Healthcare Industry News:  Curis 

Biopharmaceuticals

 News Release - September 12, 2006

Curis, Inc. Announces New Cancer Programs, Formation of China-Based Subsidiary

China Location to Initially Focus on New Proprietary Small Molecule Cancer Programs

CAMBRIDGE, Mass.--(HSMN NewsFeed)--Sept. 12, 2006--Curis, Inc. (NASDAQ: CRIS ), a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, today announced that it has formed a wholly foreign-owned enterprise form of subsidiary in Shanghai, China. Earlier in 2006, Curis had initiated development work on several proprietary cancer programs through its relationship with Shanghai ChemPartner, a leading Chinese medicinal chemistry contract researcher. With the establishment of Curis Pharmaceuticals (Shanghai) Co., Ltd. ("Curis Shanghai"), Curis will seek to leverage China's mature, cost-efficient medicinal chemistry industry as a means of broadening Curis' pipeline of drug programs.

Curis joins a growing number of U.S. pharmaceutical and biotechnology companies that have established collaborative relationships in China. Many of the largest companies in the pharmaceutical industry have established a presence in China, either through subsidiaries or through service contracts with Chinese medicinal chemistry providers, tapping into the country's extensive intellectual capital and advantageous economic environment. Curis will combine a subsidiary presence with expansion of its current contractual agreement with Shanghai ChemPartner.

Daniel R. Passeri, President and CEO of Curis, Inc., stated, "Our increased development efforts in China, as typified by the formation of Curis Shanghai, should prove to be an important asset for Curis. We expect it to be a gateway to achieving new levels of speed and efficiency in our drug development programs. We believe that by capitalizing on the recognized high level of medicinal chemistry that exists in China and the country's favorable economic conditions, we have the potential to advance multiple programs much more effectively by reducing costs, increasing productivity, and exploiting the time difference between our two operations. We believe that the collective impact of these advantages will enable us to develop drug candidates at a much more rapid pace than would otherwise be possible. For example, we initiated new cancer programs earlier in 2006, and through our collaboration in China we believe we have already generated meaningful preclinical data on several programs and expect to soon advance several programs into xenograft preclinical cancer models. Operations in China are also expected to share and support our new focus on later-stage preclinical drug programs and our de-emphasis of discovery research efforts. As we announced in June, we believe that targeting later-stage preclinical drug development programs will mitigate risk, maximize our core competencies and allow for a more rapid decision making process with respect to our programs, providing for a potentially more robust and developed pipeline."

About Curis' New Cancer Programs

In recent months, Curis has been developing several classes of new proprietary small molecule drug candidates, each of which is designed to target multiple distinct molecular pathways. Curis believes that some of the most effective currently marketed therapies are those that attack cancer from multiple directions simultaneously. In addition, Curis believes that multi-targeting has an additional advantage because such therapies may help reduce the emergence of drug resistant populations of cells within the tumor. Unlike other recent multi-targeted inhibitors, which target multiple closely related tyrosine kinase receptors, Curis' drugs are being developed as single molecules that target multiple distinct molecular pathways that Curis believes will provide anti-tumor activity across a broad range of hematologic (i.e., blood) and solid tumor cancers.

Curis anticipates that its multi-targeted pathway inhibitors may improve efficacy, prevent the emergence of drug resistance, and/or decrease the dose-limiting toxicities, possibly by virtue of the ability to reduce dosing frequency or amount. Further, Curis believes that these new inhibitors may represent a new paradigm in rational multi-pathway targeting drug development.

These new drug programs are currently in mid-preclinical testing. The Company will seek to progress several classes of compounds simultaneously through preclinical development. Factors to be considered in prioritizing potential drug candidates include efficacy, pharmacology, patient needs, path to regulatory approval, scale-up of compound synthesis, and freedom to operate. Assuming successful preclinical development, Curis expects to select a lead clinical candidate during the first half of 2007 and to file an Investigational New Drug, or IND, application by the end of 2007.

Curis expects that the cost efficiencies of its Chinese operations will allow continued development of these cancer programs as well as additional drug programs. These additional drug programs may be developed internally or acquired through in-licensing activities.

About Curis' Operations in China

Curis' operations in China will be located in Zhangjiang Hi-tech Park, Pudong, Shanghai. Programs at Curis Shanghai will initially be focused on the development of small molecule drugs that target multiple validated cancer pathways, with potential future focus areas in neurology and dermatology. The subsidiary will primarily perform medicinal chemistry services. Overall scientific leadership, program management and in vivo animal work will continue to be conducted by Curis in the U.S., where the Company has an established infrastructure.

In the near-term, these operations will provide oversight to the medicinal chemistry services that are being conducted at Shanghai ChemPartner. In the future, Curis will evaluate whether it would be more advantageous to hire its own scientists and administrative staff for the purposes of performing the medicinal chemistry services that are currently provided by Shanghai ChemPartner.

Curis has engaged approximately 20 chemists through Shanghai ChemPartner, who are working to advance its multi-targeted pathway inhibitor cancer programs. Curis has also achieved in vitro efficacy results in a preclinical cancer model for one of its new cancer drug candidates. Medicinal chemistry efforts for this compound were provided by Shanghai ChemPartner. Curis believes that this early success is a positive indicator for the viability of its new cancer programs and its strategy of pursuing medicinal chemistry efforts in China.

Personnel from Curis' U.S. operations and its Chinese subsidiary, including contracted chemists at Shanghai ChemPartner, will comprise a nearly "24/7" drug discovery and development operation, which Curis believes may result in enhanced capacity, greater productivity and new cost efficiencies. Curis anticipates that its chemistry costs will be reduced by 65%-75% compared to outsourcing chemistry with traditional western chemistry providers. The Company also believes that this cost efficiency should allow it to progress more drug programs than it could under western drug development economics.

By enabling Curis to increase internal development of compounds, implementation of this model is intended to increase the likelihood that Curis could expeditiously advance a drug candidate into further preclinical and, ultimately, clinical development.

Upcoming Goals and Objectives

Curis' near-term goal is to announce in vivo efficacy for at least one or two of its new cancer drug candidates. Curis anticipates achieving this objective in the second half of 2006. If this near-term goal is achieved, Curis could expect to select a lead clinical candidate during the first half of 2007 and to file an IND application by the end of 2007. In addition, Curis expects to either internally develop or in-license at least one additional drug program in the next six to twelve months.

Curis intends to continue to leverage important professional relationships in China in its efforts to achieve its key goals. Many of Curis' U.S.-based scientists were born and raised in China, and have maintained relationships with their peers in the country. These relationships were instrumental in the successful formation of Curis Shanghai and are expected to provide continued benefits in maintained continuity and communication between Curis, its subsidiary, and Shanghai ChemPartner.

Curis is also seeking to achieve a number of important upcoming development objectives with respect to its Hedgehog-based programs that are under collaboration with Genentech, Wyeth and Procter & Gamble. These objectives include the following:
  • Curis expects that, during the second half of 2006, Genentech will file an IND application for solid tumor indications under the Hedgehog antagonist relationship. The IND filing would result in a cash payment to Curis.
  • Curis and Wyeth are currently testing Hedgehog agonist compounds in various toxicology and efficacy models. If these tests are satisfactorily completed, Curis is hopeful that Wyeth will select a lead clinical development candidate during either the second half of 2006 or the first half of 2007. Curis is also continuing to screen for additional backup Hedgehog agonist compound classes.
  • Curis is hopeful that, during the first half of 2007, Procter & Gamble may achieve the second preclinical development objective under the topically-applied Hedgehog agonist hair growth partnership. This development objective is met upon the selection by P&G of a lead clinical candidate for hair growth and results in a $1.8 million cash payment to Curis.
Financial Guidance

Curis currently estimates that Curis Shanghai's 2007 expenses will approximate $1.5-$1.6 million, approximately all of which are research-related expenses to support approximately 20 chemists. Curis believes that existing cash, cash equivalents, marketable securities and investments, together with contractually defined cash payments that it expects to receive under its collaborations with Genentech and Wyeth, will be sufficient to support its current operating plans into 2008. The Company expects to end 2006 with cash, cash equivalents, marketable securities and investments of between $30 million and $31 million, and will seek to continue to carefully manage its cash consumption. This year-end projection does not include any cash payments the Company could receive from its collaborators assuming the achievement of specified development objectives.

About Curis, Inc.

Curis, Inc. is a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, with technologies that utilize regulatory pathways that control repair and regeneration. Curis' product development involves the use of small molecules or proteins to modulate these pathways. The company has successfully used this technology and product development approach to produce several promising drug product candidates in the fields of cancer (under collaboration with Genentech, as well new proprietary cancer programs), neurological disorders (under collaboration with Wyeth), hair growth (under collaboration with Procter & Gamble), kidney and other diseases (licensed to Ortho Biotech Products and under development at Centocor, both subsidiaries of Johnson & Johnson), as well as cardiovascular disease. For more information, please visit www.Curis.com.

Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning Curis' belief that it can leverage China's medicinal chemistry industry as a means to broaden the Company's pipeline of drug programs as well as increase the speed and efficiency with which Curis' drug programs are developed. Additional forward-looking statements, include Curis' belief that targeting later-stage preclinical drug development programs will mitigate risk, maximize its core competencies and allow for more rapid decision making process, Curis' expectation that its multi-targeted pathway inhibitors may improve efficacy, prevent the emergence of drug resistance, and decrease dose-limiting toxicities, Curis' expectation regarding development timeline for these multi-targeted pathway inhibitors, Curis' belief that the past success in its relationship with Shanghai ChemPartner is a positive indicator for viability of both its new cancer programs and its chemistry-focused Chinese subsidiary, Curis' belief that it will reduce its outside chemistry costs by 65-75% per full-time equivalent, Curis's belief that it will be able to pursue a greater amount of internal compound development and that this will increase the likelihood that Curis will advance a drug candidate into further preclinical and, ultimately, clinical development, Curis' estimated milestones under various Hedgehog-based collaborations, Curis' estimates of Curis Shanghai 2007 expenses, Curis's projection as to the period in which existing cash will be available to fund its planned operations and Curis's 2006 year-end cash balance. Forward-looking statements used in this press release may contain the words "believes", "expects", "would", "could", "will", "can", "anticipates", "plans", "seeks", "estimates" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that may cause the Company's actual results to be materially different from those indicated by such forward-looking statements including, among other things:
  • adverse results, delays and/or failures in the Company's and its strategic collaborators' and licensees' product development programs;
  • difficulties or delays in obtaining or maintaining required regulatory approvals for products being developed by the Company and its collaborators and licensees;
  • the Company's ability to obtain or maintain the patent and other proprietary intellectual property protection necessary for the development and commercialization of products based on its technologies;
  • changes in or the Company's inability to execute its business plan;
  • the risk that Curis does not obtain the additional funding required to conduct research and development of its product candidates and execute the Company's business plan;
  • unplanned cash requirements and expenditures;
  • risks relating to the Company's ability to enter into and maintain important strategic collaborations, including its ability to maintain its current collaboration agreements with Genentech, Wyeth, and Procter & Gamble as well as its license agreement with Ortho Biotech Products;
  • the risk that competitors will discover and develop signaling pathway-based or other competing therapeutics faster and more successfully than the Company and its collaborators are able to;
  • and other risk factors identified in the Company's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent reports periodically filed with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.


Source: Curis

Issuer of this News Release is solely responsible for its content.
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