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.”