Business Editors
TORONTO--(BUSINESS WIRE)--Feb. 26, 2004
Biovail Corporation (NYSE:BVF) (TSX:BVF):
-- Conducting out-licensing discussions with multiple partners
-- Flashtab immediate-release tramadol NDA submission expected H1
2004
-- Acquires rights to tramadol/acetaminophen formulation from
Ethypharm
-- Biovail/Ethypharm Shareholders Agreement modified
-- Biovail reacquires North American rights to Diltiazem CR from
Ethypharm
Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today that it has received confirmation, with an effective date of February 29, 2004, for the filing of its December 31, 2003 submission for a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Ralivia ER(TM) (tramadol hydrochloride) Extended Release tablets. Ralivia ER(TM) is a once-daily oral controlled-release medication intended for the treatment of moderate to moderately severe pain.
The application for Ralivia ER(TM) was submitted under the provisions of Section 505(b)(2) of the Food, Drug and Cosmetic Act. Clinical and safety data has been obtained from four original adequate and well-controlled trials on over 3000 patients receiving doses of up to 400mg of Ralivia ER(TM) once-daily. The submission also included 12 definitive and 5 supportive pharmacokinetic studies which demonstrated that once-daily dosing of Ralivia ER(TM) delivers the same amount of drug as Ultram given three times (TID) or four times (QID) per day, with somewhat smaller peak-to-trough fluctuations.
Ralivia ER(TM) uses Biovail's Smartcoat Technology, which is similar to that used in the development of Biovail's Wellbutrin XL formulation. Biovail believes that there is considerable opportunity for a product line offering that includes Ralivia ER(TM) intended for chronic use and oral disintegrating tablet presentations of tramadol and tramadol/acetaminophen for the treatment of acute pain. Though a final decision has not been made regarding the commercialization of Biovail's pain franchise, Biovail is currently in discussions with multiple potential partners regarding outlicensing Ralivia ER(TM) alone or in conjunction with Biovail's orally disintegrating pain products. Biovail will develop a timeline for presenting this extensive clinical data set after determining whether Biovail will launch Ralivia ER(TM) through its own sales force in the United States or outlicense it to a partner.
Biovail also confirms today that it has completed all relevant studies for its Flashtab version of immediate-release tramadol HCl. Biovail expects to submit an NDA to the FDA in the first half of 2004 for this product. The North American rights to this product were acquired from Ethypharm SA (Ethypharm) in September 2003. An immediate release form of tramadol HCl -- dosed up to 6 times daily was introduced in 1995 and is currently marketed in the United States under the brand name Ultram with sales of approximately $150 million and approximately 11 million prescriptions dispensed during 2003 including generics. The combined market for narcotic and non-narcotic analgesics generated sales of $13.9 billion in the United States for this same time period.
Furthermore, Biovail today announced that it has acquired North American rights to Ethypharm SA's (Ethypharm) Flashtab combination tramadol and acetaminophen (Flashtab tramadol/acetaminophen) product, which complements Biovail's September 2003 purchase from Ethypharm of Flashtab tramadol. A current combination tramadol and acetaminophen product is sold under the Ultracet brand for the treatment of short-term management of acute pain by a division of J&J and had sales of $262 million in the United States in 2003. Flashtab tramadol/acetaminophen may offer the convenience of an Orally Disintegrating Tablet (ODT or Flashtab or Flash Dose) for an acute pain use. This dosage presentation may be particularly advantageous for a drug that is taken multiple times per day (up to 8 tablets per day) and is further evidence of Biovail's commitment to providing innovative treatment options for pain management.
As part of the licensing agreement for Flashtab tramadol/acetaminophen, Biovail has modified its Shareholder Agreement with Ethypharm with respect to having protection on the value of its 15% equity investment in Ethypharm from an indefinite period of time to 18 months. Biovail and Ethypharm have agreed to terminate the September 2003 Diltiazem CR License Agreement and the Supply Agreement as well as terminating Biovail's obligation to provide convertible debenture financing to Ethypharm. As a result of these initiatives, the elimination of Biovail's financing commitment to Ethypharm removes a contingent obligation, simplifies reporting and provides enhanced transparency. Biovail will finalize the accounting for the transaction with Ethypharm and announce the accounting treatment as part of its 2003 earnings release scheduled for March 3, 2004.
Additional information
Tramadol
Tramadol is one of a number of analgesics, which are among the most effective medications for the treatment of chronic pain. Tramadol's minimal propensity to induce adverse effects is an advantage over morphine-like agents. Relative to morphine, tramadol causes less dependence and less respiratory depression. Ralivia ER(TM) has been developed to offer continued pain control over 24 hours as compared to the immediate-release formulations, which must be taken multiple times per day.
Subject to FDA approval, Ralivia ER(TM) will be available in 100mg, 200mg and 300mg extended release tablets. Ralivia ER(TM) should offer patients the convenience of a once-daily form of tramadol, as opposed to its current dosing regimen of up to 4 to 6 times per day.
Tramadol/acetaminophen (Ultracet)
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