Apricus Biosciences Announces NexACT Partner Has Completed pre-IND Meeting

Apricus Biosciences, Inc. recently announced its NexACT out-licensing partner, Exodos Life Science Limited Partnership, has completed a successful pre-IND meeting with the US FDA regarding its plan to conduct clinical trials to establish the safety and effectiveness of its patented, topical painkilling drug, ELS115, containing NexACT technology licensed from Apricus Bio.

Specifically, the meeting was a successful milestone in Exodos’ effort to file an IND with the FDA for a topical NSAID, combining the existing drug, ketoprofen, with Apricus Bio’s NexACT technology. The NexACT technology is designed to permit drugs to be delivered through the skin with enhanced absorption and bioavailability.

Exodos licensed Apricus Bio’s NexACT technology for the topical delivery of drugs to treat pain and inflammation. “We are very encouraged by the progress achieved thus far by Exodos, for its topical NSAID product, which the company currently expects to be ready for IND filing by mid-2012,” said Bassam Damaj, PhD, President and Chief Executive Officer of Apricus Bio. “The out-licensing of our NexACT technology has allowed Exodos to move more quickly toward its clinical goals for its first product in this important disease area.”

Apricus Bio noted that Exodos is expected to be the first NexACT technology out-licensing partner to file for approval to initiate a human clinical program.

NSAIDs, such as ibuprofen and ketoprofen, have been in use for decades, successfully reducing pain and inflammation for millions of patients. However, while these drugs work well in pill form, there are many conditions for which the ability to target the drug in a localized manner, such as for treatment of arthritis in the hands, may be advantageous. To date, the challenge has been that these drugs exhibit poor skin penetration, making such efforts to deliver them locally, unsuccessful.

This challenge may be solved by Apricus Bio’s NexACT technology, which is intended to open up the tight junctions between skin cells. As a result, certain drugs attached to proprietary NexACT chemicals may pass through the skin to reach their targets. Exodos’ drug, ELS115, a combination of NexACT technology and ketoprofen, may provide an effective and safe treatment of mild-to-moderate peripheral pain.

If the clinical studies establish that the drug is safe and can be delivered through the skin right where it is needed, the product may be an important alternative for patients with localized pain and who may also have a history of gastrointestinal, kidney or liver problems that may be exacerbated by drugs taken in pill form, be geriatric or pediatric patients, and/or patients at risk for drug interactions, if the levels of circulating ketoprofen are very low to non-existent. Exodos selected ketoprofen as the active ingredient for its drug because ketoprofen has a decades-long record of safe clinical use.

Exodos Life Sciences is a privately held pharmaceutical development company that focuses on advancing new product concepts through the 505(b)(2) process to early clinical proof-of-principle, followed by asset (project) sale. Exodos has adopted a semi-virtual model to control costs and advance projects by utilizing its experienced team and on-call external pharmaceutical experts and partners.

Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically validated NexACT drug delivery technology to enable multi-route administration of new and existing compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide.

In addition, the company is seeking to monetize its existing Rx Division product pipeline, including its first product, Vitaros, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from preclinical through Phase III, currently focused on sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes, and cosmeceuticals among others.

The company is also developing its Consumer Healthcare Division by developing a number of drugs that utilize the company’s NexACT technology to comply with the FDA’s OTC requirements, can be cleared as 510(k) topical creams that are considered to be medical devices, or approved as 505(b)(2) NDAs or ANDAs as generic drugs. The company will also seek to market such drugs through these similar procedures in foreign countries.

Bend Research Signs Technology Licensing Agreement With Merck

Bend Research Inc., a leading independent drug formulation development and manufacturing company, recently announced it has entered into a licensing agreement with Merck, through a subsidiary.

Under the terms of the agreement, Bend Research will provide Merck access to its proprietary spray-dried dispersion (SDD) technology. Depending on Merck’s additional needs, Bend may also provide Merck with access under the license agreement to additional drug delivery platforms and intellectual property, including modified-release technologies and drug discovery formulation tools.

Under the collaboration, the two companies hope to use their complementary fundamental scientific and engineering capabilities to solve complex formulation and process-development problems with an eye toward transferring these solutions to a cGMP environment.

“We are excited to extend our working relationship with Merck,” said Rod Ray, Chief Executive Officer of Bend Research. “Building stronger collaborative relationships with leading companies like Merck is important to Bend Research’s future. This relationship expands our opportunities to deliver best-in-class medicines and fits well with Merck’s mission to help provide innovative products that save and improve people’s lives.”

For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding.

Bend Research provides formulation and dosage-form support, assists in process development and optimization, manufactures clinical trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in novel formulations, including solubilization technologies, such as SDDs and hot-melt extrusion formulations, as well as controlled-release, inhalation, and biotherapeutics technologies. Bend Research has more than 240 employees based in four state-of-the-art facilities in Bend, OR.

INNERCAP Technologies Granted Patent Application for Capsular Delivery System

INNERCAP Technologies, Inc., an international drug delivery and specialty pharmaceutical company, recently announced the grant of Canadian Patent Application No. 2,481,486 titled Multi-Phase, Multi-Compartment Capsular Delivery System. The delivery system has uses for biopharmaceutical, pharmaceutical, medical foods, and nutraceutical products. In addition to the existing US, Australian, and New Zealand patents, this new Canadian patent covers the company’s multi-phase multi-compartment capsular delivery system used to enable the development of multi-compartment, multi-phase two-piece capsule delivery forms of advanced combination controlled-release products.

“This is another significant development for INNERCAP Technologies multi-phase, multi-compartment NOVACAP technology,” said Fred H. Miller, Chief Executive Officer at INNERCAP. “The continued growth of our patent portfolio establishes INNERCAP as one of the leading companies in this space in North America and globally.”

The delivery system and combinations covered by the patent have the ability to deliver therapeutic entities that have never been combined previously and now can be administered together, via an oral, implanted, or suppository capsule, in the most advantageous pharmacokinetic profile, utilizing different physical phases. This technology can therefore be used to enable capsule administration of compounds that are not normally administered as a combination product. The efficacy, safety, and side-effect profiles of drugs can be substantially improved using this delivery technology. It will also provide very significant quality-of-life improvements for patients and substantial economic savings for hard-pressed healthcare systems.

“INNERCAP’s multi-phase, multi-compartment technology has been commercially manufactured and validated in several products, demonstrating that INNERCAP’s multi-phase capsule delivery system creates real value to consumers and branded manufacturers,” added Mr. Miller.

INNERCAP was represented by Clifford M. Davidson, Esq. of the patent firm Davidson, Davidson & Kappel, LLC based in New York City, NY.

Unilife Corporation Announces Pricing of Common Stock Offering

Unilife Corporation recently announced the pricing of its underwritten registered public offering of 8,250,000 shares of common stock at a public offering price of $4.35 per share. All of the shares in the offering are to be sold by Unilife. In connection with the offering, the company also granted the underwriters a 30-day option to purchase up to an additional 1,237,500 shares of common stock to cover over-allotments, if any.

The net proceeds of the offering to the company, after deducting the underwriting discount and estimated offering expenses, are expected to be approximately $33,808,125, exclusive of any proceeds attributable to the underwriters’ possible exercise of their over-allotment option. Unilife expects to use the net proceeds from this offering to fund the continued development and commercial supply of its diversified portfolio of advanced drug delivery systems, the expansion of its workforce to support anticipated customer demands, and for working capital and other general corporate purposes. The offering is expected to close on November 21, 2011 and is subject to customary closing conditions.

Jefferies & Company, Inc. is acting as sole book-running manager for the offering. Leerink Swann LLC is acting as co-lead manager for the offering and Griffin Securities, Inc. is acting as co-manager for the offering.

Unilife Corporation is a US-based developer and commercial supplier of a diversified portfolio of advanced drug delivery systems. Unilife collaborates with pharmaceutical and biotechnology companies seeking to optimize drug lifecycles and generate differentiation for their brand in competitive therapeutic markets through the use of innovative devices that can improve patient care, protect healthcare worker, and prevent disease. Unilife has developed a broad portfolio of drug delivery systems in direct response to unmet market needs for macromolecule injectable drugs, including biologics.

Porex Corporation Introduces POREX BioDesign Glass Fiber

Porex Corporation, a proven market leader in porous media solutions for the healthcare, industrial, and consumer markets, has recently launched an innovative line of glass fiber designed to deliver precision, accuracy, and reliability when used in the most challenging filtration, separation, extraction, and purification procedures. Manufactured in various particle retention sizes and thicknesses, Porex BioDesign Glass Fiber helps prevent premature clogging and compromising flow rates when processing large volumes and challenging solutions. It can be used in a wide array of life science and diagnostic applications, including spin columns, assay plates, purification kits and IVD sample wicks, absorbent pads, and conjugate release.

“Porex is committed to developing innovative solutions that meet the needs of our healthcare and life science customers,” said William Midgette, President and Chief Executive Officer of Porex. “Our BioDesign Glass Fiber is just one of the many products that demonstrate our commitment to delivering high-quality products that provide our customers with the peace of mind they deserve.”

In addition to being binder-free, Porex BioDesign Glass Fiber offers advanced features and functionality, including Borosilicate Glass Fiber Membrane, Borosilicate Glass Fiber Composite with Porous Membrane, Hydrophilic, Fast Flow Rates, High Loading Capacity, Wide Thermal Tolerance, Easily Compressible, Large Surface Area for Optimized Retention Capacity, and Excellent Wet Strength for Membrane Handling and Integrity.

Founded in 1961 and based in Fairburn, GA, Porex is a pioneer and global leader in the development and manufacturing of sintered porous plastic products. The company primarily serves the healthcare and bioscience end markets, and also supports high-performance applications in the consumer and industrial sectors. Porex products serve filtration, venting, wicking, and diffusing functions in applications, such as blood filters, catheter vents, specialty filters, and consumable diagnostic tests.

Porex is widely recognized for its materials science expertise and proprietary designs that serve over 1,300 customers across more than 65 countries via operations in North America, Europe, and Asia. Constant innovation, outstanding technological resources, commitment to quality, and dedication to customer service distinguish Porex products as the standard of performance.

MonoSol Rx & Midatech Ltd Receive Authorization to Conduct Phase I Human Trials

MonoSol Rx, the developer of PharmFilm drug delivery technology, and its collaboration partner Midatech Ltd., a global leader and centre of excellence for the design, development, synthesis, and manufacture of nanomedicines, recently announced that is has received authorization from the Swissmedic, the Swiss regulatory agency for therapeutic products, to initiate a Phase I clinical trial in Switzerland of gold nanoparticle/insulin incorporated into PharmFilm in healthy volunteers.

The first-in-human clinical trial is designed to assess the safety profile of gold nanoparticle bound insulin when administered transbuccally to healthy volunteers. The study is a single, ascending dose, double blind study in 27 male volunteers using a eu-glycemic clamp. This Phase 1 study will be performed in a clinical research unit near Basel, Switzerland, and results of the trial are expected during Q1 2012.

“This trial represents a major advancement in the treatment of diabetes and for the millions of patients worldwide who have been waiting for an easy-to-administer oral insulin formulation that eliminates the need for injection,” stated A. Mark Schobel, President and CEO of MonoSol Rx. “We are very excited that our extensive preclinical work has satisfied the Swissmedic and to be part of a groundbreaking study that could pave the way for developing an effective transbuccal insulin therapy for this significant unmet medical need.”

The two companies are developing methodologies for the delivery of nanoparticle therapeutics under a partnership that leverages MonoSol Rx’s PharmFilm and Midatech’s biocompatible nanoparticles to develop transbuccal bioavailable formulations.

In addition, MonoSol Rx and Midatech are also evaluating additional peptides, including GLP-1, for oral buccal delivery. The first GLP-1 porcine study received positive results and the groups are now moving towards completing preclinical testing.

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm technology to deliver drugs in films. PharmFilm is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and OTC drug products, a pipeline of prescription formulations based on PharmFilm technology, and two recent FDA approvals (Zuplenz, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone sublingual film, the first sublingual film product for the treatment of opioid dependence).

MonoSol Rx’s commercialization strategy for all PharmFilm products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilm is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules, and orally disintegrating tablets. For existing and future partners, PharmFilm formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.