Achillion Pharmaceuticals, Inc., a biopharmaceutical company, engages in discovering and developing small molecule therapeutics for the treatment of infectious diseases and immune system disorders. The company is focusing its efforts on developing short-duration combination therapies for the treatment of chronic hepatitis C virus (HCV) infection that are once-daily and ribavirin-free. Primarily, the company is advancing combination regimens containing ACH-3102, a NS5A inhibitor, in phase II clinical development; ACH-3422, a NS5B nucleotide polymerase inhibitor, in phase I clinical development; and Sovaprevir, a NS3 protease inhibitor, in phase II clinical development. Drug Candidates ACH-3102, a NS5A Inhibitor The company is developing combination drug regimens that include ACH-3102, its pan-genotypic, second generation NS5A inhibitor. As of December 31, 2014, the company completed three phase IIa clinical trials with ACH-3102, including the -007 trial with sovaprevir; the -005 study, which examined the use of ACH-3102 with ribavirin alone; and the Proxy Doublet study, which examined the use of ACH-3102 in combination with sofosbuvir, a nucleotide NS5B polymerase inhibitor marketed by Gilead Sciences, Inc. under the brand name Sovaldi. ACH-3102 has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). ACH-3422, a NS5B Nucleotide Polymerase Inhibitor The company is seeking to develop combination drug regimens to address all HCV genotypes based on use of ACH-3422, its nucleotide prodrug inhibitor of HCV NS5B polymerase. ACH-3422 is tolerated in a phase Ib proof of concept study in which HCV patients receiving a once-daily 700mg dose of ACH-3422 for 14 days demonstrated mean maximal viral load reduction of 4.6 log10. Sovaprevir, a NS3 Protease Inhibitor The company has completed a phase II clinical trial that evaluated 12 weeks of treatment consisting of sovaprevir and the company’s NS5A inhibitor, ACH-3102, with ribavirin for the treatment of genotype 1 HCV (the -007 trial). In 2013, the FDA placed a clinical hold on sovaprevir after elevations in liver enzymes were noted in a phase I healthy subjects drug-drug interaction study evaluating the effects of concomitant administration of sovaprevir with ritonavir-boosted atazanavir. In 2014, the FDA lifted the full clinical hold, allowing the company to advance sovaprevir in clinical trials of HCV-infected patients, but requiring the company to seek FDA approval to conduct multi-dose clinical trials in healthy subjects. Following an internal assessment of the company’s protease inhibitor drug candidates, sovaprevir and ACH-2684, it determined to advance sovaprevir in future clinical trials with ACH-3422 and ACH-3102, rather than ACH-2684. The company plans to initiate a drug-drug interaction study with sovaprevir plus compounds that potentially impact active transport mechanisms in the liver and intestines in the first half of 2015. The company intends to continue to focus on the discovery and development of new drug candidates through its extensive expertise in biology and medicinal chemistry. Strategy The company’s strategy is to pursue patents, developed internally and licensed from third parties, and other means to otherwise protect its technology, inventions and improvements that are commercially important to the development of the company’s business. Research and Development The company incurred approximately $53.5 million in research and development costs for the year ended December 31, 2014. Intellectual Property The company has a license and development agreement with ORA, Inc. for the worldwide development and commercialization of ACH-702 delivered topically or locally. The company has a license agreement for elvucitabine with GCA Therapeutics, Ltd. (GCAT) for the treatment of both Hepatitis B and HIV infection. The license grants GCAT the right, through its Chinese joint venture with Tianjing Institute of Pharmaceutical Research, to clinically develop and commercialize elvucitabine in mainland China, Hong Kong, and Taiwan. History Achillion Pharmaceuticals, Inc. was founded in 1998. The company was incorporated in 1998 in Delaware.
300 George Street
New Haven, CT 06511
|AstraZeneca PLC||3,915 GBp||+8.50|
|Bavarian Nordic A/S||kr228.00 DKK||-2.50|
|Chimerix Inc||$6.72 USD||+0.30|
|Emergent BioSolutions Inc||$33.63 USD||+0.55|
|PharmAthene Inc||$1.71 USD||+0.03|
|View Industry Companies|
|Price/Cash Flow||NM||Not Meaningful|
Sponsored Financial Commentaries
To contact ACHILLION PHARMACEUTICALS, please visit www.achillion.com. Company data is provided by Capital IQ. Please use this form to report any data issues.