Achillion to Present Data From Studies of ACH-1625 in Hepatitis C at Asian Pacific Liver Conference
NEW HAVEN, Conn., Dec. 6, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN - News) today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011 in Bangkok, Thailand.
ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
The presentation, entitled "Viral Kinetics Modeling of Short-term Monotherapy Data of ACH-1625, an HCV Protease Inhibitor," will be presented by Dr. Atul Agarwal, Senior Director of Computational Chemistry of Achillion. (Abstract A-315-0024-00792.) The presentation describes a mathematical analysis of HCV RNA data collected after oral administration of ACH-1625 in HCV genotype 1 infected subjects. This analysis shows rapid and near complete hepatitis C virus clearance following ACH-1625 administration at all dose levels tested. In addition, mathematical modeling of HCV viral kinetics provided information that allowed for subsequent dose selection for Phase II clinical development of ACH-1625.
"These data support and further demonstrate ACH-1625's robust antiviral activity," said Dr. Agarwal. "With clinical data that demonstrated reductions in viral RNA between 3-4.25 log10, these mathematical data quantitatively show the percentage of total virus cleared after five days of ACH-1625 monotherapy. This data also identifies specific patient population characteristics."
"We are pleased to continue to put forward a large body of scientific and clinical data on ACH-1625," commented Michael D. Kishbauch, Chief Executive Officer of Achillion. "We look forward to completing the current Phase II clinical trial of ACH-1625 to further support its profile as a potential best-in-class protease inhibitor for the treatment of HCV."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies, HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
[Based on projected cash burn of $35M this year, coupled with remaining cash of $55M as of 12/31/10, I wouldn't be surprised to see ACHN do another share offering this year before they announce 12-week data for ACH-1625 at the end of the year. That's assuming the pending 28-day data for 1625 is positive and that ACHN doesn't partner 1625 after the 28-day results but before the 12-week results (I'm betting that they won't).]
Achillion Reports 2010 Fourth Quarter and Year-End Financial Results
NEW HAVEN, Conn., March 2, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN - News), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported financial results for the three and twelve months ended December 31, 2010.
For the three months ended December 31, 2010, the Company reported a net loss of $6.2 million, compared to a net loss of $6.7 million in the three months ended December 31, 2009. For the full year ended December 31, 2010, the Company's net loss was $25.5 million, compared to a net loss of $25.9 million for the year ended December 31, 2009. Cash and cash equivalents and marketable securities at December 31, 2010 were $55.2 million.
"In many ways, this past year was a transformational one for Achillion as we advanced our pipeline of HCV assets, and thereby, significantly improved our strategic position in the HCV market," said Michael Kishbauch, President and CEO of Achillion. "We expect to have three HCV compounds in the clinic shortly, with the most advanced, ACH-1625, in phase 2, and two additional candidates, ACH-2684 and ACH-2928, in phase 1. With its current profile, including impressive viral load reduction and good safety and tolerability profile, we continue to believe that ACH-1625 has the ability to become a best-in-class protease inhibitor for HCV treatment. We look forward to being able to soon announce 4-week rapid viral response, or RVR, results from an on-going phase 2 clinical trial of ACH-1625.
"With our NS5A inhibitor, ACH-2928, as well as our high-potency, pan-genotypic HCV protease inhibitor, ACH-2684, also in our pipeline of clinical candidates, we believe Achillion is well positioned to participate in the large and important HCV market. The opportunities we have for intra-company combinations of therapies provide Achillion with a significant advantage, as HCV is a disease in which combination therapies are anticipated to become the standard of care."
Fourth quarter results
The Company reported a net loss of $6.2 million for the three months ended December 31, 2010, compared to a net loss of $6.7 million for the three months ended December 31, 2009. Revenue for the three months ended December 31, 2010 totaled $2 million, compared to $61,000 in the three months ended December 31, 2009. Revenue in the fourth quarter 2010 substantially consisted of grants under the Qualified Therapeutic Discovery Program, or QTDP, a federal program administered through the National Institutes of Health.
Research and development expenses were $6.1 million in the fourth quarter of 2010, compared to $4.9 million for the same period of 2009. Research and development expenses in 2010 were primarily related to costs incurred from clinical testing of the Company's HCV protease inhibitor, ACH-1625, as well as late stage preclinical testing of the Company's HCV NS5A inhibitor, ACH-2928, and its pan-genotypic protease inhibitor, ACH-2684.
For the three months ended December 31, 2010, general and administrative expenses totaled $2.2 million, compared to $1.9 million in the same period in 2009.
Full-year results
For the year ended December 31, 2010, the Company reported a net loss of $25.5 million, compared to a net loss of $25.9 million in 2009. Total revenues were $2.4 million for the year ended December 31, 2010, consisting substantially of QTDP program grants, compared to negative $294,000 for the year ended December 31, 2009. Revenues were negative in 2009 due to a change in estimate of the Company's remaining performance obligations under its collaboration agreement with Gilead Sciences.
For the year ended December 31, 2010, research and development expenses totaled $20.5 million, compared to $18.4 million in 2009. The increase in research and development expense was primarily a result of increased clinical trial costs associated with ACH-1625, as well as IND-enabling preclinical testing costs associated with ACH-2928 and ACH-2684.
General and administrative expenses were $7.2 million for the year ended December 31, 2010, compared to $6.6 million incurred in the year ended December 31, 2009, the increase resulting from higher business development and professional services fees.
2011 Financial Guidance
The Company expects that research and development expenses during 2011 will be between $30 and $33 million and that net cash used in operating activities in 2011 will approximate $35 million based on current operating plans, anticipated timelines and the estimated cost of clinical trials and product development programs. The net loss per share is anticipated to range from $0.65 to $0.70 per share.
Conference Call
The Company will host a conference call and simultaneous webcast on Wednesday, March 2, 2011 at 4:30 p.m. Eastern time. To participate in the conference call, please dial (877) 354-0215 in the U.S. or (408) 427-3695 for international callers. A live audio webcast of the call will be accessible at www.achillion.com, under the News Center section of the website. Please connect to Achillion's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
A replay of the webcast will be available on www.achillion.com. Alternatively, a replay of the conference call will be available starting at 7:30 p.m. Eastern time on March 2, 2011, through 11:59 p.m. Eastern time on March 5, 2011 by dialing (800) 642-1687 or (706) 645-9291. The replay passcode is 48293966.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. The company's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -- hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit the company's web site at www.achillion.com or call Achillion at 1-203-624-7000.
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