Unilife Develops Proprietary Portfolio of Wearable Subcutaneous Infusion Devices

Unilife Corporation recently announced the development of its AutoInfusor portfolio of subcutaneous infusion systems for the patient self-administration of drugs in 3-, 5-, 7-, and 10-mL volumes.

Unilife has developed its AutoInfusor technology to address the unmet needs of pharmaceutical and biotechnology companies with drugs that have complex formulations with higher viscosities and requiring large dose volumes. AutoInfusors are now available for supply to pharmaceutical companies for human clinical trials in either prefilled or fill-at-time-of-use formats.

AutoInfusors are compact, single-use drug delivery systems designed for simple, intuitive, and convenient use by patients outside healthcare facilities. Consisting of a primary drug container, fluid delivery path, and drive mechanism, AutoInfusors are modular and can be customized to address the specific requirement of the drug and its target patient. They can be pre-set for infusion periods that can span minutes or hours in duration, as specified by the pharmaceutical customer.

Once the patient attaches the device onto the injection site and pushes the activation button, the automatic infusion of the drug into the subcutaneous tissue commences. With the size, shape, and functionality of the AutoInfusor being ergonomically designed for optimal wearability, the patient can continue to go about their normal daily routines during the period of dose delivery. A series of audible, tactile, and visual indicators can signal to the patient when the full dose has been delivered, at which time the AutoInfusor can be removed from the body for convenient disposal.

“Our AutoInfusors represent the world’s first and only subcutaneous infusion system ready for human clinical trials that can facilitate the patient self-administration of drugs between 3- and 10-mL dose volumes,” said Mr. Alan Shortall, CEO of Unilife. “Pharmaceutical companies are actively developing a significant number of pipeline drugs targeted for the treatment of acute, chronic, and palliative diseases. Many of these emerging macro-molecule drugs, including a number of biologics, feature a complex formulation of proteins with higher viscosities that require large volume doses. The conventional patch pumps that have been developed for the delivery of drugs, such as insulin, are largely unsuitable for delivery of these drugs. Until now, pharmaceutical companies developing these complex drugs have lacked access to a single-use subcutaneous infusion system that can enable patients to easily self-administer doses greater than 3 mL in volume.”

NanoSmart Begins Development of New Drug Delivery Platform for Cancer

NanoSmart Pharmaceuticals, Inc., a biopharmaceutical corporation developing novel cancer pharmaceuticals, has moved into its new corporate facility located in Laguna Hills, CA. The facility provides the administrative and laboratory work space necessary to begin formal development of its initial product pipeline.

“Our new location gives us a physical presence in Orange County, CA, and allows us to move forward with our strategic development goals,” said Dr. Henry Smith, CEO of the company. “We are excited about the opportunity to develop our initial products and conduct formal, nonclinical studies leading toward our initial regulatory filings.”

NanoSmart is developing a patented, novel anti-tumor-targeting platform based on fully human autoimmune antibodies. These antibodies target areas of necrosis found in many different types of cancer. NanoSmart’s drug delivery system represents a versatile platform technology with many advantages, including improved localization of cancer therapeutics leading to increased safety and efficacy. By combining these antibodies with different cancer drugs, NanoSmart has the potential to develop a very large number of novel biopharmaceutical products.

NanoSmart Pharmaceuticals, Inc., is a privately held company engaged in developing novel methods to treat cancer and other diseases. The company is focused on using its patented tumortargeting antibodies to develop a variety of biopharmaceuticals to treat many different types of cancer.

KAI Pharmaceuticals Inks $13-Million Development Deal With Ono Pharmaceutical

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, recently announced the signing of an agreement with Ono Pharmaceutical Co., Ltd. for the development and commercialization in Japan of KAI-4169, KAI’s lead product candidate.

KAI-4169 is a novel therapeutic agent in Phase II clinical testing as an intravenous (IV) formulation for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease-mineral and bone disorder (CKD-MBD). Under the terms of the agreement, Ono receives exclusive rights to all indications for injectable formulations of KAI-4169 in Japan; KAI retains commercialization rights in all other regions of the world.

KAI will receive approximately $13 million in an up-front payment from Ono, as well as significant development, regulatory, and commercialization milestones. KAI also will receive a royalty on sales. Additional financial terms of the agreement were not disclosed.

“This partnership with Ono is a critical event for the KAI-4169 program, allying us with a partner that has a strong track-record advancing innovative pharmaceutical products,” said Steven James, President and CEO of KAI. “We are excited about the continued momentum of the KAI-4169 program, and we anticipate completing the Phase II trial and reporting top-line data by the end of this year.”

“Ono’s research and development principle is to develop and deliver drugs that truly benefit patients and society. We put this into practice by tackling diseases that remain unconquered and addressing high unmet healthcare needs where patient satisfaction with current treatments is low. We believe KAI-4169 has the potential to satisfy these unmet needs and, therefore, fits Ono’s strategy very well. For example, a key differentiating advantage of KAI-4169 is that it is an IV formulation that is designed to improve drug adherence. We plan to develop KAI-4169 expeditiously in Japan,” added Gyo Sagara, Ono’s President, Representative Director, and CEO. Phase I data have demonstrated that single IV doses of KAI-4169 were safe and well-tolerated and resulted in sustained reductions in serum levels of parathyroid hormone in both healthy male subjects and end-stage renal disease (ESRD) patients with secondary hyperparathyroidism.

BioSante Pharmaceuticals Successfully Completes LibiGel Pharmacokinetic Study

BioSante Pharmaceuticals, Inc. recently announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study. The top-line results indicate that LibiGel increases levels of free testosterone, bioavailable testosterone, and total testosterone in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.

The LibiGel PK study was conducted as part of the required studies to be submitted in the LibiGel new drug application (NDA), which is anticipated by the fourth quarter of 2012. The PK study was conducted in 24 postmenopausal subjects for a total of 63 days, in the absence of estrogen therapy, as well as in the same women when treated with a transdermal estradiol patch and subsequently oral estrogen. There were no differences in blood levels of testosterone regardless of the absence or presence of estrogen therapy, whether transdermal or oral.

The data from the PK study showed that testosterone blood levels were similar on days 14, 21, 42, and 63 of the study, indicating that there was no build-up of testosterone blood levels with daily LibiGel treatment. Additionally, free and bioavailable testosterone returned to baseline levels within 36 to 48 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued. The testosterone blood levels produced in this study were very similar to those seen in the BioSante LibiGel Phase II efficacy trial reported previously, and they were very similar to blood levels observed in transdermal testosterone patch studies, which also demonstrated efficacy in the treatment of HSDD. Importantly, in the LibiGel PK study, there were no measurable increases in blood levels of the most active estrogen, estradiol, which could have occurred as a result of the conversion of testosterone to estradiol. BioSante plans to present the full PK study results at an upcoming medical meeting.

“Significantly, none of the subjects in the LibiGel PK study had average testosterone concentrations above the normal range for younger, premenopausal women, a finding that may be a key component in the safety evaluation of LibiGel by FDA,” said Michael C. Snabes, MD, PhD, Senior Vice President of Medical Affairs at BioSante. “This finding adds to our confidence that the results of our ongoing, long-term safety study of LibiGel will be favorable.”

F-Star & Merck Serono to Collaborate on Novel Targeted Biologics

F-Star GmbH recently announced that a research, license, and commercialization agreement was signed with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for the discovery of new antibody-derived therapeutics against inflammatory disease targets using F-Star’s Modular Antibody Technology.

Under the terms of the agreement, Merck Serono will nominate up to three therapeutic targets, and the parties will collaborate to jointly discover mono-specific Fc-based targeted biologics (Fcabs) and bi-specific IgG-based targeted biologics (mAb2) for which Merck KGaA will have exclusive worldwide development and commercialization rights. F-Star will receive an initial technology access fee and research-based funding and is eligible to receive additional license fees, development, regulatory, and commercialization milestones, which in aggregate, could reach $673 million, as well as undisclosed tiered royalties on product sales. Further details of the agreement were not disclosed.

“We are very pleased to have completed this agreement with Merck Serono,” said Dr. Kevin FitzGerald, Chief Executive Officer of F-Star. “Merck Serono Ventures has proved to be a supportive venture investor in F-Star, and we are now excited to expand the relationship to include collaborative discovery and development projects. F-Star has developed novel technology for the discovery of targeted biologics that offer significant improvements over conventional antibodies. This agreement builds on F-Star’s strategy to develop and demonstrate the therapeutic potential of our proprietary technology through advancing our own pipeline as well as through a limited number of very selective research collaborations.”

“We are very pleased to see our investment in F-Star through Merck Serono Ventures mature into a strategic collaboration, which reinforces our commitment to deliver innovative treatments in the area of inflammatory diseases,” said Susan Herbert, Head of Portfolio Development at Merck Serono. “We believe that F-Star’s Modular Antibody Technology has the potential to offer important functional advantages over conventional antibodies and will potentially allow us to generate highly differentiated drugs for patients with so far unmet medical needs.”

F-Star is an antibody-engineering company based in Vienna, Austria, and Cambridge, UK. The company develops improved therapeutic antibodies and antibody fragments based on its Modular Antibody Technology, which allows the introduction of additional antigen-binding sites into antibodies and antibody fragments by engineering the non-CDR loops of antibody domains. Using Modular Antibody Technology F-Star generates antibody fragments that have full antibody functionality and long half-life but are much smaller in size (Fcab) and full-sized antibodies with additional functionality or bispecificity (mAb2 ).

Alkermes Launches Corporate Operations in Ireland

Alkermes plc recently announced the establishment of its corporate operations in Ireland, with new headquarters located in Dublin. The company, including its headquarters and operations in Athlone, County Westmeath, has more than 450 employees based in Ireland and more than 1,200 employees worldwide.

Alkermes plc was created following the merger of Alkermes, Inc. with Elan Drug Technologies (EDT), the profitable, world-class drug formulation and manufacturing business unit that was formerly a part of Elan Corporation, plc.

Marking its first day of operations in Ireland, Alkermes has announced a multiyear, multimillion dollar manufacturing agreement with one of the world’s top 10 pharmaceutical companies. Under the terms of the agreement, Alkermes will manufacture the company’s finished pharmaceutical product, which will be produced at Alkermes’ Athlone, Ireland, facility. Alkermes expects this agreement to generate $15 million to $20 million in annual manufacturing revenues by 2016. The Athlone facility is one of three major manufacturing plants owned by Alkermes plc at which the company produces proprietary, partnered, and contract-manufactured drug products.

“Alkermes plc’s decision to establish its headquarters in Ireland is further demonstration of this country’s continued ability to attract companies, like Alkermes, in growth industries, to set up operations here,” said Mr. John Perry TD, Minister of State for Small Business. “Today’s announcement showcases that Ireland is very much open for business and is an excellent location to host operations of multinational companies. The additional announcement of a new contract for the Athlone facility is an indication of its track-record for successful innovation and high-quality manufacturing.”

“We are a strong, global company with a diversified product portfolio, and we look forward to accelerating our growth to create value in our business and for the patients we serve,” added Richard Pops, Chief Executive Officer of Alkermes. “Alkermes is excited to have our operations based in Ireland, which we view as a gateway to the European Union and global pharmaceutical market.”

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders, such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, MA, and manufacturing facilities in Athlone, Ireland; Gainesville, Georgia; and Wilmington, OH.