Ei Increases Capabilities Through New Partnership

Ei, A Pharmaceutical SolutionWorks, recently announced a new partnership with KeraNetics. Ei has begun a $13.2-million expansion within their recently completed 147,000-sq-ft facility in Kannapolis, North Carolina. Ei is providing product formulation and development to commercialize the patented product lines of KeraNetics. The new expansion, in part funded by a North Carolina state grant, will broaden Ei’s manufacturing capabilities. Through their relationship with KeraNetics, Ei will manufacture and produce an advanced biomaterial to support the product lines for KeraNetics.

KeraNetics specializes in the creation of therapeutic medical products utilizing keratins, a class of structural proteins with unique physical, chemical, and biological characteristics designed to promote soft and hard tissue repair and regeneration by providing an environment to support the body’s natural healing process. KeraNetics controls numerous patents for methods of purifying keratin proteins and applications for regenerative medicine and trauma.

“We are excited to announce our new partnership with KeraNetics,” said Michael Kane, CEO, Ei. “We believe KeraNetics recognizes our team as product knowledge experts. A relationship of this magnitude showcases the level of skill and technology-driven innovation that exists in the DNA of Ei. Further, it illustrates the intellectual capital Ei brings to the table and taps into the strong business-to-business relationships we have forged and continue to maintain with our customers. We are not only assisting in the development and manufacturing of exciting new products, but are providing an added value to KeraNetics as a bridge to Ei’s like-minded customers.”

“The relationship with Ei has developed as a result of KeraNetics’ intent to bring these exciting new keratin-based products to market,” addedd Kim Westmoreland, Managing Director, KeraNetics. “We were originally looking at building a facility to manufacture these cutting-edge, keratin products that would have involved years of planning and construction. After meeting the leadership team at Ei and touring their state-of-the-art facility, we realized this partnership would allow us to cut those years out of the equation and create access to these products much more quickly. We could not be more pleased.”

Luke Barnett, Director of Research and Development, KeraNetics, added, “The high level of innovation exhibited in Ei’s current product lines also played a role in their selection. The level of skill and knowledge in their research and development team is a huge asset. We were looking for a long-term relationship with a company that could assist us in not only manufacturing these products, but serve as a partner and ally in looking toward future offerings.”

Ei focuses on Rx pharmaceutical, OTC, therapeutic skin care, and animal health markets. The company provides product development services ranging from formula development, testing, and package development. Ei specializes in regulatory assistance through clinical trial manufacturing, scale-up, and commercial production as well as offering specific development and manufacturing services.

Ei prides itself on not just the cutting-edge science and state-of-the-art manufacturing expertise of its people, but the protection and strengthening of each individual customer’s brand. Continual growth of Ei in their capabilities is illustrated in this new partnership. This corporate acknowledgement of a higher level of skill and care resulted in the re-branding of Ei in 2011 from a traditional contract manufacturing organization to a Pharmaceutical SolutionWorks. Working in tandem to create unique, differential products with their customers, Ei fulfills that promise through the manufacturing and delivery stages. For more information, visit www.eisolutionworks.com.

KeraNetics is the global leader in the development and manufacturing of purified keratin medical products. Headquartered in Winston-Salem, NC, KeraNetics is developing first-in-class therapeutic medical products utilizing keratin biomaterials. For more information, visit www.keranetics.com.

SeraCare Expands AccuCell Line With Human Cord Blood Mononuclear Cells

SeraCare Life Sciences recently announced it has expanded its line of AccuCell mononuclear cells with the launch of off-the-shelf Human Cord Blood Mononuclear Cells (CBMNCs). With viability after thaw validated at greater than 90%, SeraCare cryopreserved CBMNCs are ideal for use in stem cell research; drug discovery; vaccine manufacture; production of cell-based products and instrumentation; and cell production, translation, separation, or expansion services.

“Through our global partnerships with hospitals, clinics, and licensed centers, SeraCare has access to a consistent, ready supply of the human cord blood required to produce cryopreserved CBMNCs in the quantities our customers need, when they need it,” said Tina Patel, Associate Technical Product Manager, SeraCare Life Sciences. “Many of our customers need to obtain CBMNCs rapidly and often need to compare them to Peripheral Blood Mononuclear Cells during the course of their work. By providing both of these cell lines off-the-shelf for immediate shipment, SeraCare offers customers the time-savings and efficiencies of working with a single, trusted source for material that is vital to their research and manufacturing efforts.”

In addition to the newly available off-the-shelf cryopreserved CBMNCs, SeraCare continues to provide custom CBMNC and PBMC isolations for both normal and disease-state material. Various fill sizes and cell counts from donors of diverse demographics are available. SeraCare also offers custom clinical research services to complement its CBMNC line, including whole blood fractionation, cell culture services, nucleic acid extraction, cellular analysis, immune monitoring assays and custom processing, analysis, and storage.

To ensure the highest purity and quality, SeraCare CBMNCs are processed at ISO-certified facilities following a rigorous, validated process, with donor material collected at facilities regulated by the US FDA. The product is available in large lots to support long-term research initiatives and comparisons across multiple labs.

SeraCare Human Cord Blood Mononuclear Cells are available for purchase immediately worldwide. For ordering information, contact SeraCare Customer Service at 1-800-676-1881 or view the company’s product catalog at www.seracarecatalog.com.

SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, development, and production of human diagnostics and therapeutics. The company’s innovative portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking, and contract research services. SeraCare’s quality systems, scientific expertise and state-of-the-art facilities support its customers in meeting the stringent requirements of the highly regulated life sciences industry.

Nascent & Catalent Sign Cancer Antibody Development Deal

Nascent Biologics, Inc. and Catalent Pharma Solutions recently announced the signing of a product development agreement. Under the terms of the agreement, Catalent will engineer a cell line expressing Nascent’s proprietary Pritumumab antibody using Catalent’s GPEx technology, and will subsequently produce purified monoclonal antibody to support Nascent’s Phase I/II human clinical trials with Pritumumab for treatment of an unmet clinical need, treatment of brain cancers, such as astrocytomas and glioblastomas. GPEx technology is used to generate mammalian cells with high yields and stability, which will help speed the drug to clinic.

“We are committed to bring this potential new treatment to patients afflicted with this terrible disease,” said Mark Glassy, PhD, CEO of Nascent. “Our first clinical data are very encouraging, and we look forward to working with Catalent to gather the key clinical data that will enable further development to be fast tracked with relevant regulatory agencies on a worldwide basis. Nascent Biologics is in the process of forming a commercial partnership for further clinical development, registration, and marketing of its Pritumumab product.”

“We are delighted to be part of a program that will not only validate our GPEx technology as a leading system for the manufacture of biologic products, but will also aid in significantly improving the treatment outcomes for such a serious and untreatable disease,” added Kent Payne, Vice President and General Manager of Catalent’s Biologics business.

Glioblastoma, a form of brain cancer from which Senator Edward Kennedy recently succumbed, afflicts 10,000 Americans each year, with a 1-year survival rate of 50% and a 5-year survival rate of just 3%. There is currently no effective treatment for this disease. In previous clinical trials with Pritumumab, 5-year survival rates of brain cancer patients were about nine-fold higher, at 27%. Nascent wishes to confirm and validate the earlier clinical trial data and move forward into Phase III and subsequent registration of the product.

From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings, and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing, and packaging solutions. For more information, visit www.catalent.com.

Nascent Biologics is an early stage biopharmaceutical company developing two proprietary platform technologies, MultiPharm and Uberkine, under the clinical premise that the most effective way to treat disease is to modulate (boost or suppress) the human body’s natural ability to generate an immune response. Pritumumab is the first in a series of treatments for a variety of cancers and auto-immune diseases. For more information, visit www.nascentbiologics.com.

US CMO Market Revives as Pharma Companies Increasingly Outsource

The upturn in the fortunes of pharmaceutical companies after the recession is mirrored by the US CMO market, which is expected to grow at a compound annual growth rate (CAGR) of 8.3% from 2011 to 2016. The sterile segment accounts for the highest share of revenues, with 38.7% in 2011, which is expected to rise to 47.5% by 2016.

New analysis from Frost & Sullivan’s (http://www.pharma.frost.com) Analysis of the United States Contract Manufacturing Outsourcing Market research finds that the market earned revenues of $10.73 billion in 2011 and estimates this to reach $15.97 billion in 2016.

“The continued expansion of the US pharmaceuticals industry and the big pharma’s increased outsourcing to improve cost structure and focus on core competencies will significantly augment the market’s revenue growth,” said Frost & Sullivan Consultant Jesse Sullivan. “The pharmaceutical companies that had used their excess capacity during the downturn to retain in-house manufacturing are expected to gradually outsource as the economy improves.”

Despite the inclination for pharmaceutical companies to outsource, R&D spending dipped from 2010 to 2011, resulting in fewer drugs being developed and marketed. As the CMO market’s revenue inflow is contingent on drug development, the torpid R&D activity has slowed the pace of market development.

The fragmented nature of the CMO services market has necessitated consolidation to improve profitability. Many CMO providers rely on a single client for more than 50% of their revenue. This tilts the balance of power in favor of the manufacturers and reduces prices across the industry.

“To demonstrate value to clients, CMO providers are likely to continue focusing on strategic relationships and promoting more services, such as formulation improvements, alternate dose forms, real-time order tracking, and logistics support,” said Ms. Sullivan. “Further, numerous CMO providers are offering preclinical development services, which creates long-term relationships with manufacturers.”

Analysis of the United States Contract Manufacturing Outsourcing Market is part of the Life Sciences Growth Partnership Services program, which also includes research in the following markets: European Pharmaceutical and Biotech Contract Manufacturing Markets; Strategic Analysis of Contract Research and Manufacturing Services Market in India; US Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade; and Global CRO Market: Quantitative Assessment. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation, and leadership. The company’s Growth Partnership Service provides the CEO and the CEO’s Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages 50 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 40 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.

If you are interested in more information on this research, please send an email to Britni Myers, Corporate Communications, at britni.myers@frost.com, with your full name, company name, job title, telephone number, company email address, company Web site, city, state, and country.

Horizon Partners With EMQN to Minimize Variability in Cancer Diagnostic Testing

Horizon Diagnostics (HDx), a division of Horizon Discovery Limited, a leading provider of research tools to support the development and prescription of personalized medicines, recently announced it has signed a strategic partnership agreement with the European Molecular Genetics Quality Network (EMQN). Under the terms of the agreement, HDx will provide genetically defined human cell line reference standards for distribution to molecular diagnostic laboratories around the world as part of EMQN’s annual External Quality Assessment (EQA) schemes to ensure sensitivity and reproducibility of diagnostic assays.

The reference materials provided by Horizon will contain known frequencies of mutations that currently guide the prescription of cancer therapies, and particularly melanoma, colon, and lung cancers. The reference materials will be distributed to participants in EMQN’s proficiency testing schemes, which will be assessed for their ability to accurately test the samples and provide a clear and concise test report on the results.

Diagnostic EQA providers face significant difficulties in sourcing reliable reference materials for diagnostics testing, either from patient samples or immortalized cell lines, especially as increasing numbers of rare mutations are being discovered. Horizon’s reference standards overcome this by reconstituting mutations of interest in human cell lines using its proprietary genome editing technology, GENESIS, and creating a defined wild type parental-to-mutant ratio in each sample.

“Quality assurance schemes, such as those organized by EMQN are essential to ensure that patients receive the correct treatment regimen based on their tumor mutation status,” said Dr. Paul Morrill, Commercial Director, Horizon Discovery. “Horizon’s technology offers pathologists and biologists an unprecedented level of control, and a resource for benchmarking the performance of assays against validated empirical reference standards. This is an invaluable component of patient care.”

“The availability of Horizon’s defined reference standards enables vastly improved proficiency testing across the diagnostics industry,” added Dr. Simon Patton, Director of EMQN. “We look forward to working with Horizon on developing standards for the increasing number of clinically relevant mutations that are supported through our EQA schemes.”

For more information on Horizon’s FFPE standards, please visit www.horizondx.com. For more information on EMQN, please visit www.emqn.org.

QRxPharma Successfully Completes Phase I Studies

QRxPharma recently announced successful completion of two Phase I studies in healthy volunteers for MoxDuo CR, a controlled-release Dual-Opioid utilizing a 3:2 ratio of morphine and oxycodone. The proprietary MoxDuo CR formulation, encompassing both sustained delivery technology as well as abuse-deterrent and tamper-resistant features, is designed to provide at least 12 hours of analgesia in patients suffering from moderate-to-severe chronic pain, including cancer, lower back, osteoarthritis, and neuropathic pain.

The clinical trials compared blood levels of MoxDuo CR’s components to OxyContin and MS Contin and demonstrated MoxDuo CR’s superior results, with sustained blood levels for up to 24 hours. Further studies indicated MoxDuo CR’s increased resistance to tampering.

“The successful completion of these trials confirms the advantages of this formulation and enables QRxPharma to initiate Phase II proof-of-concept clinical studies mid-year 2012,” said Dr. John Holaday, Managing Director and CEO of QRxPharma. “These data suggest MoxDuo CR may be positioned as a once- or twice-per-day formulation for treating chronic pain, with the potential advantage of significantly reduced side effects as witnessed with immediate-release MoxDuo. In the US alone, the chronic opioid pain market is a $6 billion a year opportunity.”

Two Phase I trials were conducted in healthy volunteers to evaluate the rate at which key components of the MoxDuo controlled-release (CR) formulation were absorbed, distributed, metabolized, and eliminated by the body. The first study compared MoxDuo CR (30 mg morphine SO4/20 mg oxycodone HCl) to the pharmacokinetic profiles of the same doses of MS Contin (30 mg morphine SO4) and OxyContin (20 mg oxycodone HCl) in 10 healthy adult human subjects using a three-way crossover design.

Pharmacokinetic results from the measurement of opioid blood levels over time revealed a MoxDuo CR profile consistent with expectations for a once- to twice-daily formulation.

The second study demonstrated that food consumption does not alter the pharmacokinetic profiles of morphine and oxycodone from MoxDuo CR (30 mg/20 mg) tablets using a two-way crossover design with 17 healthy volunteers. To demonstrate the effects of chronic use on steady-state blood levels, this study also measured the repetitive-dose pharmacokinetic profiles of morphine and its metabolites as well as oxycodone during repetitive (twice daily) administration of MoxDuo CR tablets for 5 days.

The MoxDuo CR tablets used in these clinical tests included QRxPharma’s proprietary Abuse Deterrence Formulation (ADF) technology. As an indication of tamper resistance, attempts to extract morphine or oxycodone by crushing and solubilizing in water or alcohol resulted in very limited (less than 15%) drug recovery. In addition, the ADF technology did not impair human bioavailability of the opioids following oral administration.

“Clinical performance of the oral MoxDuo CR formulation clearly exceeded our expectations. When directly compared to OxyContin, the largest selling opioid for chronic pain, MoxDuo CR demonstrated superior bioavailabilty and sustained blood levels for over 12 hours, especially in the 12- to 24-hour time period. At steady-state, MoxDuo CR provided very low fluctuations of oxycodone. MoxDuo CR appears to be a true once- or twice-a-day delivery system for dual opioids,” said Dr. Ed Rudnic, COO, QRxPharma. “We expect that MoxDuo CR’s sustained blood levels, ADF attributes, and potential side effect benefits will enhance the tolerability and acceptability of MoxDuo CR in the global chronic pain marketplace.”

The CR formulation of MoxDuo encompasses the same 3:2 ratio of morphine and oxycodone as in MoxDuo IR, QRxPharma’s immediate-release acute pain formulation that is scheduled for PDUFA feedback from the US FDA in June 2012. QRxPharma’s US partner for MoxDuo IR, Actavis, Inc., has the option to negotiate for the US license of MoxDuo CR pending achievement of certain MoxDuo IR sales milestones in the acute pain market. MoxDuo CR is expected to launch into the US chronic pain market in 2015.

QRxPharma Limited is a commercial-stage specialty pharmaceutical company focused on the development and commercialization of new treatments for pain management. Based on a development strategy that focuses on enhancing and expanding the clinical utility of currently marketed compounds, the company’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. QRxPharma’s lead product candidate, immediate release MoxDuo, has a Prescription Drug User Fee Act (PDUFA) date of June 25, 2012, when the NDA review by the US FDA will be completed. The company recently signed a strategic partnership agreement with Actavis, Inc. to commercialize MoxDuo IR in the US acute pain market, with product launch anticipated in 3Q, CY2012. QRxPharma may co-promote its products in the US and plans to seek strategic partnerships for worldwide markets. Additionally, the company’s clinical pipeline includes an intravenous (IV) and continuous release (CR) formulations of MoxDuo. For more information, visit www.qrxpharma.com.