10/10/2012

Cleveland BioLabs & Incuron Announce Orphan Drug Status

Cleveland BioLabs, Inc. and Incuron, LLC, a joint venture between the company and Bioprocess Capital Ventures, recently announced that curaxin CBL0102 (quinacrine) has been granted Orphan Drug status by the US FDA for treatment of hepatocellular carcinoma.

A multi-center Phase I trial of CBL0102 is ongoing in the Russian Federation in patients with liver metastases of solid tumors of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or does not exist. The trial is dosing the sixth cohort in its dose-escalation arm and, subsequent to the completion of the dose-escalation arm, will enroll an efficacy arm.

There are approximately 30,000 US and 45,000 EU annual cases of hepatocellular carcinoma, with an overall survival rate of approximately 15%. CBL0102 is an orally administered small molecule that acts by blocking activity of chromatin remodeling complex FACT, resulting in simultaneous modulation of three signal transduction pathways (p53, NF-kappaB and heat shock response) commonly deregulated in cancer.

Incuron, LLC is a Russian Federation based joint venture founded in 2010 between Russian Closed Mutual Venture Fund Bioprocess Capital Ventures, and Cleveland BioLabs. Incuron is developing CBL0102 and CBL0137 for oncology and orphan indications. To learn more about Incuron, LLC, please visit the company’s website at www.incuron.com.

Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The company’s lead compound is being developed as both a radiation countermeasure and a cancer treatment. The company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children’s Cancer Institute Australia, and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit www.cbiolabs.com.

Mayne Pharma Announces Major Acquisition

Mayne Pharma Group Limited recently announce it has entered into a binding agreement to acquire Metrics, Inc. Consideration for the acquisition will comprise an up-front payment of $105 million plus further earn-out payments of up to $15 million based on Metrics’ performance for the 12 months ended June 30, 2013.

Closing of the acquisition remains subject to material conditions, including completion of financing arrangements by Mayne Pharma and there being no material adverse event in relation to Metrics. Closing is also subject to the approval of Metrics’ shareholders; however, holders of a majority of Metrics’ capital stock have already agreed to vote in favor of the transaction.

Metrics will continue to be led by its current senior management team, and will continue to operate out of its existing Greenville facilities. The only change to Metrics’ business will be new access to enhanced resources, operational best practices, and intellectual capital that will provide significant upside and opportunity for increased levels of success for Metrics, Mayne Pharma, and the customers the two companies serve.

Founded as a contract analytical laboratory in 1994 by Burroughs Wellcome scientist Phil Hodges and ECU professor Dr. John Bray, Metrics is a privately owned, specialty pharmaceutical company based in Greenville, NC. Metrics, which has approximately 300 employees, provides contract development services to the pharmaceutical industry, and develops and manufactures niche generic drugs. Metrics has particular expertise in formulating complex oral drug products, including highly potent and unstable compounds, controlled substances (such as opiates), and products with poor bioequivalence. These products are sold in the US via exclusive distribution partners or directly through Metrics’ in-house wholesale distributor, Midlothian Laboratories.

In addition to its existing products, Metrics has a pipeline of 11 niche generic drugs in various stages of development, including two that have been filed with the US FDA and a further nine products to be filed by the end of FY13. For more information, visit www.metricsinc.com.

Founded in 1845 as FH Faulding & Co, Mayne Pharma is an Australian specialist pharmaceutical company with an intellectual property portfolio built around the optimization and delivery of oral dosage form drugs. Mayne Pharma has a long and successful history of developing and commercializing improved pharmaceuticals and has launched and marketed numerous products through partnerships with licensees in various countries around the world. Mayne Pharma focuses on delivering to patients improved versions of existing drugs in order to advance safety, efficacy, or ease of administration.

A technology driven company, Mayne Pharma has a significant product portfolio and pipeline, global reach through distribution partners in Australia, the US, Europe, and Asia, and a manufacturing facility in Salisbury, South Australia that employs more than 150 people. For more information, visit www.maynepharma.com.

Catalent Strikes Agreement With Vivus

Catalent Pharma Solutions recently announced it has entered into a Supply Agreement with VIVUS, Inc. to supply Qsymia capsules, a proprietary combination phentermine and extended-release topiramate. Utilizing its unique drug delivery capabilities, Catalent partnered with VIVUS during the development of Qsymia, including preformulation and formulation, clinical supply, and validation.

Qsymia has recently been approved by the FDA as the first once-daily combination treatment for chronic weight management in adults who are obese or overweight with a weight-related co-morbidity.

“It is extremely exciting for Catalent to see the FDA approval of this significant new therapy for weight management. As a combination therapy with two active ingredients that needed to be formulated and delivered in a controlled-release dosage form, Qsymia presented unique formulation and drug delivery challenges. We are very pleased to have partnered with VIVUS in developing Qsymia and look forward to a long and successful relationship,” commented Dr. Ian Muir, President of Catalent’s Modified Release Technologies business.

Peter Tam President of VIVUS added, “An extended-release formulation of Qsymia was critical to achieving our aim of developing a once-daily treatment. Catalent’s broad range of drug delivery capabilities and extensive experience in controlled-release technologies helped us to achieve our goal. VIVUS is also pleased to have completed a long-term commercial supply agreement with Catalent to ensure the reliable on-going supply of Qsymia.”

Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable product supply. For more information, visit www.catalent.com.

Patheon Launches Innovative Meet the Experts Program

Patheon Inc. recently announced the launch of its new Meet the Experts program. The program provides direct access to scientific and technical experts, both from Patheon as well as from renowned external consultants and industry veterans through the company’s Patheon Certified Consultants. Visitors are able to contact the expert associated with a specific technology, product, or service offering, who in turn will provide a timely response to the questions that the potential customer may need before making core business development decisions. The new site is designed with the end-user in mind and with the goal of sharing Patheon’s wealth of experience and expertise through an easy-to-use navigation center.

Visitors will also have access to Patheon’s knowledge library, which accumulates current webinars, scientific posters, and case studies generated by the company’s thought leaders related to pharmaceutical development and manufacturing services. For more information, including current services and products, visit www.Patheon.com.

Patheon Inc. is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. The company provides the highest quality products and services to approximately 300 of the world’s leading pharmaceutical and biotechnology companies. Patheon’s services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, soft gel, solid and liquid forms. For more information, visit www.patheon.com.

Bend Research & Dow Chemical to Develop Drug-Solubility Solutions & New Polymers

Bend Research Inc. and The Dow Chemical Company have formed an exclusive collaboration to provide science-based spray-dried dispersion (SDD) solutions and select enabling new polymers for poorly soluble oral drugs.

Dow and Bend Research will work together to provide the industry with fully characterized polymers supported by complete Quality-by-Design (QbD) principles and the ability to tailor materials to meet the performance needs of specific drugs. In addition, the two companies will develop and commercialize new materials for SDDs that address technology gaps in manufacturability and delivery, providing greater drug-product utility and therapeutic performance.

Dow will provide hypromellose and hypromellose acetate succinate, as well as options to tailor these materials, and next-generation cellulosic and noncellulosic polymers for enhanced performance.

The collaboration between Bend Research and Dow reduces drug-development risk by seamlessly combining materials development and optimization early in the formulation development process for SDDs to achieve optimal clinical outcomes and robustness in drug-product manufacturability. The collaboration will combine Dow’s fundamental materials design, high-throughput screening, and pilot-plant, and commercial scale-up capabilities with Bend Research’s proven SDD screening, formulation, scale-up, and technology-transfer capabilities.

“We welcome the opportunity to further focus Dow’s proven excipient and materials science expertise in the area of enhancing drug solubility, and we are enthusiastic about working with the world leader in spray-dried dispersions to ensure that our customers receive the best possible polymer solutions,” said Bob Maughon, Senior R&D Director for Dow.

Mr. Maughon noted that Dow is fully supporting this collaboration with an array of technologies, including high-throughput synthesis with API/polymer screening, laboratory-scale product development, and structure/property optimization, as well as a fully cGMP market-development plant capable of supporting clinical development of optimized solutions.

“We are proud to announce the collaboration between Bend Research and Dow,” said Rod Ray, Bend Research CEO. “Our two companies have used rigorous science, grounded in fundamentals, to develop new excipients that improve the performance of our solubilization technologies. It is extremely important to us not only to develop new technologies for our clients, but to use cutting-edge research to enhance our existing technologies. Our collaboration with Dow is part of that initiative. It also ensures our clients access to a reliable supply of solubilization excipients that meet the critical-to-quality properties that are key to the performance of their compounds.”

For more information, visit www.bendresearch.com.

4P Therapeutics Announces Major Development Partnership

4P Therapeutics, a drug delivery company with expertise in novel drug delivery technologies, recently announced a partnership with Medicure Inc. for the development of a transdermal delivery formulation of its lead drug, AGGRASTAT (tirofiban HCl).

AGGRASTAT and other antiplatelet drugs of its class (known as glycoprotein IIb/IIIa inhibitors or GPIs) are currently only administered by intravenous infusion. The delivery of tirofiban by a novel transdermal means has potential to provide significant advantages over the current treatments used in this setting, including the potential to facilitate pre-hospital administration.

“The introduction of a transdermal glycoprotein inhibitor would have a significant impact on the management of several cardiovascular conditions,” stated Dr. David Lee, Director of the Cardiac Catheterization and Coronary Intervention Laboratories, Stanford University Medical Center. “This innovation would not only enhance the ease-of-use and healthcare costs associated with the traditional uses of this class of drugs, but may also facilitate earlier, pre-hospital administration as well as a number of other new applications.”

“Based on the data generated to date, I have reason to believe that our team will be able to develop a convenient, efficient way to transdermally deliver therapeutic levels of this proven and well-established intravenous drug”, stated Steve Damon, Chief Executive Officer, 4P Therapeutics. “The fact that large pharma companies have spent hundreds of millions of dollars on attempts to introduce a non-intravenous, oral delivery form for this type of drug should serve as a testament to the tremendous market potential for this product and, most importantly, to the potential clinical benefit for patients.”

Dawson Reimer, President and Chief Operating Officer of Medicure, said, “A product that delivers tirofiban non-invasively through the skin may create value first in the same settings where AGGRASTAT is currently approved and then, with further investment, in other applications of this treatment.”

The global market for antiplatelet drugs is over $7 billion per year, of which AGGRASTAT and the other intravenous GPIs make up approximately $450 million per year.

4P Therapeutics is a private company focused on the research and development of novel drug delivery technologies and novel drug delivery-based therapeutics. The company has capabilities for developing pharmaceutical products from preclinical testing to clinical manufacturing and early stage clinical development (Phase I/II). A key company focus and area of expertise is in the development of transdermal products from currently injected compounds, including proteins, peptides, macromolecules, and biologics. Transdermal delivery of commercially available drugs or biologics that are typically delivered via injection has the potential to improve safety, efficacy, and therapeutic outcomes associated with these treatments. For more information, visit www.4PTherapeutics.com.

Medicure is a specialty pharmaceutical company focused on the development and commercialization of novel small molecule therapeutics. The primary focus of the company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for acute coronary syndromes in the US, where it is sold through the company’s US subsidiary, Medicure Pharma, Inc. For more information, visit www.medicure.com.