6/13/2012
Particle Sciences Expands cGMP Capabilities With Addition of Thin Films
Particle Sciences recently announced it has added new coating capabilities for preparing polymer film“based drug products from liquid formulations, under cGMPs.
According to Garry Gwozdz, Director, Formulation Services, “Particle Sciences’ purpose is to provide our clients with the most efficient drug product. Increasingly, we are seeing a demand for thin film“based products, particularly with respect to transdermal drug“eluting patch products, and rapidly dissolving strips. While we have been working in this area for some time, the acquisition of semi“automated coating equipment will allow us to screen more formulation approaches, and get our clients into the clinic faster with a commercially representative film“based product.”
Particle Sciences focuses on advanced drug delivery solutions, and is FDA registered and licensed for all schedules of controlled substances.
Mr. Gwozdz added that “Particle Sciences already had cGMP hot“melt film extrusion capability and now with the addition of coating and drying capabilities for liquid“based formulations, our clients have access to a complete array of viable and scalable film“manufacturing technologies.”
Particle Sciences is an integrated provider of drug development services. Particle Sciences focuses on BCS II/III/IV molecules, biologics, and highly potent compounds through a variety of technologies, including emulsions, gels, micro and nano particulates, drug/device combination products, solid solutions, and others. 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. For more information, visit www.particlesciences.com, email info@particlesciences.com, or call at (610) 861-4701.
Suzhou Pharma Services, an affiliate of Amerigen Pharmaceuticals, a new contract development and manufacturing organization specializing in solid oral dosage forms, recently announced its new corporate headquarters in
Suzhou Pharma Services is one of
The management team in
It combines Western pharmaceutical experience, expertise, and quality standards with Chinese productivity and cost advantages, offering a very attractive volume proposition to global customers.
Suzhou Pharma Services can deliver to pharmaceutical manufactures’ not only cost savings and high-quality products for Western and Global Markets, but also a local manufacturing solution for access to the growing Chinese pharmaceutical marketplace. For more information, visit www.suzhoupharma.com or email at info@suzhoupharma.com.
ZIOPHARM Doses First Patient in Phase III Cancer Study
ZIOPHARM Oncology, Inc. recently announced that the first patient has been dosed in the MATISSE study (Multicenter Adaptive Trial Investigating Small cell lung cancer Survival Endpoints), a pivotal Phase III multi-center, open-label, adaptive, randomized study of palifosfamide for the treatment of small cell lung cancer. ZIOPHARM has also recently announced the completion of enrollment in its Phase III study of palifosfamide in combination with doxorubicin for the treatment of metastatic soft tissue sarcoma in the front-line setting (PICASSO 3).
The MATISSE study is designed to enroll up to 548 chemotherapy naive patients with extensive-stage small cell lung cancer. Eligible patients will be randomized, one-to-one, to receive either palifosfamide in combination with carboplatin and etoposide (PaCE) or carboplatin and etoposide alone. The trial’s primary endpoint is overall survival.
Secondary endpoints include progression-free survival, objective response rate, and quality of life. MATISSE will be conducted at centers in North America, Europe,
“Small cell lung cancer is an extraordinarily difficult-to-treat cancer, for which there has been no novel treatment in decades,” said Lawrence Einhorn, MD, Distinguished Professor at the Simon Cancer Center of Indiana University Medical Center, Lance Armstrong Foundation Chair in Oncology, former President of ASCO and a member of ZIOPHARM’s Medical Advisory Board. “An important element of treating the disease is to find an agent that is safe and has minimal variability between patients. Palifosfamide has demonstrated broad therapeutic activity, including effects against cancer stem cells, as well as good tolerability alone and in combination with various chemotherapeutics.
MATISSE incorporates a novel, adaptive study design that should provide a clinically meaningful understanding of palifosfamide’s activity and tolerability in advanced disease as quickly as possible for this heavily underserved population.”
The study’s adaptive design includes a prospectively planned opportunity for modification of the study protocol by adjusting one or more specified components of the design in order to maintain adequate power. Evaluation of the study’s powering will be conducted by an Independent Data Monitoring Committee (IDMC) at a single, pre-planned interim analysis, scheduled to occur following 125 events. At the interim analysis, the IDMC will review all efficacy and safety data and decide whether to: 1) halt the study for efficacy or futility, 2) continue the study to its planned enrollment of 548 patients, 3) decrease sample size, or 4) increase event size.
The MATISSE study is designed around clinical data from several studies of palifosfamide, including a Phase Ib, open-label, dose escalation study of intravenous palifosfamide in combination with etoposide and carboplatin in patients with SCLC and other selected cancers, which demonstrated good tolerability and a clinical benefit rate of 67%. Data from a Phase III randomized study of ifosfamide, an in-class DNA-targeted anti-cancer therapy, conducted by the Hoosier Oncology Group (HOG) were also incorporated in to the efficacy rationale for the MATISSE study.
In this HOG study, ifosfamide demonstrated a survival benefit, the only front-line therapy added to standard of care to do so in SCLC, but was not pursued due to the excessive toxicities.
ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The company’s clinical programs include:
Palifosfamide (ZIO-201), a novel DNA-targeted cancer treatment that bypasses drug resistance mediated by ALDH (aldehyde dehydrogenase), an enzyme associated with cancer stem cells, and has a favorable toxicity profile. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase III trial (PICASSO 3) for the treatment of front-line metastatic soft tissue sarcoma and is also in a pivotal Phase III trial (MATISSE) for front-line metastatic small cell lung cancer. Additionally, the company is developing an oral capsule form of palifosfamide.
IL-12 DNA, a novel DNA therapeutic that is delivered to the patient’s tumor and expresses interleukin-12, a protein that controls anti-cancer immune responses. IL-12 DNA is currently in two Phase I studies, with plans to move into Phase II studies. ZIOPHARM’s DNA therapeutics are being developed in partnership with Intrexon Corporation through a revolutionary synthetic biology platform that allows for targeted, controlled production of therapies in humans with a biologic on/off switch (the RheoSwitch Therapeutic System. Preclinical and discovery work with multiple therapeutic approaches, such as antibodies, immunotoxins, and protein decoys, is expected to result in multiple clinical candidates in the next 12 to 24 months.
Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase I/II trial in metastatic breast cancer.
Darinaparsin (ZIO-101) is a novel mitochondrial- and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.
For more information, visit www.ziopharm.com.
GSK Successfully Uses Capsugel’s Licaps
Capsugel recently announced that its Licaps liquid-filled hard capsules have been successfully used by major healthcare company, GlaxoSmithKline (GSK), for the most established brand in the German urological market, GRANU FINK.
After initially launching the product in a soft gelatin capsule form, GSK’s Consumer Healthcare Division decided to investigate other dosage form options to try and improve the product’s quality and reduce its production-to-market lead time. GRANU FINK’s active ingredients, pumpkin seeds extracts, and pumpkin oil, were challenging to encapsulate because of the large particle size and required a long maturing period when encapsulated in traditional softgels. After testing a switch to Capsugel’s Licaps technology, GSK found the product to be leak-free and have now reduced their product lead times by an amazing 12 weeks.
“After comparing two different automated capsule sealing techniques, the Licaps capsules had intact seals during the complete period of stability testing, and we could not detect any leakage,” said Dr. Stephan Wurtz, Head of Production at GSK in Herrenberg. “Capsule integrity is a key parameter used to predict product shelf-life and especially helps with preventing too many product returns, and this is why we ultimately chose the Licaps liquid-filled hard capsules as our dosage form.”
Since Licaps capsules entered the market nearly 10 years ago, Capsugel has made multiple technological advances, including an enhanced mechanical seal with a seal zone six times greater than a banded capsule. And while they are able to effectively mask taste and odor, Licaps capsules also offer many branding options that may improve loyalty when compared with other dosage forms. According to Capsugel’s research, consumers perceive Licaps capsules to be high-quality, modern, and natural looking in a dosage form that is memorable, easy to recognize, and easy to swallow. GSK also conducted their own consumer survey to test the visual and handling acceptance of the Licaps dosage form among regular users of GRANU FINK femina, and 73% of consumers were positive about the new Licaps liquid-filled hard capsule format.
And Licaps liquid-filled hard capsules provide a solution for a variety of challenging compounds. It can improve bioavailability for poorly soluble compounds while providing effective formulation options for low-melting point compounds and safe formulation of low-dose/high potency actives. Licaps manufacturing also offers an established and robust process with the flexibility to allow for production in-house or by Capsugel. With a straightforward manufacturing transfer, including the installation of Liquid Encapsulation Microspray Sealing (LEMS) technology, Licaps capsules can even use the same line as powder-filled capsules and are sealed and dried in a
“The Licaps system has integrated well with our Bosch capsule filling equipment, and because of the expert technical assistance we had from Capsugel’s installation and formulation teams, we put in place a number of new validated production processes with five fully trained operators in a very short time,” added Dr. Wurtz. “During one shift using the Licaps system, up to 350,000 Licaps capsules can be filled. We now have full in-house control of the manufacture of our drug and supplement lines, which gives us a number of benefits.”
“We are delighted that a company such as GSK was willing to embrace and test Licaps capsules so extensively with their new pharmaceutical and nutraceutical product lines,” said Keith Hutchison, Senior Vice President of R&D at Capsugel. “Their work leads the way for other pharma and healthcare companies seeking rapid scale up and production of high-integrity liquid-filled hard capsules.”
For more information, visit www.capsugel.com.
Zogenix & Mallinckrodt Enter Exclusive Agreement
Zogenix Inc. and Mallinckrodt LLC recently announced an exclusive co-promotion agreement for SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System in the
Under terms of the agreement, Mallinckrodt’s sales team will begin selling SUMAVEL DosePro to its customer base of prescribers. The initial term of the agreement will be through June 30, 2014, and can be extended by mutual agreement of the parties in additional 6-month increments. Zogenix will continue to record all product revenues, and Mallinckrodt will be compensated in the form of a quarterly service fee that is calculated as a percentage of net sales over a baseline amount to their prescriber audience.
SUMAVEL DosePro is the first and only needle-free delivery system for subcutaneous sumatriptan for the treatment of acute migraine and cluster headache. Clinical data has shown that SUMAVEL DosePro can provide migraine pain relief within 10 minutes for some patients (16% of patients versus 4% for placebo). The product was launched in January 2010, and sales have grown sequentially every quarter since launch, reaching over 129,000 total prescriptions at the end of the first quarter 2012.
“We are pleased to have Mallinckrodt join our efforts to bring SUMAVEL DosePro to a broader audience of prescribers who are committed to helping patients manage the debilitating impact of migraine,” said Roger Hawley, CEO of Zogenix. “Adding Mallinckrodt’s large sales force to the efforts of our 95 sales representatives will double our reach to prescribers of migraine products and significantly expand our sales coverage for SUMAVEL DosePro within the primary care market. The Mallinckrodt team has extensive experience in the pain market, and is committed to educating their customers on the unique benefits of adding SUMAVEL DosePro as an exciting migraine treatment option. Our team will remain engaged with neurologists, headache specialists, and other key migraine prescribers while working closely with our new partner at the field level to effectively drive sales and implement our new sales campaign, which we’ve recently introduced.”
“We are leaders in pain management, and the inclusion of SUMAVEL DosePro to our sales efforts allows us to grow in that space, as we prepare to spin-off from Covidien next year,” added Mark Trudeau, President of Mallinckrodt. “We look forward to working with Zogenix and to launching SUMAVEL DosePro to our customers.”
Zogenix, Inc. is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. For more information, visit www.zogenix.com.
Protalix Biotherapeutics Gets $25-Million Milestone Payment
Protalix BioTherapeutics, Inc. recently announced it has received a $25-million milestone payment from Pfizer Inc. as part of the companies’ global commercial agreement for ELELYSO (taliglucerase alfa). This payment was triggered by the US FDA’s approval of ELELYSO for the treatment of type 1 Gaucher disease on May 1, 2012.
On November 30, 2009, Pfizer and Protalix entered into an exclusive license and supply agreement relating to the development and commercialization of ELELYSO. Under the terms of the agreement, Protalix granted Pfizer an exclusive, worldwide license to ELELYSO except in
Upon signing the license and supply agreement in November 2009, Pfizer made an up-front payment of $60 million to Protalix and subsequently made a $5-million payment to Protalix upon Protalix’s achievement of a performance milestone.
On March 31, 2012, Protalix had cash and cash equivalents $45.6 million. On a proforma basis, including the receipt of the $25-million milestone payment for the approval of ELELYSO in the
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. For more information, visit www.protalix.com.
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