BASF & Medi-Solve Coatings to Develop Multifunctional Coating Solutions for Medical Devices

BASF Future Business GmbH and Medi-Solve Coatings LLC recently announced a collaboration in the field of antimicrobial coatings for catheters and other minimally invasive medical devices. This collaboration combines Medi-Solve’s proprietary AquaCoat® coating technology with BASF Future Business’ proprietary HyGentic® silver-based antimicrobial additive platform. Medical device manufacturers will benefit from the enhanced safety and performance of these customized multifunctional coating solutions developed through this collaboration. Both companies presented their respective portfolios at the Medical Design & Manufacturing (MD&M) West Show in Anaheim, CA, this month.

BASF Future Business GmbH opens up new business opportunities for BASF, the Chemical Company. “In the area of medical devices materials, we are expanding our offering by developing enabling solutions for our customers in partnership with highly innovative companies, such as Medi-Solve Coatings LLC,” said Stefan Becker, Senior Manager, BASF Future Business GmbH. “Medi-Solve brings many years of experience in medical device coatings to this collaboration, and we are excited to work with their team. New functional materials for medical applications not only improve the standard of medical care for an aging population, but also address important economic needs, such as the cost pressure in the healthcare system.”

“Medi-Solve is pleased to collaborate with BASF, a world leader in antimicrobial technology,” added Ron Sahatjian, PhD, President and CEO of Medi-Solve Coatings. “Medi-Solve Coatings will be using its proprietary and patented coating technology to apply BASF’s HyGentic antimicrobial additives to dialysis catheters, PICC lines, and other catheters known to have high infection rates in clinical applications. This collaboration benefits clinicians and patients around the world by reducing possible sources of infection and improving the standard of care.”

Medi-Solve Coatings, a leading innovator in medical device coatings, works exclusively with medical device companies to provide unique and extensive coating expertise. The company is highly regarded as a coatings expert with over 40 years of industry experience and an in-depth understanding of medical device requirements. From product design through manufacturing, it is dedicated to continually improving its platform and processes for coatings and custom formulations. Medi-Solve Coatings can provide drug-eluting surfaces, anti-microbial surfaces, lubricious surfaces, or multi-functional surface properties for medical device.

Capsugel Acquires Novel FlexTab Delivery Technology

Capsugel, the world’s leading hard capsule manufacturer and an innovator in drug delivery systems, recently announced its acquisition of the FlexTabTM technology, a novel dosage form developed throughout the past 8 years within GlaxoSmithKline (GSK). The technology uses injection-molding processes to produce unique capsule-shaped dosage forms that offer a new platform for formulating a wide range of new pharmaceutical and consumer health products. The deal between Capsugel and GSK was brokered by SR One, GSK’s corporate venture fund.

“Capsugel is very excited to have this innovative technology as part of our suite of offerings”, said Keith Hutchison, Vice President of Research and Development at Capsugel. “We believe the FlexTab technology’s unique performance characteristics and novel presentation will enable us to formulate the next generation of pharmaceutical and biotech products for our customers. With fewer new drug entities coming to market, our customers are looking for other ways to improve the therapeutic effectiveness of existing APIs for patients and consumers, for example, through better patient compliance and convenience.”

The FlexTab technology allows for a variety of fill materials, including powders, pellets, liquids, micro-tablets and tablets, and can even deliver separate liquid and powder APIs in one dose. This innovation opens the door to novel product designs and customization options. It extends Capsugel’s capsule technology beyond the well-established dip-molding process used today, expanding into higher value segments and offering enhanced value for customers.

Capsugel is moving forward immediately to bring the technology and assets in-house with plans of making the new dosage form available to customers as soon as possible. Capsugel, a business of Pfizer Inc., is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, liquid-filled, and vegetarian capsules, to innovative R&D equipment and liquid formulations as part of its Licaps® Drug Delivery System, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production.

Particle Sciences & HORIBA Instruments Form Strategic Relationship

Particle Sciences, Inc., a leading pharmaceutical CRO, recently announced the establishment of a strategic alliance with HORIBA Instruments of Irvine, CA, which is the US sales and marketing division of HORIBA Limited of Kyoto, Japan. This alliance ensures that both client bases are provided with a total solution, combining the most up-to-date physical characterization tools with operational expertise in a fully GLP/GMP compliant setting. Under the arrangement, the full array of HORIBA characterization tools will be available at Particle Sciences.

“The need for particle size analysis and physical characterization in general is growing rapidly within this highly regulated environment,” said Dr. Robert Lee, Vice President of Pharmaceutical Development at Particle Sciences. “Particle Sciences is a world leader in particulate formulations and drug/device combination products. We looked for a partner that shared the same commitment to quality and innovation, and HORIBA fit the bill.”

With this in place, HORIBA clients will have a resource that can both develop and perform characterization under cGLPs and cGMPs. “Our client base ranges from start-ups to the largest multinational Pharma and Biotech companies, said Dr. Mike Pohl, HORIBA’s Vice President. “For a variety of reasons, we are often asked if we can recommend a site familiar with pharmaceutical development at which they could have work performed. We have worked with Particle Sciences for some time and have been impressed with their facility and their team. By entering into this relationship, we can ensure that our clients not only gain access to the most advanced technology, but also that the operators are highly trained to use the instruments to their fullest capability.”

“Particle Sciences is committed to remaining one of the premier drug delivery development services providers,” added Dr. Lee. “We offer a broad array of drug delivery technologies and routinely work on atypical dosage forms. It’s critical that our analytic and characterization capabilities keep pace with our formulation expertise. Additionally, as our clients scale to clinical and ultimately commercial processes, we need to ensure the methods we develop are phase appropriate and based on readily available techniques. HORIBA is the world’s largest instrument manufacturer with the most complete product offering and can now provide the level of security our clients deserve.”

“Many pharmaceutical customers are located along the East Coast,” said Dr. Pohl. “The combination of our Edison, NJ, headquarters plus the Bethlehem, PA, location of Particle Sciences, Inc., gives HORIBA a strong one-two punch to support these customers. Services ranging from sample analysis, customer support, and full consulting services will now be readily accessible to our customers.”

The HORIBA Group of worldwide companies provides an extensive array of instruments and systems for applications ranging from automotive R&D, process and environmental monitoring, in vitro medical diagnostics, semiconductor manufacturing, and metrology, to a broad range of scientific R&D and QC measurements. Proven quality and trustworthy performance have established widespread confidence in the HORIBA Brand.

Particle Sciences is an integrated provider of drug development services with deep expertise in micro- and nano-particulate drug delivery technologies and drug/device combination products with additional specialized capabilities in topical and mucosal drug products. 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.

Pantec Biosolutions Reports First Successful IVF Pregnancy Using P.L.E.A.S.E.

Pantec Biosolutions AG recently announced that a woman has successfully conceived after being implanted with a fertilized oocyte (egg cell). The oocyte donor was treated with the company’s FSH (follicle stimulating hormone) patch subsequent to skin microporation with Pantec’s proprietary P.L.E.A.S.E.® (Painless Laser Epidermal System) device. The pregnancy is the first to occur from a previously announced study in which follicular maturation was achieved using P.L.E.A.S.E. microporation and the FSH (IVF002) patch. Following the oocyte donation, the fertilized egg was transferred to the recipient, who subsequently became pregnant. The trial team was led by principal investigator, Dr. Petr Uher and medical expert, Professor Herbert Zech.

“We are very pleased that our treatment has helped a patient conceive, and we wish her the best throughout her pregnancy,” said Christof Boehler, CEO of Pantec Biosolutions. “This is an extremely important milestone not only for our company, but also for all women undergoing IVF treatments. It is a big step toward making the tedious IVF procedure more comfortable for all those hoping to get pregnant.”

Pantec Biosolutions AG is a private drug delivery company specialized in using laser microporation technology to deliver large molecular weight drugs into the epidermis for local or systemic uptake. Its proprietary P.L.E.A.S.E. (Painless Laser Epidermal System) platform enables efficient, needle-free, and painless administration of biopharmaceutical drugs, in varying and individualized dosages, through partnered patch technology. The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of $1.5 to $2 billion. Pantec Biosolutions’ P.L.E.A.S.E. platform is available both for the development of the company’s own pipeline and for penetration into new markets through strategic partnerships.

Zogenix Announces Completion of Enrollment for ZX002 Phase III Efficacy Study

Zogenix, Inc. recently announced the completion of enrollment in its pivotal Phase III efficacy study (Study 801) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate-to-severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

Study 801 is a randomized, 12-week, double-blind, placebo-controlled trial evaluating ZX002 in opioid-experienced adult subjects with moderate-to-severe chronic lower back pain. The primary efficacy endpoint is the mean change in average daily pain intensity scores between ZX002 and placebo.

Initial top-line data from Study 801 and an open-label Phase III safety study (Study 802) are anticipated to be available during the second half of 2011. As previously announced, Zogenix has completed enrollment of Study 802 to evaluate overall safety of ZX002 in patients for up to 1 year.

Pending positive Phase III clinical results, Zogenix expects to submit an NDA for ZX002 with the US FDA by early 2012. If approved, ZX002 has the potential to be the first controlled-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic. This novel formulation has the potential to address safety concerns outlined by the FDA regarding the use of certain combination prescription pain products that contain acetaminophen, which can cause liver toxicity at high doses over time. In January 2011, the FDA announced that manufacturers of certain prescription pain products containing acetaminophen will be required to reformulate or discontinue making these products within 3 years.

“After completing enrollment in both Phase III studies, ZX002 remains positioned as the first potential single-entity, controlled-release hydrocodone product,” said Stephen J. Farr, PhD, President and Chief Operating Officer. “Because it does not contain acetaminophen and allows for convenient twice-daily dosing, ZX002 may fulfill a beneficial treatment option for both patients using immediate-release hydrocodone combination products on a chronic basis and an alternative for patients already using extended-release opioids for the management of their moderate-to-severe pain. We look forward to obtaining top-line safety data from Study 802 and efficacy and safety data from Study 801 during the second half of this year to support a potential NDA submission by early-2012.”

Progenics & Salix Announce Worldwide License Agreement

Progenics Pharmaceuticals, Inc. and Salix Pharmaceuticals, Ltd. recently announced they have entered into an exclusive worldwide (except Japan) agreement by which Salix has licensed rights to RELISTOR® (methylnaltrexone bromide). RELISTOR Subcutaneous Injection is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond 4 months has not been studied.

RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. The methylnaltrexone license includes intellectual property from the University of Chicago, Progenics Pharmaceuticals, and Wyeth Pharmaceuticals, including patents and applications with expiration dates that will range from 2017 through 2031. RELISTOR was approved in the US in 2008, and currently, the drug is approved for use in over 50 countries worldwide. In 2010, RELISTOR single-use, prefilled syringes were approved for use in the US, Canada, and the European Union. Worldwide net sales of RELISTOR totaled $16 million in 2010.

Financial terms of the transaction include a $60 million up-front payment and development milestones totaling $90 million, contingent upon the achievement of certain US regulatory milestones. Salix also will pay sales-based milestones of up to $200 million plus royalties on product sales in the US, as well as 60% of all revenue received from non-US sublicensees. Salix will fund all development, registration, and commercialization activities for RELISTOR in markets worldwide other than in Japan, where Progenics has licensed to Ono Pharmaceuticals the rights to develop and commercialize subcutaneous RELISTOR.

Salix will market RELISTOR directly through its specialty sales force in the US, and outside the US, RELISTOR will be marketed with sublicenses to regional companies. The parties plan an April 2011 transition of RELISTOR commercial and development responsibility to Salix from Pfizer Inc, which acquired Progenics’ former RELISTOR partner, Wyeth Pharmaceuticals. While Salix effects a country-by-country transition of ex-US commercialization rights, Wyeth will remain the Marketing Authorization Holder for RELISTOR and will continue to supply product. In the interim, Wyeth remains responsible for all manufacturing, clinical, medical, and regulatory activities for RELISTOR outside of the US and Japan.

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