Advertisement
Under the terms of the agreement, AstraZeneca will pay MAP Pharmaceuticalsan upfront cash payment of $40 million and an additional $35 million upon thesuccessful achievement of primary endpoint and safety results in the currentlyongoing Phase III clinical study. In addition, upon the occurrence of certainevents and conditions, MAP Pharmaceuticals is eligible to receive up to $240million in other potential development and regulatory milestones. Theagreement also provides for additional progressively demanding salesperformance-related milestone payments of up to $585 million in the event theproduct is a considerable commercial success. This agreement is subject toreview by the United States Government under the Hart-Scott-Rodino Act andbecomes effective after the expiration or earlier termination of the waitingperiod (or any extension thereof).
Advertisement
AstraZeneca also will support and fund the establishment of a MAPPharmaceuticals sales force to co-promote UDB in the United States for acertain period of time after product launch. MAP Pharmaceuticals is alsoeligible to receive significant double-digit royalty payments on net sales ofUDB worldwide.
MAP Pharmaceuticals and AstraZeneca will develop UDB in the United Statesand AstraZeneca has rights to develop and commercialize UDB outside of theUnited States. Under the agreement, AstraZeneca will be responsible forfuture UDB development costs and AstraZeneca will reimburse MAPPharmaceuticals for the costs of future UDB development activities withrespect to United States registration incurred by MAP Pharmaceuticals.
David Brennan, Chief Executive Officer of AstraZeneca said, "MAPPharmaceuticals' advancement in Unit Dose Budesonide represents an importantpotential new option for treating children confronting asthma. AstraZeneca'sheritage in treating pediatric asthma, combined with MAP Pharmaceuticals'expertise can open new areas of opportunity for both companies and has thepotential to bring significant medical benefit to the wider community."
"AstraZeneca is an ideal partner for UDB given their extensive expertisein developing and commercializing respiratory therapies, including forpediatric asthma," said Timothy S. Nelson, President and Chief ExecutiveOfficer of MAP Pharmaceuticals. "We recognize AstraZeneca's leadershipposition in this therapeutic area and their potential to help MAPPharmaceuticals achieve its key objective of reaching the broadest set ofchildren who suffer from asthma. This relationship represents an importantstep in the evolution of our company, as we leverage our partner's significantexpertise and resources to help us build a commercial infrastructure forsubsequent product launches. In addition, this transaction greatlystrengthens our balance sheet and provides us with additional financialresources moving forward."
UDB is being developed utilizing a license to Elan's proprietaryNanoCrystal(R) Technology. The small size and stability of NanoCrystal(R)drug particles are designed to enable improved delivery efficiency of drugformulations to the lung via nebulization.
About UDB
UDB is being studied as a novel version of nebulized budesonide.Budesonide has been used clinically for more than 20 years. UDB is designedto be nebulized more quickly at a lower nominal dose than the commerciallyavailable product. MAP Pharmaceuticals has completed enrollment andrandomized approximately 360 patients in a Phase 3 clinical trial to evaluateUDB for the potential treatment of pediatric asthma. The last patient in thistrial is expected to complete the 12-week treatment period by the end of 2008.The safety data generated to date has shown UDB to be well tolerated with nosignificant adverse events.
About MAP Pharmaceuticals
MAP Pharmaceuticals, Inc. develops and plans to commercialize newtherapies for children and adults who suffer from chronic conditions that itbelieves are not adequately treated by currently available medicines. Thecompany applies its proprietary inhalation technologies to enhance thetherapeutic benefits and commercial attractiveness of proven drugs whileminimizing risk by capitalizing on their known safety, efficacy andcommercialization history. MAP Pharmaceuticals has two drug candidates inPhase 3 clinical trials. Unit Dose Budesonide is being developed for thepotential treatment of pediatric asthma, and MAP0004 is being developed forthe potential treatment of migraine. MAP Pharmaceuticals' pipeline alsoincludes a drug candidate in early clinical development for the treatment ofasthma and chronic obstructive pulmonary disease.
Additional information about MAP Pharmaceuticals can be found athttp://www.mappharma.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged inresearch, development, manufacturing and marketing of prescriptionpharmaceuticals and supplier for healthcare services. AstraZeneca is one ofthe world's leading pharmaceutical companies with healthcare sales of US$29.55 billion and is a leader in gastrointestinal, cardiovascular,neuroscience, respiratory, oncology and infection product sales. AstraZenecais listed in the Dow Jones Sustainability Index (Global) as well as theFTSE4Good Index. For more information visit www.astrazeneca.com
NanoCrystal(R) Technology is a registered trademark of Elan PharmaInternational Limited, Ireland, a subsidiary of Elan Corporation, plc(NYSE: ELN).
Forward-Looking Statements
This document contains forward-looking statements, which are made pursuantto the safe harbor provisions of the U.S. Private Securities Litigation ReformAct of 1995. These forward-looking statements are based on risks anduncertainties that could cause actual results to differ materially fromexpectations. These forward-looking statements should not be relied upon aspredictions of future events as we cannot assure you that the events orcircumstances reflected in these statements will be achieved or will occur.You can identify forward-looking statements by the use of forward-lookingterminology, including "believes," "expects," "may," "will," "should,""seeks," "intends," "plans," "estimates," or "anticipates" or the negative ofthese words and phrases or other variations of these words and phrases orcomparable terminology. These forward-looking statements relate to, amongother things, the impact and effects of the development and commercializationarrangement on MAP Pharmaceuticals and AstraZeneca, future demand forpediatric asthma products, potential benefits of the joint collaborationbetween MAP Pharmaceuticals and AstraZeneca and the timing of the jointcollaboration. The material factors that could cause actual results to differmaterially from current expectations include, without limitation, thefollowing: regulatory review and approval of UDB; the conduct and timing ofclinical trials; the availability, pricing and marketing of competitiveproducts, including generic products; any inability to realize all of theanticipated benefits of the development and commercialization arrangementfully or on the anticipated timeline; failure to obtain clearance of thecollaboration agreement under the Hart-Scott-Rodino Act; a downturn in thepharmaceutical industry; unexpected variations in market growth and demand forpediatric asthma products; or the effect of political or economic instabilityinternationally on the sales or production of UDB. MAP Pharmaceuticals andAstraZeneca urge investors to review in detail the risks and uncertainties intheir Securities and Exchange Commission filings, including but not limited toMAP Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter endedSeptember 30, 2008 and AstraZeneca's Annual Report on Form 20-F for the yearended December 31, 2007. MAP Pharmaceuticals and AstraZeneca disclaim anyintent or obligation to update these forward-looking statements.
SOURCE MAP Pharmaceuticals; AstraZeneca
