Contract Pharma news - World Wide

<a href= http://prepakholdings.com >PrePak Holdings, Inc.</a> has acquired <a href= http://www.testpak.com >TestPak,</a> a health care supply chain company based in Whippany, NJ. TestPak provides a range of contract packaging, development and logistics services to clients in the pharmaceutical, nutritional and consumer products industries, and specializes in solid-dose packaging. TestPak&rsquo;s three-site campus in NJ has approximately 90,000 sq. ft. of production and warehouse space, including 26 climate-controlled packaging suites.<br /> <br /> &ldquo;The acquisition of TestPak opens up significant new market opportunities for PrePak,&rdquo; said Renard Jackson, newly appointed chief executive officer of PrePak. &ldquo;We are excited about the TestPak group joining the PrePak family of companies. The TestPak facilities will not only create redundancy and backup services with our customer base, but also bring new innovations and capabilities to the whole organization.&rdquo;<br /> <br /> PrePak Holdings, based in Cookeville, TN, is a group of companies focused on contract manufacturing and packaging, has four additional locations in the U.S. In addition to TestPak, its subsidiaries are PrePak Systems, Celeste Contract Manufacturing, and Packaging and Integrated Pharmaceutical Packaging.<br /> <br /> <div style= text-align: center; ><a href= http://www.contractpharma.com/2010conference ><strong>Visit PrePak and TestPak at Contract Pharma's 2010 Contracting &amp; Outsourcing Conference September 23rd!</strong></a></div><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/84DyJY0Jglo height= 1 width= 1 />

<a href= http://www.clcbio.com >CLC bio</a> is expanding in both North and South America with the opening of a new location in Boston, MA and a new Government Sector Branch in the Washington, D.C. area. The new offices will house the company's sales, marketing and support operations in North and South America. As part of the expansion the company is adding new staff. <br /> <br /> &ldquo;Our customers and partners are clearly members of a global industry and we strongly believe that we need a significant presence in both North and South America in order to serve their interests,&quot; said Dan Conway, CLC bio&rsquo;s president of the Americas.<br /> <br /> Director of North American Consulting Services, Dr. Saul A. Kravitz, added, &quot;Our new office in Germantown, MD provides us with a strong base for supporting our US consulting customers, as well as our growing list of customers within the Federal Government and in the Maryland biotech sector.&quot;<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/sJJV1q9-wwU height= 1 width= 1 />

<strong>Rosemarie Truman</strong> has been named executive vice president of solutions at <a href= http://advancedclinical.com >Advanced Clinical</a>. Ms. Truman is responsible for the global growth, market and brand strategy for the company. She will work to help life sciences clients drive efficiency and effectiveness, as well as accelerate clinical trials at lower costs.<br /> <br /> &ldquo;Rosemarie provides the unique combination of expertise in strategic planning and implementation, dedicated work experience and the passion to drive innovation. She is truly an asset to the Advanced Clinical team and our clients,&rdquo; said Leo Sheridan, chief executive officer of Advanced Clinical.<br /> <br /> &ldquo;This position offers the opportunity to drive growth for Advanced Clinical and make a positive, sustainable impact on clients to help get drugs and devices to market faster for those who need them,&rdquo; said Rosemarie Truman. &ldquo;I am proud to be part of a talented team that wants to make a difference, not just for clients and the company, but also for people who really need the products that our clients are making.&rdquo; <br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/24_JdhGgiCM height= 1 width= 1 />

<a href= http://www.takeda.com >Takeda Pharmaceutical Co. Ltd.</a> has entered into an exclusive partnership to develop and commercialize Contrave (naltrexone SR/bupropion SR), <a href= http://orexigen.com >Orexigen</a>'s investigational drug for the treatment of obesity, in the U.S., Canada and Mexico. The two companies will work together on the development of the product, with Orexigen leading pre-approval activities, and Takeda leading post-approval activities. The parties will share development costs.<br /> <br /> Contrave is a combination therapy developed to address both biological and behavioral drivers of obesity. The pathways targeted by this treatment involve controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. Orexigen submitted a NDA to the FDA for Contrave in March 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.<br /> <br /> Orexigen will receive an upfront cash payment of $50 million and Takeda will have exclusive marketing rights in the U.S., Mexico and Canada, while Orexigen retains the right to co-promote in the U.S. Orexigen will be eligible to receive payments of more than $1 billion based on regulatory and sales-based milestones. If commercialized, Takeda will pay royalties on sales in the territory.<br /> <br /> &quot;Takeda is an ideal partner for Contrave given its proven track record in commercializing innovative medicines and its commitment to the treatment of obesity,&quot; said Michael Narachi, president and chief executive officer of Orexigen. &quot;We believe this is a great strategic partnership to enable our goal of a strong market entry for Contrave, if approved. It has been our belief that getting a partner involved early would be critical to a high-quality launch of Contrave, and with this partnership now in place, we are tightly focused on the regulatory review process and securing approval for Contrave.&quot;<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/39uIhPDrUGI height= 1 width= 1 />

<a href= http://www.veritastk.com/english/sales/distributors.html >Veritas Corp.</a> has entered into an agreement with to market and distribute <a href= http://www.epistem.co.uk >Epistem&rsquo;</a>s scientific research services in Japan. Epistem&rsquo;s contract research division, located in Manchester England, provides specialized preclinical and scientific research services to drug development and personal care companies in the areas of oncology, mucositis, inflammatory bowel disease, wound healing and skincare. Epistem has a customer base in western Europe and the U.S and the Veritas agreement will provide a sales and marketing presence in Japan.<br /> <br /> Epistem&rsquo;s chief executive officer, Matthew Walls, said, &ldquo;We are delighted to be working with Veritas. They have a strong scientific sales team and established distribution network. The Japanese drug development market provides us with an important opportunity for growth and the agreement with Veritas will allow us to develop closer links with existing Japanese customers.&rdquo;<br /> <br /> Sinsaku Iida, Veritas&rsquo; chief executive officer, said, &rdquo;It is our great pleasure to work with Epistem. Epistem's Contract Research Division has a strong preclinical and scientific research service capability, which will benefit Japanese pharmaceutical and personal care companies. Veritas&rsquo; sales network has the scientific experience necessary to introduce Epistem's high quality services to potential Japanese customers and will make for more efficient marketing and easier access for Japanese customers to Epistem.&ldquo;<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/R9DlXA8hkSs height= 1 width= 1 />

<a href= http://www.nextpharma.com >NextPharma</a> has expanded its microbiology facilities at its site in G&ouml;ttingen, Germany. The expansion includes the addition of three new labs equipped with modern air ventilation, laminar-flow benches and temperature-controlled incubators linked to a computerized monitoring system designed to ensure a constant temperature. <br /> <br /> The new labs will be used to develop and validate microbiological methods as well as to test non-sterile pharmaceutical products, medical devices and cosmetics for microbial purity and preservative efficiency. Additionally, the new labs can work sequentially to process samples enabling a high throughput of testing. The G&ouml;ttingen microbiology department now has the capacity to test 40,000 samples per year. Microbiological testing of sterile products will continue to be undertaken at NextPharma&rsquo;s Belgium facility.<br /> <br /> Sean Marett, managing director, NextPharma Technologies, Product Development Services, said, &ldquo;We are delighted to expand our microbiology department in G&ouml;ttingen, which will enable us to grow our Product Development Services offering in this field of expertise. We look forward to working with new and existing customers in the pharmaceutical, medical device and cosmetics markets.&rdquo;<br /> <br /> <div style= text-align: center; ><a href= http://www.contractpharma.com/2010conference ><strong>Visit NextPharma at Contract Pharma's Contracting &amp; Outsourcing Conference September 23rd!</strong></a></div><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/9xfB5hgWLhs height= 1 width= 1 />

<strong>Julie Heneghan </strong>has been appointed vice president of <a href= http://advancedclinical.com >Advanced Clinical</a>. Ms. Heneghan has more than 20 years of experience in the outsourcing and staffing solutions industry. In her new role, Ms. Heneghan is responsible for overseeing the strategic planning and direction of the Midwest and Eastern division. Ms. Heneghan&rsquo;s expertise includes developing and delivering large global solutions across all elements of outsourcing and staffing including: Consulting Services, Strategic Sourcing (CRO functional/cross-functional sourcing, Managed Services as well as Program Management), Talent Management and Technology Platforms for Services provided.<br /> <br /> &ldquo;Julie&rsquo;s extensive experience in outsourcing and staffing solutions and her ability to drive growth provides the expertise and strategic effectiveness we need for our company, our consultants and our clients. We are proud to have Julie on our leadership team,&rdquo; said Leo Sheridan, chief executive officer of Advanced Clinical.<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/i7bqg9qYXMM height= 1 width= 1 />

<a href= http://www.toxikon.com >Toxikon </a>has added the Comet Assay IV Analysis System developed by Perceptive Instruments to its genetic and molecular toxicology study offerings. This technology is used to accelerate the development of cancer-fighting drugs or for environmental monitoring, genetic toxicology platforms.<br /> <br /> Toxikon also provides a range of services from bioanalysis to chronic studies to FISH, blue and green screen assays, as well as genetic toxicology studies for premarket approval and IND submission. <br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/dmPHyM9qAsQ height= 1 width= 1 />

<a href= http://www.pfizer.com >Pfizer</a> has agreed to acquire <a href= http://www.foldrx.com >FoldRx Pharmaceuticals, Inc.</a>, a privately held drug discovery and clinical development company. Pfizer will make an upfront payment as well as milestone payments, but financial terms were not disclosed. The closing is expected later this year.<br /> <br /> FoldRx's portfolio includes clinical and preclinical programs for investigational compounds to treat diseases caused by protein misfolding, which is recognized as an underlying cause in many chronic degenerative diseases. The company's lead product candidate, tafamidis meglumine, is an oral, disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option. FoldRx has filed a MAA for tafamidis with the EMA and is currently pursuing a fast track filing in the U.S.<br /> <br /> Geno Germano, president and general manager of Pfizer Specialty Care Business Unit said, &quot;This transaction will add another important component to the growing portfolio of innovative in-line and investigational medicines for orphan and rare diseases within Pfizer's Specialty Care Business, and will complement the current and planned future research and clinical development taking place in Pfizer's Specialty Care Neuroscience disease area.&quot; <br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/oLryB2Jk614 height= 1 width= 1 />

<a href= http://archimedespharma.com >Archimedes Pharma Ltd. </a>was granted marketing authorization from the European Commission for its lead product, PecFent, a fentanyl nasal spray for the treatment of breakthrough cancer pain (BTCP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. BTCP is sudden, unpredictable episodes of pain that are severe to excruciating in intensity. BTCP affects 24% to 95% of all cancer patients despite background pain medication. <br /> <br /> PecFent contains fentanyl, a highly potent opioid analgesic, and uses Archimedes&rsquo; PecSys nasal drug delivery system to deliver fentanyl in a rapid but controlled manner designed to match the time course of the typical breakthrough pain episode. The marketing authorization is based on three Phase III studies in more than 650 patients. Results from two randomized, double blind, Phase III trials, show PecFent demonstrated onset of pain relief as early as five minutes as well as clinically meaningful pain relief within 10 minutes.<br /> <br /> Jeffrey H. Buchalter, president and chief executive officer of Archimedes Pharma, commented, &quot;The grant of European marketing authorization for PecFent provides a new therapy to improve the treatment options for adult patients with breakthrough cancer pain. This is also a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months.&quot;<br /> <br /> The company submitted a NDA with the FDA in August 2009 and is in the process of establishing a commercial organization to market the drug in the U.S.<br /> <br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/_0QID6NDSdk height= 1 width= 1 />

<a href= http://www.allergan.com >Allergan, Inc. </a>received approval from the FDA for Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Lumigan 0.01% is an optimized reformulation of Lumigan 0.03%. The drug will be available in 4Q10.<br /> <br /> A three-month study of patients with open-angle glaucoma or ocular hypertension with an average baseline of 23.5 mm Hg, showed Lumigan 0.01% lowered IOP as much as 7 mm Hg from baseline, with only one-third the drug exposure. The most common side effects are red eyes, eyelash growth and itchy eyes.<br /> <br /> &quot;The approval of Lumigan 0.01% provides doctors with an efficacious, safe and well-tolerated IOP-lowering medication for glaucoma patients who are either starting treatment or are changing their medication regimen,&rdquo; said Scott Whitcup, M.D., Allergan&rsquo;s executive vice president, R&amp;D, chief scientific officer. &ldquo;Lumigan 0.01% exemplifies Allergan&rsquo;s commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure.&rdquo;<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/QpQBiJPByqg height= 1 width= 1 />

<a href= http://www.nabi.com >Nabi Biopharmaceuticals</a> has entered into a five-year commercial manufacturing agreement with <a href= http://www.diosynthbiotechnology.com >Diosynth RTP, Inc.</a> for the manufacture of drug substance for the production of NicVAX, Nabi's investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse. <br /> <br /> Diosynth will manufacture the drug substance AMNic-rEPA, which is produced by conjugating nicotine hapten &mdash; sourced from another CMO &mdash; with the carrier protein rEPA. The resulting drug substance will then be combined with an adjuvant and filled in syringes to produce NicVAX. Diosynth has already validated the NicVAX manufacturing process and produced commercial-scale lots of NicVAX under contract for Nabi.<br /> <br /> &quot;This agreement is an important and exciting step in the event that the Phase III trials for NicVAX are positive and we subsequently receive regulatory approval,&quot; said Dr. Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. &quot;We are pleased to enter into this agreement with Diosynth, an experienced manufacturer of licensed biological products with a regulatory approved facility and available capacity to perform bulk manufacture of the NicVAX Drug Substance.&quot;<br /> <br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/9DbwYdW-Ir4 height= 1 width= 1 />

<div><a target= _blank href= http://www.contractpharma.com/csd/company/Quintiles >Quintiles</a> has signed an agreement with <a target= _blank href= http://www.pharmaxis.com.au >Pharmaxis</a> to provide a broad range of commercial solutions to support the European launch of Bronchitol, an innovative treatment for cystic fibrosis.</div> <div></div> <div>Quintiles will execute a comprehensive commercialization effort for Bronchitol across western Europe. Beginning with Germany in early 2011, Quintiles will later support the commercialization of Bronchitol in France, Spain, Italy, Austria, Switzerland, the Netherlands, Belgium, Luxemburg and Portugal. Quintiles&rsquo; services include development of the overall market access strategy, pricing and reimbursement, local market access, product management, and recruitment and management of field-based commercial teams.</div> <div></div> <div>Designed to reduce the amount of mucus build-up in the lungs of patients suffering from chronic respiratory conditions, Bronchitol was awarded orphan drug designation for cystic fibrosis in the EU and U.S. Pharmaxis anticipates approval for the product in Europe by the close of 2010, with promotional activities beginning in 2011.</div> <div></div> <div>&ldquo;Bronchitol is an important advancement in the treatment of cystic fibrosis,&rdquo; said Gary Phillips, acting chief executive officer, Pharmaxis. &ldquo;To get this critical therapy to patients, we need the right partner to ensure our market entry goes smoothly. Europe is a complex area in which to launch a product, and Quintiles&rsquo; experience, breadth and expertise in the region made them the ally of choice. They are experts at market access, field sales and product promotion, and understand the nature of the region.&rdquo;</div><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/O042yTOvQkU height= 1 width= 1 />

<div><a target= _blank href= http://www.contractpharma.com/csd/company/PharmaNet%20Development%20Group >PharmaNet Development Group</a> has joined <a target= _blank href= http://mdsol.com >Medidata&rsquo;s</a> &quot;ASPire to Win&quot; channel partner program, and will add the SaaS company's electronic data capture (EDC) and clinical data management (CDM) solution for use in its conduct of global clinical trials.</div> <div></div> <div>PharmaNet joined this CRO partner program to facilitate the use of Medidata Rave for a range of Phase I&ndash;IV clinical studies, including large, complex global studies, taking advantage of Rave&rsquo;s interface for clinical investigators that facilitates site recruitment and retention. Rave&rsquo;s extensive data management and reporting capabilities are designed to support the research sponsor in driving efficiencies throughout the clinical development process, according to a Medidata statement.</div> <div></div> <div>&ldquo;Our clients consistently challenge us to provide the highest-quality services while running their trials efficiently &mdash; Rave helps us achieve those goals,&rdquo; said Dalvir Gill, Ph.D., president, Late Stage Development, PharmaNet. &ldquo;It provides the scalability to support our global footprint and the flexibility we need to create eClinical environments for rapid data sharing. From its ease-of-use and multilingual support to its double data entry and robust reporting for effective data analysis &ndash; Rave will effectively support the diverse group of investigators who participate in our studies.&rdquo;</div> <div></div> <div>PharmaNet has more than ten years of experience conducting EDC trials utilizing both commercially available EDC systems and its proprietary ones. Medidata's channel partner program began in April 2005 and includes more than 25 CRO partners.</div><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/1SUMKN8nj-s height= 1 width= 1 />

<a target= _blank href= http://www.contractpharma.com/csd/company/Vetter%20Pharma%20International%20GmbH >Vetter</a> has opened a new sales office at the Illinois Science + Technology Park in Skokie, IL, home of its first U.S. manufacturing facility. The office will be managed by Troy Carpenter, who was appointed as president of Vetter Pharma International USA Inc. The new office replaces its Yardley, PA sales office, founded in 1983 as Vetter Pharma-Turm Inc.<br /> <br /> In a company statement, Vetter noted that the Midwest region is an emerging &ldquo;hotspot&rdquo; in biotechnology, and that the new office will help push business growth in North America. The manufacturing facility in Skokie &mdash; an expansion of Vetter Development Service &mdash; is scheduled to be operational in the beginning of 4Q10.<br /> <br /> Mr. Carpenter will manage Vetter key account managers across the U.S. who are responsible for all sales and business development activities in North America. Previously, Mr. Carpenter was director, Key Account Management for Sartorius-Stedim Biotech. He also acted as key account manager for Vetter Pharma-Turm from 2002 to 2007, with responsibility for sales and business development in the U.S. western region.<br /> <br /> &quot;We are very pleased to have Troy rejoin Vetter as our new president of Vetter Pharma International USA Inc.,&quot; said Peter Soelkner, Vetter managing director. &quot;Troy&rsquo;s extensive knowledge of the U.S. pharmaceutical and biotechnology markets is a tremendous asset to Vetter and will complement our key account management concept of working with clients from early development through commercial manufacturing and global market supply. Additionally, Troy&rsquo;s previous work with companies in our industry clearly demonstrates his ability to successfully develop and execute sales strategies and manage account teams for top-tier companies.&quot;<br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/jp6La5e6rrI height= 1 width= 1 />