Nanotechnology Now

Our NanoNews Digest Sponsors
Heifer International



Home > Press > NovaDel Announces European License Agreement for Ondansetron Oral Spray

Abstract:
Partnership with BioAlliance Pharma SA for Promising Drug

NovaDel Announces European License Agreement for Ondansetron Oral Spray

FLEMINGTON, NJ | Posted on May 21st, 2008

NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, today entered into a collaboration agreement with BioAlliance Pharma SA for the development and commercialization of NovaDel's ondansetron oral spray (OS) for Europe. Ondansetron is the leading 5-HT3 antagonist to prevent nausea and vomiting after chemotherapy, radiation and surgery. Upon successful development and approval, NovaDel believes ondansetron OS could be the first antiemetic to be available in Europe in an oral spray form. BioAlliance and NovaDel anticipate collaborating in the completion of development activities for Europe, with BioAlliance responsible for regulatory and commercialization activities.

Steven B. Ratoff, Chairman and Interim President and Chief Executive Officer of NovaDel said, "This agreement expands the ondansetron OS opportunity into Europe and we welcome the relationship with BioAlliance. We continue to work closely on this product in the United States, under the potential brandname Zensana™, with our sublicensee, Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical, as they progress their clinical studies in preparation for a NDA filing later this year. Ondansetron OS is an excellent fit with BioAlliance and their strategy to commercialize products in the European oncology/HIV supportive care market. We are looking forward to working closely with our colleagues at BioAlliance to establish this product as an innovative alternative to patients having difficulty taking tablets and other forms of ondansetron."

"This first-in-class, spray drug system aligns well with BioAlliance' strategy to expand its presence in supportive care for oncology and hospitalized patients, and focusing on patient convenience," said Dominique Costantini, President and CEO of BioAlliance. "NovaDel's expertise designing spray formulations will allow us to bring this unique delivery system to market. Strativa is responsible for the clinical development of this product in the US and BioAlliance will use their dossier for European registration."

Upon closing of the agreement, NovaDel receives a non-refundable license fee of $3 million. NovaDel is, under the terms of the agreement, eligible for additional development and sales-related milestone payments totaling $24 million consisting of a regulatory approval milestone of $5 million and sales-related milestone payments of $19 million as well as a royalty on net sales during the term of the agreement. NovaDel and BioAlliance will jointly develop ondansetron OS with BioAlliance paying 100% of the costs up to a certain amount after which the development costs are shared 50:50 between the parties. BioAlliance will be responsible for activities related to regulatory and pricing approvals as well as commercialization efforts throughout Europe. NovaDel will be responsible for supplying the product.

About Ondansetron OS

Ondansetron OS is NovaDel's proprietary, investigational oral spray formulation of ondansetron, the leading 5-HT3 anti-emetic therapy indicated for chemotherapy and radiotherapy induced nausea and vomiting (CINV and RINV), and post-operative nausea and vomiting. NovaDel and Strativa are jointly developing ondansetron OS in the United States under the brand name Zensana™. Par recently initiated bioequivalence studies in man and is proceeding on schedule for their submission of a new drug application (NDA) to the FDA in the fourth quarter of this year. BioAlliance expects to file the European dossier in 2009 - 2010. Anti-emetic therapies constitute the largest segment of the oncology supportive care market. According to IMS, in 2007: over two million prescriptions for ondansetron were written in the US, and; in Europe, ondansetron unit growth was 19% representing about one million prescriptions in Europe in retail and hospitals (800,000 prescriptions in the top five countries).

####

About NovaDel Pharma Inc.
NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs. The Company’s proprietary technology offers, in comparison to conventional oral dosage forms, the potential for faster absorption of drugs into the bloodstream leading to quicker onset of therapeutic effects and possibly reduced first pass liver metabolism, which may result in lower doses. Oral sprays eliminate the requirement for water or the need to swallow, potentially improving patient convenience and adherence.

NovaDel’s oral spray technology is focused on addressing unmet medical needs for a broad array of existing and future pharmaceutical products. The Company's most advanced oral spray candidates target angina, nausea, insomnia, migraine headaches and disorders of the central nervous system. NovaDel plans to develop these and other products independently and through collaborative arrangements with pharmaceutical and biotechnology companies. To find out more about NovaDel Pharma Inc. (AMX: NVD), visit our website at www.novadel.com.

ABOUT BIOALLIANCE PHARMA SA

BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products which address resistance issues. The company has launched its first portfolio product (Loramyc®) in France and already received European Marketing Authorizations in UK, Germany, Belgium, Denmark and Luxemburg. The compound has completed the pivotal Phase III clinical development in oropharyngeal candidiasis in the USA. In addition, two other innovative products are currently in Phase III clinical trials: acyclovir Lauriad® in oral herpes (based on the same Lauriad® muco-adhesive technology as Loramyc®, which enables targeted release at the disease site) and doxorubicin Transdrug® in primary liver cancer (based on the Transdrug® nanoparticle technology, designed specifically for intracellular targeting of resistant cells). The company is also developing a new therapeutic entities program focused on the oncology and infectious disease markets. In 2007, the company established strategic alliances for commercializing Loramyc® in Europe (with JV SpeBio) and the USA with Par Pharmaceuticals. In March 2008, BioAlliance Pharma signed a partnership agreement with Handok Pharmaceuticals for commercializing Loramyc® in Korea, Taiwan, Singapore and Malaysia. For more information, visit BioAlliance Pharma's website at www.bioalliancepharma.com

FORWARD-LOOKING STATEMENTS:

Except for historical information contained herein, this document may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company’s actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the successful completion of its pilot pharmacokinetic feasibility studies, the ability to develop products (independently and through collaborative arrangements), the ability to commercialize and obtain FDA and other regulatory approvals for products under development and the acceptance in the marketplace for oral spray products. The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted. Further, the Company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the Company’s control. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company’s most recent Annual Report and Registration Statements, filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary statements contained in such filings.

For more information, please click here

Contacts:
For NovaDel:
NovaDel Pharma Inc.
Michael Spicer
908-782-3431 ext. 2550
Chief Financial Officer

or
For BioAlliance:
Dominique Costantini
+33 1 45 58 76 01
President and CEO

or
Nicolas Fellmann
+33 1 45 58 71 00
CFO

or
ALIZE RP
Caroline Carmagnol
+33 6 64 18 99 59

Copyright © Business Wire 2008

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

New method in the fight against forever chemicals September 13th, 2024

Energy transmission in quantum field theory requires information September 13th, 2024

Breakthrough in proton barrier films using pore-free graphene oxide: Kumamoto University researchers achieve new milestone in advanced coating technologies September 13th, 2024

Quantum researchers cause controlled ‘wobble’ in the nucleus of a single atom September 13th, 2024

Nanomedicine

NYU Abu Dhabi researchers develop novel covalent organic frameworks for precise cancer treatment delivery: NYU Abu Dhabi researchers develop novel covalent organic frameworks for precise cancer treatment delivery September 13th, 2024

Unveiling the power of hot carriers in plasmonic nanostructures August 16th, 2024

Nanobody inhibits metastasis of breast tumor cells to lung in mice: “In the present study we describe the development of an inhibitory nanobody directed against an extracellular epitope present in the native V-ATPase c subunit.” August 16th, 2024

The mechanism of a novel circular RNA circZFR that promotes colorectal cancer progression July 5th, 2024

Announcements

Giving batteries a longer life with the Advanced Photon Source: New research uncovers a hydrogen-centered mechanism that triggers degradation in the lithium-ion batteries that power electric vehicles September 13th, 2024

NYU Abu Dhabi researchers develop novel covalent organic frameworks for precise cancer treatment delivery: NYU Abu Dhabi researchers develop novel covalent organic frameworks for precise cancer treatment delivery September 13th, 2024

New discovery aims to improve the design of microelectronic devices September 13th, 2024

New method in the fight against forever chemicals September 13th, 2024

Patents/IP/Tech Transfer/Licensing

Getting drugs across the blood-brain barrier using nanoparticles March 3rd, 2023

Study finds nanomedicine targeting lymph nodes key to triple negative breast cancer treatment: In mice, nanomedicine can remodel the immune microenvironment in lymph node and tumor tissue for long-term remission and lung tumor elimination in this form of metastasized breast cance May 13th, 2022

Metasurfaces control polarized light at will: New research unlocks the hidden potential of metasurfaces August 13th, 2021

Arrowhead Pharmaceuticals Announces Closing of Agreement with Takeda November 27th, 2020

Alliances/Trade associations/Partnerships/Distributorships

Manchester graphene spin-out signs $1billion game-changing deal to help tackle global sustainability challenges: Landmark deal for the commercialisation of graphene April 14th, 2023

Chicago Quantum Exchange welcomes six new partners highlighting quantum technology solutions, from Chicago and beyond September 23rd, 2022

CEA & Partners Present ‘Powerful Step Towards Industrialization’ Of Linear Si Quantum Dot Arrays Using FDSOI Material at VLSI Symposium: Invited paper reports 3-step characterization chain and resulting methodologies and metrics that accelerate learning, provide data on device pe June 17th, 2022

University of Illinois Chicago joins Brookhaven Lab's Quantum Center June 10th, 2022

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project