Christian Velmer has been appointed president and managing director of Wyeth Canada, effective November 17, 2008. Mr. Velmer replaces Arnout Ploos Van Amstel, who has taken a position as senior vice president and general manager, Institutional Business Unit for Wyeth.
   
"Mr. Velmer brings to his new position an extensive knowledge of pharmaceutical company management. I'm pleased to welcome him aboard and I look forward to the continued progress of the Canadian business under his leadership," said Andreas Krebs, president, Europe/Middle East/Africa and Canada, Wyeth.
   
Most recently, Mr. Velmer was senior vice president Western Europe for Merck Serono in Frankfurt, Germany where he was responsible for the management of 16 countries across Europe. Prior to joining Merck Serono, Mr. Velmer held various senior executive positions with Johnson & Johnson and Bayer in Europe, Asia Pacific and Latin America.

The FDA has granted Pfizer's Selzentry (maraviroc) full approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. Selzentry was originally granted accelerated conditional approval in August 2007 based on 24-week data from Phase III studies.  
   
The full approval is based on 48-week data from the MOTIVATE (Maraviroc Plus Optimized Therapy in Viremic Antiretrovial Treatment Experienced Patients) studies. The studies compared the safety and effectiveness of Selzentry plus optimized background therapy to placebo plus optimized background therapy in treatment-experienced CCR5-tropic HIV-1 patients.
   
Accelerated conditional approval is granted to medicines that provide a therapeutic advantage over existing treatments for serious or life-threatening diseases. The FDA grants full approval status once longer-term safety and efficacy data is established. Once full approval is granted, restrictions that apply to conditionally approved medicines are lifted.
   
“Selzentry has been on a long journey, from its initial discovery by Pfizer scientists in 2000 to this full FDA approval,” said Dr. Howard Mayer, Pfizer’s executive director, and development team leader for HIV/AIDS. “We are extremely excited with this important milestone in Selzentry’s lifecycle and the potential improvement it may bring to treatment-experienced people living with HIV/AIDS.”

Compugen Ltd. has signed a collaboration agreement with Merck KGaA, a division of Merck Serono, for CGEN-855, Compugen's novel peptide targeting the FPRL1 G-protein coupled receptor (GPCR). This peptide has demonstrated the potential to treat inflammatory diseases and other indications such as cancer, metabolism and cardiovascular diseases.
    
Under the agreement, Compugen will conduct additional research and Merck Serono has an option to exclusively license the peptide for worldwide development and commercialization.
   
“We are very proud to add Merck Serono to the growing list of leading pharma companies with which we have collaborations for the advancement of our product candidates,” said Compugen chief executive officer, Mr. Alex Kotzer. “We are also pleased to be the first Israeli biotech company that has signed an agreement with Merck Serono under the Global Enterprise Partnership program of the Chief Scientist of Israel.”

Roche and Memory Pharmaceuticals have signed a definitive merger agreement under which Roche will acquire Memory Pharmaceuticals for $50 million in cash. Memory develops drug candidates for the treatment of central nervous system (CNS) disorders such as Alzheimer's disease and schizophrenia. The company's nicotinic alpha-7 agonist drug candidates in these disease areas—currently being developed in partnership with Roche—include: R3487/MEM 3454, in Phase II trials for Alzheimer's disease and schizophrenia; and R4996/MEM 63908, in Phase I for Alzheimer's disease.
   
"Acquiring Memory Pharmaceuticals will enable Roche to secure the future development of its promising nicotinic alpha-7 agonists," said William Burns, chief executive officer, Division Roche Pharmaceuticals. "The innovative work carried out by the scientists at Memory Pharmaceuticals will be fully integrated into Roche's R&D portfolio with the aim of providing new hope for patients and caregivers affected by devastating diseases such as Alzheimer's."
   
Jonathan Fleming, chairman of the board of directors of Memory Pharmaceuticals said, "Since founding Memory Pharmaceuticals in 1998, we have focused on developing medicines that could make a real difference to the lives of CNS patients. I am proud of the progress our dedicated team has made and I am confident that Roche's capabilities and experience in the CNS field will enable our research to realize its full potential."

Abraxis BioScience, Inc. has entered into an agreement with AstraZeneca UK Ltd., under which Abraxis would re-acquire the exclusive rights to market Abraxane (paclitaxel protein-bound particles for injectable suspension) in the U.S. The agreement is subject to approval by the board of directors of Abraxis.
   
“We believe the time has come to further build our commercialization platform for Abraxane in the U.S.,” said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. “We have gained much in our collaboration with AstraZeneca and they have done a commendable job in building market share. At the same time as building our sales organization, we will be advancing the development of our pipeline of new nab™ product candidates, and will expand our program of studies to support new indications for Abraxane,” continued Dr. Soon-Shiong.
   
Abraxis has developed a clinical program in an effort to gain new indications for Abraxane as well as other product candidates using the nab technology platform. This program includes eight Phase III trials, for which five protocols have been reviewed by the FDA for study design, 65 investigator-initiated Phase II trials and 16 Phase I studies. Late stage trials for abraxane include: 1st line lung cancer, 1st line melanoma, 1st and 2nd line pancreatic cancer, 1st line ovarian cancer, and 1st line gastric.

DSM Biologics, a business unit of DSM Pharmaceutical Products, and Dutch biotechnology company Crucell N.V., have signed a commercial license agreement with Hungary-based Gedeon Richter Plc. Under the agreement, Gedeon Richter will be allowed to develop and produce certain biopharmaceuticals using the PER.C6 platform.
    
Crucell's PER.C6 technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. DSM's XD technology has been developed as a system to drive yield improvements in mammalian systems.
   
Terms of the agreement were not disclosed.

King Pharmaceuticals, Inc. has agreed to acquire Alpharma, Inc. for approximately $1.6 billion. The agreement, if approved by shareholders, will expand King's pain drug business with Alpharma's drug Kadian and pain patch Flector. Alpharma also has an experimental pain drug Embeda.
   
An FDA advisory panel recently stated that the morphine-based Embeda is somewhat less attractive to drug abusers, which the agency may require the company to claim on its label. King and partner Pain Therapeutics have a similar drug, Remoxy, pending approval. An advisory panel said Remoxy appeared less susceptible to abuse than other similar drugs such as Purdue Pharma's Oxycontin.
   
According to a company statement, King expects to achieve cost savings of $50 million to $70 million in the second full year following completion of the transaction, mainly from general and administrative cost cuts and R&D savings, as well as avoiding the expense of new sales representatives for the launch of its new pain drug.
   
In 2007 King's revenue was $2.7 billion and Alpharma's revenue was $722 million.

Bristol-Myers Squibb has exercised its option to develop and commercialize Exelixis Inc.'s IND candidate XL413, a selective inhibitor of Cdc7 targeting cancer cells. Under the terms of the collaboration agreement, BMS' selection of XL413 entitles Exelixis to a milestone payment of $20 million. In addition, Exelixis has exercised its option to co-develop and co-commercialize the drug in the U.S. Following the transfer of the development program BMS will lead all global activities. The parties will co-develop and co-commercialize XL413 in the U.S. and share those profits 50/50. Exelixis will be entitled to receive royalties on product sales outside of the U.S.
   
“To our knowledge, no other selective inhibitors of Cdc7 have advanced to this stage of preclinical development, giving XL413 the potential to become a first-in-class therapy,” said Michael M. Morrissey, Ph.D., president of R&D at Exelixis. “Our colleagues at Bristol-Myers Squibb have substantial expertise in developing and commercializing innovative cancer therapies, and we are excited to have another opportunity to work with them.”
   
“Providing innovative medicines to patients with cancer is central to our company’s mission,” said Francis Cuss, senior vice president, Discovery and Exploratory Clinical Research, BMS. “Cdc7 inhibition represents a novel approach to cancer treatment and we are pleased to add XL413 to our growing pipeline of cancer compounds, and to further expand our productive collaborations with Exelixis.”

Akorn, Inc. has entered into a five-year contract manufacturing supply  agreement with an undisclosed drug company. Akorn will be responsible for the manufacturing and supply of the ophthalmic drug product. Akorn is the ANDA holder and expects to begin supplying the product in the first half of 2009.

Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “We are very pleased to have been selected as the contract manufacturer for this ophthalmic product. The completion of this agreement represents the fifth new ophthalmic partnership in 2008 for  our contract manufacturing business. We continue to seek opportunities in ophthalmics, liquid and lyophilized injectable products in order to expand our contract pharmaceutical business segment revenues.”

The U.S. District Court for the District of New Jersey has granted AstraZeneca Pharmaceuticals' motion for a temporary restraining order (TRO) halting sales of Teva's generic Pulmicort Respules (budesonide inhaled solution). In conjunction with the order against Teva, AZ will also stop all sales of its authorized generic budesonide inhalation suspension product and take the necessary steps to comply with the Court's decision. Par Pharmaceutical is the licensed distributor for AZ's generic version of Pulmicort Respules.
   
The TRO remains in effect until further notice by the Court. This action does not impact sales of branded Pulmicort Respules.

Michael Kamarck, Ph.D., has been promoted to president, Technical Operations & Product Supply (TO&PS), Wyeth. Dr. Kamarck will be responsible for all aspects of technical operations and product supply for the company, including its Pharmaceutical, BioPharma, Vaccine, Consumer Healthcare and Nutritional units. He succeeds Charles Portwood, who has been appointed to the new role of executive vice president, TO&PS Operational Excellence. Both positions will report to Joseph Mahady, president, Wyeth Pharmaceuticals.
    
Dr. Kamarck joined the company in 2001 and successfully led the expansion of Wyeth's global biotechnology manufacturing network. Dr. Kamarck previously served as executive vice president, TO&PS where he was responsible for biotechnology and pharmaceutical operations at 13 international sites and for process development of the late-stage pipeline. Before joining Wyeth, Dr. Kamarck served as senior vice president of operations for the newly formed Bayer Biologicals.
   
"Dr. Kamarck brings strong leadership as well as superb technical and scientific skills to this critical role. He will continue the transformation of our TO&PS organization as we supply medicines of exceptional quality to our customers and patients," said Mr. Mahady.
   
Mr. Portwood joined Wyeth in 2001 as president, Global Supply Chain, Wyeth Pharmaceuticals and has guided the transformation of the TO&PS organization.
   
"Charlie has taken our TO&PS organization to a whole new level of competency and performance," said Mr. Mahady. "He has been instrumental in creating this succession plan and in building a depth of talent in the TO&PS leadership team. We are pleased he will remain an integral part of the Wyeth organization. We are counting on him to support improvement and standardization efforts across the Wyeth manufacturing network."

GlaxoSmithKline received approval from the FDA for Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta is the first oral thrombopoietin (TPO) receptor agonist therapy for the treatment of adult patients with chronic ITP.
    
Chronic ITP is a bleeding disorder marked by increased platelet destruction and/or inadequate platelet production in the blood. Promacta has been shown to stimulate cells in the bone marrow to produce platelets.
   
As a result of the approval, Ligand Pharmaceuticals will be entitled to receive a $2 million milestone payment from GSK. Ligand will also earn royalties in the range of 5%-10% on annual sales of the drug.
   
GSK also reported positive Phase II data in patients with thrombocytopenia associated with hepatitis C and initiated two Phase III trials in patients with hepatitis C in 4Q07. A Phase II study in patients with chemotherapy-induced thrombocytopenia has been completed, a Phase III study is ongoing in chronic liver disease and a Phase I study is ongoing in patients with sarcoma receiving the adriamycin and ifosfamide regimen. GSK expects an MAA submission for the long-term treatment of ITP by the end of the year.

Isogen has made the first phase launch of its contract aseptic manufacturing facility in Delaware. Isogen's 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. Isolator-based lyo-capacity is planned for later in 2009.

The company contends that its 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 dramatically reducing costs and risks that are inherently 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, Isogen's chief executive officer. "Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with cGMP standards. At the same time many new pipeline drugs moving into clinical trials require unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards."

Isogen will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical laboratory services and pharmaceutical engineering consulting. Isogen's Advanced Sterile Filling offers full product segregation and isolator-based sterile processing. The facility meets global regulatory standards and operates according to cGMP, the company assures.

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Carlos V. Paya, M.D., Ph.D., will be named president, Elan Corporation, plc on November 25, 2008. Dr. Paya will be based at Elan’s South San Francisco campus, with particular focus on and responsibility for leading the company’s scientific, clinical and medical initiatives and delivering successful results in these areas. He will also bring additional depth and executive management perspective to Elan’s strategic assessments and decisions in all areas of the company.

Kyran McLaughlin, chairman of Elan's board, said, “As an immunologist, a former vice dean of Clinical Investigation at Mayo, and as a successful industry executive, Dr. Paya has a unique set of attributes and experiences that perfectly match the opportunities and challenges facing Elan.”

Dr. Paya will lead the continued integration of Elan’s R&D teams, and all of the company’s medical, scientific and research functions will be accountable to him, including Development, Research, Clinical Relationships and the offices of the chief scientific officer and chief medical officer. The chief medical officer will also retain specific accountabilities to chief executive officer Kelly Martin, as they relate to patient safety.

Dr. Paya will also assume responsibility for Elan’s commercial and marketing functions, with a primary focus on strategic planning, marketing positioning and product life cycle management. The company’s corporate and business development responsibilities will be shared by Dr. Paya and Shane Cooke, Elan’s executive vice president and chief financial officer.

Dr. Paya joins Elan from Lilly, where he was vice president, Lilly Research Laboratories and Global Leader of the Diabetes and Endocrine Platform, responsible for the company’s insulin franchise.

Prior to Lilly, Dr. Paya had a 16-year relationship with the Mayo Clinic in Rochester, MN, which began with his acceptance into the Mayo Graduate School of Medicine in 1984 and concluded with a six-year tenure as professor of Medicine, Immunology and Pathology and vice dean of the Clinical Investigation program.

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Parexel International has opened an office in Lima, Peru to provide regulatory consulting and clinical research capabilities. With the addition of the Peru office, Parexel now has locations throughout five important biopharmaceutical centers in Latin America, which also include Argentina, Brazil, Chile, and Mexico. This expansion further strengthens the company's position as one of the largest biopharmaceutical services providers in this emerging region for clinical development, according to a company statement.

"Parexel has had a presence in Latin America since 1997, and a long-term commitment to providing clients with high quality services in the region," said Josef H. von Rickenbach, chairman and chief executive officer of Parexel. "Due to the increasing globalization of clinical research, client demand for our capabilities in Latin America has been steadily increasing, and over the last seven years Parexel has experienced double-digit growth in the region. Peru is a key growing market in Latin America, with approximately 28 million people. The opening of our Peru office marks a significant opportunity for clients to further expand their clinical development programs throughout Latin America."

Capabilities provided by Parexel's Latin American locations include regulatory advice for clinical development, as well as a broad range of services including project management, site management, data management, medical affairs, biostatistics, and bioanalysis for the conduct of Phase II-IV studies.

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ImClone Systems has received approval from the FDA to manufacture multiple products at its BB50 manufacturing facility. This approval significantly expands ImClone’s total available production volume capacity for its proprietary pipeline of novel antibodies, which are now entering late-stage clinical development.

“This multi-product FDA approval of BB50 significantly enhances ImClone’s operational flexibility as we scale up production of our robust pipeline of proprietary antibodies for the growing number of Phase II and III trials that will be commencing in the next year,” said Richard P. Crowley, senior vice president, Biopharmaceutical Operations of ImClone. “ImClone has one of the largest biologic production capacities in the world and this approval is an important milestone in our efforts to maximize the global potential of both Erbitux and our portfolio of novel fully-human antibodies, which together represents one of the deepest pipelines in oncology today.”

ImClone’s 250,000-sq.-ft. multi-suite BB50 facility received FDA approval to manufacture Erbitux in August 2007. Together with the company’s BB36 manufacturing facility, ImClone has a total production volume capacity of up to 140,000 L at its Branchburg, NJ campus. This is among the largest antibody manufacturing capacities in the biotechnology industry and is a key component of ImClone’s fully integrated operations supporting the development and commercialization of the company’s antibodies, according to an ImClone statement.

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PacificGMP has entered into a cGMP contract manufacturing agreement with Actinium Pharmaceuticals, a biopharmaceutical company developing new targeted therapies for cancer. PacificGMP will manufacture and perform fill/finish of Actinium's HuM195 monoclonal antibody for a Phase I/II clinical trial. A stability study of the final product will also be conducted. HuM195 is a monoclonal antibody that is currently being tested in a Phase I trial to treat acute myeloid leukemia.

"We are delighted to establish a partnership with Actinium Pharmaceuticals and initiate cGMP production for their new Phase I/II clinical trial," said Leigh N. Pierce, president of PacificGMP. "With our strong track record of monoclonal antibody production, this project is a perfect fit for our companies and we look forward to efficiently providing Actinium with a high quality GMP product."

"We are excited to work with PacificGMP, a company with demonstrated expertise in biopharmaceutical manufacturing. Their capabilities and ability to quickly step into this role are precisely what Actinium was looking for in a manufacturing partner," said Howard Wachtler, president and chief executive officer for Actinium.

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Rich Fante has been named president of AstraZeneca's U.S. business. Mr. Fante takes over from Tony Zook, whose role was expanded after recently being named president of MedImmune, AZ's wholly-owned biologics business. Mr. Zook is chief executive officer of AstraZeneca North America and head of global marketing.

Said Mr. Zook, "Rich brings strong leadership and a wealth of experience that is invaluable to our business and for improving patient health."

Previously, Mr. Fante served as AZ's vice president, Brand Strategy & Portfolio Operations. He led the development and execution of marketing strategies for all AZ brands in the U.S. He has held a number of leadership roles in his 13 years at AZ, including vice president-Primary Care for the gastrointestinal and respiratory franchises, including Nexium and Pulmicort Respules.

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Nancy Lurker has been named chief executive officer of PDI, Inc., a provider of contract sales and commercial services to the biopharmaceutical industry. She was also named to the board of directors.

Ms. Lurker previously served as senior vice president and chief marketing officer for Novartis Pharmaceuticals Corp., the U.S. subsidiary of Novartis AG, where she oversaw a product portfolio in multiple therapeutic areas representing multi-billion dollars in annual sales. While at Novartis she launched numerous products including Exforge, Tekturna, Reclast and Exelon Patch, as well as several marketing and productivity initiatives.

Prior to Novartis she was president and chief executive officer of ImpactRx, a privately owned company offering among its services the evaluation of the impact of pharmaceutical promotion on the prescribing behavior of the nation's highest prescribing physicians.

“I am excited to be joining PDI,” said Ms. Lurker. “PDI is a company with a long and proven heritage. I believe in its long-term future. While there are industry and company challenges, my goal will be to focus on strategies for growth and to return the company to profitability. Customer focus, sales excellence and superior service delivery will be at the top of our agenda. I look forward to working with the people of PDI and its customers as we solidify a long-term growth track.”

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The FDA plans an Accelerated Approval for Genzyme's Myozyme drug, produced at the 2000 L bioreactor scale for the treatment of Late Onset Pompe disease. According to a Genzyme statement, the two parties need to agree on the design of a post-approval verification study and the FDA must complete its review of the Risk Evaluation and Mitigation Strategy (REMS) for the product. Genzyme submitted the REMS earlier this month. The FDA has classified this submission as a major amendment to the BLA for Myozyme produced at the 2000 L scale, and has extended the PDUFA date by 90 days to February 28, 2009. Genzyme will be required to submit the final protocol for the verification study after approval.

Genzyme currently has U.S. approval to sell Myozyme produced at the 160 L bioreactor scale, and the company has been seeking clearance from the FDA for 2000 L-scale production. Genzyme submitted a separate BLA for the product using the 2000 L manufacturing process on May 30, following a determination by the FDA that Myozyme produced at the 160 L and 2000 L scales should be considered as two separate products because of comparability differences.

“We’re very pleased to have additional clarity from the FDA on what it will take for 2000 L-scale product approval,” said Genzyme’s senior vice president of Global Market Access, Alison Lawton. “The ongoing communication with the FDA has been positive, and the agency has done a substantial amount of work in a short time to facilitate approval of this product for patients.”

Myozyme is a treatment for Pompe disease, a progressive, debilitating and life-threatening inherited disorder affecting approximately 2,000 people in the U.S. As part of the accelerated approval procedure, a verification study is required to demonstrate clinical benefit of the 2000 L-scale product during the post-marketing period.

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Lilly and United Therapeutics Corp. have entered into a license and a supply agreement related to the U.S. commercialization rights for the pulmonary arterial hypertension (PAH) indication of Lilly's molecule, tadalafil. The PAH indication is currently under regulatory review in the U.S, Canada, Mexico, Japan and the EU.

United Therapeutics will make an upfront payment of $150 million to Lilly for the exclusive rights to commercialize tadalafil for PAH in the U.S., as well as for a product manufacturing and supply arrangement. Lilly will manufacture and supply tadalafil to United Therapeutics and will retain authority globally for all regulatory, development, intellectual property and manufacturing aspects of the tadalafil molecule for all potential indications. Lilly will also retain commercialization rights to tadalafil for PAH outside of the U.S. In addition, Lilly will purchase $150 million of common stock from United Therapeutics.

"United Therapeutics brings substantial expertise and passion to the treatment of patients with PAH and will be an excellent partner for this product," commented Dr. Gwen G. Krivi, Ph.D., vice president of Lilly Research Labs and global brand development platform leader for Lilly. "Their experience in this field will greatly enhance the ability to provide tadalafil for PAH, if approved, as a new therapeutic option for this very serious disease. We are also pleased to make a financial investment in a promising and profitable biotechnology company. The collaboration with United Therapeutics adds to the success of Lilly's networking strategy."

"The addition of tadalafil for PAH expands our portfolio and strengthens United Therapeutics' position in the area of cardiovascular disease," said Martine Rothblatt, Ph.D, chairman and chief executive officer of United Therapeutics. "Building upon the success of Remodulin, we are committed to addressing the unmet medical needs of patients. We also welcome the support and confidence expressed by Lilly through their financial investment in our company."

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Pfizer has launched the Regenerative Medicine research unit. According to the company, this independent unit will research the biology of stem cells and the opportunity they provide to discover and develop a new generation of regenerative medicines for major medical needs. The unit will explore the use of stem cells to develop treatments that may prevent disability, repair failing organs and treat degenerative diseases with the goal of delivering new medicinal products using cells as therapeutics.
   
Corey Goodman, Ph.D., president of Pfizer’s Biotherapeutics and Bioinnovation Center, said, “The formation of this new unit represents another key step forward in Pfizer’s commitment to be at the forefront of new approaches in biotherapeutics and bioinnovation and to expand our research efforts and expertise into emerging areas of biomedical science, like regenerative medicine, that have great potential for human health.”
   
The unit will be led by chief scientific officer Ruth McKernan, Ph.D. Dr. McKernan said, “I’m very excited to lead this new research unit. While there is still a lot to understand about how stem cells can be used therapeutically, we believe it is one of the most promising areas of scientific research.”
   
Pfizer Regenerative Medicine will operate as one of the company’s new small, independent research units aimed at bolstering the biotechnology culture and environment. The unit will be co-located in the biotech hubs of Cambridge, UK and Cambridge, MA. It is expected to expand to employ 70 researchers. According to the company, these scientists will operate in small, flexible teams, with the capability to make decisions quickly and effectively. The Cambridge UK site will focus on neural and sensory disorders. The Cambridge, MA site will focus on endocrine and cardiac research.

ADMETRx, a contract research group that provides in vitro ADME discovery support, will collaborate with Roche to advance the development of its multicriteria decision-making models applied to drug discovery.

ADMETRx chief executive officer and chief scientific officer Phil Burton, Ph.D., said, “Effectively using all the data available in a discovery program to prioritize or advance candidates with the best development potential is a significant challenge in the pharmaceutical industry. The multi-criteria decision-making methods developed by ADMETRx are intended to help Roche scientists to make these critical decisions, ultimately improving the success of candidates at each step in the development process.”

Sigma-Aldrich has entered a distribution agreement with AlphaGenix, Inc., a developer and manufacturer of products for basic and clinical life science research. Sigma-Aldrich will now be the exclusive supplier of AlphaGenix-developed antibodies and research tools for the fields of regenerative medicine and stem cell biology.
   
The new product offerings include antibodies to stem cell markers and the tools for 3-D stem cell culture systems, such as MaxGel, a human derived extracellular Matrix (ECM) and HydroMatrix, a synthetic peptide that offers the precision and control of a synthesized matrix of a highly crosslinked peptide hydrogel. Both MaxGel and HydroMatrix promote cell growth and migration and have been shown to support the proliferation and enhance function of many cell types, including neural stem cells, neurons, glia, astrocytes, fibroblasts, and keratinocytes.
   
"It is increasingly important to design cell culture assays that closely mimic the behavior of cells in living tissues," said Carl Schrott, director of marketing for regenerative medicine and research cell culture at Sigma-Aldrich. "Through this partnership, we will offer our customers new tools to grow stem cells that resemble their in vivo counterparts, and the high-quality antibodies needed to study them."

Curis, Inc. and its collaborator Genentech granted a license to Roche for rights (outside the U.S.) to GDC-0449, an oral small molecule Hedgehog pathway inhibitor. Roche, through a previous agreement with Genentech, had an option to obtain a license to commercialize certain Genentech products in non-U.S. markets.
   
“We are pleased with Roche’s exercise of its option to license ex-U.S. rights to GDC-0449 from Genentech. We believe the collaborative worldwide development activities of Genentech and Roche could greatly expand the potential value of this compound,” said Curis president and chief executive officer, Dan Passeri. “Roche brings its significant clinical development and commercialization experience to advance and market GDC-0449 outside of the U.S. We are extremely pleased with our collaborator Genentech’s progress in advancing GDC-0449 and we believe that Roche’s experience will complement Genentech’s ongoing development efforts.”
   
Genentech discovered GDC-0449 and under the collaboration agreement with Curis, was jointly validated through a series of preclinical studies. Genentech and Roche collaborate on the clinical development and commercialization of the drug. Under the terms of Curis’ collaboration agreement with Genentech, Curis is eligible to receive cash payments upon the successful achievement of certain clinical development and regulatory milestones, as well as royalties on potential sales.
   
GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech expects to initiate additional Phase II trials in advanced ovarian cancer and advanced basal cell carcinoma in the coming months.

Tony Zook has been appointed president of MedImmune. Mr. Zook was previously responsible for heading the company on an interim basis. MedImmune is the wholly owned biologics business for AstraZeneca and in addition to MedImmune, Mr. Zook is responsible for AstraZeneca's U.S. and Canadian businesses, as well as its global marketing organization.
   
"I am pleased to continue working with the leadership team here at MedImmune to advance our strategic plan to discover, develop and deliver innovative biologic treatments that can positively impact patient health," said Mr. Zook.

UPS is expanding its options for healthcare customers with the addition of a new facility in Puerto Rico. The 150,000-sq.-ft. facility, expected to open in 1Q09, will be capable of storing medical devices and sensitive and perishable pharmaceutical and biotech products, as well as expand a supply chain network for delivery throughout the world. The facility will be located in San Juan and will use the same validated technology platform employed in its U.S. and Canadian healthcare distribution centers.
   
UPS provides its Proactive Response, a 24-hour proactive monitoring service for healthcare products that notifies customers of potential delays in the supply chain, and for air freight shipments, its Temperature True, a 24-hour monitoring service that tracks as many as 21 shipment milestones to help ensure product integrity.
   
“Puerto Rico is among the leading markets for pharmaceutical and biotech product research and production worldwide,” said Jorge Castillo, UPS Puerto Rico country manager. “Our new facility will strengthen our distribution network and enrich customers’ opportunities for growth by providing greater global market access and lower cost-sourcing through the UPS network.”
   
“Our healthcare services are among the most advanced systems in the industry and as a result, UPS provides peace of mind by effectively managing customer supply chains,” said Bill Hook, vice president, global strategy, UPS Healthcare. “Our investments allow us to provide first-class service to the global pharmaceutical industry.”

Biovitrum AB and Wyeth have extended their ReFacto supply agreement through December 31, 2015. Biovitrum will continue to be the sole producer of drug substance for Wyeth for ReFacto, as well as Xyntha/ReFacto AF, the successor products, and will continue to receive royalties from Wyeth's global sales. Biovitrum's co-promotion rights in the Nordic region remain unchanged. Biovitrum's total revenues from the ReFacto business amounted to $143 million in 2007. ReFacto, Xyntha and ReFacto AF are recombinant protein drugs for hemophilia A.

"We are very pleased to be able to announce the prolongation of our long and successful collaboration with Wyeth. The agreement enables us to together provide the new improved Xyntha and ReFacto AF internationally, and to improve the lives of hemophilia patients." commented Martin Nicklasson, chief executive officer of Biovitrum. "The agreement validates our biotechnology therapeutic production capabilities and expertise."

Compass Pharma Services, though its partnership with Mactec Packaging Technologies, is offering customers Mactec's packaging machines for short-run blister packaging applications as well as its custom tooling and package design services. Mactec manufactures small-footprint blister packaging machinery for hospital unit dose and other short-run packaging applications. The two companies formed a strategic alliance in August 2007. Compass Pharma has also restructured its customer service organization and processes in an effort to provide contract pharmaceutical packaging customers with faster and more personal service for packaging projects.

"For project clarity and efficiency, our new organization means customers have a single point of contact and communication for all contract packaging jobs," said Kevin Flanagan, chief executive officer, Compass Pharma Services. "Because of this new organization, we are more responsive and agile when responding to complex or deadline-intensive tasks such as pharmaceutical blister packaging for new drug launches, stability testing or seasonal spikes in demand.

Don Wrocklage will continue to lead Compass Pharma's customer service and sales administration department. He has worked for the company and its predecessor organizations for 30 years and has expertise in contract pharmaceutical packaging engineering and has contract pharmaceutical manufacturing knowledge.

The company has appointed two new sales administrators, Joanne Sountis and John Perla. Prior to joining the company, Ms. Sountis worked as a medical assistant in an orthopedics medical practice. She is a member of the American Managed Care Pharmacy Association, American Pharmacists Association and the New Jersey Society of Health Systems Pharmacists. Mr. Perla previously worked as head of administration for a division of Ferguson Enterprises, a national distribution company.

Merck Serono recently held a cornerstone ceremony at the Merck Serono Biotech Center (MSBC), its production site in Corsiersur-Vevey, Switzerland, to mark the expansion of the site. The expansion will enable the production of greater quantities of Erbitux, in order to meet growing patient needs, as well as the production of potential future treatments in autoimmune and inflammatory diseases currently under clinical development. Erbitux, Merck Serono’s monoclonal antibody for the targeted treatment of colorectal and head and neck cancers, is currently available in around 70 countries.

“The expansion of the Merck Serono Biotech Center embodies our company’s primary commitment to bringing therapeutic innovations to patients with serious unmet medical needs,” said Elmar Schnee, general partner and board member of Merck KGaA and president of Merck Serono. “This investment will cement our company’s position as a leader in biotechnology, while contributing to the local economy with the creation of more than 200 new jobs, and its construction will create business opportunities for local companies.”

Hanns-Eberhard Erle, executive vice president Technical Operations of Merck Serono, added, “This expansion underscores our commitment to excellence at all levels and will serve as a catalyst towards our goal of becoming a responsible world leader in providing specialist therapies. Through efficient manufacturing processes to scale up the production and the use of state-of-the-art technologies, the Merck Serono Biotech Center will continue to be one of the top centers of excellence for biotechnology in the world.”

Two new dedicated production suites with 120,000 liters of bioreactor capacity, plus a state-of-the-art wastewater treatment station and a logistic center, will be added to the existing facilities by the end of 2010. After inspection by worldwide health authorities, including the EMEA and Swissmedic, the production of Erbitux is expected to start at the MSBC in 2012.

Avid Bioservices, Inc. is expanding its biomanufacturing capabilities with the installation of two Thermo Scientific HyClone Single-Use Bioreactors (SUB) at its facility in Tustin, CA. These systems enhance the company's cell culture production services. The purchase of the 1000 L SUB follows the successful evaluation of a 100 L SUB in the company’s process development labs.  
    
The HyClone bioreactors consist of a reusable stainless steel outer support container and SUB BioProcess Container (BPC) that integrates with existing bioreactor control systems, providing the advantages of single-use bioprocessing without having to install a new bioreactor system. The retrofit product replaces the stainless steel bioreactor vessel in existing bioreactor systems, making it a flexible and economic option to increase bioreactor capacity, according to the company.
   
The company plans to use the 100 L SUB to produce antibodies and recombinant proteins in multi-gram quantities for clients and will also support the scale-up work for the 1000 L S.U.B, which will be used to produce clinical material under cGMP conditions.

“The growing demand for our biomanufacturing services led us to assess a number of options for increasing our capacity while maintaining our high quality,” said Richard Richieri, senior vice president of bioprocess development and manufacturing at Avid Bioservices.  “The Thermo Scientific HyClone SUB disposable system provides a state-of-the-art cell culture production solution that is cost-effective and complements our existing bioreactor production suite.  Based on our positive evaluation of the 100 L system, we are pleased to proceed with the larger unit, making Avid the first company in southern California to install the 1000 L SUB system.”

David W. Keiser, will retire from his position as president of Alexion Pharmaceuticals by the end of this year. Mr. Keiser, a co-founder of Alexion, played a central role in the commercial launch of Soliris in the U.S. and Europe, and helped to build a broad platform for continued growth in those and other territories. He was appointed chief operating officer since 1992 and president in 2002. Mr. Keiser will remain on the board of directors through the expiration of his current term in 2009 and will be available for consultation in the future. His responsibilities will be distributed among current members of the senior management team, reporting to Leonard Bell, M.D., the company's chief executive officer.
   
Mr. Keiser joined the company shortly after it was established in 1992, as executive vice president and chief operating officer. He played a central role in managing the company's manufacturing and regulatory efforts and established commercial teams in the U.S. and Europe to support the 2007 launch of Soliris.
   
"David is a unique individual and executive and I have enjoyed working with him as Alexion built its global organization. His top-level expertise and broad experience were instrumental in our evolution from the early group of scientists into an international organization that is now able to deliver Soliris to a growing number of patients in a growing number of countries," said Dr. Bell. "Under David's leadership, we initiated the development of our world-class teams in the U.S. and Europe, and laid a strong foundation for market entry in Asia and the Pacific, the Middle East and Latin America. We are deeply grateful to his numerous, durable contributions to Alexion, and to the people and processes he has put in place to ensure our ongoing success in coming years."

BioBlocks, Inc. and outsourcing partner, MannKind Corp., will continue their lead optimization collaboration. The two companies have worked together since January 2007, and have met milestones utilizing BioBlocks' expertise in medicinal chemistry and lead optimization and Mannkind's experience with novel therapeutic modalities. According to the companies, the success of the partnership is attributed to the focus on integrating project management towards a results-based collaboration, as opposed to fee-for-service outsourcing. Financial terms were not disclosed.

Based on its progress with certain drug targets, MannKind was able to explore new mechanisms of action for a first-in-class therapeutic for an important disease indication. BioBlocks led the group to a series of potent, selective, and efficacious lead compounds over a period of 18 months. The project utilized BioBlocks' facility in Budapest, Hungary to maximize medicinal chemistry FTE resources, including sophisticated chemistries, chemical series development, and cheminformatics.
   
Qingping Zeng, associate director, medicinal chemistry and lead discovery of MannKind, said, "Our lead discovery and optimization collaboration with BioBlocks has helped us reach important milestones in our first project with them, leading to increased momentum and visibility for the initiative. We have found BioBlocks' results-oriented medicinal chemistry approach to be a very valuable asset to our drug discovery programs, and we are pleased to continue our collaboration with them."

WuXi PharmaTech has signed a new three-year, in vitro ADME collaboration agreement with Pfizer. The companies will establish ADME assays to provide in vitro screening services on compounds WuXi PharmaTech synthesizes for Pfizer. The evaluation of ADME properties is a key step in the drug discovery and development process. WuXi's goal is to provide key information for the improvement of pharmacokinetic properties of Pfizer's compounds.
   
The two companies have been involved in various collaborations, including synthetic chemistry, parallel medicinal chemistry (PMC), and ADME and bioanalytical services.
   
"This new agreement further strengthens our already productive relationship with Pfizer, one of our largest customers for many years, and it is the direct result of our research capability and firm commitment to quality and customer satisfaction," said Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech.
   
"A high quality and flexible Asia R&D partnership network is critical to Pfizer's emerging market and Asia strategy. We want to build a strong relationship with leading CROs such as WuXi PharmaTech to tap into the scientific talents and R&D capabilities in Asia," commented Dr. Steve Yang, vice president and head of Asia R&D at Pfizer.

GlaxoSmithKline and XenoPort, Inc. withdrew the NDA for Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The FDA has requested that the data in a single study be reformatted. GSK will conduct a review of other trial data sets as well. The withdrawal does not relate to the content of the filing. GSK plans to resubmit the NDA as soon as the revisions are made.
   
The resubmission delays a $23 million milestone payment to XenoPort from GSK and Astellas Pharma, associated with the acceptance of the NDA for Solzira. Solzira is a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by using high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.

ArQule, Inc. and Daiichi Sankyo Co., Ltd. have entered into two agreements forming a strategic relationship for the development and discovery of new oncology therapeutics.
   
The two companies will co-develop ARQ 197, an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase, to treat cancer. They will also advance the application of ArQule’s kinase inhibitor discovery platform (AKIP) to develop a new generation of highly selective anti-cancer kinase inhibitors. Daiichi Sankyo will pay a $75 million upfront payment to ArQule for the two agreements.
   
“We are delighted to welcome Daiichi Sankyo as a partner in our shared quest to bring innovative cancer therapeutics to patients and their physicians,” said Paolo Pucci, chief executive officer of ArQule. “With this announcement, we complete the ARQ 197 partnership process and set the stage to bring the ARQ 197 development program to the next level. We are also very pleased to broaden this relationship by welcoming Daiichi Sankyo as our first partner for ArQule’s AKIP platform.    
   
“Daiichi Sankyo looks forward to being able to collaborate with ArQule to realize differentiated and innovative approaches in the treatment of these devastating diseases,” said Takashi Shoda, president and chief executive officer of Daiichi Sankyo. “This strategic partnership is the next important milestone for Daiichi Sankyo to solidify a strong and viable pipeline in oncology.”

Bilcare Global Clinical Supplies has enhanced its ability to develop formulation dosage forms for preclinical and early-phase drugs with the addition of fluid bed granulation technology and the In-Cap capsule system.
   
The fluid bed granulation technology extends Bilcare's solid-dosage formulation capabilities. The system is equipped with Wurster coating inserts, enabling the delivery of specialized, high-precision coating processes for granules and non-pareils for the creation of sustained- and controlled-release tablet and capsule formulations.
   
The In-Cap capsule system for preclinical and early-stage development is capable of filling several thousand capsules per hour in multiple permutations. This equipment adds development and clinical manufacturing capabilities for various formulation types, including powders, pellets, tablets and liquids.
   
According to Vincent Santa Maria, president of Bilcare GCS, Americas, the addition of new technology is part of the company's capital investment program in its U.S. facilities. "With these upgrades, Bilcare GCS can now quickly produce a wider variety of drug dosage forms with high product quality at or above industry standards," he said. "These investments in R&D services further prove our commitment to being a full-service partner to our global customers."

InNexus Biotechnology has developed a new antibody product from its DXL platform technology, DXL1218 (EGFR), for the potential treatment of colorectal cancer.
   
"Recent experimental data suggests that DXL1218 (EGFR) is superior to competing commercialized products on the market, such as Erbitux, in terms of potency and efficacy," said Jeff Morhet, chief executive officer and chairman of InNexus. "I am very excited, as this latest development lends further support to the robustness and predictability of the DXL platform and the superiority of products from the platform over presently commercialized offerings."
   
Research partner, Pablo Legorreta, chief executive officer of Royalty Pharma, said, "We are quite pleased with the rapid progress of InNexus. Jeff has had a vision for rapid product development based on DXL technology coupled with advanced in vivo studies and a significant regulatory strategy. We look forward to their continued rollout of products and performance."

AMRI

3Q Revenues: $61.4 million (+29%)

3Q Earnings: $7.0 million (+250%)

YTD Revenues: $172.9 million (+19%)

YTD Earnings: $17.4 million (+78%)

Comments: Total contract revenue for the quarter was $54.1 million (+30%). Discovery Services revenue was $16.4 million (+57%). Development/Small Scale Manufacturing revenue was $14.5 million (+11%). Large Scale Manufacturing revenue was $23.2 million (+29%). Allegra royalties dropped 5% to $5.7 million. Milestone revenue from the company's licensing agreement with BMS was $1.5 million in the quarter. Earnings also include a $1.2 million adjustment to record income tax benefits from certain R&D activities.

Pfizer is discontinuing the Phase III development program for its investigational compound (CP-945,598) for weight management. CP-945,598 is a selective antagonist of the cannabinoid type 1 (CB1) receptor. The company has decided to discontinue the development program based on changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval.
   
“While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,” said Martin Mackay, president, Pfizer Global R&D. “As part of our ongoing portfolio prioritization, we will refocus research and development resources on high priority therapeutic areas that address an unmet medical need and have a high probability for success.”
   
Sanofi-Aventis is also discontinuing all trials of its obesity drug, Acomplia. According to a Sanofi-Aventis statement, the decision was made "in light of recent demands by certain national health authorities."
   
The company recently suspended sales of Acomplia in Europe following the recommendation from the EMEA to temporarily suspend sales because of risks that include depression, anxiety and stress disorders. The drug had been marketed in 18 EU countries since 2006.
   
The FDA rejected the drug last year after a panel of advisers recommended doing so, citing Acomplia's increased risk of suicidal thoughts.
   
More than 700,000 overweight and obese people around the world have been treated with Acomplia, gaining significant health benefits, according to Sanofi-Aventis. The company had been testing it for use in various types of patients including a possible treatment for cigarette smoking cessation. The drug is believed to work by blocking the same pleasure centers in the body that are stimulated when marijuana smokers get very hungry.

GlaxoSmithKline plans a 12% (or 1,800) reduction in its U.S. sales force as part of a restructuring effort. The company plans to shift some sales representatives from its pharmaceutical unit to its vaccine unit, which will result in a reduction of about 1,000 employees. That will leave it with a U.S. sales force of about 7,500 by the end of the year.
   
As part of the restructuring, the company plans to group its sales staff around specific treatment areas such as respiratory, for the asthma drug Advair and allergy medicine Veramyst, rather than geographically, as it had been organized in the past. According to GSK spokeswoman Mary Anne Rhyne, health professionals have told the company that "they want to see fewer reps but want to see people with specialized training and information."
   
According to the company, Research Triangle Park, NC will be designated as its sole U.S. headquarters. Previously, the company's site in Philadelphia shared this status. Ms. Rhyne said no significant work-force cuts would take place immediately in Philadelphia.

Patheon has opened its new headquarters for its European operations in Zug, Switzerland. The new headquarters will manage the company's commercial and pharmaceutical development services sales, marketing and customer support activities in Europe. Certain support functions — such as procurement and supply chain — will also be managed in Zug, which is near Zurich.
   
"Patheon has grown rapidly in Europe through acquisition and organic growth with sites located in France, Italy, and the UK. Thus far the sites have operated more independently, which is less than ideal for effective and harmonized communications to our clients. By moving key European managers to a regional headquarters and centralizing the key business functions for our operations across all European sites in one distinct location, Patheon will be more nimble to accelerate growth in the region, enhance profitability and ultimately better serve our clients," said Wes Wheeler, Patheon's chief executive officer and president.
   
"We are relocating key European decision-makers from our existing sites in Europe to our new European headquarters and intend to recruit positions locally. We expect to employ approximately 25 people in Zug," said Aldo Braca, president of Europe. "The quality, education-level, and accessibility of a multilingual local labor force are very high in Zug. This coupled with its efficient and business friendly administration makes it an ideal location for our European headquarters."

Kendle

3Q Revenues: $181.1 million (+27%)

3Q Earnings: $11.0 million  (+189%)

YTD Revenues: $517.3 million (+25%)

YTD Earnings: $24.4 million (+98%)

Comments: Early stage revenues were $11.2 million (+138%). Late stage revenues were $110.9 million (+19%). The acquisition of DecisionLine Clinical Research Corp. accounted for 6% of growth in the quarter. New business awards totaled a record $212 million in the quarter, (+21%). Contract cancellations totaled $38 million or 18% of sales for the quarter. Net income for 3Q07 included a charge for the write-off of deferred financing costs related to the company's term debt. Services revenues in the quarter by geographic region were as follows: North America (+50%); Europe (+37%); Latin America (+9%); Asia-Pacific (+4%).

Hospira

3Q Revenues: $925.5 million (+10%)

3Q Earnings: $81.8 million (+38%)

YTD Revenues: $2.7 billion (+9%)

YTD Earnings: $216.3 million (earnings were $60.7 million YTD07)

Comments: Revenue growth in the quarter was driven by strong sales in Specialty Injectable Pharmaceuticals as well as increased demand in Medication Management Systems product lines. Sales increased in all segments: the Americas (+10%); Europe (+10%), Middle East and Africa (EMEA) (+23%). YTD07 earnings reflect Mayne Pharma integration and other acquisition-related charges.

Enzon

3Q Revenues: $49 million (+4%)

3Q Loss: $2.0 million (earnings were $87.5 million in 3Q07)

Comments: Total product sales were $28.9 million in the quarter (+16%) driven by Oncaspar sales, up 19% to $12.5 million. Contract manufacturing revenues were $5.3 million (+40%) due to growth from additional business and timing of shipments to customers. Royalty revenues were $14.6 million (-20%) as a result of the sold portion of Peg-Intron royalties. R&D expenses increased to $15.7 million (+49%) primarily due to $1.0 million in milestones related to the LNA platform program and the increase in costs associated with manufacturing process improvements and pharmaceutical properties of Oncaspar and Adagen.

Metrics, Inc. has opened a new larger scale manufacturing facility. As part of its expansion, the company has brought online two packaging lines, two granulating rooms and three compressing rooms, including a double-sided, 45-station tablet press. This allows the company to handle batch sizes as large as 500 kilograms with a blending capacity of 46 cubic feet and a total capacity of 1 billion tablets per year.
   
The new manufacturing space is a result of the company’s recently completed $18-million, 47,000-sq.-ft. expansion that doubled the size of its facility. With the expansion, the company can now accommodate topical powders and oral liquids. Specific services include: high shear wet granulation; fluid bed drying; top spray fluid bed granulation; direct compression; direct powder fill encapsulation; Wurster coating; 48-inch pancoating; and bottle packaging. The company can also provide development-, clinical- and commercial-scale controlled substances Schedule II through V. The expansion for these services includes: four new analytical labs; stability storage; a dedicated cytotoxic and potent lab; and a new microbiology lab. The company has also brought antibiotic assay and sterility testing online to offer full microbiological support of sterile products. As part of this growth, the company is adding 50 pharmaceutical scientists and technicians.
   
“For those of us who have worked with Metrics since its beginning, it has been a long-time dream to offer a full array of services that allow clients to keep development and commercial manufacturing projects under our roof,” said Phil Hodges, president. “It’s exciting to see the dream come to life, and we hope the additional capacity makes Metrics an even more attractive partner to clients and potential clients.”

West Pharmaceutical Services

3Q Revenues: $256.2 million (+6%)

3Q Earnings: $13.3 million (+9%)

YTD Revenues: $806.3 million (+6%)

YTD Earnings: $68.3 million (+5%)

Comments: Pharmaceutical systems segment sales were $190.5 million (+10%). Favorable currency translation contributed 4.7% points of that growth. Sales of traditional vial components, metal Flip-off seals, and safety and reconstitution products grew while prefillable syringe component sales declined due to a lower demand for ESA product packaging. Tech Group segment sales were $68.3 million in the quarter (-4%). Sales in 3Q07 included $7.3 million of sales of the discontinued Exubera device and $3.7 million of packaging for an OTC product.

Stora Enso and Medixine, a health care software provider, have signed an agreement under which the two companies will partner in marketing a new electronic compliance monitoring service. This service is based on Medixine's mobile and server software and Stora Enso's Pharma DDSi intelligent packaging solution.
    
Stora Enso's packaging solution reminds patients to take their medications and records when each tablet is taken from the package. This compliance data is stored in the microchip embedded in the package and can be read with a mobile phone and transmitted automatically to a server where it is available to those responsible for the patient's care. Data collection and management are based on Medixine's software.
    
"Anti-migraine medication is one example of the future applications of this new system. Keeping a migraine diary is easy with the help of the package by simply answering questions about the symptoms. The package automatically records the amounts of drugs taken and the hours at which they were taken. All this information can easily be made available to a doctor in the form of a clear report; all the patient needs to do is touch the pharmaceutical package with his or her mobile phone," said Medixine's managing director, Dr. Tapio Jokinen.
    
"Lapses of memory and other medication errors are regrettably common when a patient is cared for in his or her own home. This puts the patient's health in jeopardy and causes unnecessary medical costs. Compliance monitoring is also needed by pharmaceutical companies to demonstrate the efficacy of their drugs. Stora Enso's Pharma DDSi package was developed to meet this demand," said Ismo Saarinen, director, Stora Enso Pharmaceutical Solutions. "The services provided by Medixine are based on state-of-the-art technology and the company's software solutions are already used in 16 countries."

Pfizer received approval from the FDA for Toviaz extended release tablets for the treatment of overactive bladder (OAB) symptoms. The once-daily drug can help regulate the involuntary contractions of the bladder associated with OAB over a period of 24 hours. These contractions cause frequent, sudden urges to urinate. Overactive bladder affects an estimated one in six Americans but remains highly undertreated, according to the company. The two doses of Toviaz, 4 mg and 8 mg, allow dosing flexibility to optimize treatment based on the individual patient response and tolerability.

     The approval is based on two Phase III studies of 1,964 OAB patients. Patients showed an 88% median reduction in urge urinary incontinence with Toviaz 8 mg versus 50% with placebo. Treatment with 8 mg reduced the number of urinations per day by as much as 19% compared to an 11% reduction with placebo. Reductions in wetting accidents were seen as early as week two of treatment and maintained over 12 weeks.

 

 

 

Halozyme Therapeutics started a Phase II study of recombinant human hyaluronidase enzyme (rHuPH20) co-formulations with Humulin R (regular insulin human injection) and with Humalog (insulin lispro) in Type 1 diabetic patients. This study is designed to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics (PK) after administration of each of four study drugs: Humulin R with and without rHuPH20 and Humalog with and without rHuPH20.

     This crossover design, single blind, open label study is designed to collect data on at least 20 patients who complete the study. The study allows for insulin dose titration and each patient will receive a minimum of four and as many as three additional study drug injections that include Humalog and Humulin R with and without rHuPH20. Study drug will be injected subcutaneously into the abdomen immediately prior to ingestion of a standardized liquid meal.

     The primary endpoint will be a PK measure of the plasma insulin concentration from zero to 60 minutes after injection. Secondary endpoints will include additional PK data, as well as blood glucose concentration at various time points. Safety data such as adverse reactions, hypoglycemia, blood chemistry, and injection site tolerability will be collected, measured and evaluated. Patients may be on study for as long as 14 weeks from screening to completion. Results from the study are expected in mid-2009.

     A Phase I euglycemic clamp study in 26 volunteer subjects who received an injection of Humulin R or Humalog with and without rHuPH20, showed that the co-injections were well tolerated and demonstrated faster insulin absorption and shorter time to peak concentration for the insulin plus enzyme combination compared to insulin alone. Metabolic effects such as glucose lowering activity for the combination of insulin plus rHuPH20 were also greater and occurred earlier than for insulin administered alone. Also, the combination of Humulin plus rHuPH20 demonstrated faster insulin absorption and a shorter time to peak concentration when compared to Humalog alone.

 

 

 

 

 

 

Cephalon, Inc., received approval from the FDA for Treanda for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. In March, Treanda received approval for the treatment of patients with chronic lymphocytic leukemia, the most common form of leukemia in the U.S.

     Indolent NHL, a subset of non-Hodgkin's lymphoma, is a slow-growing but serious cancer of the lymphatic system that is not curable with currently available treatments. Patients with indolent NHL are prone to multiple relapses after initial therapy. According to the National Cancer Institute, an estimated 30,000 people in the will be diagnosed this year with indolent NHL.

     The FDA approval is supported by a trial of 100 patients with indolent B-cell NHL who had progressed during or within six months of treatment with a regimen that included rituximab. The study demonstrated that patients had a high response rate to treatment with Treanda, and these responses to the treatment were durable. The results showed that treatment with Treanda as a single agent resulted in an overall response rate of 74%, which means that after treatment, the cancer diminished or disappeared in approximately three out of four patients. Additionally, patient response to treatment in the pivotal study lasted a median of 9.2 months and patients remained alive and their disease did not progress for a median of 9.3 months.

 

 

 

 

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