Natrecor lawsuits

Median length of follow up is 31.8 months range 5.5-70 ; . Seventeen of the twenty patients are alive and in remission. One patient with a follow up of 5.5 months had a positive PET scan at his 100 day restaging but no CAT scan correlation. Two patients died of relapsed lymphoma early post transplant 2months, 4months ; . One patient died of regimen related toxicity at day + 22. The progression free survival PFS ; is 85% 95% CI 69-100 ; and overall survival 85% for the entire group. figure 2 ; For the patients transplanted beyond 1st CR the OS is 81% 95% CI 62-100 ; figure 3 ; and PFS is 81% 69-100.

Abnormalitieswere classified according to the International System for Human Cytogenetic Nomenclature!' Stuiistical analysis. Differences in the distribution of clinical and biologic features among subgroups of patients were analyzed by Pearson's chi-square test for categorical variables or the Kruskal-Wallis test for continuous variables. Life tables for eventfree survival were constructedby the method of Kaplan and Meier, with differences compared by the log-rank test. Early death or failure to enter remission was considered an event at zero time. Patients with AML who underwent bone marrow transplantation were censored at the time of the procedure. In September of last year, company officials said that a CHF deal was imminent. Then, on the brink of signing a contract, Cytokinetics pulled out of negotiations and decided to continue the program on its own, at least for the time being. They had the near-term money they needed, thanks to the IPO. They had a project team "with more acute cardiology experience than any other company--bar none, " says Blum. That group includes researchers--brought in both as consultants and employees--who worked on nesiritide NatreCor ; at Scios Inc. acquired by Johnson & Johnson in 2003 ; , eptifibatide Integrilin ; at Cor and tissue plasminogen activator tPA ; at Genentech Inc. One key to abandoning the deal was the hiring of CHF specialist Andrew A. Wolff, MD as CMO and SVP clinical research and development. Before joining Cyto-kinetics, Wolff spent ten years at CV Therapeutics Inc. One of the rationales for partnering the CHF program was that that the company would need help in identifying and developing an orally available compound. But just around the time that Wolff came on board, according to Sabry, it became apparent that Cytokinetics might have generated just such a compound on its own. And Wolff helped confirm the viability of continuing work on the chronic care indication in-house. Sabry thinks Phase I will commence some time this year. But another important factor in ditching the partnership, says Blum, was the strategic plan. According to Blum, it helped determine that Cytokinetics no longer needed the development capabilities it initially sought from the partner. In particular, the timeline projections for scenarios with and without a partner indicated no difference in time to market. And, from a financial standpoint, the company's leadership determined that, with the IPO, Cytokinetics could afford to handle the programs internally through at least proof-of-concept and would get a better return on investment by waiting to do a deal. Going Solo in Development But before Cytokinetics reaches its new dealmaking stage, Blum and his colleagues will need to find the funding that that the aborted deal would have provided. As of December 31, 2004, Cytokinetics had 6.2 million in cash, anticipating a net burn for 2005 of about million, up from about million in 2004--that leaves it with about two years worth of capital, less than it needs to get the CHF compound through proof-of-concept. Blum notes that the company has raised over 4 million in private financings, million through the IPO, and has never had a down round. But past is not necessarily prologue. There's still the option of partnering its CHF program. The company, however, would be getting, at best, the same value for the project that it probably was given in the abandoned alliance and would thus be doing something it has assiduously worked to avoid: using dealmaking to raise capital. Another possibility--though one that Cytokinetics also wants to avoid--would be cutting back on discovery. A Contrast in Approaches The strategy pursued by Exelixis, which began as a genetics-based technology platform company, provides an interesting contrast--as well some similarities--to the course taken by Cytokinetics. Exelixis and Cytokinetics which until recently had a combinatorial chemistry collaboration ; have both largely relied on internal R&D. And major deals with GSK represent defining partnerships for both. But the structures of those partnerships also say a lot about the differences between the two companies. In its original deal with GSK, Exelixis was to deliver a set of molecules that met certain criteria, including validation through proof-of-concept Phase IIa ; . GSK agreed to fund the program with a minimum of million, as well as an million loan facility. At proof-of-concept, GSK could then exercise an option to take over development, paying roughly million for the privilege, along with additional milestones as the product progresses and low double-digit royalties. Exelixis also received a million up-front payment, a million equity investment and has certain North American co-promotion rights. The Cytokinetics agreement with GSK is, in some ways, a mirror image of the Exelixis GSK alliance. Exelixis received considerably more cash and retained control over development through Phase II. Cytokinetics' deal is arguably weighted more downstream: it hands over development to GSK, but keeps some later stage and commercialization rights, including funding to support any copromotion efforts that it might undertake. Of course, at its stage of development, Cytokinetics couldn't offer a partner the sorts of development capabilities that GSK sought from Exelixis. To some extent, though, Exelixis was limited by the GSK alliance. The more productive it was, the more it would have to find the money to prosecute its programs--but since GSK owned rights to them all it would need some innovative financing structure to push them forward, without signing up another partner. That's one reason Exelixis bought X-Ceptor Therapeutics Inc.--to get a.

Natrecor lawyer