NeurogesX and Astellas Enter Commercialization Agreement for Qutenza(TM)
San Mateo, California and Staines, England (ots/PRNewswire) -
- Conference Call Today at 9:00am ET
- Covers Europe, Middle East and Africa
- Includes Licensing Option and Development Funding for NGX-1998
NeurogesX, Inc. (NASDAQ: NGSX) and Astellas Pharma Europe Ltd.,(Astellas), the European subsidiary of Tokyo based Astellas PharmaInc. announced today that the companies have entered into anexclusive Distribution, Marketing and License agreement for thecommercialization of Qutenza(TM) in the European Economic Area (EEA)including the 27 countries of the European Union, Iceland, Norway,and Liechtenstein as well as Switzerland, certain countries inEastern Europe, the Middle East and Africa. The agreement closelyfollows the European Commission's approval received in May 2009, ofQutenza (capsaicin 179 mg) cutaneous patch for the treatment ofperipheral neuropathic pain in non-diabetic adults, either alone orin combination with other medicinal pain products.
Under terms of the agreement, Astellas will commercialize Qutenzain the above-mentioned territories and perform certain development ofQutenza including post-marketing commitments, to support Qutenza inthe EU market. NeurogesX will receive EUR 30 million (approximately$42 million) for Qutenza commercialization rights, and EUR 5 million(approximately $7 million) for a license option of NGX-1998, thenext-generation liquid formulation which uses the same activeingredient as Qutenza.
Astellas has an established and strong product portfolio withfranchises in the therapeutic areas of urology, transplantation,dermatology and infectious disease. Commenting on the agreement,Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd.,said, "We are very pleased to enter into this agreement withNeurogesX. Astellas is dedicated to developing a specialty focusedfranchise and Qutenza's launch in the European Union fits with ourstrategy. We are confident in the market potential for Qutenza givenits safety and efficacy to provide site-specific pain management forup to 12 weeks. Leveraging our foothold in these territories with ourstrong sales and marketing teams and Qutenza's product profile, weare positioning for a successful commercial launch that willintroduce an important new product to patients with neuropathicpain."
Anthony DiTonno, CEO of NeurogesX, commented, "Securing anagreement with Astellas for the commercialization of Qutenza inEurope and additional territories is a significant milestoneachievement for NeurogesX. Selecting the right partner was especiallyimportant to us since the European Union represents the firstapproval and the initial launch market for Qutenza. Astellas brings atremendous amount of sales experience and presence across Europe andwe are confident in our partner's ability and commitment to launchQutenza with the motivation required for commercial success. Havingsecured a commercial partnership in Europe, we are now turning ourfull attention to the remaining steps involved for the potential U.S.approval and commercialization of Qutenza."
Under the Distribution, Marketing and License Agreement,NeurogesX will receive two upfront payments from Astellas, EUR 30million (approximately $42 million) for Qutenza commercializationrights and EUR 5 million (approximately $7 million) for aco-development and commercialization option of NGX-1998.
NeurogesX is eligible for additional sales-based milestonepayments and additional option payments related to the liquidformulation totaling approximately EUR 70 million ($97 million) androyalties based on a double-digit percentage of net sales forQutenza.
Astellas has committed investment for additional studies tosupport the marketing and promotion of Qutenza and to fulfillpost-marketing commitments outlined in the European Commission'sapproval. These post-marketing commitments include a long-term safetystudy of Qutenza in on-label indications.
The option payment to license NGX-1998 includes an initialupfront payment as mentioned previously as well as further optionpayments as development progresses. These payments are intended, inpart, to accelerate NGX-1998 into Phase 2 clinical evaluation. In theevent that Astellas exercises its option for NGX-1998, the companiesexpect to collaborate in Phase 3 development.
All payments to NeurogesX are expressed in euros and the dollarequivalents expressed in this press release are stated at currentexchange rates. Actual conversion rates will vary depending onexchange rates in effect at the time payments are due.
Conference Call Details
NeurogesX will hold a teleconference today at 9:00 a.m. ET (6:00a.m. PT) to discuss the distribution and licensing agreement withAstellas Pharma Europe Ltd.
To participate, please dial 1-877-407-0789 (USA) or1-201-689-8562 (International). To access the live web cast pleasevisit the Investor Relations section on the corporate web site athttp://www.neurogesx.com.
A replay of the conference call will be available beginning June22, 2009 at 12:00 p.m. ET (9:00 a.m. PT) and ending on July 2, 2009by dialing 1-877-660-6853 (USA) or 1-201-612-7415 (International),Account Number: 3055, Conference ID Number: 326456. A replay of thewebcast will also be available on the corporate website for onemonth, through July 22, 2009.
About NeurogesX, Inc.
NeurogesX (NASDAQ: NGSX) is a biopharmaceutical company focusedon developing and commercializing novel pain management therapies.Its initial focus is on chronic peripheral neuropathic pain,including postherpetic neuralgia (PHN), painful HIV-distal sensorypolyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN).NeurogesX' late stage product portfolio is led by its productcandidate Qutenza, a dermal patch designed to manage pain associatedwith peripheral neuropathic pain conditions. Qutenza is currentlyapproved in the European Union for the treatment of neuropathic painin non-diabetic adults, either alone or in combination with othermedicinal products for pain. NeurogesX submitted a new drugapplication (NDA) for Qutenza to the U.S. Food and DrugAdministration (FDA) which was accepted for filing by the FDA inDecember 2008 and was given a Prescription Drug User Fee Act (PDUFA)date of August 16, 2009.
NeurogesX' second most advanced product candidate, NGX-1998, is atopically applied, liquid formulation containing a high concentrationof capsaicin designed to treat pain associated with neuropathic painconditions. NGX-1998 has completed three Phase 1 studies andNeurogesX is currently evaluating the timing of entering Phase 2development.
NeurogesX' early stage product pipeline includes pre-clinicalcompounds, which are prodrugs of acetaminophen and various opioids.The company has evaluated these compounds in vitro and in vivo and iscurrently seeking development partners for these programs.
About Astellas Pharma Europe Ltd.
Astellas Pharma Europe Ltd., located in the UK, is a Europeansubsidiary of Tokyo-based Astellas Pharma Inc. Astellas is apharmaceutical company dedicated to improving the health of peoplearound the world through the provision of innovative and reliablepharmaceutical products. The organization is committed to becoming aglobal company by combining outstanding R&D and marketingcapabilities and continuing to grow in the world pharmaceuticalmarket. Astellas Pharma Europe Ltd., is responsible for 20 affiliateoffices located across Europe, the Middle East and Africa, an R&Dsite and three manufacturing plants with approximately 3,400 staff.For more information about Astellas Pharma Europe Ltd., please visitour website at http://www.astellas-europe.co.uk/.
Safe Harbor Statement
This press release contains forward-looking statements forpurposes of the Private Securities Litigation Reform Act of 1995 (the"Act"). NeurogesX disclaims any intent or obligation to update theseforward-looking statements, and claims the protection of the SafeHarbor for forward-looking statements contained in the Act. Examplesof such statements include, but are not limited to, expectations withrespect to the successful commercial launch and market potential ofQutenza; expectations with respect to the activities of NeurogesX andAstellas under the Distribution, Marketing and License Agreement (theAgreement); the potential receipt of post-execution payments underthe Agreement; potential uses of proceeds from the Agreement;expectations regarding additional studies, including a safety studyto be carried out by Astellas under the Agreement; the timing ofregulatory decisions with respect to the NDA for Qutenza with theFDA, including the PDUFA date for the NDA; plans for entry into aU.S. commercialization partnership for NeurogesX pre-clinicalcompounds; and plans for clinical development of NGX-1998.
Such statements are based on management's current expectations,but actual results may differ materially due to various risks anduncertainties, including, but not limited to; NeurogesX' productcandidates may have unexpected adverse side effects or inadequatetherapeutic efficacy; Astellas may not devote sufficient resources orpersonnel to the commercialization of Qutenza; adoption of Qutenza byphysicians may be longer than anticipated; discussions withgovernmental or administrative entities may not result in adequatereimbursement or pricing to support commercialization efforts forQutenza; Astellas may not elect to make option related payments orco-develop NGX-1998; positive results in Qutenza clinical trials maynot be sufficient to obtain FDA approval; the FDA may requestadditional clinical trials or other information prior to grantingapproval for Qutenza; and other difficulties or delays in thesuccessful commercialization of Qutenza, carrying out activities orobtaining payments under the Agreement and in clinical developmentof, and obtaining regulatory approval for, NeurogesX' productcandidates. For further information regarding these and other risksrelated to NeurogesX' business, investors should consult NeurogesX'filings with the Securities and Exchange Commission.
ots Originaltext: Astellas Pharma Europe LimitedIm Internet recherchierbar: http://www.presseportal.de
Contact:NeurogesX, Inc., Stephen Ghiglieri, Chief Financial Officer, +1-(650)-358-3310, Astellas Pharma Europe. Mindy Dooa, Corporate Communications Director, +44-(0)7826-912-339, firstname.lastname@example.org. The Ruth Group, Sara Pellegrino (investors), +1-(646)-536-7002, email@example.com. Jason Rando (media)/Janine McCargo, +1-(646)-536-7025/7033, firstname.lastname@example.org, email@example.com
Astellas Pharma Europe Limited
In Zusammenarbeit mit Medizinfuchs
NeurogesX and Astellas Enter Commercialization Agreement for Qutenza(TM)