Javelin Pharma (JAV) is focused on the late stage clinical development of three Phase 3 compounds while seeking partnerships for a non-dilutive source of funding. In mid-January, JAV established a partnership for Dyloject (injectable diclofenac) with Therabel Pharma to market the drug in Europe, where it is already approved for use.
The deal is worth up to $71M (with $12M in upfront cash and $59.5M in sales/regulatory milestones) and extends Javelin's cash resources until early 2010, during which time the Company expects to achieve additional clinical and regulatory milestones in addition to marketing partnerships for its other late-stage compounds in the U.S. market and other regions.
JAV will receive double digit royalties while drastically reducing expenses as Therabel assumes the manufacturing, marketing and regulatory responsibilities for the countries covered in the agreement – removing $16M in commercialization costs incurred by JAV during 2008.
On the manufacturing side, JAV has expanded its manufacturing agreement with Baxter (NYSE:BAX) beyond the U.S. to include Europe and has received approval from the U.K. Regulatory Authority to allow BAX as the future supplier of Dyloject. Once the Baxter product is active in the channel, it will reduce the cost of goods in Europe by about 40%, which is expected to occur in several months after Therabel completes its purchase of the existing Dyloject inventory.
Since Baxter is already the primary manufacturer of Dyloject in the U.S. market, the cost profile will be lower from the start in the domestic market. JAV expects to file a NDA for Dyloject during late 3Q09 or early 4Q09 and has already completed much of the preliminary work for the filing.
Last December, JAV released topline results for its second Dyloject pivotal Phase 3 clinical trial, which demonstrated effectiveness across all five primary study endpoints. JAV is focused on securing partnerships for its two lead compounds, Dyloject and Ereska, in the U..S. while Therabel works to expand sales in the E.U.
A Dyloject partnership is likely to occur first thanks to strong results in two pivotal Phase 3 clinical trials (abdominal and orthopedic surgeries) and an expected NDA filing during 3-4Q09. JAV is also close to completing an 850 patient observational study for Dyloject to assess its safety and add to the existing database from previous clinical trials and marketing experience in the E.U., with results expected by mid-09 for the open label safety study.
In the U.S. market, Dyloject would have competition from just one other injectable NSAID treatment, which is ketorolac. Dyloject is likely to have a more favorable side effect profile (less vein irritation, bleeding complications) and less label restrictions (i.e. no extra black box warnings, no dosage adjustments for elderly or kidney/liver impairment patients).
Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression.
JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in the next few weeks, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). Enrollment in the trial was completed two months ahead of schedule and management guided for results in the next few weeks during the conference call on March 12. A NDA filing for Ereska is possible by late 2009.
Rylomine (intranasal morphine) is the Company's final late-stage pain drug in development for the treatment of moderate to severe acute pain, representing a unique delivery system for what is a widely used opiate pain killer. Rylomine offers the advantages of intravenous (IV) morphine administration with the convenience of a needle-free, single-use device for self administration. A second pivotal Phase 3 clinical trial remains for Rylomine with the potential for partnerships as with the two lead compounds outlined above.
With cash resources to fund operations until early 2010, JAV is poised for an eventful 2009 with the potential for two NDA filings for FDA approval of Dyloject and Ereska, in addition to near-term clinical trial results assessing the safety of Dyloject and pivotal Phase 3 study results for Ereska.