SNSS - Sunesis Pharmaceuticals Inc. - Page 21
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Millennium Pharmaceuticals and Sunesis Pharmaceuticals Announce Collaboration for Kinase Inhibitors in Oncology
Sunesis Receives a $4M Payment
These programs were part of Sunesis' 2004 multi-kinase inhibitor collaboration with Biogen Idec. Following Biogen Idec's November 2010 announcement to focus on neurology and spin out or outlicense its oncology assets, Millennium acquired two of these oncology assets and will continue the development of these in collaboration with Sunesis. Biogen Idec and Sunesis are continuing a separate collaboration focused on a unique preclinical kinase inhibitor program involved in immunology.
"We are very excited to be working with Millennium, a company that focuses on developing first-in-class and best-in-class oncology compounds," stated Daniel Swisher, Chief Executive Officer of Sunesis. "We look forward to Millennium's transition of the pan-Raf kinase investigational agent into clinical studies, while we continue to focus our resources and attention on our ongoing Phase 3 VALOR trial for vosaroxin in AML."
"These kinase inhibitor programs represent an important addition to our portfolio and reflect our strategy to develop novel oncology therapies by targeting the underlying pathways of the disease process," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "In addition, the Raf kinase inhibitor investigational agent offers a compelling development opportunity as it targets a clinically validated pathway. We look forward to building on the strong preclinical dataset as we advance this program into clinical trials."
Non-clinical data from the oral and selective pan-Raf inhibitor were presented at the EORTC-NCI-AACR meeting in November 2010. Data were presented that demonstrated potent pan-Raf kinase inhibition in biochemical kinase assays. Data were also presented that showed profound antitumor activity in both large B-Raf mutant melanoma tumor models, tumor models of B-Raf wild-type melanoma and other B-Raf wild-type tumor types.
Under the terms of the agreement with Biogen Idec and Millennium, Sunesis has received a $4 million upfront payment from Millennium. Sunesis continues to be eligible to receive up to $60 million in pre-commercial milestone program payments and royalties on sales of future collaboration products. In addition, Sunesis has retained its future co-development and co-promotion rights.
"We are delighted to transition our collaboration with Sunesis on these oncology programs to Millennium, a world-class oncology organization," said Steven Holtzman, Executive Vice President of Corporate Development at Biogen Idec. "We look forward to seeing the oncology programs progress under Sunesis and Millennium's new collaboration, as we continue to drive forward our partnership with Sunesis on our immunology program."
Conference Call Information
Sunesis will host a conference call on April 5, 2011, 10:00 a.m. Eastern time to discuss the license agreement. The call can be accessed by dialing 866.831.6267 (U.S. and Canada) or 617.213.8857 (international) and entering the passcode 12246875. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on Sunesis' website for two weeks.
About Raf Kinase Program
The Raf kinases (A-Raf, B-Raf and C-Raf) are key regulators of cell proliferation and survival within the mitogen-activated protein kinase (MAPK) pathway. The MAPK pathway is frequently disregulated in human cancers, often via activating mutations of Ras or Raf.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the US, and has a robust clinical development pipeline of global product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium and Takeda are available through their respective websites.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit www.sunesis.com.
This press release contains forward-looking statements, including statements related to the respective collaborations between Millennium: The Takeda Oncology Company and Sunesis and between Biogen Idec and Sunesis. These forward-looking statements are based upon current expectations and actual results and the timing of events could differ materially from those discussed in such forward-looking statements as a results of risks and uncertainties, which include, without limitation, risks related to the timing of the development of products under the collaborations, the achievement of milestones, the ability and willingness of Millennium or Biogen Idec to progress collaboration compounds and for Sunesis to receive milestone payments, royalties and co-promotion and co-development rights. These and other risk factors are discussed under "Risk Factors" and elsewhere in the companies' most recent annual and quarterly reports. The companies expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the companies' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
The Sunesis Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8773
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
MILLENNIUM and the logo are trademarks of Millennium Pharmaceuticals, Inc.
CONTACT: Investor and Media Inquiries: Manisha Pai Millennium Pharmaceuticals, Inc. 617-551-7877 Investor Inquiries: Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717 Media Inquiries: David Pitts Argot Partners 212-600-1902
South San Francisco based Sunesis (SNSS) announced a license agreement on April 5 with Millennium Pharmaceuticals to develop its pan-Raf kinase inhibitor. Under the terms of this deal, Sunesis received $4 million upfront and potentially $60 million in milestones as well as royalties. Millennium will pay for all costs of the Phase I trial, after which Sunesis will have the option to co-develop and co-promote the drug, gaining better royalty terms as a result.
I spoke by phone with President and CEO Dan Swisher about the Millennium deal. Dan was upbeat about the prospects of the b-RAF inhibitor licensed to Millennium. This asset had been jointly owned by Biogen Idec (BIIB) and Sunesis. In November last year, Biogen decided to refocus on neurology and exit oncology; the two companies then worked together to find a new partner for the compound, leading to the Millennium deal. A second oncology compound was also part of the deal but its target was undisclosed. It is still in pre-clinical studies.
Dan tells me the RAF compound is the culmination of six years of pre-clinical research. He believes its potent activity against all three RAF isozymes may give it a leg up against specific b-RAF inhibitors such as the highly touted Plexxikon drug, noting that the Plexxikon compound showed very good responses initially but patients often encountered drug resistance after the first year of treatment. By potently inhibiting a-RAF, b-RAF, and c-RAF, Dan believes their candidate has the potential for a more durable response.
The first order of business will be for Millennium to get the compound into the clinic, which is expected later this year. It will first be tested in patients with advanced solid tumors; the "low hanging fruit" would be melanomas with mutated b-RAF, Dan says. This of course, is the indication being pursued for Plexxikon’s b-RAF inhibitor, PLX4032. Development will be led by Millennium so he wasn’t able to tell me much about their future development plans except to say they will be looking into doing some combination studies.
Sunesis has the right to opt in to co-develop the compound after Phase I, which Dan likens to a "free option" because indeed, the company will have contributed no funds up to that point. The decision will then be made based on the data, the company’s portfolio, and cash resources.
The company is currently focusing most of its resources on its late stage compound, vosaroxin, for the treatment of relapsed AML. The trial, termed VALOR began enrolling patients in the U.S. last December and will soon begin adding patients in 13 countries around the world. Vosaroxin has shown good Phase II activity in combination with the chemotherapy cytarabine, extending overall survival about two-fold over historical results. The Phase III trial will compare vosaroxin + cytarabine vs. cytarabine alone, with survival as the primary endpoint.
One aspect of the trial I like is the interim analysis set for the middle of 2012. At that time, the Data Safety Monitory Board will analyze the data and decide if the trial is futile or successful- either case would lead to an early end. The board can also allow the trial to continue unchanged; or if it appears promising but insufficient powered, the trial size can be increased by 50% from its current target enrollment of 450 patients. Final data is expected to be available in 2013.
With what seems almost like a haphazard drug approval process by the FDA, investors often feel assured by a Special Protocol Accessment (SPA), a type of written agreement with the FDA on the design and planned analysis for a clinical trial. While Sunesis doesn’t have an SPA for the VALOR trial, Dan assures me the company has been in constant communication with the FDA with consistent feedback regarding their trial design. He also suggested SPAs may be less important for what he terms a "conservative clinical trial" that has survival as the primary endpoint.
Sunesis is not the only company to flout the conventional wisdom. Calistoga Pharmaceuticals also initiated its Phase III without an SPA. In that case, the CEO did not want to wait the six-month processing time in order to stay ahead of the competition.
AML has been a graveyard for drug developers of late. According to Dan, there have been no new drugs to treat the disease in 30 years. If data for vosaroxin holds up from its Phase II trial, the standard of care for patients after the fist relapse will change drastically. With no competing drugs, the company estimates potential vosaroxin sales, if approved, could range between about $400-$600 million.
With over $50 million in the bank, Sunesis has ample cash to fund its operations; dilution will not be an immediate concern. The Phase II vosaroxin data looks good, with the caveat being it was a single arm trial. For investors able to stomach some risk, Sunesis looks cheap for a promising Phase III company.
Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in SNSS over the next 72 hours.