9/12/2012

Cobra Biologics & Algeta Sign Monoclonal Antibody Agreement

Cobra Biologics Ltd and Algeta ASA recently announced a new contract manufacturing partnership for Algeta’s fourth Targeted Thorium Conjugate (TTC) program. The program will focus on the development of an undisclosed monoclonal antibody, which is highly selective for a validated cell surface target on hematological cancer cells, linked to Algeta’s alpha-particle emitter thorium-227 (Th-227).

Under the terms of the contract manufacturing agreement, Cobra will be providing cell line development through its maxXpress service, GMP cell banking, analytical and process development, scale-up, toxicology, and GMP production, as well as stability studies.

Algeta will be benefiting from Cobra’s maxXpress service, which combines the UCOE protein expression technology with the experience and expertise of Cobra Biologics’ cell line development team and the Cello robotic clone selection system, to enable rapid clone selection and production of the monoclonal antibody.

“We are delighted that Algeta has chosen Cobra as the manufacturer of a monoclonal antibody,” said Peter Coleman, CEO of Cobra Biologics. “Algeta’s contract forms part of a very successful year in which we are seeing significant expansion in our antibody contract manufacturing as customers see the advantages Cobra’s comprehensive services provide.”

Cobra Biologics is a leading international clinical and commercial contract manufacturer of biologics and pharmaceuticals with three GMP-approved facilities. It offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of medicinal products. For more information, please visit www.cobrabio.com.

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. The company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA. performing commercial operations. For more information, please visit www.algeta.com.

Growth Predicted for the European Vaccines Market

As vaccine manufacturers increasingly tend to leverage on novel technologies, and potential late-stage vaccine candidates progress the pipeline and reach the commercialization stage, the European vaccines market is expected to witness significant growth rates. Next-generation vaccines, such as edible plant-based vaccines, could also have a significant impact on vaccines development.

New analysis from Frost & Sullivan, Analysis of the European Vaccines Market, (www.pharma.frost.com), finds that the European vaccines market earned revenues of $6.36 billion in 2011 and estimates this to reach $12.05 billion in 2018 at a compound annual growth rate (CAGR) of 9.6% from 2011-2018.

The high levels of unmet medical needs for diseases, such as AIDS, malaria, and tuberculosis, that affect millions of people every year and contribute to increasing healthcare expenditure, present huge growth potential and untapped market opportunities, thereby fuelling increased R&D investments and government support for vaccine development.

“The future growth of the vaccine industry is likely to be propelled by the adult vaccines segment,“ said Frost & Sullivan Senior Research Analyst Aiswariya Chidambaram. “The tremendous success rates of the recently launched influenza and HPV vaccines have attracted the attention of market participants toward the adult vaccines.The vast majority of the vaccines in pipeline are novel, innovative vaccines based on new antigens, targeting malaria, tuberculosis, dengue fever, allergies, and herpes.“

Anticipation of capacity demand remains a key challenge for vaccine manufacturers, particularly during pandemic outbreak of diseases.

“Speculation of vaccine production capacity considering unanticipated needs, such as pandemic outbreaks, epidemics, and bioterrorism, is likely to have a huge impact on the growth and sustenance of vaccine manufacturers in Europe,” added Chidambaram. “Vaccine manufacturers are under the compulsion to maintain excess reserve supply owing to the tender-based vaccine procurement, lest they miss out on huge business opportunities.“

Accurate estimation of capacity demand and product differentiation will therefore be critical for market participants to garner a substantial share of the market.

“The highly fragmented nature of the European market will require market participants to accurately predict manufacturing capacity and fulfil global requirements during emergency situations, thereby enabling them to stay ahead of competition and prevent being hit by excess or inadequate capacity,“ concluded Chidambaram.

West Announces Self-Injection Technology Agreement

West recently announced an agreement with Janssen Biotech, Inc. to collaborate on the development and manufacturing of an innovative self-injection product. The technology, developed by Janssen Biotech, has been specifically designed to meet the needs of patients by facilitating easier self-injection of pharmaceutical and biologic drug products. West will market the new injection technology under the name SelfDose. See www.selfdose.com.

West will be responsible for co-developing and handling the commercial scale-up and manufacture of the product, and will have the ability to offer the SelfDose injection technology as part of its expanding portfolio of self-injection technology platforms. The SelfDose injection technology complements West’s ConfiDose and SmartDose injection technologies, and offers a solution for improved manual injection.

Providing the best solution to the challenges of packaging and delivering today’s sensitive and complex biopharmaceutical products requires not only an effective drug container, but also a delivery system that can enable safe, effective, and reliable delivery of the medication, especially when the administrator may be a patient. The SelfDose injection technology can help meet these challenges.

“We are delighted to have formalized our relationship with Janssen Biotech around this drug delivery platform and look forward to working together to commercialize the SelfDose injection technology, providing manufacturing, development, and regulatory support through the remainder of the process,” said Donald E. Morel, Jr., PhD, West’s Chairman and CEO. “We value the opportunity to strengthen our long-standing relationship and are excited by this agreement. We look forward to working with Janssen to help them meet their business goals to restore health and serve patients.”

West’s innovative system, device, and component solutions help improve the safety and administration of injectable drugs. West’s proprietary materials science, formulation research, and manufacturing technologies advance the quality, therapeutic value, development speed, and rapid market availability of pharmaceuticals, biologics, and vaccines. For more information, visit www.westpharma.com.

Quotient & Pulmatrix Announce Completion of Innovative Program

Quotient Clinical and Pulmatrix recently announced the completion of an early clinical program to achieve proof-of-concept data in COPD patients for PUR118, Pulmatrix’s lead iCALM (inhaled dry powder cationic airway lining modulator) therapeutic. The design and preliminary results from this program were presented at the European Respiratory Society (ERS) 2012 conference in Vienna, Austria.

The clinical program was based upon a single, innovative, and flexible clinical design to enable timeline acceleration from clinical entry into initial safety and tolerability evaluation in healthy volunteers, through to pharmacodynamic/efficacy data in mild-moderate COPD patients (GOLD Stages 0-2). Positive proof-of-concept data was achieved in less than 9 months, compared to conventional timelines that can typically stretch to more than 2 years.

“Our work with Pulmatrix has evolved into a landmark case study to illustrate how early development processes and timelines can be expedited,” said Mark Egerton, Managing Director, Quotient Clinical. “This single, four-part protocol seamlessly integrated healthy volunteer and COPD patient investigations by building in flexibility, enabling the project team to rapidly respond to emerging safety and PD data. In addition, an adaptive biomarker strategy encompassing a range of anti-inflammatory, respiratory, and imaging biomarkers was utilized. We are now using this as a model for designing early exploratory and development programs.”

“This innovative, flexible, and adaptive clinical design implemented by Quotient allowed dose-ranging safety and efficacy data to be compiled and understood in a timeframe that was markedly faster than is typical of early-phase clinical drug development. This permitted the potential of our lead iCALM drug candidate, PUR118, to be appreciated much earlier and in greater depth than a conventional path could accommodate,” added John Hanrahan, MD MPH, Chief Medical Officer and Senior Vice President at Pulmatrix.

InSite Vision Introduces DuraSite 2

InSite Vision Incorporated recently introduced DuraSite 2, its next-generation enhanced drug delivery system that provides a broad platform for developing superior ophthalmic therapeutics. DuraSite 2 increases the tissue penetration for topically delivered ocular drugs with the aim of improved efficacy and dosing convenience.

The company also announced topline data from a large-scale comparative study that demonstrates superior drug retention and tissue penetration for DuraSite 2 as compared to DuraSite. DuraSite 2 is based on InSite’s proven original DuraSite technology, and incorporates a cationic polymer to achieve sustained and enhanced ocular delivery of drugs. InSite scientists formulated both DuraSite 2 and DuraSite with the commonly used cataract surgery drug, ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), and conducted experiments to evaluate the difference between the two delivery systems and the commercially available ketorolac solution.

InSite recently completed a three-arm preclinical pharmacokinetic study comparing DuraSite 2 versus DuraSite versus ketorolac in an industry-standard animal model. Results of this study show that the DuraSite 2 formulations of ketorolac demonstrated significantly higher drug levels than DuraSite plus ketorolac, or ketorolac alone, achieving more than 2x and 4x concentrations in the aqueous humor of the eye, respectively. Further, there was no indication of eye irritation using the DuraSite 2 formulation. InSite plans to submit detailed data from this study for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2013 Annual Meeting.

“With DuraSite 2, we have developed a powerful new ophthalmic drug delivery platform that improves upon our well-established DuraSite technology and has surpassed our expectations, achieving multifold tissue penetration and positive safety results in a well-designed, large-scale preclinical study,” said Lyle Bowman, PhD, Vice President of Development of InSite Vision. “InSite scientists have unique expertise in formulating novel ophthalmic therapeutics, and we believe DuraSite 2 could be critical in optimizing the profile of approved and future ocular drugs, extending the drug retention on the eye and reducing dosing frequency and the amount of drug needed to achieve efficacious results. In addition to these potential clinical advantages, the intellectual property surrounding DuraSite 2 was filed in early 2009, providing potential patent life into 2029 for this new drug delivery system, as well as increased protection for all drugs formulated with DuraSite 2.”

DuraSite 2 patent applications were submitted in 2009 in the United States and Europe and published in 2010. Both patents are pending issuance. InSite Vision plans to utilize the DuraSite 2 platform in all future pipeline product candidates. Additionally, InSite will be finalizing and announcing a broad and novel licensing program with the intent of making DuraSite 2 a standard drug delivery technology in the ophthalmology industry, and provide access to industry partners through both exclusive and non-exclusive licensing and/or commercialization agreements.

While eye drops are a proven delivery mechanism for numerous ocular drugs, efficacy of these agents is impeded by tears and blinking, which rinse the drug from the surface of the eye and limit retention and absorption. InSite’s DuraSite and DuraSite 2 platforms are sustained delivery technologies using a synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. DuraSite and DuraSite 2 enable topical delivery of a solution, gel, or suspension and can be customized for delivering a wide variety of potential drug candidates. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite and Besivance®.

InSite Vision is advancing a portfolio of novel preclinical to clinical-stage ophthalmic products based on the DuraSite platform and anticipates advancing future ophthalmic product candidates using the DuraSite 2 platform. For more information, please visit www.insitevision.com.

Third Critically Ill Patient Successfully Treated With PLX Cells Under Compassionate Use

Pluristem Therapeutics, Inc. recently announced the company’s Placental eXpanded (PLX) cells were successfully administered to a third patient in Hadassah Medical Center; thus, a series of three life-saving compassionate use treatments were completed. The outcome of those treatments potentially suggests that the company’s PLX cells may have significant potential to treat a range of indications of bone marrow diseases.

The latest patient, a 45 year old male, diagnosed with Acute Myeloid Leukemia (AML), a form of blood cancer, underwent chemotherapy to treat the cancerous cells. Treatments with chemotherapy remove cancerous cells as well as normal cells in the bone marrow, leaving the patient needing bone marrow transplantation. The patient received an unrelated (allogeneic) bone marrow transplant. However, he suffered from severe and long-standing pancytopenia with associated complications after receiving hematopoietic stem cell transplantations.

Due to the patient’s major life-threatening condition, 144 days post bone marrow transplantation, PLX cells were injected intramuscularly (IM) at a dose of 600×106 cells, divided into two administrations, 1 week apart, under compassionate use treatment. No local or systemic side effects were observed. In addition, the patient’s general clinical condition and wellbeing significantly improved, resulting in his release from Hadassah Medical Center.

The series of the compassionate use treatments were led by Professor Reuven Or, Director of the Bone Marrow Transplantation and Cancer Immunology at Hadassah Medical Center in Jerusalem. Professor Or received a special permission by the Ministry of Health of the State of Israel, to try treating critically ill patients with bone marrow transplant failure that have no available alternative treatments, with PLX cells.

According to Professor Or, “Following three successful treatments, which were conducted for the first time in the world, in Hadassah Medical Center, we can say that PLX cells from the placenta saved the life of patients suffering from bone marrow failure. We are very encouraged by the results and hope that future clinical trials will show the effectiveness of the PLX cells. I believe that the PLX treatment holds huge hope for patients who suffer from different conditions of bone marrow failure and once approved, will be available for every patient who needs it.”

This is the third patient, out of three treated, to display impressive clinical improvement following the administration of PLX cells. The first two patients responded, 4 and 9 days respectively, after the second PLX cell administration, with improvement of tri-linage hematopoiesis.

“We are extremely proud that the hard work, research, and testing we have put into producing our PLX cells has now actively contributed toward saving the lives of these severely ill patients,” said Zami Aberman, Chairman and CEO of Pluristem. “Additionally, with these three patients, we have data to suggest that our PLX cells may be helpful for rescuing both allogeneic as well as autologous bone marrow transplant failures.”

Last month, Pluristem announced that it has filed the necessary documents requesting that the US FDA grant orphan drug status to its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia, a critical hematological emergency that is treated by a bone marrow transplantation. It has been estimated that there are 30,000 bone marrow transplants each year in the US alone. For more information, visit www.pluristem.com.