Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

– Achillion Achieves 100% SVR12 in Eight-Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV (“Proxy Study”) Including Nine of 12 Patients With Viral Loads Higher Than 6 Million IU/ml at Baseline –

– Reports Additional Preclinical Results for ACH-3422, Uridine-Analog Nucleotide NS5B Polymerase Inhibitor –

NEW HAVEN, Conn., Nov. 8, 2014 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced the presentation of results from the ongoing Phase 2 study of ACH-3102 in a late breaker poster and data in three preclinical posters on ACH-3422. The poster presentations are being made at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting 2014, which takes place through November 11, 2014 in Boston, MA.

Achillion gets FDA Incentives for Hepatitis C Drug

 

NEW HAVEN, Conn. – May 15, 2012 – Achillion Pharmaceuticals Inc. said Tuesday it will receive incentives from regulators as it studies a new experimental treatment for the hepatitis C virus.

The Food and Drug Administration awarded fast track status to Achillion’s drug candidate ACH-3102. The agency’s decision will allow Achillion to file its application for marketing approval piece by piece instead of waiting to collect all the clinical trial data for the drug, and Achillion will be able to consult with the FDA more often as it develops the drug. The FDA may also choose to review the full application in six months instead of the usual 10 months.

Achillion said it started clinical trials of ACH-3102 on Wednesday. Those trials are intended to test the drug’s safety and its side effects rather than its effectiveness. The company plans to study a combination of ACH-3102 with its most advanced drug candidate, ACH-1625. Achillion hopes that combined, the drugs could be part of a hepatitis C a regimen that could treat the disease without interferon. Interferon is a common part of hepatitis C treatment but can cause serious side effects, including flu-like symptoms that can last for months.

Shares of Achillion gained 1 cent to $6.90 in midday trading. Earlier the stock rose as much as 7.4 percent.

Achillion gets FDA incentives for hepatitis C drug

NEW HAVEN, Conn. Achillion Pharmaceuticals Inc. said Tuesday it will receive incentives from regulators as it studies a new experimental treatment for the hepatitis C virus.

The Food and Drug Administration awarded fast track status to Achillion’s drug candidate ACH-3102. The agency’s decision will allow Achillion to file its application for marketing approval piece by piece instead of waiting to collect all the clinical trial data for the drug, and Achillion will be able to consult with the FDA more often as it develops the drug. The FDA may also choose to review the full application in six months instead of the usual 10 months.

Achillion said it started clinical trials of ACH-3102 on Wednesday. Those trials are intended to test the drug’s safety and its side effects rather than its effectiveness. The company plans to study a combination of ACH-3102 with its most advanced drug candidate, ACH-1625. Achillion hopes that combined, the drugs could be part of a hepatitis C a regimen that could treat the disease without interferon. Interferon is a common part of hepatitis C treatment but can cause serious side effects, including flu-like symptoms that can last for months.

Shares of Achillion gained 1 cent to $6.90 in midday trading. Earlier the stock rose as much as 7.4 percent.

ACH-1625 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C

NEW HAVEN, Conn., Jan. 4, 2012 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, announced today the receipt of a Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACH-1625 for the treatment of chronic hepatitis C virus (HCV). ACH-1625 is a once-daily protease inhibitor with broad genotypic coverage against HCV that was discovered by Achillion and is currently being evaluated in a Phase 2 clinical trial.

Achillion hepatitis drug gets faster FDA review

NEW HAVEN, Conn. – A chronic hepatitis c
treatment being developed by from Achillion Pharmaceuticals received
fast track designation, allowing for a quicker review by regulators.

Achillion
said Wednesday the treatment, labeled ACH-1625, is in mid-stage
clinical testing. The designation allows drug developers to submit their
applications to the Food and Drug Administration piece by piece instead
of having to file all the paperwork at once.

It also allows for more frequent interaction with regulators and a possible priority review.

Achillion
Pharmaceuticals Inc., based in New Haven, Conn., said the drug received
the designation due in part to its once-daily dosing and its potential
to offer improved safety and tolerability compared to the current
standard of care.

Hepatitis
C treatments represent a big opportunity for drugmakers. The virus can
lead to life-threatening liver damage and is the main cause of liver
transplants in the United States. Analysts expect the market for those
treatments to expand in the coming years.

Other
companies developing potential drugs include Pharmasset Inc. which is
being acquired by Gilead Sciences Inc. Earlier this year, the FDA
approved two pills that offered the first new breakthrough treatments
for the liver disease in 20 years. The Vertex Pharmaceuticals Inc.
hepatitis C pill Incivek rang up about $420 million in this year’s third
quarter. Another pill, Merck & Co.’s Victrelis had $31 million in
sales.

Achillion to Present at the 23rd Annual Piper Jaffray Health Care Conference

NEW HAVEN, Conn., Nov. 21, 2011 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that members of the Company’s executive team will present at the upcoming 23rd Annual Piper Jaffray Health Care Conference on Wednesday, November 30, 2011 at 11:00 a.m. EST at The New York Palace Hotel, in New York, NY.

The live audio broadcasts and the subsequent archived webcasts of the Company’s presentations will be available on the Company’s website, http://www.achillion.com, under the “News Center” section. The audio recording will be archived for 30 days following the live presentation. Please connect to Achillion’s website several minutes prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary.

About Achillion Pharmaceuticals

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 including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.

Achillion Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C

NEW HAVEN, Conn., June 22, 2011 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment naïve HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.

Achillion Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C

NEW HAVEN, Conn., June 22, 2011 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment naïve HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.

The clinical trial has advanced into the second segment of a Phase 2a, randomized, double-blind trial evaluating the safety, tolerability and antiviral activity of oral ACH-1625 in combination with standard of care (SOC) consisting of pegylated interferon alfa-2a and ribavirin. Patients will be randomized to receive once daily doses of 200 mg, 400 mg or 800 mg of ACH-1625 in combination with SOC for 12 weeks of dosing. Patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48.

The trial will take place in the United States and Europe and is designed to enroll approximately 60 HCV-infected patients. The 12-week complete early virologic response (cEVR) trial results are anticipated to be announced in the fourth quarter of 2011.

“Initiating the second segment of this Phase 2 clinical trial allows us to build upon the robust RVR results we observed with ACH-1625, and to further augment the safety and efficacy database by taking the opportunity to study multiple doses of ACH-1625,” commented Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. “We expect that the results will provide important insight to benchmark the activity of our once-daily protease inhibitor and we look forward to reporting cEVR results by the end of this year.”

“This next study segment with ACH-1625 is yet another important milestone achieved for this potentially best-in-class protease inhibitor and for Achillion’s broader HCV pipeline,” said Michael D. Kishbauch, President and Chief Executive Officer of Achillion.

Achillion Announces Positive RVR Results With ACH-1625 to Treat Chronic Hepatitis C

NEW HAVEN, Conn., March 30, 2011 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced top-line results from its on-going Phase 2a clinical trial of ACH-1625 dosed once daily (QD) in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin), a current standard of care (SOC) in patients with chronic hepatitis C (HCV) infection. The analysis demonstrated that 75-81% of patients receiving ACH-1625 achieved rapid virologic response (RVR) with a promising safety and tolerability profile. ACH-1625 is an inhibitor of HCV NS3 protease that was discovered by and is being developed by Achillion.

Achillion Announces Positive RVR Results With ACH-1625 to Treat Chronic Hepatitis C

NEW HAVEN, Conn., March 30, 2011 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced top-line results from its on-going Phase 2a clinical trial of ACH-1625 dosed once daily (QD) in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin), a current standard of care (SOC) in patients with chronic hepatitis C (HCV) infection. The analysis demonstrated that 75-81% of patients receiving ACH-1625 achieved rapid virologic response (RVR) with a promising safety and tolerability profile. ACH-1625 is an inhibitor of HCV NS3 protease that was discovered by and is being developed by Achillion.