Carticept Medical Receives 510(k) Clearance for Navigator Delivery System

Carticept Medical, Inc., a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, recently announced it has received clearance from the FDA to market its Navigator Delivery System (Navigator DS) in the US.

The Navigator DS is a computer-controlled, drug delivery system designed to automate preparation and delivery of pain-relieving medications for joint pain. The system prepares physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials. In addition to eliminating multiple needle exposures to healthcare workers and minimizing the potential for contamination of the medication, automating this procedure ensures accurate dose preparation and saves significant labor for a busy physician practice. The injection is then delivered into the painful joint under precise computer control. The Navigator DS automates accurate medical record keeping by recording the treatment data for transfer to an electronic record management system or direct print-out.

“The Navigator DS is the first injection system of its kind ,” said Timothy J. Patrick, President and Chief Executive Officer of Carticept. “Receiving FDA clearance is an important milestone for Carticept Medical that will allow us to launch this proprietary technology to the US orthopedic and sports medicine market.”

“This technology can be a valuable tool for the accurate and efficient delivery of injections,” added John Reach, MD, Director, Yale Foot and Ankle Service, Department of Orthopaedic Surgery, Yale University School of Medicine. “This system can significantly enhance practice logistics and increase patient throughput in orthopedic and sports medicine clinics.”

Based in Alpharetta, GA, Carticept Medical, Inc. is a privately held medical device company established in 2005 to develop and market innovative solutions for patients with osteoarthritis or cartilage damage. Major investors include Domain Associates, New Enterprise Associates, and SonoSite, Inc.

Unilife Wins Supply Contract With Nation’s Largest Healthcare Alliance

Unilife Corporation recently announced it has been awarded a 2-year contract by Premier Purchasing Partners, L.P., the group purchasing enterprise of the Premier healthcare alliance, for the supply of its Unitract 1-mL safety syringes.Premier, Inc. is the nation’s largest healthcare alliance, helping to improve performance and providing group contracting to more than 2,500 US hospitals and over 76,000 healthcare sites nationwide.

“Our Unitract 1-mL safety syringes, which are designed for use when drawing medication from a vial or ampoule, can provide optimal protection to healthcare workers and others at risk of infection from needlestick injuries. Unitract represents the first and only known range of insulin and tuberculin syringes with automatic, operator-controlled needle retraction features that are fully integrated within the syringe. We are delighted to have signed our first Group Purchasing Organization (GPO) contract with Premier for the sale of our Unitract 1-mL syringes to US healthcare facilities. In addition to being one of the largest GPOs in the US, Premier is also a leading national advocate for injection safety. Despite the widespread conversion of US healthcare facilities to the mandatory use of needlestick prevention products, healthcare workers continue to remain at risk of harm from many types of conventional safety syringe technologies. We look forward to supporting Premier and its members to enhance the level of protection offered to US healthcare workers.”

The Unitract range of 1-mL insulin and tuberculin syringes utilize a unique combination of automatic and fully integrated safety features to provide optimal protection to healthcare workers and patients at risk of needlestick injuries when injecting a drug supplied in a vial or ampoule. An audible, tactile click signals the automatic (passive) activation of the needle retraction mechanism upon the full injection of the dose. Operators can control the speed at which the needle is withdrawn directly from the body into the barrel of the syringe by relieving thumb or finger pressure on the plunger. The plunger is then locked to prevent needle re-exposure, tampering, or device reuse. Unitract 1-mL syringes are manufactured at Unilife’s FDA-registered manufacturing facilities in York, PA.

Unilife Corporation is a US-based developer, manufacturer, and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines.

Intellect Neurosciences & ViroPharma Announce $126.5-Million Global Licensing Agreement

Intellect Neurosciences, Inc. recently announced that it has granted an exclusive license to ViroPharma Incorporated regarding certain of Intellect’s licensed patents and patent applications related to Intellect’s clinical-stage drug candidate, OX1, a multimodal, metal-binding, extremely potent antioxidant molecule, which has been demonstrated to protect nerve cells from highly oxidizing neurotoxins. ViroPharma plans to develop and commercialize OX1 as a treatment of Friedreich’s Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation.

Under the terms of the exclusive license agreement, Intellect has agreed to transfer to ViroPharma all of Intellect’s intellectual property rights, data, and know-how related to its OX1 research and development program. In return, ViroPharma has agreed to pay a $6.5-million up-front licensing fee and will pay additional milestones based upon defined events. The maximum of these milestone payments assuming successful advancement to market could amount to $120 million. In addition, ViroPharma will pay a tiered royalty of up to a maximum of low double digits based on annual net sales.

Intellect recently announced completion of Phase I clinical trials for OX1. Dr. Daniel Chain, Intellect’s Chairman and CEO, has played a leadership role in the development of OX1 since its therapeutic potential was originally discovered by scientists at NYU Medical School and University of South Alabama in the late 1990s. The universities, which own certain patents in relation to OX1, are entitled to a portion of revenues received by Intellect from any sale or license of OX1 pursuant to an exclusive license agreement between Intellect Neurosciences and the universities.

“We are pleased to enter into a strategic relationship with ViroPharma, which has ample resources, drug development capabilities, and orphan drug marketing expertise to accelerate the development and commercialization of OX1,” said Dr. Chain. “This transaction is the first for Intellect related to an internally developed compound. It is consistent with our business strategy to create high-value assets that can generate revenues to support further development of drugs for the ultimate benefit of patients in desperate need of novel treatments for life-threatening conditions.”

OX1 is a multimodal antioxidant molecule noted for its potent free radical scavenging activity, metal-binding activity, and activation of mitochondria, which are responsible for energy production in cells. In addition, OX1 has been tested in numerous different models of neurodegenerative diseases and shown to protect nerve cells from highly oxidizing stimuli caused by metals and other neurotoxins. OX1 has been tested for safety across species and found to be safe and well tolerated in human Phase I clinical trials. It is administered as a powder in capsules for oral ingestion and is rapidly absorbed by the body.

Friedreich’s Ataxia is rare hereditary disease affecting 1 in 50,000 individuals of European descent caused by a mutation in a gene which encodes frataxin, a protein essential for proper functioning of mitochondria, the energy pumps of the cell. In the absence of frataxin, iron in the cytoplasm builds up and causes free radical damage. The disease causes progressive damage to the nervous system, resulting in symptoms ranging from gait disturbance to speech problems; it can also lead to heart disease and diabetes. The ataxia of Friedreich’s ataxia results from the degeneration of nerve tissue in the spinal cord, in particular sensory neurons essential for directing muscle movement of the arms and legs. The spinal cord becomes thinner and nerve cells lose some of their myelin sheath. The primary site of pathology is spinal cord and peripheral nerves. Symptoms typically begin sometime between the ages of 5 and 15 years, but may occur in the 20s or 30s. The disease usually presents with progressive staggering or stumbling and frequent falling. The symptoms are slow and progressive. The median age of death is 35 years. Currently, there are no FDA-approved drugs for FA.

Intellect Neurosciences, Inc. is a Manhattan-based biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer’s disease and other serious neurodegenerative disorders. The company’s pipeline includes Alzheimer’s monoclonal antibody products licensed to major pharmaceutical companies, OX1 licensed to ViroPharma, melatonin for treatment of amyloidosis-related diseases, Recall-Vax, a novel Alzheimer’s vaccine, IN-N01 a humanized monoclonal antibody targeting beta amyloid and tau immunotherapy approaches.

Particle Sciences Granted Patent on Self-Sterilizing Medical Devices

Particle Sciences Inc. (PSI), a leading pharmaceutical CRO, has received Notice of Allowance for a method of sterilizing medical devices. The patent covers the notion of using free radical generating moieties in or on the medical device. Free radicals are, of course, an effective mode of sterilization. So, as an example, a catheter coated with a free radical generating particle would, upon the proper stimulation, generate surface free radicals eliminating any early biofilm that might be forming. Ultraviolet light delivered to the catheter would be an example of a viable energy source to stimulate free radical production.

“Particle Sciences is a technology-driven organization,” said Mark Mitchnick, CEO of Particle Sciences. “We have applied for over 10 patents in the past several years either on our own or as coinventors on behalf of our clients. In addition, we have in-licensed several key patent families in the area of drug delivery and are considering additional technology acquisitions. This specific idea flowed from our drug-eluting medical device work and our background in photochemistry. As a drug delivery CRO, however, this technology is a bit out of our area of focus. Because of that, we will look for an opportunity to out license the patents that have both US and EU approval.”

Particle Sciences Inc. is an integrated provider of drug development services. Particle Sciences utilizes a broad suite of drug delivery technologies to address a diverse range of challenges. With special expertise in particulate-based formulations and drug/device combination products, Particle Sciences has become a leader in drug delivery development. Through a full range of formulation, analytic, bioanalytic, and sterile and non-sterile manufacturing services, the company provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic.

Zosano Pharma & Asahi Kasei Pharma Enter Agreement for Transdermal Patch for Up to $132.5 Million

Zosano Pharma, Inc. and Asahi Kasei Pharma Corporation (AKP) recently announced they have entered into a long-term strategic collaboration for the development, commercialization, and supply of a weekly transdermal patch formulation of Teribone (teriparatide acetate), AKP’s formulation of human parathyroid hormone (human PTH 1-34), for the treatment of osteoporosis patients with a high risk of fracture.

Under the terms of the agreement, AKP has received exclusive rights to develop and commercialize the transdermal patch formulation of Teribone in Japan, Korea, China, and Taiwan. AKP is responsible for clinical and regulatory development and commercialization activities. The transdermal patch product uses Zosano’s patented, clinically validated, and GMP-manufactured microprojection technology (known as ZP Patch Technology) to administer human PTH (1-34) through the skin. It is expected to offer the benefits of self-administration, weekly dosing, room temperature stability, and pain-free delivery without the need for an injection.

The agreement was signed on February 22, 2011, although AKP and Zosano agreed not to disclose the agreement until the subcutaneous injection form of Teribone for osteoporosis patients was approved in Japan, which occurred on September 26, 2011. With the development of a microprojection patch formulation of Teribone, AKP is further reinforcing both its R&D pipeline and its commitment to patients in the field of orthopedics, especially in the area of osteoporosis.

“AKP and Zosano have joined their world-class and complementary assets to create what we believe have the opportunity to be the best-in-class product for bone growth in severe osteoporosis patients,” said Gail Schulze, Chief Executive Officer of Zosano. “We believe this relationship will provide a product with superior fracture reduction and enhanced patient compliance compared to the currently available PTH injectables to those patients with a high degree of unmet need.”

As part of the agreement, AKP has paid Zosano $7.5 million in up-front consideration. In addition, AKP will pay over $25 million in milestone payments related to development, regulatory, and launch accomplishments. Zosano will receive revenue-based royalties based on sales of the microprojection patch formulation of Teribone in the Asian territories, as well as reimbursement for all development and manufacturing costs. AKP is committing significant additional financial and technical resources toward the development of the patch for the treatment of osteoporosis in the Asian territories, and expects to begin clinical trials in Japan in 2012. AKP and Zosano plan to continue discussions regarding the extent of their strategic collaboration, including potential joint development of the patch in other territories.

“Our partnership with Zosano reinforces AKP’s commitment to seek out innovative products that complement our existing portfolio in orthopedics and address significant unmet medical needs in Asia,” said Toshio Asano, President and Representative Director of AKP. “We look forward to expanding the potential for Teribone in this novel, transdermal form as a convenient treatment for patients suffering from osteoporosis in the Asian territories.”

Teribone is a human parathyroid hormone preparation that facilitates bone formation. A Phase III clinical trial in Japan demonstrated that, with weekly subcutaneous injections for 72 weeks, Teribone decreased the risk of developing new vertebral fracture by 78.6% compared to placebo treatment. The efficacy in inhibiting fracture is obtained by increasing bone strength with both improved bone quality and increased bone density. The subcutaneous injection form of Teribone for osteoporosis patients was approved in

Zosano’s ZP Patch Technology is based on microprojections that deliver therapeutic compounds (including peptides, proteins, small molecules, and vaccines) to the skin’s outer layer and provide rapid and efficient systemic drug delivery in a convenient, needle-free, and pain-free system. Zosano’s ZP Patch Technology is the most clinically validated microneedle technology in the world, having been tested in more than 450 patients with over 20,000 patches successfully applied to humans in Phase I and Phase II clinical studies.

Puma Biotechnology Announces Licensing Agreement With Pfizer

Puma Biotechnology, Inc., a development-stage biopharmaceutical company, recently announced an agreement with Pfizer to license the worldwide commercial rights to neratinib, a potent, irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, ErbB1 (EGFR), ErbB2 (HER2), and ErbB4 (HER4) kinases. Neratinib is being studied in the neoadjuvant, adjuvant, and metastatic settings in patients with HER2/ErbB2 positive breast cancer.

Under the terms of the agreement, Puma will assume sole responsibility of global product development and commercialization of neratinib. Pfizer will be entitled to receive payments upon Puma’s achievement of certain development milestones of neratinib, as well as royalty payments for any sales of neratinib.

Puma intends to focus the development of neratinib on the treatment of patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy. Neratinib has previously been tested in numerous clinical trials both as single agent and in combination with other anticancer drugs in this patient population. In these studies, neratinib demonstrated substantial clinical activity and was well tolerated. Based on the results of these studies, Puma intends to initiate clinical trials in this patient population in the first half of 2012.

Prior to the licensing agreement with Puma, Pfizer had been sponsoring two clinical trials of neratinib: 1) the NEfERTT trial, a Phase II randomized trial of neratinib in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of patients who have not received previous treatment for HER2-positive metastatic breast cancer, and 2) the ExteNET trial, a Phase III study investigating the effects of neratinib after adjuvant trastuzumab in patients with early stage breast cancer. Consistent with Puma’s strategy to refocus clinical development of neratinib in patients with HER2-positive metastatic breast cancer who have received prior lines of trastuzumab-based therapy, Puma intends to stop enrollment of new patients and proceed with winding down both trials.

In addition, Puma announced that it completed a private placement of approximately 14.7 million shares of its common stock to institutional investors that resulted in gross proceeds of approximately $55 million to the company. The shares were issued at a purchase price of $3.75 per share. Leerink Swann LLC acted as sole placement agent for the transaction. Adage Capital Partners, L.P. was the lead investor in this financing, which also included significant participation from Brookside Capital, H&Q Healthcare Investors, H&Q Life Science Investors, Jennison Associates LLC, Orbimed Private Investments IV, and funds managed by T. Rowe Price Associates, Inc., as well as a number of other well-known healthcare institutional investors. Proceeds from the private placement will be used primarily to fund the continued clinical development of neratinib.

In conjunction with the private placement, Puma completed a reverse merger with Innovative Acquisitions, Inc., a public reporting company with no prior business operations. The transaction was completed by the merger of a wholly owned subsidiary of Innovative Acquisitions with Puma that resulted in Puma remaining as the surviving company and a wholly owned operating subsidiary of Innovative Acquisitions. Immediately after the initial merger, Puma was merged directly into Innovative Acquisitions, and this resulted in Innovative Acquisitions surviving. Stockholders of the former Puma (including those that participated in the private placement) received shares of Innovative Acquisitions in exchange for their Puma shares, and the former Puma stockholders now hold 100% of the resulting company’s equity in the same proportion as such stockholders owned immediately following the precedent private placement.

Puma Biotechnology, Inc., is a development-stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The company is initially focused on the development of PB-272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2 positive metastatic breast cancer.