So, finally we have that *expected* bad news. DVT is on hold for now. They tried to compensate this with acute UA path. It may be good decision, for now, until clear strategy and drug potential (if any) crystallize.
Now, as I said early, it is up to rNIF and how will stroke trial work. I do not think that *street* has high hope for stroke trial, but may greater returns were when I bet against street. Will see?
Miljenko
Tuesday October 23, 4:03 pm Eastern Time
Press Release
SOURCE: Corvas International, Inc.
Corvas International Reports Third Quarter Results
- Company Also Announces Next Stage for rNAPc2 Clinical Development And Reviews Progress in Cancer Programs -
SAN DIEGO, Oct. 23 /PRNewswire/ -- Corvas International, Inc. (Nasdaq: CVAS - news) today reported financial results for the third quarter ended September 30, 2001, which were in line with management's expectations. Operating revenues of $131,000 and operating expenses of $5.6 million resulted in a net loss of $4.3 million, or $.16 per share. In the third quarter of 2000, operating revenues of $856,000 and operating expenses of $4.3 million resulted in a net loss of $3.1 million, or $.15 per share.
For the nine months ended September 30, 2001, operating revenues of $294,000 and operating expenses of $23.1 million resulted in a net loss of $18.3 million, or $.67 per share. Results for the first nine months of 2000 included operating revenues of $5.3 million, operating expenses of $13.7 million and a net loss of $7.6 million, or $.37 per share.
The decrease in revenues comparing the first nine months of 2001 to the same period of 2000 resulted from the fact that in the second quarter of 2000 the Company received a $2.5 million license fee from Schering-Plough for the hepatitis C virus inhibitor program and reached the contractual end in 2000 of the research and development funding portion of collaborative agreements with Schering-Plough covering inhibitors of both thrombin and hepatitis C. The increased operating expenses in 2001 were primarily attributable to non-recurring costs associated with manufacturing of the Company's proprietary anticoagulant drug candidate, rNAPc2, which was completed in the second quarter of 2001. Growth in personnel and research activities in support of the Company's cancer programs also contributed to the increased expenses.
Corporate highlights during the third quarter 2001 included:
* Initiation of a collaboration with Dyax Corp. to discover, develop and
commercialize novel cancer therapeutics, including peptides and
antibodies, focusing on inhibitors for two serine protease targets.
* Initiation of a research and exclusive license agreement with
Georgetown University relating to Georgetown's intellectual property
for matriptase, a novel serine protease cancer target.
* Presentation at the American Chemical Society annual meeting of the
three-dimensional structure of matriptase, which is expected to advance
rational drug design against cancer targets in the serine protease gene
family.
* Initiation of an agreement with Incyte Genomics, Inc. for a multi-year
subscription to its genomics database that Corvas believes will
facilitate the discovery and prioritization of cancer targets in the
serine protease gene family.
Corvas also announced that the next stage of clinical evaluation for rNAPc2 will be for the treatment of acute coronary syndromes (ACS), which include unstable angina. The Company expects to initiate a double-blinded, placebo-controlled dose-ranging Phase II clinical study in patients with unstable angina in 2002. In anticipation of studies in ACS, Corvas completed a Phase IIa safety study in patients undergoing elective coronary angioplasty. Results from this Phase IIa trial will be presented on December 10, 2001, at the 43rd annual meeting of the American Society of Hematology in Orlando, Florida. The Company also recently initiated a Phase I study to assess the safety and pharmacokinetics of rNAPc2 following intravenous administration as a prerequisite to treating acute conditions.
Corvas also completed a Phase II trial with rNAPc2 for the prevention of deep vein thrombosis (DVT) and associated pulmonary embolism (PE) in patients undergoing total knee replacement surgery. As previously announced, the Phase II trial in DVT was the subject of a recent end-of-Phase II meeting between Corvas and the Food and Drug Administration (FDA). Based on the meeting and subsequent communications with the FDA, the Company has concluded that, while the Phase II trial for DVT indicated that rNAPc2 is safe and effective as a potential treatment for the prevention of DVT/PE, Corvas would need to conduct an additional Phase II trial to firmly establish a fixed dosing regimen in order to move forward in this indication.
``At this juncture, we believe unstable angina presents a greater market opportunity for rNAPc2 based on a strong medical need for more effective anticoagulant agents in this indication,'' said George P. Vlasuk, Ph.D., Executive Vice President and Chief Scientific Officer. ``Therefore, we have made a commercial decision to focus on the clinical development of rNAPc2 in unstable angina at this time and will continue to pursue partnering opportunities for the program. Future clinical development of rNAPc2 in DVT will depend on securing an appropriate partner.''
There are approximately 700,000 unstable angina patients diagnosed each year in the United States with an annual worldwide incidence of approximately 1.7 million people. Unstable angina is characterized by severe chest pain, even at rest, that results from the formation of a blood clot in one or more of the blood vessels of the heart. Even with current therapies, approximately 10-20% of unstable angina patients will experience a subsequent clinical event such as a heart attack or will die.
``Corvas remains committed to the clinical development of rNAPc2 and continues to believe that DVT offers a viable commercial opportunity for this drug; however, in assessing the relative competition and market opportunities, we believe we can add greater value to the rNAPc2 program by moving forward in unstable angina,'' said Randall E. Woods, President and CEO. ``As we transition into 2002, Corvas is well positioned to execute on our cardiovascular and cancer programs. We look forward to the expected completion of enrollment in the Phase IIb efficacy study of UK-279,276 (formerly rNIF) being conducted by our collaborator Pfizer for ischemic stroke and continued progress on scientific and corporate development fronts that we believe will move our cancer programs more rapidly toward the clinic.'' |
