BASF has signed a definitive agreement to sell its manufacturing facility in Shreveport, LA and the related contract manufacturing business for finished pharmaceuticals to Dr. Reddy's Laboratories, headquartered in Hyderabad, India. Financial details were not disclosed.
   
As part of the agreement, BASF's 150 employees will transfer to Dr. Reddy's. The 42-acre Shreveport facility currently manufactures and packages prescription and OTC pharmaceutical products, liquids, tablets and creams for the North American market. BASF is divesting the site and related business in order to concentrate on core businesses in its Care Chemicals division, which include custom synthesis services, excipients and active ingredients for the pharmaceuticals industry.
   
"BASF's contract manufacturing activity for finished pharmaceuticals is limited to North America and not linked to the technological growth areas of the company's Pharma Ingredients and Services business. We want to continue to grow our excipients and custom synthesis operations to better serve the pharmaceutical industry in the future," said Martin Widmann, head of BASF's Pharma Ingredients and Services global business unit. "We assessed a variety of strategic options, but ultimately concluded that a divestiture is the best scenario not only for BASF but also for the future of the Shreveport site and its employees."
   
"We are excited about the acquisition of BASF's finished dosage manufacturing facility in the U.S. as it enables us to strengthen our supply chain for North America, provides a strong platform for pursuing additional growth opportunities and also provides access to strong customer relationships with branded and generic companies," said Satish Reddy, managing director and chief operating officer, Dr. Reddy's Laboratories.

Imogene Grimes, Ph.D. has been appointed to vice president of Data Sciences Strategic Services, PAREXEL International Corp. In this role, Dr. Grimes will contribute to the continued expansion of the company's data science services, including data management, biostatistics, and applications of IT to the clinical development process. Her responsibilities include advising clients on clinical study design, analysis methodology, and related regulatory guidelines. Dr. Grimes provides support for strategic data services, such as preparation of integrated data files suitable for registration packages and preparation of electronic submissions, compliant with regulatory expectations.
   
"The biopharmaceutical industry is undertaking more complex clinical research such as using adaptive designs with the potential to detect safety and efficacy signals earlier. Dr. Grimes will bring experience with advanced statistical methods to PAREXEL, which we believe will be a tremendous asset to our clients in bringing novel treatments to patients sooner," said Mark A. Goldberg, M.D., president of Clinical Research Services and Perceptive Informatics at PAREXEL International.
   
Prior to joining the company, Dr. Grimes served as vice president, Statistics, Data Management and Informatics at Regeneron Pharmaceuticals, where she provided statistical and data management expertise for all phases of drug development research. Previously, she was vice president Statistics and Data Management at Yamanouchi Pharma America, and held senior management positions at Pfizer and GlaxoSmithKline.

Genentech and Biogen Idec's Phase II/III study of Rituxan for systemic lupus erythematosus (SLE) did not meet its primary endpoint of a major clinical response (MCR) or partial clinical response (PCR), compared to placebo at 52 weeks. The study also did not meet any of the six secondary endpoints. The companies have a separate ongoing late-stage study in lupus nephritis, an inflammation of the kidneys, and results from that study are expected in 1Q2009.
    
“We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. “We believe the ongoing Phase III trial in lupus nephritis (LUNAR) remains an important study as it evaluates the potential of Rituxan in a different patient population.”
   
“There is a critical need to discover new therapeutic pathways in lupus as no new therapy has been approved in more than 30 years. We will analyze the full set of data from this trial in the coming months, share the findings with regulatory authorities, and apply the key insights to our continued research in lupus,” said Evan Beckman, M.D., Senior Vice President, Immunology R&D, Biogen Idec.
   
Rituxan is currently approved to treat non-Hodgkins lymphoma and rheumatoid arthritis.

Merck received a Not Approvable action letter from the FDA regarding its NDA for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
   
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.
   
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Dr. Kim.
   
In the FDA's letter, the agency also rejected the proposed trade name Cordaptive for MK-0524A. The company said at the appropriate time it expects to pursue the alternative trade name Tredaptive for use in the U.S.

Covance

1Q Revenues: $434.0 million (+15%)

1Q Earnings: $49.1 million (+26%)

Comments: Early development revenues were $202.0 million (+13%) led by growth of toxicology and chemistry services. Operating income increased 16% to $50.6 million. Late-stage development revenues were $210.4 (+18%). Growth was led by performances in central laboratory (+30%) due to an increase in kit volumes and clinical development as well as a strengthening of the Swiss franc. Operating income was $38.9 million (+33%). Backlog at March 31, 2008 grew 20% to $2.86 billion.

SGS Life Science Services has opened three new offices in Poland, Czech Republic and Romania as part of an initiative to expand its Global Clinical Development (GCD) services. The offices located in Prague, Warsaw, and Bucharest, respectively, will provide clinical trial monitoring services, study feasibility, and site selection, as well as support the regulatory aspects in these countries.
   
“The opening of the new offices addresses the request of many of our sponsors to conduct trials in Central and Eastern Europe in order to benefit from the vast pool of treatment-naïve patients, faster enrolment times, and the cost benefits these countries offer,” said Luc Braeken, vice president of Global Clinical Development. “Highly qualified and motivated investigators, low drop out rates of enrolled patients and the high quality of the clinical data are additional advantages of conducting trials in Central and Eastern Europe.”
    
The offices are staffed with teams experienced in conducting clinical trials in the pharmaceutical and CRO industry as well as in academia. The teams cover a wide range of therapeutic areas with special emphasis in CNS, infectious disease and cardiovascular disease. Also, SGS’ main office for GCD in Belgium will provide complementary services including project management, data management and statistics, regulatory affairs, and medical affairs.  

Kuslima Shogen, chief executive officer and scientific founder of Alfacell Corp., will retire from the company on or before March 31, 2009. The company also announced that the royalty agreement between Ms. Shogen and Alfacell has been terminated.
    
The termination of the royalty agreement could reduce payments to Ms. Shogen by an estimated $20 million during the next 10 years, if the company's lead compound Onconase, is granted marketing approval by the FDA.
   
Under the terms of the retirement agreement, Ms. Shogen will continue to receive her current salary for two years after she steps down. In exchange for the termination of the royalty agreement, Ms. Shogen will receive a cash bonus, an additional cash bonus upon FDA approval of Onconase for the treatment of malignant mesothelioma, a stock option grant based the approval of Onconase, cash payments for the first two years following approval, and cash payments from Alfacell if sales of Onconase exceed $100 million.
   
"Tina's contributions to Alfacell and the science behind Onconase have been immeasurable," said David Sidransky, M.D., Alfacell's chairman. "Her dedication and commitment are unmatched and I know that I speak for everyone at Alfacell in offering congratulations as she moves on to a well-earned retirement."
   
Also, the company has named Lawrence A. Kenyon president. Mr. Kenyon joined Alfacell in January 2007 as executive vice president, chief financial officer and corporate secretary. He was promoted to chief operating officer and elected to the board of directors in November 2007.  
   
"It is a comfort for me to entrust the further development and potential commercialization of our exciting pipeline to Mr. Kenyon," said Ms. Shogen. "It has been a privilege to be part of Alfacell where I have experienced the rare opportunity to make an important scientific contribution and achieve the realization of my life's work."
   
"Our focus has begun to shift towards the necessary steps to grow Alfacell and maximize value for our shareholders," added Mr. Kenyon. "The termination of the royalty agreement will allow us to enhance our ability to increase investment in our promising technology platform. We are excited about the future of Alfacell, and I would like to congratulate Tina and commend her for the sound scientific foundation she has built for us."

Roche's Phase IIa study of R1626, an investigational therapy for chronic hepatitis C virus (HCV) infection, has shown a significant end-of-treatment response rate when given in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). R1626 also shows a high barrier to the development of resistance.
   
After four weeks of treatment with this triple combination, followed by 44 weeks of Pegasys and Copegus, levels of HCV were undetectable in 84% of patients infected with genotype 1 virus. This was higher than patients treated with Pegasys and Copegus alone for the entire 48-week treatment period (65%).  
   
R1626, discovered and developed by Roche, belongs to a class of antivirals called polymerase inhibitors, which are being studied with the current standard hepatitis C combination therapy with pegylated interferon and ribavirin.
   
The Phase IIa multicenter trial enrolled 104 patients with genotype 1 HCV, who had not previously received treatment. The primary endpoint was to evaluate the four-week efficacy and safety of combining R1626 with Pegasys alone or with Pegasys plus Copegus, in comparison to a current HCV standard of care, pegylated interferon plus ribavirin.
   
A Phase IIb study with R1626 was initiated in November 2007 to determine the optimal dose of R1626 in combination with Pegasys and Copegus. This Phase IIb trial, called POLI 1, is now fully enrolled with approximately 500 patients with genotype 1 hepatitis C.

Schering-Plough reported results from a planned interim analysis of an ongoing Phase II study of boceprevir, its investigational oral hepatitis C protease inhibitor, in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1. The ongoing study evaluates boceprevir in 28-week and 48-week treatment regimens.
   
In the 28-week treatment regimen, patients received 4 weeks of Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) prior to the addition of boceprevir. The rate of sustained virological response at 12 weeks after the end treatment (SVR 12) was 57%. This treatment regimen provided an indication of early predictability of response with patients who had undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment achieving an SVR 12 rate of 86%.
   
In the ongoing study, HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir is being evaluated in three treatment regimens: 4 weeks of Pegintron and Rebetol therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment); boceprevir in combination with Pegintron and Rebetol for 28 or 48 weeks (triple combination); and boceprevir in combination with Pegintron and low-dose Rebetol for 48 weeks, compared to a control of Pegintron and Rebetol alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is sustained virologic response after 24 weeks of follow up.

Catalent Pharma Solutions plans to more than double its bioreactor capacity, adding a 1,000-liter bioreactor train at its Middleton, WI facility by 2009. The expansion is in response to increased demand for production to support clinical trials. The company has supplied two biopharma companies with GPEx-produced proteins that are currently being used in FDA-approved IND clinical trials.
   
The GPEx technology is designed to aid in the development of new biopharmaceuticals in a compliant, timely and cost-effective manner. According to the company, the GPEx system produces stable, high-yielding mammalian cell lines for protein production more quickly and efficiently than competing technologies. In addition, GPEx technology has generated more 150 cell lines for production of recombinant proteins and antibodies, one of which is currently being used to manufacture a commercially available biosimilar product.

Amgen

1Q Revenues: $3.6 billion (-2%)

1Q Earnings: $1.1 billion (+2%)

Comments: Worldwide sales of Aranesp decreased 25% to $761 million, with U.S. sales down 38% to $405 million due to prescribing restrictions as a result of adverse cardiovascular events. Epogen sales were $554 million (-11%) due to a reduction in dose/utilization due to ESA label changes and implementation of the Erythropoietin Monitoring Policy (EMP). Combined sales of Neulasta and Neupogen were $1.1 billion (+7%). Sales of Enbrel were $951 million (+30%). Sensipar sales were $133 million (+27%). R&D expenses were $661 million (-18%), reflecting cost recoveries derived from licensing transactions with Daiichi Sankyo and Takeda in Japan.

Astellas Pharma and CoMentis have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from CoMentis' beta-secretase inhibitor program, including its lead candidate CTS-21166, an orally bioavailable, small-molecule beta-secretase inhibitor being developed as a disease-modifying treatment for Alzheimer's disease. The agreement also includes a research collaboration to develop additional beta-secretase inhibitors.
   
CoMentis will receive an upfront payment of $80 million and an equity investment of $20 million. CoMentis may receive as much as $660 million in development milestones and performance-based commercialization milestones. CoMentis also has the right to receive development milestones for next-generation beta-secretase inhibitors discovered under the terms of the collaboration. Astellas will fund the pre-Phase III global development costs and CoMentis will share the Phase III development costs. Astellas has exclusive worldwide commercialization rights while CoMentis retains the right to co-promote in the U.S., where profits will be shared. CoMentis will receive royalties on sales outside the U.S.
   
"CoMentis' beta-secretase inhibitors have the potential to become first-in-class disease modifying therapeutic agents and we believe that Astellas has the expertise and commitment necessary to develop and commercialize these compounds," said W. Scott Harkonen, M.D., CoMentis' president and chief executive officer. "This licensing agreement will allow CoMentis to benefit through significant up-front licensing fees and milestones, while retaining substantial economic participation in the commercialization of beta-secretase inhibitors."
   
CoMentis recently reported results from a Phase I trial assessing safety, tolerability and pharmacokinetics of CTS-21166 following intravenous administration. CTS-21166 demonstrated excellent pharmacokinetic properties including dose proportional exposure and very low inter-subject pharmacokinetic variability. In addition, the pharmacokinetic profile is consistent with daily dosing and will support a commercial product.

Bristol-Myers Squibb

1Q Revenues: $5.2 billion (+20%)

1Q Earnings: $661 million (-4%)

Comments: Growth was driven by pharmaceutical sales, which totaled $4.2 billion. U.S. sales increased 26% to $2.5 billion and International sales increased 14% to $1.7 billion. Sales of Plavix and Avapro/Avalide (both part of the company's alliance with Sanofi-Aventis) increased 39% to $1.3 billion and 13% to $305 million, respectively. Plavix sales benefited year-to-year because of 1Q07's brief introduction of a generic version by Apotex. Abilify sales were $454 million (+24%). Reyataz sales were $297 million (+13%). Sales of the Sustiva Franchise increased 21% to $273 million. Baraclude sales were $108 million (+140%). Orencia sales were $87 million (+112%). R&D expenses were $795 million (+1%). In the quarter, the company completed the sale of its Medical Imaging business to Avista Capital Partners for approximately $525 million.

ImClone Systems 

1Q Revenues: $162.6 million (+15%)

1Q Loss: $55.9 million (earnings were $28.8 million in 1Q08)

Comments: Erbitux sales were $417.3 million (+12%). Royalty revenue related to Erbitux was $95.0 million (+24%). License fees and milestone revenue was $24.1 million (-18%). This decrease was due to the amended agreement with BMS for the co-development and co-commercialization for Erbitux in North America. Manufacturing revenue was $25.4 million (+54%) due to increased demand for Erbitux. Operating expenses for the quarter were $120.1 million (+27%) with SG&A representing $24.8 million (+51%), royalty expenses representing $23.5 million (+40%), and manufacturing costs of $24.1 million (+73%). R&D expenses were flat at $47.7 million. The company also recorded an impairment charge of $84.9 million related investments in auction rate securities (ARS).

Azopharma Product Development Group, Inc. plans to implement Xcelodose technology at ApiCross Drug Delivery Technologies, its formulations development facility. Xcelodose technology is a powder micro-dosing system developed by Meridica that offers a powder dispensing system for small-scale capsule filling. Xcelodose Technology assists in conserving research material as well as reducing various preformulation activities.
   
The technology provides precision filling with low weights and minimal waste, eliminating the need for blending. Other benefits include: minimizing or eliminating the need for early formulation development and associated reduction of stability testing, reducing amount of API needed to get to first-in-human studies and reducing analytical development costs during early phase development.   

According to Phil Meeks, Azopharma's chief executive officer, “Xcelodose technology allows us to more precisely prepare doses of clinical trial material. This enables our clients to stretch out valuable research material which is often costly and time consuming to make."
   
He added, “Many of our clients are small or virtual companies that are trying to minimize their financial burn rate. If we can save them a trip to the synthesis lab or reduce their time in Preformulation, we’ve gone a long way in stretching their resources.”

GlaxoSmithKline will acquire Sirtris Pharmaceuticals Inc. for approximately $720 million in cash. The acquisition enhances GSK's metabolic, neurology, immunology and inflammation research efforts with sirtuins, a recently discovered class of enzymes believed to be involved in the ageing process. Sirtris Pharmaceuticals has established a drug discovery capability using sirtuin modulation for the treatment of human disease. Their focus has been on the development of SIRT1 activators for the treatment of Type 2 Diabetes Mellitus (T2DM).
   
Sirtris will become part of GSK's Drug Discovery organization, while continuing to operate from labs in Cambridge, MA as an autonomous drug discovery unit. Dr. Christoph Westphal, chief executive officer and vice chair, and the Sirtris management team will continue to lead this unit.
   
"Modulation of this family of enzymes is a potentially transformative science that could address diseases associated with metabolism and ageing such as diabetes, muscle wasting, and neurodegeneration," commented Moncef Slaoui, chairman GSK R&D. "This acquisition continues GSK's strategy of pursuing the best new science, externally or internally, to bring new medicines to patients and value to the GSK pipeline. Our intent is to retain all Sirtris employees and continue the entrepreneurial and innovative culture they created."
   
Dr. Westphal commented, "We have built a dynamic and scientifically-driven organization. We expect this transaction will accelerate our vision to target sirtuins to treat diseases of metabolism and ageing and deliver tremendous value to patients, our shareholders and our employees. We look forward to working with GlaxoSmithKline and their world-class research, development and commercialization organization."
   
The acquisition, subject to customary closing conditions, is expected to close in 2Q08.

Schering-Plough

1Q Revenues: $4.7 billion (+56%)

1Q Earnings: $291 million (-48%; earnings were $565 million in 1Q07)

Comments: Global Pharmaceutical sales totaled $3.6 billion, which includes $1.3 billion of Organon Biosciences revenues. Sales of Remicade were up 36% to $507 million. Nasonex sales were $307 million (+8%); sales of Temodar were $236 million (+20%); Pegintron sales were $225 million (+4%); sales of Claritin (international only) were $128 million (+14%); sales of Avelox were $142 million (+24%). The global cholesterol joint venture with Merck, which covers Vytorin and Zetia, achieved $1.2 billion in sales for the quarter. S-P does not record the JV sales but incurs SG&A expenses and marks the revenues as equity from a JV. Acquisition-related charges in the quarter were $23 million related to the OBS acquisition. R&D expenses were $880 million (+24%), $96 million of which is related to upfront R&D payments.

1Q Revenues: $942 million (+32%)

1Q Earnings: $163 million  (+23%)

Comments: Growth in the quarter was driven by Avonex sales (+19% to $536 million), Tysabri sales (+283% to $115 million) and Rituxan revenues from the joint business arrangement with Genentech (+19% to $247 million). In the quarter, the company announced new Tysabri safety data showing a favorable benefit-risk profile and no cases of progressive multifocal leukoencephalopathy (PML) since its re-launch in the U.S. Biogen Idec recognized $115 million of the Tysabri sales based on its collaboration with Elan. R&D expenses were $258 million (+35%).

Genzyme Corp. has plans to build a new R&D center in Beijing as part of its ongoing global expansion and commitment to establishing a long-term presence in China. The total cost for the project is estimated to be $90 million.
   
The new R&D facility will be used for Genzyme's key areas of focus, including orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. The facility, which will incorporate a green design, will include laboratory-scale operations for the MACI (matrix-induced autologous chondrocyte implantation) cell therapy and polyclonal antibody operations.
   
"This new site represents a major step forward in our effort to improve the lives of patients in China by introducing innovative new medical products," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "As we expand our presence in China, we look forward to making a significant contribution to the growth of the country's life sciences industry."
   
Genzyme currently markets Synvisc and Thymoglobulin in China, and is preparing to launch additional products next year. Genzyme currently has 25 employees working in offices in Beijing and Shanghai.
   
The 200,000-sq.-ft. facility will be located in Zhongguancun (ZGC) Life Science Park and will be constructed with low-impact environmental techniques and methods that incorporate a range of green features including: a living roof to reduce pollution caused by storm water runoff; a solar thermal system that will provide a significant portion of the building's hot water and reduce its energy consumption; and low-flow fixtures to limit water usage. The company is seeking necessary government authorizations and expects to complete and open the facility in 2010. The facility will accommodate 350 employees.
   
Genzyme's core R&D operations are located in Massachusetts. The company also has a research site in Cambridge, U.K. The Beijing facility will be the company's second product-focused R&D site outside of the U.S.

Wyeth

1Q Revenues: $5.7 billion (+6%)

1Q Earnings: $1.2 billion (-5%)

Comments: Pharmaceutical sales were $4.8 billion (+6%). Growth in the quarter was driven products, Enbrel, Prevnar and Nutritionals, offset, in part, by lower sales of the Protonix family of products due to generic competition. Effexor sales were $1.0 billion (+15%); Prevnar sales were $706 million (+14%); Enbrel sales outside the U.S. and Canada were $606 million (+36%). Alliance revenue was up 21% to $369.0 million due to an increase in Enbrel alliance revenue. R&D expenses were $839.4 million in the quarter (+12%). Wyeth gained three new product approvals in the quarter: the FDA approved Xyntha for patients with hemophilia A and Pristiq to treat adult patients with major depressive disorder; in Canada Relistor was approved for subcutaneous use for the treatment of opioid-induced constipation in patients with advanced illness receiving palliative care.

The FDA has informed Genzyme that Myozyme (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Genzyme currently has U.S. approval to sell Myozyme manufactured at the 160L scale and has been seeking FDA clearance for the 2000L scale. Production at this larger scale has been approved in more than 40 countries.
   
Based on the global clinical experience of nearly 900 patients currently receiving Myozyme produced at the larger scale, Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe. Myozyme is the only treatment for Pompe disease is a rare, progressively debilitating and life-threatening inherited disorder.
   
The FDA will require Genzyme to submit a separate BLA to gain approval for the 2000L scale. The company expects the FDA to give the BLA priority review and to act on the application by the end of this year, in which case, commercial 2000L Myozyme could be available in the U.S. during 1Q2009.
   
In May 2007, Genzyme in collaboration with the FDA created the Myozyme Temporary Access Program (MTAP) for severely affected adults with Pompe disease in the U.S.  
   
"We are extremely disappointed in the FDA's decision because it will further delay broad patient access to Myozyme, which is not possible under the MTAP program," said Henri A. Termeer, Genzyme's chairman and chief executive officer.
   
As a result of the delay in the approval of 2000L production, 2008 Myozyme sales are expected to be approximately $275-$285 million compared to previous guidance of $320-$330 million.    

Novartis 

1Q Revenues: $9.9 billion (+9%)

1Q Earnings: $2.3 billion (+10%)

Comments: Pharmaceuticals sales were up 6% to $6.3 billion. Key drivers included Diovan, up 11% to $1.4 billion, and contributions from the rollout of the new high blood pressure medicines Exforge and Tekturna/Rasilez, approved in 2007. Exforge sales were $72 million and Tekturna/Rasilez sales were $28 million in the quarter. Cardiovascular franchise sales fell 3% to $1.6 billion. Growth in the quarter reflects contributions from Sandoz, Consumer Health and Vaccines and Diagnostics, up 12%, 14% and 21% respectively.

Merck

1Q Revenues: $5.8 billion (+1%)

1Q Earnings: $3.3 billion (+94%)

Comments: Worldwide sales of Singulair were $1.1 billion (+10%); Cozaar and Hyzaar sales were $847 million (+6%); Fosamax and Fosamax Plus D sales were $470 million (-37%); Januvia, Janumet and Isentress sales were $1.8 billion (+14%). Worldwide sales of vaccines were $986 million in the quarter (+9%). Combined worldwide sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough joint venture, were $1.2 billion (+6%). R&D expenses were $1.1 billion in the quarter (+5%). Restructuring costs, primarily employee separation costs associated with the company's global restructuring program, net of gains on the sales of facilities and related assets, were $70 million. Earnings in the quarter include a $2.2 billion gain related to a distribution from AstraZeneca LP.

Lilly 

1Q Revenues: $4.8 billion (+14%)

1Q Earnings: $1.1 billion (+109%)

Comments: Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris and Yentreve collectively grew 33% to $1.7 billion, and accounted for 35% of total sales. Cymbalta sales were $605.1 million (+37%). Cialis sales were up 74% to $336.9 million. Alimta sales were $247.2 million (+32%). Zyprexa sales were $1.1 billion (+1%). R&D expenses were  $877.1 million (+5%). In the quarter, the company terminated development of its AIR Insulin program with partner Alkermes. The FDA accepted and gave priority review status to the company's NDA for prasugrel as a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention. 1Q07 earnings were impacted by in-process R&D expenses associated with the ICOS acquisition.

Patheon has completed the sale of its York Mills facility in Toronto, Canada for $12.3 million. The agreement to sell the facility, announced in December 2007, is part of Patheon's global restructuring plan.
   
The company is currently in the process of transferring all commercial production and development services to its Whitby facility, with a smaller portion being transferred to its sites in Mississauga and Cincinnati. This is an effort to improve capacity utilization and profitability at the continuing Canadian sites. Patheon is de-commissioning the York Mills facility and has leased back the facility for as many as two years in order to facilitate this process.
   
"We are pleased that we have completed another step in our global restructuring plan and are now focused on consolidating our resources at Whitby and improving our productivity in our Canadian Operations," said Wes Wheeler, chief executive officer, Patheon.

Joseph G. Stowell of the Chao Center for Industrial Pharmacy and Contract  Manufacturing has been appointed to serve on the U.S. Pharmacopeia (USP) Expert Committee for monograph development: ophthalmology, oncology, and dermatology.
    Mr. Stowell is the Chao Center's quality assurance director and an adjunct assistant professor in Purdue University's School of Pharmacy and Pharmaceutical Sciences, where he has been teaching for more than 20 years. He was responsible for the undergraduate teaching labs in the school for organic, analytical and the integrated laboratory series, as well as writing the laboratory manuals used in these courses.

Elan Corp. and development partner Wyeth have suspended a mid-stage clinical trial of ACC-001, an experimental Alzheimer's vaccine, in order to look into a potentially serious side effect suffered by a patient in the study.
   
Dosing in the study was stopped after the patient was hospitalized with skin lesions. The physician serving as lead researcher suspected it to be a case of vasculitis, an inflammation of blood vessels.   
   
"Following discussion with the FDA, all further dosing has been suspended while this particular event is fully evaluated," said Jonathan Birt, a spokesman for Elan. "We are working with health regulators and the physician to further understand the clinical and scientific issues," Mr. Birt added.
   
According to Mr. Birt, the patient has been released from the hospital and the lesions are healing.

Eli Lilly and Co. announced plans to streamline a portion of its manufacturing operations in Indianapolis in an effort to align manufacturing capacity and engineering support services with the needs of the business. This streamlining affects sites that manufacture APIs for the insulin products Humalog and Humulin as well as the osteoporosis drug Forteo.
   
Lilly is offering a voluntary exit program to employees in selected areas, with enhanced financial incentives. This program is expected to reduce the company's Indianapolis employment by as many as 500 people, mostly in manufacturing but a portion of R&D as well.
   
"For several years we have focused on strategic efforts to lower costs, increase flexibility, and improve productivity across the business," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "This strategy calls for reducing investments in some areas while increasing investments in others, and the streamlining decisions announced today are an example of this."
   
Dr. Lechleiter added, "We are constantly assessing our manufacturing capacity and taking the necessary steps to align it with the demands of the business. In particular, we must align our production capacity with anticipated customer demands over a time period in which some products will lose patent protection while other new products are launched."
   
"While these are necessary decisions, they are difficult because they affect our people," said Dr. Lechleiter. "From a peak employment level in mid-2004, we have reduced our global headcount by 12%, or about 5,500 people. These reductions have occurred primarily through attrition. But at times, including this one, we have had to take additional measures as we have restructured our operations. As we fulfill our responsibilities to all of our stakeholders, we are intent on upholding the Lilly values by treating all employees -- particularly those directly affected by these changes -- fairly and with the utmost respect."

Pfizer

1Q Revenues: $11.8 billion (-5%)

1Q Earnings: $2.8 billion (-18%)

Comments: Pharmaceutical revenues in the quarter were $10.9 billion (-6%). Lipitor revenues were $3.1 billion (-7%), Celebrex revenues were $611 million (+2%), Lyrica revenues were $582 million (+47%). Revenues from new products, Sutent and Chantix, were $190 million (+86%) and $277 million (+71%), respectively, despite added warnings to the label of Chantix in January 2008. Revenue decline in the quarter was primarily due to the U.S. losses of exclusivity of Norvasc (March 2007) and Zyrtec (January 2008), while earnings were dented further by increased in-process R&D expenses associated with acquisitions of CovX and Coley Pharmaceutical Group. R&D expenses were $1.8 billion in the quarter (+8%).  

Gilead Sciences

1Q Revenues: $1.3 billion (+22%)

1Q Earnings: $496.1 million (+22%)

Comments: The company achieved record product sales of $1.1 billion (+36%). HIV product sales were $964.7 million in the quarter (+37%). Truvada sales were $479.4 million (+39%), Atripla sales were $324.2 million (+70%), Viread sales were $152.7 million (-5%). Sales of Hepsera for chronic Hepatitis B, were $83.0 million (+16%). Sales of AmBisome were $71.0 million (+15%). R&D expenses in the quarter were $155.3 million (+19%).

GlaxoSmithKline and Regulus Therapeutics have entered into a worldwide strategic alliance to discover, develop and market novel microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Regulus is a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals.
   
The alliance leverages Regulus’ expertise and intellectual property in the discovery and development of microRNA-targeted therapeutics and provides GSK with an option to license product candidates directed at four different microRNA targets in inflammatory disease. Regulus will be responsible for the discovery and development of the microRNA antagonists through clinical proof of concept, unless GSK chooses to exercise its option earlier. If GSK exercises this option, the company will have an exclusive license to drugs developed under each Regulus program for further development and commercialization on a worldwide basis. Regulus will have the right to further develop and commercialize any microRNA therapeutics that GSK chooses not to develop.
   
Regulus will receive $20 million in upfront payments from GSK, including a $15 million option fee and a $5 million note (guaranteed by Isis and Alnylam) that will convert into Regulus common stock under certain specified circumstances. Regulus could be eligible to receive as much as $144.5 million in development, regulatory and sales milestone payments for each of the four therapeutics discovered and developed as part of the alliance. Regulus could also receive nearly $600 million in option, license and milestone payments, as well as tiered royalties on worldwide sales of products resulting from the alliance.
   
“We are focused on finding innovative medicines through both internal efforts and by 'virtualizing' a portion of the inflammatory diseases pipeline. We are very excited to be working with Regulus and exploring the therapeutic opportunities in inflammation offered by targeting microRNAs, an exciting new area of biology,” said Jose Carlos Gutierrez-Ramos, Ph.D., senior vice president and head of the Immuno-Inflammation Center of Excellence for Drug Discovery of GSK.
   
“GSK is an outstanding partner for Regulus, and we look forward to expanding our efforts in inflammation where a new class of therapeutics could offer novel options to treat disease,” said Kleanthis G. Xanthopoulos, Ph.D., president and chief executive officer of Regulus.

Abbott

1Q Revenues: $6.8 billion  (+14%)

1Q Earnings: $937.9 million (+35%)

Comments: Growth in the quarter was driven by Humira, Niaspan and Kaletra. Humira sales were $878 million (+54%), Niaspan sales were $176 million (+24%), and Kaletra sales were $353 million (+18%). In March, Abbott and Takeda ended the TAP joint venture, splitting the assets. Abbott will have U.S. rights to Lupron, as well as cash payments for the next five years. In the quarter, the FDA approved Humira for psoriasis and for juvenile rheumatoid arthritis, and Simcor for cholesterol.  Earnings in the quarter excludes after-tax charges of $37 million for cost reduction initiatives, $15 million for acquired in-process R&D, and $7 million for acquisition integration.

GlaxoSmithKline and Pozen, Inc. received FDA approval of Treximet for the treatment of migraine attacks in adults. Treximet is the first migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of GSK's migraine-specific medicines, and an anti-inflammatory pain reliever in a single tablet. The product is expected to be available in U.S. pharmacies by mid-May.
   
Treximet contains 85 mg sumatriptan, formulated with RT Technology, and 500 mg naproxen sodium. Sumatriptan is the active ingredient in GSK's Imitrex Tablets, available in 25 mg, 50 mg and 100 mg strengths. The approval of Treximet was based on data from two double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers. In the trials, Treximet showed a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. Treximet also provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components. Treximet was generally well-tolerated in these studies.

Michael Rubenstein, currently president of Alcan Packaging's Global Pharmaceutical Packaging business, has been appointed to the newly created position of chief growth and innovation officer. In this new role, Mr. Rubenstein will lead a team dedicated to help deliver the company's strategy to create sustainable value through innovation, customer partnerships and new growth platforms.   
   
Mr. Rubenstein has held several senior management positions in the packaging industry and has 30 years of experience, complemented with studies in Printing Technology at the Rochester Institute of Technology and an immersion in World Class Partnerships at Duke University.
   
“Establishing this team under Michael Rubenstein’s direction demonstrates our passion for packaging and serving our customers with inspiring solutions,” said Ilene Gordon, president and chief executive officer of Alcan Packaging. “We are committed to excel and achieve our growth agenda. This newly assembled, high-caliber organization, consisting of talent primarily from across our business, will ensure we are even more closely linked with our customers.”
   
Also, Mike Schmitt, who continues as president, Food Packaging Americas, takes over as president of the $1 billion Global Pharmaceutical Packaging unit. The businesses are headquartered in Chicago and Kirkland, respectively and will continue to be run separately. “I look forward to the challenges of these expanded responsibilities and to working with the Global Pharmaceutical team to implement their strategy of growth and manufacturing excellence,” said Mr. Schmitt. “While Food Americas and Global Pharmaceutical are different businesses with their own characteristics, they share a common focus to satisfy customers and a passion to exceed expectations," he added.
   
Mr. Schmitt  has 25 years of experience in the packaging industry. He joined the company in 2000 as head of the Food & Specialty Flexibles business unit after spending 17 years with Bemis Corp.

Roche announced plans to acquire Piramed Limited, a privately-owned UK company focusing on therapeutics targeting PI3-kinase (PI3-K). Roche will spend $160 million on the acquisition, along with a $15 million milestone payment, due upon commencement of phase II clinical trials for the company's oncology program.

Through this acquisition, Roche's R&D pipeline is strengthened by Piramed's two major research programs targeting PI3-K-alpha in oncology and PI3K-delta in inflammatory disease. The PI3-K-alpha program has a compound in Phase I and is currently being developed in collaboration with Genentech, in whom Roche has a majority ownership interest. The previously unpartnered PI3-K-delta program, while at a preclinical stage, will be integrated into the Roche Group's R&D portfolio for inflammation.

The PI3-K pathway is known to play an important role in disease progression and in resistance to chemotherapeutics in cancer cells. According to a Roche statement, preclinical studies have demonstrated the activity of PI3-K inhibitors in a broad range of tumours such as breast and lung cancer, as well as their potential importance in treating inflammatory diseases such as rheumatoid arthritis.

"The integration of Piramed's promising research and development reaffirms and further strengthens Roche's leadership in oncology," said William M. Burns, chief executive officer of Roche Pharmaceuticals Division. "In addition, this acquisition augments our research efforts in debilitating diseases such as rheumatoid arthritis."

Michael Moore, chief executive officer of Piramed, said, "Since Piramed was formed in 2003, we have struck a significant licensing deal with Genentech and advanced our highly promising first oncology product into the clinic. Today's acquisition by Roche underlines the value of our pipeline and is a testament to the quality of the science developed by our team. With Roche's undisputed excellence in oncology and inflammatory disease, Piramed has found a secure long term home for some world class science."

J&J 1Q08

1Q Revenues: $16.2 billion (+8%)

1Q Earnings: $3.6 billion (+22%)

Comments: Pharmaceutical sales rose 3% to $6.4 billion, hurt by regulatory and safety issues for Procrit, as well as generic competition for Risperdal, Duragesic and Aciphex. U.S. pharma sales were up 1% to $4.1 billion, while international sales, aided in part by currency rates, were up 8% to $2.4 billion. Global sales of Remicade grew 37% to $1.0 billion.

Simon S. Higginbotham has been promoted to the role of president at Kendle. Chris Bergen, who previously had served as president and chief operating officer, will continue to serve in the latter role. Mr. Higginbotham will provide global leadership for worldwide customer and business expansion to include strategic customer relations and new market opportunities. Alan J. Boyce will assume his previous role of vice president and chief marketing officer. Mr. Boyce served as Kendle's vice president, Global Clinical Development – Europe and Africa from 2003 to 2007. In his new role he will provide global leadership for the company's new business development and marketing initiatives.

"As we embark on the next stage of our corporate growth, it is imperative we have the dedicated leadership strength in place to support our needs as a larger global organization," said Candace Kendle, Pharm.D., the company's chairman and chief executive officer. "Simon Higginbotham is a proven leader within Kendle and has been a key member of our executive team since joining the company in 2004. He has demonstrated outstanding leadership and customer focus and has delivered exceptional results across his tenure with our company, guiding our global sales organization to record results. We are extremely pleased to announce his promotion to this new leadership role and look forward to his continued contributions to our organization." Mr. Higginbotham has more than 20 years' experience in senior leadership positions in the CRO and biopharmaceutical industries. He currently serves on the board of directors of the Association of Clinical Research Organizations (ACRO).

Dr. Kendle continued, "We also are pleased to announce the return of Alan Boyce to Kendle. Alan has an in-depth understanding of the Kendle organization and our customers and we look forward to his leadership as we continue to focus on delivering best-in-class clinical development solutions." Mr. Boyce most recently was Chief Operating Officer for Synexus. He also spent 18 years in senior sales and marketing roles with Procter & Gamble Pharmaceuticals.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for Risperdal Consta  to the FDA seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD).

FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor's care. The condition may affect 10-20% of the 27 million people with bipolar disorder worldwide, according to a statement from J&JPRD's manufacturing partner, Alkermes, Inc.

The sNDA is based on results from a recent study comparing patients who received Risperdal Consta and standard treatment to those who received standard treatment combined with placebo. The study found that patients with FRBD had a significant delay in the time to an initial relapse when Risperdal Consta was combined with standard treatment. The study was presented at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland on February 3, 2008.

Risperdal Consta was approved for the treatment of schizophrenia in the U.S. in 2003. Risperdal Consta is marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S.

SynCo Bio Partners has signed a master services agreement with OncoMed Pharmaceuticals, under which SynCo will fill and finish batches of OncoMed's lead product, antibody OMP-21M18, for use in Phase I clinical trials.

Pierre Warffemius, SynCo's chief executive officer, said, "We are delighted that a company at the forefront of cancer therapies has recognized our expertise in biopharmaceutical processing by choosing us to fill their lead antibody for early clinical trails."

Paul J. Hastings, president and chief executive officer of OncoMed, added, "We selected SynCo Bio Partners because we needed a GMP-accredited contract manufacturing organisation that had a proven track record in filling biologics. With SynCo's expertise in all aspects of biopharmaceutical manufacture, they were an ideal partner for us at this crucial stage in our development."

OncoMed recently announced a worldwide strategic alliance with GlaxoSmithKline to develop cancer stem cell antibody therapeutics. One of the key projects in this alliance will be the development of OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.

SynCo will fill and finish antibody OMP-21M18 at its Amsterdam-based facility. This facility is able to fill a wide range of biopharmaceuticals into vials, including protein, polysaccharide, and live-microbial-based products using the latest filling and finishing equipment, according to a SynCo statement.

Alcon plans to build a facility in Singapore that will manufacture pharmaceuticals to be distributed throughout most of Asia. The company plans to break ground in 2009, with the plant becoming fully functional in 2012. Alcon will employ more than 150 employees within three years after production begins.

The company reports that sales of therapeutics for eye diseases and conditions have risen at a CAGR of 20% in Asian markets. "This growth has been driven by many of Alcon’s major brands such as Travatan, Patanol and Vigamox ophthalmic solutions, Tobradex ophthalmic ointment, and Systane eye drops," according to a company statement. The new facility will enable Alcon to distribute products in this region more efficiently and cost effectively.

Alcon will lease a 20-acre plot of land on which the company will build a 250,000-sq.-ft. facility in the Tuas Biomedical Park. The company expects to manufacture at a rate of more than 53 million units per year at this facility by the end of the third year of operation.


"Given the rapid growth in this region, this plant is integral to our ability to meet future market demands," said Ed McGough, Alcon's senior vice president, global manufacturing and technical operations. "After a lengthy and careful analysis of potential plant locations and through close collaboration with the Singapore Economic Development Board, we selected Singapore due to its highly skilled and reliable workforce and well-established government infrastructure."

Novartis recently announced plans to acquire Alcon in the next several years, at a total cost of $39 billion.

Novartis AG has promoted two senior U.S. executives to head its U.S. drugs unit and overall U.S. operations. Ludwig Hantson, head of Novartis' specialty medicines unit in the U.S., has been promoted to chief executive of Novartis Pharmaceuticals Corp., the company's North American drugs affiliate. He succeeds Alex Gorsky, who in February resigned to become chairman of the Ethicon surgical products division of Johnson & Johnson.
   
Mr. Hantson has previously run Novartis' pharmaceutical operations in Canada and has been a senior company executive in Europe. Before joining the company in 2001, he spent 13 years as a senior executive for clinical development and marketing at the Jannsen pharmaceuticals unit of J&J.
   
Gary Rosenthal, chief financial officer of the company's North American drugs unit, has been promoted to president and chief executive of Novartis Corp. He succeeds Paulo Costa, who plans to retire in late June.

Genentech

1Q Revenues: $3.1 billion (+8%)

1Q Earnings: $790 million (+12%)

Comments: Rituxan sales were $605 million (+13%), Avastin sales were $600 million (+13%), and Herceptin sales were $339 million (+9%). 1Q08 Avastin U.S. sales include a net deferral of approximately $1 million related to the company’s Avastin Patient Assistance Program. R&D expenses were up 1% to $617 million, representing 20% of operating revenues. The company expects to submit a sBLA to the FDA for accelerated approval of Avastin for the treatment of relapsed glioblastoma multiforme in 2H08.

Laureate Pharma, Inc. has entered into a contract manufacturing agreement with Alopexx Pharmaceuticals to produce Alopexx's mAb F598 antibody under cGMP conditions. This antibody will be used in clinical trials and later for commercial production for the treatment and prevention of Staphylococcus aureus infections.  
   
"We are pleased that Alopexx chose Laureate Pharma as their manufacturing partner," said Robert J. Broeze, Ph. D., president and chief executive officer of Laureate. "We will closely collaborate with the Alopexx team and help them drive their product from development into the clinic."
   
"Laureate Pharma has a track record of demonstrated expertise in biopharmaceutical manufacturing, including capabilities in both clinical and commercial-grade materials," said Dr. Daniel Vlock, president and chief executive officer of Alopexx. "We look forward to our partnership with Laureate and advancing our antibody therapeutics program into the clinic."

Takeda Pharmaceutical Co. Ltd. and Millennium Pharmaceuticals, Inc. have entered into a definitive agreement under which Takeda will acquire Millennium for approximately $8.8 billion in cash. Upon completion of the acquisition, Millennium will become a wholly-owned subsidiary of Takeda and will continue operations in Cambridge, MA, as a standalone business unit. Millennium will be known as Millennium Pharmaceuticals, Inc., a Takeda Company.
   
Millennium, a leading biopharmaceutical company, markets the oncology drug Velcade for Injection in the U.S. Velcade is approved in more than 85 countries. Millennium has a pipeline of novel product candidates in oncology and inflammation. This includes a drug for the potential treatment of inflammatory bowel disease (IBD), which is expected to enter Phase III trials in late 2008/early 2009. Millennium reported total revenues of approximately $528 million in 2007.
   
The acquisition is part of Takeda's goal to become a global leader in oncology in the areas of discovery, development, regulatory affairs and commercialization. Millennium and Takeda will combine research, development and commercialization capabilities in an effort to accelerate the potential of an emerging drug pipeline.
   
"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, president of Takeda. "Takeda is committed to becoming a global leader in oncology by delivering novel therapies that improve the standards of care for patients. Millennium has strong discovery, development and commercial capabilities led by a well-established management team. We are pleased that Dr. Deborah Dunsire, Millennium president and chief executive officer, and the current management team intend to continue to lead the company. Our strong desire is to retain Millennium employees, who have created an entrepreneurial and innovative culture."
   
"We are extremely proud of the commitment and passion of our employees, who have built this vibrant organization. We look forward to continued success as we join the Takeda Group," said Deborah Dunsire, M.D., president and chief executive officer, Millennium. "Both companies share a common vision to develop breakthrough medicines for patients, become a global leader in oncology and expand the global reach of our IBD product candidates. We expect this transaction to help accelerate that vision and deliver tremendous value to patients, shareholders and our employees."
   
The transaction, subject customary closing conditions, is expected to close in 2Q08.

Patheon has opened its new early phase development facility in Milton Park in Oxfordshire, UK. The 13,500-sq.-ft development facility has newly constructed formulation labs and a fully equipped analytical lab. The facility will focus on the early phase development of solid, semi-solid and oral liquid dosage forms, and includes GMP manufacturing areas for the production of clinical trial materials for Phase I/II trials. The company's Quick To Clinic programs, which work to accelerate molecules to clinical trials while minimizing API requirements, will be supported at the site. The facility holds an Investigational Medical Product License from the MHRA (UK).
   
"The Milton Park facility was created to meet our customers' growing demand for rapid early phase development capacity in a strategic location", said Norman Barras vice-president, Pharmaceutical Development Services, Europe. "We believe that our Quick to Clinic(TM) approach will provide a valuable opportunity to shorten the development times of our customers' projects."
   
"Milton Park is one of many significant additions that we plan to make in our development service offerings", added Wes Wheeler, chief executive officer. "We are constantly striving to understand our customers' needs and then respond accordingly."

PharmEng International, Inc. has appointed John Durham as corporate vice president, business development for Keata Pharma, Inc., a wholly owned subsidiary of PharmEng. Keata has pharmaceutical contract manufacturing facilities in Arnprior, ON and new facilities in Sydney, Nova Scotia that provide formulation development and testing services to manufacture and package products in solid and liquid dosage forms, including aseptic manufacturing.
   
Prior to joining the company, Mr. Durham was president of the Draxis Pharma Division of Draxis Health, Inc., responsible for pharmaceutical contract manufacturing operations including business development, strategic planning, supply chain and logistics. He has also held senior positions with Banner Pharmaceuticals, Novartis Canada and McNeil Consumer Products.  
   
"I am certain that John's extensive management experience and strong health science background will be of great benefit to Keata," said Alan Kwong, CEO of PharmEng International Inc. "His reputation and proven track record in the sector makes him well-suited for his new responsibilities at Keata. He will be a strong addition to the senior management team as we build the book of business for Keata," concludes Mr. Kwong.

Pfizer has updated the U.S. product labeling for Exubera (insulin human [rDNA original]) Inhalation Powder to include a warning with safety information about lung cancer cases observed in patients who used the drug.
   
This update is based on an ongoing review of post-marketing trial data from a program initiated by Pfizer and the FDA to monitor respiratory safety. Over the course of the program, 6 of the 4,740 Exubera-treated patients versus 1 of the 4,292 patients not treated with Exubera developed lung cancer. In addition there was a post-marketing report of lung cancer in one Exubera-treated patient. The update to the labeling states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera.
   
“Pfizer is vigilant in monitoring adverse drug reports for all its products, including Exubera, which has shown in clinical trials to be a safe and effective medicine in the treatment of adults with type 1 or type 2 diabetes,” said Joe Feczko, M.D., Pfizer’s chief medical officer.
   
In October 2007 Pfizer announced that it would stop marketing Exubera because it did not meet customers’ needs nor the company's financial expectations. After the lung cancer warning, Nektar Therapeutics announced that it has stopped its search for a new marketing partner. Pfizer will be discussing the timing of marketing authorization withdrawals with regulatory agencies.
   
“Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients’ glycemic control,” said Dr. Feczko.

GlaxoSmithKline has received a warning letter from the FDA related to reporting requirements for approved medicines. The letter follows a routine inspection of the company's 2007 reporting processes.
   
The inspection revealed omissions from periodic reports to the FDA regarding its diabetes drug Avandia, such as the start and progress of clinical trials, and summaries of final data from some clinical trials. The inspection also reviewed the company's processes for reporting individual adverse events, which resulted in no inspection citations.
   
"We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway," said Dr. Ronald Krall, chief medical officer at GlaxoSmithKline, who stressed that the omissions did not interfere with the timely reporting of adverse event information to the FDA.
   
The FDA began inspecting GSK's records in August to see if the company was reporting all Avandia data in full. It found that between 2001 and 2007, the company failed to report the initiation of nine clinical studies, and failed to update the FDA about the progress of more than 12 other studies. After the inspection, the company initiated a review of applicable processes and reporting systems. GSK is now updating its procedures in an effort to improve compliance in this area of reporting.
   
Concerns about the drug arose last year when a study showed that patients taking Avandia had a higher risk of suffering a heart attack than those taking other oral diabetes medicines or placebo pills. In November, GSK added a warning to Avandia's label describing the study's findings.  

Analytical Bio-Chemistry (ABC) Laboratories, Inc. has made a strategic organizational change aimed at supporting the drug development efforts of specialty, virtual and other small drug development companies. The company’s new Pharmaceutical Program Management unit will assist sponsors with study design and regulatory consulting services, as well as oversight of operational performance, facilitate collaboration and ensure timely delivery of its products utilizing metrics-driven performance measurement.
   
“The business of contracted pharmaceutical development has shifted in recent years,” said John Bucksath, senior vice president and general manager of ABC Laboratories’ pharmaceutical services division. “Small, entrepreneurial companies are responsible for a larger share of development, and most turn to contract laboratories like ABC for analytical support services. We’ve found those same customers often seek help understanding the types of studies and data required to support IND and NDA applications, and place a high value on direct, frequent communication. Our Program Management unit brings a new level of personalized service to the table.”
   
Patrick Noland has been named vice president of program management and will lead the unit. Mr. Noland has 30 years of pharmaceutical development, research and manufacturing experience, which includes direct responsibility for pharmaceutical product development, extractables and leachables, method validation, and technical support for product and material investigations.
   
Also supporting ABC’s Program Management initiative is Noel Premkumar, Ph.D., who was recently named the pharmaceutical division’s chief scientific officer. Dr. Premkumar has more than 20 years of industry experience conducting in-vivo and in-vitro xenobiotic metabolism studies, and has extensive knowledge of FDA, ICH, EPA, OECD, and JMAFF guidelines, as well as Phase 0 guidance for radiolabeled micro-dosing studies. Dr. Premkumar has been with ABC Laboratories since 1990, and was a key player in developing the company’s DMPK and bioanalytical programs.

Bristol-Myers Squibb has selected a compound from its collaboration with Isis Pharmaceuticals as a development candidate. As a result, Isis will receive a $2 million milestone payment. The two companies have an ongoing collaboration to identify antisense drugs that target proprotein convertase subtilisin kexin 9 (PCSK9). The development candidate is an antisense inhibitor of PCSK9 that helps regulate the amount of cholesterol in the bloodstream.

The selection of this development candidate marks the achievement of the first milestone in this collaboration, which was announced in May, 2007. The compound was designed to selectively inhibit the production of PCSK9 and could offer a new and complementary mechanism to current lipid-lowering therapies for the prevention and treatment of cardiovascular disease.

"In less than a year, we have been able to identify and characterize a number of antisense drugs that inhibit PCSK9 in preclinical studies and out of those, identified an attractive development candidate. With the selection by BMS of this development candidate, we have achieved our first milestone. The rapid progress we have made with our PCSK9 program is representative of the efficiency of our antisense technology to quickly move from target to drug," said Brett Monia, Ph.D., Vice President of Antisense Drug Discovery of Isis. "PCSK9 is a new and exciting target for the management of lipids both to prevent and treat cardiovascular disease. Furthermore, our antisense technology is uniquely suited to provide viable clinical drug candidates for PCSK9 and other targets that are not accessible using standard drug discovery approaches. This newest development candidate is the third clinical candidate to arise from our cardiovascular drug discovery program within the past four years, and we look forward to working with Bristol-Myers Squibb to advance this drug through development."

DDN Pharmaceutical Logistics has selected the Synchrony Supply Chain Integrity Suite by Axway to "ensure a safe and secure pharmaceutical supply chain and in anticipation of drug pedigree legislation pending in California and other states," according to an Axway statement. After an extensive review process involving multiple ePedigree solution vendors, DDN chose Synchrony Supply Chain Integrity Suite as the best solution to address both industry demands and the company's specific needs.

"Our clients rely on us to help manage the logistics involved with distributing their pharmaceuticals from point of manufacture to the patient, including everything from inventory management and storage to order management and shipment," said Ross Bjella, president, DDN Pharmaceutical Logistics. "It's imperative our distribution system be able to securely and efficiently move pharmaceuticals and that we comply with industry regulations set up to safeguard patient safety. Because we take this responsibility seriously, and recognizing that the drug pedigree laws will most likely be enacted in numerous states, we selected Axway’s Synchrony solution, believing it to be the best fit for us."

Synchrony Supply Chain Integrity Suite is made up of components that work together and can be customized to address a company’s specific needs. DDN  will work with Axway in April to implement the solution and train internal staff. Following that, DDN will begin working with its clients to build the interfaces necessary between their manufacturing sites, DDN's ERP system and Synchrony. The Axway solution is designed to help DDN Pharmaceutical Logistics and its clients realize increased supply chain visibility, compliance with industry regulations and improved patient safety standards.

"As the distribution system for pharmaceuticals in the U.S. is quite complex, some pharmaceutical companies turn to organizations like DDN Pharmaceutical Logistics for assistance, given their deep expertise in the area," said Kim Loughead, director, healthcare solutions, Axway. "As such, DDN Pharmaceutical Logistics wants to be ahead of the curve when it comes to integrating the very best technology to improve supply chain operations. Although ePedigree legislation continues to develop, the solutions are already out there to help organizations tackle this problem. In the coming months, we will work closely with DDN Pharmaceutical Logistics to ensure their clients realize the full benefits of the Synchrony Supply Chain Integrity Suite."

Gavin Corcoran, M.D., FACP, has been appointed to the newly created position of chief scientific officer at Stiefel Laboratories. The position was created to "reinforce the already critical role played by the R&D organization and the unity between all R&D departments," according to a company statement. It also will further strengthen the collaboration among Stiefel's five R&D facilities around the world.

Mr. Corcoran will oversee global scientific and operational activities related to product development and support; medical and scientific affairs; clinical and preclinical research; pharmacovigilance; portfolio planning; and regulatory affairs.

"Gavin's promotion to chief scientific officer is a testament to the wonderful work he has done for Stiefel since he came on board," said Brent Stiefel, executive vice president, Global Corporate Development and Product Portfolio. "We chose him to lead our R&D division because his vast experience along with his keen understanding of the industry arms him with the insight that will improve today's skin treatments and develop tomorrow's solutions."

Prior to his promotion, Corcoran served as senior vice president, Global R&D. He joined Stiefel in 2005 as senior vice president, Global Clinical and Regulatory Affairs and has been a driving force in advancing the expansion of a world-class, global research and development organization. With this promotion, Corcoran will remain in Stiefel's R&D headquarters in Research Triangle Park and continue to report to Brent Stiefel.

Nestlé S.A. and Novartis AG have reached an agreement under which Nestlé will sell 74 million of its shares of Alcon, Inc. to Novartis in a cash transaction valued at $11 billion. Novartis would initially own a minority stake in Alcon of approximately 25%, but through option rights, plans to acquire Nestle’s remaining 52% stake for an additional $28 billion between January 2010 and July 2011.
   
“I welcome Novartis as a minority investor, and I believe the agreement validates Alcon’s leadership and bright future in the attractive and growing eye care market,” said Cary Rayment, Alcon’s chairman, president and chief executive officer. “It is also a testament to all of our employees who have been responsible for making Alcon the global leader in the eye care market.”
   
The agreement also provides for the expansion of the Alcon board of directors from eight to 10 members, with one of the additional members designated by Nestlé and one designated by Novartis. The nominees for these additional board seats are James Singh, currently Nestlé’s executive vice president and chief financial officer, and Daniel Vasella, M.D., chairman and chief executive officer of Novartis. The purchase and sale transaction is subject to regulatory approvals.

Jubilant Organosys Ltd. and Draxis Health, Inc. have entered into an agreement whereby Jubilant will acquire all outstanding common shares of Draxis for approximately $255 million.
   
Mr. Shyam S. Bhartia, chairman and managing director of Jubilant, and Mr. Hari S. Bhartia, co-chairman and managing director of Jubilant, commented, "Draxis represents a unique opportunity in the North American market, offering Jubilant entry into the attractive, regulated, high growth and high margin radiopharmaceutical business. It also enables Jubilant to consolidate its position in the sterile and non-sterile contract manufacturing business. With this acquisition Jubilant will become one of the leading providers of contract manufacturing of small volume parenterals to large pharmaceuticals and biotech companies in North America. Jubilant is committed to grow Draxis by supporting management and employees through new product launches, entry into new markets and expansion of customer base."
   
Under the agreement, Draxis, in certain circumstances, can terminate the arrangement and accept an unsolicited superior proposal, subject to fulfilling certain conditions. Draxis has agreed to pay Jubilant a break fee of $10.5 million in such circumstances and certain other limited circumstances if the transaction is not completed. The transaction, subject to customary closing conditions, is expected to close in 2Q08.

Keryx Biopharmaceuticals is restructuring in an effort to reduce its cash burn rate and re-focus its development efforts. The restructuring plan, which follows the negative outcome of the company's Phase III trial of Sulonex for the treatment of diabetic nephropathy, and subsequent decision to terminate the ongoing Phase IV trial, is intended to conserve financial resources and to focus efforts on programs and opportunities that are most likely to provide long-term shareholder value.
   
The company anticipates that the restructuring, which includes a 50% workforce reduction, will reduce its cash burn rate to approximately $10 - $15 million for the remainder of the year. The company will have approximately 25 full and part-time employees following the staff reduction.
   
The company expects to end the first quarter of 2008 with approximately $50 million of cash and cash equivalents. Expenses are expected to total approximately $17 million at the end of the first quarter and are primarily related to shutting down the Sulonex clinical program and restructuring costs.
   
Under the restructuring plan, the company plans to terminate approximately 12 of 20 early-stage clinical studies of KRX-0401 (perifosine); to continue Zerenex studies and market research; to delay a KRX-0401 Phase III trial until additional data are accumulated from on-going studies of perifosine as a treatment for various tumor types; to terminate a license agreement for KRX-0601 (UCN-01); and close the company's San Francisco, CA and Memphis, TN offices as well as the Wisconsin manufacturing suite, which was built to support the commercialization of Sulonex.
   
In addition, the company plans to explore opportunities to monetize portions of its technology assets, which may include partnerships, strategic alliances and pursuit of creative product-specific financing alternatives.
   
Michael S. Weiss, chairman and chief executive officer, stated, "This has been a challenging process, but through these measures we believe that we have designed a strategy by which we will conserve our financial resources and strengthen our ability to execute on our goals to move our drug candidates forward, thereby better positioning the Company for future success."

GlaxoSmithKline received approval from the FDA for its Rotarix vaccine for the prevention of rotavirus gastroenteritis in infants. With two doses, Rotarix offers protection against the most common rotavirus types in the U.S. and allows infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Rotavirus infects virtually every child in the U.S. by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide.
   
Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data of Rotarix show that protection was sustained through the first two years of life and was highly effective against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). Rotarix was also effective against rotavirus gastroenteritis of any severity (79%).
   
AVANT Immunotherapeutics, Inc. licensed the technology for Rotarix to GSK in 1997 for worldwide commercialization. The approval was based on one of the largest clinical development programs undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa.

Paul Covington, M.D. is retiring as executive vice president of development and chief medical officer of PPD, Inc., effective June 30. He will serve as a special project adviser through January 2009 to assist with selected projects and the transition of his responsibilities.
   
“Paul is one of the most talented physicians in our industry, and his leadership and unwavering commitment to excellence have played a significant role in the continued growth and success of our company,” said Fred Eshelman, chief executive officer. “I am grateful for Paul’s many contributions and tireless efforts during his 17-year tenure with PPD. On behalf of our board of directors and all of our employees, I wish him well in his retirement and immense satisfaction in his pursuit of personal interests outside of our industry.”
   
Dr. Covington has global responsibility for regulatory affairs, pharmacovigilance, medical communications, laboratory and Phase I services. He joined the company in 1991 as medical director and served as senior vice president of medical and regulatory affairs and chief safety officer prior to being promoted to his current role in 2002.
   
The company anticipates naming a successor to Dr. Covington by mid-2008. The company also expects to enter into a consulting agreement with him following his full retirement in 2009.

Spectrum Pharmaceuticals, Inc. received approval to market Levoleucovorin for Injection from the FDA following application submissions supported by data from BioScreen Testing Services, Inc.  
    
"We offer our sincere congratulations to Spectrum," said Bradford Rope, president of BioScreen Testing Services. "BioScreen looks forward to a continuing partnership, providing release testing support during the manufacture of Levoleucovorin, as well as additional development support for the many drugs in Spectrum's pipeline. BioScreen provides contract testing services to companies and has contributed data to support many submissions to the FDA.

Schering-Plough has launched a new Productivity Transformation Program (PTP) to cut costs and increase productivity in an effort to save $1.5 billion annually. The program is in response to intensifying pressures in the U.S. market, centering on the Merck/Schering-Plough joint venture that markets cholesterol products Zetia and Vytorin. A panel of cardiologists recently called for doctors to limit use of these cholesterol drugs after a recent study showed that the drugs provided no benefit in slowing the progression of heart disease.
   
The targeted savings represent approximately 10% of the company's FY07 cost base, including Organon BioSciences (OBS) and manufacturing. The $1.5 billion savings target includes $500 million of previously announced integration synergy targets from the November 2007 acquisition of OBS.
   
Approximately $1.25 billion (80%) of the planned savings are expected by the end of 2010, with the balance achieved by 2012.
   
"Savings and productivity improvements will be realized across the company and around the world. No area will be exempt," said Fred Hassan, SP's chairman and chief executive officer. "Our first actions will be to execute reductions in high overhead cost areas, beginning with reductions in higher management levels in the company's headquarters and elsewhere. A major focus will be the U.S., where the most intense new pressures on our industry and our company are centered." Mr. Hassan added, "We will be executing this cost saving, productivity-enhancing program with care and prudence. We will not engage in across-the-board cost cutting. We will avoid unwise short-term actions. We will be focused on the same goal that has driven our company over the past nearly five years of my tenure as CEO: driving high performance for the long term."
   
The plan will include the elimination of about 5,500 jobs or 10% of the company's headcount, as well as consolidation of middle management functions and increased use of shared staff support and shared services. The company will review and re-size investments in sales and marketing and R&D, including strategic reductions in its project portfolio and will also reduce the number of plants globally and create more focused and high-efficiency plants by 2012.
   
"Hard new realities are requiring hard new actions. The reality is that we face today a new political and overall environment in the U.S. that is increasingly discouraging pharmaceutical innovation. An example of these intense overall new pressures has been the confusion in the cholesterol market largely caused by the overreaction to conflicting results of the relatively small ENHANCE clinical trial, involving Vytorin. This confusion, in the absence of an open and balanced scientific discussion of this clinical trial, have caused an unwarranted concern among millions of patients who need to get to their cholesterol goals," said Mr. Hassan.

Akorn, Inc. has signed a five-year supply agreement with Fresenius Kabi for a new premix product. Premix medications are ready to use intravenous drug products.
   
Under the terms of the agreement, Akorn will be responsible for development, marketing and distribution of the premix product. Fresenius Kabi will manufacture the product at its intravenous solutions manufacturing facility in Halden, Norway. The product is expected to launch in 2012. Akorn will own the ANDA. Financial terms of the agreement were not disclosed.
   
Arthur S. Przybyl, Akorn's president and chief executive officer, stated, “We look forward to partnering with Fresenius Kabi on this novel premix product. Additional niche products will be added that provide unique market value and fulfill customer needs."

Metrics, Inc. is expanding its stability storage, boosting its capacity for service by 50%. The $18-million, 47,000-sq.-ft. expansion will include new state-of-the-art environmental specialties (ESI) chambers with redundant mechanical systems that will maintain proper environmental conditions, even in the event of a power failure. The chambers will be fully operational and validated by 2Q2008. The chambers meet International Conference on Harmonization (ICH) and U.S. Pharmacopeia (USP) guidelines. Also, for chambers without redundancy features, the company will maintain empty back-up chambers pre-set to conditions so that client studies can be transferred immediately if necessary.
   
“Since we’ve been functioning at capacity at Metrics for some time now, we are pleased we can now provide our clients with the greater stability storage capacity they need,” said Phil Hodges, president. Headquartered in Greenville, N.C., Metrics provides quality pharmaceutical formulation, clinical trial material (Phase I through Phase III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.
   
The expansion is taking place at Metrics’ existing 50,000-sq.-ft. cGMP facility. Following the expansion, the company will be able to increase production to one billion tablets a year, up from 50 million.

Teresa F. Winslow has been named senior vice president, global business development and James Miskel has been appointed vice president, strategy and corporate development, MDS Pharma Services. Ms. Winslow will direct global business development efforts and Mr. Miskel will focus on strategic partnerships.
   
"I'm delighted to add these two experienced leaders to our senior management team," said MDS Pharma Services president David Spaight. "Their skills and knowledge will allow us to seize emerging opportunities to accelerate the growth of our business."
   
Ms. Winslow is an experienced executive leader of business development in the healthcare industry. She previously served as president, Dendrite Americas and senior vice president, Dendrite International, a supplier of sales force and marketing effectiveness solutions for the pharmaceutical industry. Ms. Winslow was responsible for operations, sales and marketing functions and led double-digit growth of the company's largest division.  
   
Mr. Miskel joins the company from Wyeth Pharmaceuticals, where he was assistant vice president for business planning and strategy. He spent much of his career with McKinsey & Co. leading growth strategy, operational improvement, and acquisition work in the Americas and Europe for pharmaceutical and medical device companies.  

Pfizer has discontinued a Phase III clinical trial of single-agent tremelimumab (CP-675,206) in patients with advanced melanoma, after the review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.

The company has communicated with worldwide regulatory authorities and investigators regarding the discontinuation of the trial. Investigators will work with their patients to determine if they are benefiting from treatment and therefore should continue treatment with tremelimumab.

"Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high risk area of research with significant unmet medical need. We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer," said Charles Baum, M.D., Ph.D., vice president and Oncology Therapeutic Area head at Pfizer Global Research and Development. "We will continue to assess the study data to understand the clinical benefit seen in some patients who received tremelimumab."

The full data set from the study is being analyzed, and more details are expected to be available at the American Society for Clinical Oncology Annual Meeting in June 2008.

"We have a robust pipeline within Pfizer Oncology and we remain committed to the discovery and development of novel cancer treatments which hold promise for patients with cancer," said Dr. Baum. "We are extremely grateful for the strong support we have received for this clinical trial from the physicians, study staff, and most importantly from the patients."

Pfizer is developing several classes of agents in its Immuno-Oncology pipeline including CD40 agonists, toll-like receptor (TLR) agonists and vaccines.

Abraxis BioScience, Inc. has initiated enrollment in its Phase II clinical trial to evaluate the efficacy and safety of Coroxane for the prevention and reduction of restenosis following revascularization of the superficial femoral artery (SFA).

Coroxane (nanometer-sized paclitaxel and Abraxane) is a novel, solvent-free, albumin-bound form of paclitaxel used for cardiovascular applications. Abraxane is the first and only approved protein-bound, nanometer-sized, solvent-free taxane and is the first commercial product to validate Abraxis’ proprietary nab technology platform. Abraxane is marketed for the treatment of breast cancer.

Earlier preclinical and clinical studies investigated the potential for Coroxane as an alternative to drug eluting stents in coronary arteries. Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis,  noted that the company currently intends to seek a strategic partner for the development and marketing of Coroxane.

Tthe Phase II trial, led by principal investigator John Rundback, M.D., director of the Interventional Institute at Holy Name Hospital in Teaneck, N.J. and Associate Professor of Clinical Radiology at Columbia University College of Physicians and Surgeons, is a randomized, open-label, prospective, multicenter study that will compare the safety and efficacy of three different Coroxane dosing schedules to primary percutaneous balloon angioplasty with provisional stenting, the standard treatment for stenosis in the SFA.

“The present study is an important step forward in providing a treatment alternative to patients with moderate to long segment SFA disease using Coroxane. The novel mode of delivery allows platform independent treatment and can be used regardless of the initial revascularization method," said Dr. Rundback. "Since drug eluting stents have not yet clearly shown long-term benefit, a different strategy for delivering this very bioactive agent to the site of balloon injury has tremendous potential to expand the therapeutic options and improve outcomes for these patients."

Approximately 150 patients will be monitored for restenosis of the target vessel at nine months as evaluated by angiography and duplex ultrasound.

Dr. Reddy’s Laboratories has entered into a definitive agreement with The Dow Chemical Company to acquire a portion of the Dowpharma Small Molecules business associated with sites in Mirfield and Cambridge, UK.

The acquisition will include the relevant business, customer contracts, associated products, process technology, intellectual property, trademarks as well as the transfer of the facilities at Mirfield and Cambridge. The two sites and the business employ around 80 people. Dr. Reddy’s will also have a non-exclusive license to Dow's Pfenex Expression Technology for biocatalysis development.

Satish Reddy, managing director and chief operating officer at Dr. Reddy's, said, "The proprietary chiral and biocatalysis technology at the Cambridge site and the scaleup capability in the Mirfield site will add significant value to the company. This acquisition will also bring strengths in industrial synthesis of complex prostaglandins and carbohydrate chemistry. These newer capabilities will add to our existing R&D and commercial infrastructure to position Dr. Reddy's as a leading provider of custom pharmaceutical services globally."

The financial terms and conditions of the transaction have not been disclosed. The transaction is scheduled to close on April 30, 2008 pending regulatory approval.

Medicis has announced the promotions of Mark A. Prygocki to executive vice president, chief operating officer, Vincent Ippolito to executive vice president, sales and marketing, and Richard D. Peterson to executive vice president, chief financial officer and treasurer. These promotions follow the departure of Richard Havens who has, until now, served as the company's executive vice president, sales and marketing. Mr. Havens will be leaving Medicis as a first step towards his eventual retirement. He has agreed to act in a consultancy capacity exclusively to Medicis at an agreed upon hourly rate, and will assist primarily with strategic initiatives and business development activities.

"I am pleased that we are able to promote highly talented, well-respected individuals with proven track records from within the organization," said Jonah Shacknai, Medicis' chairman and chief executive officer.

Mr. Prygocki joined Medicis in 1991 and was appointed to the position of chief financial officer, treasurer and corporate secretary in May 1995. In January 2001, Mr. Prygocki was also appointed as executive vice president. Prior to joining the company, he served at Citigroup and Ernst & Young.

Mr. Ippolito joined Medicis in 2003 and most recently served as senior vice president of North American sales since January 2006. Prior to joining the company, he was employed by Novartis from 1986 to 2003.

Mr. Peterson joined Medicis in 1995 and most recently served as senior vice president, finance. He has held various accounting- and finance-related positions since joining Medicis in 1995. Prior to joining the company, he was employed by PricewaterhouseCoopers.

Mike Wilkinson, Ph.D. has been named executive vice president of global clinical development at PPD, Inc. He will provide strategic leadership to the company's Phase II-IV operations in North America, Latin America, Europe, Middle East/Africa and Asia Pacific.

Dr. Wilkinson most recently served as global head of internal medicine and vice president of project management for another CRO. His responsibilities included global operational and financial oversight and accountability for all internal medicine clinical trials. His industry experience also includes a tenure as clinical development project management practice leader at a pharmaceutical consulting organization.

"Mike Wilkinson brings an exceptional resume with strong leadership across a variety of roles and is uniquely qualified to direct our Phase II-IV global clinical development operations," said William Sharbaugh, PPD's chief operating officer. "With more than 25 years of project management experience, he is extremely skilled at building and leading successful project teams and will play a key role in helping us strategically expand our global operations."

Prior to joining the biopharmaceutical industry eight years ago, Dr. Wilkinson spent 27 years in the U.S. military where he began his career as a Navy SEAL. His many roles included aviation physiologist, White House liaison officer with Marine One Executive Transport, director of operations for the Joint Special Operations Medical Training Center and project director for the V-22 Osprey military aircraft.

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