Nektar Therapeutics has sold some of its pulmonary delivery assets, technology, and intellectual property to Novartis for $115 million in cash. Novartis now owns "certain dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment and manufacturing facility lease obligations," according to a Nektar statement. The sale also transferred to Novartis approximately 140 Nektar personnel, as well as certain IP and manufacturing methods, including manufacturing and royalty rights to Novartis' Tobramycin inhalation powder (TIP) program.

Nektar continues to own its Bayer HealthCare-partnered program NKTR-061 (Amikacin Inhale) and royalties from the Ciprofloxacin inhaled powder program (CIP), also partnered with Bayer HealthCare. In addition, Nektar retains its NKTR-063 (inhaled vancomycin) program, as well as all intellectual property specific to inhaled insulin.

Roger Viney, Ph.D. has been named director of sales & marketing Europe and Asia for Hovione. Thomas Eisele, Ph.D. has been named general manager R&D at the company and Steve Beagle has been named director of sales & marketing, North America.

Dr. Viney will lead Hovione's sales and marketing efforts outside North America and is based at Hovione headquarters in Loures, Portugal. Steve Beagle will lead those efforts for the North America territory and is based at the Hovione's Technology Transfer Center in New Jersey. Both Dr. Viney and Mr. Beagle are responsible for the development of sales and marketing strategies in line with the strategies of Hovione's four business units: Exclusive, Particle Design, Generics and Pharma. Dr. Eisele is responsible for corporate R&D and reports to chief executive officer Guy Villax. The R&D group includes Process Chemistry, Analytical Chemistry, Particle Design, Project Management and Pilot Plant.

"We are pleased to welcome Roger, Thomas and Steve to the Hovione team," said Mr. Villax. "These three individuals have a distinguished track record in the industry and their extensive experience will be an invaluable resource to the company and broadens the executive management team at an important stage in the growth of our business."

Prior to joining Hovione, Dr. Viney held various positions at Rhone-Poulenc/Rhodia from 1993 to present, most recently in Global Business Management. Prior to that he worked in senior roles in sales, marketing and technical management.

Dr. Eisele worked in Switzerland for 13 years in the area of Custom Research and Custom Manufacturing at CarboGen-Amcis, Rohner and SynphaBase. During that time Dr. Eisele held several positions in R&D, marketing and sales, global business development, shared services and general management. He began his professional career at Nycomed in the area of Medicinal Chemistry.

Mr. Beagle has a diverse 24-year history working in global roles within the pharmaceutical industry ranging from product management to sales and marketing. He is well known in the pharmaceutical manufacturing community and brings a wealth of knowledge to this position. Most recently he was at DSM where he was senior director of Business Development. Prior to this position he was at Stiefel Laboratories where he held management positions in Business Development and Technical Service. Mr. Beagle has also worked for BASF, American Cyanamid, and R.W. Greeff.

King Pharmaceuticals has initiated the Phase II trial evaluating the efficacy and safety of T-62, an investigational drug for the treatment of neuropathic pain.

Dr. Eric Carter, chief science officer of King, remarked, “T-62, a new chemical entity, is an adenosine A1 allosteric enhancer that increases the effectiveness of the body’s endogenous adenosine to treat neuropathic pain. The successful development of this product would address a substantial unmet medical need for more effective medicines to treat this serious condition.”

The Phase II trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain. The study is expected to enroll approximately 130 patients in as many as 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design. Each patient will complete a seven-day screening period, a 28-day treatment period, and a 14-day post-treatment period.

Matthew K. Fust has been named executive vice president and chief financial officer of Onyx Pharmaceuticals. Mr. Fust will serve as Onyx's principal financial and accounting officer and report to N. Anthony Coles, M.D., the company's president and chief executive officer.

"Matt is a proven leader who brings extensive senior management and operational experience to Onyx, as well as a shared strategic vision to create a leading biopharmaceutical company," said Dr. Coles. "His demonstrated capabilities in implementing corporate and financial strategies and accelerating corporate growth have been reflected throughout his career. On behalf of the board and the other members of the executive team, it is a pleasure to welcome Matt."

Most recently, Mr. Fust was executive vice president and chief financial officer at Jazz Pharmaceuticals, which he joined in 2003. From 2002 until 2003, he was chief financial officer at Perlegen Sciences, a biotechnology company. Previously, he served as senior vice president and chief financial officer at Alza Corp. where he was an executive from 1996 until 2002. From 1991 until 1996, Mr. Fust was a manager in the healthcare strategy practice at Anderson Consulting.

Actavis Inc. has reached agreement with the FDA on a Consent Decree of Permanent Injunction the company’s Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe.

The decree only affects operations at Actavis Totowa in NJ. These include two oral-dose manufacturing sites, and one packaging facility. Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA’s cGMP and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly.

“We have been working with the FDA to address compliance issues at the Totowa facilities,” said John LaRocca, Actavis Inc.’s chief legal officer. “We have an entirely new management team in place at Little Falls and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the FDA is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.”

Prior to reaching this agreement, Actavis engaged Parexel to assess Actavis Totowa facilities. Parexel has 25 years of experience in helping companies bring safe and effective treatments to the global marketplace. Parexel will continue to work with Actavis Totowa to facilitate ongoing compliance with the Consent Decree, according to an Actavis statement.

The FDA has accepted Savient Pharmaceuticals' BLA for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted Savient's BLA a priority review status which accelerates the review period to six months. This designation is assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The target date for an FDA decision on pegloticase is April 30, 2009.

The BLA submission is based on the two replicate, six-month Phase III clinical trials, performed under the auspices of a special protocol assessment. Additionally, the BLA includes data from the open label extension (OLE) study for pegloticase, per the request of the FDA. The OLE study allowed those patients who completed the Phase III trials to continue or begin receiving pegloticase for an extended period of time. The data set includes 101 patients with at least twelve months of continuous treatment. Pegloticase was previously granted orphan drug designation by the FDA.

Treatment-failure gout occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with allopurinol at the maximum medically appropriate dose or for whom allopurinol is contraindicated.

GlaxoSmithKline and Archemix Corp. have entered a worldwide strategic alliance to discover, develop and commercialize aptamer therapeutics to treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease. Aptamers are synthetized oligonucleotides, or short nucleic acid sequences, that bind to proteins with high affinity and specificity.
   
The alliance leverages Archemix’s expertise and intellectual property in the discovery and development of aptamer therapeutics and provides GSK with an option to license product candidates directed at seven different aptamer targets related to inflammatory disease.
   
Under the terms of the agreement, Archemix will receive $27.5 million in upfront payments, including a $6.5 million equity investment by GSK in the company. Archemix could also be eligible to receive as much as $200 million in development, regulatory and sales milestones for each of the seven aptamer therapeutics which may be discovered and developed as part of the alliance. Archemix would also receive tiered royalties on worldwide sales of products that may result from the alliance.
   
Archemix will be responsible for the discovery and development of the aptamer therapeutics through clinical proof of mechanism, unless GSK chooses to exercise its option earlier. GSK would then have an exclusive license to drug candidates developed under each program for further development and commercialization on a worldwide basis. Archemix will have the right to develop and commercialize any aptamer therapeutics that GSK does not select.
   
“We are very excited about this collaboration with GSK. GSK is an outstanding partner with leadership and expertise in inflammation, and we look forward to expanding our efforts in inflammation where aptamers could offer novel options to treat disease,” said Errol DeSouza, Ph.D., president and chief executive officer of Archemix. “This is another step forward in our strategy to leverage our intellectual property estate together with our significant internal capabilities in order to develop aptamers for a variety of therapeutic areas with key partners who are experts in their field.”
   
"This innovative multi-target drug-discovery deal is an important extension of our externalization strategy and provides GSK with an outstanding opportunity to work with the world leader in aptamer discovery and development," said Jose Carlos Gutierrez-Ramos, Ph.D., senior vice president and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery in GSK. "The application of aptamers with their unique properties is an exciting opportunity that holds enormous potential for the treatment of many devastating diseases of the immune system."

Forest Laboratories, Inc. and Pierre Fabre Medicament have entered into a definitive collaboration agreement to develop and commercialize F2695 in the U.S. and Canada. F2695 is a selective norepinephrine and serotonin reuptake inhibitor being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.
   
Under the terms of the agreement, Pierre Fabre will receive an upfront payment of $75 million and is eligible to receive milestone payments and royalties on sales. Forest will be responsible for the clinical development and commercialization of F2695 in the U.S. and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide.
   
"We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004," commented Howard Solomon, chairman and chief executive officer of Forest. "We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market."
   
"Pierre Fabre is looking forward to working with Forest on this exciting product opportunity," said Jean-Pierre Garnier, chief executive officer of Pierre Fabre Medicament. "Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695."
   
In a recently completed Phase II study in more than 550 patients with major depressive disorder, F2695 demonstrated statistically significant improvement compared to placebo on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale ("MADRS"). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale ("HAMD-17") and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment.

Kerri Schoedel, Ph.D. has been promoted to scientific director, clinical pharmacology for Kendle's Early Stage unit in Toronto. Dr. Schoedel will provide overall scientific direction and leadership to the clinical pharmacology group, as well as lead strategic planning and policy development as it relates to scientific assessment.  She is experienced in the field of psychopharmacology and the assessment of drug abuse liability, and also has experience in pre-clinical and clinical studies and working with regulatory authorities.
   
“I am thrilled to announce Kerri’s appointment to scientific director, clinical pharmacology,” said Phil Davies, vice president, Early Stage.  “We look forward to Kerri's continued contributions and leadership as Kendle further advances its established position as the leading authority in Early Stage psychopharmacology and human abuse liability. This appointment also reinforces our commitment to grow and advance our global Early Stage team and capabilities.”
   
Dr. Schoedel joined DecisionLine, formerly Ventana Clinical Research Corp. and now part of Kendle, in 2004. She began her career as a research scientist and was promoted to senior research scientist. In these positions, she was responsible for providing scientific input to project teams, assisted with clinical study and protocol design and provided project management for clinical research projects.

Sanofi-Aventis and Novozymes have signed a development and marketing collaboration for a potential new antibiotic. The drug candidate is an antimicrobial peptide named Plectasin NZ2114 that targets the treatment of severe infections, such as pneumonia and septicaemia, caused by bacteria like Staphylococcus and Streptococcus.

SA has been granted an exclusive worldwide license for the development, registration and commercialization of the drug. The two companies will  work to develop and implement commercial-scale manufacturing of the drug substance, with the goal of introducing a recombinant process building on Novozymes' proprietary expression technology.

"Plectasin NZ2114 is the first drug candidate that Novozymes has outlicensed for further preclinical and clinical development. Teaming up with one of the largest pharmaceutical companies in the world is the type of collaborations we were looking for," said Per Falholt, executive vice president, R&D, Novozymes.

"The innovative mechanism of action of Plectasin NZ2114 makes it potentially active against bacteria resistant to currently available treatments. We are looking forward to developing Plectasin NZ2114 for the treatment of severe infections such as pneumonia, septicaemia, and complicated skin and soft tissue infections," said Dr. Marc Cluzel, senior vice president, R&D, Sanofi-Aventis.

AstraZeneca and MAP Pharmaceuticals have formed an exclusive worldwide agreement to develop and commercialize Unit Dose Budesonide (UDB), MAP Pharmaceuticals’ proprietary nebulized formulation of budesonide. UDB is being developed by MAP Pharmaceuticals as a potential treatment for pediatric asthma and is currently in Phase III. UDB has the potential to be nebulized more quickly and at a lower nominal dose than the commercially available product.

AZ will pay MAP an upfront cash payment of $40 million and an additional $35 million upon the successful achievement of primary endpoint and safety results in the currently ongoing Phase III study. MAP is also eligible to receive as much as $240 million in other potential development and regulatory milestones, as well as additional progressively demanding sales performance-related milestone payments of as much as $585 million in the event the product is a "considerable commercial success," according to an AZ statement.

MAP and AZ will develop UDB in the U.S. and AZ has rights to develop and commercialize UDB outside of the U.S. MAP is eligible to receive significant double-digit royalty payments on net sales of UDB worldwide, and AZ will support and fund the establishment of a MAP sales force to co-promote UDB in the U.S. for a certain period of time after product launch.

AZ will be responsible for future UDB development costs and will reimburse MAP for the costs of future UDB development activities with respect to U.S. registration.

David Brennan, AZ's chief executive officer, remarked, “MAP Pharmaceuticals’ advancement in UDB represents an important potential new option for treating children confronting asthma. AstraZeneca’s heritage in treating pediatric asthma, combined with MAP’s expertise can open new areas of opportunity for both companies and has the potential to bring significant medical benefit to the wider community.”

UDB is being developed utilising a license to Elan's proprietary NanoCrystal Technology. The small size and stability of NanoCrystal drug particles are designed to enable improved delivery efficiency of drug formulations to the lung via nebulization, according to AZ.

Amgen has submitted a Biologics License Application (BLA) with the FDA for denosumab, an investigational RANK Ligand inhibitor. Amgen is seeking approval for treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA contains data from six Phase III trials involving more than 11,000 patients, according to Amgen.

"Two Phase III pivotal studies with fracture endpoints, in the PMO and prostate cancer settings, demonstrated denosumab's ability to reduce fracture, and all six studies showed denosumab's ability to increase bone mineral density at all skeletal sites measured," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "This submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies."

Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.

PharmaNet Development Group is working with a financial advisor to pursue strategic alternatives, including the potential sale of the company. “The Board of Directors and management believe that pursuing strategic alternatives will maximize shareholder value,” commented Jeffrey P. McMullen, president and chief executive officer. “I strongly believe this approach will provide a more positive outcome for our clients and employees.”

As part of the process, the company recently received several confidential, non-binding written expressions of interest from a number of parties, none of whom are direct competitors, according to a company statement. The company does not intend to comment further on the strategic alternative process unless or until a definitive agreement has been reached or the Company changes its strategic direction. UBS Investment Bank is working as its financial advisor.

Oncothyreon Inc. has announced plans to restructure and focus on development of two compounds, PX-478 and PX-866. PX-478 is an inhibitor of hypoxia inducible factor-1 alpha that is currently in a Phase I trial for advanced metastatic cancer and lymphoma. PX-866 is an inhibitor of PI-3 kinase that is also in a Phase I trial in patients with advanced cancer.

The company will reduce the size of its workforce and its senior management team. Approximately eight employees in its Edmonton facility, primarily engaged in preclinical work and administrative functions, will be fired. In addition, Edward Taylor, vice president and chief financial officer, and Rao Koganty, Ph.D., vice president and head of Synthetic Biologics, will be retiring, effective December 31, 2008. The resignation of Lynn Kirkpatrick, Ph.D., as chief scientific officer effective December 31, was previously announced. Oncothyreon also intends to close its Tucson facility in 2009 and to transfer to Seattle or outsource activities in support of PX-478 and PX-866 that are currently conducted in Tucson.

In addition, Oncothyreon has sold responsibility for the manufacture of Stimuvax to Merck KGaA. Merck and its EMD Serono Canada subsidiary have purchased current inventory and certain assets utilized for the manufacture of Stimuvax for net payments of approximate $13 million. As part of the transaction Merck KGaA has assumed control of Oncothyreon's Edmonton, Canada facility, which is primarily utilized for the manufacture and development of Stimuvax.

EMD Serono Canada intends to offer employment to the majority of Oncothyreon's 52 employees in Edmonton. In addition, Merck KGaA will be responsible for all further development costs related to Stimuvax, including commercial-scale manufacturing process development, and for the cost of goods at commercialization. The royalty rates payable to Oncothyreon on future net sales of Stimuvax, if any, have been adjusted to reflect that Oncothyreon is no longer responsible for these costs. Potential payments upon achievement of certain milestones under the previous agreements between Merck KGaA and Oncothyreon remain unchanged.

Stimuvax is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a glycoprotein antigen widely expressed on common cancers. It is currently in Phase III.

"We believe that an intense focus on these exciting product candidates is the best means to create value with our available resources," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. "We currently expect to complete the Phase I trials for each of these products and, if the data are supportive, to move each of them into Phase I trials in 2009. We believe the approximately $13 we received from the sale of manufacturing rights for Stimuvax and certain assets to Merck KGaA, together with existing cash, will be sufficient to fund these objectives."

With the payments from the sale of manufacturing rights for Stimuvax and current inventory and certain assets to Merck KGaA, together with existing cash, the company has sufficient cash resources to fund operations into the first quarter of 2010, according to a company statement

Wyeth has acquired Thiakis Limited, a privately held biotechnology company based in the United Kingdom. Thiakis' lead product candidate, TKS1225, is being studied for the treatment of medical obesity and other co-morbidities. TKS1225 and related compounds are synthetic versions of the natural gastrointestinal peptide oxyntomodulin.

Wyeth is paying approximately $30 million for Thiakis, with potential milestone payments of as much as $120 million. Thiakis was founded in 2004.

"This acquisition is evidence of our commitment to develop and bring to market innovative, high-value medicines that have the potential to address significant unmet needs in critical therapeutic areas such as metabolic disorders," said Mikael Dolsten, M.D., Ph.D., president, Wyeth Research. "Thiakis' R&D program fits well with our goal of addressing the medical burden of obesity in a targeted manner using biologic-based therapies."

"As we take this important step with Wyeth, we are certain we have chosen the right company to follow through on our vision and commitment to develop and commercialize important new therapies that help address the growing worldwide medical epidemic of obesity," says John Burt, D.Phil. ACMA, chief executive officer and co-founder of Thiakis.

GlaxoSmithKline has signed a license agreement with DSM Biologics and Crucell, allowing GSK to research a recombinant protein on the PER.C6 platform. Financial terms of the agreement were not disclosed.

"We are very pleased to enter into this collaboration with GSK," said Ronald Brus, Crucell's chief executive officer. "This agreement further underscores the potential of our PER.C6 production technology for generating recombinant proteins."

"The PER.C6 production technology continues to surpass our expectations as a robust manufacturing platform with its ever extending and global reach into the Research and Development departments of major healthcare players," Karen King, president of DSM Biologics, commented. "This agreement with GSK brings us closer to our mission of making the PER.C6 technology a gold standard for industry use."

Auxilium Pharmaceuticals and Pfizer have entered into a strategic alliance for the development, commercialization and supply of Xiaflex, a novel, first-in-class, biologic for the treatment of Dupuytren's contracture and Peyronie's disease. Pfizer will receive exclusive rights to commercialize Xiaflex in the 27 member countries of the EU and 19 other European and Eurasian countries. In addition, Pfizer will be primarily responsible for regulatory activities for Xiaflex in these countries.

Pfizer will make an up-front payment of $75 million to Auxilium and as much as $410 million in milestone payments, with $150 million tied to regulatory milestones and $260 million based on sales milestones. Auxilium will receive increasing tiered royalties based on sales of Xiaflex in Pfizer's territories.

Auxilium will remain primarily responsible for the global development of Xiaflex and will be responsible for all clinical and commercial drug manufacturing and supply. Pfizer will share clinical development costs for certain trials required for the EU and be responsible for all discretionary development within the countries for which it has exclusive rights to commercialize Xiaflex. Pfizer will have a right of negotiation to obtain exclusive rights to commercialize Xiaflex pipeline indications in its territories.

Auxilium has completed Phase III trials for Xiaflex in Dupuytren's contracture and expects to file a biologics license application (BLA) in the U.S. for the treatment of Dupuytren's contracture in early 2009. Pfizer expects to file Xiaflex for approval for the treatment of Dupuytren's contracture in Europe in 2010. Xiaflex is also being evaluated in a Phase IIb trial for Peyronie's disease, with top-line data expected in late 2009.

"Today, Pfizer and Auxilium have forged a compelling partnership and together we believe we have the opportunity to offer the first, effective non-surgical treatment for two diseases," said Armando Anido, chief executive officer and president of Auxilium. "With the strength of Pfizer's commercialization and development organization, this relationship greatly enhances our ability to effectively introduce this potentially groundbreaking technology for the treatment of Dupuytren's contracture and Peyronie's disease in Europe."

Covance has purchased a minority equity stake in Caprion Proteomics, a  provider of proteomics-based services. Covance has also hired a new vice president to lead its Biomarker team and that it plans to establish a Biomarker Center of Excellence at its Greenfield, IN campus.

These moves are intended to enable Covance to capitalize on the emerging high-growth service market in biomarker discovery, verification, validation, and deployment across the drug development continuum, from preclinical to post-marketing surveillance.

Covance will serve as the exclusive CRO distributor of Caprion's proteomic biomarker services. In addition, Caprion will serve as Covance's exclusive proteomic discovery provider. Through this alliance, Covance and Caprion will offer pharmaceutical and biotechnology drug development customers a "distinctive, innovative, and integrated biomarker solution," according to a Covance statement.

"We are very pleased to be adding Caprion's solid scientific capabilities and leading biomarker technology platform to Covance's line up," said Deborah Tanner, corporate senior vice president and president of Covance Central Laboratory Services. "We expect that our clients will have a keen interest in this additional capability given Caprion's impressive track record of accelerating biomarker validation for early drug safety and efficacy assessment."

"We are excited to join forces with Covance's market-leading central laboratory and world-class scientific talent," said Martin LeBlanc, president and chief executive officer of Caprion. "Over the past five years, Caprion has established a large pharmaceutical customer base through employing our distinctive, best-in-class technology platform, which we expect will be further adopted in the market as a result of our alliance with Covance. Most importantly, we believe this alliance, which combines Covance's leading research services platform with Caprion's leading biomarker platform, will yield superior biomarker solutions for our clients."

Covance's Biomarker Center of Excellence will focus specifically on biomarker testing and validation and leverage the discovery support services of Caprion and of the services that already reside at Greenfield, including in vivo preclinical safety and efficacy assessment, and a variety of sophisticated preclinical imaging modalities.

The biomarker business will be led by Thomas Turi, Ph.D., Covance's new vice president of Biomarkers. In his new role, Dr. Turi will be responsible for building the Center of Excellence for Biomarkers leading the Biomarker Expert Team.

Dr. Turi joins Covance with more than 14 years of experience leading drug discovery projects ranging from exploratory through early development programs. Prior to Covance, Dr. Turi spent his career at Pfizer, where he held a broad array of scientific leadership positions of increasing responsibility. Most recently, Dr. Turi served as the senior director of Translational Biomarkers and Mechanistic Biology at Pfizer's laboratories in Groton, CT.

GlaxoSmithKline and Dynavax Technologies have entered a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases.

Dynavax will receive an initial payment of $10 million and GSK will receive an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis. Dynavax’s lead inhibitor drug candidate, DV1079, is a bifunctional inhibitor of TLR7 and TLR9, and is expected to enter clinical development in the fourth quarter of 2009.

“Our alliance with GSK provides an opportunity to create an entirely new product franchise for Dynavax,” commented Dino Dina, M.D., president and chief executive officer of Dynavax. “Our TLR inhibitors have the potential to create significant value for our newest collaborator GSK as well as for our stockholders. Alliances with major pharmaceutical companies have enabled Dynavax to establish a diverse pipeline of innovative products, while contributing valuable cash for our programs.”

Dynavax will conduct research and early clinical development in as many as four programs and is eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. Dynavax will receive tiered royalties on sales and has retained an option to co-develop and co-promote one specified product.

PPD, Inc. plans to expand its global central lab services into Singapore in response to growing demand in Southeast Asia. The lab is expected to begin operations in mid-2009 and will provide biopharmaceutical clients with a "comprehensive range of highly customized lab services," according to a PPD statement.

"Southeast Asia is an attractive region for conducting clinical trials, and Singapore is an important biopharmaceutical hub," said Agostino L. Fede, Ph.D., senior vice president of PPD and head of PPD's global central labs. "Establishing a direct lab presence in Singapore will enhance our abilities to reduce turnaround time and deliver high quality specimens and laboratory results at better logistics costs for our clients."

PPD has provided a range of clinical development services in Singapore for several years, including clinical trial management and monitoring, patient recruitment, site identification and regulatory affairs. The equipment in Singapore is identical to platforms located at PPD's global central labs in Brussels, Belgium;, Highland Heights, KY, and Beijing, China. Assays will be extensively cross validated among PPD's locations to produce combinable data, according to the company.

PPD's Singapore lab will interface directly with ConneXion, the company's proprietary global computer system, to ensure consistent management and real-time reporting.

Quotient Bioscience Group Ltd. has acquired Pharmaceutical Profiles Group (PPG), which will be integrated into Quotient Bioresearch. Founded in 1990, Pharmaceutical Profiles is a  provider of Phase I drug development services to the global pharmaceutical and biotechnology industries. It offers an integrated formulation development, manufacturing and clinical testing platform incorporating a range of technologies, and covers the development of optimized oral, intravenous, and inhaled clinical dosage forms. It is based in Nottingham, UK and has 75 employees. The company will change its name to Quotient Bioresearch in the next year.

Its addition to Quotient's unit will give the bioresearch business an "integrated metabolic sciences service offering, spanning radio synthesis through to human AME studies," according to a Quotient statement.  It will also continue to build on PPG’s position in accelerated clinical formulation development. Mark Egerton will retain his role as managing director of Pharmaceutical Profiles, which will continue to operate from its existing Nottingham Phase I facility.

Pharmaceutical Profiles represents the fifth acquisition to date for Quotient, which was established in early 2007. The enlarged group will have revenues approaching $60 million and employ more than 450 people in the UK.  Quotient will continue to operate from its existing sites in Newmarket, Rushden, Nottingham, Edinburgh and London. 

Paul Cowan, chairman and chief executive officer of Quotient, said, “We are delighted to have completed the acquisition of Pharmaceutical Profiles.  It brings with it a world-class reputation and an innovative service offering, which we plan to expand.  It fits extremely well with our strategy of adding complementary drug development capabilities to the existing service offering of Quotient Bioresearch.”

Jazz Pharmaceuticals has fired 71 employees (24% of its work force) to lower operating expenses. The company expects to record a charge of approximately $1.9 million in 4Q08 related to the move. Separately, the company's chief financial officer, Matt Fust, has decided to leave the company at year end to pursue other professional interests. His responsibilities will be assumed by other members of the executive management team.

The reduction does not affect the company's sales force. Jazz currently markets and sells Xyrem and Luvox CR. The company will continue development of JZP-6 (sodium oxybate) for the treatment of fibromyalgia syndrome. The company recently announced positive top-line results from the first of two  Phase III clinical trials of JZP-6. JZP-8, Jazz Pharmaceuticals' product candidate providing intranasal delivery of clonazepam for the treatment of acute repetitive seizures, is continuing in Phase II.

"Concentrating our company's efforts on growing sales of our commercial products and pursuing selected development programs, while streamlining our operations, will reduce ongoing operating expenses and minimize the need for additional financing," said Samuel Saks, M.D., chief executive officer of Jazz Pharmaceuticals. "We thank all of our employees for their hard work on behalf of the company and their efforts to help us provide important products for patients and physicians. In particular, I would like to thank Matt for his many contributions since the formation of the company."

The FDA has approved Abbott's Trilipix delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. TRILIPIX has not been shown to prevent heart disease or heart attack, according to an Abbott statement.

"Only 35% of patients with lipid problems are currently being treated with lipid therapies and many are not reaching treatment targets for all three key lipids," said Michael Davidson, M.D., clinical professor and director of Preventive Cardiology, University of Chicago Pritzker School of Medicine. "The approval of Trilipix is good news for patients because now there is a new treatment option that can be used alone or in combination with a statin to help address lipid problems."

Trilipix was studied in 2,698 patients with mixed dyslipidemia, a disorder of all three key lipids affecting millions of American adults. In the studies, mixed dyslipidemia was characterized by elevated LDL (bad cholesterol) and triglycerides (a type of fat found in the blood) and low HDL (good cholesterol). These studies demonstrated that Trilipix used in combination with the most commonly prescribed statins helped patients manage all three key lipids better than the corresponding therapies alone.

AAIPharma and Cortria Corp. have signed a deal granting Cortria the right to use AAIPharma’s proprietary, controlled release oral drug delivery technology known as ProCR in conjunction with Cortria's TRIA-662 drug candidate.
 
ProCR is a novel controlled-release technology developed by AAIPharma for use with orally administered drug products. TRIA-662 is Cortria's lead drug candidate, currently in Phase II clinical development for dyslipidemia. In preliminary human studies, TRIA-662 has shown the potential to provide the benefits for niacin therapy without causing skin flushing, a common, use-limiting side effect of niacin agents.
 
"We believe TRIA-662 is one of the most exciting drug candidates in the cardiovascular pipeline today and we are pleased to work with Cortria to help develop this product candidate for patients with dyslipidemia," said Lee Karras, senior vice president of Global Pharmaceutical Services at AAIPharma.  “Our goal is to work with companies like Cortria who have best-in-class therapeutic candidates and who can further benefit from best-in-class oral drug delivery solutions to maximize therapeutic performance.”
 
“AAIPharma has a rich history of providing oral solid dosage formulation development and has already been an outstanding partner for CORTRIA in the area of analytical services,” commented Daniel Grau, chief executive officer and vice chairman of Cortria. “Through this new agreement, we look forward to expanding our relationship with AAIPharma by applying its ProCR™ technology in the development of commercial formulations of TRIA-662.”
 
Terms of the license agreement have not been disclosed.

The FDA has granted Schering-Plough marketing approval for PEGintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C. This represents the first and only approved peginterferon in combination with ribavirin for treating pediatric hepatitis C. It is estimated that approximately 130,000 children in the U.S. are infected with the hepatitis C virus (HCV); the most common mode of HCV infection for pediatric patients today is maternal-infant transmission.

The only previously approved therapy in the U.S. for treating pediatric hepatitis C is SP's conventional interferon Intron A in combination with Rebetol. Rebetol is available both as capsules and in an oral solution formulation specifically available for pediatric use.

"With the FDA approval of PEGintron combination therapy for this new indication, U.S. physicians now have access to the current standard of care for hepatitis C for use in treating their pediatric patients. Thankfully, the number of children with hepatitis C is small, although this chronic infection over time can lead to serious liver disease," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "This approval further underscores Schering-Plough's leadership and long-term commitment to developing new treatment options and innovative therapies to meet the needs of patients with hepatitis C."

The approval of PEGINTRON for the pediatric indication is based on the results of a clinical trial in 107 previously untreated patients three to 17 years of age with chronic hepatitis C and compensated liver disease.

Weight loss and growth inhibition were common side effects in the trial, and some children who experienced growth inhibition during therapy still had inhibited growth velocity 6 months following the end of treatment. Most common adverse reactions (more than 25%) observed in these studies were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting. Three percent were treated for clinical hypothyroidism.

Patheon 4Q08 (ended 10/08)

4Q Revenues: $172 million (+6%)

4Q Earnings: $37 million (loss of $7.5 million in 4Q07)

FY Revenues: $717 million (+13%)

FY Loss: $1.4 million (loss of $94.6 million in FY07)

Comments: Commercial manufacturing revenues increased 11% for the year to $577.7 million, reflecting growth in European, Canadian and Puerto Rican operations. Pharmaceutical Development Services revenues grew 20% to $139.5 million. After the fiscal year ended, Patheon chose to shut down operations in Carolina, PR, contending that the cost savings outweighed the uncertainty of a sale. Severance costs related to this move are expected to be $3 million in 1Q09. Chief executive officer Wes Wheeler contended that this will be the last major restructuring step for Patheon.

Bristol-Myers Squibb and Exelixis have entered a global collaboration covering two novel anti-cancer molecules. Bristol-Myers Squibb agreed to pay Exelixis an upfront cash payment of $195 million for the development and commercialization rights to two Exelixis molecules: XL184, a small molecule inhibitor of MET, VEGFR2 and RET, which is currently in Phase III development for medullary thyroid cancer, and XL281, a small molecule inhibitor of RAF kinase, which is currently in Phase I development for the treatment of patients with advanced solid tumor malignancies. BMS will make additional license payments of $45 million in 2009.

The companies have agreed to co-develop XL184. Exelixis will have the option to co-promote XL184 in the U.S. The companies will share worldwide development costs and commercial profits on XL184 in the U.S. Exelixis will be eligible to receive sales performance milestones of as much as $150 million and double-digit royalties on sales outside the U.S.

The clinical development of XL184 will be directed by a joint committee. It is anticipated that Exelixis will conduct a significant portion of clinical development activities through 2010. Exelixis may opt out of the co-development of XL184, in which case Exelixis would instead be eligible to receive development and regulatory milestones of as much as $295 million, double-digit royalties on XL184 product sales worldwide, and sales performance milestones.

BMS will receive an exclusive worldwide license to develop and commercialize XL281 and will be responsible for funding all future development. Exelixis is eligible for development and regulatory milestones of as much as $315 million, sales performance milestones of as much as $150 million and double-digit royalties on worldwide sales of XL281.

“For nearly a decade, the foundation for our close collaborations with Exelixis has been a commitment to discover and develop new medicines to help patients prevail over serious disease,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, R&D at BMS. “XL184 and XL281 represent significant new opportunities to inhibit the progression of many different tumor types. This agreement represents the next pearl in our on-going String of Pearls initiative, designed to accelerate our company’s strategy to transform into a biopharma leader by blending external scientific innovation with our own internal research and development expertise. Together with Exelixis, we intend to fully explore how these compounds can potentially extend the treatment options of patients with cancer."

“There have been many attempts to blend the best of big pharma with the best of biotech, and over the years Exelixis and BMS have learned how to do just that. This new collaboration maximizes the capabilities and strengths of each partner and sets the stage for the aggressive development of XL184 and XL281. The collaboration provides the development programs with appropriate resources and positions both compounds to be developed to their full potential in indications with significant commercial potential,” said George Scangos, president and chief executive officer of Exelixis.

Elan Corp. will realign itself to focus more resources on its pipeline. Concrete plans have not been released, but the company plans to cut a number of positions and "additional refinement to Elan’s commercial activities in Tysabri for Crohn’s disease," according to a company statement. Elan will close its offices in New York and Tokyo during the 1Q09.

Elan's chief executive officer Kelly Martin said that the changes have been under evaluation for several months, remarking, “We continually evaluate our pipeline, product portfolio, and company structure with a goal of maintaining our flexibility and ability to invest in the most valuable product opportunities for patients while driving value for our shareholders.”

Elan president Carlos V. Paya, M.D., Ph.D., said that Elan will shift its effort from what is a traditional sales commercial model to a model based on clinical support and education. He added, “We will continue providing the appropriate clinical information and scientific data to support the key gastroenterologist relationships we have established in the U.S. Elan continues to believe Tysabri is an important therapeutic option for patients with moderately to severely active Crohn’s disease for whom conventional CD therapies and anti-TNFs are not viable.”

Hovione has agreed to acquire Pfizer's Loughbeg Active Pharmaceutical Ingredients (API) site in Cork, Ireland. This site manufactures intermediates for Lipitor's API. The deal is scheduled to be completed by early April 2009. Hovione Cork will employ 70-80 staff. During the next two years, Hovione will transfer in products from its Loures, Portugal site and validate processes for new compounds in expectation of drug approval. The terms of the transaction were not disclosed but Hovione will continue to provide manufacturing services for Pfizer.

The plant is multi-purpose and is able to address a large number of specialized chemistries such as hydrogenation and low temperature chemistry. The Cork site also provides Hovione with a new, $85 million capability to produce spray-dried formulations.

The site has had a number of owners, starting in 1984 with Angus Fine Chemicals, then Hickson & Welch, Warner Lambert, Pfizer and now Hovione. In the last 10 years Pfizer has invested several hundred million dollars in plant and equipment there, making it a modern, well equipped site, meeting the highest standards in the industry, according to a Hovione statement.

"We made clinical trial materials for more than 40 drug candidates last year. We have been investing heavily in R&D for more than six years and now have a strong development pipeline but have not invested in manufacturing assets since 2001, so it was time that we expanded our manufacturing capacity," said said Miguel Calado, Hovione's chief financial officer. "This site offers everything that our customers might want: large scale capacity, the highest standards, in a location where tax benefits are available to them and a well trained, innovative workforce."

Discussing the decision to invest in Ireland when many analysts point to China as the trend of the future, Hovione chief executive officer Guy Villax remarked, "We have been manufacturing in China for over 25 years — we know very well what China can do for the Pharma industry, but we also know what it can't do — and it is for those reasons that we are now in Cork. The Cork site, the New Jersey Technology Transfer Centre, Loures in Portugal and Taizhou and Macau in China now provide Hovione with the right range of capabilities in the correct geographies - every site meets FDA requirements for APIs but every site is suited to a different and well defined mission."

Joern Aldag will resign from his position as president & chief executive officer of Evotec, effective December 31, 2008. Dr. Mario Polywka, chief operating officer, and Dr. Klaus Maleck, chief financial officer, will jointly lead the Company until a permanent successor is announced.

Dr. Flemming Ornskov, Evotec's chairman, said, "During his 11-year tenure, Joern Aldag played a pivotal role in the transformation of Evotec from a technology provider to an integrated, CNS-focused biopharmaceutical company. Today the company has a very strong financial position and a deep preclinical and clinical pipeline of CNS drug candidates that provide a strong basis for future success. On behalf of the Evotec board, I would like to thank Joern Aldag for his effective and very successful leadership of the Company and we wish him ongoing success for his future endeavors."

Helsinn Birex Pharmaceuticals, Helsinn's drug product manufacturing facility in Dublin, Ireland, recently obtained authorization for Manufacture of Investigational Medicinal Products (IMP) for products for human use from the Irish Medicines Board according to EU Directive 2001/20/EC.

The IMP licence enables Helsinn Birex Pharmaceuticals to package, test, store and release of material for use in clinical trials. "Having this authorization expands the range of development activities we can manage within the company and can offer as a service to our partners and confirms again the company's advanced quality systems and technical capabilities," said Helsinn's chief operations officer, Dr. Giorgio Calderari.

Since 2007 the company has invested in packaging and labelling equipment and facilities to enable it to do both primary and secondary packaging of such products. In the future these activities can be managed directly by Helsinn, giving the company better cost control and ability to react to last-minute changes, according to a company statement.

The first packaging run has been completed for a study involving the Groups lead compound Palonosetron (ALOXI, ONICIT). Obtaining the IMP licence, follows on from the successful inspection of Helsinn Birex Pharmaceuticals by the FDA earlier this year.

Almac Clinical Services completed a successful inspection of its Durham, NC operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This marked the final inspection covering the group’s main sites for clinical supplies and follows inspections performed at the Craigavon, UK and Audubon, PA facilities within the last four months.

The voluntary inspection, which occurred in November 2008, observed that the Durham site was fully compliant with EU GMPs, with no critical or major failures noted, according to an Almac statement.

Paul O’Connor, vice president, quality at Almac Clinical Services, commented, “The inspection at our Durham site is the third and final outcome in demonstrating global GMP compliance for Almac Clinical Services. Once again we have proven our company-wide attitude towards a total quality ethos and this has been reflected in the results of the recent inspections. I would like to thank all of our staff for their hard work towards achieving this success.”

Robert Dunlop, the group's president, added, “Congratulations to all staff across our three sites who have put significant effort into the design and implementation of our quality systems. This result gives our client base an assurance of high standards and consistency across all of our operational sites. Quality is one of Almac’s core values and we use the strength of our systems, facilities and people to differentiate ourselves in the marketplace.”

Patheon has opened its new U.S. headquarters and analytical lab facilities in the vicinity of Research Triangle Park (RTP), NC. The new pharmaceutical development laboratory will support Patheon's current U.S.-based pharmaceutical development operations in Cincinnati and will initially offer stability studies, validation testing and analytical chemistry services.

Wes Wheeler, chief executive officer and president of Patheon Inc., remarked, "North Carolina is a rapidly growing center for the pharmaceutical industry, which now boasts 334 biotechnology-related companies. It is a pro-business community which combines attractive corporate incentives with a high quality of life for our employees. We are delighted to open our new U.S. headquarters and our new laboratory here, in the vicinity of Research Triangle Park."

The company recently announced that JLL Patheon Holdings, a holding company of private equity investors JLL Partners, is considering a bid to take Patheon private.

Valeant Pharmaceuticals has signed a definitive agreement to acquire Dow Pharmaceutical Sciences (DPS), Inc. According to a Valeant statement, the transaction will boost Valeant's dermatology franchise in the U.S. through the acquisition of a specialized dermatology R&D organization, including a newly approved product and a robust pipeline of five dermatology products, three of which are in Phase II clinical development.

Valeant will pay Dow $285 million, subject to certain closing adjustments. Approximately $8 million in cash will be retained from current Dow accounts, making the net amount paid $277 million. In addition, there are commercialization milestones that may ultimately raise the price of the acquisition. DPS' current annualized revenues are approximately $45 million, of which approximately $20 million represents royalty payments from products already out-licensed by DPS.

DPS recently received approval from the FDA for Acanya, a novel topical prescription medication indicated for the treatment of mild to moderate acne. Acanya is expected to be launched in the U.S. in early 2009. Dow has products in clinical development for the treatment of rosacea, moderate to severe acne, fungal infections and common warts. Valeant anticipates at least one DPS product will enter Phase III in 2009, with a product launch possible by 2012. In addition, DPS operates a topical products services business dedicated to working with external sponsors for the formulation and development of topical therapies.

"This acquisition grows our scale and capabilities in dermatology, thus solidifying Valeant's future as a leading company in the development and commercialization of dermatology medications," stated J. Michael Pearson, chairman and chief executive officer of Valeant. "Gordon Dow, the founder of Dow Pharmaceutical Sciences, and his team are highly regarded with innovative formulation and development expertise, exemplified by having worked on 10 dermatology approvals from the FDA in the past few years and with projects underway in eight of the top 10 dermatology diagnoses. We are excited that they will be joining the Valeant team as we believe the synergies between our newly acquired Coria franchise and Dow's business will provide sustainable growth for many years to come."

Merck Serono, a division of Merck KGaA, has received marketing authorization from the European Commission for Kuvan for the treatment of hyperphenylalaninemia (HPA) in phenylketonuria (PKU) or BH4 deficient patients. Kuvan, which had previously received Orphan Medicinal Product designation from the European Medicines Evaluation Agency (EMEA), is the first drug approved in Europe for HPA due to PKU or BH4 deficiency.

"To date, there has been no drug treatment available in Europe for patients suffering from PKU, a debilitating inherited condition that can cause serious brain damage in children and transient to lasting impairments in adults if a strict diet is not observed throughout life," said Roberto Gradnik, executive vice president Commercial Europe at Merck Serono. "With the approval of Kuvan, Merck Serono provides patients access to an efficient treatment to better control their blood phenylalanine levels. This will contribute to improving their quality of life and may ultimately reduce the risk of lasting mental impairment."

There are approximately 35,000 patients diagnosed with hyperphenylalaninemia due to PKU or BH4 deficiency in the EU. PKU and BH4 deficiency are rare diseases caused by genetic defects in the metabolism of the amino acid phenylalanine (PKU), or in the enzymes responsible for the recycling and synthesis of the cofactor BH4 (BH4 deficiency), resulting in hyperphenylalaninemia, i.e. abnormally high levels of phenylalanine in the blood. Hyperphenylalaninemia can cause serious brain damage in infants and children, and transient to lasting neurocognitive impairment in adult patients.

Previously, the only therapy option for PKU patients in Europe to manage their disease was through a diet highly restricted in phenylalanine (food with high levels of phenylalanine include meat, fish, nuts, dairy products and some vegetable and fruits) associated with daily amino-acid supplementation. Non-adherence to the restrictive diet and adequate control of blood phenylalanine levels can result in a decline in mental and behavioral performance.

The marketing authorization is supported by data from two international, double-blind, randomized, placebo-controlled Phase III clinical trials in patients with hyperphenylalaninemia due to PKU. The data show that treatment with Kuvan reduces blood phenylalanine levels and increases the proportion of patients with blood phenylalanine levels within target range, resulting in a higher dietary phenylalanine tolerance, which may reduce the need to limit phenylalanine intake in patients' diet.

As an Orphan Medicinal Product and the first drug approved for the treatment of HPA, Kuvan will receive 10 years of data protection in the European Union for this therapeutic indication. Launch of Kuvan in Europe is expected to start in the first half of 2009.

Parexel International has established an alliance with Safe Implementation of Treatments in Stroke (SITS) International, the world's largest network of clinical sites with specialized capabilities in the area of stroke. Through this alliance, Parexel's clients can benefit from SITS' access to investigator sites that are dedicated to the treatment of patients suffering from acute stroke and to the conduct of Phase II - IV stroke-related clinical studies.

"In joining forces with Parexel, SITS looks forward to furthering the growing field of stroke research and speeding the introduction of important treatments to patients," said Nils Wahlgren, M.D., Ph.D., chairman of SITS International. "We look forward to working with Parexel to implement stroke programs throughout our expanding network of sites." The SITS network currently comprises more than 800 investigator sites in 40 countries.

Said Mark A. Goldberg, M.D., chief operating officer, Parexel, "Our alliance with SITS is representative of our dedication to providing clients with expanded capabilities in the area of stroke, including accelerated study start-up and patient recruitment for clinical development programs. We are pleased to combine our in-depth central nervous system therapeutic area expertise with the highly specialized capabilities of SITS to help clients execute stroke-related studies more efficiently on a global basis."

Ben Venue Laboratories has received the 2008 Governor's Award for Outstanding Achievement in Environmental Stewardship. Presented by  Governor Ted Strickland (D-OH) and the State of Ohio Environmental Protection Agency, the award recognizes Ben Venue for its environmental, health and safety management system that "strives to promote a safe and healthy manufacturing environment, including brownfield reuse and re-development, LEED (Leadership in Energy and Environmental Design) construction design and application for Silver Certification for its recently completed 90,000 square foot Lab and Office facility, recycling and reuse, energy saving, and water conservation," according to a BV statement.

Coordinated by Ohio's EPA, the award seeks to acknowledge Ohio businesses and organizations demonstrating a commitment to go above and beyond compliance, maintain aggressive environmental performance goals, and provide a process for communicating with others about program activities and progress toward established goals.

Submitted nominations were rated and the Ohio EPA completed site audits with the finalists to select eight honorees. "I'm honored to recognize these forward-thinking award winners, which have all demonstrated cutting-edge achievements and a commitment to environmental stewardship in Ohio," said Ohio EPA director Chris Korleski in a press release issued by the Governor's office.

Roche has dosed the first patient in a Phase I pharmacokinetic trial with a subcutaneous formulation using Halozyme Therapeutics' Enhanze Technology of a biologic directed to a Roche exclusive target. This has triggered a milestone payment under the collaboration agreement between the two companies.

Roche has also selected an additional exclusive target under the existing license and collaboration agreement. Roche will pay Halozyme for exclusive, global rights for the application of its hyaluronidase enzyme, rHuPH20, to a fourth biologic target selected by Roche.

"Roche and Halozyme have successfully completed the necessary drug product formulation and preclinical studies required to initiate a clinical trial. Entering the clinic is a significant achievement and demonstrates Roche's strong commitment to a successful partnership," said Jonathan Lim, M.D., Halozyme's president and chief executive officer. "We are very pleased with the progress that is being made through our collaboration. Roche is a global leader in the development of biologics and we are excited that they have selected a fourth exclusive target, in addition to the three already under development, further validating Halozyme's core technology."

Roche has also maintained its rights to other targets covered in the license and collaboration agreement. An aggregate payment of $10.25 million will be made to Halozyme for commencing a Phase I clinical trial, exercising exclusive global rights to a fourth biologic target and for annual maintenance fees.

In addition, Halozyme has entered into a supply agreement with Roche to provide rHuPH20 for use in formulations with biologics directed against Roche targets covered under the licensing and collaboration agreement. Halozyme is continuing scale-up of its manufacturing processes to enhance yields and efficiencies in order to produce multi-kilogram quantities of enzyme. Halozyme will supply rHuPH20 to Roche to fulfill all of its clinical development and commercialization requirements.

Bristol-Myers Squibb and AstraZeneca have expanded their worldwide collaboration to include the development and commercialization of dapagliflozin in Japan. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in Phase III clinical trials in several countries, including the U.S., to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.

BMS and AZ entered into a global R&D and commercialization collaboration in January 2007, but it excluded Japan. The companies now have agreed to co-develop dapagliflozin in Japan with AZ covering operational and cost responsibility for all development and regulatory activities on behalf of the collaboration. The two companies will jointly market the product in Japan, sharing all commercialization expenses and activities and splitting profits/losses equally. BMS will manufacture dapagliflozin and also book sales. Dapagliflozin is currently being studied in Phase II clinical trials in that market.

“BMS and AZ have been working together to develop dapagliflozin for type 2 diabetes for nearly two years; this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship,” said Lamberto Andreotti, executive vice president and chief operating officer, BMS. “Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than six million people in Japan living with type 2 diabetes.”

“Last year, the cost of treating and preventing type 2 diabetes and its complications in Japan was more than $18.4 billion, which is a significant cost to Japanese society,” said Bruno Angelici, executive vice president, International Sales and Marketing Organization, AZ. “We have a long-standing presence in Japan, and our agreement with BMS to bring a potentially important type 2 diabetes treatment to market in the region will not only help reduce this cost burden, but also reduce the impact this disease has on the country’s health.”

BioMerieux has acquired PML Microbiologicals Inc., a provider of culture media and microbiological products in North America, for nearly $30 million. PML has manufacturing and marketing teams based in Portland, OR and Toronto, Canada.

The acquisition will enable bioMerieux to become a leading provider in the U.S. of microbiology testing solutions for pharmaceutical companies, according to a company statement. In addition, bioMerieux will enter the North American clinical prepared culture media (PPM) market, becoming the top PPM provider for clinical applications in Canada.

Founded in 1969, PML has 205 employees with 2007 sales of $24 million. BioMerieux purchased all of PML's shares from the privately held Pelican Life Sciences Group for $29.6 million. PML has an range of products for use in the clinical and pharmaceutical industries, holding proprietary technologies for innovative culture media. PML specializes in reagents, including prepared culture media for sterility testing and environmental monitoring, as well as control organisms, which are complementary to bioMerieux's offering.

"This new acquisition, our sixth in two years, reinforces the North American market position of bioMerieux's core business, microbiology," declared Stephane Bancel, bioMerieux's chief executive officer. "In the current challenging economic context, we are pleased to add another reagent-only business to our portfolio that will boost bioMerieux's recurring sales."

"The PML acquisition brings to our customers in the pharmaceutical industry an enhanced range of high performance, innovative solutions for the control of their manufacturing environment and products," added Alexandre Merieux, corporate vice president, Industrial Microbiology.

Nigel McBean has been named vice president and director of operations at IndiPharm's operational headquarters in Mumbai, India. Mr. McBean will be responsible for all operational activities, including identification and recruitment of investigators and clinical research sites, regulatory approvals, project and site management, monitoring, and pharmacovigilance. He will be based in Mumbai and will be responsible for expanding and managing the staff for the India-based operations.
    
Mr. McBean has experience managing clinical research projects in Asia and the Pacific, ranging in size from 20 patient single-center studies to 5000 plus patient global studies.  He has managed global clinical projects in North and South America, Africa, the Middle East and Europe across multiple therapeutic areas including infectious diseases, oncology, cardiovascular, dermatology, urology and immunology.  
    
Mr. McBean was previously the director of Multi-Centre Research for PRACS Institute Ltd. (now part of the Cetero Research Group), where he implemented an electronic clinical management system to support projects from inception to final clinical report.  He also developed a clinical database that evaluates potential sites based on investigator details and experience, the facilities and staff, local regulatory turnaround time, recruitment performance, patient demographics, and site availability.  
     
James A. Bannon, IndiPharm’s chairman of the board said, “Western clients will benefit from Nigel’s global clinical trial management experience and his direct leadership of our Indian operations in meeting the project timelines, quality standards and regulatory expectations.”  The foundation of the Indian operations is the Indian Investigator Network (IIN), which will be managed by Mr. McBean.  The IIN is a network of clinical investigators with extensive experience in multinational clinical trials in a wide range of therapeutic areas.
 

K. Peony Yu, M.D., has been named vice president, clinical development at FibroGen. Dr. Yu has expertise in design and execution of all phases of clinical development programs, including clinical and regulatory strategy, interactions with regulatory authorities in the U.S. and EU, as well as experience with successful leadership of clinical teams.

Dr. Yu was most recently vice president, clinical research, at Anesiva, Inc., where she was responsible for management of clinical research, statistics/data management, clinical operations, and medical affairs/medical information for all clinical programs, including the late-stage clinical development and approval of Zingo, a drug-device combination for pain management. Prior to Anesiva, Dr. Yu was director, clinical development, at ALZA Corp. (a subsidiary of Johnson & Johnson) where she was global clinical lead for IONSYS, a drug-device combination for post-operative pain, and led a successful NDA resubmission with the FDA and multiple interactions with European regulatory authorities resulting in marketing approval in 25 European countries. Prior to ALZA, Dr. Yu held previous posts at Pain Therapeutics, Inc. and Elan Pharmaceuticals.

“Peony’s experience in leading multifunctional clinical teams with proven success in advancing investigational products through all stages of clinical development through regulatory approval will be an important asset to FibroGen,” said Frank H. Valone, M.D., chief medical officer of FibroGen. “We look forward to her leadership of our multiple clinical programs in the U.S. and globally.”

Orexigen Therapeutics will cut several programs in order to focus on its obesity drugs, Contrave and Empatic. Proof-of-concept Phase II trials for OREX-003 (zonisamide and olanzapine to mitigate antipsychotic-associated weight gain) and OREX-004 (fluoxetine and naltrexone to reduce symptoms of obsessive-compulsive disorder) have been discontinued. The company will hold onto its intellectual property in these assets and retains the option to restart both programs.

Orexigen is directing all of its efforts and resources to Contrave and Empatic, its obesity product candidates. It anticipates announcing the results from the first Phase III clinical trial for Contrave in January.

Dr. Gary Tollefson has resigned as director, president and chief executive officer, to focus on his continued recovery from a previously disclosed diagnosis of acute leukemia. Chief business officer Anthony McKinney and vice president of neuroscience Frank Bymaster have left Orexigen pursue other opportunities. Dr. Michael Cowley will step down from his role as chief scientific officer, but will consult for the company.

"While our balance sheet remains strong, the company recognizes the challenges of the current economic environment and the need to focus our resources on our late-stage obesity programs," said Eckard Weber, M.D., the company's interim president and chief executive officer and executive chairman. "I would like to thank Gary, along with the other members of the departing group, for their extensive contributions to Orexigen. We believe we are in a very favorable position largely as a result of their efforts."

Elaine Taylor has been named director of research services at Camargo Pharmaceutical Services. Ms. Taylor will perform all scientific research writing activities and provide full life-cycle support from clinical study protocols through regulatory submission and post approval activities.

Ms. Taylor joins Camargo with more than 20 years of experience in the pharmaceutical industry and research expertise in analytical chemistry, products research, pharmacology, toxicology and clinical studies (Phase I-IV). Her background also includes a thorough understanding of regulatory affairs and requirements of the FDA, European and Canadian authorities.

Prior to joining Camargo, Ms. Taylor held numerous positions at Proctor & Gamble, most recently as the senior medical writer with responsibilities of preparing and writing a variety of documents for Phase I-IV clinical studies.

MedImmune has initiated a Phase II clinical trial in patients with chronic asthma to determine the safety of subcutaneous dosing of MEDI-563 a humanized monoclonal antibody (MAb) that targets the interleukin-5 receptor (IL-5R). Preclinical data suggest that inhibiting the IL-5R pathway may lead to a targeted approach for treating patients with asthma, supporting continued study of this antibody, according to the company.

MEDI-563, which was generated using BioWa's POTELLIGENT Technology platform, has previously been investigated in a Phase I open-label dose-escalating study to evaluate the safety and tolerability of a single intravenous infusion in adults with mild-to-moderate asthma. Data from the completed study demonstrated that the antibody was well-tolerated with biologic activity producing substantial and prolonged depletion of blood eosinophils, thus supporting its continued development.

The antibody is also currently being evaluated in a double-blind, placebo-controlled Phase I study to evaluate the safety and tolerability and effects of the antibody on airway eosinophils in adults with asthma.

"Asthma can be a very debilitating disease, and despite current therapies, patients are in need of novel treatment options," said Nestor Molfino, M.D., vice president, clinical development, pulmonary disease. "Some asthmatics may show an increased circulation of eosinophils in blood -- a certain type of white blood cell believed to play a critical role in the severity and disease pathway of asthma; therefore administration of this antibody may increase asthma control."

Dr. Shoibal Mukherjee has been named senior vice president – Clinical Development, at GVK Biosciences Pvt. Ltd. William Harel, Ph.D. has been named vice president – Business Development, West Coast USA.

Prior to joining GVK BIO, Dr. Mukherjee served in Ranbaxy and Pfizer in senior positions. He graduated as a physician and is an M.D. and D.M. in Pharmacology. Professionally trained in clinical and pharmaceutical medicine, Dr. Mukherjee has experience in managing clinical trials, medical affairs, clinical data management, and clinical pharmacology. He is the founding president of the Indian Society for Clinical Research and a member of several committees.

“Expanding and enriching our leadership team is critical for GVK BIO’s vision of being a leading life-sciences services company," said D. S. Brar, chairman of GVK BIO. "Dr. Shoibal Mukherjee has extensive experience in managing global clinical trials and will play a pivotal role in the growth of the company’s Development services."

Dr. Harel is responsible for developing the business of clinical research in the U.S. and globally.  He  has more than 20 years of experience in various companies, including Chiron Corp., AAIPharma and Neeman Medical International.

Isogen, a contract development and manufacturing organization for sterile filling, is launching its new facility in Delaware on January 21. The company will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical lab services and pharmaceutical engineering consulting. The Phase I facility will accommodate GMP vial and syringe filling, ranging in fill size up to 4,000 units per shift in fully segregated, isolator-based fill lines in a potent capable facility. The company plans to add to its isolator-based lyophilization capacity later in 2009. According to the company, the facility will enable customers to plan and execute the supply of integrated sterile clinical and small scale commercial launches of single or multiple therapeutics at the same time, while reducing costs and risks associated with other in-house and outsourced alternatives.
   
“Isogen’s facility launch will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply,” said Les Edwards, chief executive officer, Isogen. “Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with current Good Manufacturing Practice (cGMP) standards. At the same time many new pipeline drugs moving into clinical trials require Isogen’s unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards,” Mr. Edwards concluded.

PRA International has entered an agreement with Frontage Laboratories, Inc., enabling PRA Early Development Services’ U.S. Clinical Pharmacology Center to offer full analytical lab testing services to its Phase I – IV trial services in North America.  
   
Under the collaboration agreement, Frontage Laboratories will offer specialized cGMP/GLP compliant bioanalytical services through PRA. Services also include pharmacokinetic and biostatistical consultancy and data support, including data management, biostatistical and PK/PD analysis, and ICH-compliant report writing. Frontage operates a bioanalytical and biomarker research center in Malvern, PA.  
   
PRA’s facility near Kansas City, MO, runs Phase I and Phase IIa studies with a focus on first in human studies and other complex PK studies. Adding bioanalytical testing services aligns the clinical and lab processes in an effort to save time by avoiding clinical trial delays.
   
Dr. Wim Tamminga, senior director, PRA Early Development Services commented, “We selected Frontage Laboratories as part of our strategy to offer clients a seamless package consisting of clinical and laboratory services. This service allows us to accelerate Phase I studies and to give sponsors the ability to make better decisions earlier in the drug development process. Frontage is the right partner for this collaboration because they are already a well-established provider of cGMP/GLP compliant testing services. Quality of service, location, and scientific knowledge are what make Frontage Laboratories the best collaborative partner for our bioanalytical services.”
   
Song Li, chief executive officer, Frontage Laboratories said, “We are delighted that PRA chose Frontage Laboratories to assist in delivering service excellence to all clients and customers across the United States. Our scientific team is recognized industry wide for their expertise in solving complex bioanalytical method development issues quickly and cost effectively, allowing our clients to advance to Phase I studies faster. We look forward to building a collaborative relationship with PRA that not only streamlines project execution but also places a strong emphasis on project management.”

Thomas Davidson, Ph.D., has been appointed director of toxicology and pharmacology, Ricerca. Dr. Davidson is responsible for the company's study directors, peer review of toxicological reports and ensuring on-time delivery of these reports.
   
Prior to joining the company, Dr. Davidson was the director of toxicology at Enzon Pharmaceuticals, Inc. in Piscataway, NJ.  Prior to Enzon, he served as executive director of drug safety evaluation at Bristol-Myers Squibb in New Brunswick, NJ.  Dr. Davidson also held previous roles as the director, associate director and group leader for the department of biologics evaluation at BMS in Syracuse, NY.
    
“Tom has an extensive background in conducting toxicology and pharmacology studies which will benefit our clients,” said Ian Lennox, chairman and chief executive officer, Ricerca. "Tom Davidson’s addition to Ricerca as director of toxicology represents a significant milestone in our continued growth of toxicology as an essential element of Ricerca's strategy and continued success in meeting or exceeding our clients’ expectations of advancing their preclinical compounds with timely and high quality toxicology study results."

WuXi PharmaTech (Cayman) Inc. will discontinue its U.S. biologics manufacturing operations at its Philadelphia facility as of December 31, 2008, resulting in the elimination of approximately 100 positions. The company plans to expand biologics testing, cell banking and cell therapy services at the facility.
   
WuXi anticipates biologics manufacturing revenues will be less than 4% of total expected annual revenue in 2008. In 2009, the company expects cost savings of approximately $10 million as a result of the discontinued operations.
   
Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech, said, "WuXi has been fortunate, even in current market conditions, to continue to experience rapid growth in our global business. This growth reflects our reputation for providing high-quality laboratory services to our clients in a cost-efficient manner. With our continued focus on growth and profitability, we are moving to mitigate operating risks in our biologics manufacturing operations, all of which are based in Philadelphia, and are shifting our Philadelphia-based resources to biologics testing and laboratory services, which continue to show strong customer demand. Our biologics testing, cell banking and cell therapy operations in Philadelphia and our St. Paul and Atlanta operations will be unaffected by these actions."

Sparta Systems, Inc. has added two software industry veterans to drive global expansion efforts. Tom Dalle-Molle, vice president of North American sales, and Nathan Birtle, vice president of EMEA and APAC sales, will use their enterprise solutions expertise to lead worldwide sales and support for the company’s TrackWise enterprise quality management software.

Prior to joining the company, Mr. Dalle-Molle was vice president of sales for SAP’s Consumer Products Group. Before SAP, Mr. Dalle-Molle was instrumental in building PeopleSoft from a $500 million to a $6 billion company, working in roles such as managing director for the Northeast and general manager of the global accounts business. Mr. Dalle-Molle has more than 30 years of experience in the software industry, having held key positions in sales and marketing at companies such as Primavera and Control Point Solutions.

Mr. Birtle previously served as the European sales director for Zoomix, an enterprise master data management provider. Prior to Zoomix, Mr. Birtle held various executive, sales and marketing positions at Arbortext, IBMUK, and Tivoli Systems.

“As the market leader in enterprise-class quality management, the industry looks to Sparta to produce innovative solutions that drive efficiency and compliance efforts across the global supply chain,” said James E. McGowan, president and chief executive officer, Sparta Systems. “With this in mind, we’ve strategically appointed Tom and Nathan, two stellar software executives, to lead our worldwide sales efforts. The experience these veterans bring to Sparta will position the company for future growth as we continue to address the global quality management and compliance needs of companies around the world.”

NextPharma received a successful FDA Inspection at its Waltrop site in Germany. The inspection covered the company's product development services activities, including technology transfer, analytical method validation and stability testing, and contract manufacturing services, including facility qualification and process validation.
   
The two-part investigation included pre-approval assessment of data/records against the regulatory submission and compliance of the Quality Management System with the FDA six GMP systems. The inspection also confirmed that the approach to facility qualification and risk management was satisfactory.
   
Bill Wedlake, chief executive officer, NextPharma Technologies, commented, "We are delighted to have received such a positive result at Waltrop and I’d like to commend the site team and the quality specialists who have contributed to this excellent achievement."

Paladin Labs has entered an agreement with GSK and Glaxo Group Ltd. under which Paladin will be the exclusive distributor of Dexedrine (dextroamphetamine sulfate) in Canada for three years, after which Paladin has the option to purchase all remaining rights to the product in Canada. GSK will provide certain distribution support services for an interim period. The two companies have also entered a strategic relationship whereby Paladin will have the first right to partner with GSK on a number of products that GSK may choose to license or divest in Canada. Financial terms were not disclosed.
   
Dexedrine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and in the adjunctive treatment of narcolepsy. According to IMS Canada, the ADHD market in Canada was valued at about $120 million in 2007. Dexedrine sales in 2007 were $14 million.
   
"This agreement will allow us to add to our portfolio of specialty pharmaceutical products and to build significant critical mass for our organization. Not only will we be adding close to $14 million to our top line next year, but just as importantly, we are establishing a strategic relationship with GSK for potential future transactions like this one," said Jonathan Ross Goodman, president and chief executive officer of Paladin Labs.
   
"We are very pleased to establish this preferred partner relationship with Paladin owing to their clear history of success in commercializing products like Dexedrine and their record of building win-win relationships with partners," said Paul Lucas, president and chief executive officer of GSK. "Dexedrine has a long history of efficacy and safety in improving the lives of Canadians suffering from ADHD and narcolepsy. In the very capable hands of Paladin, we are confident that it will continue to meet the needs of Canadian patients and their healthcare providers."

Lilly has withdrawn its sNDA from FDA for Cymbalta for the management of chronic pain. Lilly plans to resubmit the application in 1H09, adding recent positive data from a study in chronic osteoarthritis pain of the knee.
   
Lilly submitted the application in 2Q08 based on three clinical trials: one positive study in chronic osteoarthritis pain of the knee and two studies in chronic low back pain, one positive and one that didn't meet its primary endpoint. In discussions between Lilly and the FDA, agency reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.
   
"This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application," said John Hayes, M.D., a vice president at Lilly Research Laboratories.
   
The drug is currently FDA-approved for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.

Vical, Inc. received a $1.0 million milestone payment from Merck based on Merck's planned initiation of a Phase I trial of an investigational plasmid DNA (pDNA) cancer vaccine. The vaccine is based on Vical's DNA gene delivery technology and encodes human telomerase reverse transcriptase (hTERT), which is the subject of a separate license agreement.
   
"The breadth of applications for Vical's gene delivery technology continues to grow, and now encompasses vaccine candidates against infectious diseases and cancer, cancer immunotherapies, and gene-based angiogenesis for cardiovascular diseases," said Vijay B. Samant, Vical's president and chief executive officer. "We are pleased that our long-standing partner Merck is expanding to a second clinical-stage evaluation of our technology in the cancer area."

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