Abbott has received marketing authorization from the European Commission for the use of Humira as a treatment for moderate-to-severe plaque psoriasis. In one clinical trial, more than 80%  of patients taking Humira achieved skin clearance of 75%  or better and in another, almost three quarters of patients achieved 75% clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90% clearance as early as 16 weeks into treatment.

Psoriasis is the fifth approved indication for Humira in the EU. Humira is the first fully human, self-injectable biologic for the treatment of psoriasis. The FDA is reviewing the drug for the same indiciation.

Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis.

BASi (Bioanalytical Systems)

4Q Revenues: $10.4 million (-3%)

4Q Loss: $203,000 (net loss of $736,000 in 4Q06)

FY07 Revenues: $45.2 million (+5%)

FY07 Earnings: $926,000 (net loss of $2.7 million in FY06)

Comments: Sales declined in 4Q07 due to a drop in bioanalytical revenues, partly offset by growth in toxicology services and sales of the company's Culex automated pharmacology systems. Net loss in the quarter included $354,000 in severance charges to several company officers and directors.

Richard M. Shepperd, BASi's president and chief executive officer, commented, "We are pleased that we can report progress in our performance for the fiscal year ended September 30, 2007, the company's first profitable year in four years. Had we not had the severance costs associated with completing our management change in the fourth quarter of this year, we would have shown profitable results in each quarter of the year. Our people worked hard to make this happen; however, major efforts remain to build consistently profitable operations in our Baltimore clinic and UK operations. Both of these operations have new management and new or renovated facilities where we will continue our effort to match their performance to the strength of the markets in which they do business. Our work is cut out for us, to build on the turnaround we began this past year."

Akorn, Inc. has received a satisfactory inspection from the FDA as part of a pre-approval inspection of the company's lyophilization facilities in Decatur, IL. Akorn had cGMP issues in the past, but the recent inspection led the Chicago office of CDER to conclude that Akorn's responses to the problems are acceptable.

As a result of the inspection, Akorn is now eligible for pending product approvals in its ophthalmic, ampoule, liquid vial and lyophilization production filling suites in the Decatur site.

Arthur S. Przybyl, Akorn's president and chief executive officer stated, "We are pleased to announce the results from the latest FDA inspection of our Decatur, IL manufacturing facility. Akorn remains committed to maintaining a comprehensive and robust quality system in order to remain in compliance with current good manufacturing practice regulations. This positive result is a significant event for Akorn. The results of this recent inspection allow us to commercialize our lyophilization manufacturing capabilities. We believe a shortage of lyophilization manufacturing capacity still exists in the market place."

Merck Serono and Flamel Technologies have entered into a collaboration to investigate the applicability of Flamel's Medusa technology for the extended release of a therapeutic protein of Merck Serono’s portfolio. Merck Serono will make an upfront payment of $2.8 million to Flamel for investigating the therapeutic protein and will fund R&D efforts performed by Flamel. Financial terms, including a license agreement to cover potential commercialization, were not disclosed.

"We are delighted to enter into this partnership with Flamel, as it gives Merck Serono access to a technology that may further improve the therapeutic potential of compounds in our portfolio," said Bernhard Kirschbaum, Merck Serono's head of research. "As Flamel's Medusa technology allows for longer intervals between administrations of injectable proteins compared to standard formulations, we hope to offer an improved convenience for patients requiring treatment by injection. As a consequence, we anticipate that employing this technology will lead to better treatment outcomes for patients."

Stephen H. Willard, Flamel's chief executive officer, remarked, "We are pleased to have reached an agreement with Merck Serono. The Medusa platform is a best-in-class technology for the controlled delivery of proteins, peptides, and other molecules. This applicability to a wide range of molecules is a key strength of the platform, as is the ability to sustain release without affecting bioactivity. Merck Serono is the ideal partner for this project and we look forward to working together on such an exciting opportunity."

MPI Research and Shanghai Medicilon have formed a joint venture in preclinical services. Medicilon-MPI Preclinical Research (Shanghai) LLC will be located initially at the Zhangjiang Hi-Tech Park in Shanghai, China. The group will open a 50,000-sq.-ft. preclinical testing facility in the Chuansha Economic Park in early 2008. This new facility will meet the regulatory standards set forth by the US FDA and other regulatory agencies worldwide, according to a joint statement.

The JV is intended to provide current and future customers access to a broad range of both GLP and non-GLP preclinical services. By 2009, the new company will be fully operational, in terms of conducting FDA/IND enabling studies, offering additional preclinical support services, submitting INDs and NDAs, and will have AAALAC accreditation.

"With one fourth of the world's population, China is an important force in shaping the global pharmaceutical and biotechnology markets," said William U. Parfet, chairman and chief executive officer of MPI Research. "We have carefully looked for more than three years to find a CRO partner that shares our values and commitment to excellence, and we have finally found one in Shanghai Medicilon. We look forward to forging a future together as a worldwide leader of preclinical research services."

Dr. Chun-Lin Chen, co-founder of Medicilon, Inc. and Shanghai Medicilon, will serve as the chief executive officer of Medicilon-MPI Preclinical Research. Dr. Chen received his Ph.D. from Oklahoma State University and completed post-doctoral training in the U.S.

A multidisciplinary team of experts originating from MPI Research headquarters will relocate to Shanghai and form a GLP Advisory Board to oversee FDA GLP compliance. This team will have a broad range of experience in small and large animal toxicology, safety pharmacology, pharmacokinetics, animal care, quality assurance, report writing, pathology, and study direction. In partnership with the MPI Research team, more than 70 Shanghai Medicilon professionals will be joining the newly formed organization.

Bilcare recently inaugurated its Centre of Excellence in Pune, India. The site has dedicated R&D sections for Packaging Research, Material Research, Analytical Research, Drug Sensitivity Studies and Package Design. The opening was attended by Dr. APJ Abdul Kalam, India's former president, and Dr. John L. LaMattina, president of Pfizer Global R&D. Drs. Kalam and LaMattina have recently helped Bilcare develop an anti-counterfeiting product to increase product warrant and traceability, according to a press statement.

Mohan Bhandari, chairman and managing director of Bilcare Limited, remarked, "Bilcare is emerging fast as a knowledge company with unique research capabilities to address the critical challenges of the pharmaceutical industry. With this product and the R&D center launch, we are now in a position to offer complete solutions to our global customers on counterfeiting and ensure better healthcare for tomorrow."

The Centre is also equipped with Asia's first integrated Flexo Printing machine, as well as a state-of-the art pilot plant, which was inaugurated by Dr. R Chidambaram, principal scientific advisor to the government of India, according to a press statement.

Wendel Barr has been named to the role of chief operating officer at Covance. Mr. Barr, who is currently president of Early Development North America, will assume operating responsibility for Covance's business units worldwide and will report to Joe Herring, Covance's chairman and chief executive officer. In addition, Mike Lehmann, currently general manager of the preclinical laboratory facility in Madison, WI, was named president of labs North America and will serve on Covance's Global Leadership Council.

Mr. Barr joined Covance in 2000 as Vice President and General Manager of Labs North America. In 2003, he was promoted to his current role, overseeing the expansion of the Early Development North America operations in Madison, as well as planned construction in Chandler, AZ, and Manassas, VA. Prior to joining Covance, Mr. Barr was global vice president and general manager of Marconi Medical Systems. He also spent 15 years at GE in a broad variety of positions of increasing responsibility.

"These moves reflect the depth and strength of our leadership talent that enables us to promote executives from within Covance," said Mr. Herring. "Wendel is a proven leader who has demonstrated exemplary management capabilities, a track record of accomplishment, and strong client focus, as reflected by the impressive growth and expansion of our Early Development North America operations. Wendel's appointment will allow me to further focus on strategies that would continue to drive growth and deliver value to our clients, employees, and shareholders."

Pfizer has agreed to acquire CovX, a privately-held biotherapeutics company specializing in preclinical oncology and metabolic research and a developer of a biotherapeutics technology platform. The price was not disclosed.

Based in La Jolla, CA, CovX will operate as a division of Pfizer’s new Biotherapeutic and Bioinnovation Center.

Said Jeffrey Kindler, chairman and chief executive officer of Pfizer, "The acquisition of CovX is a further step in Pfizer's strategy to acquire and identify new product candidates that we can put into development, leveraging both Pfizer's expertise and that of world-class scientists charged with discovering and bringing in new compounds. We are looking for the best science wherever we can find it, with a special focus in our priority areas, such as biotherapeutics."

CovX's biotherapeutic platform is a technology that links therapeutic peptides to an antibody scaffold. The peptide targets the disease while the antibody scaffold allows the peptide to remain in the body long enough to achieve therapeutic benefit. The technology thereby allows half-life extension and bioavailability to support optimal dosing regimens for peptide therapeutics. CovX has generated three early-stage compounds, one diabetes and two oncology compounds, that are expected to strengthen Pfizer’s biologic pipeline portfolio.

"This deal demonstrates Pfizer’s ongoing commitment to build a competitive biotherapeutics enterprise through the acquisition of talented scientists, promising product candidates and a cutting edge technology platform," said Dr. Corey Goodman, president of Pfizer's Biotherapeutic and Bioinnovation Center. "CovX scientists will remain in place, which reflects our decision to partner differently and maximize the productivity of the research initiatives underway outside of our walls."

Sidney Taurel, chief executive officer and chairman of Eli Lilly & Co., will retire as CEO at the end of March, 2008. He will remain chairman until December 31, 2008, at which time he will retire from the board and from the company. John C. Lechleiter, Ph.D., currently president and chief operating officer, will assume the role of president and chief executive officer as of April 1, 2008.

Mr. Taurel has been the company's chief executive officer since July, 1998, and the chairman of its board of directors since January 1, 1999. He joined Lilly in 1971 as a marketing associate in Eli Lilly International. After sales and marketing experiences in Brazil, Eastern Europe and France, he became general manager of the company's affiliate in Brazil in 1981. He subsequently assumed the London-based role of vice president of Lilly's European Operations in 1983, and then moved to Indianapolis in 1986 as president of Lilly International. In 1993 he was named an executive vice president of the company and president of the pharmaceutical division, and in 1996 was promoted to president and chief operating officer of the corporation.

"I am grateful to have spent nearly 37 years with this great company, and deeply honored to have had the opportunity to lead it for the last 10. I am very proud of what my Lilly colleagues around the world have accomplished together during a decade of both successes and challenges," said Mr. Taurel. "I believe that 2008 is the right time for me to retire for a number of reasons. First, the company has executed very well over the past couple of years, exceeding both our and our shareholders' expectations. As a result, the company is operationally very sound and positioned for continued success. Second, I and the senior leadership team have laid out a vision for the company that will guide Lilly for many years to come, and this gives me great confidence about Lilly's future success. And third, John has been preparing for his new role as my successor for several years, and 2008 is the right time for him to assume his place as the leader of the company."

Mr. Taurel's successor, Mr. Lechleiter, has served as president and chief operating officer since October 2005. He joined Lilly in 1979 as a senior organic chemist in process R&D, and he became a head in that department in 1982. In 1984 he began serving as director of pharmaceutical product development for the Lilly Research Center (Erl Wood) in Windlesham, England, and he subsequently returned to the U.S. in 1986 as manager of R&D projects for Europe. In 1988, he became director of development projects management, and in 1989 assumed additional responsibility for pharmaceutical regulatory affairs, chemistry, manufacturing and control. In 1991 he was named executive director of pharmaceutical product development and became vice president in 1993. Mr. Lechleiter was appointed vice president of regulatory affairs in 1994, vice president of Lilly Research Laboratories in 1996, and senior vice president of pharmaceutical products in 1998. In 2001 he became executive vice president for pharmaceutical products and corporate development, and then became executive vice president of pharmaceutical operations in early 2004.

"I am humbled and excited by this opportunity to lead Eli Lilly and Co., particularly during a time of profound challenge and unprecedented opportunity. We will stand firm by the timeless values laid down by our founders, yet act decisively to maintain our strong competitive position," said Mr. Lechleiter. "We will be guided by an exciting new vision for our future that places individual patient outcomes at the core of our endeavors."

Celltrion, Inc., a Korean biopharmaceutical company, has received approval from the FDA to serve as a CMO for Bristol-Myers Squibb to produce Orencia, a treatment of rheumatoid arthritis. BMS submitted an sBLA to meet expected long-term demand for the biologic drug.

"We are pleased to continue our strategic business partnership with BMS. Achieving sBLA approval from the FDA to manufacture Orencia is an important milestone that reinforces our vision to become a fully integrated global biotechnology company," said Jung-Jin Seo, chairman and chief executive officer of Celltrion. "Celltrion is dedicated to working with our business partners to exceed their quality requirements while providing manufacturing value. It is our commitment to quality service that will attract other global biopharmaceutical companies to our manufacturing capabilities."

In a press statement, Celltrion noted that it "the only Asian large-scale cell-culture contract manufacturing facility which has successfully obtained approval from the U.S. FDA."

Bristol-Myers Squibb has signed an agreement with Avista Capital Partners, a private equity firm, to sell BMS Medical Imaging for $525 million. BMS MI is a leading supplier of medical imaging products for nuclear and ultrasound cardiovascular diagnostic imaging procedures.

"As Bristol-Myers Squibb continues to focus on evolving into a next- generation BioPharma company, we determined the best way to maximize the value of Medical Imaging for shareholders was to sell this business and reinvest the proceeds into our pharmaceutical research, development and commercialization efforts," said James M. Cornelius, chief executive officer, BMS. "At the same time, we believe that Medical Imaging can maximize its potential under new ownership, and Avista has a proven track record of success in the healthcare field."

David Burgstahler, a partner at Avista Capital Partners, said, "BMS MI is widely recognized as a pioneer in cardiovascular imaging agents, and for its strong technical manufacturing expertise. BMS MI is a great fit for our healthcare portfolio, as it addresses the healthcare industry's increasing need for improved diagnostic tools. We believe it is well-positioned for continued success."

The transaction is expected to be completed by the end of January 2008, subject to customary regulatory approvals, at which time BMS MI will operate as an independent company under a new name. Don Kiepert, the founder and former chairman, chief executive officer, and president of Point Therapeutics, will become the chief executive officer of the company upon completion of the transaction. "I am thrilled to be partnering with the existing management team of BMS MI and Avista Capital as we transition BMS MI to an independent company," said Kiepert.

BMS MI will be Avista's sixth investment in the healthcare industry. On December 13, 2007, Avista agreed to acquire from Boston Scientific its Fluid Management and Venous Access businesses. Also in 2007, Avista made healthcare investments in BioReliance and VWR International, and in 2006 Avista announced investments in Nycomed and MedServe.

Lilly and Ambrx Inc. have entered into a collaboration to discover and develop novel treatments in several therapeutic areas, including metabolic diseases, central nervous system disorders and other diseases. The collaboration will apply Ambrx's unique protein optimization technology, ReCODE, with Lilly's expertise in biologics discovery, development and commercialization to pursue drug candidates, including therapeutic antibodies and improved variants of native proteins.

Under the terms of the agreement, Ambrx will receive an initial upfront payment and ongoing research support payments. Ambrx may also receive potential R&D milestones and, if assets resulting from the collaboration are successfully commercialized, Ambrx would receive additional milestones and royalties. Other terms of the deal were not disclosed. This collaboration builds on an earlier agreement signed between the two companies in January 2007.

Stephen W. Kaldor, Ph.D., Ambrx's president and chief executive officer, remarked, "This new collaboration allows us to use our existing ReCODE technology to produce high quality protein clinical candidates while simultaneously affording us the ability to expand our reach into new areas such as therapeutic antibodies. In addition, this agreement will further solidify Ambrx's financial condition for the next several years."

Amgen and Oxford Genome Sciences (UK) have entered into a strategic collaboration to discover, develop and commercialize novel therapeutic antibodies for the treatment of cancer. This collaboration will enable OGS to  strengthen its pipeline of fully human therapeutic antibodies (mAbs) in cancer based on the target discovery capabilities of its unique OGAP database.

OGS and Amgen will jointly discover novel antibodies for the treatment of cancer. The companies will generate fully human antibodies using Amgen's XenoMouse technology, which was acquired through its acquisition of Abgenix. These antibodies will be raised against the novel druggable targets that OGeS has identified through its unique Oxford Genome Anatomy Project (OGAP) database.

The agreement covers as many as six oncology programs. Amgen will have the right to select as many as three programs, while OGS will retain rights to the remainder. Once Amgen has produced the initial antibody leads, OGeS will carry out the initial preclinical assessment of each antibody program.

Patheon announced that it plans to sell its facility in Carolina, PR, while retaining two other sites in Caguas and Manati. The announcement came during the company's 4Q07 financial statement. The quarter ended October 31.

The Carolina site is a 230,000-square-foot facility with 200 employees, and specializes in the manufacture of oral cephalosporin solid dosage forms, including tablets, capsules and powders for suspension. The facility currently manufactures four products for six clients. Said outgoing chief executive officer Riccardo Trecroce, "We have concluded that Carolina -- a high-quality site with specialized capabilities and expertise - would be of greater strategic value to another company with a focus on manufacturing oral cephalosporins. This divestiture will allow us to focus on improving operating performance and growing our business at the Caguas and Manati facilities." During the quarter, the company announced the sale of its Niagara-Burlington OTC facility to Pharmetics.

For the quarter, revenues from continuing operations grew 1% to $167 million. The company posted a net loss (including discontinued units) of $9.1 million in the quarter, down from a loss of $22.2 million in 4Q06. For FY07, revenues from continuing operations was up 1% to $677 million, with a net loss of $94.6 million, compared to a loss of $288.2 million in FY06. Patheon took a goodwill writeoff of $255 million in FY06, which accounts for much of that year's net loss.

Strong revenue growth in its European operations was offset by deteriorating revenues in PR (attributed to generic competition for Omnicef and Zocor) and a decline in Canadian sales (attributed to API delivery delays for a major prodct).

Neurocrine Biosciences announced that it will lay off approximately 130 employees at its San Diego campus, as a part of its restructuring program to prioritize its R&D programs and associated costs and expenses after an FDA delay on insomnia treatment indiplon. Following the firings, Neurocrine will have approximately 120 employees.

One Dec. 13, the FDA issued Neurocrine an "approvable letter" for indiplon, requesting additional clinical and preclinical data on the drug before it will consider approval. The company's NDA covered 5mg and 10mg doses of the drug. In May 2006, Neurocrine submitted a filing for a 15mg dose of the drug, but the FDA asked for reanalysis of safety and efficacy data; development partner Pfizer pulled out of the project after that. The company is preparing a formal meeting request to the FDA to discuss the most recent approvable Letter.

Gary Lyons, president and chief executive officer of Neurocrine, remarked, "It is with great disappointment that we have to make this difficult decision that will have such an effect on so many of our employees and their families. We are greatly saddened to move in this direction after our employees have continually demonstrated only the highest level of dedication and commitment. However, in order to meet our goals on other high priority programs, we have to refocus our resources as quickly as possible. I want to sincerely thank the departing employees for their tremendous efforts and wish them great success in the future."

GlaxoSmithKline has exercised its option to exclusively license XL880 from Exelixis for further development and commercialization. XL880 is a small molecule compound currently being evaluated in Phase II trials in patients with papillary renal cell carcinoma (PRC), gastric cancer and head and neck cancer. Under the terms of the collaboration between Exelixis and GSK initiated in October 2002 and amended in January 2005, GSK's selection of XL880 entitles Exelixis to a selection milestone of $35 million and additional payments upon the attainment of specific development and commercialization milestones. The $35 million milestone will be applied to repayment of an advance that GSK paid to Exelixis in 2005. Exelixis is also entitled to receive double-digit royalties on product sales if the compound is approved for marketing and commercialized. Exelixis will have certain co-promotion rights to XL880 in North America.

George A. Scangos, Ph.D., president and chief executive officer of Exelixis, remarked, "We believe that XL880 has substantial potential as a first- and best-in-class therapy, and GSK and Exelixis look forward to the completion of the ongoing XL880 Phase II trials and evaluation of pivotal trial options. We believe that GSK's selection of XL880 validates our strategy of building a franchise in the area of MET inhibition to exploit the potential of this promising target."

The collaboration between Exelixis and GSK, which is managed by GSK's Center of Excellence for External Drug Discovery (CEEDD), covers seven compounds and their back-up and follow-up compounds currently in the Exelixis development pipeline. Under the terms of the collaboration, Exelixis submits the covered compounds to GSK as they achieve clinical proof-of-concept, which is a pre-determined measure of efficacy, generally based on Phase II trial data, and GSK has the option to select two compounds, and potentially a third compound, for further clinical development and commercialization. However, in the case of XL880, GSK requested in August 2007 to review the compound's data prior to achievement of proof-of-concept. Exelixis agreed to the request and submitted the XL880 data package to GSK in September 2007.

The board of directors at Biogen Idec have elected to keep the company independent, after a two-month flirtation with selling out to a larger company. The company announced that it did not receive "any definitive offers" for an acquisition. Company shares dropped 28% in value after the announcement

Refocused on its independent status, the company reiterated its year-end 2010 goals:

• Get 100,000 patients on Tysabri;
• Derive more than 40% of the its revenue from international business;
• Launch four new products and/or existing products in new indications;
• Have six programs in late-stage clinical development; and
• Generate revenue growth at a 15% compound annual growth rate (CAGR) and non-GAAP EPS at a 20% CAGR from 2007 through 2010.

Elan, BI's collaborator in Tysabri, announced that it will continue to work with BI on gaining FDA approval of Tysabri for Crohn's disease and building the drug's presence among multiple sclerosis patients.

Merck has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, PEDVAXHIB, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, COMVAX . The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck. The affected doses of PEDVAXHIB and COMVAX were distributed starting in April 2007.

The company is conducting this recall because it can not assure sterility of these specific vaccine lots. Routine evaluation of manufacturing processes revealed the potential contamination of the lots in question. Sterility tests of the vaccine lots that are the subject of this recall have thus far not found any contamination in the vaccine.

"The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low," according to a company statement. Still, the company contends that the risk is large enough to warrant a recall.

Merck is working closely with the FDA and CDC to inform affected healthcare providers of this recall. The company is also in the process of communicating with public health authorities and healthcare providers in the U.S. and in other countries where these lots were distributed, as appropriate.

"We are taking this action because we are committed to ensuring the quality of our vaccines," said Mark Feinberg, M.D., Ph.D., vice president, Medical and Policy Affairs, Merck Vaccines and Infectious Diseases. "We know that our vaccines can play an important role in the nation's public health system, and we are committed to resolving this issue as quickly as possible to ensure that our vaccines are readily available."

Physicians are advised not to administer any vaccine from the vaccine lots being recalled. Individuals who received vaccine from these lots should complete their immunization series with a Haemophilus b conjugate-containing vaccine not affected by this recall, but do not need to be revaccinated to replace a dose they received from a recalled lot. The efficacy of the vaccine was not affected.

Novartis has announced a restructuring plan called, "Forward," to reduce costs and improve efficiencies. According to a company statement, the plan "is expected to simplify working processes and decision making by eliminating layers, concentrating on core activities and systematically capturing growth opportunities, particularly in emerging markets." This will include firing 2,500 staffers -- out of a total of 100,000 -- as part of its strategy to generate $1.6 billion in annual savings. Novartis will take a $450 million charge in 4Q07 to pay for the restructuring.

The company cited the standard set of "industry challenges" to explain the need for a restructuring: price pressures on drugs, growing R&D costs, a risk-averse regulatory environment and more aggressive generic competitors, the latter of which Novartis benefits from, thanks to its generics division, Sandoz.

"Forward" will include the following initiatives, as quoted from Novartis' press statement:

• Organizational structures will be streamlined in corporate functions as well as in the Pharmaceuticals and Consumer Health Divisions, particularly involving general management and administrative areas.
• In the Pharmaceuticals Division, the effectiveness of the worldwide sales forces will be improved with a more geographic-tailored marketing approach. Duplication between global, regional and local activities will be eliminated, while certain non-core support activities will be outsourced.
• The Consumer Health Division will remove organizational layers to streamline processes and eliminate duplications, while some product supply chains will be restructured to optimize capacity utilization. In certain business units, regional management structures will be modified in order to better focus resources on global or local activities.
• The Novartis Institutes for BioMedical Research will focus on disease areas with significant new opportunities and review its research activities globally to take advantage of synergies among disease areas and locations to increase efficiency.
• Initiatives are underway to capture savings from the creation of Group-wide shared functions, including procurement and information technology, that will provide greater economies of scale and leverage opportunities in low-cost countries.
• Novartis will form a new cross-divisional operation to accelerate growth in small emerging markets, expanding the presence of all Novartis products in regions that include Northern and Sub-Saharan Africa, Central Asia and parts of Southeast Asia.

The company announced that firings "will be handled in a socially responsible manner with fair and respectful treatment of associates," and that it will with works councils and comply with local labor laws.

Merck has filed an IND with the FDA for a cancer vaccine candidate that targets telomerase. Merck is developing the vaccine under a July, 2005 Research, Development and Commercialization License Agreement with Geron Corp., which provided exclusive worldwide rights to develop and commercialize non-dendritic cell-based vaccines targeting telomerase. Geron received a $4 million milestone payment from Merck after the IND filing, and is eligible to receive additional development milestones as well as royalties on worldwide product sales.

"We are pleased with the progress that Merck has made in advancing this program towards the clinic," said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. "We appreciate the collaborative nature of our relationship with Merck and look forward to working with them to realize the therapeutic potential of this cancer vaccine candidate."

West Pharmaceutical Services will implement a restructuring plan for its Tech Group segment. The restructuring "addresses the recent reduction in business due to changes in customers' marketing plans by reducing the operating costs and increasing the manufacturing efficiency of the segment," according to a West statement. The unit was involved in manufacturing the delivery device for Exubera, a product that Pfizer abandoned in October.

The company will reduce spending throughout the Tech Group segment by consolidating two tool production operations into one facility in Scottsdale, AZ, and by reducing and consolidating other production, engineering and administrative operations in North America. The plan is expected to be completed by December, 2008. As a result of the restructuring, the Tech Group workforce will be reduced by approximately 250 workers, or 13%.

West will incur as much as $12 million in restructuring charges, consisting primarily of severance costs and fixed asset write-downs. The company expects to gain $3 million of cost savings in 2008 and annual operating savings of approximately $7 million from 2009 on.

"These actions, while difficult, are essential to West to create the right operational footprint for the level of business we have today and ensure we remain competitive and financially strong for the future," said Donald E. Morel, Jr. Ph.D., West's chairman and chief executive officer. "The restructuring will match the size of our operations to Tech's forecasted business and allows us to focus our human and financial resources on our strategic goal of expanding Tech's proprietary product portfolio."

Bristol-Myers Squibb and Gilead Sciences have formed an agreement to commercialize Atripla in Europe for the treatment of virologically suppressed adults with HIV-1 infection. If approved in the EU, Atripla would represent that region's the first and only once-daily single tablet regimen for HIV-1 infection. The companies expect the European Commission to issue its decision by the end of the year.

BMS and Gilead have agreed to share responsibility for commercializing the drug throughout the EU and certain other European countries. Gilead will record revenues from future net sales of Atripla in most of the European countries, while Bristol-Myers Squibb will record revenues in most of the European countries at percentages relative to the contribution represented by its individual product.

BMS recently concluded an agreement with Merck (U.S.) granting BMS rights to co-commercialize Atripla with Gilead in all of the European Union and certain other European countries. Previously, Merck had the exclusive right to market any product containing efavirenz (a component of ATRIPLA) in all European countries other than the UK, Germany, France, Italy, Spain and the Republic of Ireland.

Atripla is a combo of three drugs: Sustiva (BMS), Emtriva (Gilead) and Viread (Gilead). The latter two are marketed as a single pill under the name Truvada. Atrpla is currently sold in the U.S. and Canada through a joint venture between BMS and Gilead. ATRIPLA was approved by the FDA in July 2006 and by Health Canada in October 2007. Gilead and Merck previously announced a collaboration to distribute Atripla in developing countries.

John Goodacre has been named executive vice president and general counsel of Quintiles Transnational Corp. Previously senior vice president, Global Risk Management and Quality Assurance, Mr. Goodacre joined Quintiles in 1998 as vice president, European legal affairs.

In his new role, Mr. Goodacre is responsible for Quintiles' global legal function and risk management, and has also been named to the company's Executive Committee. He reports to Mike Mortimer, executive vice president and chief administrative officer.

"John has a thorough understanding of Quintiles and the clinical research industry, having served the company in various capacities over the past 20 years -- including as outside counsel when we formed Quintiles (UK) Limited, our first international subsidiary, in 1987," said Dennis Gillings, CBE, chairman and chief executive officer of Quintiles. "With his strong legal background and experience in leading our risk management and QA group, John will help Quintiles continue to grow and protect our interests."

Shareholders of Gene Logic have approved the sale of the company's genomics assets to Ocimum Biosolutions and the subsequent renaming of the company as Ore Pharmaceuticals. The genomics sale is expected to close later this week and will effectively launch Ore Pharmaceuticals as a new company focused on drug repositioning and development. After the filing of necessary legal documents later this week, the company will be renamed officially.

"Effective with the closing of the Ocimum transaction, we will inaugurate a new company with a clearly defined purpose," stated Charles L. Dimmler, III, president and chief executive officer of Gene Logic. "As a drug repositioning and development company, our sole purpose is to supply the demand of pharmaceutical companies for product innovation to enrich their development pipelines. Our shareholders' votes signify their endorsement of our strategy to transform the company, a transformation we have been engaged in for the past year. We are positioned well, with the industry's leading indication-seeking program, partnerships with eight pharmaceutical companies, and a drug candidate of our own, GL1001, for which we are seeking a development partner."

Ore Pharmaceuticals will be engaged exclusively in repositioning clinical-stage drug candidates that have stalled in development for reasons other than safety.

GlaxoSmithKline and OncoMed Pharmaceuticals have formed a strategic alliance to discover, develop and market novel antibody therapeutics to target cancer stem cells. These cells are believed to play a key role in the establishment, metastasis and recurrence of cancer. The alliance will be conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).

The alliance leverages OncoMed's expertise in the discovery and development of cancer stem cell antibody therapeutics and provides GSK with an option to license four product candidates directed at multiple cancer stem cell targets from OncoMed's broad library of monoclonal antibodies. OncoMed will receive an undisclosed initial payment that includes cash and an equity investment. In addition, OncoMed is eligible to earn milestone payments of as much as $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory and commercial milestones. OncoMed will also receive double-digit royalties on all collaboration product sales. GSK will have an option to invest in a future initial public offering by OncoMed.

OncoMed has established a diverse pipeline of monoclonal antibodies to target multiple pathways important in the activity of cancer stem cells. The alliance with GSK includes OncoMed's lead antibody product candidate, OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.

In the alliance, OncoMed will utilize its proprietary in vivo xenograft cancer stem cell models to identify MAbs in a specific, undisclosed cancer stem cell pathway. OncoMed will develop the most promising of these monoclonal antibodies, including OMP-21M18, through clinical proof of concept across multiple indications. Upon achievement of clinical proof of concept in an agreed indication, GSK will have an exclusive option to license that MAb. GSK would then assume responsibility for funding of further clinical development and commercialisation on a worldwide basis. OncoMed retains the option to participate in development and commercialization of OMP-21M18 on pre-agreed terms.

Eisai Co., Ltd. will acquire MGI Pharma for approximately $3.9 billion in an all-cash transaction. The acquisition has been unanimously approved by MGI's board; it is expected to occur by means of a tender offer followed by a cash merger, is subject to customary closing conditions and regulatory approvals, and is expected to be completed during the first quarter of 2008.

According to a press statement, Eisai "expects MGI's marketed and pipeline products in oncology and acute care, as well as its R&D and commercial capabilities, including field sales specialists, together with Eisai's existing oncology products, global infrastructure and R&D capabilities, will create a base for continued sales growth, pipeline enhancement and the opportunity for synergies." The acquisition is also intended to boost Eisai's presence in the U.S.

Mr. Haruo Naito, Eisai's president and chief executive officer, said, "Strategically, we expect this transaction to allow Eisai to significantly strengthen its oncology business and increase the likelihood of achieving our current strategic plan targets and our future revenue and earnings growth."

Eisai is currently in the midst of a "Dramatic Leap Plan" (DLP), its fifth midterm strategic plan. Under the DLP, which spans April 1, 2006 to March 31, 2012, Eisai has continued to achieve steady growth in all regions, including Japan, the U.S., Europe and Asia, with a special focus on integrative oncology. Eisai has strengthened its oncology R&D and marketing infrastructure in the U.S. through the October 2006 acquisition of four oncology products from Ligand Pharmaceuticals and the April 2007 acquisition of Morphotek, Inc. In addition, Eisai is building a new oncology facility for manufacturing and formulation R&D at its North Carolina site.

To facilitate the acquisition, Eisai has established a subsidiary, Jaguar Acquisition Corp., which is wholly-owned by Eisai Corp. of North America. Subsequent to the completion of the tender offer, Jaguar will be merged into MGI and the combined entity will then become a wholly-owned subsidiary of Eisai Corp. of North America.

The acquisition price represents a premium of approximately 38.7% to MGI's closing share price of $29.55 on November 28, 2007. Eisai intends to finance the acquisition through existing internal financial resources, as well as bank loan financing, and has secured commitment for the debt required to consummate the transaction.

Janssen-Cilag has submitted an MAA for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The MAA was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State, and Austria, Finland, Germany, Italy, Portugal and Spain will act as the Concerned Member States for the application. Regulatory submissions in other regions of the world are expected to follow.

Dapoxetine is the first oral pharmacologic agent developed specifically for the treatment of men with PE. The safety and efficacy of dapoxetine for the treatment of men with PE were studied in five, double-blind, placebo- controlled, Phase III clinical trials involving more than 6,000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa.

The most common adverse drug reactions reported during clinical trials were headache, dizziness, nausea, diarrhea, insomnia and fatigue.

Seattle Genetics has begun a Phase IIb trial of SGN-40 in combination with Rituxan plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company's collaboration agreement with Genentech, Inc., Seattle Genetics will receive a $12 million milestone payment for initiating the study.

"This trial will provide key data on the safety and potential efficacy of adding SGN-40 to standard second-line therapy for the treatment of patients with relapsed diffuse large B-cell lymphoma," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are moving forward with this global trial based on the encouraging safety profile and clinical activity observed in our phase I single-agent trial in patients with DLBCL, together with preclinical data demonstrating enhanced efficacy of SGN-40 when combined with chemotherapy."

The phase IIb, randomized, double-blind, placebo-controlled clinical trial, named SeaGen MARINER, is expected to enroll approximately 200 relapsed or refractory DLBCL patients at more than 60 medical centers worldwide. Patients will receive either Rituxan, ifosfamide, carboplatin and etoposide (R-ICE) plus SGN-40 or R-ICE plus placebo. The primary endpoint of the study is complete response rate. Additional endpoints include safety, tolerability, failure-free and overall survival.

Urigen Pharmaceuticals has established a partnerships with Hyaluron Contract Manufacturing (HCM) to develop URG101, Urigen's proprietary fixed dose combination of FDA-approved drugs targeting painful bladder syndrome (PBS).
 
"Urigen's development program with Hyaluron is a critical step forward for URG101," commented William J. Garner, M.D., president and chief executive officer of Urigen. "Hyaluron, with its quality-focused and innovative drug development team, makes an excellent partner for us as URG101 progresses through its development. We look forward to working with the drug development team at Hyaluron to provide a solution to PBS through the commercialization of our product."
 
"We are very pleased to have been selected by Urigen to undertake the development of their kit targeting PBS," stated Shawn Kinney, HCM's president. "The collaborative spirit already demonstrated by both companies’ employees bodes well for a successful development program."

Bristol-Myers Squibb has publicized the details of its restructuring initiative as it works to become a "next-generation BioPharma company." With the aim of generating $1.5 billion in annual pre-tax savings by 2010 (the year that top-seller Plavix loses patent protection), the company plans to fire 4,300 staffers -- approximately 10% of its workforce -- in the process of reducing its roster of manufacturing sites by 50% by the end of 2010 and reducing the number of brands in its "mature products portfolio" by 2011.

Costs for the firings and closings are projected to be between $900,000 and $1.1 million. Said chief executive officer James M. Cornelius, "It is difficult to see our valued colleagues leave the company, but right-sizing our workforce across all areas is critical to achieving our productivity goals and enhancing the competitive position of the company. While we are reducing headcount in certain functions, we will continue to invest in R&D, biologics and commercialization talent."

The company plans to sell its medical imaging business and is also looking at "strategic alternatives" for its ConvaTec (ostomy supplies) and Mead Johnson (baby nutritionals) units.

Pharmetics, Inc. has entered into an agreement to acquire the Niagara-Burlington commercial manufacturing business of Patheon for approximately $5.75 million. Pharmetics will acquire the assets -- including equipment, facilities and land -- at Patheon's facilities in Fort Erie and Burlington (Gateway Drive) in Ontario.

The two sites currently serve 14 clients, manufacturing and packaging about 60 OTC pharmaceutical products in a range of dosage forms, including tablets, liquids and powders. Laval, Quebec-based Pharmetics will continue to employ the entire active workforce of about 250 commercial manufacturing employees at the two sites and, subject to assignment of third-party contracts, will continue to manufacture and supply all products currently manufactured at the  sites. Pharmetics is a privately owned contract manufacturer of vitamins, herbal products, supplements and OTC pharmaceutical products.

"Once the decision was made to seek a buyer for our OTC business, we had three key priorities: continuity of service for our clients, continuity of employment for our staff, and the sale of the facilities to a purchaser who could capitalize on the strategic value of these assets," said Riccardo Trecroce, outgoing chief executive officer of Patheon. "We are very pleased that in this transaction with Pharmetics, all three of these objectives will be achieved."

"These sites will provide Pharmetics with conveniently located, high-quality capacity and expertise with which to expand our business and serve our growing client base," said Ephriam Kandelshein, co-president of Pharmetics.

The transaction is expected to be completed on or about January 31, 2008.

Edward J. Schutter has been appointed to president and chief operating officer of Sciele Pharma. In his new position, Mr. Schutter will continue to report directly to chief exeutive officer Patrick Fourteau and will be responsible for day-to-day operations of the company in addition to his sales and marketing duties.

Mr. Schutter joined Sciele in April 2006 as executive vice president and chief commercial officer. Prior to that, he was employed by Solvay Pharmaceuticals in a variety of management positions during his 15-year tenure there, most recently as vice president, global business development and licensing.

Mr. Fourteau said, "Since joining the company, Ed has been a key member of our executive team and came to Sciele with a strong record of driving business development, sales growth and improved operations. Ed's primary focus will be on implementing our sales and marketing strategies, optimizing growth, and launching two to three new products each year beginning in 2008."

Pfizer and Adolor Corp. have signed an exclusive collaboration to develop and commercialize novel compounds, ADL5859 and ADL5747, for the treatment of pain. Both compounds are proprietary Delta opioid receptor agonist candidates with the potential to treat a wide range of inflammatory, neuropathic and acute pain conditions.

The companies will form a Joint Steering Committee to guide the development and commercialization of products resulting from the collaboration. Pfizer will be responsible for securing regulatory approvals and commercialization on a worldwide basis.

The terms of the agreement provide for Pfizer and Adolor to share revenues and expenses 60/40 in the U.S. Outside the U.S., Pfizer will fund development activities and, upon commercialization, Adolor will receive royalties on Pfizer net sales. Adolor will receive an upfront, non-refundable payment of $30 million, plus $1.9 million reimbursement for prior Phase II development costs. Adolor may also receive payments of as much as $232.5 million upon the achievement of development and regulatory milestones for its Delta compounds. More than 50% of these milestones may be earned prior to regulatory approval of the compounds, with the first milestone payment available to be earned on commencement of Phase IIb clinical studies.

"We are pleased to be partnering with Pfizer in this very exciting program," said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. "Our vision for the Delta agonists has been to develop a new class of opioids, delivering analgesia without some of the complicating side effects of traditional mu agonists. Pfizer brings extensive pain management development and commercial expertise to this collaboration and we look forward to working with Pfizer in the pursuit of this vision."

ADL5859 is in a Phase II development program exploring analgesic efficacy in inflammatory pain associated with rheumatoid arthritis and acute post-dental surgery pain. Additional programs are planned to evaluate ADL5859 in patients with diabetic peripheral neuropathy and osteoarthritis. All future development work is subject to a Joint Development Committee. Adolor expects to begin Phase I clinical testing of ADL5747 in the first quarter of 2008.

"This collaboration demonstrates our commitment to executing against the R&D plan we outlined, including expanding our Phase II portfolio with a strong focus in our key therapeutic areas," said Dr. Martin Mackay, president of Pfizer Global R&D. "Pfizer has a strong history in bringing to market novel pain solutions including Lyrica, Neurontin and Celebrex. However, there still remains a significant unmet medical need for patients suffering from a variety of debilitating pain conditions."

Avid Bioservices has signed a manufacturing supply and technology transfer agreement with Arius Research. The agreement covers Arius' lead cancer stem cell antibody, which targets a novel epitope of CD44 found in breast, colon and prostate cancers. Avid will begin manufacturing drug supply under cGMP  for human trials that Arius plans to initiate in 2008.

"This new agreement reflects our extensive experience and broad capabilities in manufacturing monoclonal antibodies, as well as the good working relationship we have already developed with the Arius team," said F. David King, vice president of business development of Avid.

"Avid's proven expertise in the scale-up and manufacture of clinical and commercial grade antibodies should further support the significant progress we are achieving with our CD44 Cancer Stem Cell program," said Dr. David Young, chairman, president and chief exeutive officer of ARIUS. "Avid will provide us with a supply of our CD44 targeting drug to initiate human clinical trials in 2008, subject to the clearance of our IND by the FDA."

ARIUS is advancing the formal preclinical toxicology program for the program, an anti-cancer antibody targeting a novel epitope of CD44 found in breast, colon and prostate cancers.

Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc.

Quest Pharmaceutical Services, LLC, a GLP-compliant CRO providing testing services to support preclinical and clinical research and development, has formally changed its name to QPS, LLC.

The company commissioned independent market research to evaluate the pharmaceutical research industry's recognition and perception of both the Quest Pharmaceutical Services and QPS names. The name change "supports the company's mission to provide meticulous quality, performance driven by an adherence to client timelines and impeccable client service," according to a company statement.

Founded in 1995, QPS has bioanalytical and DMPK facilities at its Newark, DE headquarters and a bioanalytical laboratory in Taipei, Taiwan. Regional sales offices are maintained in Boston, Connecticut, Pennsylvania, California, New Jersey, and Texas.

Two Johnson & Johnson subsidiaries, Centocor, Inc. and Janssen-Cilag International NV, have submitted marketing approval applications for ustekinumab (CNTO 1275) in the U.S. and Europe for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Centocor has submitted a BLA wit the FDA and Janssen-Cilag International  an MAA to the EMEA. Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis, according to a joint statement.

It is estimated that 125 million people worldwide have psoriasis, including 2% of both the U.S. and European populations, or some 7.5 million Americans and 10 million Europeans. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.

"We are very encouraged by the promising results that we have seen through the ustekinumab clinical development program evaluating the efficacy and safety of this novel biologic in the treatment of moderate to severe plaque psoriasis," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc.

CMC Biopharmaceuticals A/S has reached an agreement with Lilly to buy the biologics development and manufacturing operation of ICOS Corp., which Lilly bought on in January 2007. CMC, a Copenhagen, Denmark-based bio-CMO, will purchase the biologics facility in Bothell, WA. The new operation, CMC ICOS Biologics Inc., will develop and manufacture therapeutic proteins for early clinical trials.

In a statement, the company said that it is planning "significant investment in the facility to enable production of late-stage clinical trial and commercial biopharmaceuticals." CMC plans to retain the 127 employees currently working at the Bothell facility.
 
"We're extremely excited about our acquisition of ICOS Biologics. We feel strongly that the skills inherent in the employees that work here are of great value to the biologics industry and will complement the abilities of our expert workforce in Europe," said David Kauffmann, CMC's chairman.

Mads Laustsen, CMC's chief executive officer, remarked, "Our plans to upgrade the facility in order to manufacture commercial product will mean that we can provide additional services to both existing and new clients. Moreover, by establishing a presence in the USA, we've placed CMC in an enhanced position to actively seek opportunities to grow our business."

David A. Dodd has been named president, chief executive officer and chairman at BioReliance Corp. From 2000 through 2006, Mr. Dodd served as president and chief executive officer of Serologicals Corp., a publicly traded company that was sold to Millipore Corporation in 2006 for $1.4 billion. From 1995 to 2000, he was pPresident and chief executive officer of Solvay Pharmaceuticals, a subsidiary of the Solvay Group. Mr. Dodd entered the pharmaceutical industry in 1977 with Abbott Laboratories and served at McDonnell-Douglas Healthcare Systems, Bristol-Myers Squibb and Wyeth. Mr. Dodd currently serves as non-executive chairman at Stem Cell Sciences plc.

"David brings an impressive record of maximizing the potential and competitive impact of the companies he manages," said David Burgstahler, a partner at Avista Capital Partners, the private equity firm that acquired BioReliance from Invitrogen in April 2007. "He is a compelling and focused leader with proven ability at not only expanding revenues and profits at a rapid pace, but at the same time building very strong organizations with dedicated management teams. We look forward to working with David to continue to advance BioReliance’s leadership in its industry space."

Novartis and MorphoSys AG have formed a comprehensive, 10-year, $600 million strategic alliance for the discovery and development of biopharmaceuticals. The deal is aimed at establishing a pipeline of innovative drugs, and establishes Novartis as MorphoSys's preferred collaborator for HuCAL-based drug discovery. According to a MorphoSys statement, this will allow the company to focus on drug discovery and development and help it wean itself from new or extended fee-for-service discovery deals. The agreement supersedes the existing one between the companies.

Under the agreement, Novartis will make a major long-term commitment to MorphoSys's human antibody technology, HuCAL. Over the 10-year lifetime of the agreement, the parties will engage in approximately double the annual number of therapeutic antibody discovery programs as compared to their previous alliance, encompassing a wide range of diseases. MorphoSys also has options to participate in certain development activities in various programs, with part of the early stage costs being funded by Novartis. Under the co-development options, MorphoSys may elect to participate in these projects through cost and profit sharing with financial participation reflecting its level of investment in the respective programs.

The alliance also includes rights to co-promote products in specific territories through creation of MorphoSys's own sales force. In addition to programs pursued jointly, Novartis has accelerated its plan to internalize HuCAL at its research sites under the option agreed in the original contract between the companies.

Based on a 10-year term, committed total annual payments sum to more than $600 million in technology access, internalization fees and R&D funding, not including reimbursement of R&D costs related to early stage development activities. Including development milestones, total payments could exceed $1 billion, assuming the collaboration successfully runs its maximum term (Novartis has  the option to end the alliance after seven years or extend it to 12 years). MorphoSys is also entitled to royalty payments and/or profit sharing on any future product sales.

"This is a transforming deal for MorphoSys. This alliance heralds a new chapter in our corporate development as it offers us the perfect construct to increase significantly the value of our proprietary drug development pipeline while simultaneously maximizing our financial interest in partnered programs," commented Dr. Simon Moroney, chief executive officer of MorphoSys AG. "The first antibody from our collaboration with Novartis entered the clinic three years after signature. The proven success of our relationship and demonstrated commitment of the collaborator was a key factor in our decision to enter this substantially expanded new deal. This deal maximizes the value of our partnered antibody pipeline and the additional cash-flows within the strategic partnership with Novartis will become a major value driver for MorphoSys."

"Over the past three years MorphoSys has been an instrumental collaborator in the build up of Novartis internal biologics discovery and development efforts," said Abbie Celniker, Global Head, Novartis Biologics.  "We look forward to continuing our collaboration with the MorphoSys team under this expanded alliance."

Aptuit, Inc. has completed the acquisition of Evotec's Chemical and Pharmaceutical Development (CPD) business. The move allows Aptuit to integrate an API facility in Oxford, England and a recently expanded parenteral fill/finish facility in Glasgow, Scotland into its global network.

According to an Aptuit statement, "The integration of these development and small-scale manufacturing facilities in Europe completes a unique global API supply chain where small scale development takes place in the U.S. and Europe with commercial scale undertaken in new state-of-the-art facilities in India."

"Over the past 18 months we've assembled by strategic acquisitions the core competencies that are key to reducing the time and cost burdens of drug development for our customers, and that also build on our commitment to operate an efficient, integrated global network. This particular acquisition is an important building block for Aptuit as we move toward completing that network," said Michael A. Griffith, Aptuit's chief executive officer and founder.

AstraZeneca has completed enrollment of patients in the ZEST (Zactima Efficacy Study versus Tarceva) study, the first of four Phase III trials for the investigational once-daily oral anti-cancer drug vandetanib. Data from the study is expected in 2008.

ZEST is a randomized, double-blind, multi-center Phase III study to assess the efficacy of vandetanib versus erlotinib in overall survival (OS) and progression-free survival (PFS) in more than 1,150 patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line anti-cancer therapy.

"Non-small cell lung cancer is an area of high unmet medical need, and we hope vandetanib will offer a beneficial new treatment option for people with lung cancer," said Dr. Peter Langmuir, Medical Science Director at AstraZeneca.

ZEST is part of a Phase III clinical trial program to gain a broad understanding of how vandetanib may benefit people with lung cancer. The other studies also have punchy names:

• ZODIAC (vandetanib + docetaxel versus docetaxel alone)
• ZEAL (vandetanib + pemetrexed versus placebo + pemetrexed); and,
• ZEPHYR (vandetanib + best supportive care (BSC) versus placebo + BSC).

Hans Christian Teisen has been named senior vice president and chief financial officer at LifeCycle Pharma. He replaces Michael Wolff Jensen, executive vice president and chief financial officer, who has decided to leave the company, effective March 2008, to pursue other opportunities.

Mr. Teisen is currently the chief financial officer of Bavarian Nordic. Previously, he served as vice president of finance, IT, procurement & strategy at Rockwool A/S Denmark. He has worked for The Ministry of Foreign Affairs, where he served as Head of Section, Foreign Policy Department in Denmark; First Secretary of Embassy, Royal Danish Embassy, London; and Head of Section - EU, Maastricht Treaty, EMU and Economic Cooperation.

"I would like to thank Michael for his significant efforts and contributions to the success of LifeCycle Pharma," said Dr. Flemming Ørnskov, President and CEO of LifeCycle Pharma. "We are pleased to have attracted a qualified replacement for Michael well before his departure and we look forward to having the wealth of knowledge and deep financial experience that Hans has to offer our growing organization."

ImmunoVaccine Technologies Inc. (IVT) has successfully scaled-up the manufacturing process for its vaccine platform, Vaccimax. The manufacturing development was performed by Dalton Pharma Services.

VacciMax is a vaccine-enhancement platform comprised of a special emulsion of liposomes, antigens, adjuvants and oil, according to IVT. To prepare VacciMax for human cancer clinical trials, IVT has been developing its platform to meet all regulatory requirements, including manufacturing in a GMP setting. Having successfully produced VacciMax at a commercially relevant batch size, the company plans to license the technology worldwide for the therapy and prevention of cancer and infectious diseases.

"We are pleased to collaborate with IVT and wish to congratulate the entire team on meeting such an important milestone. The successful scale-up of VacciMax was a direct result of the Dalton and IVT teams' strong technical capabilities and project management skills," remarked Peter Pekos, president and chief executive officer of Dalton Pharma Services.

IVT's testing verified that development batches produced at Dalton at an increasing scale retained their expected biological activity. Analytical testing also showed that the various elements of the platform are chemically stable. The latest batch produced at the 50-litre scale also met manufacturing and chemical specifications.

Regeneron Pharmaceuticals and Sanofi-Aventis have entered a new collaboration, which will include a greater SA stake in the biopharma. The companies will work to discover, develop, and commercialize fully-human therapeutic antibodies utilizing Regeneron's proprietary VelociSuite of technologies.

SA will also make an $85 million upfront payment to Regeneron and will fund as much as $475 million of research during the next five years. SA will have an option to extend the research agreement for as many as three additional years.

As part of the agreement, SA will boost its ownership of Regeneron from approximately 4% to 19% by purchasing 12 million newly issued shares. SA has an option to expand its ownership to 30% in the next four years. Like most major pharma companies, SA aims to expand its presence in biologics.

SA will have the exclusive option to co-develop with Regeneron each drug candidate in the collaboration portfolio. Development costs will be shared between the two companies, with SA funding drug candidate development costs up front and Regeneron reimbursing half of the development costs from its share of future profits.

The first therapeutic antibody to enter clinical development under the collaboration is an antibody to the Interleukin-6 receptor (IL-6R), which has started clinical trials in rheumatoid arthritis. The second is expected to be an antibody to Delta-like ligand-4 (Dll4), which is currently slated to start its clinical development in 2008.

For any new product successfully developed as part of the collaboration, SA will take the lead in commercialization activities and will consolidate the sales. Regeneron will have the right to co-promote any and all collaboration products worldwide. In the U.S., profits will be shared equally. Outside the U.S., profits will be split on a pre-determined sliding scale with sanofi-aventis’ share ranging from 65% to 55%. Regeneron will also be entitled to receive as much as $250 million in sales milestone payments when the collaboration achieves certain aggregate annual ex-U.S. sales levels, starting at $1 billion.

QLT Inc. has formed a Special Committee to "review all strategic alternatives available," according to a company statement. The committee, comprised of three independent directors from the board, has appointed Morrison & Foerster, LLP as legal counsel. The committee has been charged, among other things with the responsibility for "exploring alternative ways to maximize shareholder value," including a selloff of all or part of the company.

QLT's board is reviewing proposals from several investment bankers and expects to appoint a Financial Advisor in the near future to assist the committee in the evaluation of strategic alternatives.

Boyd Clarke, QLT's chairman, remarked, "The board of directors believes that the net value of the assets of the company exceeds the value represented by the stock price. We had hoped to address that disconnect through the deployment of our current strategic plan. However, as the gap continues to widen we have decided that, other than as contractually required, making significant additional investments in all of our current products and technologies would be inconsistent with our objective of maximizing shareholder value."

Visudyne, the company's lead product for age-related macular degeneration (AMD), has seen sales deteriorate in the face of competition. The company also took a $110 million charge in 2Q07 related to a patent dispute.

DynPort Vaccine Co. and Baxter International have received a $201.2 million contract modification from the U.S. Department of Health and Human Services (HHS) for the development of Baxter's cell-cultured seasonal and pandemic influenza candidate vaccines.

The contract funds development of the seasonal influenza vaccine through FDA licensure, and the pandemic vaccine candidate through Phase II clinical trials in adults and pediatric Phase I clinical trials. DVC, the prime contractor for this effort, is providing overall management of the clinical trials. Baxter is developing the candidate vaccines, and will manufacture the vaccines and own all clinical data and licenses.

The clinical portion of a Phase I/II clinical trial to test the safety and immunogenicity of Baxter's cell-culture-derived split virus seasonal influenza vaccine candidate in Europe was recently completed. Preliminary data announced in July 2007 indicate that the vaccine induced strong antibody responses and good tolerability in all study populations. DVC and Baxter vaccinated the first volunteers of a Phase III trial in healthy adults using the seasonal vaccine candidate in the U.S. on Nov. 26, and plan to enroll patients in a Phase I clinical trial for a pandemic influenza clade 2 strain vaccine candidate in 2008. This trial will also be conducted in the U.S.

"The progress made on the pandemic and seasonal influenza programs in such a short time reflects the priority and importance of this development program for both companies," said Dr. Robert V. House, president and chief scientific officer of DVC. "By combining Baxter's technology with DVC's biologics life-cycle and contract management expertise, the team has made great progress in advancing these two influenza vaccine candidates."

Bethany Mancilla has been promoted to senior vice president, business development at Gene Logic, where she will lead the company's partnering and licensing efforts. Since July 2004, Ms. Mancilla has been involved in the formation and development of Gene Logic's Drug Repositioning partnerships with pharmaceutical companies including Pfizer, Roche, Abbott, Merck-Serono, Organon, and Solvay. She is also leading the company's efforts to secure a development partner for its proprietary drug candidate, GL1001, for inflammatory bowel disease (IBD).

Ms. Mancilla has more than 15 years of business development experience in the biotechnology sector, including more than nine years with Gene Logic. Prior to her assignment to the Drug Repositioning Business, she was responsible for spearheading the development of the company's toxicogenomics business and, to advance the program’s development, she formed a consortium with major pharmaceutical companies such as Pfizer and Wyeth. Before joining Gene Logic, Ms. Mancilla was director of business development at BCM Technologies the venture and technology transfer subsidiary of Baylor College of Medicine, where she was involved in the creation and financing of four start-ups: GeneMedicine, Meretek Diagnostics, Sennes Drug Innovations, and Receptor Pharmaceuticals.

Pharmacopeia has identified a pair of new lead compounds for advancement in its alliance with GlaxoSmithKline. The first of the lead compounds forms the basis of a new lead optimization program focused on identifying a treatment for respiratory disease. The other newly identified lead compound is the second from a program in inflammatory pain. As a result of the identification of these new lead compounds, Pharmacopeia will receive milestone payments totaling $1 million from GSK, which is conducting the work through its Center of Excellence for External Drug Discovery (CEEDD)

Pharmacopeia has received $10 million from GSK in connection with early discovery activities and is entitled to an additional $5 million payment upon the completion. Pharmacopeia is also entitled to success-based milestone payments totaling as much as $83 million per program and potential double-digit royalties on the sales of any product commercialized by GSK under the multi-program alliance. Should GSK decline its option to complete pivotal trials of alliance programs, Pharmacopeia may independently pursue them, subject to its obligations to GSK under the agreement.

"With the identification of these two compounds, our collaboration has now identified a total of three new leads this year," said Hugh Cowley, senior vice president of GSK and head of the CEEDD at GSK. "We are extremely pleased to see the continued rapid and impressive achievements of the team driving this successful collaboration."

"Since entering into this collaboration just over 18 months ago, we have advanced multiple programs focusing on compelling targets toward development candidates," said David Floyd, Ph.D., executive vice president and chief scientific officer of Pharmacopeia. "We are very pleased that progress within the collaboration exceeds our initial estimates and that compounds are coming from multiple programs in multiple therapeutic areas. We're particularly happy to have added a second lead to our ongoing pain program as this significantly increases its chances of overall success."

Valeant Pharmaceuticals has reached full enrollment in RESTORE2, its second Phase III study of retigabine in the treatment of epilepsy. Retigabine is a first-in-class neuronal potassium channel opener demonstrated to be effective in a recently published Phase IIb epilepsy study. The two RESTORE trials (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) are designed to evaluate the efficacy and safety of retigabine as an adjunctive therapy in patients with refractory partial-onset seizures who are receiving one, two or three concomitant antiepileptic drugs (AEDs). RESTORE2 is investigating retigabine at 600 and 900 milligrams per day while RESTORE1 is investigating retigabine at 1,200 milligrams per day.

"More than 50 million people worldwide have epilepsy and the global market for AEDs is more than $13 billion and growing," said Timothy C. Tyson, Valeant's president and chief executive officer. "The development of retigabine, which will be the first and only potassium channel opener for the treatment of refractory epilepsy, is our highest R&D priority at Valeant. We are pleased to be leading the way in the research and development of potassium channel openers for the treatment of important neurological disorders such as epilepsy and neuropathic pain."

Five hundred and thirty-nine patients have enrolled in RESTORE2, which is being conducted in 69 sites across Europe, Israel, Australia, South Africa and the United States. The RESTORE1 trial is being conducted in 49 sites across the United States, Argentina, Mexico, Brazil and Canada. To date, more than 85% of eligible patients involved in RESTORE trials have chosen to enter into ongoing open-label extension studies.

Following the anticipated completion of the RESTORE trials in 2Q08, Valeant plans to file an NDA and MAA for retigabine, with an anticipated launch in 2009.

Genzyme and Fovea Pharmaceuticals SA have entered into a collaborative research pact centered on Fovea's proprietary high content technology platform that allows the identification of new targets involved in photoreceptor degeneration in retinal dystrophies. The companies will collaborate to develop gene-related therapies using Fovea's selected targets and Genzyme's gene delivery technologies.

Fovea's scientific, clinical and pharmaceutical expertise in retinal diseases and Genzyme's extensive know-how in protein production and gene delivery will offer customized solutions for the understanding of the disease mechanisms, with the goal to develop new therapeutic strategies to prevent or reduce the severity of blindness, according to a Fovea statement.

"This first research partnership signed with Genzyme demonstrates the interest of our proprietary discovery platform," said Bernard Gilly, chairman and chief executive officer of Fovea. "This collaboration underscores the substantial opportunity that our expertise in retinal diseases and unique platform provide to increase the efficiency and probability of success in ophthalmology drug discovery and development."

Santen Pharmaceutical Co., Ltd., of Osaka, Japan has begun Phase I/IIa trials of DE-102, its steroidal treatment for macular edema, employing Oakwood Laboratories' Chroniject™ sustained release delivery technology. The product's microsphere formulation and its sterile filling was accomplished at Oakwood's Cleveland manufacturing facility.

"Oakwood is very pleased to have been able to solve some difficult technical issues in order to bring this product to commercial manufacturing scale, and to the point of clinical use," said Mark Smith, Oakwood's president. “We look forward to the continued development of this product.”

According to Mr. Smith, the company's Chroniject technology has been shown to offer an adaptable and easily scaleable system for the development and manufacture of injectable sustained release dosage forms of multiple drug classes.

Akorn, Inc. has received approval from the FDA for its supplemental BLA for a unit-dose preservative-free Tetanus Diphtheria vaccine. The company expects to launch the vaccine in 1Q08.

In March 2007, Akorn announced that it had entered into an exclusive distribution agreement with Massachusetts Biologic Laboratories for Tetanus Diphtheria vaccine. Since September 2007, Akorn has been marketing a multi-dose preserved version of the Tetanus Diphtheria vaccine. This new approval will allow Akorn to effectively compete in the estimated $225 million U.S. market, according to the company.

MedImmune has begun dosing patients in the first Phase I trial of CAM- 3001, a fully human MAb targeting the alpha subunit of the granulocyte-macrophage colony stimulating factor receptor (GM-CSFR). The study is designed to evaluate the safety and tolerability of single doses of CAM-3001 in patients with rheumatoid arthritis (RA), and represents the first clinical trial in which a MAb targeting GM-CSFR is being investigated in this population. MedImmune currently holds exclusive, worldwide rights to develop and market CAM-3001 under an agreement with CSL Limited.

"Commencing this trial demonstrates that researchers at MedImmune are at the forefront of innovation using monoclonal antibodies and evaluating their potential to serve as new treatment options for patients with chronic, debilitating inflammatory diseases, including RA," said Ian Anderson, Ph.D., vice president of research - respiratory, inflammation and autoimmunity.

In the trial, patients will receive CAM-3001 at Charite Research Organisation in Berlin, Germany across a range of escalating doses and will be monitored for as long as seven months. Dose escalation will stop if maximum tolerated doses are reached.

GlaxoSmithKline has entered an agreement to acquire Reliant Pharmaceuticals Inc. for $1.65 billion in cash. Reliant is a privately held specialty pharma company focused on cardiovascular therapies. In the nine months ending September 30, 2007, the company's net sales were $341 million, up 62% YTD.

Through its strategic in-licensing strategy, Reliant has developed a portfolio of specialty drugs for heart disease, including U.S. rights to Lovaza, a treatment for adult patients with very high levels of triglycerides. Launched in late 2005, Lovaza achieved $206 million in sales, up 115% in the nine months ending September 30, 2007. Reliant currently markets three other in-licensed cardiovascular products: high blood pressure treatments DynaCirc CR and InnoPran XL, and Rythmol SR, which treats abnormal heart rhythms, or arrhythmia.

Chris Viehbacher, president, U.S. Pharmaceuticals, GSK, said, "The addition of Lovaza to the GSK portfolio adds a new driver of sales growth in the US business. It represents a strong strategic fit, complementing Coreg CR, a leading treatment for heart failure and hypertension, and adds to our growing profile in the cardiovascular disease area."

"Today is a momentous date for Reliant," said Bradley T. Sheares, chief executive officer of Reliant. "We are very proud of the work that our employees have done to build this company, particularly the energy and perseverance of our sales teams, who have demonstrated their worth in building a formidable Lovaza franchise in less than 24 months. We see great additional potential through this acquisition for Lovaza and the patients who could benefit from it."

The acquisition is subject to approval by the U.S. FT C and is expected to close before year-end.

Wesley P. Wheeler has been appointed chief executive officer of Patheon Inc., effective December 10, 2007. Mr. Wheeler will succeed Riccardo Trecroce, who plans to leave the company in 2008, following a transition period.

"With Patheon's restructuring initiatives well underway, we are focused on taking the company forward to the next phase of growth and profitability," said Ramsey Frank, managing director of JLL Partners, the company's largest shareholder, and chairman of Patheon Inc.'s corporate governance committee. "Wes Wheeler is a highly experienced pharmaceutical executive with a proven record of leading successful, international businesses. His in-depth knowledge of the industry and breadth of pharmaceutical experience will serve Patheon well as we move forward to grow and deliver improved value to our stakeholders."

"We would like to thank Riccardo Trecroce for his commitment and contributions to Patheon over his seven years with the Company," said Peter Green, chairman of Patheon's board of directors. "Riccardo led Patheon through a particularly challenging time in its evolution, successfully recapitalizing the company earlier this year and launching restructuring and operational initiatives to improve the Company's profitability. We thank him for his dedication and wish him every success in his future endeavours."

Mr. Wheeler has 29 years of multinational experience in pharmaceutical manufacturing, sales and marketing, R&D and engineering, with three global pharmaceutical companies. He joins the company from Valeant Pharmaceuticals International, where he served most recently as president, North America, R&D and global manufacturing. Prior to joining Valeant in 2003, he served as president and chief executive officer of DSM Pharmaceuticals, Inc., where he led the company through a business turnaround, significantly increasing new business, compliance and profitability in approximately 13 months. Prior to DSM, Mr. Wheeler was senior vice president of logistics and strategy for GlaxoSmithKline, where he was responsible for managing the manufacturing rationalization of Glaxo Wellcome and SmithKline Beecham. He also served as vice president of marketing for Glaxo Wellcome, responsible for antibiotic, antiviral, gastrointestinal and metabolic products as well as developing the marketing services infrastructure for the company.

Merck has suspended enrollment in clinical trials for the investigational Aurora kinase inhibitor, MK-0457, pending analysis of all efficacy and safety data for the drug. The decision was based on preliminary safety data, in which a clinical safety finding of QTc prolongation was observed in one patient. Merck and collaborative partner Vertex Pharmaceuticals, Inc. have a broad R&D program underway to evaluate Aurora kinase inhibitors targeting cancer.

MK-0457 is being studied in a Phase II trial in patients with treatment-refractory chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), as well as a Phase I trial in patients with advanced leukemias. Patients currently enrolled in these trials may continue to be treated with the drug, with additional monitoring for QTc prolongation. A recently initiated Phase I trial of MK-0457 in combination with dasatinib in patients with CML or Ph+ALL has also been suspended. Also, development of the Aurora kinase inhibitor MK-6592 has been discontinued after the compound did not meet pharmacokinetic objectives in a Phase I study.

Covance, Inc. purchased a partially constructed manufacturing facility in Prince William County's Technology Park from Eli Lilly. The company intends to transform the current facility into a 410,000-sq.-ft. state-of-the-art early drug development lab offering safety testing and chemistry analysis services.

"The increased demand from our biopharmaceutical clients for our preclinical safety service offerings has led Covance to seek opportunities to enhance and expand our operations in Northern Virginia and build upon our multi-year global expansion plans," said Wendel Barr, Covance senior vice president and president of early development North America. "For 60 years, Covance operations in Northern Virginia have made significant contributions to the development of new medicines for HIV/AIDS, breast cancer, heart disease, leukemia, diabetes, Alzheimer's, multiple sclerosis, cystic fibrosis, deadly infections, and many other debilitating diseases. With our long history in the area, we are looking forward to continuing our relationships as a member of the community as well as contributing to the diversification of the local economy."

Covance plans to relocate approximately 450 current employees from its existing operations in Vienna, VA and Chantilly, VA by 2011, and hire an additional 100 employees by 2014. The company plans to invest approximately $175 million in the project. Covance expects to receive approximately $3.7 million in financial incentives from the Commonwealth of Virginia and Prince William County.

Biogen Idec and Neurimmune Therapeutics AG entered an agreement for the worldwide development and commercialization of fully human antibodies for the treatment of Alzheimer’s disease (AD). The alliance will focus on the development of antibodies that bind to amyloid beta (Aβ), a pathogenic molecule thought to cause neurodegeneration and loss of cognitive function in AD patients. Currently there are no therapies for AD approved to slow or stop disease progression.

Neurimmune will conduct research to identify potential therapeutic antibodies using the company’s Reverse Translational Medicine (RTM) platform. Biogen Idec will be responsible for the development and commercialization of all products. Neurimmune could receive as much as $380 million in upfront and success-based milestone payments, as well as a royalty on sales of any products.

“Biogen Idec has the manufacturing, development and commercialization capabilities to leverage our discovery and technology expertise. With their extraordinary experience in the development of biopharmaceuticals as well as their deep history in neuroscience, Biogen Idec is the perfect partner for Neurimmune,” said Edward Stuart, Ph.D., chief executive officer of Neurimmune. “Our RTM platform is well suited to the identification of novel, safe immunotherapies for the treatment of human disease and we are particularly proud to have entered into this deal less than one year after the founding of the company.”

“Biogen Idec has built a leading position in the development and commercialization of treatments for neurological diseases such as multiple sclerosis. This alliance with Neurimmune enables us to be at the forefront of applied Alzheimer’s research, with access to an outstanding team of researchers and a remarkable technology platform,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Neurology R&D, Biogen Idec.

Dr. Victor Kiri has been appointed director of pharmacoepidemiology within Parexel International's Clinical Research Services business. Dr. Kiri will be responsible for advising clients in the design and conduct of comparative observational studies, offering epidemiological analysis for compounds in development, and guiding strategic decisions regarding future areas of research and product development.

"Regulatory pressures are increasing client demand for pharmacoepidemiological assessments and related studies as part of late phase clinical development," said Mark A. Goldberg, M.D., president of Clinical Research Services and Perceptive Informatics at Parexel. "One of Parexel 's strengths is our late phase development service offering that we call Peri-Approval Clinical Excellence or PACE. Dr. Kiri's in-depth experience in late phase study design and safety-related issues further expands our capabilities to provide clients with integrated pharmacoepidemiology and pharmacovigilance solutions."

Prior to joining the company, Dr. Kiri managed epidemiology research at GlaxoSmithKline. He previously served as a consultant on health outcomes to the U.K. Department of Health for more than 15 years. Dr. Kiri has been appointed as Adjunct Professor o