Myriad Pharmaceuticals today announced the company has entered into a definitive agreement to acquire Javelin Pharmaceuticals . The acquisition augments Myriad's portfolio of product candidates with Dyloject(TM) (diclofenac sodium for injection), a New Drug Application (NDA)-submitted candidate with the potential, based on its safety and efficacy profile, to become a valuable addition to hospital formularies as an injectable NSAID for the multimodal management of moderate-to-severe postoperative pain.
Under the Agreement and Plan of Merger, Myriad Pharmaceuticals will acquire all of the outstanding shares of Javelin common stock in exchange for Myriad Pharmaceuticals stock, resulting in the Javelin stockholders owning approximately 41% of the combined company immediately after the closing. The ownership interest of Javelin shareholders may increase up to a maximum of approximately 45% depending upon the timing of
FDA approval of Javelin's lead drug candidate Dyloject. The transaction is expected to close in the first quarter of 2010. Concurrent with the closing of the transaction, Myriad Pharmaceuticals' board of directors may be expanded to eight members, including up to two members to be nominated by Javelin.
"We believe that this transaction represents a highly effective vehicle to unlock the long-term potential of Myriad Pharmaceuticals and near-term value of Javelin Pharmaceuticals," commented Adrian Hobden, Ph.D., President and Chief Executive Officer of Myriad Pharmaceuticals. "Myriad is well positioned to successfully launch Dyloject upon FDA approval by leveraging our financial resources and the expertise of our core commercial team. In turn, we believe that potential Dyloject revenue will support the development of our existing clinical stage drug candidates MPC-4326, Azixa, and MPC-3100."
Martin Driscoll, Chief Executive Officer of Javelin Pharmaceuticals, added, "This agreement creates a fully integrated biotechnology company with a submitted NDA for approval of a specialty care product, Dyloject, backed by significant financial resources, a broad pipeline for growth, and a seasoned management team for future commercialization efforts."
An NDA for Dyloject was submitted by Javelin on December 2, 2009. Dyloject is an injectable formulation of diclofenac. The development package includes data from two positive Phase 3 studies in postoperative abdominal and orthopedic pain together with safety data accrued from greater than 1,300 patients.
Diclofenac, a member of the class of drugs known as non-steroidal, anti-inflammatory drugs, or NSAIDs, is widely prescribed as an oral treatment for postoperative pain due to its combination of efficacy and tolerability. There remains an underserved medical need in the hospital setting for injectable NSAIDs that are safe, effective and fast-acting in patients unable to take oral medications. Effective use of injectable NSAIDs offers the potential to reduce opioid use and thereby accelerate patient recovery and shorten hospitalization. There is a growing demand for alternatives to opioids in the management of postoperative pain.
"Dyloject has demonstrated a very exciting profile in controlled studies showing statistically significant results in two registration trials, which have been submitted to the FDA for approval consideration earlier this month," said Ed Swabb, Chief Medical Officer of Myriad Pharmaceuticals. "If approved, Dyloject will be an important tool in the therapeutic armamentarium for multimodal management of postoperative pain."
Dyloject is approved and marketed in the United Kingdom by Therabel Pharma N.V. Myriad Pharmaceuticals will assume all rights to future milestone payments and royalties due from Therabel Pharma N.V.