5/1/2012
3M DDS to Enhance Manufacturing Capabilities
3M Drug Delivery Systems recently announced the expansion of the pressurized metered dose inhaler (pMDI) fill line at its facility in Northridge, CA, significantly extending the company’s manufacturing capability. The addition of the pressure fill line complements the existing state-of-the-art cold fill line in the facility and enhances 3M Drug Delivery Systems’ inhalation manufacturing services for customers. With the expansion, 3M Northridge can manufacture new and marketed pressure filled pMDI products for its customers on a global scale, solidifying 3M Drug Delivery Systems’ start-to-finish reputation as a single-source provider for the development and commercialization of the pMDI. Additionally, the company has established a Qualified Person (QP) release route to
“This expansion reflects our continued growth,” said Louise Righton, Global Divisional Marketing Manager for 3M Drug Delivery Systems. “Customers are responding enthusiastically to our manufacturing expertise, which capitalizes on Lean Six Sigma methodology to drive efficiency.”
Since creating the first metered dose inhaler 50 years ago, 3M Drug Delivery Systems has continued to lead in the development of new technologies and manufacturing services for inhaled drug delivery. 3M Drug Delivery Systems currently has four strategically located pMDI filling sites, and the company has experience manufacturing products for distribution in more than 60 countries worldwide.
In the early stages of product development, 3M Drug Delivery Systems offers formulation screening and optimization for both solutions and suspensions, including particle engineering to improve dosing performance. The company also offers an array of pMDI components, such as valves and canisters that can be customized to fit customers’ needs, as well as actuators and dose counters, which improve the patient experience.
Learn more about 3M’s metered dose inhalers and manufacturing expertise at 3m.com/dds or visit 3M Drug Delivery Systems at the INTERPHEX 2012 conference at booth No. 3155, May 1-3 in
AAIPharma Services Opens New
AAIPharma Services Corp. officially opened a 40,000-sq-ft, state-of-the-art
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AAIPharma Services Corp. is a leading provider of contract services that encompass the entire process of pharmaceutical drug development from discovery through commercialization. The company’s wide array of capabilities includes analytical chemistry, formulation development, material testing services, microbiology, and clinical and commercial contract manufacturing and packaging. AAIPharma Services serves more than 500 clients around the globe. It is headquartered in
Ypsomed Launches New Commercial Product
Ypsomed recently announced it is expanding its mylife product range with the innovative self-injection system mylife DailyDose, which will initially be sold in six European countries. This Swedish innovation ideally compliments the mylife product range, which provides diabetes patients with an extensive selection of products that promote an active and independent lifestyle.
The credit-card sized self-injection system consists of three small syringes, which are prefillable with the diabetic’s daily insulin requirement. Mylife DailyDose can be tucked away comfortably and discretely and used as needed. The transparent case makes it possible to tell at a glance, which dose was already administered.
“Be it sport, travelling, or going out – for diabetics, it is not always practical to carry traditional injection or infusion systems. With mylife DailyDose, a reliable solution is always at hand, which outperforms existing alternatives with regard to practicability and costs. We are delighted to have mylife DailyDose in our mylife product range,” explained Simon Michel, Member of the Executive Board of the Ypsomed group.
The distribution contract with the Swedish manufacturer
The Ypsomed Group is a leading, independent developer and manufacturer of injection systems for self-medication and a renowned diabetes specialist with over 25 years of experience. Originated in 2003 from the famous company Disetronic, today it offers insulin pumps and injection systems as well as pen needles for the treatment of diabetes, growth disturbances, infertility, and other therapeutic areas. Ypsomed is regarded as a leader in innovation and technology and is the preferred partner of pharmaceutical and biotech companies in the self-medication field.
Ypsomed has established itself with the umbrella brands mylife Diabetescare and YDS Ypsomed Delivery Systems in retailing and in business-to-business trading. Under the brand name mylife Diabetescare, Ypsomed offers patients an extensive range of self-manufactured products or commercial products for treatment of diabetes. The range from YDS reflects the many years of experience and competence in the field of injection systems. With an innovative and patent-protected product line of pen systems and autoinjectors, which can be adapted to customer requirements, contract production in the development and production sectors as well as the assembly of injection systems with medications Ypsomed thus offers demand-orientated product and service solutions to pharmaceutical and biotech companies worldwide. For more information, visit www.ypsomed.com.
Strength of Aptalis Pharmaceutical Technologies Patents Confirmed by AMRIX Verdict
Aptalis Pharmatech, Inc. (previously known as Eurand, Inc.); Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceuticals Industries Ltd; and Anesta AG prevailed in their appeal to the US Court of Appeals for the Federal Circuit that reversed a lower court’s determination and held that two patents covering the AMRIX muscle relaxant (Cyclobenzaprine Hydrochloride Extended-Release Capsules) are valid. The full text of the Court’s decision can be found at: http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-1399-1409.pdf
The two patents, owned by Aptalis Pharmatech, Inc. and licensed to Cephalon, expire in 2023 and 2025. The patents, along with other additional patents that protect AMRIX, are all listed on the FDA’s Orange Book and will be enforced to the fullest extent possible.
AMRIX is a convenient extended-release (once-daily administration) dosage form of cyclobenzaprine that is indicated for short-term relief of muscle spasm as an adjunct to rest and physical therapy. Prior to the approval of AMRIX in 2007, only immediate-release formulations of cyclobenzaprine were available, such formulations often requiring administration two to three times daily. According to recent IMS data, Cyclobenzaprine is the most frequently prescribed drug for muscle relaxation in the
The use of Aptalis Pharmaceutical Technologies DIFFUCAPS Technology in AMRIX satisfies an unmet medical need by providing a modified-release formulation, once-daily dosing of cyclobenzaprine, thereby allowing for increased patient compliance.
“Aptalis Pharmaceutical Technologies endeavors to offer to our partners the most effective patent protection possible of our broad and diversified portfolio, and this court decision confirms the strength of these formulation patents,” said John Fraher, President of Aptalis Pharma.
The Aptalis portfolio is composed of numerous patents with broad claims directed to its formulation technologies and related materials, processes, equipment, and methods of manufacture. Aptalis also has many product-related patents, which contain more specific claims directed to particular drugs or classes of drugs in combination with its formulation technologies. Aptalis’ owned and in-licensed patent portfolio consists of over 900 granted patents and pending applications.
Aptalis Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODTs (orally disintegrating tablets) and other dosage forms. Together, these technology platforms combined with licensing, manufacturing, and R&D capabilities enable Aptalis Pharmaceutical Technologies to produce customized drug formulation solutions for partners across a range of dosage forms and therapies. Aptalis Pharmaceutical Technologies develops and manufactures products for its partners and supports the drug development process for the Aptalis Pharma pipeline and portfolio of products. For more information about Aptalis Pharmaceutical Technologies, visit www.AptalisPharmaTech.com.
Harlan & Ipsen Enter Agreement to Enhance Early Stage Development Services
Harlan Laboratories Contract Research Services (CRS) and Ipsen, a global specialty-driven pharmaceutical company, recently announced they have strengthened their collaboration with a new business agreement.
Under the terms of the agreement, the two companies have entered into a 3-year program on the development of early preclinical stage drug candidates with exclusivity in some specific areas. As a result, Harlan Laboratories has consolidated its standing in the early stage of the drug development process and has established itself as a leader in preclinical drug development.
Harlan Laboratories CRS is one of the world’s leading contract research organizations for the pharmaceutical, agrochemical, and chemical industries. The company offers a wide range of pharma services with particular expertise in inhalation, infusion, reproductive toxicology, neurotoxicology, immunology, genetic toxicology, oncology, and CNS.
The company’s specialized Pharma ADME (Absorption, Distribution, Metabolism and Excretion) department is primarily based at its site in
“This new agreement with Ipsen is in line with our strategy to satisfy the needs of the pharmaceutical industry in the preclinical arena and underlines our willingness to be close to our customers, helping them to make their drug candidates successful,” said Dr. Ciriaco Maraschiello, Head of Global General Toxicology, Harlan Laboratories CRS. “We are delighted to be working with Ipsen and believe this collaboration will offer clients an unrivalled level of expertise and support in the early development of new drug formulations. This is a very important agreement. which highlights our commitment to the pharma sector and reinforces our presence in the drug discovery segment of the drug development process.”
OncoSec ElectroChemotherapy Demonstrates Potential as Alternative to Surgery
OncoSec Medical Inc., which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, recently announced positive interim analysis of data from 81 subjects in a Phase IV study of primary and locally recurrent squamous cell carcinoma of the head and neck (HNSCC) treated with OMS ElectroChemotherapy in Europe. The study demonstrated the therapy’s ability to provide local tumor control and quality of life outcomes that compare favorably to standard outcomes associated with surgery. These results were presented at the 5th European Conference on Head and Neck Oncology in
The primary goal of this Phase IV head and neck cancer study was to assess the ability of the OMS ElectroChemotherapy to control growth or recurrence of the cancer 8 months following treatment, equivalent to surgery as compared to historical controls, with respect to primary (new) tumors and locally recurrent tumors. In this interim analysis, local tumor control was achieved in 46/49 (94%) primary tumors and 12/21 (57%) recurrent tumors. This meant that there was no recurrence of the tumors during the monitoring period. These were excellent results that were on par with the expected outcomes of surgery. Furthermore, evaluation of safety using the OMS ElectroChemotherapy for this patient population demonstrated that the treatment was safe and well-tolerated with no grade three or higher adverse events related to treatment reported during this study.
In addition, the secondary endpoint of preservation of organ function and appearance using validated quality of life instruments demonstrated a positive outcome. The functional outcome measurement to evaluate quality of life assesses the ability to swallow, normalcy of diet, and ability to eat in public and is often assessed by the Performance Status Scale for Head and Neck cancer (PSSHN); general quality of life was assessed by the European Organization for Research and Treatment of Cancer Core QOL questionnaire (EORTC QLQ). Treated patients showed a mean overall score of 264 at baseline versus 249 at 8 months (p = 0.3412), indicating no significant difference in quality of life following treatment with OMS ElectroChemotherapy. This is an excellent outcome; if the patient had been treated with surgery, the expectation and historical experience would result in a greater degradation of function and quality of life for these patients as determined by the PSSHN and EORTC QLQ scores. Therefore, treatment with OMS ElectroChemotherapy provided a significant benefit in maintaining quality of life while achieving an equivalent local control compared to surgery. Additional secondary endpoints for this study included evaluation of pharmacoeconomic factors (hospital costs, extent of medical interventions, and medication use) as well as clinical performance of the OncoSec Medical System and applicator. The conclusions regarding these endpoints were positive and will be reviewed in a final publication.
“There is a significant unmet clinical need for an alternative to surgery that selectively destroys cancer cells without harming normal healthy tissue,” said Dr. Paul Goldfarb, Medical Director of OncoSec and Principal Investigator of this study. “This therapy provides patients who would typically be subjected to disfiguring surgery with potentially improved treatment outcomes.”
Punit Dhillon, President and CEO, said, “Our OMS ElectroChemotherapy treatment provided safe and clinically beneficial outcomes for patients while maintaining quality of life. We strongly believe in the clinical relevance of the OMS ElectroChemotherapy program and believe these results will help prospective partners to better define the broad applicability and market opportunity for this novel treatment.”
This Phase IV pre-marketing study was conducted in 11 European clinical centers of excellence with institutional review board and competent authority approval and carried out under standard good clinical practices using OncoSec’s OMS ElectroChemotherapy treatment platform for primary and recurrent head and neck cancer.
OncoSec’s ElectroChemotherapy enables local application of a chemotherapeutic agent, bleomycin, directly into a tumor and the healthy margin of tissue surrounding the tumor and selectively kills cancerous cells. As opposed to surgery, this therapeutic approach can avoid removal of healthy tissue, providing beneficial appearance, organ function and quality of life outcomes.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers and metastatic disease. OMS ElectroOncology therapies address an unmet medical need and represent a potential solution for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec’s core technology is based upon its proprietary use of an electroporation platform, the OncoSec Medical System (OMS), to significantly enhance the delivery and uptake of a locally delivered DNA-based immuno-cytokine (OMS ElectroImmunotherapy) or chemotherapeutic agents (OMS ElectroChemotherapy). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec’s clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy targeting lethal skin cancers. More information is available at www.oncosec.com.
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