Schering-Plough received approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Temodal capsules for the treatment of malignant glioma.

The approval follows a priority review of the J-NDA submission, which was granted in September of 2005 in order to satisfy an unmet medical need in Japanese patients. Temodal, marketed as Temodar in the U.S., is approved in 77 countries. Temodal will become available once pricing is determined by the Japanese MHLW.

Malignant gliomas are primary brain tumors that develop from glial cells. Approximately 30% of primary brain tumors are gliomas, which affect approximately six to eight people per 100,000 people worldwide. Both glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are types of high-grade gliomas. GBM is the most common and aggressive form of primary brain tumor. Approximately 2,500 patients are diagnosed with malignant glioma in Japan each year.

Merck's NDA for MK-0431A, an oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for review by the FDA. The company expects a decision on the NDA by the end of March 2007. The company is also filing for approval in countries outside the U.S.

MK-0431A is an investigational treatment for type 2 diabetes that combines the novel approach to controlling blood sugar of Januvia, an investigational DPP-4 inhibitor, with metformin, a widely-prescribed medication for type 2 diabetes, into a single tablet. DPP-4 inhibitors work by enhancing the body's own ability to lower blood sugar when it's elevated. The combination drug is designed to provide a treatment option for patients who need two or more oral agents to help control their blood sugar.

Abbott received FDA approval for Humira for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). AS is an autoimmune disease affecting the spine and large peripheral joints that causes inflammatory back pain and stiffness and also can be associated with other inflammatory diseases of the skin, eyes and intestines. In its severe form, AS can result in complete spinal fusion, causing extreme physical limitation and loss of quality of life.

Humira is also approved by the FDA to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and clinical trials are currently under way evaluating Humira in other autoimmune diseases. Humira received approval in the EU to treat patients with severe, active AS in June of this year.  

Metrics, Inc. has promoted Gerald D. Sakowski to senior vice president of business operations. In his new role, Mr. Sakowski will oversee all of the company’s operations and will also focus on continued growth through business development.

“I can’t think of a more capable person to lead our company’s operations than Jerry,” said Phil Hodges, chief executive officer. “With more than 18 years of experience in this ever-evolving industry, Jerry has the knowledge, skills and sound judgment necessary to ensure that Metrics remains a leader among contract pharmaceutical companies.”

Mr. Sakowski has spent his entire career working within the contract testing services industry. He worked more than six years with Oneida Research Services in Whitesboro, NY, serving as a group leader in its physical testing services division. After serving at Applied Analytical Industries in Wilmington, N.C., as its analytical business manager, he joined Metrics in 1997 as director of marketing and sales, later becoming director of business development. He was promoted to vice president of business development in 2002.

Schering-Plough Corp. received recommendation for approval of Suboxone from the Committee for Medicinal Products for Human Use (CHMP) of the EMEA. Suboxone sublingual tablets are for the substitution treatment of opioid dependence, within a framework of medical, social and psychological treatment.

Substitution treatment for opioid dependence is when opiate misuse is replaced with an oral opioid medication, such as buprenorphine or methadone, to deter intravenous misuse. Suboxone is intended for use in adults and adolescents 15 years of age and older who have agreed to be treated for addiction.

The CHMP recommendation will serve as the basis for a European Commission approval, which would result in Marketing Authorization with unified labeling valid in the 25 EU member states as well as in Iceland and Norway.

InterMune

2Q Revenues: $24.1 million (-10%)

2Q Loss: $44 million* (loss of $23.7 million in 2Q2005)

YTD Revenues: $48.5 million (-12%)

YTD Loss: $56.8 million (loss of 41.1 million YTD2005)

Comments: Revenues for the quarter were comprised solely of Actimmune sales. 2Q2005 revenues consisted of Actimmune and Aralast sales. The company stopped co-promoting Aralast in December 2005. R&D expense for quarter was $24.8 million, up 38%

*Results for the quarter include a $30 million reserve related to a proposed settlement with the government regarding promotional activities for Actimmune.

Enzon Pharmaceuticals, Inc. and Santaris Pharma have entered into a collaboration to develop and commercialize a series of RNA Antagonists based on Santaris Pharma's LNA technology and utilizing Enzon's oncology drug development expertise.

Under the terms of the agreement, Enzon is licensing two of Santaris Pharma's preclinical development compounds, the HIF-1 alpha antagonist (SPC2968) and the Survivin antagonist (SPC3042), and six additional proprietary RNA Antagonist candidates for oncology drug targets selected by Enzon. Enzon will have exclusive rights to develop and commercialize these compounds in the U.S. and other non-European territories. Santaris will retain commercialization rights in Europe. Also, Enzon will have the opportunity to explore the potential of its next-generation PEGylation Customized Linker Technology for additional benefits.

Enzon will make an initial up-front payment of $8 million to Santaris Pharma, and an additional $3 million upon the identification of certain LNA targets. Additional payments will be made based on successful pre-specified discovery, development and regulatory milestones, representing a total of more than $200 million. Enzon will pay royalties to Santaris Pharma on net sales of RNA Antagonist products resulting from the collaboration in non-European territories.

"This important collaboration is in line with our strategic goal of advancing our presence in oncology while leveraging our access to proprietary new technologies," said Jeffrey H. Buchalter, Enzon's chairman and chief executive officer. "This partnership will greatly enhance our R&D pipeline with the addition of two new clinical programs in the next six-to-12 months and another six preclinical compounds entering the pipeline over the next few years."

"We are delighted to be in partnership with Enzon Pharmaceuticals, whose new management has extensive experience of developing and commercializing innovative oncology drugs, making them an ideal partner for Santaris," said Keith McCullagh, president and chief executive officer, Santaris Pharma. "Together we are committed to building a unique portfolio of RNA Antagonist drugs with the potential to address some of the underlying genetic causes of disease and improve patient outcomes in the treatment of cancer."

Genentech, Inc. has appointed Gary Harbour, Ph.D. to vice president, commercial quality, South San Francisco and has promoted Robert Andreatta to controller.

Dr. Harbour will be responsible for leading the quality function in all commercial bulk, filling and packaging operations in South San Francisco. He will report to Vince Anicetti, vice president, commercial quality. He joins the company from Pfizer, where he was senior director of global manufacturing quality operations Europe and a member of Pfizer's quality leadership team. Prior to that, Dr. Harbour held various quality and global supply vice-presidential roles with Upjohn and then Pharmacia and served on the board of directors for various international companies.

Mr. Andreatta will be responsible for accounting and reporting, financial services, collaborations finance, and tax and will report to John Whiting, vice president, finance and chief accounting officer. Mr. Andreatta joined the company in 2003 as director, collaborations finance. He has held positions of increasing responsibility, including director, corporate accounting and reporting, and senior director, corporate finance and assistant controller. Prior to his employment with Genentech, he was chief operating officer and chief financial officer at HopeLink Corp. Prior to that, he was an audit partner with KPMG.

Bristol-Myers Squibb

2Q Revenues: $4.9 billion (flat)

2Q Earnings: $667 million (-34%)

YTD Revenues: $9.5 billion (+1%)

YTD Earnings: $1.4 million (-10%)

Comments: U.S. pharmaceutical sales increased 5% to $2.2 billion driven by growth of Plavix, Avapro/Avalide, Erbitux, Abilify, Reyataz and Sustiva, and sales of new products Emsam and Orencia. These sales partially offset the loss of exclusivity of Pravachol. R&D expenses increased by 14% to $740 million in the quarter. International pharmaceutical sales were down 8% to $1.7 billion mainly due to a decline in Pravachol and Taxol sales resulting from increased generic competition in Europe. Sprycel for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia and Atripla for HIV, recently received approval.

Kendle

2Q Revenues: $81.9 million (+34%)

2Q Earnings: $4.3 million (+198%)

YTD Revenues: $159.1 million (+33%)

YTD Earnings: $9.2 million (+156%)

Comments: Service revenues for the quarter were $62.1 million, up 24%. New business awards were $84 million and contract cancellations for the quarter were $17 million. Total business authorizations, which consist of backlog, totaled $350 million. Revenues by geographic region for the quarter were 60% in the Americas, 37% in Europe and 3% in the Asia-Pacific region.

Millennium

2Q Revenues: $120 million (+9%)

2Q Loss: $17.9 million (loss of $44 million in 2Q2005)

YTD Revenues: $242.6 million (+4%)

YTD Loss: $38.5 million (loss of $80 million YTD2005)

Comments: U.S. Velcade sales increased 34% to $58.8 million in the quarter. Royalties associated with Integrilin Injection worldwide sales and Velcade ex-U.S. sales were $34.2 million for the quarter. Revenue from strategic alliances increased 42% to $27.2 million in the quarter. R&D expenses were down 9% to $79 million in the quarter.

Pfizer plans to apply for marketing approval for heart drug torcetrapib as a single pill, rather than as a combo-drug with Lipitor, according to a company statement. Torcetrapib is being evaluated in clinical trials and is approximately a year and a half from potential approval. Clinical trials show that torcetrapib substantially raises the levels of high-density lipoproteins (HDL), the "good" cholesterol, providing a novel approach to preventing heart attacks and strokes. Analysts predict that it could reach sales of several billion dollars annually.

Previously, Pfizer planned to sell torcetrapib only in combination with Lipitor, one of several medicines called statins that lower levels of low-density lipoproteins (LDL), or "bad" cholesterol, according to the company. However, by offering torcetrapib only in a combination pill, the company would have forced patients taking other statins—such as Merck's Zocor—to switch to Lipitor to gain the benefits of torcetrapib.

Controversy around the combination plan consisted of cardiologists stating that not all patients can easily switch from one statin to another, and some cannot take statins at all. In addition, there were commercial and legal challenges relating to whether offering torcetrapib only with Lipitor might violate antitrust laws. Pfizer previously contended that, since the drug would almost always be prescribed in conjunction with a statin, it would be too costly to test each major statin with torcetrapib.

According to Dr. Joseph Feczko, Pfizer's chief medical officer, "Pfizer expects to offer torcetrapib as a stand-alone drug as well as in combination with Lipitor. The change comes in part because of the criticism Pfizer has faced. We didn't appreciate how this would be perceived." As a result, patients will be able to take torcetrapib alongside whatever statin they now use, or even as a stand-alone pill, although most doctors will likely prescribe it with a statin.

Hollister-Stier Laboratories has purchased seven acres of land adjacent to its Spokane, WA facility. The purchase of the 294,535-sq.-ft. lot provides the company with the additional space needed for the $30 million expansion that begins this fall, as well as room for future expansion. The company will install a new high-speed filling line to more than double its current capacity. The new filling line and cleanroom complex will be constructed on a portion of the land closest to the current facility. This new line can handle 2 mL - 100 mL vials and fill approximately 400 vials per minute.

"We recognize what our customers' value," stated Anthony Bonanzino, Ph.D., president and chief executive. "HollisterStier's commitment to providing our customers with a high quality manufacturing facility in addition to superior service is our first priority. We are pleased with the recent land purchase as it reflects our ongoing investment in the future of our customers, employees, services and our community."

Avalon Pharmaceuticals and ChemDiv, Inc. have entered into a collaboration for the discovery and development of small molecule oncology therapeutics. Avalon will use its AvalonRx platform to discover new active compounds in screens against selected targets and target pathways. ChemDiv will provide Avalon access to its Discovery outSource services platform, including the largest commercially available chemical library, as well as medicinal and synthetic chemistry for the discovery and development of new active compounds.

The two companies will share development costs and the value of any lead candidate resulting from their research efforts. Additional terms of the agreement provide Avalon with the right to select 200,000 compounds from the ChemDiv library for use in all of Avalon's discovery programs.

"This is a classic win-win situation for both companies," stated Kenneth C. Carter, Ph.D., president and chief executive officer of Avalon Pharmaceuticals. "We are pleased to partner with ChemDiv, where we are both able to leverage expertise in the ongoing effort to discover new cancer therapeutics through the combination of our AvalonRx drug discovery platform and ChemDiv's compound library, chemistry resources and expertise."

"We are excited about this partnership with Avalon," said Nikolay Savchuk, president and chief executive officer of ChemDiv, Inc. "This collaboration is based on the synergy of ChemDiv's discovery assets and research resources along with Avalon's unique drug discovery engine. We believe that this combination of both Avalon's and ChemDiv's technologies will result in a reduction of the time and effort required to identify and develop new breakthrough therapeutics."

AMRI has entered a multi-year drug substance manufacturing agreement with New River Pharmaceuticals, Inc. Under the agreement, AMRI will manufacture the API in New River's compound, NRP104, a treatment for attention deficit hyperactivity disorder (ADHD) that is currently under review with the FDA. AMRI participated with New River in the development of the chemical process to manufacture NRP104. Financial terms were not disclosed.

"AMRI is delighted to continue its relationship with New River Pharmaceuticals," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D. "We are well positioned to manufacture this compound based on our long history of manufacturing, as well as our strength in chemical development. Our expertise and specialized capabilities in the area of active ingredient manufacturing provide a unique and value-added capability to AMRI customers."

Krish Krishnan, New River's chief financial officer and chief operating officer, commented, "We are confident that AMRI is a solid choice for manufacture. AMRI has the current capability of delivering a quality product in a timely manner, leading us to conclude that it is the best candidate for manufacturing NRP104 for an expected product launch in the first quarter of 2007."

Covance

2Q Revenues: $335 million (+14%)

2Q Earnings: $35 million (+32%)

YTD Revenues: $656 million (+14%)

YTD Earnings: $68 million (+32%)

Comments: The company achieved record net orders of $555 million in the quarter, driving its backlog up 31% to nearly $2 billion. Early development revenues for the quarter grew 11% to $156 million and operating income increased 16% to $39 million in the quarter. Late-stage development revenues were up 16% to $179.5 million and operating income increased 6% to $28.5 million.

Enzon Pharmaceuticals received approval from the FDA for its sBLA for Oncaspar, an oncology product for use as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). Oncaspar had previously been indicated for patients with ALL who require L-asparaginase in their treatment, but developed hypersensitivity to the native forms.

The FDA approved the new first-line indication for Oncaspar based on data from two studies conducted by the Children's Cancer Group (CCG), CCG-1962 and CCG-1991, with safety data from more than 2,000 pediatric patients.

Acute Lymphoblastic Leukemia is an aggressive blood cancer, which will affect almost 4,000 people in 2006, according to the American Cancer Society. ALL is the most common form of cancer in children, representing 23% of cancer diagnoses among those younger than 15 years of age.

Czura Thornton Ltd. has acquired Chiltern International for an undisclosed amount. Czura Thornton, a private investment group led by Antony Czura and Nick Thornton, has acquired more than 90% of Chiltern, a global CRO, with the remainder expected to be acquired over the next few weeks.

Chiltern runs national and international Phase I to Phase IV trials across a broad range of therapeutic areas. The company has offices throughout the U.S., Europe and India, with headquarters in Slough, UK, and Carlsbad, CA. Chiltern provides clinical operations, project management, bio-analytical, data management, biostatistics, medical writing, quality assurance and regulatory and medical affairs services to the pharmaceutical, biopharmaceutical and medical device industries. The company also offers clinical contract personnel services.

Simon Garnham, co-founder of Chiltern, will step down as chief executive officer effective immediately. A new chief executive will be announced soon. Nick Thornton, who has been named executive vice chairman, will also act as chief executive until the announcement. Roland Boyd has been appointed chief financial officer.

“We have long admired Chiltern’s reputation in the industry for providing a comprehensive range of high quality products and excellent customer service,” said Mr. Thornton. “We look forward to bringing the investment and resources needed for the next phase of the Company’s growth as a leading, global, full-service clinical CRO. We are committed to ensuring a smooth transition for the customers and employees of Chiltern, with no impact in the day to day operation of the business anticipated as a result of this change in ownership.”

Mr. Garnham commented, “My family is delighted to have found a buyer that understands our business so well and is committed to maintaining our high quality service offering and to our most important resource, our people, who have worked so hard for Chiltern’s success. We look forward to seeing Chiltern’s continued growth and would like to thank all our staff, suppliers and customers for their support over many years.”

Schering-Plough

2Q Revenues: $2.8 billion (+11%)*

2Q Earnings: $237 million (loss of $70 million in 2Q2005)**

YTD Revenues: $5.4 billion (+10%)

YTD Earnings: $630 million (earnings were $78 million YTD2005)

Comments: Sales growth drivers for the quarter included Remicade, Nasonex and Peg-Intron. Remicade sales were up 31% to $307 million; Nasonex sales were up 21% to $242 million; Peg-Intron sales were up 25% to $226 million. R&D spending increased 22% to $539 million in the quarter.

* Results do not include sales of the cholesterol products marketed in partnership with Merck. Global cholesterol joint venture sales, which include Vytorin and Zetia, totaled $958 million in the quarter compared to sales of $514 million in 2Q2005. Including an adjustment of 50% of global cholesterol joint venture net sales, the company's sales would have totaled $3.3 billion.

** Special charges for 2Q2005 included an addition of $250 million to the company's litigation reserves relating to the Massachusetts investigation into the company's practices regarding average wholesale price.

Merck

2Q Revenues: $5.8 billion (+6%)

2Q Earnings: $1.5 billion (+108%)*

YTD Reveneus: $11.2 billion (+3%)

YTD Earnings: $3 billion (+44%)

Comments: Zocor sales were $990 million, down 14% due to loss of marketing exclusivity. Singulair sales reached $950 million, up 30%. Rotateq sales were $31 million for the quarter. The Merck/Schering-Plough partnership reported global sales of Zetia and Vytorin reached $973 million as compared to $507 million in 2Q2005. R&D expenses were $1.2 billion for the quarter, up 24%, including $296 million recorded in the quarter for acquired research resulting from the GlycoFi acquisition. The company received product approvals for Gardasil and Zostavax in the quarter.

*Results reflect restructuring costs and a credit of $7 million related to separations as well as gains on the sales of facilities associated with the company's restructuring program.

ImClone Systems and Merck KGaA have revised their licensing agreement for cancer drug Erbitux. Under the terms of the new agreement, Merck will sublicense certain intellectual property rights from ImClone related to the development of antibodies targeting a protein known as epidermal growth factor to Takeda Pharmaceutical Co.

Merck will pay ImClone $3.2 million when the agreements are executed and an additional $6.3 million upon ImClone's written consent to the sublicense. Also, Merck has increased its royalty for all sales of Erbitux outside the U.S. and Canada, effective July 1.

Amgen

2Q Revenues: $3.6 billion (+14%)

2Q Earnings: $14 million (earnings were $1 billion in 2Q2005)*

YTD Revenues: $6.8 billion (+13%)

YTD Earnings: $1 billion (-46%)

Comments: Worldwide sales of Aranesp increased 26% to $1 billion and combined sales of Neulasta and Neupogen increased 12% to $1 billion in the quarter. North America sales of Enbrel increased 13% to $724 million. Sales of Epogen were down 5% to $613 million. R&D expenses increased 29% to $729 million in the quarter.

*Earnings for the quarter and YTD reflect acquired in-process R&D of $1.1 billion related to the acquisition of Abgenix.

Lilly

2Q Revenues: $3.9 billion (+5%)

2Q Earnings: $822 million (loss of $252 million 2Q2005)*

YTD Revenues: $7.6 billion (+6%)

YTD Earnings: $1.7 billion (earnings were $484.6 million YTD2005)

Comments: Sales increase for the quarter was driven by the company's newer products and accelerating sales of Cymbalta, up 92% to $310.4 million. Newer products--Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris and Yentreve--collectively grew 48% to $920.2 million, and accounted for 24% of total sales, up from 17% in 2Q2005. Lilly ICOS joint-venture income was $22.5 million, compared with a loss of $0.5 million in 2Q2005. This increase was due to growing Cialis sales and decreased selling and marketing expenses. The company submitted an NDA for Cymbalta for generalized anxiety disorder in the quarter.

*Results for the quarter and YTD reflect a product liability charge for Zyprexa of $1.1 billion.

Pfizer

2Q Revenues: $11.7 billion (+3%)

2Q Earnings: $2.4 billion (-30%)*

YTD Revenues: $23.5 billion (flat)

YTD Earnings: $6.5 billion (+73%)**

Comments: Lipitor, Celebrex, Geodon and Lyrica performed well in the quarter: Lipitor sales were up 9% to $3.1 billion; Celebrex sales were $471 million, up 17%; Geodon sales were up 14% to $165 million and Lyrica sales were $271 million, up 38%. The company received approval/launched four products: Zeven, Eraxis, Exubera, and Chantix.

*Results for the quarter includes an impairment charge of $1.2 billion related to the developed technology rights and the write-off of machinery and equipment for Bextra. Results also include a merger-related in-process R&D expense write-off of $513 million related to the acquisition of Rinat Neurosciences Corp.

**YTD earnings include the tax provision related to the repatriation of foreign earnings of $1.7 billion. Results reflect the sale of the Consumer Healthcare business to Johnson & Johnson for approximately $16.6 billion, as discontinued operations.

Wyeth

2Q Revenues: $5.2 billion (+9%)

2Q Earnings: $1 billion (+9%)

YTD Revenues: $10 billion (+8%)

YTD Earnings: $2.2 billion (+6%)

Comments: Pharmaceuticals revenue growth of 11% for quarter was driven by Enbrel and Prevnar. Enbrel sales (outside the U.S. and Canada) were $370 million, up 36% and Prevnar sales were $518 million, an increase of 60%. The company submitted two NDAs in the quarter, for bazedoxifene (osteoporosis) and desvenlafaxine succinate (vasomotor symptoms). Also, Tygacil was approved in Europe.

Gilead Sciences has agreed to exercise its option to purchase Corus Pharma for $365 million. Gilead anticipates that the deal will close in the 3Q2006, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and satisfaction of other closing conditions.

Also, Gilead and Novartis Vaccine and Diagnostics, Inc. have entered into an agreement whereby Novartis has agreed to dismiss its ongoing litigation with Corus for an undisclosed payment.

In April 2006, Gilead invested $25 million in Corus, becoming the second largest shareholder in the company and gaining an exclusive option to purchase the remaining shares of the company.

Novartis has announced plans to build the first cell culture-derived influenza vaccines manufacturing plant in the U.S. at a site in Holly Springs, NC. Construction of the $600 million site is expected to begin in 2007. At the same time, Novartis announced the first EU submission of a cell culture-derived influenza vaccine. The submission was made in June. U.S. clinical trials started in 2005 and are ongoing.

"We are taking the lead in moving flu cell culture vaccine manufacturing closer to a commercial reality now that the site for a U.S. manufacturing plant has been chosen and the first EU submission for a flu cell culture vaccine have been completed," said Dr. Daniel Vasella, Novartis' chairman and chief executive officer. "Novartis is pioneering this innovative vaccine technology to bring reliability and flexibility of the manufacturing process to a next level and be able to meet the growing need for seasonal influenza vaccines and to quickly respond to a potential pandemic influenza threat once the factory has been completed."

A total investment of approximately $600 million, including a recent $220 million award from the Department of Health and Human Services, is planned to complete the Holly Springs site. Novartis is also making additional investments in its site in Marburg, Germany to expand capacity for flu cell culture vaccines production in Europe. The vaccines for the EU and U.S. clinical trials were produced at the Marburg site, where the product was developed.

Once completed and approved for commercial production, the planned NC site is expected to annually produce up to 50 million doses of seasonal trivalent flu vaccines, which will be for use in the U.S., according to Novartis. In the event of an flu pandemic, the site is planned to have a capacity of up to 150 million monovalent doses annually within six months of a pandemic declaration.

MDS Pharma Services has launched a new therapeutic focus on metabolic disorders such as diabetes, dyslipidemia, obesity and metabolic syndrome ─conditions that damage the cardiovascular system. The initiative builds on the business unit's expertise in biomarkers and its experience in managing global clinical trials involving these increasingly prevalent conditions. According to the Centers for Disease Control and Prevention, one-third of the adult population in the U.S. is currently obese, and more than 200 million people worldwide have diabetes.

"The top pharmaceutical companies have programs in these areas, and in 2006 about a quarter of our Global Clinical Development revenue is expected to come from work associated with metabolic disorders," said MDS Pharma Services president David Spaight. "We have made a strategic decision to become a leader in this arena and have a dedicated team working in metabolic disorders. MDS Pharma Services' extensive panel of biomarkers for metabolic disorders and our expertise in this area are critical to this work."

The Global Clinical Development division of MDS Pharma Services is currently managing more than 12 trials involving metabolic disorders. These include large cholesterol studies in North and South America, a global obesity morbidity study, and large diabetes studies in Europe and the Americas.

BioWisdom, Ltd. has extended its existing collaboration with AstraZeneca. The two companies have been working together to build specific Intelligence Networks to enhance AstraZeneca's drug discovery process. AstraZeneca will further evaluate BioWisdom's Sofia Platform for the development of Intelligence Networks in other areas of the company. Financial details were not disclosed.

"We have been working with BioWisdom for the past two years and have been impressed by the potential of its latest technology development to enhance our scientific understanding of the cause and effects around drug toxicity" said David Cook, associate director, pathways capability at Astra Zeneca. "By understanding the effects previous drugs have exhibited on drug toxicity biomarker profiles, in combination with clinical disorders and other factors, we hope to be better able to guide our own discovery and development activities in light of this new knowledge."

"In today's pharmaceutical R&D environment, being able to support a critical business decision by a systematic assessment of relevant knowledge is a significant competitive advantage. By using our Intelligence Networks, AstraZeneca will be in a better position to make more informed decisions based on a coherent picture of all available data." said Gordon Smith Baxter, chief executive officer of BioWisdom." He added, "The leading pharmaceutical companies increasingly view Intelligence Networks as the new best practice for improved information transparency and decision making, and are coming to BioWisdom. This is a core part of our business and it is growing steadily."

Tandem Laboratories is offering Good Laboratory Practices (GLP) compliant assay services using BioVeris Corp.’s products. Tandem acquired the BioVeris' M-Series Analyzer, reagents and BioVerification training to expand their offering of assay technologies for biopharmaceutical and pharmaceutical customers. Tandem added the new methods to offer greater sensitivity, range and drug tolerance for GLP- compliant immunogenicity.

Tandem's vice president and general manager of the biomarker and immunoanalytical division, Ira DuBey, said, "We chose BioVeris' assay platform to complement our other methodologies for its advantages in assay performance, especially in pharmacokinetic and immunogenicity assays. Today, many more of our clients ask for BioVeris' ECL detection for their assays, and Tandem Laboratories is focused on delivering the highest quality testing coupled with customized service to our clients."

BioVeris' chief executive officer, Samuel Wohlstadter, said, "We are pleased that Tandem Laboratories is the first CRO to adopt the M-SERIES platform for bioanalytical testing. We welcome Tandem as an experienced and well trained company that can support life science customers."

With the increased number of biopharmaceutical products on the market, the two companies believe that immunogenicity testing will become a large percentage of pharmaceutical drug development tests.

Eli Lilly and Co. received approval from the FDA for Gemzar for use in the treatment of women living with recurrent ovarian cancer. This marks the fourth approval Gemzar has been granted by the FDA.

The approval specifies that Gemzar be used in combination with carboplatin, a widely-used agent, for women with advanced ovarian cancer that has relapsed at least six months after initial therapy. Clinical data showed that patients treated with a combination of Gemzar and carboplatin experienced a significant improvement in progression-free survival and response rates compared to carboplatin alone.

Gemzar has been on the market in the U.S. for 10 years and is approved in more than 90 countries. It is Lilly's second best-selling drug and last year generated sales of $1.3 billion.

PPD

2Q Revenue: $309 million (+26%)

2Q Earnings: $36.4 million (+75%)

YTD Revenue: $608 million (+24%)

YTD Earnings: $78 million (+46%)

Comments: Development segment revenue for the quarter was $278.9 million, up 24%. Discovery sciences segment revenue was $4.6 million, up 27%. R&D expense for the quarter was $1.3 million compared to $11.4 million in 2Q2005. This decline was related to the July 2005 transfer of PPD's development and commercialization rights to the dipeptidyl peptidase IV (DPP4) inhibitor program to Takeda San Diego, Inc. Revenue for the second quarter 2006 included reimbursed out-of-pocket expenses of $25.5 million, compared to $16.6 million in 2Q2005.

Johnson & Johnson
 
2Q Revenues: $13.4 billion (+5%)

2Q Earnings: $2.8 billion (+7%)

YTD Revenues: $26.4 billion (+3%)

YTD Earnings: $6.1 billion (+13%)

Comments: Worldwide pharmaceutical sales were $5.8 billion for the quarter, up 3.2%. Sales growth for the quarter was driven by Risperdal, Remicade, Topamax, and Concerta. During the quarter, the FDA approved Ionsys, the first needle-free, patient-activated analgesic system and Remicade for reducing signs and symptoms in pediatric patients with moderately to severely active Crohn's disease.

Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals have received Fast Track designation from the FDA for their application of the intravenous form of methylnaltrexone, which is being investigated for the treatment of postoperative ileus. The FDA Fast Track designation facilitates development and expedites regulatory review of drugs that the FDA recognizes to potentially address an unmet medical need for serious or life-threatening conditions.

Methylnaltrexone is an investigational drug that is being studied as a treatment for the peripheral side effects of opioid analgesics that does not affect the pain relief provided by these analgesics. Methylnaltrexone is being developed in three dosage forms: subcutaneous and oral forms as treatment platforms for opioid-induced constipation, and an intravenous form for postoperative ileus. In December 2005, Wyeth and Progenics Pharmaceuticals entered into a collaboration agreement to develop and commercialize methylnaltrexone.

The Fast Track designation will allow the companies to submit the NDA on a rolling basis, and also to request priority review, cutting the review period from 10 months to six.

Progenics has completed a Phase II study of intravenous methylnaltrexone showing accelerated gastrointestinal recovery in patients following segmental colectomies. In the 2006 third quarter, Wyeth and Progenics plan to initiate global Phase III studies in patients at high risk for developing postoperative ileus. An NDA submission is planned for the intravenous form in late 2007 or early 2008.

Schering-Plough has appointed John M. Carroll as vice president, Global Internal Audits. He will be a member of the Operations Management Team and an elected officer of the company. Mr. Carroll will report to Brent Saunders, senior vice president, Global Compliance & Business Practices, and succeeds Anne Renahan, who recently was appointed vice president, finance, Consumer Health Care.

Prior to joining Schering-Plough, Mr. Carroll was with American Standard Companies where he was most recently vice president and general auditor and an elected officer. Before American Standard, he worked at Bristol-Myers Squibb, holding a number of senior finance positions. He began his career with Ernst & Young.

Auxilium Pharmaceuticals has signed an agreement with UK-based Cobra Biologics to manufacture additional cGMP and BLA batches for AA4500. The companies anticipate that this manufacturing activity will be completed by the end of 2006.

The agreement does not cover long-term production of AA4500 for commercial sale, but the companies will be discussing a non-exclusive long-term supply agreement for AA4500 during the second half of 2006.

AAIPharma has appointed Martin Tyson to the position of senior vice president, Information Systems and Technology. Mr. Tyson will be responsible for all aspects of the company's information systems worldwide. He brings to AAIPharma more than 30 years of pharmaceutical experience designing and managing information technology systems. Mr. Tyson's experience includes IT systems integration, business process and system reengineering, strategic planning, and the development and deployment of validated systems meeting regulatory requirements worldwide.

Mr. Tyson previously held positions of increasing responsibility at Glaxo Wellcome  and Quintiles Transnational, where he served as senior vice president and chief information officer.

BioMachines Inc. has launched a new services division: Applied Proteomics Services. The group provides diverse proteomic sample preparation, fractionation and mass spectrometry services for state-of-the-art analysis. Applied Proteomics Services will utilize its fully integrated technology platform to provide real advantages in data quality, throughput and the ability to review, interpret and troubleshoot experimental outcomes.

The new division arises from an agreement with the University of Massachusetts Medical School's Proteomic Fractionation Group (PFG); BioMachines will leverage the experience of UMMS researchers Sunny Tam, Ph.D. and Douglas Hinerfeld, Ph.D. to support the Applied Proteomics Services group.

"This new relationship combines the deep knowledge and expertise of the PFG team with proven sample preparation automation equipment, to offer our customers the best combined set of resources on the market," said Tom Larrichio, BioMachines' chief executive officer. "Protein-based biopharmaceuticals are enjoying great commercial success. Specifically, monoclonal antibodies are a very exciting area, where sales are projected to grow from a $15 billion market in 2005 to a $27 billion market in 2010. This is in addition to protein analysis that is required for small-molecule therapies. We are focused on this growing market by providing expertise in protein analysis through a fee-for-services model."

Alexion Pharmaceuticals will buy a new facility in Rhode Island to make its experimental drug, Soliris, for a rare blood disorder, according to a Reuters report. Soliris is intended to treat Paroxysmal Nocturnal Hemoglobinuria, which affects between 8,000 and 10,000 people in the U.S. and Europe and causes red blood cells to be attacked and destroyed by the body's own immune system. The drug will be filed in the second half of 2006 with the FDA and EMEA. The drug Soliris is presently manufactured by Lonza Biologics of Switzerland at a plant in Portsmouth, New Hampshire.

The 55,000-sq.-ft. plant in Smithfield, RI, was previously used by Dow Chemical as a biopharmaceutical facility. Alexion will retrofit the plant to include two 10,000-liter bioreactors and associated purification suites with a pilot plant. The company hopes to begin manufacturing Soliris at the Rhode Island plant in 2008.

The U.S. District Court for the District of Delaware has determined that Forest Laboratories' patent covering escitalopram, the active ingredient in Lexapro, is both valid, enforceable and infringed by Ivax/Teva's proposed generic product. The ruling confirms patent rights for Lexapro, which expire in March 2012, for Forest and its partner H. Lundbeck A/S of Denmark.

CuraGen Corp. and TopoTarget A/S have started a Phase I/II clinical trial evaluating the safety and potential efficacy of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of inoperable hepatocellular (liver) cancer. This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for PXD101.

The trial is an open-label study being led by Dr. Winnie Yeo at the Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales Hospital in Shatin, Hong Kong. The Phase I portion of the study aims to establish the maximum tolerated dose (MTD), pharmacokinetics, and safety profile of PXD101 for patients with inoperable hepatocellular cancer. Approximately 15 patients will be enrolled in the dose escalation portion of the study and receive PXD101 in continuous three-week cycles until disease progression. Following determination of the MTD, the Phase II portion of the trial will be initiated and enroll up to 29 additional patients to assess the safety and potential efficacy of PXD101. Assessment of tumor response will be evaluated using the RECIST criteria. Secondary pharmacological studies evaluating histone acetylation, induction of cell-cycle arrest or apoptosis, and changes in gene expression will be conducted in a subset of enrolled patients.

"Hepatocellular carcinoma, also known as liver cancer, is an aggressive form of cancer that has limited treatment options for those patients who have inoperable disease. Preclinical research suggests that HDAC inhibitors, such as PXD101, have activity against hepatocellular carcinoma cell lines, potentially restoring normal gene expression and causing cancer cell death," stated Dr. Yeo, Principal Investigator. "Therefore, we are very excited to begin this trial and learn more about the safety and potential activity of PXD101 in the treatment of this disease."

Merck has won Vioxx trial #7 as a NJ jury rejected the claims of a patient who blamed her heart attack on nearly three years of Vioxx use. The jury found that Merck acted responsibly in informing the medical community about the benefits and risks of the drug.

The plaintiff, Elaine Doherty of Lawrenceville, NJ, said that she took Vioxx 25 mg daily from June 28, 2001, until she suffered a heart attack on Jan. 19, 2004, at age 65. She continued to take the medicine until Merck voluntarily withdrew it from the market in September 2004.

"The company acted responsibly, the science was on our side, and the jury agreed," said Jim Fitzpatrick of Hughes Hubbard & Reed, a member of Merck's defense team in Doherty v. Merck. "Mrs. Doherty would have suffered a heart attack whether she was taking Vioxx or not. Before ever hearing of Vioxx, Mrs. Doherty had multiple risk factors for heart disease, including high cholesterol, diabetes, high blood pressure and obesity."

The verdict was the third time in four cases that a NJ jury found in Merck's favor on a plaintiff's product liability claim.

"Merck is pleased with the jury verdict," said Kenneth C. Frazier, senior vice president and general counsel of Merck. "Today's outcome reinforces our commitment to defend these cases on a case-by-case basis."

Merck also made news yesterday with the departure of Bradley Sheares, who served as president of U.S. human health since 2001. Mr. Sheares was replaced by Adam Schechter, who previously served as general manager of Merck's Zetia/Vytorin partnership with Schering-Plough

Bristol-Myers Squibb and Gilead Sciences received approval from the FDA for Atripla for the treatment of HIV-1 infection in adults. Atripla is the first-ever once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. The product combines Sustiva, manufactured by BMS, and Truvada, manufactured by Gilead Sciences. In December 2004 the two companies established a joint venture to develop and commercialize the STR.

Truvada is a fixed-dose product that contains two of Gilead's anti-HIV medications, Viread and Emtriva, in a once-daily tablet for use as part of combination therapy. Atripla will be available in the U.S. shortly.

"We appreciate the recognition by the FDA of this important therapeutic advance, and with their approval of Atripla in just over two months, patients will now have rapid access to the first once-daily single tablet regimen for the treatment of HIV-1 infection in adults," said John C. Martin, Ph.D., president and chief executive officer of Gilead Sciences. "We are proud to have worked closely with Bristol-Myers Squibb in this precedent-setting collaboration to simplify therapy for physicians and patients."

"With the approval of Atripla, Bristol-Myers Squibb continues two decades of progress in the development and commercialization of medications to treat HIV. Partnering with Gilead, we are able to address another area of need for adults infected with HIV-1," said Anthony C. Hooper, president, U.S. Pharmaceuticals, BMS. "Atripla is an important step forward as we continue our focus on discovering, developing and providing innovative treatments for serious diseases."

The once-daily STR contains three medicines from two classes of anti-HIV drugs. Atripla contains 600 mg of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors (NRTIs). All three active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication.

Rentschler Biotechnologie GmbH is expanding its facilities, buildings and laboratory units at the company’s site in Laupheim, Germany. This will increase production capacities for antibodies and mammalian cell culture-derived proteins. “By expanding our production capacity we will establish Rentschler Biotechnologie as a market supplier of antibodies," said Dr. Nikolaus F. Rentschler, the company's chief executive officer.

The Rentschler Group will invest $64 million in its biotechnology segment to build two fermentation suites with a total volume of 5,000 liters (2,500 L each) for market production and several smaller suites ranging from 250 to 500 liters for clinical supplies, creating more than 100 jobs. The first new production line will be operational early in 2008. In the future, 10 independent GMP facilities will be available for the production of biopharmaceuticals.

At its 3,500 square-meter facilities in Laupheim, the company currently has the capacity for manufacturing clinical supplies and market supply of low-dosed drugs. According to the company, by setting up additional fermenter suites, the Rentschler Group will strengthen its biotechnology business of custom manufacturing services from cell line development to large-scale cGMP production, registration of drugs and fill and finish.

AAIPharma, Inc. has appointed Ninad Deshpanday, Ph.D. to the newly created position of vice president of pharmaceutical business development. Dr. Deshpanday will be responsible for all North American business development activities in Pharmaceutical Development, including Analytical, Biotechnology, Formulations Development, GMP Manufacturing and Clinical Trial Materials for both Oral and Parenteral dosage forms.

Dr. Deshpanday has more than 15 years' experience in pharmaceutical development. Prior to joining the company, he was vice president of drug product development for Synta Pharmaceuticals, with responsibilities for all CM&C activities. Prior to that, he served as technical business director for the pharmaceutics division of Cardinal Health. Previously, Dr. Deshpanday held leadership positions at AAIPharma, including senior manager of formulations development and global product director of pharmaceutics.

"Dr. Deshpanday possesses a unique combination of leadership skills and technical expertise in pharmaceutical development, and is a great addition to our business development team," stated Pete Megronigle, senior vice president of North American business development. "This appointment represents AAIPharma's continued focus on maximizing technical capabilities with regional effectiveness and broadening its position in the marketplace."

Recently, at the annual DIA meeting, FDA deputy commissioner for operations and chief operating officer, Janet Woodcock announced that, CDISC (Clinical Data Interchange Standards Consortium) will lead a collaborative group of industry stakeholders to focus on the Critical Path Opportunity to enable standardized collection of clinical research data at investigative sites.

Dr. Woodcock said, "The industry needs consensus on the definition of high quality data and that standardization is the best tool for ensuring quality. CDISC has done excellent work so far on the data standards we all use." FDA/HHS have endorsed the CDISC standard for eSubmission data—SDTM (Study Data Tabulation Model), and listed it as a specification in FDA Guidance. Based on CDISC's role enabling consensus around clinical data standards, CDISC leadership will now be used to bring together a collaborative group to develop standards for data collection.

Earlier this year, CDISC was asked to assume this leadership role from the Association of Clinical Research Organizations (ACRO), which initiated the project last year. ACRO has agreed to continue its involvement and currently there are ten organizations involved with the collaborative group, including: American Medical Informatics Association (AMIA), National Clinical Research Resources (NCRR), National Institutes of Health (NIH), and Pharmaceutical Research Manufacturers Association (PhRMA). CDISC is currently seeking funding for this project.

"CDISC will bring its standards-development process and global approach to this initiative," said CDISC board chairperson and SAIC vice president, Dr. David Hardison. "We feel this is a critical aspect of the overall CDISC mission to facilitate protocol-based biomedical research, from the protocol authoring and generation of data collection tools through results reporting, making the process easier for investigative sites and all stakeholders."

DPT Laboratories, Ltd. has recently adopted an electronic enterprise content management (ECM) system that enhances its ability to maintain secure, organized documentation in accordance with the FDA's current Good Manufacturing Practices (cGMP) regulations.

"DPT is a contract service provider providing drug and device development and manufacturing services for our clients, and maintaining regulatory compliance is a key factor for us and for our clients," said, Kay Mary Harrell, senior director of regulatory affairs for DPT, a DFB company. "This new software system implementation provides our clients another level of assurance that DPT invests in its infrastructure and desires to be pro-active when it comes to compliance."

The ECM software provides assurance that the manufacturing personnel are using the most updated version of procedures. This ECM system also provides a clear audit trail with electronic signatures showing everyone who has modified a document. The EMC system also allows DPT to create electronic technical documents for clients, which its clients can include as part of their submission package to the FDA.

Schering-Plough Corp. has made executive changes within Schering-Plough Research Institute (SPRI), the R&D arm of Schering-Plough.

Thomas P. Koestler, Ph.D., has been named executive vice president and president of SPRI and a member of the company's Executive Management Team (EMT). Dr. Koestler was previously executive vice president, global development, SPRI, and an advisor to EMT. He succeeds Cecil B. Pickett, Ph.D., who is retiring from the company to join Biogen Idec. Also, Catherine D. Strader, Ph.D., executive vice president, discovery research, SPRI, has been promoted to executive vice president, SPRI, and chief scientific officer of the company.

Dr. Koestler will be responsible for all aspects of SPRI, including heading up the Pharmaceutical Leadership Board (PLB). The PLB guides the strategic direction of product development programs and oversees the movement of projects through the development, registration and launch phases.

He joined the company in August 2003 as executive vice president, global regulatory affairs and project management, SPRI. Later, Dr. Koestler was responsible for setting the strategic direction and implementation plans for the pharmaceutical development organization, including worldwide clinical development, pharmaceutical sciences, global regulatory affairs and global project management.

Prior to joining SP, he was senior vice president and head of global regulatory affairs for Pharmacia. Before that, he was senior vice president and global head, drug regulatory affairs, compliance assurance, clinical safety and epidemiology for Novartis. He also served as senior director, drug regulatory affairs, at Ortho McNeil and as director of regulatory affairs at Bristol-Myers Squibb.

Dr. Strader is responsible for the drug discovery operations of SP, including biology, genomics, medicinal and structural chemistry research, through both internal programs and external collaborations. The discovery group is focused on finding novel therapeutic agents in the areas of respiratory, cardiovascular, oncology, neurobiology, inflammation and infectious diseases, pursuing both small molecule and biologics-based approaches to treatment. She will also chair the Research Leadership Committee, with oversight responsibility for the company's preclinical research portfolio.

She joined the company in 1995 as vice president, CNS, cardiovascular and genomics research. She was appointed senior vice president, discovery biological research, in 2002 and assumed her most recent position in 2003. She came to the company from Merck Research Laboratories, where she served as executive director, department of molecular pharmacology and biochemistry.

Genentech

2Q Revenues: $2.2 billion (+44%)

2Q Earnings: $531 million (+79%)

YTD Revenues: $4.2 billion (+40%)

YTD Earnings: $952 million (+64%)

Comments: U.S. product sales increased 41% in the quarter to $1.7 billion driven by Rituxan sales, up 17% to $526 million; Avastin sales up 72% to $423 million; Herceptin sales up 111% to $320 million and Tarceva sales up 47% to $103 million. R&D expenses increased 40% to $390 million in the quarter.

Recent trends suggest there may be little growth globally in the number of anti-infective vaccines entering clinical trials for the rest of this decade, according to a recent analysis from the Tufts Center for the Study of Drug Development.

"Despite widespread agreement that new vaccines are an important public health priority, development remains slow, expensive, and risky," said Tufts CSDD Director Kenneth I. Kaitin.

According to the study, since 1990 the number of companies initiating development of new vaccines and the number of pathogens targeted—38 companies and 35 targets—have remained essentially unchanged.

Mr. Kaitin said, "The benefit-to-risk profile for vaccines is typically more stringent, liability concerns are often greater, and the return on investment is frequently lower, which partly explains why there aren't more vaccine development programs in place." He added that in the near term vaccine R&D is likely to focus on readily transmitted pathogens, such anthrax, dengue, and Ebola.

The Tufts CSDD study also found that of eight new vaccines approved during 2000-2005, only three targeted pathogens that were not associated with childhood diseases or influenza. Also, the five most-studied targets were hepatitis B, hepatitis C, herpes simplex, smallpox, and West Nile viruses and account for 60% of all antiviral vaccines currently in development. According to the study, the success rates for anti-infective vaccines developed in the 1990s ranged from 17% to 25%. Development time for new vaccines averaged 80 months during the past decade and FDA approval averaged 13.9 months.

So far in 2006, the FDA has approved Rotateq, a rotavirus vaccine, and Gardasil, a human papilloma virus vaccine. ACAM2000, a smallpox vaccine currently under review, may be approved later in the year.

Merck received approval from the FDA for Emend for the prevention of postoperative nausea and vomiting (PONV), one of the most common side effects associated with surgical procedures. The recommended dose of Emend for PONV is a single, oral 40 mg dose administered within three hours prior to the induction of anesthesia.

Emend is believed to work through a novel mechanism that primarily blocks nausea and vomiting signals to the brain. This mechanism is distinct from how current anti-vomiting therapies work, including 5-HT3 receptor antagonists (Zofran). Emend represents the first new class of therapy for the management of PONV in more than 10 years.

The approval for Emend is based on two multi-center, randomized, double-blind, active comparator-controlled, parallel-group studies of 1,658 patients undergoing open abdominal surgery. Emend 40 mg was superior to Zofran 4 mg IV for the prevention of vomiting (emesis) from 0 to 24 hours following surgery. Prevention of vomiting was defined as no emetic episodes and was one of two primary endpoints in the study. Of patients taking Emend 40 mg, 84% of patients did not experience vomiting through 24 hours compared to 71% of patients taking Zofran 4 mg IV.

GlaxoSmithKline received approval from the FDA for Avandamet for use as initial treatment of type 2 diabetes, as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy for use in patients who were uncontrolled on metformin monotherapy. With this recent approval, physicians can start their type 2 diabetes patients on Avandamet. The approval for Avandamet coincides with the company's announcement that its supply of the drug has been re-established.

Cardinal Health has signed agreements to manufacture and package Tamiflu for Roche to help meet current and future demand for the influenza medicine, which is recommended by the World Health Organization as a frontline treatment against a potential pandemic avian flu outbreak.

Under the terms of the manufacturing agreement, Cardinal will manufacture 75 mg hard gelatin capsules of Tamiflu on behalf of Roche at one of Cardinal's manufacturing sites in Europe. The companies also have arrangements in place for Tamiflu packaging and printed insert production at facilities in the U.S.

"Roche has demonstrated global leadership through its commitment to increase production in advance of a possible avian flu outbreak," said Joseph Papa, chairman and chief executive officer of the Pharmaceutical Technologies and Services segment of Cardinal Health. "Cardinal Health's pharmaceutical manufacturing and packaging expertise allows companies like Roche to expand production in a timely manner. This model is vital in preparing for and responding to situations like avian flu, where rapid, cost-effective solutions are critical to success."

Crucell and DSM Biologics have chosen Invitrogen to enter its partnership for the PER.C6 licensing business Vendor Network for monoclonal antibodies and recombinant proteins.

Through its PD-Direct services, Invitrogen has experience with the PER.C6 technology and will offer PER.C6 licensees the benefit of expertise developed as a leader in clone generation services. Invitrogen will also continue to develop and optimize clone generation solutions specifically tailored to the PER.C6 human cell line.

The Vendor Network was created to develop and provide high-quality biotechnology tools and services tailored to PER.C6. It will consist of leading tool and service providers offering, for example, PER.C6 clone generation programs, medium, bioreactor and other production equipment and devices, and process development services. The vendors will enhance the performance of the PER.C6 technology platform.

Serono received approval from the European Commission for an update of the Summary of Product Characteristics (SmPC) of Rebif, in order to align it with current medical practice. In the EU, Rebif can now be prescribed after the diagnosis of multiple sclerosis (MS) has been confirmed based on one attack and subsequent positive magnetic resonance imaging (MRI) scans.

The 'therapeutic indication' section of the SmPC of Rebif now takes into account the McDonald criteria, which are the current reference criteria for the diagnosis of MS. The McDonald criteria utilize MRI evidence as an alternative to a second attack, and allow the same patients to be diagnosed with more sensitivity and specificity. Current understanding of the disease supports that it is critical to initiate treatment as soon as the diagnosis of MS is established to ensure the best possible outcome for the patients.

The updated SmPC of Rebif is valid immediately in all 25 member states of the EU. In most other regions of the world, the therapeutic indication of Rebif already takes into account the McDonald criteria.

Novozymes acquired Delta Biotechnology, Ltd. from the Sanofi-Aventis Group as part of its strategy to extend its portfolio of products that are used as key ingredients in biopharmaceutical products. Delta, a wholly-owned subsidiary of Novozymes, operates as a self-contained business unit with both its R&D and manufacturing facilities based in Nottingham, UK. The new company will operate under the name Novozymes Delta Ltd.

Novozymes Delta develops and manufactures recombinant protein products using highly engineered proprietary Saccharomyces cerevisiae yeast strains. The company also licenses its yeast based expression system to pharmaceutical, healthcare and biotech partners. Recombumin, the company’s lead product, is the first and only animal-free, commercially available recombinant human albumin. It is used in the manufacture of human therapeutics approved by both the FDA and the EMEA.

Novozymes' chief executive officer, Steen Riisgaard said, "Delta Biotechnology is a good match for our existing projects in ingredients for the biopharma industry. The acquisition will bring us significant know-how and technology, and will support our continued expansion in this area."

Dermot Pearson, commercial operations director of Novozymes Delta said, “Novozymes will set the direction and has the resources that will enable us to further progress our yeast-based protein expression capabilities to the benefit of our global customer base. The market for safe, animal-free recombinant proteins is growing and, with Novozymes backing us, we’ll be in a great position to satisfy this market."

PDL BioPharma, Inc. plans to move its corporate headquarters from Fremont to Redwood City, CA during the third quarter of 2007. PDL has signed long-term leases for two existing buildings that total approximately 450,000 sq.-ft. The new headquarters will be located in the Pacific Shores Center in Redwood City and includes an existing office building and a building shell, which together will house the company's research, clinical development and administrative operations.

"PDL is essentially out of space in our current location, and the leases we currently hold for the majority of our space in Fremont expire in the near future. This new site should accommodate our staffing and operational growth necessary to achieve our Vision 2010 aims, notably to launch new products, build our pipeline and optimize sales of our marketed products in North America," said Mark McDade, chief executive officer of PDL.

Locus Pharmaceuticals, Inc. has entered into a research agreement with Ono Pharmaceutical Co., Ltd. to apply its proprietary computational technologies, and capabilities in chemistry, biology and crystallography to develop IND-directed preclinical drug candidates for Ono. The molecular target is a protein kinase selected by Ono. Protein kinases function as control switches for many biochemical pathways inside cells and are of particular interest as targets for the development of novel therapeutics. Financial terms of the agreement were not disclosed.

"We look forward to this multi-year collaboration with Ono, which allows us to apply and leverage all of our internal drug development capabilities as well as our kinase knowledge-base," said H. Joseph Reiser, Ph.D., chairman and chief executive officer of Locus. "We have already demonstrated the power of our computational approaches and proprietary algorithms in our internal kinase programs and in other kinase-related collaborations, so we expect to bring significant value to Ono's efforts against this target."

"We have dedicated ourselves to creating innovative medicines that will be truly beneficial to patients," said Daikichi Fukushima, Ph.D., executive director of research headquarters at Ono. "This collaboration with Locus, a world leader in computational drug discovery technologies, is a great chance for Ono to strengthen its drug discovery capabilities."

The Association of Clinical Research Organizations (ACRO) and the FDA have announced a new initiative to modernize the clinical trial process with the formation of a collaborative group to support the development of data collection standards for regulated biomedical/clinical research.

The collaborative is part of the FDA's Human Subject Protection/Biomedical Research (HSP/BiMo) effort, a component of the agency's Critical Path Initiative. The Clinical Data Interchange Standards Consortium (CDISC), dedicated to improving the efficiency of medical product development, will lead the effort and will encourage broad stakeholder involvement, including representatives of ACRO along with those from FDA, National Institutes of Health (NIH), including the National Center for Research Resources (NCRR) and the National Library of Medicine (NLM), American Medical Informatics Association (AMIA), C-Path Institute, Pharmaceutical Research and Manufacturers Association (PhRMA), and others.

"We must have high-quality data to support new product applications," said Dr. Janet Woodcock, deputy commissioner for operations at the FDA. "Data collection standards will be enormously helpful to regulatory review and decision-making, and I applaud the efforts of ACRO, CDISC and others to significantly move this project forward."

In 2005 ACRO, in consultation with the FDA, initiated a pilot project aimed at standardizing the collection of clinical trial data. ACRO produced template forms for the collection of adverse event (AE) and concomitant medication (CM) clinical trial data, and outlined principles for standardizing the myriad case report forms (CRFs) currently used.

"We are very pleased that CDISC, which has been leading the charge for data standards for the exchange and submission of electronic data, has agreed to take on an initiative that will provide value to all levels of the clinical trial enterprise," said Douglas Peddicord, Ph.D., ACRO's executive director. "We look forward to working on data collection standards as one way to make the clinical trial process more efficient."

The FDA, CDISC and ACRO will convene in December 2006 at a Drug Information Association (DIA) stakeholders conference entitled, "The Quest to Enable the Electronic Clinical Trial." The two-day meeting will be held in Baltimore, MD and will focus on ways to optimize the clinical trial process with news tools and technology.

Cardinal Health has made organizational changes to align its manufacturing businesses and sharpen its focus on expanding the market for its products and services outside the U.S.

David L. Schlotterbeck has assumed additional responsibility for Cardinal Health's Pharmaceutical Technologies and Services (PTS) and Medical Products Manufacturing (MPM) segments, in addition to his current responsibility for the Clinical Technologies and Services (CTS) segment. As chief executive officer of Pharmaceutical and Medical Products, Mr. Schlotterbeck will lead an organization of approximately 23,000 employees and $6 billion in revenues.

According to a company statement, PTS, MPM and CTS will remain separate financial reporting segments and separate internal organizations, but the new structure will "foster a uniform approach to lean manufacturing and Six Sigma initiatives, and common processes for innovation, R&D, and sourcing."

"Dave's extensive manufacturing experience and more recent leadership in transforming our CTS segment make him an ideal choice for this new, important role," said R. Kerry Clark, president and chief executive officer of Cardinal Health. "The leadership structure we now have in place across Cardinal Health will help us streamline decision making, create new and innovative solutions with more insight and speed, and enable us to accelerate the work we do to make health care safer and more productive."

The company has also appointed R. G. G. (Rudy) Mareel as president of International. In this role, Mr. Mareel will develop and implement the company's international strategy. He will also assume the responsibilities of John Parker, president of Cardinal Health Europe, who plans to retire.

Mr. Mareel joins the company from Royal Numico, a global clinical and specialized nutrition products co., where he was president of the Amsterdam-based clinical nutrition division and a member of its executive board. Prior to joining Royal Numico in 2001, he worked for several years at Becton Dickinson, where he served in a number of global positions, most recently as worldwide vice president and general manager of BD Biosciences, Immunocytometry Systems.

BASi has made several promotions at its corporate center contract research laboratories in West Lafayette, IN. Emilio Cordova, Ph.D. has been named director of business development. Janna Chambers is now senior director of client services, a newly created position. Tracy Creel has been named assistant director of Bioanalytical operations. Mark Gehrke, Ph.D. has been appointed director of Bioanalytical development and Timothy Grever has been named director of Bioanalytical operations.

Icon has opened two new offices, one in Warsaw, Poland and one in Vilnius, Lithuania, as part of its continuing expansion in Eastern Europe. That region provides high availability of patient volunteers and a strong network of investigator sites, key factors in the management of clinical trials, according to the company.

Dr. Peter Sowood, president of Icon Clinical Research in Europe said, "The opening of Icon offices in these strategic Eastern European countries, complements our existing network of offices in Riga, Moscow and Budapest and strengthens our capabilities in what is an increasingly significant area for clinical research."

Both the Warsaw and Vilnius offices will offer the full range of Icon services and will support future drug development in the region.

The organization formerly known as the Pharmaceutical Fine Chemicals business of Clariant is now Archimica — a global fine chemicals business focused on commercialization solutions for the pharmaceutical industry. The new business consists of all assets and personnel that previously supported commercial activities for the manufacture of high-tech building blocks, regulatory starting materials, cGMP intermediates and APIs for the pharmaceutical industry.

Archimica will be headquartered in Frankfurt, Germany with manufacturing and technology development sites in the U.S., the UK, Germany, France and Italy.

Ralf Pfirmann, global business director of the new Archimica said, "For the past five years, our Pharmaceutical Fine Chemicals business has been working to implement a strategy to be a premiere supplier for the pharmaceutical industry. Going forward, this will not change. We will have the same excellent personnel working within the same frameworks at all of our global sites. This means that our technology development, process expertise, manufacturing excellence, and our state-of-the art regulatory compliance efforts will remain the same. Today we are not just a chemical business and we are not just a pharmaceutical manufacturing business, we have evolved our business model to create value for the pharmaceutical industry where they need it."

The development and commercialization of generic APIs will continue in the new organization. Also, each of the manufacturing and R&D sites previously serving the Pharmaceutical Fine Chemicals business will continue to do so under Archimica. These include Pharmaceutical Centers of Excellence in Springfield, MO, (in combination with a Puerto Rico facility) and Origgio/Isso, Italy that currently form the business' FDA/cGMP manufacturing capability. They also include sites in Bon Encontre/Tonneins, France that conduct the business' bulk sterile API manufacturing and Sandycroft, UK where high intensity chemistry as well as the manufacture of APIs is practiced. The Frankfurt, Germany site is the business' global Pharmaceutical Services Technology Center, focusing on expanding the use of leading chemical and biological technologies in the development of new processes.

Genentech has received FDA approval of Lucentis for the treatment of neovascular (wet) age-related macular degeneration (AMD). The FDA approved Lucentis after a six-month Priority Review and will ship the product immediately.

The Phase III trials showed that 95% of patients treated with Lucentis maintained their vision and vision improved by at least three lines (or 15 letters) on the study eye chart in as many as 40% of these patients at one year. Lucentis is an injectable bio-drug designed to inhibit the formation and leakage of new blood vessels in the back of the eye, the primary cause of central vision loss associated with this disease.

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