Lang Previously was Global Head, Clinical Research and Development for Analgesia in Novartis' Consumer Health Division
Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today announced that Dr. Eric Lang has been appointed Vice President of Clinical Research. Dr. Lang comes from Novartis, where he was most recently the Global Head of Clinical Research and Development for Analgesia for its Consumer Health Division. In that capacity, he was responsible for the design and implementation of the clinical strategy for its global analgesics franchise.Dr. Lang was a member of the team which obtained US FDA regulatory approval for Novartis’ Voltaren Sodium Gel® (topical diclofenac sodium) in 2007, the first topical NSAID approved in the USA for osteoarthritis. Prior to Novartis, Dr. Lang held roles of increasing responsibility at Johnson & Johnson for seven years. Dr. Lang received his medical degree at Ben Gurion University of the Negev in Beer Sheba, Israel and completed an acute and chronic pain fellowship at Emory University Medical School.
“I am pleased to welcome Eric to the Javelin team. Eric’s successful clinical and regulatory experience in analgesics, including Voltaren Sodium Gel, should greatly benefit Javelin. Javelin plans to file two high quality New Drug Applications in the US later next year, one is for Dyloject™ an injectable form of diclofenac sodium for acute treatment of pain. Eric will report to Dr. Daniel Carr, our President and Chief Medical Officer,†stated Javelin’s CEO, Martin J. Driscoll.
“I am delighted to join Javelin at such an important time. I look forward to contributing to the preparation of the US NDA filings for Dyloject™ and our intranasal ketamine product Ereska™ as well as, helping to shape their commercial labels and strategy. There is a significant unmet clinical need for non-opioid pain drug candidates like Dyloject and Ereska globally,†said Dr. Eric Lang.
About Dyloject
Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the United States and Marketed in the United Kingdom. Javelin plans on submitting a New Drug Application to the US FDA for Dyloject during 2009. Diclofenac is a prescription nonsteroidal anti-inflammatory drug ("NSAID") that is widely prescribed to treat post-operative pain due to its combination of effectiveness and tolerability. Dyloject has the potential to provide an attractive alternative to other NSAIDs for the treatment of post-operative pain, and to decrease the need for morphine or other opioids in this setting. There still exists an underserved medical need for a safe and effective injectable NSAID in the hospital setting. In its pivotal UK registration trial, Dyloject's efficacy and safety were shown to be significantly superior to those of the IV formulation of diclofenac currently marketed in the UK. Each dose of the competitive formulation requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has the potential to save the UK NHS up to GBP 50 per postoperative patient. This pharmacoeconomic benefit, coupled with Dyloject's superior clinical attributes, differentiates Dyloject from the competitive diclofenac product, as well as from any of the other marketed IV NSAID products. Dyloject is presently being marketed in the UK for the treatment of acute moderate-to-severe pain. Subsequent submissions and approvals in other European countries are anticipated through a regulatory strategy following the Mutual Recognition Process.
About Javelin Pharmaceuticals, Inc.:
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. The Company has one marketed drug in the UK and three drug candidates in US Phase 3 clinical development. For additional information about Javelin, please visit the company's website at http://www.javelinpharmaceuticals.com.
Forward Looking Statement:
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.