Businessweek

Infinity Pharmaceuticals, Inc., a drug discovery and development company, focuses on the discovery, development, and delivery of medicines for difficult-to-treat diseases. Hedgehog Pathway Inhibitor Program The company’s main product candidate is saridegib, also known as IPI-926, a novel, potent, oral molecule that inhibits the Hedgehog pathway by binding to the Smoothened receptor, a protein that plays a critical role in the malignant activation of the Hedgehog pathway. The company is in the process of evaluating saridegib in a randomized, double-blind Phase 2 clinical trial to assess the safety and efficacy of saridegib. Mundipharma International Corporation Limited (Mundipharma) has commercialization rights outside of the United States for products arising out of its Hedgehog pathway inhibitor program. Hsp90 Inhibitor Program Retaspimycin hydrochloride (HCl), also known as IPI-504, is a novel, potent and selective inhibitor of heat shock protein 90, or Hsp90. Cancer cells depend on Hsp90 to maintain many proteins critical for cancer growth, proliferation and survival in a functional state. Certain anticancer therapies may enhance the dependency of cancer cells on Hsp90. Retaspimycin HCl is being evaluated in a randomized, double-blind Phase 2 clinical trial in combination with docetaxel, a chemotherapy. The company has worldwide development and commercialization rights for its Hsp90 inhibitor program. PI3K Inhibitor Program The phosphoinositide-3-kinases, or PI3Ks, are a family of enzymes involved in immune cell functions, including cell proliferation and survival, cell differentiation, and cellular trafficking. PI3K-delta and PI3K-gamma, two isoforms of PI3K, play key roles in inflammatory and autoimmune diseases. Additionally, in certain hematologic malignancies, PI3K-gamma and PI3K-delta contribute to the survival and proliferation of cancer cells. The company’s main compound in this program is IPI-145, a potent, orally-available inhibitor of PI3K-delta and PI3K-gamma. Mundipharma has commercialization rights outside of the United States for products arising from its PI3K inhibitor program. Other Programs The company has various projects in earlier stages of development, encompassing emerging targets in fields, such as cancer metabolism, apoptosis and protein homeostasis. Through its internal discovery activities, the company also discovered IPI-940, a novel, orally available inhibitor of fatty acid amide hydrolase (FAAH). The company has licensed worldwide development and commercialization rights to its FAAH program to Mundipharma and its independent associated company, Purdue Pharmaceutical Products L.P. (Purdue). Strategic Alliances Mundipharma and Purdue In 2008, the company entered into a strategic alliance with Mundipharma and Purdue to develop and commercialize pharmaceutical products. The alliance is governed by strategic alliance agreements that the company entered into with each of Mundipharma and Purdue. The agreement with Purdue is focused on the development and U.S. commercialization of products targeting FAAH. The alliance includes product candidates that inhibit or target the Hedgehog pathway, FAAH, PI3K, and product candidates arising out of its early discovery projects in all disease fields that are conducted during a prescribed discovery period’. Intellectual Property In the United States, the company has 20 issued or allowed patents related to its clinical-stage programs expiring on various dates between 2024 and 2029 as well as various pending patent applications and foreign counterpart patent filings which relate to its proprietary technologies. The company has eight issued or allowed U.S. patent applications covering saridegib and related molecules, which expire on various dates between 2025 and 2029, excluding any patent term extension. These patents include composition of matter, pharmaceutical composition, method of treatment, and synthetic method claims. The company has 11 issued U.S. patents covering retaspimycin HCl and related molecules, which expire on various dates between 2024 and 2025, excluding any patent term extension. These patents and allowed patent applications include composition of matter, pharmaceutical composition, method of treatment, and synthetic method claims. In addition, as of February 29, 2012, the company had several hundred additional patents and patent applications filed worldwide, substantially all of which pertain to its product development programs. Research and Development The company’s research and development expense for the year ended December 31, 2011 was approximately $108.6 million. Regulations Before any of the company’s products may be marketed in the United States, the company must comply with the Federal Food, Drug and Cosmetic Act, which involves the following: preclinical laboratory and animal tests performed under the U.S. Food and Drug Administration’s (FDA) Good Laboratory Practice (GLP) regulations; development of manufacturing processes which conform to FDA-mandated current Good Manufacturing Practices, or cGMPs; submission and acceptance of an investigational new drug application (IND) which must become effective before clinical trials may begin in the United States; adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for its intended use; and the submission to and review and approval by the FDA of a New Drug Application (NDA) prior to any commercial sale or shipment of a product. The company also is subject to regulation under the Occupational Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other present and potential future foreign, federal, state, and local laws and regulations.