|Curis Announces Agreement to Develop CUDC-907; Watson Launches Generic LIPITOR®|
|By Staff and Wire Reports|
|Wednesday, 30 November 2011 17:42|
Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, announced the Company has entered into an agreement under which The Leukemia & Lymphoma Society (LLS) will support Curiss ongoing development of its oral small molecule dual Pi3K and HDAC inhibitor CUDC-907, for patients with B-cell lymphoma and multiple myeloma.
We are delighted to collaborate with LLS to further develop CUDC-907. Our preclinical evidence suggests that its dual synergistic inhibition of PI3K and HDAC acts by disrupting cancer pathway networks that are important to the emergence and growth of B-cell lymphoma and multiple myeloma, said Dan Passeri, Curiss President and Chief Executive Officer. LLSs capital commitment to this program, along with their extensive knowledge of hematological malignancies, will be important resources as we seek to advance this promising first-in-class molecule.
This agreement was entered into as part of LLSs Therapy Acceleration Program (TAP), a strategic initiative to speed the development of therapies that have the potential to change the standard of care for patients with blood cancers, especially in areas of high unmet medical need.
Under the agreement, LLS will fund approximately 50% of the direct costs of the development of CUDC-907, up to $4 million. Curis is currently conducting preclinical studies of CUDC-907 required to file an investigational new drug application (IND) seeking to advance the molecule into a Phase Ia dose escalation clinical trial in B-cell lymphoma and multiple myeloma. Curis expects to file the IND and start patient enrollment in the second half of 2012. If this study is successful, LLS has also agreed to support Curiss subsequent Phase Ib or Phase IIa study in one or more specific indications as well as Curis ongoing investigation of biomarkers for CUDC-907 in these diseases.
Curis will be obligated to continue development of CUDC-907 following the term of this agreement, provided that study results are positive and that there is a regulatory path forward and would be required to make a payment to LLS if it did not continue development in this success scenario. In the event that future studies of CUDC-907 are unsuccessful, the funding received from LLS would be treated as a non-refundable grant to Curis. Assuming that Curis licenses or partners CUDC-907 in B-cell lymphoma or multiple myeloma, or, in the event that Curis commercializes the drug candidate itself in these indications, Curis would be obligated to pay LLS future milestones of up to 2.5 times the funding amounts received from LLS under the agreement, primarily upon meeting defined regulatory submission, approval and commercialization objectives.
Watson Pharmaceuticals, Inc. (NYSE:WPI) confirmed Watson Pharmaceuticals, Inc., has launched an authorized generic version of LIPITOR®(atorvastatin calcium tablets) as part of an exclusive agreement with Pfizer Inc. Watson began shipping the product today. LIPITOR®is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL, triglycerides and to increase HDL cholesterol.
Under the terms of the exclusive supply and distribution agreement, Pfizer manufactures and supplies Watson with all dosage strengths of the authorized generic product. Watson markets and distributes the product in the United States. Pfizer will receive a share of the net sales from Watson's sales of the product. The agreement runs until November 30, 2016. Other terms of the agreement have not been disclosed.
For the most recent twelve months ending September 30, 2011, LIPITOR®had sales of approximately $7.8 billion, according to IMS Health (RX) data.
Stratos Product Development LLC today announced its President, Sean MacLeod, and AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) Chief Executive Officer, Richard King, will present at the BIOMEDevice conference in San Jose on Stratos' continued collaboration with AcelRx to support software and electrical design of AcelRx's lead product candidate, ARX-01.
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Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the Company has entered into an agreement under which The Leukemia & Lymphoma Society (LLS) will support Curis’s ongoing development of its oral small molecule dual Pi3K and HDAC inhibitor CUDC-907, for patients with B-cell lymphoma and multiple myeloma.
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