licensure of the Advate manufacturing facility in Neuchatel, Switzerland. Prior to joining the company, she managed quality control and quality assurance activities for Hybritech, at the time a division of Eli Lilly and Beckman Instruments. She also spent nine years in academic research at the University of California.

DSM Biologics and AC Immune SA have signed a Memorandum of Understanding in which the parties have agreed that DSM will be the development and manufacturing partner for AC Immune’s monoclonal antibody against Alzheimer’s disease. The development and manufacturing activities will be done in DSM Biologics’ FDA-approved manufacturing facility in Groningen, The Netherlands. AC Immune is based in Lausanne, Switzerland.

“After an intensive market analysis we have decided to choose DSM as our partner for the production of AC Immune’s conformation-specific monoclonal Alzheimer’s antibody, ACI-01-Ab7, based on the best quality to cost offerings by DSM,” said Andrea Pfeifer, chief executive officer of AC Immune.

“DSM Biologics is very exited to contribute to the development of AC Immune’s promising drug for treating Alzheimer's disease and is looking forward to the mutually beneficial collaboration,” said Terry Novak, chief marketing officer, DSM Pharmaceutical Products.

Pharmacopeia and GlaxoSmithKline have entered a drug discovery and development alliance. Pharmacopeia and GSK--through its recently established Center of Excellence for External Drug Discovery (CEEDD)--will collaborate to deliver clinically validated therapeutic candidates to GSK's global R&D organization.

The goal of the alliance is for Pharmacopeia to discover active molecules and bring them to clinical proof of concept, yielding novel candidates in broad therapeutic areas. GSK will have exclusive options to conduct Phase III trials and to commercialize products from the collaboration on a worldwide basis. Pharmacopeia will retain rights to programs for which GSK does not exercise its option.

Under the terms of the agreement, Pharmacopeia will receive $15 million in cash payments from GSK. Also, each drug development program pursued under the alliance will be subject to success-based milestone payments totaling as much as $83 million for a successful program and royalties.

Caprion Pharmaceuticals' Applied BioMedicine group has entered a research collaboration with Vertex Pharmaceuticals. The collaboration will use Caprion's CellCarta proteomics platform to support clinical biomarker discovery. Caprion will identify potential pharmacodynamic biomarkers in samples from certain clinical and preclinical studies conducted by Vertex.

"Caprion is looking forward to working with Vertex on this clinical biomarker discovery collaboration," said Dr. Daniel Chelsky, chief scientific officer at Caprion. "We believe that Caprion's capabilities in the discovery of protein biomarkers may significantly impact development efforts for one or more Vertex compounds."

Caprion's proprietary proteomics platform comprehensively profiles proteins and provides an unprecedented level of protein expression and identification in tissues and blood plasma. Caprion is presently conducting biomarker discovery programs in other indications for several pharmaceutical and biotechnology companies and its own clinical programs.

GenVec, Inc. has begun a Phase II study to evaluate the anticancer activity of TNFerade in patients with metastatic melanoma. The open-label, single-arm, multi-center study will assess tumor response after four weeks of intratumoral injections of TNFerade plus concomitant radiation therapy in 29 patients with stage III or IV metastatic melanoma who are ineligible for curative surgery or unlikely to benefit from other treatment options. Patients will be evaluated two months after the completion of therapy and followed for three years thereafter.

In a Phase I trial in patients with solid tumors, three patients with stage IV metastatic melanoma had complete local response and prolonged disease-free survival after local TNFerade lesion injection plus concomitant radiation; two of those patients remain disease-free approximately four years after treatment. This compares to the average survival rate of less than 2 years for patients with stage IV metastatic melanoma. Previous studies have demonstrated the ability of TNFerade to suppress the metastasis of melanoma into the lymph nodes in an animal model.

TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF-alpha), an immune system protein with potent anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF-alpha in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.

Genentech has purchased OriGene Technologies, Inc.'s TrueClone Collection of full-length human cDNAs suitable for transfection and direct in vitro expression. OriGene cDNA clones are expression-ready, authentic full-length cDNA plasmids for use in target and lead identification and validation. The cDNAs allow scientists to easily query the roles of genes in disease phenotypes and pathways.

"OriGene's mission is to build the most comprehensive collection of human full-length cDNAs in expression-ready vectors and to make this collection available to all researchers for systematic studies of human gene functions," said Karl Kovacs Ph.D., vice president of Alliance Management at OriGene. "We are glad to see our clones involved in the highly innovative research at Genentech."

Immunicon Corp. has extended its R&D Agreement with Pfizer for the development of new reagents designed to detect certain undisclosed antigens on circulating tumor cells (CTCs). The collaboration began in February 2003 and is now amended to permit the parties to initiate new clinical research studies by adding new Appendices signed by both parties to the Agreement. A new Phase I trial has been added to the Agreement and will begin enrollment immediately.

Byron Hewett, president and chief executive officer for Immunicon said, "We are very pleased to expand our collaboration with Pfizer, one of the world's premier pharmaceutical companies. As the developer of the instrument and reagents for rare cell detection, Immunicon offers pharmaceutical and biotechnology companies a unique advantage compared to reference labs and clinical research organizations. As is the case with Pfizer, Immunicon scientists work closely with our partners to develop assays and kits that are specifically paired with targeted treatments, and offer testing services to validate these assays in clinical trials with kits, reagents and instrument configurations that may not be commercially available. By working with Pfizer and other pharma/biotech companies as well as with the FDA, we hope to establish CTCs as a standard biomarker in oncology drug development."

Galapagos' service division, BioFocus, has entered into a three-year collaboration with Roche. Under the terms of the agreement, BioFocus will supply Roche with exclusive chemical compound libraries. Financial terms were not disclosed.

BioFocus will synthesize novel chemical compound libraries based on Roche's framework structures and provide these collections on an exclusive basis to Roche. These libraries will be generated using a combination of BioFocus' molecular informatics tools and a wide range of synthetic chemistry capabilities. BioFocus designs and synthesizes both exclusive as well as non-exclusive (SoftFocus) chemical compound libraries that can be used in drug discovery programs, including hit finding, lead optimization and patent exemplification.

"We are very pleased with this new agreement to deliver exclusive compound libraries to complement Roche's drug discovery programs," said Onno van de Stolpe, chief executive officer of Galapagos. "With a strong set of design tools and world-class synthetic chemistry capabilities, BioFocus continues to secure new business by providing high-quality libraries to the pharmaceutical and biotech industries."

SGX Pharmaceuticals, Inc. has entered into a license and collaboration agreement with Novartis focused on the development and commercialization of BCR-ABL inhibitors for the treatment of drug resistant Chronic Myelogenous Leukemia (CML). Under the terms of the agreement, SGX will receive from Novartis $25 million in upfront payments and the purchase of SGX common stock. Along with success-based milestones, but excluding royalties, total payments to SGX could exceed $515 million, including a minimum of two years of research funding.

"Novartis is the leader in developing novel targeted therapies to treat CML," said Mike Grey, president and chief executive officer of SGX Pharmaceuticals. "With their extensive experience developing and commercializing Gleevec as well as development of the novel investigational compound, nilotinib/AMN107, we believe they are the ideal partner with whom to develop our series of next-generation BCR-ABL inhibitors. This is a tremendous validation of our FAST technology for generation of novel lead molecules for key therapeutic targets."

SGX will be responsible for completing preclinical development of the lead candidate and submitting an IND application with the FDA. SGX will also be responsible for the completion of an initial Phase I study. Novartis will then be responsible for conducting further clinical development and commercialization of the compound.

BioBalance Corp., a wholly owned subsidiary of New York Health Care, has received approval from the FDA to begin U.S. trials of its proprietary biotherapeutic agent, Probactrix, a prescription drug for pouchitis. Pouchitis is a debilitating complication that can develop following corrective surgical treatment of ulcerative colitis, in which a pouch is constructed to enable normal bowel movements after removal of the diseased colon. This pouch can become inflamed, leading to debilitating gastrointestinal symptoms. Currently, there are no approved treatments for pouchitis. Current management involves short-term and occasionally chronic treatment with antibiotics.

The Phase I/II, randomized, placebo-controlled, multi-center study will be conducted in approximately 63 antibiotic-dependent pouchitis patients to demonstrate the ability of a prescription formulation of Probactrix to maintain symptomatic response of pouchitis symptoms after antibiotic withdrawal.

Probactrix is a single strain of non-pathogenic E.coli M-17 that was originally isolated from the intestinal microflora of a healthy volunteer. One mechanism of action is believed to work by selective displacement of pathogenic bacteria in the digestive tract and preventing their re-colonization, restoring a healthy balance of intestinal flora without the potential negative consequences of antibiotic use.

Amgen has received approval from the FDA for extended, every-three-week, dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration.

The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks in addition to the recommended starting dose of 2.25 mcg/kg once weekly. The new dosing recommendations are based on a randomized, double-blind, Phase III study that evaluated the safety and effectiveness of every-three-week administration of Aranesp.

Inex Pharmaceuticals has signed an exclusive research collaboration agreement with Alnylam Pharmaceuticals to evaluate use of Alnylam's RNAi therapeutics with Inex's systemic liposomal delivery technology. The collaboration will evaluate multiple targets including apolipoprotein B (apoB), a protein involved in cholesterol metabolism. The agreement will build on preliminary data published by Alnylam and Nature magazine, showing that the systemic delivery of an apoB RNAi therapeutic significantly reduced blood cholesterol levels.

Under the terms of the agreement, Alnylam has the option to execute a global exclusive license for specific RNAi therapeutic targets. The license agreement would include upfront license fees, future milestone payments and royalties as the products are commercialized. Alnylam also has the right to expand the option to negotiate license terms for additional targets. The exercise of the license option is dependent on the successful completion of the research collaboration and the completion of Inex's spinout of its Targeted Immunotherapy technology into Tekmira Pharmaceuticals Corp. Tekmira would provide the required personnel and funding to support the research collaboration and license agreement.

QSV Biologics, Ltd. has signed a contract with biomedical company, Tissue Therapies, Ltd., for the process development and cGMP manufacture of clinical quantities of some of the therapeutic protein components of the VitroGro platform for the accelerated healing of burns. These are some of the essential components of the VitroGro, formulation that Tissue Therapies will use in a clinical trial later this year. Tissue Therapies is an Australian company developing biomedical technologies for wound healing, tissue regeneration and various cell culture applications.

Under the agreement, QSV will be responsible for technology transfer, process development, scaling-up and cGMP production in QSV's manufacturing facility in Edmonton, Alberta. Terms of the final contract have not been disclosed.

Dr. Graeme Macaloney, QSV founder and chief executive officer, said, "We are extremely pleased to be selected by Tissue Therapies to be their GMP manufacturer of choice for these components. The Tissue Therapies' management and technical team represent a top-notch international organization developing a valuable therapeutic breakthrough for the treatment of burns and related conditions. Working with an Australian-based biopharmaceutical company represents a milestone for QSV in extending our global presence and underscores the benefit of the Health Canada Mutual Recognition Agreement with Australia and other jurisdictions like the EU."

Dr. Steven Mercer, Tissue Therapies' chief executive officer, said, "We are very happy to have established a commercial relationship with QSV for the supply of essential GMP components for our VitroGro products. This agreement was the result of a careful international assessment of potential suppliers, with selection criteria including cGMP, technical and scientific experience, quality of production facilities and international health regulatory expertise. QSV impressed us in all these areas, particularly with their professionalism and scientific and regulatory expertise. We look forward to a long term, mutually beneficial relationship."

Bayer has bid approximately $20 billion to acquire Schering AG. Schering, based in Berlin, is recommending the offer to its shareholders, according to a company statement. Schering also recently received an offer of $17.9 billion by Merck KGaA, which that company does not plan to increase.

Currently, Bayer's largest business is producing polyurethane, polycarbonates and other manufacturing materials, which accounted for about $13 billion in sales last year. Schering is a leader in oral contraceptives and also specializes in cancer drugs, while Bayer has recently focused its research on cancer and cardiovascular drugs.

"We have for some time believed that Schering was the ideal partner for moving into specialty pharmaceuticals," Arthur Higgins, the chief executive of Bayer's health care division. "We have two excellent German companies coming together."

The chairman of Schering, Hubertus Erlen, said, "Both business are complementary and follow the same strategy. Together they will be even more competitive."

According to a Bayer company statement, the merger could result in about 6,000 jobs being eliminated, or 10% of the combined work force. The company, based in the Rhine River town of Leverkusen, estimates it will save $837 million annually from the merger by 2009. Among the areas in which a Bayer-Schering combination would be valuable, according to Mr. Higgins, was in the marketing of cancer drugs. Bayer recently introduced a kidney cancer drug in Britain, and expects to receive approval to sell it in the U.S. later this year. Schering has an established sales force for its portfolio of cancer drugs, which Bayer could utilize.

Baxter International, Inc. plans to invest approximately $60 million during the next five years to expand production capacity at its four manufacturing facilities in China to support sales growth in the company's Medication Delivery and Renal businesses.

"This investment symbolizes Baxter's strong commitment to meeting local needs for critical products and advancing healthcare in China and across the Asia Pacific region," said Peter J. Arduini, president of Baxter's medication delivery business. "It also underscores the importance of this key market in Baxter's continuing geographic expansion and growth."

Baxter provides hospitals throughout China with a range of intravenous solutions and specialty products that are used in combination for fluid replenishment, general anesthesia, nutrition therapy, pain management, antibiotic therapy and chemotherapy. The company also serves a growing population of patients within the country with products and services to treat end-stage kidney disease.

GlaxoSmithKline has begun distributing a medicine tagged with radio frequency identification (RFID) technology as part of a pilot project to help protect patient safety. The tags will be placed on all bottles of Trizivir, an HIV medicine, distributed in the U.S. When scanned at close range, the tags will help verify that the medicine bottle contains authentic Trizivir. This drug was selected for the project because it has been listed by the National Association of Boards of Pharmacy as one of 32 drugs most susceptible to counterfeiting and diversion.

"This is one more step toward safeguarding Americans' supply of medicine," said Mark Shaefer, vice president of the HIV and Infectious Disease Medicine Development Center at GSK. "The hope is that RFID tags can tighten the supply chain even further to help assure patients that the medicine they buy is indeed the medicine their doctor has prescribed."

The FDA has asked the pharmaceutical industry to develop standards and pilot processes for RFID that may lead in the next few years to broad adoption and use of the technology.

RFID uses a tiny silicon chip and antenna about the size of a postage stamp that is attached to each bottle of medicine. The chip stores a unique product code that reflects information about the drug's manufacturing and shipping history. The product code can be read by pharmaceutical wholesalers and pharmacists using a hand-held or stationary electronic device that is placed within 2-18 inches of the tag. The tag can be read by wholesalers when it is received from the manufacturer and when it is shipped to pharmacies, who would then record when they have received the medicine. This allows manufacturers to more precisely account for medicine as it moves through the distribution chain and to authenticate medicine at the point of dispensing.

The company noted that the technology does not collect any patient information. The RFID tag contains information about the product only, not the patient. GSK will not collect any personally identifiable information about patients through this technology.

RFID-tagged bottles of Trizivir will begin appearing on pharmacists' shelves in mid April.

Carol G. Gallagher, Pharm. D., has been named vice president, commercial affairs, at Anadys Pharmaceuticals. Dr. Gallagher will be responsible for commercial affairs, including business development, market planning and strategic planning. "We are very pleased that Carol is joining Anadys," said Kleanthis G. Xanthopoulos, Ph.D., Anadys' president and chief executive officer. "Her leadership and experience in managing many therapeutic agents with multiple partners on a worldwide basis will be critical to Anadys as we build the foundation of our commercialization strategy."

Prior to joining Anadys, Dr. Gallagher was the vice president, sales, marketing and product planning at CancerVax Corp. Previously, she was senior director of oncology marketing at Biogen Idec. During that time, her role included leadership of the Rituxan collaboration with Genentech. She also worked as director, global marketing planning for oncology and ophthalmology at Pfizer, and held other marketing positions, including product and new product management roles, at Agouron Pharmaceuticals, Lilly and Amgen.

Charles River Laboratories International, Inc. has signed a licensing agreement with Washington University, in which Charles River will utilize WU's novel murine norovirus and culture system. Murine norovirus (MNV) was discovered to be a non-enveloped RNA virus which has the potential to infect laboratory mice. To protect the integrity of research animals, a reliable testing method is desired to rule out the possibility of murine infection by this pathogen. Utilizing Washington University's culture system technology, Charles River's Research Animal Diagnostic Services division has expanded its comprehensive portfolio of assays for screening of mouse samples by creating assays to detect MNV.

William Barbo, CRL's corporate vice president, Research Model Services, said, "Charles River is pleased to join Washington University in this licensing agreement. Utilizing the innovative MNV technology developed in the laboratories of Dr. Skip Virgin at the university, Charles River will continue to be in the forefront of laboratory animal diagnostic testing."

HollisterStier Laboratories has announced plans for a $30 million facility expansion. The company will add a second high speed filling line that can handle 2-100mL vials and fill approximately 400 vials per minute, doubling its current laboratory space, while adding an office complex. The clean room complex includes aseptic compounding areas, a new component preparation area, and an aseptic storage area. HollisterStier also projects increasing personnel by approximately 40% during the next three years.

"The new filling line and expanded lab space enhances our ability to meet the unique needs of our customers. With the expansion, we will also increase our various customer support teams," stated Anthony Bonanzino, Ph.D., president & chief executive officer.

HollisterStier is doubling its laboratory space for the Quality Assurance and Quality Control departments. "QA is one of the most vital components to our organization. The new construction allows for critically needed lab bench space and new instrumentation," he said.

The project increases the Spokane, Washington facility to a total of 185,000 sq. ft. Construction on the laboratories and office building begins in the fall of 2006 with completion expected in May of 2007. The construction for the filling line begins in Q42006, with commercial production commencing in Q42008.

Merck and NicOx S.A. have signed an agreement to collaborate on the development of new antihypertensive drugs using NicOx's proprietary nitric oxide-donating technology.  This agreement follows the successful completion of the companies' research collaboration, which has generated promising results.

Under the terms of the agreement, NicOx will receive an upfront payment of $11.2 million and is eligible for potential further milestone payments of $340.2 million. NicOx has the option to co-promote on a fee-for-detail basis products that result from the agreement to specialist physicians, such as cardiologists, in the U.S. and certain major European countries.  In addition, Merck will pay NicOx industry standard royalties on the sales of all products resulting from the collaboration.

The agreement covers nitric oxide-donating derivatives of several major classes of antihypertensive agents for the treatment of high blood pressure, complications of hypertension, and other cardiovascular and related disorders.  Merck has the exclusive right to develop and commercialize antihypertensives that use NicOx's nitric oxide-donating technology for the treatment of systemic hypertension.

NicOx will continue to be involved in the new research program, which will be focused on identifying lead candidates for development, while Merck will fund and manage all further preclinical and clinical development activities following selection of lead compounds.

"We are very pleased to be entering into this new collaboration with NicOx, which aims to address one of the world's leading health problems," said Anthony Ford-Hutchinson, Ph.D, executive vice president, research medicine, Merck Research Laboratories.  "We believe NicOx's innovative NO-donating technology has the potential to lead to the development of new and improved antihypertensive medicines.  With this new agreement, we are building on our excellent existing relationship with NicOx to combine NicOx's research skills with Merck's industry-leading development and marketing capabilities in this area, with our joint goal of advancing patient care."

Dr. Jeffrey Leiden will step down as president and chief operating officer of Abbott's pharmaceutical products group to pursue other career interests. Richard Gonzalez, currently president and chief operating officer of medical products, will assume the role of president and COO for all operations of the corporation, effective March 27.

Aptuit, Inc. has named Stuart E. Needleman senior director, API Development. Mr. Needleman brings more than 20 years experience in the global development, scale-up, and manufacture of regulated API for new and established compounds. He has been involved in projects for both small and large pharmaceutical companies, successfully matching API supply from discovery to post-launch commercial quantities. Mr. Needleman will lead the company's charge to bring capabilities in API development to its customers and will focus on identifying acquisition opportunities at the API kilo laboratory and pilot plant scale.

Mr. Needleman has worked for Cambrex; Oxford Asymmetry, where he created a significant North American presence; ChiRex Inc. as vice president business development; Rhodia Pharma Solutions as general manager development operations and most recently as president, North America for Arch Pharmalabs with headquarters and manufacturing operations in India.

Schering-Plough Corp. has named Rodney Freeman vice president, global supply chain management. In this new role, Mr. Freeman will be responsible for planning, customer service, distribution and logistics for the company's global pharmaceutical business and Consumer Health Care division. He is based in Kenilworth, NJ and reports to Dr. Ian McInnes, senior vice president, global supply chain.

Mr. Freeman was most recently executive director, global supply chain planning, providing strategic direction for all global supply chain planning activities. Freeman joined the company in 1991 as a management associate and has held positions of increasing responsibility in manufacturing, global marketing and global supply chain management.

Eli Lilly and Co. and Biosite, Inc. have signed an agreement to collaborate on a clinical trial employing a therapy strategy for Lilly's severe sepsis drug, Xigris. The trial, RESPOND (Research Evaluating Serial Protein C levels in severe sepsis patients ON Drotrecogin alfa), will investigate the use of a multipurpose biomarker, Protein C, to be used in connection with the administration of Xigris.

Under the terms of the agreement, Biosite will develop a rapid, point-of-care diagnostic capable of measuring Protein C levels. Lilly will use the Biosite test, as well as other existing FDA approved Protein C tests, to enroll patients in its upcoming Phase IIb trial, which is expected to begin in the fourth quarter of this year. Investigators also will use the tests to help with individualized dose and duration of Xigris therapy and to evaluate patient response. The agreement also grants Biosite rights to intellectual property in the field of sepsis diagnosis. Financial terms of the agreement were not disclosed.

Laureate Pharma, Inc. has entered into a biopharmaceutical development and manufacturing agreement with Bradmer Pharmaceuticals, Inc. for process development and cGMP manufacture of the monoclonal antibody precursor of Neuradiab, Bradmer's candidate for treatment of brain cancer. The project is well underway and Laureate expects to supply Bradmer with product by the end of this year. Terms of the agreement were not disclosed.

"We are excited to apply our experience and expertise in monoclonal antibody development and production to Bradmer's important new clinical candidate for patients that suffer from brain cancer," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate Pharma. "Our relationship with the management of Bradmer and its potential new cancer therapy meets our strategic objective of working with innovative partners and products."

"Neuradiab has been evaluated in multiple Phase I and Phase II trials conducted by Duke University for the treatment of GBM. More than 160 patients have safely received Neuradiab treatment and the results have clearly demonstrated the important clinical benefit of this product," said Mark C. Rogers, M.D., chief executive officer of Bradmer. "Our partnership with Laureate Pharma is a crucial step in our manufacturing strategy and our plans to initiate a multi-center clinical trial over the next year."

Neuradiab is a monoclonal antibody used to treat glioblastoma multiforme (GBM), the most common and deadly form of brain cancer. In a recent Phase II trial of newly diagnosed GBM patients, Neuradiab used in combination with the current standard therapy, extended median survival by 42% to 91 weeks compared with 64 weeks for a historical control group. Bradmer intends to initiate a multi-center clinical trial at U.S. GBM treatment sites across the country late this year or early in the first quarter of 2007.

Sanofi-Aventis has signed an agreement with Roche concerning the production of shikimic acid by fermentation for Roche's Tamiflu supply chain. Shikimic acid is the key raw material for the manufacture of Tamiflu's active ingredient (oseltamivir). Under the terms of the agreement, Sanofi-Aventis will supply Roche exclusively with the shikimic acid obtained. The shikimic acid will be produced in the Saint-Aubin-les-Elbeuf plant in France. This site, covering 18 hectares, has a fermentation capacity of 4000 m(3), and employs 270 staff.

Schering-Plough Corp. has appointed Gregory J. Szpunar, R.PH., Ph.D., group vice president, global project management, Schering-Plough Research Institute (SPRI). In this role, Dr. Szpunar is responsible for executing and managing a global project management function for the company's product development and commercialization process. He is based in Kenilworth and reports to Thomas Koestler, Ph.D., executive vice president, global development, SPRI.

Dr. Szpunar joined the company from Biovail Corp., where he served as chief scientific officer and senior vice president for R&D and manufacturing. Prior to that, he was senior vice president, product development, at Pharmacia Corp.

Kendle has entered into agreements to acquire Latin America CRO, International Clinical Research Ltd. and related companies, adding to its global clinical development capabilities in the Phase II-IV arena through new operations in Argentina, Brazil, Colombia and Chile. The move supports the company's strategic business expansion in high-growth regions to deliver global trials for its biopharmaceutical customers, and builds on existing capabilities in Mexico and Peru. The acquisition is the culmination of an ongoing relationship between Kendle and International Clinical Research, in which the two companies have worked together in recent years on drug development programs in Latin America.

"We are thrilled to be able to offer our customers the benefit of expanded reach and expertise in Latin America for their global clinical trials," said Candace Kendle, Pharm.D., chairman and chief executive officer. "This acquisition builds on our thriving operations in the region and positions Kendle to drive future growth in our global clinical development business."

Financial terms of the agreement were not disclosed. The transaction is expected to be complete in the second quarter. The acquired operations will operate under the Kendle name and will report to Dennis Hurley, Dr.Sc., vice president, global clinical development, Latin America.

International Clinical Research Ltd. was founded in 2002 by Raul Bozzo, M.D., and has approximately 25 clinical associates offering CRO and biopharma industry experience in Phase II-IV development, with significant therapeutic strengths in cardiovascular, oncology, central nervous system, endocrinology, infectious disease and pain/inflammation. Upon completion of the acquisition, Dr. Bozzo will assume the role of medical director, Latin America and country manager for Argentina and Chile. Mariagabriela Alterio, M.S., and Alcione Braga will serve as country managers for the new operations in Colombia and Brazil, respectively.

"We are excited to join Kendle," said Dr. Bozzo, "We believe this merger will provide great benefit to our customers, to our associates, and to the development of clinical research in Latin America. Joining a global organization opens a world of opportunity for us. Kendle's reach will bring a wider variety of trials to the region, and our highly specialized staff and country-specific expertise will add value to Kendle's Latin America operations."

Evotec has achieved the second milestone in its research collaboration with Boehringer Ingelheim. Under the terms of the drug discovery contract, Evotec will receive a milestone payment from Boehringer for the identification of a number of lead series for a priority receptor target. Further projects within the collaboration are progressing and are on track to achieve additional project milestones for which Evotec is entitled to additional payments. The contract also provides substantial long-term upside through potential payments for successful milestone achievements during clinical development and royalties when new drugs reach the market. Financial details were not disclosed.

Dr. Mark Ashton, executive vice president, business development services at Evotec, commented, "Cooperating with prestigious pharmaceutical companies such as Boehringer Ingelheim is central to Evotec's success. We are extremely proud that we have achieved our second milestone with Boehringer and that we have been able to rapidly advance hit compounds, discovered from screening this target at Evotec, to qualified lead series. This is an excellent validation of our research contribution and is even more pleasing as it comes right at the time that we have significantly extended and expanded our partnership."

Professor Mikael Dolsten, head of corporate division R&D, Boehringer Ingelheim, said, "We are very pleased with the rapid progress achieved in the collaboration. The basis for this second milestone achievement was both the strong interdisciplinary project work as well as the good team spirit between the Boehringer Ingelheim and Evotec scientists. We are looking forward to further progress with the two advanced projects and to further exciting research activities."

Crucell N.V. and allied contract manufacturer DSM Biologics have signed a PER.C6 research license agreement with Japanese pharmaceutical company UMN Pharma. This license agreement allows UMN Pharma to use the PER.C6 cell line in its UMN-03 project, which aims to employ a fusion protein in the treatment of muscular dystrophy and metabolic diseases such as obesity and type II diabetes mellitus. Also, the two companies will provide UMN Pharma with various services including vector construction, clone generation, process development and cGMP manufacturing, through its own facilities in Groningen, The Netherlands and within the PER.C6 vendor network.

Under the terms of the agreement, UMN Pharma will pay a signing fee and annual maintenance fees. The additional services will also attract fees. Further financial details were not disclosed.

TCP Reliable and Alternatives Technology Pharma (ATP) have signed multi-year commercial agreements for the temperature controlled packaging and cold chain market in North America. Under this agreement, TCP will be the exclusive reseller and distributor of ATP’s cold chain services and monitoring solutions for the U.S. market. TCP acquires the rights for commercializing ATP’s computerized solutions: ATP-ThermoProfile, ATP-Sentinel, ATP-Mirador and ATP-DOCOS, all solutions being specially developed for the pharmaceutical and life sciences industry and fulfilling the regulations of the U.S., Canada and Europe.

Also, ATP will be the exclusive sales agent of TCP’s temperature controlled packaging solutions in Canada. The two companies also agree to install in Laval, Quebec, a joint-ventured laboratory for all design and testing activities related to temperature controlled and cold chain packaging in Canada. The pharmaceutical and life sciences market in North America, including pharmaceutical developers, importers, manufacturers, wholesalers, transporters and retailers, will be the primary target of ATP and TCP companies.

Maurice Barakat, president and chief executive officer of TCP Reliable said, “Our pharmaceutical customers will have easy access to the tools required to help them control their supply chain processes and to implement temperature controlled packaging solutions best suited to their needs.”

Jean Bedard, vice president and chief executive officer of ATP said, “With TCP as a strategic partner, we are proud to propose to the North American Life Sciences industry a complete and integrated cold chain package going from the cold chain compliance services through environmental conditions monitoring solutions, to the cold chain packaging and supplies. Together, ATP and TCP will provide a more complete cold chain expertise to fulfill the needs of the North American Life Sciences industry.”

Millennium Pharmaceuticals, Inc. will receive a $10 million payment from Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) based on sales milestones reached for Velcade for Injection in territories outside the U.S.

"This milestone payment reflects the continued worldwide growth of Velcade, a market-leader in relapsed, refractory multiple myeloma, with more than 33,000 patients treated globally," said Marsha Fanucci, chief financial officer and senior vice president at Millennium. "We believe Velcade represents a more than $1 billion peak worldwide opportunity and, together with J&JPRD, we continue to pursue clinical development to realize the potential of Velcade."

In June 2003, Millennium entered into an agreement with Ortho Biotech Products, L.P. and its research affiliate, J&JPRD, to collaborate on the commercialization and continued clinical development of Velcade. Under the terms of the agreement, Ortho Biotech and its affiliate, Janssen-Cilag, commercialize Velcade outside of the U.S. and Millennium receives royalties on sales outside the U.S. In addition, Millennium may receive payments for achieving clinical, development and regulatory approvals and sales milestones outside of the U.S.

Centocor, Inc. and Schering-Plough Corp. have been granted approval from the European Commission for Remicade for the treatment of moderate to severe, active ulcerative colitis (UC) in patients who have had an inadequate response to conventional therapy or who are intolerant to such therapies. The approval makes Remicade the first biologic therapy approved to treat active UC in the EU and also marks the eighth indication Remicade has received in the EU for the treatment of immune-mediated inflammatory disorders.

The approval of Remicade for UC is based on data from the ACT 1 and ACT 2 (Active Ulcerative Colitis Trial) clinical trials. ACT 1 and ACT 2 were multicenter, Phase III, randomized, double-blind, placebo-controlled, trials conducted to evaluate the safety and efficacy of Remicade for the treatment of adult patients with moderately to severely active UC who experienced an inadequate response to conventional therapy.

PDL BioPharma, Inc. has named Andrew Guggenhime senior vice president and chief financial officer. Mr. Guggenhime will join the company's senior management team reporting directly to chief executive officer Mark McDade, and will be responsible for all financial and information technology operations of the company.

Mr. Guggenhime joins the company from Neoforma, Inc. where he had been chief financial officer since October 2000. In this role, he was responsible for the accounting, finance, financial planning and analysis, investor relations, legal and facilities departments. He was previously vice president of corporate development, managing Neoforma's corporate development, business development, international and strategic efforts. Prior to joining Neoforma, he was a vice president in the Healthcare Investment Banking group of Merrill Lynch & Co., where he specialized in working with healthcare services firms and healthcare Internet companies on a variety of transactions, including mergers and acquisitions, initial public offerings, add-on equity offerings and debt offerings. Previously, he worked at Wells Fargo & Company in a number of capacities.

The Science Center, a leading venture ecosystems for life sciences and biotechnology companies, has partnered with Aqumen Biopharmaceuticals, KK of Fukuoka, Japan to open a U.S. base for the company's operations. The partnership is part of a broader Science Center strategy to help ease the transition for international companies in the U.S. by offering services and management support to accelerate commercialization of innovations.

"This is a win-win for the economies of Japan and the U.S.," said Pradip Banerjee, Science Center president and chief executive officer. "The North American market makes up 70% of the world pharmaceutical market, so companies that operate in the U.S. in their early stages stand to succeed sooner. The Science Center has created a new Global Operating Model for early stage companies to gain worldwide exposure and reach utilizing the Science Center's unique approach to "Powering Commercialization."

"We decided to locate Aqumen's U.S. operations at the Science Center because of its unique strategy and strong management team," said Hardy Kagimoto, MD, Aqumen chief executive officer. "Our strong research base in Japan together with the Science Center's 'soft landing' strategy opens a broader market for Aqumen's innovations." The company is a Kyushu University-launched venture company developing medicines and surgical tools for the treatment of age-related macular degeneration and other ophthalmic disease and diagnostic applications.

Science Center will provide management resources, laboratory space, administrative support, and regulatory guidance. Science Center chief scientific officer Dr. Mitchell Glass is serving as interim chief executive officer of Aqumen's U.S. subsidiary and Dr. Banerjee sits on Aqumen's board of directors.

Bristol-Myers Squibb Co. has plans to build its new biologics facility in the U.S. The company's board of directors approved a capital expenditure in the amount of $660 million for the construction of a large-scale multi-product bulk biologics manufacturing facility. The facility will be modular in design in order to accommodate future expansion.

Schering-Plough Corp. is focusing on key regions and countries through a number of strategic actions in the company's Global Pharmaceutical Business. The changes are part of the company's six- to eight-year Action Agenda to transform itself into a global high performance competitor for the long-term. These changes come as the company works to deliver the 12- to 18-month Turnaround Phase that began in October 2005.

Schering-Plough has restructured its Europe-based regional organization (EUCAN) into two separate areas to increase its focus on the marketplaces of Europe, Central and Eastern Europe, Canada, the Middle East and Africa. Also, the former Latin America/Far East Region has been divided into two separate organizations as Latin America and the renamed Asia-Pacific Region.

"These changes allow us to focus even more effectively on the needs of our customers in different markets, to better manage and drive growth and to build a competitive edge through innovation, speed and flexibility," said Fred Hassan, chairman and chief executive officer, Schering-Plough.

Apet Iskenderian continues in his current position as president, EUCAN Region, for the Global Pharmaceutical Business, encompassing the two new EUCAN Regions I and II. He will continue to be based in the UK and is a member of the company's Operations Management Team (OMT). Mr. Iskenderian reports to Carrie Cox, executive vice president, Schering-Plough, and president, Global Pharmaceutical Business.

Francesco Granata, M.D., has been appointed group vice president, EUCAN Region I. This region covers Canada, Denmark, Finland, France, Germany, Ireland, Italy, Norway, Spain, Sweden and the UK. Dr. Granata joined the company from Pfizer, Inc., where he served as president, Africa and Middle East Region from April 2003, and since January 2004 as president, Northern Europe Region, responsible for the Nordic and Benelux countries. He also served in positions of increasing responsibility with Dow Chemical, Glaxo and Dompe Biotec, before joining Pharmacia and Upjohn as managing director and president of its marketing company in Italy.

Bruno Strigini, Pharm.D., has been appointed group vice president, EUCAN Region II encompassing Austria, Belgium, Greece, the Netherlands, Portugal, Switzerland, as well as Central and Eastern Europe and Middle East and Africa. Dr. Strigini joined the company from UCB-CellTech in Brussels, where he served as president, international operations. Prior to that he was in charge of the UCB Japan/Asia-Pacific Region, and head of global marketing, business development and strategy. He also held positions of increasing responsibility with SmithKline Beecham in the UK and New Zealand, and the Fournier Group in Europe.

Gilles Picard has been appointed vice president and general manager for Schering-Plough France, reporting to Dr. Granata. Most recently, Mr. Picard was vice president of the company's country operations in Austria, Belgium, Denmark, Finland, Greece, the Netherlands, Norway, Portugal, Sweden and Switzerland. He joined the company in 1993 as business unit director in France for Animal Health, and has held positions of increasing responsibility in marketing and general management in the U.S. and Europe.

Pierre Verstraete has been appointed group vice president and president, Latin America Region. Formerly senior vice president and general manager for Schering-Plough France, Mr. Verstraete has served as vice president and general manager for Spain and was vice president of marketing in the U.S. He began his career in the pharmaceutical industry in Latin America with Ciba-Geigy in Bogota, Colombia, joining Schering-Plough in 1986 as general manager for Venezuela then Mexico as general manager in 1988. He is based in Kenilworth and is a member of the OMT, reporting directly to Ms. Cox.

Alfredo M. Blanco, former president of the Latin America and Far East Regions, retired at the end of 2005 following a 13-year career with the company and a 50-year career in the pharmaceutical industry. While at Schering-Plough, Mr. Blanco dramatically grew the pharmaceutical business across many countries and continents, serving as a key member of the team helping to build the company internationally.

Rodney W. Unsworth has been appointed group vice president and president for the Asia-Pacific Region (excluding Japan), formerly called the Far East Region. Based in Sydney, Australia, Mr. Unsworth remains a member of the OMT. Previously, he was actively involved in assisting medical research-based companies in Australia to commercialize innovation. Prior to these activities, he served as regional president, Asia-Pacific for Pharmacia Corp. He reports directly to Ms. Cox.

Schering-Plough's country operation in Japan continues under the leadership of Masao Torii, president, who is based in Osaka and Tokyo. Mr. Torii, who continues to report to Ms. Cox, joins the OMT. Tony Alvarez, vice president, commercial operations, for the company in Japan, reports to Mr. Torii. In this role, Mr. Alvarez will be responsible for commercial activities supporting the global pharmaceutical business in Japan, where he will be based.

Biovail Corp. has made changes to its business infrastructure, reorganizing itself into three distinct business units: Biovail Drug Delivery (BDD), which comprises Biovail's drug-delivery technologies, its drug-development capabilities and its strategic partnerships; Biovail Pharmaceuticals U.S. (BPUS), which focuses on the promotion of products to specialists in niche therapeutic markets; and Biovail Pharmaceuticals Canada (BPC), which promotes products to both to specialist and primary-care physicians in Canada.

"The constantly changing dynamics of the global pharmaceutical marketplace have made it necessary for Biovail to further refine the organizational infrastructure that supports its business," said Dr. Douglas Squires, chief executive officer of Biovail. "The changes that we've announced will further enable Biovail's Business Units to facilitate our mission and key core competency—to apply advanced drug-delivery technologies to improve the clinical effectiveness of medicines."

The company has also made changes to its executive management team. Greg Gubitz, formerly chief operating officer at MDS Capital Corp., has been named senior vice president, Crystaal Pharmaceuticals. Mr. Gubitz will assume a leadership role in the proposed spin-off.

Dr. Gregory Szpunar, senior vice president, R&D and chief scientific officer, will leave Biovail to pursue a senior position with a large pharmaceutical company. The company expects to name his successor shortly.

Douglas L. Ludwig has been named chief financial officer and executive vice president of Patheon. Mr. Ludwig replaces Rodger Roden who has left the company to pursue other interests.

Mr. Ludwig is an accountant with more than 25 years of finance experience. Most recently, he served as chief financial officer and executive vice president of Four Seasons Hotels, Inc. Mr. Ludwig's 22-year career with Four Seasons covered many key positions within the corporate finance organization. Previously, he worked with KPMG for seven years. In his new position, Mr. Ludwig will report to chief executive officer Robert Tedford.

Tibotec Pharmaceuticals Ltd.'s NDA for TMC114, an investigational HIV protease inhibitor, has been accepted for priority review by the FDA. The goal date for the NDA will be June 23, 2006.

The NDA is based on the efficacy and safety results of the 24-week analysis of two randomized, controlled studies, POWER 1 and POWER 2, and supportive open label safety data from POWER 3. Phase III trials of TMC114, boosted with low-dose ritonavir, are currently ongoing in both treatment-experienced and treatment-naive HIV-1 infected patients. TMC114 is available through an expanded access program (EAP) in the U.S. for people living with HIV who need the compound to construct a viable treatment regimen and who are not eligible for other Tibotec clinical trials.

Pending U.S. regulatory approval, Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will commercialize the product in the U.S. The trade name for the marketed product has not yet been determined.

Novavax, Inc. and Bharat Biotech International Ltd. (BBIL) have entered a strategic alliance to pursue the rapid development of pandemic influenza vaccine for India and certain other south Asian markets. Under the terms of the agreement, BBIL will fund all preclinical and clinical studies for these markets and assist in developing an efficient manufacturing process for the Virus-Like Particle (VLP) based influenza vaccine. BBIL will be responsible for the sale and distribution of the vaccine in India and other surrounding countries. Novavax will receive unrestricted access to all preclinical and clinical data generated by BBIL and will receive royalties on all future sales located within BBIL's geographic territories. Novavax's VLP vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease. This is the first time that VLP technology has been applied to create an influenza virus vaccine. The technology is a particularly good fit for addressing pandemic flu because it does not rely on the supply of embryonated eggs for the production of the vaccine, according to the company. Novavax has recently adopted a manufacturing process that reduces contamination risk and produces high, cost-effective yields of the influenza VLP vaccine. This technology can also be used to rapidly create vaccines against emerging threats or new strains of existing pathogens.

Commenting on the agreement, Dr. M.K. Bhan, secretary, Department of Biotechnology, Government of India said, "This is a very positive development. In the spirit of combining global expertise to collectively combat the threat posed by the rapidly spreading avian influenza virus, the department of biotechnology and the Government of India stand ready to provide all enabling support to ensure the success of this partnership between Novavax and BBIL".

Dr. Rahul Singhvi, president and chief executive officer of Novavax said, "We are delighted that BBIL has chosen Novavax's VLP and Novasome adjuvant technologies to develop, produce, and distribute a vaccine against H5N1 and other strains of avian influenza for the Indian population. BBIL has established itself as a leader in adopting innovative vaccine technologies as evidenced by their collaborations with Wyeth and Acambis. We believe that by leveraging the clinical, process and manufacturing capabilities of BBIL, we will be able to expedite the development and regulatory approval of our VLP-based pandemic influenza vaccines around the world".

Millennium Pharmaceuticals and co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) have initiated a three-arm, randomized, Phase II study of Velcade and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior chemotherapy treatment. The study will assess the potential benefits of combining the activity of two targeted therapies with different mechanisms of action. Also underway is a two-arm, randomized, Phase II study of Velcade in combination with erlotinib for patients with locally advanced or metastatic NSCLC and a study of single-agent Velcade in relapsed bronchioalveolar carcinoma and adenocarcinoma of the lung. In newly diagnosed patients with NSCLC, a study to evaluate Velcade in combination with other agents has recently been completed.

The Phase II randomized, open-label, multi-center study will enroll approximately 135 patients. The primary endpoint is objective response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Secondary endpoints of the study include disease control rates, time to progression, progression-free survival and safety. Patients will be assigned to one of three treatment groups: Velcade in combination with pemetrexed, pemetrexed alone or Velcade alone.

Diosynth Biotechnology has entered into a long-term commercial supply agreement with Dendreon Corp. for the manufacture of the recombinant antigen component of Provenge, Dendreon's investigational immunotherapy for prostate cancer. The product will be manufactured for market launch and commercial sale in the Diosynth Biotechnology facility in North Carolina. Subsequent manufacturing may also be done at Diosynth's large-scale cell culture facilities in the Netherlands.

This agreement reflects a continuing collaboration between the two companies beginning with the initial agreement for process development and scale-up through the more recent manufacture of conformance lots. "We value the ongoing confidence Dendreon has in Diosynth, entrusting us to provide commercial supply for Dendreon's leading product candidate," said Frank Tielens, president, Diosynth Biotechnology. "In addition to our industry-leading custom process development, analytical characterization and cGMP manufacturing of recombinant molecules, Diosynth contributes significant value through its expertise in scale-up and cGMP manufacturing with the Baculovirus expression system."

Provenge is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. Provenge is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer.

Celgene Corp.'s sNDA for Revlimid, for the treatment of relapsed or refractory multiple myeloma, has been granted a Priority Review designation by the FDA. The company is seeking approval to market Revlimid in combination with dexamethasone as a proposed indication for the treatment of multiple myeloma patients who have received at least one prior therapy. Priority Review is granted to products that, if approved, would be a significant improvement compared to existing marketed products or therapies in the treatment, diagnosis, or prevention of a disease.

The sNDA submission is based on the safety and efficacy results of two large randomized Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating Revlimid plus dexamethasone in multiple myeloma patients that have received at least one prior therapy. Based on a pre-specified interim analysis, both studies achieved the primary endpoint of time to disease progression (TTP) with combination therapy of lenalidomide and dexamethasone over that of placebo and dexamethasone.

Patheon

1Q Revenues: $157.9 million (+3%)

1Q Loss: $11.5 million (earnings were $6 million in 1Q2005)

Comments: Revenues from MOVA operations were $29.4 million for the quarter compared with $23.9 million. Revenues from other sites were $128.5 million compared with $130 million in 2005. Prescription manufacturing revenues and pharmaceutical development services (PDS) revenues both increased by 5%, offset by over-the-counter (OTC) revenues, which declined by 10%.

HollisterStier signed a contract with Roxro Pharma, Inc. to fill/finish Roxro’s first pain management candidate, ROX-888, through commercialization, under cGMP. The two companies are purchasing new and specialized equipment to accommodate the project. Roxro plans to file an NDA for ROX-888 with the FDA after completion of its Phase III trials.

“Our custom multidisciplinary team is excited to assist Roxro in further developing their unique drug product and delivery system,” stated Anthony Bonanzino, Ph.D., HollisterStier's president and chief executive officer. “This is further evidence of our commitment to providing excellent customer service and fulfilling specific contract manufacturing goals for each of our clients.”

ImClone Systems and Bristol-Myers Squibb received approval from the FDA for Erbitux for use in the treatment of squamous cell carcinoma of the head and neck. Designed to inhibit the function of the epidermal growth factor receptor (EGFR)—a molecular structure linked to tumor growth—Erbitux is the first and only monoclonal antibody to be approved for the treatment of head and neck cancer.

With this approval, Erbitux is now indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed. These indications are based on a Phase III study that demonstrated a survival and locoregional control advantage when Erbitux was added to radiation therapy, and a Phase II study, where Erbitux therapy alone reduced tumor size.

UCB has submitted a BLA to the FDA for the approval of Cimzia for the treatment of Crohn's disease. If approved, Cimzia would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease.

The BLA includes safety and efficacy data from clinical trials in more than 1,500 patients with Crohn's disease. The studies (PRECiSE 1 and PRECiSE 2) that support the BLA submission met their primary endpoints by demonstrating that Cimzia induced clinical response and maintained clinical response and remission in a significant percentage of patients with Crohn's disease. The Cimzia BLA package represents the largest biologic clinical trial database and broadest, in terms of patient types, submitted to the FDA for Crohn's disease treatment, according to UCB.

VGX Pharmaceuticals and Dowpharma contract manufacturing services, a business unit of The Dow Chemical Co., have signed an R&D Agreement to advance the development of VGX-100, VGX's novel cancer compound in preclinical development. Under the terms of the agreement, Dowpharma will perform a feasibility study for the expression of VGX-100 using its Pfenex Expression Technology. Pfenex Expression Technology accelerates speed to market for vaccines and biotherapeutics by improving quality, boosting yields of protein expression, and reducing the cost of existing microbial systems.

VGX Pharmaceuticals has discovered that specific viral proteins can induce selective apoptosis (programmed cell death) in rapidly dividing cancer cells without affecting normal cells. Preclinical studies have found that VGX-100 induces tumor death through apoptosis in a variety of established human tumor cells derived from the breast, prostate, brain, and other sources. The initial clinical studies will target individuals with Non-Hodgkin's Lymphoma. "This is an important relationship for us as we continue to develop VGX-100," said J. Joseph Kim, Ph.D., president and chief executive officer of VGX Pharmaceuticals. "The signing of the agreement came at the perfect time in the development cycle of this discovery. The feasibility studies will determine the extent to which we can expedite the production of our protein from the laboratory to production, so we can rapidly advance VGX-100 into the clinic."

"Pfenex Expression Technology is proven to improve protein production and consistently outperforms other microbial expression systems," said Nick Hyde, global business director, Dowpharma. "We look forward to working with VGX to increase protein yields and expedite the development of this promising compound."

Genentech and Biogen Idec received approval from the FDA for the therapeutic antibody Rituxan in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderate-to-severe rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B-cells. Through this unique mechanism of action, Rituxan may affect multiple pathways by which B-cells are believed to contribute to the initiation and development of RA.

The approval was based on data from three randomized, double blind, placebo-controlled studies of patients with active RA. Results of the Phase III trial, known as REFLEX, showed that a significantly greater proportion of patients who received a single treatment course of two infusions of Rituxan with a stable dose of MTX achieved American College of Rheumatology (ACR) 20, 50 and 70 response rates compared to patients who received placebo and MTX. At 24 weeks, patients receiving Rituxan displayed clinically and statistically significant improvements in RA signs and symptoms, including pain and disability. Rituxan was also shown to reduce biologic markers of inflammation.

Astellas Pharma has acquired Dynogen Pharmaceuticals NC-based research facility. The research facility specializes in state-of-the-art preclinical studies for genitourinary disorders. Financial details were not disclosed.

"We've built an impressive clinical and preclinical pipeline through our unique understanding of the neuroscience underlying gastrointestinal and genitourinary disorders, leveraging that knowledge to generate strong intellectual property and utilizing that intellectual property to enable an aggressive in-licensing program," said Lee R. Brettman, M.D., president and chief executive officer of Dynogen. "We've maximized the value of the North Carolina facility in this effort, and now will focus all of our efforts on advancing the development of our five clinical programs and our late-stage preclinical programs."

"Dynogen has built a facility with first-class capabilities for evaluating the clinical potential of urological development candidates especially in the area of lower urinary tract disorders. The acquisition of this research facility will strengthen our capabilities in this key area," said Isao Yanagisawa, Ph.D., senior corporate officer of Astellas Pharma.

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