Hans Peter Hasler has been named chief operating officer, Biogen Idec. Mr. Hasler has served as executive vice president, global neurology and head of International. In his new role, he will oversee all commercial operations as well as the company’s business development function.
   
“In view of the continued expansion of our commercial businesses, and the advances of our extensive pipeline, it is important to further integrate Biogen Idec’s commercial units,” said James C. Mullen, Biogen Idec’s chief executive officer. “Bringing together these businesses to enhance our commercial and new product opportunities on a global basis is a logical step in the continued implementation of our growth strategy -- and Hans Peter Hasler is the ideal person to fill this new organizational role. Over the last few years, Hans Peter has led the great success and growth of our business outside the U.S. I am confident that we will continue meeting and exceeding our goals under his strong and capable leadership.”
   
Mr. Hasler joined the company in 2001 from Wyeth Pharmaceuticals where he worked for eight years, serving since 1998 as senior vice president, head of Global Strategic Marketing. He was also a member of the Wyeth executive committee and chair of the Commercial Council. From 1993 to 1998, he served in senior management capacities, including managing director of Wyeth Group, Germany; general manager of Wyeth in Switzerland; and general manager of central Eastern Europe. Prior to joining Wyeth, Mr. Hasler held several positions at Abbott and Sanofi Pharma in Switzerland.

Bilcare Global Clinical Supplies has completed the expansion of its warehouse facility in Phoenixville, PA, doubling ambient storage capacity at the facility. This expansion is part of a four-phase project to expand the warehouse and distribution area. The project is scheduled for completion in the third quarter of this year.     
   
“The increase in storage capacity is the next step in a series of global upgrades designed to demonstrate to customers that Bilcare is a company focused on providing high-quality service and cutting-edge technology for its customers to ensure on-time project completion,” said Bilcare GCS Americas president, Vincent Santa Maria.
    
During the last several months, the company has made improvements globally including increasing the number of its packaging rooms, upgrading equipment, expanding its storage and distribution facilities, enhancing its formulation and analytical development services and technical capabilities, improving its IVRS/IWRS capabilities and integrating global operations.   

Catalent Pharma Solutions is now offering warehousing and worldwide logistics solutions for storage, distribution, management, and the fulfillment of compliance requirements. The company's logistics services provide for short- or long-term storage in cGMP facilities for drug products, pharmaceutical excipients, and APIs, including potent APIs.
    
Warehousing services include: cGMP drug product and cGMP bulk API warehousing with storage of small and large quantities at controlled temperatures of 15°C to 25°C, refrigerator (2°C to 8°C), and freezer (-25°C to -15°C). Services include shipments to customer-designated sites, inventory counts, and destruction. Additional services for cGMP bulk API include dispensing, shipment preparation, retaining samples, fulfillment and shipment services, and handling of both non-potent and potent APIs.
   
Worldwide logistics services include: compliance management, managed import process, import/export permitting (CBP, FDA, DEA), logistics and transportation management, free trade zone service, export process management, import/export compliance audit program, and freight pay and audit services.

Bristol-Myers Squibb will acquire Kosan Biosciences, a cancer therapeutics company, for approximately $190 million in cash. The acquisition adds two classes of anticancer agents to BMS's pipeline, novel Hsp90 (heat shock protein 90) inhibitors and epothilones.
   
“Helping patients prevail against serious disease is paramount at Bristol-Myers Squibb,” said Jim Cornelius, BMS' chairman and chief executive officer. “We pursue innovative science, both internally and externally, that can accelerate the discovery and development of new medicines. Kosan’s technology, coupled with our development and commercialization capabilities, will result in new treatment options for patients, and represents another important milestone in the execution of our strategy to become a next-generation BioPharma leader.”
   
Helen S. Kim, Kosan’s president and chief executive officer, remarked, “Kosan has evolved from a research platform to a development company, and we have reached a turning point in our growth as an independent company. We believe that this transaction represents a timely opportunity to place our clinical programs and technology assets in the hands of a world-class company with the experience and expertise to bring innovative cancer treatment options to patients in need.”
   
The two companies have also entered into a separate license agreement under which BMS has an exclusive worldwide license to Kosan’s epothilone compounds and related intellectual property and has been assigned its epothilone IND applications. Under the license agreement, Kosan will receive an initial payment of $25 million and is entitled to milestone payments related to the development of epothilone product candidates and royalty payments on sales of such products.

Eli Lilly and Co. has submitted a sNDA to the FDA seeking approval for a new indication for Cymbalta (duloxetine HCl) for the management of chronic pain. The submission is based on clinical trial results in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previous studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was studied in moderate chronic pain in adults who required daily treatment for an extended period of time.
   
Cymbalta is currently approved to treat major depressive disorder, generalized anxiety disorder, and the management diabetic peripheral neuropathic pain.

Wyeth's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers has been granted Fast Track designation by the FDA. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes in addition to the seven serotypes included in Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
   
Fast Track designation is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need. Wyeth plans to submit the BLA on a rolling basis and expects the application to be completed in 1Q09.
   
The 13-valent pneumococcal conjugate vaccine is being studied in Phase III global trials in both infants and adults.

Amy W. Schulman has been named senior vice president and general counsel, Pfizer, effective June 23. Ms. Schulman will be responsible for leading the company’s legal division. She will serve on the company’s Executive Leadership Team (ELT) and will report directly to chairman and chief executive officer Jeffrey B. Kindler.
   
Ms. Schulman joins the company from DLA Piper, where she was a partner and co-leader of the firm’s mass tort/class action practice. Ms. Schulman handled some of the most complicated legal, scientific and regulatory issues facing the world’s most respected companies, including Pfizer. While at DLA Piper, Ms. Schulman served as lead national counsel in the multi-district litigation involving Bextra and Celebrex. She joined DLA Piper in 1997 and served on the firm’s Global Board and U.S. Executive and Policy Committees.
   
“Amy is a highly regarded and effective legal strategist who has vast experience leading large teams of attorneys,” Mr. Kindler said. “We are fortunate to have someone of her caliber join Pfizer. We know first hand the outstanding qualities that Amy brings to us. Her knowledge of the legal, business and regulatory challenges facing the pharmaceutical industry and her experience tackling large, complex cases make her uniquely qualified to lead Pfizer’s legal team.”

ImmunoGen, Inc. has selected Cytovance Biologics for process development, cell banking and cGMP manufacturing of a proprietary ImmunoGen antibody.
   
Cytovance will use its 44,000-sq.-ft., multi-product cGMP production facility in Oklahoma City, OK for the project. Cytovance specializes in the production of clinical antibody and recombinant protein products derived from cell culture at scales as high as 500L (w/v) from both fed-batch and perfusion processes.
   
“We are very pleased to partner with ImmunoGen and provide manufacturing excellence to their products,” said Darren Head president and chief executive officer of Cytovance. “Our relationship with ImmunoGen is an excellent example of our business model, value, services and state-of-the-art facilities.”

Pall Corp.

3Q Revenues: $661.7 million (+18%)

YTD Revenues: $1.8 billion (+15%)

Comments: In the quarter, life science sales were $253.0 million (+3%) with Medical sales of  $124.6 million (-3%) and BioPharmaceuticals sales of  $128.4 million (+10%). YTD life science sales were $712.0 million (+6%). Medical sales were flat at $360.0 million and BioPharmaceuticals sales $352.1 million.

GVK BIO has entered into a research agreement with Wyeth Pharmaceuticals, a division of Wyeth, to discover drug candidates focused on pre-defined discovery targets. GVK BIO will utilize in-house capabilities in discovery chemistry, informatics, biology and ADME to advance this program.

GVK BIO will be responsible for identifying drug candidates, which will be transferred to Wyeth to advance these compounds towards clinical studies. Under the agreement, GVK BIO will receive an initial payment and will be eligible for success-based milestone payments, but terms were not disclosed.

GV Sanjay Reddy, managing director, GVK Biosciences said, "It is a momentous occasion for us. GVK BIO has had a successful partnership with Wyeth on various chemistry research activities dating to 2006. This research agreement expands our work together and builds on GVK BIO's core strengths. This agreement further validates India's capability to do innovative research along with leading pharmaceutical and biotech companies."

Alnylam Pharmaceuticals and Takeda Pharmaceutical Co. Ltd. have formed a strategic platform alliance in RNAi therapeutics in the fields of oncology and metabolic disease with the option to expand to additional therapeutic areas.

This collaboration provides Takeda with broad, worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. The agreement also includes the transfer of platform technology from Alnylam to Takeda, a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi therapeutic targets, subject to certain Alnylam third party obligations.

Takeda becomes Alnylam’s strategic partner for RNAi therapeutics over a five-year period and the only Asian company to obtain a right of first negotiation to develop and commercialize Alnylam RNAi therapeutic development programs for the Asian market, excluding Alnylam’s ALN-RSV01 program. In addition, Alnylam obtains opt-in options to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S. market on a 50-50 basis.

The partnership includes $100 million in upfront payments and $50 million in near-term technology transfer payments for a non-exclusive license in two therapeutic fields and has a potential value in excess of $1 billion in future R&D and commercial milestones, upon successful commercialization of multiple products. At Takeda’s option, the scope of the partnership can be expanded to include additional fields with a $50 million per field expansion payment. Alnylam is also eligible to receive research and development funding related to the drug discovery collaboration. In addition, Alnylam is eligible to receive up to $171 million in development and commercial milestone payments and significant royalties per product.

WuXi PharmaTech has named Dr. Peng Wang to the role of vice president of Discovery Biology. Dr. Wang will oversee the company's growing portfolio of discovery biology service offerings. He will report directly to Dr. Ge Li, the company's chairman and chief executive officer.

Prior to joining WuXi PharmaTech, Dr. Wang was a research fellow at Schering-Plough Research Institute where he worked for 18 years with increasing responsibilities. He has extensive experience in discovery biology, including target validation research, assay development, screening, in vitro and in vivo biological and pharmacological studies, and mechanism of action and biomarker research. As a discovery team co-chair and biology group leader at Schering-Plough, Dr. Wang made significant contributions to the nomination of several development candidates, four of which are at various phases of clinical trial.

"I am very delighted to welcome Dr. Wang on board at this exciting time. Dr. Wang's depth of experience will undoubtedly help the company to accelerate the development of our discovery biology services, and strengthen our medicinal chemistry and biologics discovery capabilities," commented Dr. Li.

Mary Haak-Frendscho, Ph.D. has been appointed president and chief scientific officer, Takeda San Francisco, Inc. Dr. Haak-Frendscho will be responsible for leading all activities at the company, including overall research and preclinical development, process development studies and operations for antibody therapeutics. Takeda San Francisco, established in November 2007, is a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd. of Osaka, Japan.      
   
"Dr. Haak-Frendscho's strong leadership skills and biotechnology experience will greatly contribute to the success of Takeda San Francisco," said Shigenori Ohkawa, Ph.D., general manager, pharmaceutical research division, Takeda. "Takeda San Francisco will play an increasingly critical role in the expansion of Takeda's R&D capabilities as we look to promote the development of antibody therapeutics, and I am confident that Dr. Haak-Frendscho will help us realize our goals in the antibody field."
   
Dr. Haak-Frendscho has more than 17 years of pharmaceutical and biotechnology experience having held positions at Genentech, Abgenix and most recently, at XOMA, where she served as chief science officer and vice president, preclinical R&D.

William J. Conroy has been appointed vice president of operations and engineering at Microfluidics, a wholly owned subsidiary of MFIC Corp. In this position, Mr. Conroy will have P/L responsibility for the operating division of both Microfluidics and MFIC, including product design and engineering, production and purchasing. Mr. Conroy will also assume responsibility for overall systems quality and reliability, and will report directly to Michael C. Ferrara, chief executive officer.
   
Mr. Conroy has more than 25 years of high-tech product management, quality control and operations experience. Most recently, he served as senior vice president of production and operations at RemoteReality Corp., which designs and manufactures products for the military/defense and securities business sectors. Mr. Conroy has also held senior level operations, manufacturing and quality control positions at Northrop Grumman (formerly Fibersense Technology Corp.), Karl Storz Endovision, Circon ACMI and Kohler Co.  

DOR BioPharma has opened a new corporate office in the UK. The new office gives DOR a presence in the EU to better facilitate the Named Patient Access program that will be administered by IDIS, also based in the UK. Serving as the company's official interface for regulatory interactions within the EU, the office will operate as DOR BioPharma UK Ltd. and will be located at: BioPark, Broadwater Road, Welwyn Garden City, Hertfordshire.
   
"The new DOR UK office gives us a multinational presence that we have not previously had," said Christopher J. Schaber, Ph.D., President and CEO of DOR. "This new office will aid us in achieving our strategic vision of making orBec available to patients throughout Europe through our Named Patient Access programs while we conduct our confirmatory Phase III clinical trial. It also has the potential to facilitate the conduct of new clinical trials in Europe as well as to provide support to European business relationships in the future."

Norwich Pharmaceuticals, Inc. has made several appointments as part of the company's initiative to expand its contract manufacturing and packaging services. Douglas L. Drysdale has been appointed to the newly created position of chief executive officer and Thomas Salus and Robert Klehr will be responsible for new business development. Mr. Salus and Mr. Klehr will be based in NJ and will share responsibility for covering the U.S.
   
Mr. Drysdale most recently served as vice president, Mergers & Acquisitions for Actavis Group. He previously held positions at Alpharma, Inc. as vice president, global business development, and at Forest Laboratories. Mr. Drysdale has been involved in more than 100 pharmaceutical and biotech transactions.
   
Christopher R. Calhoun, who will continue serving as president of Norwich Pharmaceuticals, said, "We are very excited to have someone of Doug's caliber as our CEO. His in-depth pharmaceutical experience will help Norwich accelerate its current rate of growth, while remaining true to the high standards of quality and uncommon value that the industry has come to expect from us."
   
Mr. Salus and Mr. Klehr both have held managerial and sales positions within the pharmaceutical outsourcing industry. Mr. Salus most recently applied his business development experience on behalf of Glatt Pharmaceutical Services. Prior to Glatt, Mr. Salus held positions with Banner Pharmacaps and AAI, Inc.
   
Bob Klehr joins the company after serving as director of business development for DPT Laboratories. Prior to DPT, Mr. Klehr held positions at Patheon and Fisher Scientific Co.
   
The company plans to make future capital investments in its business to support its growth plan. In 2008, Norwich will add a new packaging line, a capsule bander, and two Bosch 1500 encapsulators.

Eli Lilly and Co. has made changes across its executive leadership structure. "Earlier this year I asked each of our senior leaders to look closely at their respective areas to determine if they were optimally structured to meet the demands of our business and our company goals," said John C. Lechleiter, Ph.D., who assumed the role of Lilly president and chief executive officer on April 1, 2008. "As a result of this thorough review, we are implementing a number of changes that will minimize bureaucracy by reducing the number of layers of management, will speed decision-making by clarifying roles and accountabilities, and will allow us to respond more quickly to critical business needs."
   
Tim Franson, M.D., vice president of global regulatory affairs, will retire from the company after 22 years of service. Dr. Franson has held roles of increasing responsibility throughout his career at Lilly, including positions in medical (both in the U.S. and in Europe), health economics research and decision sciences, clinical research, and regulatory affairs.  
   
Alan Breier, M.D., vice president of medical and chief medical officer, has been appointed full professor in the department of psychiatry at the Indiana University School of Medicine after an 11-year career at Lilly. Dr. Breier joined the company in 1997 from the National Institutes of Health (NIH) and has published more than 235 scientific articles in areas related to the cause and treatment of severe mental illnesses. He was also honored by the American Psychiatric Association for excellence in medical student education. Dr. Breier has held a variety of leadership roles at Lilly on the Zyprexa product team as well as in medical, and has served as the chief medical officer since 2003.
    
The primary change for the company's Lilly Research Laboratories (LRL) structure is the creation of a combined global regulatory, medical and patient safety organization, which will create a single point of accountability for regulatory and medical affairs. Tim Garnett, M.D., currently vice president of global patient safety, will assume the role of vice president and chief medical officer and will lead this new organization.
   
Jen Stotka, M.D. has been named vice president of global regulatory affairs and Don Therasse, M.D. will assume the role of vice president of global patient safety. Both will report to Dr. Garnett.
   
Karim Bitar has been named president, European operations. Mr. Bitar has 12 years of experience with Lilly, and has held a variety of international roles, most recently as general manager of Lilly Italy.
   
Philippe Prufer will assume the role of vice president and area director of European mid-size as well as central and eastern European markets. In addition, the markets of Africa, the Middle East, and the Commonwealth of Independent States (CIS) will be combined with the Asian markets (other than China and Japan) and will be led by Eberhard Ludewigs, who will serve as vice president and area director of this expanded region.
   
Newt Crenshaw, currently president and general manager of Lilly Japan, will assume the newly-created role of vice president of policy, pricing, reimbursement and access, and international corporate affairs. Mr. Crenshaw will be based in Indianapolis and will report directly to Alex Azar, senior vice president of corporate affairs. Replacing Crenshaw in Japan will be Alfonso (Chito) Zulueta, currently Lilly's area director for Asia.
   
Enrique Conterno, currently vice president of Lilly's U.S. neuroscience business, will become vice president for health care professional markets. In this role, he will lead all Lilly USA efforts aimed at health care professionals, and he will also have therapeutic responsibility for the neuroscience, diabetes and osteoporosis brands.
   
Jack Bailey, currently vice president of U.S. sales and marketing, business-to-business, will become vice president for account-based markets, and he will have responsibility for institution-based customers. Mr. Bailey will also have therapeutic responsibility for the oncology, endocrine and cardiovascular brands.
   
Bryce Carmine, executive vice president of global marketing and sales, has implemented changes to the company's sales and marketing operations. Rich Pilnik, currently vice president and chief marketing officer, has announced his retirement from the company. Mr. Pilnik spent 25 years with the company and has held a variety of sales and marketing positions, including general manager of Lilly Mexico and area director for Latin America and Canada. Mr. Pilnik has twice served as the company's chief marketing officer, from 1998 to 2001 and from 2006 to present. From 2001 to 2006 he served as president of Lilly Europe.
   
The company's global marketing and international marketing organizations are being consolidated, and Dan Hasler, currently vice president of global brands, will assume the role of vice president of this expanded organization. Nancy Lilly, currently vice president of U.S. sales and marketing for specialty products, is being named to the role of vice president of new product planning and market analytics, responsible for leading new product planning, market research, global pricing and business development.
   
Transitions for all of the executive leadership and organizational changes will begin immediately, and the new structure will be fully in place by July 1, 2008.

Orly Zargar has been appointed the West Coast business development representative for Personal Care, BioScreen Testing Services, Inc. Ms. Zargar is responsible for supporting and contributing to the company's continued growth.
   
"Orly is proving to be a great asset to the BioScreen sales team," said Kelly Templeton, business development manager. "As the West Coast business development representative, her focus is on the ever-growing personal care industry in California. Orly is charged with expanding new business, and strengthening BioScreen's relationships with our personal care clients."

Daiichi Sankyo Co., Ltd. has entered into an agreement to acquire U3 Pharma AG, a privately held German biotechnology company focusing on antibody research for the treatment of cancer. Daiichi Sankyo will purchase all of the stock and make a one-time payment of $235 million. The transaction is subject to customary closing conditions.
   
U3 Pharma was founded by Professor Axel Ullrich of the Max Planck Institute of Biochemistry, whose gene technology-based and oncology-focused research led to the development of the oncology drugs Herceptin and Sutent. U3 Pharma was established in 2001 and currently employs 27 people, the majority of whom work in R&D.
   
U3 Pharma's pipeline of targeted therapeutics includes programs focusing on fully-human antibodies as potential therapies for breast, lung and colorectal cancers, among others. The company's lead product, which is being co-developed with Amgen, is U3-1287 (AMG 888), the first fully-human anti-HER3 monoclonal antibody (mAb) to inhibit oncogenic signaling and tumor proliferation. The companies intend to initiate clinical development of this compound this year.
   
"Our acquisition of U3 Pharma is an ideal strategic fit for our oncology portfolio," said Takashi Shoda, president and chief operating officer of Daiichi Sankyo Co., Ltd. "We currently have three human monoclonal antibodies in development. Additionally, in March, 2008, we announced that we were expanding our joint research venture with another German company, MorphoSys AG, for its advanced Human Combinatorial Antibody Library and its phage display technologies. One of our goals for Daiichi Sankyo is to increase our presence in novel therapeutics in the oncology arena."

Almac Clinical Technologies, a division of the Almac Group, has signed a record $12 million worth of new studies within the past several weeks, including a global mega-study involving almost 20,000 patients.
   
Almac Clinical Technologies president Jim Murphy commented, "We are seeing an increase in the number of large, global, complex trials as well as smaller adaptive clinical trials, each requiring sophisticated randomization and drug management approaches. Sponsors seem to be turning to experienced global firms, such as Almac, with strong project management expertise and technologies to make those trials successful."

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. have updated the clinical development program for aflibercept, and provided results from a Phase II study in advanced ovarian cancer. The companies reported that a recent study did not achieve its primary endpoint of demonstrating that patients in either arm of the study achieved a RECIST (Response Evaluation Criteria in Solid Tumors) response rate that was statistically significant.
   
The two companies are now enrolling approximately 4,000 patients in the U.S., Europe, and other countries, in four Phase III studies that combine aflibercept with standard chemotherapy regimens. The studies include: second-line treatment for metastatic colorectal cancer in combination with folinic acid, 5-FU, and irinotecan; first-line treatment for metastatic pancreatic cancer in combination with gemcitabine; first-line treatment for metastatic androgen-independent prostate cancer in combination with docetaxel and prednisone; and second-line treatment for metastatic non-small cell lung cancer in combination with docetaxel. A Phase II first-line study of aflibercept in metastatic colorectal cancer in combination with folinic acid, 5-FU, and oxaliplatin is expected to begin later this year.
   
“We and sanofi-aventis are continuing to evaluate the data from this trial in order to determine the next steps for aflibercept in advanced ovarian cancer,” commented George D. Yancopoulos, M.D., Ph.D., president of Regeneron Research Laboratories.

Oso Biopharmaceuticals Manufacturing, LLC has purchased the Albuquerque, NM-based sterile injectables manufacturing business of Catalent Pharma Solutions. Terms of the transaction were not disclosed.
   
The unit provides cGMP glass vial filling and lyophilization services for injectable drugs and biologics for both commercial and clinical projects. Oso Biopharmaceuticals will retain all employees associated with the business and continue to serve existing the unit's customers in North America and Europe.
   
Dr. Stuart Rose, chief executive officer and president of Oso Biopharmaceuticals, said, “We are delighted to have been successful in acquiring Catalent's sterile injectables business based in Albuquerque. It fits exceedingly well with our strategy to build a world class, high quality contract manufacturing company. We will work tirelessly with the talent pool in Albuquerque to meet the highest demands and expectations of our global customer base.”
   
Richard Yarwood, group president of sterile technologies for Catalent, said, “We are pleased to have completed this planned step in the evolution of our Sterile Technologies business. We are also pleased that Oso Biopharmaceuticals has acquired this business, as we expect they will continue to provide the facility’s customers the high degree of quality and compliance they have received in the past. We also appreciate the commitment Oso Biopharmaceuticals has demonstrated to the future of the business, and to the dedicated employees at the site.”

Dr. Bernard Tisserand and Dr. Jonny L. Salyer have been named executive medical directors for respiratory disorders and metabolic disorders, respectively, MDS Pharma Services.
   
"Pharmaceutical companies are pursuing clinical research programs to address these disorders, and we have made a strategic decision to become a leader in these key therapeutic arenas by establishing dedicated teams headed by experienced medical professionals," said MDS Pharma Services President David Spaight. "In the past 10 years, MDS Pharma Services has managed more than 150 clinical projects involving respiratory conditions and metabolic disorders. With expert project teams in Africa, Asia Pacific, Europe, Latin America and North America, we can offer our clients worldwide access to patients with these conditions."
   
Dr. Tisserand has held a number of senior positions in clinical operations and project management at MDS Pharma Services. In his earlier roles, he managed teams of project directors, project leaders and clinical research associates supporting studies in asthma, allergic rhinitis, COPD, CAP and other major therapeutic areas. He has been with the company for 18 years.
   
Dr. Salyer has 30 years of relevant experience in research, medicine and the contract research industry. Prior to joining the company, she worked for a leading provider of central lab services in Indianapolis, where she served as director of medical affairs since 2001, supporting Phase I-IV clinical research.  

KAI Pharmaceuticals has initiated enrollment in a Phase I study of KAI-1678, a first-in-class, isozyme-selective inhibitor of the epsilon protein kinase C pathway. KAI-1678 has been shown to be highly effective at reducing pain responses in a wide variety of preclinical pain models.
   
“Epsilon PKC has been shown to have an important role in both inflammatory and neuropathic pain. KAI-1678 is the first clinical-stage compound that is a specific inhibitor of epsilon PKC,” commented Gregory Bell, senior vice president of development and chief medical officer. “Current therapies for the management of pain, such as opioids and nonsteroidal anti-inflammatory drugs (NSAID), can be limited by side effects and inadequate efficacy. There is a need for novel therapeutics with unique mechanisms of action that provide effective pain relief with reduced side effects.”
   
The randomized, double-blind, placebo-controlled, rising dose study will evaluate the safety, tolerability and pharmacokinetics of KAI-1678 in healthy males. The study will enroll five cohorts and is expected to complete this quarter.  

Schering-Plough Corp. has extended its collaboration with MorphoSys AG for one year. The collaboration, announced in May 2006, has a maximum term of five years until 2011 and may be extended by SP after each year. Under the agreement, SP will continue to have access to MorphoSys's antibody library HuCAL GOLD at its research site in Palo Alto, CA, the location of Schering-Plough Biopharma. The contract also provides SP with the option to develop and commercialize HuCAL-derived therapeutic antibodies, in which case MorphoSys would receive exclusive license fees, milestone payments, and royalties. Under the extended agreement MorphoSys continues to receive annual user fees for access to its HuCAL platform. Further financial details were not disclosed.
   
"Today's news is yet another clear signal that our HuCAL technology will continue to form the basis of antibody-based drug development programs at a number of leading pharmaceutical companies,'' commented Dr. Simon Moroney, chief executive officer of MorphoSys. "We are very pleased with Schering-Plough's decision to continue using our HuCAL GOLD technology for their antibody development programs.''

InterMune, Inc.'s pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the FDA. Fast Track designation is granted for drugs intended to treat a serious or life threatening condition that have the potential to address an unmet medical need. The FDA facilitates the development and expedites the review of applications for fast track products.
   
Dan Welch, chairman and chief executive officer of InterMune, said, "There are no approved medicines to treat patients who suffer from IPF, a uniformly fatal disease characterized by scarring and inflammation of the lungs. The FDA's action in granting fast track designation is an indication of pirfenidone's potential to address this serious, unmet medical need. We look forward to reporting top-line results of our Phase III CAPACITY program of pirfenidone in IPF, in January of 2009."

ImClone Systems' data from the Phase II OPUS study show that the addition of Erbitux to Folfox chemotherapy significantly improves both response rate and progression-free survival over Folfox alone in the first-line treatment of metastatic colorectal cancer (mCRC) patients whose tumors do not have mutations of the K-Ras oncogene (K-Ras wild-type).
   
The randomized first-line Phase II study of 337 patients compared Erbitux plus Folfox to Folfox alone in epidermal growth factor receptor (EGFR)-expressing mCRC patients who have not previously been treated. Oxaliplatin-based chemotherapy regimens, including Folfox, are used in the majority of first-line colorectal cancer patients in the U.S. The study’s primary endpoint was response rate, which was found to be 46% in the Erbitux-plus-Folfox arm compared with 36% in the Folfox-only arm. When the wild type K-Ras patients are selected from the population, the response rate in this group increased to 61% in the Erbitux-plus-Folfox arm compared with 37% in the Folfox-only arm. With the progression-free survival endpoint, the risk of disease progression was reduced by 43% by the addition of Erbitux to Folfox chemotherapy in wild-type K-Ras patients.  
   
In several recent clinical studies, screening patients for the K-Ras biomarker has been shown to be a highly effective tool in determining which patients will respond better to a particular cancer therapy. The non-mutated, or “wild type,” K-Ras gene is expressed in about 65% of mCRC patients.

Felix M. Negron has been appointed senior vice president to lead Pall Corporation's global manufacturing and supply chain operations for the company’s Life Sciences business.
   
Mr. Negron has 20 years of pharmaceutical operations and quality assurance experience and was recognized as the Puerto Rico Manufacturers Association’s 2007 Industrial Leader of the Year. He joined the company in 2003 as general manager for Pall Life Science’s operations in PR. Mr. Negron initiated a successful Process Excellence program for continuous improvement at the company's PR facility.
    
“Felix’s influence on our Puerto Rico operations was so profound that we’re now implementing his approach across our global life sciences manufacturing facilities,” said Roberto Perez, president of Pall Life Sciences. “By 2010, his Process Excellence approach will be applied to Pall’s sales, R&D, and human resources functions as well. Felix’s operations expertise and ability to drive operational excellence throughout the entire life sciences organization will allow Pall meet its aggressive growth goals — and meet our customers current and future needs.”
    
Prior to joining the company, Mr. Negron spent 12 years with Johnson & Johnson as quality assurance director, engineering and process excellence director, and as executive director of business excellence, among other positions within the operations and quality assurance functions.
 

Invitrogen Corp. has created a new business unit in cell therapy. The field of cell therapy offers potential for new, novel therapies in fields such as wound care, neurological and immune disorders, and cardiovascular diseases, according to the company. The new Cell Therapy Systems business will be responsible for integrating relevant technologies — including Dynal magnetic beads for cell isolation, Gibco cell expansion media and Molecular Probes cell characterization tools — to meet the needs of companies and researchers involved in developing cell therapies.
   
“Moving cell therapies through the research, clinical and commercial phases of development presents its own unique challenges, which Invitrogen is uniquely positioned to address,” said Joydeep Goswami, Invitrogen’s vice president, Stem Cells and Regenerative Medicine. “We bring project management capabilities to the table, pulling together tools, reagents, and services from across the company to meet the specific needs of cell therapy companies. By offering integrated solutions, we can help accelerate the field toward groundbreaking therapies.”
   
Invitrogen also recently announced the acquisition of CellzDirect, Inc. and Cascade Biologics, as well as a minority investment in Q Therapeutics, Inc., a biotechnology company pursuing cell therapeutic indications for the central nervous system.

Array BioPharma and AstraZeneca plan to add two additional randomized Phase II trials for AZD6244 (ARRY-886). The trials, which will begin 2H08, will study AZD6244 in combination with a cytotoxic chemotherapeutic agent; one trial will be in melanoma patients and the other in non-small cell lung cancer patients. These plans are based on AZD6244’s activity as a single agent in previous monotherapy Phase II trials and preclinical data.
   
“We believe that AZD6244 holds promise for cancer patients and we look forward to the initiation of these additional Phase II trials,” said John Yates, M.D., chief medical officer of Array BioPharma. “We’re pleased to be working with AstraZeneca’s experienced oncology team and are excited about their strong commitment to bringing this novel treatment to people with cancer.”
   
AZ acquired exclusive worldwide rights to AZD6244 and certain second-generation compounds for all oncology indications in December 2003. Array was responsible for filing the IND and conducting the Phase I testing of AZD6244 and  AZ is responsible for all other aspects of clinical development and commercialization. Array retains the rights to all therapeutic indications outside of oncology for compounds not selected as part of the collaboration.

Garry A. Nicholson has been appointed senior vice president, general manager of Pfizer’s newly created Oncology Business Unit. Reporting to Ian Read, president of Pfizer Worldwide Pharmaceutical Operations, Mr. Nicholson will serve as head of the company's oncology franchise, with direct responsibility for clinical development, medical affairs, commercial development, sales and marketing.
   
“Garry is a highly regarded and accomplished executive whose experience in the global oncology market makes him exceptionally qualified to lead this important new growth area for Pfizer,” Mr. Read said. “The oncology market is expected to grow significantly in the next decade. This is being driven by breakthrough science, the rapid uptake of new agents that meet high unmet medical need and treatments that are enabling cancer patients to live longer.”
   
Mr. Nicholson is a senior pharmaceutical executive with extensive experience in product development, marketing, sales and general management on a worldwide basis. He joins the company from Eli Lilly and Co., where he spent more than 10 years as executive director of the U.S. Oncology Business Unit and subsequently in an expanded role as Global Oncology Platform Leader. In the latter role, Mr. Nicholson was responsible for the global oncology franchise, including the oncology therapeutic area strategy, portfolio management, Phase II/III development, global integration of oncology medical and marketing strategies, regulatory submissions and approvals, and licensing and partnerships. Mr. Nicholson was also directly accountable for the company’s oncology drug development budget and review of country and regional forecasts and income statements. In addition, he played a key leadership role in business development and licensing initiatives in oncology. Under Mr. Nicholson’s leadership, Lilly’s global oncology sales exceeded $2.5 billion in 2007.

Peter Soelkner will be heading a number of divisions at the Ravensburg-based business of Vetter Pharma-Fertigung GmbH & Co. KG, which specializes in the filling of prefilled injection systems. He will be responsible for global key account management, corporate marketing, supply chain management and project management. Mr. Soelkner will be joining the current managing directors Max Horn and Thomas Otto in handling company business.
   
Mr. Soelkner has 10 years of sales experience in the international pharmaceutical and biotech industries. He previously served as vice president Global KAM at Stedim Biotech, USA, where managed the successful merger of Sartorius and Stedim, now Sartorius Stedim Biotech. From 2003 to 2007 Mr. Soelkner served as director of the key account management at Vetter. He managed the implementation of the “End to End Supply Chain Organization” concept at Vetter, attaining an "Operational Excellence Class A" certification for the company within a record time of 11 months.
   
“Peter Soelkner is our candidate of choice," said Mr. Horn. “He has the necessary experience in international management and a great deal of expertise in the pharma and biotech industries, plus he is already completely familiar with the structures and products of our company. This makes him the perfect man for us.”

Steven M. Klosk has been appointed president and chief executive officer and a member of the board of directors of Cambrex. James A. Mack, president and chief executive officer since 1995 and chairman since 1999, has announced plans to retire. The company will separate the positions of chairman and chief executive officer and John R. Miller, currently lead director, will assume the position of non-executive chairman of the board. Mr. Mack will remain a board member and advisor until his retirement on June 30, 2008.
    
Mr. Klosk joined Cambrex in October 1992 as vice president, administration. He held several positions of increasing responsibility serving as executive vice president, administration, executive vice president and chief operating officer for Cambrex Pharma and BioPharmaceutical Business Unit, and assumed direct responsibility for the BioPharmaceutical Business Unit serving as chief operating officer. In January 2007 he was appointed executive vice president and chief operating officer for the Corporation.  
   
"I have enjoyed my many years with Cambrex and now is the right time to turn the Company over to new leadership. I am confident that with his many years with Cambrex, Steve will ably continue the pattern of growth that is so much a part of the Company," commented Mr. Mack.
   
"I am excited about the opportunity to lead the Cambrex team as we focus on our growth initiatives in proprietary products and polymeric drug delivery, highly potent compounds, controlled substances and our growing pipeline of new custom development products. In addition, we are well positioned to leverage our recently completed facility near Milan, Italy to support our leading position in generic active pharmaceutical ingredients," said Mr. Klosk. "I am extremely grateful to Jim for his many years of outstanding service to Cambrex and for his personal mentorship."

Patheon, Inc. has made several executive management changes with the following appointments: Eric W. Evans as chief financial officer, Paul M. Garofolo as senior vice president and chief information officer, Warren A. Horton as vice president Global Quality Operations, and Doaa A. Fathallah as senior vice president, general counsel Europe and Global Pharmaceutical Development Services.
           
Wes Wheeler, Patheon's chief executive officer and president said, "Eric Evans will be responsible for managing the company's financial function, and will work with me and our executive team as we create strategic and operational improvements in the business."
   
Mr. Evans has more than 24 years of experience in various financial leadership roles in the pharmaceutical industry following a significant career in the steel industry. He joins the company from Novartis AG. He has experience in all aspects of finance as well as extensive operating, analytical, leadership, and business development experience.
   
"Paul Garofolo is a proven leader with a track record of developing and stewarding long-term global Information Technology strategies and implementing new applications and processes. I am confident he will lead Patheon to cost effective global IT platforms. Paul will have responsibility for Information Technology globally including the development and implementation of a five year global IT Master Plan for Patheon. In addition he will assume responsibility for 'The Patheon Advantage', Patheon's lean six sigma excellence program," said Mr. Wheeler.
   
Mr. Garofolo has 14 years of experience in IT and management consulting most recently with Valeant Pharmaceuticals where he served as chief information officer. He has led all aspects of global IT organizations including development and implementation of long-term IT strategies as well as implementation of new applications and processes.
   
"Doaa Fathallah will be responsible for all legal matters for Europe and Global Pharmaceutical Development Services," Mr. Wheeler continued. Ms. Fathallah joins the company from Valeant Pharmaceuticals International where she was general counsel Europe, Middle East and Africa (EMEA) and was responsible for all legal matters in the EMEA region. She also has extensive experience in all aspects of corporate and business law from her private practice where she represented privately held and publicly traded companies.
   
"Warren Horton will be responsible for establishing a new Quality System to be consistently applied at all Patheon sites. He will also ensure that the company meets all regulatory requirements for quality and compliance," Mr. Wheeler said. Mr. Horton has more than 10 years of experience in the pharmaceutical industry. He joins the company from DSM Pharmaceuticals, Inc. where he was responsible for quality assurance and regulatory affairs. In addition he has experience dealing with a large variety of dosage forms, efficient production and quality control and assurance in a variety of liquid and semi- solid topical products.
   
"I am delighted to welcome these executives to the Patheon leadership team. One of my near-term priorities has been to strengthen and rebuild the executive team for Patheon. These individuals bring proven track records, expertise and strong leadership," Mr. Wheeler concluded.

AstraZeneca received approval from the FDA for Seroquel for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. Seroquel is approved by the FDA for the treatment of schizophrenia, and both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder.
   
The FDA approval was based on two multicenter, randomized, double-blind, placebo-controlled trials that evaluated Seroquel when used as an adjunct therapy to lithium or divalproex in the maintenance treatment of adult patients with bipolar I disorder. The study design included a 12 to 36 week stabilization phase, which was followed by a longer-term, randomized, double-blind treatment phase that had a mean duration of exposure of 213.2 days for Seroquel and 152.4 days for placebo.
   
The primary endpoint, which was time to recurrence of a depressive, manic, or mixed mood event, was significant for Seroquel compared with placebo in both studies. Study results indicated that patients treated with Seroquel plus lithium-or-divalproex had a risk reduction of 70% relative to those treated with placebo plus lithium-or-divalproex for time to recurrence of a mood event. This reduction in risk was significant for both recurrence of manic episodes and depressive episodes. The proportion of patients who relapsed when treated with Seroquel was 19% versus 50% of patients on placebo.

West Analytical Services LLC has introduced a testing platform to help mitigate the risks associated with testing pulmonary and nasal drug products and their delivery devices. The company’s analytical services for pulmonary and nasal drug products include early-stage development, clinical development and post-product launch stages for pharma, biopharma and medical device clients. West provides testing for: Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs), nasal and oral sprays, and nebulizers at its FDA-registered, cGMP lab in Lionville, PA.
   
“Moving pulmonary and nasal drug products from early-stage development to the market is challenging for pharmaceutical, biopharmaceutical and medical device companies,” said Fran DeGrazio, vice president, marketing and strategic business development. “The challenges include testing the drug product and delivery device. Companies may not have a proven device selection process in place and may not have validated laboratory methods or instruments required to test the drug product and the device. Any misstep along the way runs the risk of costly project delays.”

Rick Lapointe has been appointed president of HollisterStier Laboratories’ Contract Manufacturing unit, responsible for overseeing business development, manufactur¬ing, engineering, validation and process development functions. Mr. Lapointe is the chair of the Contract Op¬erating Committee and reports directly to chief executive officer Anthony D. Bonanzino, Ph.D. He has served as senior vice president of operations for HollisterStier since 2004 and previously worked for Burroughs Wellcome.  

Catalent Pharma Solutions

3Q Revenues: $453.3 million (+4%)

3Q Loss: $31 million (earnings were $21.8 million in 1Q07)

YTD Revenues: $1.4 billion (+8%)

YTD Loss: $72.5 million (earnings were $41.4 million YTD07)

Comments: The company attributed its revenue growth primarily to the effect of a weaker dollar. Without that factor, net revenues would have declined 2%, due primarily to lower North American volumes in printed components and commercial packaging. Sterile Technologies revenue was $76.7 million (+18%) in the quarter and $221.3 million YTD (+22%), thanks in part to the company's new steriles facility in Brussels. Packaging Services revenue was $125.3 million (-12%) in the quarter and $410.7 million YTD (-1%). SG&A expenses were $80.1 million (+21%) in the quarter and $238.6 million YTD (+11%).

HollisterStier Laboratories has completed the construction of a full-service 6,000-sq.-ft. lab  that includes analytical testing services with an analytical chemistry department. The lab is part of the company’s $42 million, 71,000-sq.-ft. facility-wide expansion project that more than doubles current manufacturing capacity.
   
The company has also expanded its 172,000-sq-.ft. facility to include a new Small Volume Parenterals (SVP) line to aseptically fill liquid and lyophi¬lized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 liters.
   
The new line (SVP II) houses a 25,500-sq.-ft. vial filling complex with a Bosch FLC 3080 vial filler equipped with a nondestructive automatic check weigh system, diaphragm filling pumps and speeds as high as 400 vpm. The line offers multiple options for compounding including aseptic compounding, portable compounding vessels, and large fixed compounding tanks. The vial inspection and packaging area includes inspection, labeling, Ink Jet coding and secondary packaging.
   
SVP II is designed for multi-product manufacturing, both commercial and clinical trial material, with one product manufactured in the area at a time. SVP II includes advances in pharmaceutical technology such as automated non-destructive fill checks and ISO5 oversealing. In addition, two GEA lyophiliz¬ers will be added in a new ISO5/6 facility and ready for production in 1Q09.
   
“The expansion of our facilities is a reflection of the successes that our organization has worked hard to achieve,” said Anthony Bonanzino, Ph.D., chief executive officer of HollisterStier. “We take pride in the quality and efficiency we provide our customers. Our reputation as world-class contract manufacturers has allowed for us to be in a position to expand upon our capabilities so that we can continue to best serve our customer-base.”

Prevalere Life Sciences has opened a new biotechnology lab at its Whitesboro, NY headquarters, enhancing the current 48,000-sq.-ft. facility and housing seven labs. The company transformed unfinished space into a 1,800-sq.-ft. immunoassay lab, where it will conduct pharmacokinetic and immunogenicity testing.
   
“Over the last six years that we have been working in the biotechnology field, we’ve seen many breakthrough therapies emerging, leading to increased demand from our clients that required an expansion in this area” said Dr. Mario Rocci, Jr., Prevalere's chief executive officer. “We see this expansion as another opportunity to advance our mission of providing innovative R&D services to meet the evolving needs of the pharmaceutical and biotechnology communities.”
   
This expansion is considered to be Phase I of a two-phase project to meet future demand increases with a second new lab that could be up and running within 60 days. Prevalere has relocated its current team of immunoassay scientists to this new wing of the facility, and plans to hire more scientists in this area. Twenty employees were added in 2007, and seven more employees have been added this year to date.

Forest Laboratories and Daiichi Sankyo have terminated their co-promotion agreement for AZOR (amlodipine and olmesartan medoxomil), Daiichi Sankyo's fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Daiichi Sankyo will receive a one-time payment of $44.1 million from Forest Labs related to the termination. Beginning July 1, 2008, Daiichi Sankyo will be responsible for the promotion of AZOR.
   
A second agreement between the two companies, under which Forest co-promotes Benicar and Benicar HCT, has been extended to end on May 31, 2008. Also, there will be a residual period where Forest will continue to receive income from Benicar and Benicar HCT profits, which is not set to expire until March 31, 2014.
   
Howard Solomon, chairman and chief executive officer of Forest, commented, "We have enjoyed a very fruitful partnership with Daiichi Sankyo since our initial collaboration of Benicar, which began in 2002. Our decision to reallocate resources to our currently marketed products causes us to forego the opportunity to continue to participate in the promotion of Daiichi Sankyo's excellent product AZOR."
   
Daiichi Sankyo president and chief executive officer, Joseph P. Pieroni said, "Our first co-promotion agreement with Forest provided us with important additional resources to build our franchise of Benicar and Benicar HCT into significant products in the antihypertensive market while we built our own sales force. Our second co-promotion collaboration for AZOR allowed us to quickly and comprehensively educate the medical community about this new combination antihypertensive. Now we can take over full responsibility for the continued success of these brands."

Takeda  FY Results (April 1, 2007 – March 31, 2008)

FY Revenues: $13.9 billion (+5%)

FY Earnings: $3.6 billion (+6%)

Comments: FY growth was driven by Actos sales of $4.0 billion (+18%) and Candesartan/Blopress sales of $2.2 billion (+8%). Lansoprazole sales were $1.5 billion (-1%). Leuprorelin sales were $1.3 billion (-3%). Operating income was $4.1 billion (-8%). R&D expenses were up 43% due to enhancement of R&D activities, in-licensing and alliance activities, including the termination of a license agreement with Amgen.

Takeda Global R&D Center and Affymax achieved positive 12-month data from their ongoing Phase II trial evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anemia associated with chronic kidney disease (CKD). Preliminary trial data showed that Hematide administered once every four weeks was well tolerated and maintained mean hemoglobin levels between 11 and 12 g/dL in patients with CKD, both pre-dialysis and hemodialysis, over a 12-month period.  
   
The companies also announced the results of two other Hematide studies. One assessed safety and tolerability of the compound in CKD, for patients already on hemodialysis, and the other studied Hematide in CKD patients with Pure Red Cell Aplasia (PRCA), a rare but serious condition in which the body produces antibodies to erythropoiesis stimulating agents (ESAs) and the patient’s endogenous erythropoietin. Patients who develop PRCA are usually transfusion-dependent. In this study, treatment of these patients with Hematide resulted in maintenance of hemoglobin levels within target in the absence of transfusions.
   
Dr. David Recker, senior vice president, Clinical Sciences at Takeda said, “The focus for Takeda and Affymax are the needs of patients, which is at the forefront of drug development. Together, we are working to bring this novel potential treatment option to patients with CKD-induced anemia and to the physicians who treat them.”

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. received approval from the FDA for updated labeling for Abilify as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults. Abilify has been approved as a monotherapy for the treatment Bipolar I Disorder in adults since September 2004.
   
The approval of Abilify used in combination with lithium or valproate is based on results from a six-week, randomized, double-blind, placebo-controlled study in adults with manic or mixed episodes of Bipolar I Disorder who had an inadequate response to a two-week, lead-in phase of mood stabilizer monotherapy (lithium or valproate). The study showed that add-on Abilify was superior to lithium or valproate with adjunctive placebo in the reduction of the Young-Mania Rating Scale (Y-MRS) Total Score and the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score for Mania.
   
The FDA also approved a new recommended starting and target dose of 15 mg daily for Abilify monotherapy in the treatment of Bipolar I Disorder in adults. This approval is based on results from two randomized, double-blind, placebo-controlled studies in adults with manic or mixed episodes of Bipolar I Disorder. The study showed that Abilify was superior to placebo in the reduction of the Y-MRS Total Score and CGI-BP Severity of Illness Score for Mania.

Draxis Health

1Q Revenues: $19.2 million  (-9%)

1Q Loss: $2.4 million (earnings were $2.5 million in 1Q07)

Comments: Contract manufacturing revenues were $12.6 million (-11%) due to lower revenues of Genzyme's Hectorol. Sterile products represented approximately 65% of manufacturing revenues compared to 78% in 1Q07. Radiopharmaceutical sales were $6.1 million (+6%). The increase was primarily a result of the inclusion in revenues of a chargeback for freight services beginning on April 1, 2007. 1Q07 earnings benefited from milestone payments of $0.8 million from Shire BioChem, Inc. and $0.5 million from a business interruption insurance claim.

Eurand

1Q Revenues: $24.9 million (+24%)

1Q Loss: $1.6 million (loss of $1.2 million in 1Q07)

Comments: Product sales were $32.0 million (+17%). Royalties were $2.7 million (+103%). R&D expenses were $7.1 million (+21%). Revenues include $1.4 million from the Source CF acquisition.

Enzon Pharmaceuticals, Inc. announced plans to spin off its biotechnology business into an independent company focusing on the development of cancer treatments. Enzon will fund the new company with $150 million, which is expected to provide two to three years of R&D activity. The transaction, which is subject to approval from Enzon's board of directors, is expected to close in the fourth quarter.
   
Jeffrey H. Buchalter, Enzon's chief executive officer, will head the new company and Enzon's current chief financial officer, Craig Tooman will be responsible for the specialty pharmaceuticals business. Each company will have separate management teams.
   
"By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure," said Mr. Buchalter.
   
Enzon will also retain rights to its currently marketed drugs, which include Oncaspar for leukemia, Depocyt for meningitis, Abelcet for fungal infections and Adagen for severe combined immunodeficiency disease. In addition, it will retain rights to its royalty revenues.
   
The company also recently reported 1Q08 results. Revenues were $48.8 million (+18%). Earnings were $1.5 million compared to a loss of $2.8 million in 1Q07.

Quintiles Transnational Corp. has signed an agreement to acquire Eidetics, a privately held consulting firm located in Boston. Eidetics provides research-based market insights and data analytics to support business decision making in drug development and commercialization. No purchase price was disclosed.
   
The acquisition of expands Quintiles' consulting offerings in the areas of product development, commercialization and market access. Quintiles is expanding its consulting practices in an effort to help its pharmaceutical, biotech and medical device clients navigate the complex business environment.
   
"The addition of Eidetics to our Quintiles Consulting business will further strengthen our ability to provide our clients with distinctive, data-driven, strategic solutions to their toughest challenges throughout the product lifecycle," said Jay Norman, president, Quintiles Consulting.
   
"We are excited about the opportunity to become part of the Quintiles organization," said Jim Kirk, partner at Eidetics. "We believe that joining Quintiles Consulting will build upon the past success of Eidetics' business, while providing our clients enhanced clinical, patient and provider data, greater therapeutic depth and access to global resources."

Eli Lilly and Co. received approval from the FDA for Strattera for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults.
   
The safety and efficacy of Strattera in the maintenance of ADHD was demonstrated in an 18-month trial of about 600 pateints aged six to 15 years, who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD. The study showed Strattera was superior to placebo in maintaining continuous efficacy in patients, as measured by the ADHD Rating Scale (ADHD-RS). Additionally, patients taking Strattera had lower relapse rates (3%) as compared to patients taking placebo (12%). Strattera was generally well tolerated. The most common side effects reported in the study were headache and the common cold (nasopharyngitis).  

MedImmune it has enhanced its leadership team to guide the company's expanded product pipeline and core scientific research. Jacqueline Hall has been appointed global vice president, product development team leadership; Lorin Roskos, Ph.D. has been appointed vice president and global head of pharmacokinetics (PK), pharmacodynamics (PD), and bioanalysis in translational sciences, and Beth Wensley has been appointed vice president, project management. In addition, Erik-Jan Dekker, Ph.D. joined the organization as vice president, international regulatory affairs, vaccines, and Reginald Seeto, M.D., joins as vice president, global strategic marketing and portfolio management.

"It is imperative that we have strong leaders who can channel the  
continued growth of our product portfolio, particularly as we seek to  
build out the organization globally," said David M. Mott, chief  
executive officer and president. "Jacqui, Lorin, Beth, E-J and Reg  
have the innate talent, industry experience and drive for results that  
will contribute to MedImmune's continued leadership in biologics."

Based at the Cambridge, UK site, Ms. Hall is responsible for the  
strategic leadership of global product development teams that are  
responsible for the generation and execution of development plans for biologics products. She joined Cambridge Antibody Technology (CAT), now MedImmune, in 2006 as vice president, project management. Previously, Ms. Hall served as project leader at GlaxoSmithKline where she was responsible for the strategic development of product candidates from selection through to market launch. She has also held positions at SmithKline Beecham, Pharmaco-LSR and Schering-Plough.

Dr. Roskos is responsible for managing and integrating preclinical and clinical PK/PD and bioanalytical groups at the company's sites in MD, CA and in England. Dr. Roskos joined the company in 2008 after a year at AstraZeneca as executive director of R&D. Dr. Roskos had previously spent six years at Abgenix, Inc., as the head of PK and toxicology, and has prior experience in PK and drug metabolism at Amgen and Eli Lilly.

Ms. Wensley oversees the global project management team that provides strategic project management in driving forward the product development teams and the overall product development portfolio. Ms. Wensley joined MedImmune in 2001, and has previously served as senior director, CA operations; director, supply chain operations; and associate director, project management.

Based in the Netherlands as the company's new vice president,  
international regulatory affairs, vaccines, Dr. Dekker will lead  
MedImmune's expansion overseas. In his previous position at Baxter  
Healthcare, he was the global senior director, regulatory affairs,  
biologics, responsible for worldwide vaccine and biosurgery marketing authorization applications. Prior to Baxter, Dr. Dekker was the director of regulatory affairs globally at Laboratoire Francais du  
Fractionnement et des Biotechnologies in France.

Dr. Reginald Seeto is responsible for providing strategic guidance on investment decisions and managing commercialization efforts for new products in various stages of development. In his previous position at Organon International, he was the vice president of global marketing, fertility, immunology, oncology and vaccines. Previously, Dr. Seeto was the executive director of marketing at Boehringer Ingelheim Pharmaceuticals and served as an engagement manager at McKinsey & Co.

Hospira

1Q Revenues: $888.7 million (+14%)

1Q Earnings: $65.4 million (loss of $29.4 million 1Q07)

Comments: In the Americas, pharmaceuticals revenues grew was 11% to $462.6 million. However, the "Other Pharmaceuticals" unit, which  
includes injectables and contract revenues, dropped 3% to $121.9  
million. Asia Pacific pharmaceuticals revenue was $49.7 million  
(+58%). 1Q07 loss includes $66.2 million of acquired in-process R&D  
charges related to the Mayne Pharma acquisition.

Patricia Williams has been appointed to the position of vice 
president, commercial operations, Kendle. In this newly created 
position, Ms. Williams will provide leadership for global contract 
execution and negotiation with the company's biopharmaceutical 
customers, including master service agreements and changes in scope. She will be based in Kendle's European headquarters in Crowthorne, England and will report directly to Chris Bergen, chief operating officer.

"I am pleased to welcome Patricia to this key leadership role," said 
Bergen. "As global contracts of $10 million or more continue to drive 
double-digit growth within the CRO industry, her expertise will be 
invaluable in developing and negotiating innovative contract solutions that support both Kendle's profitable growth and meet the changing and long-term needs of our customers."

Ms. Williams has a decade of global contract management expertise and joins the company from one of the world's largest CROs, serving most recently as vice president, global contracts. Her experience also includes serving as assistant global director, Proposal Development and Contract Management for another global CRO.

Kendle

1Q Revenues: $158.8 million (+20%)

1Q Earnings: $5.6 million (+33%)

Comments: The company achieved record service revenues of $114.1  
million and record new business awards of $180 million, both up 20%.  
Total business authorizations were $917 million (+31%). Net service  
revenues by geographic region were 46% in North America, 42% in  
Europe, 7% in Latin America and 5% in the Asia/Pacific region.

Merck plans to reduce the size of its U.S. sales force by 15%, firing 1,200 reps. The move comes in the wake of slowing cholesterol drug sales as well as increased generic competition, according to the company.
   
"Merck is taking this step as part of our previously disclosed, continuing efforts to optimize our cost base and improve Merck's effectiveness and efficiency across all aspects of our business as part of our Plan to Win strategy," said Kenneth Frazier, president, Global Human Health. "With eight successful launches of Merck products approved in the U.S. since 2006 now behind us, and with an unexpected delay in a new product approval, we decided to accelerate the achievement of efficiencies we anticipate gaining as we transition to our new commercial model in the U.S."

New Phase III data for Novartis' Menveo show that the vaccine produced a greater immune response against meningococcal serogroups A, C, W-135 and Y in adolescents 11-18 years of age compared to Sanofi Pasteur's Menactra. Infection with any of these four vaccine-preventable serogroups can lead to bacterial meningitis, an infection of the membrane around the brain and spinal cord, or sepsis, a serious infection of the blood stream. Menveo is an investigational quadrivalent meningococcal conjugate vaccine being developed by Novartis Vaccines.
   
Results of this comparator trial show that adolescents who were immunized with Menveo generated higher levels of antibodies against all four serogroups compared to Menactra. Notably for serogroup Y, among adolescents with low levels of immunity at the time of vaccination, 81% of subjects receiving Menveo generated a protective immune response vs. 54% with Menactra. Serogroup Y causes approximately 39% of meningococcal disease cases in the U.S.
   
Meningococcal disease, a leading cause of bacterial meningitis, is a rare but contagious and potentially life-threatening infection. The US CDC recommends routine immunization with a quadrivalent meningococcal conjugate vaccine for all adolescents 11-18 years of age, college freshmen living in dorms and people in other high risk groups who are two to ten or 19-55 years of age.

Goodwin Biotechnology, Inc. (GBI) has completed the expansion of its cGMP manufacturing space, doubling its capacity. The expansion includes the addition of a 200L and 500L stirred tank bioreactor train to its hollow fiber and perfusion capabilities, and is in response to the growing industry needs for biological manufacturing.
    
Stephanie Finnegan, GBI's chief executive officer, said, “This is the culmination of a dream we envisaged a decade ago.  This was finally made possible by the investment and support of our parent company, Wallace Pharmaceuticals. Our team is eager to scale up our operations to manufacture life-saving therapeutics for late-stage clinical trials. We are proud to be an integral component of the rapidly growing biopharmaceutical presence in Florida.”
   
GBI manufactures a monoclonal antibody, NPC-1C for advanced pancreas cancer, for Neogenix, as well as Q Therapeutics' IgM antibody, a component used in the isolation of stem cells to treat diseases of the central nervous system. Also, a growing service area for GBI involves the conjugation of antibodies and recombinant proteins to various linkers to be used in radio-immunotherapy and the delivery of chemotoxins in small doses directly to the patients’ cancer sites.  
    
"On behalf of Neogenix Oncology, I would like to extend our congratulations to the team at Goodwin Biotech. Completing a major expansion like this is a major undertaking, and its completion marks an important milestone in the company's growth and development. We are particularly pleased to be working with a group of such dedicated and talented individuals, and we all look forward to the day when cancer patients will benefit from our hard work," said Tom Lytle, chief operating officer, Neogenix Oncology.

Bristol-Myers Squibb is selling its therapy and surgical care unit, ConvaTec, to two private equity firms, Nordic Capital and Avista Capital Partners for $4.1 billion. The sale, expected to close in the third quarter, is part of the company's strategy to shift its focus to biopharmaceuticals. This strategy also includes the sale of the company's medical imaging unit for $525 million, as well as plans to sell between 10% and 20% of its Mead Johnson Nutritional unit.
   
"These decisions support our next-generation biopharma strategy," said chairman and chief executive officer, James M. Cornelius. "We will now have additional financial resources to expedite that strategy as we continue to work to help patients prevail over serious diseases."
   
In December, the company announced plans to lay off about 4,300 employees (10% of its work force) and close more than half of its manufacturing plants as part of its goal to save $1.5 billion annually by 2010.

AMRI

1Q Revenues: $53.6 million (+11%)

1Q Earnings: $4.7 million (+47%)

Comments: Total contract revenue increased to $45.3 million in the quarter (+10%).  Discovery Services revenue was $13.3 million (+34%). Development and Small Scale Manufacturing revenue was $13.2 million (+29%). Large Scale Manufacturing revenue dropped to $18.7 million (-11%). Allegra royalties were $8.2 million (+15%).

Eisai Corp. of North America has appointed Cynthia Schwalm president of Eisai Inc. In her new role, Ms. Schwalm will have full operating responsibility for leading Eisai Inc., the U.S. commercial operation of Eisai Co., Ltd.
   
Ms. Schwalm has a strong track record of building high-performing organizations that drive global growth and nearly 25 years of senior healthcare experience in the fields of pharmaceuticals, biotechnology and medical devices. She will report to Lonnel Coats, president and chief operating officer, Eisai Corp. of North America.  
   
"Ms. Schwalm is an exciting addition to our company. She will be instrumental in driving Eisai's integration of MGI Pharrma and strengthening our presence in the U.S. as a top 20 pharmaceutical company," said Mr. Coats.
   
Ms. Schwalm joins the company from Amgen, Inc., where she served as vice president and general manager of the U.S. Oncology Business Unit. In this role she led the 500-person business unit, oversaw all oncology strategy and served as a member of Amgen's senior management team responsible for talent development in medical affairs, drug development, regulatory, and health economic functions.
   
Prior to Amgen, Inc., she held positions of increasing responsibility at various Johnson & Johnson companies. In her last assignment at J&J, she spent several years in the UK as the managing director of Ortho Biotech UK & Ireland.

QSV Biologics has been awarded a cGMP manufacturing contract for a recombinant protein under development by Pfizer. The protein, intended for clinical trials, will be manufactured at QSV's Edmonton facility in Canada. The project, to begin immediately, will include technology transfer, scale-up and cGMP manufacturing.
   
Graeme Macaloney Ph.D., P.Eng., founder, president and chief executive officer of QSV, said, "We are extremely pleased and honored that Pfizer has chosen QSV Biologics from a strong field of contending CMOs as their manufacturing partner for this project. The execution of this contract is the culmination of extended evaluations by the Pfizer organization, reflecting QSV's continuing dedication to quality, speed and value. This project is an extremely good fit for our capabilities and indicative of our ability to respond to the challenging requirements of respected companies like Pfizer."
   
"Pfizer is pleased to engage QSV for the clinical manufacturing of a complex biotechnology product," said Rick Rutter, Ph.D., vice president of Global Biologics in the Pharmaceutical Sciences division of Pfizer Global R&D. "Speed to clinic is of great importance for early development candidates and QSV has a record of delivering quality product on-time and on-budget. QSV will play a supporting role in realizing Pfizer's vision of becoming a top-tier biotherapeutic company."

Pfizer plans to invest $297 million in a new biotech plant in Ireland for the production of experimental medicines. The facility will develop and produce small-scale quantities of products for Phase II and III trials, and will create approximately 100 jobs over the course of three years.
   
The facility at Shanbally in County Cork will be adjacent to Pfizer's existing operation in Ringaskiddy and will be completed by the end of 2009.
   
Nat Ricciardi of Pfizer Global Manufacturing said, "The investment reflects the U.S. group's determination to become a leader in biotech medicine, which is a growing focus for many drug companies worldwide."

Roche has exercised its option to further develop and commercialize Memory Pharmaceuticals' lead nicotinic alpha-7 agonist drug candidate, MEM 3454, for neurological and psychiatric disorders. This decision triggers a $6 million milestone payment and entitles Memory to future payments upon the achievement of additional milestones and royalties on product sales, including a $17 million milestone payment for completion of the ongoing Phase IIa study in cognitive impairment associated with schizophrenia (CIAS). Memory also retains an option to co-promote the drug in the U.S.
   
"We are excited that Roche shares our enthusiasm for MEM 3454 and its potential to address the cognitive deficits associated with debilitating CNS disorders," stated Vaughn M. Kailian, president and chief executive officer of Memory Pharmaceuticals. "We have aggressively advanced MEM 3454 through early-stage clinical trials, including a positive Phase IIa trial in Alzheimer's disease. We believe that Roche's continued commitment to the program, together with its expertise in later-stage clinical development and commercialization, will provide the support and capabilities to realize the full potential of this compound."
   
In the Phase IIa study in Alzheimer's disease, MEM 3454 demonstrated a statistically significant effect on multiple measures of cognition. The compound is currently being evaluated in a Phase IIa trial in CIAS, with results expected in 4Q08. The trial is expected to enroll approximately 160 patients and is designed to assess the safety, tolerability and cognitive effects of three doses of MEM 3454 in CIAS patients. The two companies also recently expanded their schizophrenia development program for MEM 3454 to include a biomarker study, which will be funded by Roche. Memory expects to initiate the biomarker trial this summer, with results expected by early 2009.

The FDA has issued a warning letter to Merck & Co. regarding several manufacturing deficiencies at its main vaccine plant in West Point, PA. The letter states that the FDA found "significant objectionable conditions" in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26th to Jan. 17th. The FDA's warning letter was issued because Merck's response to the FDA report sent after the inspections was considered to be "inadequate to address the serious deviations noted."
   
The same plant recalled two vaccines in December, PedvaxHIB, to prevent Haemophilus influenza type B, and Comvax, a combination vaccine for Haemophilus B and hepatitis B, after sterility problems were discovered.
   
According to the letter, the company didn't thoroughly investigate when vaccine batches failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed anyway. The letter also said the plant didn't have written procedures, tests or other lab controls to ensure "identity, strength, quality, and purity" of products. However, according to the FDA, the issues identified are not likely to affect the safety of the vaccines made at the facility or their availability.
   
"We're committed to working with the FDA to ensure that all these issues are addressed to their full satisfaction," said Amy Rose, a Merck spokeswoman. "We are confident in the quality, effectiveness and safety of our medicines and vaccines," she said. Merck will be submitting additional information to the FDA and will discuss the information in a meeting, which is requested in the warning letter.  

GlaxoSmithKline has made several changes to its corporate executive management team. The appointments will take effect on May 22 when Andrew Witty officially assumes the role of chief executive officer.
   
Mr. Witty remarked, "It is clear that our industry is facing a rapidly changing environment. Demand for innovative medicines and healthcare products continues to grow, however we are also presented with increasing challenges, such as cost containment, regulatory pressures and generic competition."
   
He emphasized the need for GSK's business regions to drive sales growth, and announced new operational structures to expand and improve the company's capability, particularly in emerging markets and in Asia.
  
"Emerging markets, such as Brazil, Russia, India, China and the Middle East, are significant growth drivers of the future. They are already contributing close to 25% of today's market growth and are forecast to grow even faster in the future, around triple the rate of western countries. It is essential that we have an operating structure that is dynamic and responsive to the opportunities in these markets," said Mr. Witty. "I am therefore creating a new Emerging Markets region which will ensure that we devote the focus required to build on our excellent foundations in those markets and truly establish ourselves as a trusted, long-term partner, one that is actively working to address the specific healthcare needs in those countries," he said.
   
A new Asia Pacific region will also be created, which includes Japan and Australia. As part of the changes to business regions, GSK has realigned markets in North America (combining the U.S., Canadian and Puerto Rican businesses) and has established new operational areas in Europe in an effort to maximize opportunities for growth.
   
The company's new corporate executive team includes: Julian Heslop, chief financial officer; Moncef Slaoui, chairman, R&D; Chris Viehbacher, president, North American Pharmaceuticals; Simon Bicknell, senior vice president, company secretary and compliance officer; John Clarke, president, Consumer Healthcare; Marc Dunoyer, president, Asia Pacific; Eddie Gray, president, Pharmaceuticals Europe; Abbas Hussain, president, Emerging Markets; Duncan Learmouth, senior vice president, Corporate Communications & Global Community Partnerships; Bill Louv, chief information officer; Dan Phelan, chief of staff; David Pulman, president, Global Manufacturing & Supply; David Redfern, chief strategy officer; Jean Stephenne, president and general manager, Biologicals; Claire Thomas, senior vice president, Human Resources, senior vice president and general counsel.  

Robert R. Ruffolo, Jr., Ph.D. will retire as president, Wyeth Research and senior vice president, Wyeth, later this year. He will be succeeded by Mikael Dohlsten, M.D., Ph.D.
   
Dr. Ruffolo joined Wyeth in November 2000 and has been responsible for all pharmaceutical R&D for the company, including discovery, drug safety and metabolism, chemical and pharmaceutical development, clinical R&D and research operations.
   
"Bob Ruffolo has been the driving force of our R&D progress, establishing Wyeth as one of the research leaders in the pharmaceutical industry," said Bernard Poussot, Wyeth's president and chief executive officer. "His legacy will be our pipeline, recognized as one of the industry's most innovative. Bob has helped position our company for future growth through robust research and development programs in oncology, women's health, vaccines, inflammation, cardiovascular and metabolic diseases and neuroscience -- led by our multi-platform effort in Alzheimer's."
   
Dr. Ruffolo's work has been recognized throughout his 31-year career in the pharma industry with a number of prestigious awards including: The Pharmaceutical Research and Manufacturers of America's (PhRMA) 2008 Discoverer's Award for his efforts in the discovery and development of Coreg while at GlaxoSmithKline; the 2006 Scrip Award for Management Team of the Year for The Wyeth R&D Executive Team (RADEX)—formed and chaired by Dr. Ruffolo; and the George B. Koelle Award for Scientific Excellence.
    
Dr. Dohlsten was previously executive vice president within Pharmaceutical R&D/Medicine at Boehringer Ingelheim. He was responsible for leading the company's pharmaceutical research in the U.S., Canada, Germany, Italy, Austria and Japan, with major programs in seven therapeutic areas including: respiratory, inflammation/immunology, oncology, virology, cardiovascular, metabolism and CNS. He was also a member of the corporate management team responsible for reviewing all worldwide development projects and licensing opportunities. Prior to joining Boehringer, Dr. Dohlsten spent more than 15 years in various leadership roles in pharmaceutical research including positions with AstraZeneca and Pharmacia & Upjohn.
   
"We look forward to Dr. Dohlsten's leadership as we work together to continue our success at Wyeth Research," said Mr. Poussot. "His experience with industry in a broad range of therapeutic areas, and his vision going forward, match well with our scientific objectives. We know Mikael's global experience and perspective will be an inspiration to Wyeth's outstanding research teams."

In a busy week for Dr. Reddy’s Laboratories, the company has completed its acquisition of The Dow Chemical Company’s Dowpharma Small Molecules Business along with its Mirfield and Cambridge, UK sites. Financial terms of the transaction were not disclosed.
   
The acquisition includes the relevant business, customer contracts, associated products, process technology, intellectual property and trademarks, as well as the transfer of the Mirfield and Cambridge facilities. Employees directly related to the business at each site will become part of Dr Reddy’s. Dr. Reddy’s will also have a non-exclusive license to Dow’s Pfenex Expression Technology for biocatalysis development.

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