Inex Pharmaceuticals Corp. regained full ownership of its lead anticancer drug, Onco TCS, from Elan Corp plc.
Elan's motivation in dropping responsibilities related to Onco TCS is grounded in the company's decision last year to withdraw from oncology and focus on neurology, pain management and autoimmune disease. Onco TCS is being studied in several cancers, including non-Hodgkin's lymphoma (NHL). (See BioWorld Today, Aug. 12, 2002.)
For Inex, of Vancouver, British Columbia, the opportunity to work with Elan and to purchase full rights from the company has been fruitful, David Main, president and CEO of Inex, told participants in a conference call Thursday.
"We are very pleased and believe we have negotiated an excellent deal, one that gives us a lot of flexibility moving forward and puts us back in control of our own destiny with Onco TCS," he said.
Inex said it has regained 100 percent ownership of Onco TCS (Transmembrane Carrier System) by reacquiring the 19.9 percent equity interest held by Elan. Also, Inex retains a fully paid-up license to Elan's intellectual property related to Onco TCS.
Jeff Charpentier, Inex's chief financial officer, told conference call listeners the deal does not involve advance cash payments or ongoing royalties to Elan. Instead, Inex's financial obligation will be met through three milestone payments totaling US$8 million.
Main would not discuss any specifics related to the milestones, including whether they were equal payments or what events would trigger them. However, he said, "if all goes well, they will be paid in two years."
Dublin, Ireland-based Elan is no longer obligated to purchase $2 million of Inex's common shares on the filing of a new drug application. Elan will retain ownership of two Inex convertible notes of $12 million and $15 million, plus cumulative interest on each of 7 percent per year. After April 27, 2004, Elan has the choice of converting the notes into Inex common shares at conversion rates of $5.71 and $5.07 per share, respectively. Otherwise, no repayment of principal or interest is due until April 27, 2007.
Inex's stock (TSE:IEX) closed Thursday at C$3.50, up 35 cents.
Signed in April 2001, the deal between the companies was valued at up to $39 million. (See BioWorld Today, May 1, 2001.)
In total, Elan has paid Inex $25.5 million, including a $5 million up-front equity investment and $15 million under a development loan, Main told BioWorld Today.
Main said Inex will seek another partner, "but I can't promise we will have found one by the time we file in the U.S."
He expects to file in the U.S. during the third quarter for use in heavily pretreated and relapsed or refractory NHL based on positive results from a pivotal Phase II/III trial. (See BioWorld Today, Dec. 4, 2002.)
The 102-patient study (minimum third-line therapy) produced an overall response rate of 24 percent in single-agent therapy, Main said.
Inex's stock suffered severely, falling 33 percent to close at C$3.44 in early December, when results of the Phase II/III trial were released. At the time, one analyst told BioWorld Today investors were probably comparing the 24 percent response rate to an earlier trial (Phase I/II) in which the response rate was 44 percent.
When asked about it, Main said comparing the trials was like comparing apples to oranges. The Phase I/II, he said, included a broader population with people who were not as sick.
Interim analysis of two other Phase II studies of Onco TCS used in combination with other cancer drugs showed reduced tumor size in patients with aggressive NHL.
In the 69-patient Phase II study, the company said all patients (first-line) responded to therapy, and 67 patients (97 percent) completely responded with all tumors eliminated. In the second Phase II, a nine-patient study using Onco TCS in combination with rituximab, the company said six patients responded, including three with completely eliminated tumors and three with decreased tumor size.
Onco TCS, developed by Inex, is comprised of the off-patent cancer drug vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology. The technology provides prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. The company said those characteristics are designed to increase the effectiveness and reduce the side effects of the drug.