Catalent & Sanwa Announce Exclusive License Agreement

Catalent Pharma Solutions and Sanwa Kagaku Kenkyusho Co., Ltd. have recently entered into an exclusive agreement to bring Sanwa’s innovative drug delivery tableting technology to global markets. This novel technology will be marketed by Catalent in all markets outside of Japan, Korea, China (Hong Kong), and Taiwan. OSDrC® is a fully developed optimized dose delivery technology and has already been commercially proven by Sanwa in Japan. Catalent will now utilize its global footprint, leading modified-release delivery expertise, and integrated manufacturing know-how to bring OSDrC to the global market. This technology enables significant improvements to therapeutic and drug delivery release profiles. It is anticipated that Catalent will commence customer product development trials at its Winchester, KY, facility in January 2012.

OSDrC optimized dose delivery technology enables the design of single or multi-core tablets, with a practically endless variety of core numbers, shapes, sizes, and placement within the tablet. This flexible-core capability offers the broadest available range of controlled-release designs for drug formulators, providing the potential for optimal dosing, therapeutic product profiles, and plasma release profiles to meet patient needs in a high-quality, one-step manufacturing process.

OSDrC technology can produce pulsatile tablets, bi-layer tablets, multi-core tablets, dividable tablets, delayed-release tablets, and direct-compression orally dissolving tablets with better quality and release control design than standard tableting technologies.

This technology expands Catalent’s capabilities in designing pulsatile targeted drug delivery, immediate- and extended-release combination tablets, and combination product tablets containing multiple active drugs. OSDrC, in addition to other recent technology advances at its Winchester, KY, and Schorndorf, Germany, facilities, is part of an overall growth initiative for Catalent to expand its leading modified-release technology capabilities.

“We are excited to partner with Sanwa as we continue to expand and innovate our modified-release technology solutions and manufacturing capabilities,” said Dr. Ian Muir, President of Catalent’s Modified Release Technologies business. “The addition of OSDrC optimized dose delivery technology will enhance Catalent’s ability to solve our customer’s controlled-release formulation challenges – by providing the broadest and highest quality range of drug delivery technologies and scientific expertise in the industry. It is a perfect fit with our existing controlled-release, Zydis® and Lyopan® fast-dissolve, and Stick Pack modified-release technology platform to enhance our ability to bring more products and better treatments to the market.”

“OSDrC technology already has an existing application in the Japanese market,” added Mr. Kazuo Yamamoto, President of Sanwa. Catalent’s global presence, modified-release technology scientific expertise, and integrated manufacturing and packaging services make them the ideal partner for Sanwa as we make this innovative technology available for global customers to improve their products.”

Michael J. Valazza, RPh, Global Vice President of Catalent’s Modified Release Technologies business, will be presenting this new technology at the 38th Annual Controlled Release Society Conference on Sunday, July 31 from 8:30-9:30 AM at the Gaylord National Hotel and Convention Center in National Harbor, MD. If you would like to conduct any follow-up interviews or learn more about OSDrC technology, please contact Patricia McGee at To learn more about Catalent’s modified-release technologies, please visit

Particle Sciences & Absorption Systems Form Relationship for Enhanced Services

Particle Sciences Inc. (PSI), a leading pharmaceutical CRO, and Absorption Systems, a leading provider of preclinical pharmacokinetic services, recently announced the two companies are working together to provide their clients with enhanced drug development services by integrating preclinical pharmacokinetic data into the dosage form development scheme.

“Particle Sciences has always had a methodical approach to drug product development,” said Robert Lee, PhD, Particle Sciences’ Vice President Pharmaceutical Development. “Dosage form design is best done when informed by the in vivo solubility, permeability, and metabolism of the drug. This is true for oral drug products as well as other routes of administration. Absorption Systems has put in place a scaled in vitro/ex vivo/in vivo approach to obtaining this data, which lends itself to our needs. For those clients who desire it, Particle Sciences can integrate this data stream into our drug product development plan. Ultimately, this should prove to be a cost-effective way to drive efficiency and minimize time to the clinic.”

“Our portfolio includes a number of physicochemical and biological tests that can make formulation development a more rational and efficient process,” added Chris Bode, PhD, Vice President Scientific & Corporate Communications at Absorption Systems. “Particle Sciences is a leader in drug formulation and manufacturing, and we are very pleased they are leveraging our toolset in their efforts. I believe this is consistent with their overall innovative and comprehensive approach to drug product development.”

Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs and medical devices. The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems’ commitment to innovation and is soon to be an industry assay standard for in vitro drug interaction assessment.

Particle Sciences is an integrated provider of drug development services, focusing on emulsions, gels, particulates, and drug/device combination products with additional specialized capabilities in topical and mucosal drug delivery. Through a full range of formulation, analytic, and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic.

Zogenix & DURECT Announce Agreement for Antipsychotic Product Candidate

Zogenix, Inc., a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and DURECT Corporation, a specialty pharmaceutical company focused on the development of pharmaceutical systems based upon its proprietary drug delivery platform technologies, recently announced a development and license agreement.

Under the agreement, Zogenix will be responsible for the clinical development and commercialization of a proprietary, long-acting injectable formulation of risperidone using DURECT’s SABER controlled-release formulation technology in combination with Zogenix’s DosePro needle-free, subcutaneous drug delivery system. The Companies will also share non-clinical development responsibilities. Zogenix expects to initiate clinical studies for the new product candidate, Relday, in patients with schizophrenia in early 2012 following filing of an IND application.

Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia and bipolar I disorder in adults and teenagers 13 years of age and older. Relday will be developed to address unmet clinical needs in this large patient population.

The companies expect that, if approved, Relday will be the first once-monthly, subcutaneous antipsychotic product available in a needle-free delivery system to enter the long-acting injectable antipsychotic market. The existing long-acting injectable risperidone product, which achieved global net sales of $1.5 billion in 2010, requires twice-monthly, 2-mL intramuscular injections with a 21-gauge or larger needle. The companies also expect that, if approved, Relday will provide a new long-acting treatment option for patients that currently use daily oral antipsychotic products. The combined market for oral and injectable antipsychotic products is estimated at more than $16 billion in 2010. The companies believe the SABER controlled-release technology will allow Relday to be delivered subcutaneously without a needle on a once-monthly basis with a simplified dosing regimen, improved pharmacokinetic profile, and significant reduction in injection volume. This will be enabled by DosePro’s unique ability to deliver highly viscous formulations.

“Relday is the result of a focused preclinical formulation development effort with DURECT,” said Roger L. Hawley, CEO of Zogenix. “We believe Relday has best-in-class potential because it consists of a proven drug with improved attributes that our market research indicates are preferred by psychiatrists. The target audience of US psychiatrists can be covered efficiently with a relatively small sales force. Outside the US, we expect Relday will be of great interest to prospective commercial partners. We look forward to working with DURECT to file an IND for Relday that will enable initiation of clinical development in early 2012.”

“Consummation of this collaboration further demonstrates the flexibility and broad potential associated with our SABER depot technology platform, which we are also employing in our POSIDUR program in Phase III as well as with proteins and peptides in multiple feasibility projects,” added James E. Brown, DVM, President and CEO of DURECT Corporation. “In conjunction with the DosePro delivery system, our goal is to develop a product that meets psychiatrists’ and patients’ preferences for a long-acting, subcutaneous, needle-free antipsychotic medication. Zogenix has successfully developed and commercialized a CNS product, and we are pleased to work with them on this exciting opportunity with Relday.”

Under the terms of the agreement, Zogenix will make an up-front payment of $2.25 million to DURECT, with the potential to pay DURECT up to an additional $103 million in future clinical, regulatory, and commercial milestone payments based upon successful achievement of certain events. Zogenix will have exclusive global rights to commercialize Relday and will pay DURECT a royalty on Relday product sales.

Generex Publishes Studies Confirming & Extending the Antigen Express Ii-Key Platform Technology

Generex Biotechnology Corporation recently announced the publication of studies conducted at the Mayo Clinic using the Antigen Express proprietary Ii-Key technology. Antigen Express, Inc., the company’s wholly owned subsidiary, has used this technology platform in the development of self-potentiating immunotherapeutic vaccines for cancer. AE37, an Ii-Key HER-2 hybrid, is currently the subject of a controlled, randomized, and single-blinded Phase II clinical trial in patients with HER-2 expressing breast cancer.

The publication, MHC Class II Epitope Nesting Modulates Dendritic Cell Function and Improves Generation of Antigen-Specific CD4 Helper T Cells, was published in the peer-reviewed Journal of Immunology. A significant finding of the report, conducted in a mouse model, was that specific CD4+ T cell (T-helper) activation by Ii-Key hybrids excludes T regulatory (immune suppressor) cells. T regulatory cells (immune suppressor) may hinder active immunotherapy of cancer. The lack of activation of this cell type has been observed previously in clinical studies of AE37 (an Ii-Key-HER-2 hybrid), both in breast as well as prostate cancer patients.

The senior author of the study, Dr. Keith Knutson, has been one of the pioneers in the field of CD4+ T-helper cell stimulation for active immunotherapy of cancer. “We are pleased to see this further confirmation of the potential of our technology,” said Dr. Eric von Hofe, President of Antigen Express. “Dr. Knutson has been one of the most important leaders in the field. The confirmation of the lack of T regulatory cell activation, known to have immune suppressive effects, adds to our prior findings and suggests Ii-Key hybrids could have potential in the field of cancer immunotherapy.”

“This study further supports the differentiating profile of AE37 with other cancer immunotherapies and provides additional momentum to AE37’s clinical development,” added Jos van der Woert, who has accepted the position of Chief Executive Officer of Antigen Express.

Prior clinical studies of an Ii-Key hybrid peptide being developed by Antigen Express, AE37, including a Phase I trial in patients with prostate cancer and a separate trial in patients with breast cancer, have been reported as the subject of four publications in leading peer-reviewed journals. In brief, those studies showed that AE37 is safe, well-tolerated, and produced immunological responses that were above-and-beyond what had been hoped for. When compared with two other HER-2 vaccines that have been evaluated in the clinic, AE37 produced the greatest HER-2-related delayed-type hypersensitivity (DTH) reactions in immunized patients. Of all immunological responses examined in patients undergoing active immunotherapy for cancer, it has been argued that a strong DTH response most reliably predicts efficacy. In addition, it was found that AE37 was the only peptide able to generate an immunological response when administered without an adjuvant (co-stimulatory agent). Finally, (as previously indicated) AE37 also was the only peptide shown to decrease the level of T regulatory cells.

A controlled, randomized, and single-blinded Phase II clinical study of AE37 in HER-2 expressing breast cancer patients is currently underway to establish clinical efficacy. The study endpoint is a reduction in cancer relapse after 2 years compared to the current standard of care treatment. There are currently over 200 patients enrolled in the study with node positive or high-risk node-negative breast cancer. While positive preliminary results suggested that statistically definitive results may be obtained in 2012, it was decided to enroll an additional 100 patients early in 2011 to ensure sufficient patient numbers. In particular, these additional patients are required to have low HER-2 expression levels such that they are not eligible for Herceptin. Although 75% of breast cancer patients have some level of HER-2 expression and are eligible for AE37, only 25% have HER-2 levels high enough to be eligible for Herceptin. The population of patients with low-to-intermediate levels of HER-2 expression currently has no treatment option. For this reason, it is anticipated that a Phase III trial will be conducted in this specific patient population having low-to-intermediate HER-2 expression levels.

QRxPharma Announces NDA Filing

QRxPharma Limited recently announced initiation of the NDA approval process for MoxDuo IR with the US FDA. This NDA submission sets the stage for the regulatory approval process for MoxDuo IR for the treatment of moderate-to-severe acute pain, a $2.5-billion segment of the $8 billion spent annually on prescription opioids in the US. MoxDuo IR, an immediate-release Dual Opioid pain therapy, is a patented 3:2 fixed ratio combination of morphine and oxycodone.

“In just 4 years, we have successfully moved MoxDuo IR through clinical trials and NDA submission by demonstrating its effectiveness and safety. Achievement of this milestone clearly establishes the value of this Dual Opioid product to patients and prescribers as well as potential partners,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. “The timeframe and capital efficient manner in which these milestones were achieved are impressive accomplishments compared to conventional industry development and cost benchmarks.”

This NDA submission is based on a full clinical and manufacturing program for MoxDuo IR. As agreed with the FDA, the NDA for MoxDuo IR is being submitted under 505(b)(2) regulations wherein approval for a new drug may be obtained more efficiently because the approval process can rely upon historical data regarding its already approved components. A 505(b)(2) approval also provides commercial benefits because, in parallel to patents which cover MoxDuo until 2029, it affords to the sponsor additional regulatory market exclusivity, allowing companies to develop a marketing strategy with a brand consumers recognize and may prefer in a potentially wide-open market.

As agreed with the FDA during its pre-NDA meeting with the company in March 2011, the NDA manufacturing section filing initiated the NDA review and is classified as an early submission, enabling sponsors like QRxPharma to obtain a head-start on the overall review process, with the remaining technical documentation to follow in August. Approval of an NDA typically takes 10 to 12 months from submission. Later this year, the company will augment the filing with additional safety information derived from the recently completed Study 022.

The US NDA package will serve as the core component of MoxDuo registration submissions in Europe, Australia, Canada, and elsewhere. The company believes that the recently completed Study 022 demonstrating a clinically significant reduction in respiratory depression, the major cause of death from opioids, will be attractive to regulators and prescribers and will also facilitate label claim advantages for MoxDuo IR when the European Marketing Authorisation Application (MAA) is submitted in 2012.

“To our best knowledge, QRxPharma’s NDA is only the second NDA filed with the FDA by a stand-alone Australian therapeutics company within the past decade. The company is on track for product approval and sales in 2012 when MoxDuo IR is to be launched into the $8-billion US pain market,” added Dr. Holaday.

The development program included three pivotal Phase III studies for the treatment of moderate-to-severe post-operative pain. In head-to-head comparisons with morphine, oxycodone, Percocet, and placebo, more than 700 patients have been treated with MoxDuo IR in seven clinical trials over the company’s successful Phase III program. Clinical data have consistently demonstrated that MoxDuo IR achieves equal or better pain relief with fewer incidences of moderate-to-severe side effects in those comparisons using current standards of care.

Life Technologies Develops Potent Drug Delivery Technology for Therapeutics Market

Life Technologies corporation recently announced it has developed new drug delivery technology specially designed for therapeutic applications that is 100-fold more potent than previous formulations. The technology is available for licensing as part of a new out-licensing program.

Scientists at Life Technologies have developed the novel proprietary siRNA delivery reagents by using new lipid molecules and formulation design to significantly improve potency and minimize toxicity in vivo. A single dose of 12.5 micrograms siRNA per kilogram can achieve 50% knock-down of a target gene, according to Keith Farnsworth, Product Management Leader at Life Technologies.

“Historically, delivery of siRNA has been problematic due to the high risk of toxicity and hampered efficiency,” he said. “Life Technologies’ new formulations provide the pharmaceutical and biotech industries a viable platform to help develop siRNA drugs that overcome these challenges.”

The availability of the new formulations follows Life Technologies’ 2010 launch of Invivofectamine 2.0, a lipid-based siRNA delivery technology for the research market that can knock down up to four genes in vivo in lab models for extended periods with a single application. The novel formulations available through the out-licensing program use different molecules that make it ideal for therapeutic applications. For more information, contact Maya Tanaka, Sr. Manager, Business Development and Licensing, (760) 268-7982;