6/6/2012

Royer Biomedical Receives Approval to Test Polymer Delivery System

Royer Biomedical, Inc. (RBI) recently announced it received FDA approval to proceed with human testing of AppliGel-G (Gentamicin) in management of diabetic foot ulcers (DFU). AppliGel is a patented proprietary dissolvable non-immunogenic polymer drug delivery system platform. It has demonstrated efficacy in biofilm and infection eradication, without significant systemic API levels.

“This represents an important milestone in the development of AppliGel,” said William Wolf, MD, RBI’s President and CEO. “We are excited at the prospect of helping diabetics and their physicians in the management of this difficult and limb-threatening disorder. We look forward to gaining final approval for topical, injectable, and implantable drug delivery applications for antibiotics, chemotherapeutics, and analgesics to address DFU, cancers, and other conditions requiring sustained medication in a dissolvable platform without immunogenic reaction or the need for removal. Our AppliGel polymer platform’s shelf stability, ease of application, and ability to deliver pharmaceuticals without significant adverse effects has been well-demonstrated in the veterinary world, and the prospect of collaborating with Johns Hopkins University Hospital and Georgetown University Hospital to improve patient outcomes in Cancer and Diabetes is truly exciting.”

Royer Biomedical, Inc. is a mid-stage biotechnology enterprise targeting novel drug delivery systems. RBI has developed proprietary bioabsorbable polymer hydrogel technology for topical and internal controlled release of a wide variety of pharmaceuticals, including antibiotics, chemotherapeutic agents, and local anesthetics. The various polymer and calcium-based matrix formulations have extensive patent protection in the US, Europe, Asia, Australia, and Mexico. The company is focusing on novel polymer hydrogel-based drug delivery systems to provide next-generation therapies for diabetes, cancer, and localized infection. For more information, visit www.royerbiomedical.com.

Bayer HealthCare & Covance Form Strategic Partnership

Bayer HealthCare and Covance Inc. recently announced they have decided to establish a long-term strategic partnership in the area of clinical drug development, including R&D services related to Phase II-IV clinical studies and central laboratory services. The new strategic partnership marks a next level of the broad-based cooperation both partners have developed over the past years and represents the efforts to maximize its benefits across the Bayer HealthCare organization.

Bayer’s goal is to better leverage Covance’s broad range of experience and services across the R&D portfolio to attain best-in-class operational delivery, efficiency, and quality whilst also delivering significant financial benefits to both organizations.

“This agreement marks a significant milestone in strengthening our relationship with Covance, which we have built over several years, and provides an opportunity for both partners to develop a broader-based partnership in the future to deliver mutual benefits to both organizations,” said Kemal Malik, Member of the Executive Committee and Head of Global Development at Bayer HealthCare.

“We are extremely proud to have established an enduring relationship with Bayer HealthCare built on trust and proven performance that is now elevating to a strategic partnership,” added John Watson, President, Strategic Partnering, and Chief Commercial Officer, Covance. “We look forward to working together with Bayer HealthCare to identify opportunities to leverage our broad portfolio to generate more efficiencies, thereby reducing the overall time and cost of drug development.”

Covance, with headquarters in Princeton, NJ, is one of the world’s largest and most comprehensive drug development services companies with annual revenues greater than $2 billion, global operations in more than 30 countries, and more than 11,000 employees worldwide. For more information, visit www.covance.com.

JHP Pharmaceuticals to Produce Clinical & Commercial Supply of an Innovative Injectable

JHP Pharmaceuticals recently announced it has entered into an agreement with an undisclosed pharmaceutical company to produce clinical and commercial supply of an innovative injectable used in the cardiovascular setting.

“We are pleased to serve this important customer and recognize that being selected to produce this injectable is based on our expertise with complex formulations coupled with our competence in both clinical supply and commercial supply,” said Stuart Hinchen, President and CEO of JHP. “JHP’s extensive experience working with products through their life cycle, starting with clinical trials through approval, product launch, and global commercialization provides customers with a measure of confidence allowing them to focus on their day-to-day business priorities.”

JHP’s Rochester, MI, manufacturing site’s 25-year history in contract manufacturing is a result of a solid cGMP compliance record, a quality-driven experienced staff, and a customer-centric approach.

JHP Pharmaceuticals, headquartered in NJ, provides contract manufacturing of sterile products, including biologics, small molecule, controlled substances, vaccines, ophthalmics, otics, and antibiotics for large and small pharmaceutical and biotech organizations.

JHP’s sterile manufacturing facility, located in Rochester, MI, sits on over 80 acres of land and includes a 171,000-sq-ft production building and warehouse. The production facility utilizes three high-speed filling lines, a clinical filling line, and four lyophilizers. The site also includes separate facilities for chemistry, sterility testing, and analytical methods development.

The company has the capability to manufacture small-scale clinical through large-scale commercial products. JHP employs more than 370 staff in the US in its manufacturing, product development, regulatory, sales and marketing, and corporate areas. For more information, please visit www.jhppharma.com.

Catalent to Sell Commercial Packaging Operations

Catalent Pharma Solutions recently signed a definitive agreement to sell its US commercial packaging operations based in Philadelphia, PA, and Woodstock, IL, to a company affiliated with Frazier Healthcare. The transaction is subject to certain closing conditions and is expected to close in the next few months.

The transaction does not involve Catalent’s Clinical Supply Services operations in Philadelphia, or the Blow-Fill-Seal business in Woodstock. It also does not involve any commercial packaging activity that Catalent conducts outside North America.

Catalent’s decision to sell its US commercial packaging operations is based on the company’s business strategy to focus on growing its world-leading businesses in development solutions and advanced delivery technologies, clinical trial supplies, advanced blow/fill/seal aseptic delivery technology for respiratory, ophthalmic, and other products, as well as offering integrated solutions for the development and supply of injectable biologics and complex pharmaceutical products.

Frazier Healthcare was founded in 1991 to invest exclusively in healthcare, and is a leading provider of growth equity and venture capital to high-growth and emerging healthcare companies.

From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings, and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging solutions. For more information, visit www.catalent.com.

New Clinical Trial Design Promises to Accelerate Approvals

The Food and Drug Administration (FDA) has drafted a regulatory guidance describing a new way of conducting breast cancer drug trials that promises to reduce substantially the time and cost of getting new treatments to patients. The approach is based on a trial design being tested in the I-SPY 2 TRIAL, an innovative Phase II breast cancer trial being conducted under the auspices of the Biomarkers Consortium, a public-private partnership led by the Foundation for the National Institutes of Health (FNIH) that includes representatives from NIH, FDA, and multiple pharmaceutical companies and academic research centers.

Patients with early stage breast cancer have typically had to wait for years to receive new cancer drugs, which are usually tested first in patients with later-stage metastatic disease and approved for use in more curable early stage cancer only after additional randomized clinical trials. The draft guidance, which is described in the current issue of the New England Journal of Medicine, establishes a potential new pathway for accelerated approval of drugs tested prior to surgical removal of tumors in certain types of high-risk patients with localized, early stage disease. The FDA signaled it may now grant approval of new drugs that have shown clinical benefit, based on data from patients receiving this type of “neoadjuvant” treatment whose invasive cancer has disappeared by the time of surgery (pathological complete response).

“Better options for patients with high-risk breast cancer are urgently needed,” said Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research at FDA. “The FDA guidance explains how a promising drug identified in trials such as I-SPY 2 could be evaluated for FDA approval, so patients could have rapid access if the drug proved better than current treatments.”

The I-SPY 2 Trial, which is being led by Laura Esserman, MD, MBA, at the University of California at San Francisco (UCSF) and Dr. Donald Berry, MD, at MD Anderson Cancer Center in Houston, uses specific genetic signatures – biomarkers – in the tumors of patients to select those who are most likely to benefit from testing using the new approaches. The biomarkers are also incorporated into a unique “adaptive” trial design that allows researchers to measure the relative benefit of treating patients with different tumor profiles with a specific drug and guide treatment assignments for subsequent trial participants. I-SPY 2 can test new treatments with significantly fewer participants and in half the traditional time, which will significantly lower costs under the new guidance.

The use of the I-SPY 2 design as a basis for accelerated drug approvals was first discussed in an article in the December issue of the Journal of the American Medical Association co-authored by Drs. Esserman and Woodcock.

“We are truly excited to see that the FDA is supportive of trials like I-SPY 2,” said Dr. Esserman, the Co-principal investigator of I-SPY 2. “This really moves us much closer to getting the right drugs to the right patients now, and at a time when they can be cured.”

The trial, which was launched 2 years ago, is screening multiple cancer drugs at 19 major cancer research centers across the country. Scientists from the National Cancer Institute, FDA, pharmaceutical and biotechnology companies, as well as breast cancer patient advocates also contributed to the design of the trial, which is managed by FNIH and Quantum Leap Healthcare Collaborative with support from Quintiles, a global biopharmaceuticals services provider. Funding for I-SPY 2 is provided by non-profit foundations, including The Safeway Foundation, several pharmaceutical companies, and other private sector and philanthropic donors. The FDA is accepting public comment on the new recommendations through July.

Scientists Restore Full Movement to Paralysed Rats

Gregoire Courtine and his team at Ecole Polytechnique Federale de Lausanne saw rats with severe paralysis walking and running again after a couple of weeks following a combination of electrical and chemical stimulation of the spinal cord together with robotic support.

“Our rats are not only voluntarily initiating a walking gait, but they are soon sprinting, climbing up stairs, and avoiding obstacles,” said Dr. Courtine, whose results from the 5-year study will be published in the journal Science on this month.

Dr. Courtine is quick to point out that it remains unclear if a similar technique could help people with spinal cord damage, but he adds the technique does hint at new ways of treating paralysis. Other scientists agree.

“This is ground-breaking research and offers great hope for the future of restoring function to spinal injured patients,” said Elizabeth Bradbury, a Medical Research Council senior fellow at King’s College London.

But Ms. Bradbury notes that very few human spinal cord injuries are the result of a direct cut through the cord, which is what the rats had. Human injuries are most often the result of bruising or compression and it is unclear if the technique could be translated across to this type of injury. It is also unclear if this kind of electro-chemical “kick-start” could help a spinal cord that has been damaged for a long time, with complications like scar tissue, holes, and where a large number of nerve cells and fibres have died or degenerated.

Nevertheless, Dr. Courtine’s work does demonstrate a way of encouraging and increasing the innate ability of the spinal cord to repair itself, a quality known as neuroplasticity. Other attempts to repair spinal cords have focused on stem cell therapy, although Geron, the world’s leading embryonic stem cell company, last year closed its pioneering work in the field. The brain and spinal cord can adapt and recover from small injuries but until now that ability was far too limited to overcome severe damage. This new study proves that recovery from severe injury is possible if the dormant spinal column is “woken up.”

Norman Saunders, a neuroscientist at the University of Melbourne in Australia, said in an emailed statement reacting to the study that although it remains to be seen whether the technique can be translated to people, “it looks more promising than previously proposed treatments for spinal cord injury.”

Bryce Vissel, Head of the Neurodegenerative Diseases Research Laboratory at the Garvan Institute of Medical Research in Sydney, said the study “suggests we are on the edge of a truly profound advance in modern medicine: the prospect of repairing the spinal cord after injury.”

Dr. Courtine hopes to start human trials in a year or two at Balgrist University Hospital Spinal Cord Injury Centre in Zurich. “Our rats have become athletes when just weeks before they were completely paralysed,” he said. “I am talking about 100% recuperation of voluntary movement.”