>>DENVER--(BUSINESS WIRE)--March 6, 2006--Myogen, Inc. (Nasdaq: MYOG - News), a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today reported 2005 full-year results. As of December 31, 2005, the Company had cash, cash equivalents and investments of $182.3 million. Net loss for the year ended December 31, 2005, was $63.0 million, or $1.68 per share, compared to a net loss of $57.7 million, or $2.00 per share last year.
"2005 was an incredibly exciting and rewarding year for Myogen and all of its constituents: patients, physicians, investors and employees," said J. William Freytag, President and Chief Executive Officer of Myogen. "We reported positive results for our two late-stage product candidates, ambrisentan and darusentan, as well as continued progress in our discovery research program and, with the support of the investment community, were able to secure additional funding to continue the advancement of these programs. 2006 looks to be another busy and potentially rewarding year with ambrisentan ARIES-1 data expected in April, initiation of our darusentan Phase 3 program and launch of commercial operations for Flolan expected in the second quarter and, hopefully, the submission of the ambrisentan NDA in the fourth quarter."
2005 Highlights
Positive top line results of darusentan Phase 2b resistant hypertension clinical trial
Positive top line results of ambrisentan ARIES-2 Phase 3 pulmonary arterial hypertension clinical trial
$125 million equity financing
Product Portfolio Update
Ambrisentan: Ambrisentan is a non-sulfonamide, propanoic-acid class, type-A selective endothelin receptor antagonist that is being evaluated as a once-daily oral therapy for patients with pulmonary arterial hypertension (PAH). Ambrisentan has been granted orphan drug designation for the treatment of PAH in both the United States and European Union.
ARIES-1 & -2
ARIES-1 & -2 are two pivotal Phase 3 trials evaluating ambrisentan in patients with PAH. Each trial was designed to enroll 186 patients. ARIES-1 enrolled 202 patients primarily from North America plus selected international sites, while ARIES-2 enrolled 192 patients primarily in Europe plus selected additional international sites. Positive top line results for ARIES-2 were reported in December 2005. Additional results of the trial will be presented at ATS 2006 -- San Diego, the annual International Conference of the American Thoracic Society to be held May 19-24, 2006, at the San Diego Convention Center in San Diego, California.
Patient enrollment in ARIES-1 was completed on November 30, 2005, and the last patient completed the 12-week trial on February 21, 2006. The Company expects to report top line results of the trial in April 2006. The primary efficacy endpoint of this trial is the change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo. With a targeted sample size of 62 patients per arm, the trial has approximately 90% power to detect a placebo-corrected treatment effect of 35 meters for each dose group. A fixed-sequence approach for analysis, starting with the 10 mg dose and then proceeding to the 5 mg dose, will be used to control the Type I error for the two comparisons.
After the initial 12-week assessment period, all patients in the ARIES trials have the option to continue ambrisentan therapy in a long-term study. To date, more than 400 patients have been enrolled in this and other long-term studies. The incidence of confirmed serum aminotransferase test results greater than three times the upper limit of the normal range (3xULN) remains less than 1%.
AMB-222
In February 2006, the Company announced positive top line results of AMB-222, an open-label trial in which ambrisentan was administered to 36 PAH patients who had previously discontinued bosentan, sitaxsentan or both due to serum aminotransferase abnormalities. The primary endpoint of the trial was the incidence of serum aminotransferase concentrations greater than 3xULN during the 12 week evaluation period that resulted in discontinuation of drug treatment.
None of the 36 patients enrolled in the study had a recurrence of liver function abnormalities that resulted in discontinuation of ambrisentan during the initial 12-week evaluation period (the primary endpoint of the study). One patient had a transient serum aminotransferase test result greater than 3xULN at week 12 that resulted in dose reduction from 5 mg to 2.5 mg ambrisentan. This patient remains on ambrisentan therapy and has not had a recurrence of serum aminotransferases greater than 3xULN. Patients have continued to receive ambrisentan therapy for periods up to 10 months (mean exposure of 6 months) and no further occurrence of serum aminotransferase concentrations greater than 3xULN has been observed.
AMB-105
The Company recently completed a Phase 1 study examining the potential for drug-drug interactions between ambrisentan and sildenafil. The study results demonstrated that multiple doses of ambrisentan had no significant interaction with sildenafil. Similarly, multiple doses of sildenafil did not alter the pharmacokinetics of ambrisentan. Full results of AMB-105 will be submitted for presentation at a future scientific conference.
AMB-106
The Company recently completed a Phase 1 study examining the potential for drug-drug interactions between ambrisentan and warfarin. The study results demonstrated that multiple doses of ambrisentan had no significant effect on prothrombin time, international normalized ratio (INR) and/or the pharmacokinetics of warfarin. Full results of AMB-106 will be submitted for presentation at a future scientific conference.
Darusentan: Darusentan is a non-sulfonamide, propanoic-acid class, type-A selective endothelin receptor antagonist that is being evaluated as a once daily oral therapy for patients with resistant hypertension.
DAR-201
In August 2005, the Company announced positive top line results of a Phase 2b randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of darusentan in patients with resistant systolic hypertension. Enrollment of 115 patients was completed in April 2005. Patients underwent forced titration every two weeks through 10, 50, 100 and 150 mg of darusentan or placebo until the target dose of 300 mg once a day was achieved. The treatment period for the study was 10 weeks.
Results of the trial demonstrated that 300 mg of darusentan dosed once daily provided statistically significant, placebo-corrected reductions in systolic and diastolic blood pressure. Clinically meaningful reductions in systolic and diastolic blood pressure were also observed at earlier time points at lower doses. Trial results also demonstrated darusentan was generally well tolerated suggesting a favorable safety profile. There was no difference in the incidence of premature discontinuations in the darusentan arm compared to the placebo arm. Furthermore, there were no observed serum aminotransferase concentrations above two times the upper limit of the normal range. Additional results from the Phase 2b study will be presented at ACC.06, the 55th Annual Scientific Session of the American College of Cardiology, which will be held March 11-14, 2006, in Atlanta, Georgia.
Based on these results, the Company plans to conduct an international Phase 3 clinical program (DAR-311 and DAR-312) to further evaluate darusentan for the treatment of patients with resistant hypertension. The Company expects to initiate the Phase 3 program in the second quarter of 2006.
DAR-311
The primary objective of this Phase 3 randomized, double-blind, placebo-controlled parallel group trial is to determine if darusentan is effective in reducing systolic blood pressure in resistant hypertension patients currently treated with full doses of four or more antihypertensive medications, one of which is a diuretic. Patients are eligible for enrollment in this trial if they have a systolic blood pressure greater than or equal to 140 mmHg and no other compelling conditions. For patients with diabetes and chronic kidney disease, the blood pressure inclusion criterion is a systolic blood pressure greater than 130 mmHg. Approximately 352 patients will be randomized to one of three doses of darusentan (50, 100, or 300 mg qd) versus placebo in a ratio of 7:7:7:11. The treatment period for the trial is 14 weeks. The primary endpoint of the trial is change from baseline to week 14 in trough sitting systolic blood pressure as compared to placebo. Upon completion of the 14-week assessment period, patients will be eligible to enroll in a long-term safety study.
DAR-312
The primary objective of this Phase 3 randomized, double-blind, placebo-controlled trial is to determine if darusentan is effective in reducing systolic blood pressure in patients with resistant hypertension. Patients are eligible for enrollment in this trial if they have a systolic blood pressure greater than or equal to 140 mmHg despite treatment with full doses of three antihypertensive drugs, one of which is a diuretic, and no other compelling conditions. For patients with diabetes and chronic kidney disease, the blood pressure inclusion criterion is a systolic blood pressure greater than 130 mmHg. Approximately 770 patients will be randomized to darusentan, active control (guanfacine, an antihypertensive drug that acts as a central alpha agonist) or placebo, in a 3:3:1 ratio. The treatment period for the trial is 14 weeks. The efficacy analysis of the trial is change from baseline to week 14 in trough sitting systolic blood pressure compared to placebo and then compared to the active control. Upon completion of the 14-week assessment period, patients will be eligible to enroll in a long-term safety study.
Patients enrolled in the two long-term studies will be treated and followed for safety for at least six months with a mean exposure expected to be in excess of one year. The Company may undertake additional studies in this indication for commercial and regulatory support.
Drug Discovery Research: Myogen is continuing to move forward with its drug discovery program, which is the subject of a broad collaboration with Novartis. The program is focused on the discovery, development and commercialization of new therapeutics for the treatment of heart muscle disease.<<
snip
Not saying Thelin is better, saying that they're going to be pretty close; that affinity isn't going to make a huge clinical difference. As such, Thelin's lead in the marketplace will be very helpful. We'll get another good read in another month or so, eh?
Cheers, Tuck |
