Avanir & Concert Announce Exclusive License Agreement

Avanir Pharmaceuticals, Inc. and Concert Pharmaceuticals, Inc. recently announced they have entered into an exclusive license agreement that provides Avanir worldwide rights to develop and commercialize Concert’s deuterium-modified dextromethorphan (d-DM) for the potential treatment of neurological and psychiatric disorders. The agreement includes the rights to multiple deuterium-modified dextromethorphan compounds.

Under the terms of the agreement, Concert will receive an up-front payment and is eligible to receive additional milestone payments upon achievement of certain predefined clinical, regulatory, and commercial targets as well as tiered royalties on worldwide sales of products containing d-DM. Avanir will have overall responsibility for research, development, and commercialization of d-DM. Concert will provide manufacturing support for investigational new drugenabling studies.

“Concert’s DCE Platform (Deuterated Chemical Entity Platform) has produced several deuterium-modified dextromethorphan compounds that we believe may provide therapeutically effective levels of dextromethorphan, potentially without the need for an enzyme inhibitor such as quinidine,” said Greg Flesher, Senior Vice President of Corporate Development and Chief Business Officer of Avanir Pharmaceuticals. “As part of our portfolio strategy, we intend to explore the utility of d-DM in neurological and psychiatric disorders where dual NMDA antagonists and sigma-1 agonists may be beneficial.”

“We are very pleased to enter into this collaboration with Avanir, who we believe has the unique expertise to best maximize the broad clinical potential of d-DM. Avanir’s knowledge of dextromethorphan-based therapeutics and their proven track record to bring drugs to the market make them the ideal partner for this program,” added Roger Tung, PhD, President and CEO of Concert Pharmaceuticals. “d-DM is a great example of how deuterium modification can, in favorable cases, create drug candidates with the unique opportunity for both substantially improved therapeutic properties over existing medicines, and lower development expense and risk compared to typical new chemical entities.”

d-DM was developed using Concert’s proprietary DCE Platform (Deuterated Chemical Entity Platform), and is a deuterium-containing analog of dextromethorphan. The deuterium-modified dextromethorphan compounds are covered under US Patent No. 7,973,049 that was issued to Concert in July 2011, as well as patent applications in other countries.

The incorporation of deuterium into specific molecular positions of dextromethorphan, resulting in d-DM, maintained the pharmacology of dextromethorphan and provided significantly enhanced resistance to CYP2D6 metabolism and improved plasma exposure in preclinical testing. As a result, d-DM has the potential to be effective as a treatment for neurological and psychiatric disorders for which dextromethorphan has shown pharmacological activity.

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with nervous system disorders of high unmet medical need. For more information about Avanir, please visit www.avanir.com.

Concert Pharmaceuticals, Inc is a clinical-stage biotechnology company focused on applying the company’s DCE Platform (deuterated chemical entity platform) to create novel and differentiated small molecule drugs. Concert’s approach leverages decades of pharmaceutical and clinical experience to reduce the time, risk, and expense needed to create important new medicines. The company has a broad research pipeline encompassing many therapeutic areas, including antiviral disease, renal disease, and CNS disorders, among others. Founded in 2006, Concert has raised more than $110 million of venture and institutional capital. For more information on Concert Pharmaceuticals, please visit www.concertpharma.com.

Aptar Unveils Innovative Delivery Devices for the Future

Aptar Pharma, a world leader in the development and manufacturing of nasal and pulmonary drug delivery devices, recently announced it had presented its latest innovation, eDevices, at the Pharmapack Europe tradeshow, held this past February in Paris, France.

Many patients with chronic diseases do not take their drugs as prescribed by their physician. Poor adhesion to the prescribed regimen may cost as much as $300 billion per year to the American healthcare system (Medco Studies). Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments. (WHO, 2003). With the objective in mind of enhancing patient adherence, Aptar Pharma has been working for more than a decade ago on smart solutions leveraging electronics for future drug delivery devices.

There is a growing trend by health authorities across the world toward increasing regulations. As an example, any new drug product using an asthma pressurized Metered Dose Inhaler in the US needs to be fitted with a dose-indicating or counting system to allow the patient to monitor the number of doses remaining. Another move applies to the multidose nasal spray devices for controlled substances, such as opioids, that are used to treat breakthrough pain. Some countries require these devices to have a dose counter and/or a locking mechanism to prevent overdose and drug abuse.

While electronics allow a dose counter to display large and highly legible digits (compared to mechanical counters), time-controlled robust locking systems can only be achieved with electromechanical components.

User studies have confirmed that electronic drug delivery devices are now as well accepted by the majority of consumers as smart portable devices, such as phones, games, and pads. Because these drug delivery devices are designed with a patient-centric approach, the targeted patient population finds them very convenient to use.

With more than 15 years of experience in smart drug delivery solutions, Aptar Pharma presented its two new electronic drug delivery eDevice platforms, known as e-Dose Counter and e-Lockout, at the Pharmapack Europe tradeshow.

The e-Dose Counter is a cost-effective solution that meets regulatory recommendations for nasal and sublingual spray delivery of controlled substances. The use of electronics allows the counting display to be large and highly visible, making it suitable for patients of all conditions and ages. Electronics can also provide patient comfort features, such as acoustic feedback and flashing displays to inform and warn.

The e-Lockout counts and displays the number of actuations and also prevents the device from being used for a period of time after a predefined number of actuations. Its locking system, which warns of overdosing, is recommended by regulators for nasal and sublingual spray delivery of controlled substances used in breakthrough pain management. In addition to counting and displaying the number of actuations and locking, some of the key features that can also be incorporated into e-Lockout include patient aids and feedback as well as data transmission. These two eDevice platforms are specially aimed at improving patient compliance.

With all these innovative developments, Aptar Pharma is able to offer robust and cost-effective solutions for enhancing patient compliance. Smart devices will have an important role to play in integrated healthcare provider systems as these start to be deployed in the mid to long-term future,” said Joachim Koerner, Vice President eDevice R&D, Aptar Pharma Prescription Division.

For more information on eDevices, please visit www.aptar.com/pharma/prescription-division.

Absorption Systems’ Innovation Rewarded With New US Patent for CellPort Technologies

Absorption Systems recently announced a new US patent issued on January 31 that protects intellectual property around its P-glycoprotein (P-gp) knockdown cell line within the company’s CellPort Technologies brand. The new patent, No. 8,105,828, extends the patent coverage on the company’s transporter knockdown technology beyond previously issued patents in the US, Europe, and Panama. Absorption Systems’ proprietary, cell-based test systems enable drug developers to definitively predict clinical drug-drug interactions (DDIs) involving drug transporters.

DDIs represent an underappreciated healthcare problem and can lead to side effects, therapeutic failure, or death. The antiarrhythmic drug digoxin is the most common victim of DDIs involving P-gp due to its narrow margin of safety. The risk is particularly high among the elderly due to the fact that most elderly people take multiple medications. According to an article in the Journal of the American Medical Association, as many as 2.2 million older Americans are at risk of a major DDI, nearly all of which could be avoided with identification, awareness, and avoidance of such combinations.

The newly patented in vitro test systems were the brainchild of Absorption Systems’ Chief Scientist, Dr. Ismael Hidalgo, who leads the company’s research and development in preclinical testing, which includes collaborations with academic, industrial, and US FDA scientists.

“This patent is another validation of our commitment to developing better, more predictive tools that improve drug safety and ultimately save lives. CellPort Technologies can provide very definitive data on drug transporters that is required by regulatory agencies, such as the FDA. And the technology is exclusive to Absorption Systems,” said Dr. Hidalgo.

CellPort Technologies is a suite of cell lines designed to provide definitive data regarding interactions between drugs and specific transport proteins. Drug transporters have been identified by regulatory agencies, such as the FDA and the European Medicines Agency (EMA) as key mediators of unintended DDIs. To create these test systems, Absorption Systems scientists used RNA interference to knock down the expression of one transporter at a time, in such a way that the resulting knockdown phenotypes are stable. By using the knockdown cells in parallel with the parental cells, it becomes very clear, by process of elimination, if a drug interacts with a specific transporter.

Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology, and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics, and medical devices. The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems’ commitment to innovation and is soon to be an industry assay standard for in vitro drug interaction assessment.

To learn more about CellPort Technologies and to view a video on the patented knockdown cell lines, visit www.absorption.com/cellport.

The new FDA draft guidance on drug interaction studies is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292362.pdf.

EMA draft guideline on the investigation of drug interactions is available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/05/WC500090112.pdf.

The influential International Transporter Consortium white paper on transporters and drug development is available at http://www.nature.com/nrd/journal/v9/n3/full/nrd3028.html.

Neuronex Announces $100-Million Merger Agreement

Neuronex recently announced the signing of a merger agreement with Acorda Therapeutics that, if completed, would result in full acquisition by Acorda and potential payments to Neuronex equity holders of over $100 million. A closing of the agreement will mark the second successful exit for the entrepreneurial drug development management team.

The signing of the agreement entitled Neuronex to an initial payment of $2 million upon signing of the agreement and $500,000 of up to $1.2 million for research and development costs prior to closing. In addition, Neuronex equity holders would be entitled to receive $6.8 million in connection with closing of the agreement, and after closing up to $18 million with the achievement of regulatory and manufacturing milestones. Neuronex equity holders would also be entitled to receive up to $105 million in sales milestones plus a tiered royalty-like earnout payment on sales ranging from upper single digits to low double digits.

Neuronex, launched in 2010, was primarily funded by a Chattanooga based angel group that also participated in the team’s previous company Addrenex Pharmaceuticals, and loans from the NC Biotechnology Center. The company is developing a proprietary nasal spray formulation of diazepam, licensed from SK Biopharmaceuticals Co., Ltd., to be used as rescue medication in patients with certain seizure disorders. The product, if approved, would meet a significant unmet need for patients. Currently the only available treatment for breakthrough seizures is a rectally delivered diazepam gel formulation.

Neuronex is the second of three companies, all privately held and located in North Carolina‘s Research Triangle Park region, formed by a management team lead by Chief Executive Officer Dr. Moise Khayrallah.

“Our approach is to rapidly bring innovative drugs to market to improve patients’ lives and enable our investors to achieve a positive return. I am proud to say that we are progressing quickly to achieve our goal again through this merger announcement and potential acquisition by Acorda Therapeutics,” said Dr. Khayrallah.

Addrenex Pharmaceuticals, a specialty pharmaceutical company that developed a robust pipeline of four drugs over 3 years, was acquired by Shionogi Pharma in November 2009 through a $29 million transaction in which investors received multiple returns on their investment in less than 3 years.

Aerial BioPharma, founded in January 2011, is focused on developing biologics and small molecules to treat conditions of the Central Nervous System. Its pipeline includes a product in Phase II for the treatment of narcolepsy and a preclinical biologic licensed out of UNC Chapel Hill being developed for both acute and chronic pain conditions. In addition to seed funding from the management team, early funding for Aerial has come from angel groups in Chattanooga and Raleigh.

“The team’s clinical expertise and thorough knowledge of the drug development process enables us to identify and develop drug candidates for indications with a high probability of technical success and a clear development and regulatory path to approval,” added Dr. Khayrallah. “We have continued to combine good science with clinical intuition and seasoned industry experience to ensure that Aerial is already off to a fast start.”

Neuronex Inc. is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat central nervous system diseases and disorders. Neuronex is based in Morrisville, NC, on the edge of Research Triangle Park. For more information, visit www.neuronexinc.com.

Aerial BioPharma is a privately held biopharmaceutical company focused on developing biologics and small molecules for conditions in the Central Nervous System. Aerial is based in Morrisville, NC, on the edge of Research Triangle Park. For more information, visit www.aerialbio.com.

Sol-Gel Signs $27-Million Drug Delivery Deal

Sol-Gel Technologies Ltd. recently announced it has entered into a second development and licensing agreement with a leading US pharmaceutical company for the development and commercialization in the US and Canada of a major dermatologic drug.

Under the terms of the new agreement, Sol-Gel will receive $27 million, composed of an initial non-refundable payment as well as additional license fees and development payments upon the successful completion of various milestones. The US partner will fund the product’s development. Sol-Gel will be entitled to receive royalties from net sales. The new agreement follows a similar $25-million deal made with the same company.

“This repeat collaboration reinforces Sol-Gel’s position as a leading player in the development of encapsulation technologies for application to topical drug products,” said Dr. Alon Seri-Levy, Co-Founder and CEO.

Sol-Gel Technologies Ltd. is a private specialty pharmaceutical company based in Ness Ziona, Israel. The company develops novel drugs for the dermatology market and provides state-of-the-art solutions and lifecycle management opportunities for dermatological companies. Sol-Gel’s patented drug delivery system enhances the efficacy, safety, and stability of topical drugs by encapsulating the drug substances in an inert, clear-silica microcapsule shell and by releasing the active pharmaceutical ingredients in a time-controlled manner. The technology enables Sol-Gel to offer the derma market advanced topical drug products that are more effective and/or have fewer side effects than existing drugs.

“Sol-Gel is maximizing its value by creating a diverse proprietary product pipeline with high market potential and by collaborating with global pharmaceutical companies,” added Gil Bianco, Chairman of Sol-Gel.

Sol-Gel’s pipeline includes an innovative topical therapy for rosacea known as DER45-EV Gel currently undergoing a Phase II multi-center study in the US; a new generation of anti-acne kits, targeting the $1-billion acne therapy market; and other dermatology products that have been significantly improved by Sol-Gel’s proprietary drug delivery technology.

Haselmeier Establishes New Pen Injector Assembly Facility

Haselmeier, a leading designer and manufacturer of pen injection systems, recently announced it will establish a new manufacturing facility in Bangalore, India, to produce and supply high-quality, competitively priced pen injectors for the pharmaceutical industry in India. The reusable and easy-to-use pen is based on the i-pen technology and designed to allow accurate and reliable dosing.

Haselmeier’s new facility will cover approximately 1,100 square meters, including a clean room suite for the assembly of reusable pens. The manufacturing capacity can be swiftly adapted to changing market needs.

“As the incidence of diabetes is increasing significantly in India and other developing countries, and with it, the demand for injection pens will also increase,” said Jochen Gabriel, Chairman of Haselmeier. He added that “device manufacturers will be faced with supplying high-quality and affordable pen injectors in those countries. By establishing production in India, we will be well prepared for this challenge.”

Haselmeier India Pvt. Ltd. has been incorporated in August 2011. In the meantime, the company has acquired a suitable location and hired key personnel to prepare for production readiness within the shortest possible time. The new facility will expand Haselmeier’s manufacturing capacity, which currently consists of facilities in Germany and the Czech Republic. Haselmeier plans to build its own facility in India within the next years, which will foresee vertical integration of crucial manufacturing steps, such as injection moulding and printing. For more information, visit www.haselmeier.com.

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