Achillion Announces That Janssen Has Initiated a Phase 2a Study to Evaluate the Combination of AL-335, Odalasvir (ACH-3102), and Simeprevir for the Treatment of Genotype 1 Chronic HCV

Once Daily Triple Direct-Acting Antiviral Regimen Will be Evaluated for Treatment Durations of Four, Six or Eight Weeks

NEW HAVEN, Conn., Oct. 16, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has initiated treatment in a phase 2a clinical trial to evaluate the safety, pharmacokinetics and efficacy of AL-335, odalasvir (also known as ACH-3102), and simeprevir in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection.

This phase 2a study is a randomized, open-label, three-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor, and simeprevir, an HCV NS3/4A protease inhibitor. Patients will be randomized to one of three treatment arms and receive once daily treatment for a duration of four, six or eight weeks. The primary objective of the study is to establish the safety of the treatment regimen with secondary endpoints consisting of pharmacokinetics, the proportion of subjects achieving sustained viral response (SVR), and the effect on the viral resistance profile after treatment. The study is expected to enroll approximately 60 patients across the three treatment arms.

As previously announced on May 19, 2015, Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir.

Further information about the study can be found at www.clinicaltrials.gov. Study identifier: NCT02569710.

Read more...

Achillion Reports 100% SVR12 From Second Cohort of Patients in the Previously-Completed Six Week Phase 2 Trial Evaluating Odalasvir (ACH-3102) and Sofosbuvir for Genotype 1 HCV ("Proxy Study")

- 100% SVR12 reported for all patients treated for six- (n=18) or eight-weeks (n=12) —
- Odalasvir (ACH-3102) is the subject of an exclusive, worldwide development and commercialization license granted to Janssen -

NEW HAVEN, Conn., Sept. 17, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced additional interim results from a Phase 2 study evaluating odalasvir (also known as ACH-3102), a NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for either six or eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection. Of the patients treated for six weeks in this cross-over cohort, 100 percent (n=6/6) remained HCV RNA undetectable twelve weeks after completing therapy (SVR12). Previously, Achillion reported results from this study including 100 percent SVR24 for the initial cohorts including 12 patients treated for eight weeks and 100 percent SVR24 for 12 patients treated for six weeks.

In May 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir, ACH-3422, and sovaprevir.

ACH-3102 - 017: Phase 2 pilot study evaluating six- and eight-weeks of treatment in combination with sofosbuvir for genotype 1 treatment-naïve HCV

Achillion conducted a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of odalasvir and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study was determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were initially enrolled, including six observational patients (group 1). Twelve patients completed eight weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV. At baseline, the median HCV RNA was 7.15 log10 (range 5.5 — 7.8 log10). Of the 12 patients, 100 percent achieved SVR24. Odalasvir and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment.

Following achievement of the pre-specified response rate of 100 percent, the six observational patients plus six additional patients (group 2) were enrolled and received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Median HCV RNA at baseline was 6.95 log10 (range 6.2 — 8.0 log10) and six patients had GT 1a HCV. Of the 12 patients, 100 percent achieved SVR24.

Six additional rollover patients (group 3), enrolled into the final cohort, also received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Baseline characteristics included five of six patients with genotype 1a HCV, four of six patients with non-CC IL28B (two patients with IL28B TT), and a median baseline HCV RNA of 6.32 log10 IU/ml (range 6.0 — 7.3 log10 IU/ml). In all, a total of 18 patients (group 2 and 3) received six weeks of treatment and all subjects, 100 percent, achieved SVR12.

About the Achillion Worldwide HCV Collaboration with Janssen

On May 19, 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir. A key objective of the collaboration is to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. Achillion announced on August 3, 2015 that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) had initiated a Phase 1 clinical trial to evaluate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 in healthy volunteers. Janssen previously stated its goal of initiating Phase 3 development with a triple regimen for HCV by early 2017.

About HCV

The hepatitis C virus (HCV) is one of the most common causes of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-quarters of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection.

About Achillion Pharmaceuticals

Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients' lives. Achillion believes that its scientific excellence, integrated capabilities and experienced team position it to successfully achieve its goal of advancing new products along the entire continuum from the bench to the patient. Achillion's pipeline is currently focused on small molecule therapeutics for infectious disease and complement-related diseases. www.achillion.com

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," "focus," "will," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: comply with its obligations under and otherwise maintain its collaboration agreement with Janssen on the agreed upon terms; demonstrate, either alone or through its collaborators, the requisite safety, efficacy and combinability of its drug candidates, and advance the preclinical and clinical development of its drug candidates under the timelines it projects in current and future clinical trials; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete effectively and successfully; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014, its quarterly report on Form 10-Q for the quarter ended June 30, 2015, and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.


Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com

Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com

Investors:
Tricia Truehart
The Trout Group, LLC
Tel. (646) 378-2953
ttruehart@troutgroup.com

Will the J&J Deal With Achillion Transform the Hep C Market?

As drug makers jockey for their share of the fast-growing hepatitis C market, the deal between Johnson & Johnson JNJ -0.35% and Achillion Pharmaceuticals ACHN -15.26% has Wall Street analysts rethinking forecasts.

The deal, which was announced late yesterday after a Twitter rumor had Gilead Sciences GILD -0.35% buying Achillion, calls for J&J to invest $225 million and assume responsibility for development costs. Ultimately, the value of the agreement could reach $1.1 billion, depending on milestones reached.

For J&J, the move may help reposition the company as a player in the hepatitis C market. And for Achillion, the collaboration provides a deep-pocketed partner for a company that some saw as a buyout target. But to what extent will this transform the hepatitis C market and what are the implications for the other drug makers? Here are what some of the wags are saying…

Read more...

Achillion Enters Into Worldwide Collaboration for Hepatitis C With Janssen

- Transactions include up to $1.1 billion in potential development, regulatory and sales milestone payments and a separate equity investment -

- Achillion eligible for tieredroyalties between mid-teens and low-twenties on future worldwide sales -

- Janssen responsible for all development costs within the collaboration and all subsequent costs related to commercialization of the assets -

- Conference call scheduled for today at 5:00 p.m. ET -

NEW HAVEN, Conn., May 19, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.

"We are excited to collaborate with Janssen for the worldwide development of our HCV assets in combination with their HCV portfolio. We believe that Janssen's renowned expertise in HCV development and commercialization enables a synergistic opportunity to rapidly advance our combined HCV assets toward the market while simultaneously achieving an optimized treatment regimen for all HCV patients," said Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "Furthermore, we believe that their investment in Achillion through Johnson & Johnson Innovation - JJDC allows us to maximize the value from our HCV portfolio and also positions us to become a leader in complement factor D inhibition, applying our broad platform to a wide number of complement-related diseases. We believe this strategy provides an ideal scenario to create further value for our shareholders."

Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.

A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.

Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation - JJDC, Inc. will invest $225 million in Achillion and, in return, receive approximately 18.4 million newly issued, unregistered shares of Achillion at a price of $12.25 per share.

The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.

Centerview Partners acted as exclusive financial advisor to Achillion. Leerink Partners also advised the Company. WilmerHale acted as legal counsel for Achillion in connection with the transactions.

Conference Call
Achillion will host a conference call and simultaneous webcast on Tuesday, May 19, 2015 at 5:00 p.m. Eastern time. To participate in the conference call, please dial (866) 205-4820 in the U.S. or (419) 386-0004 for international callers. A live audio webcast of the call will be accessible at http://www.achillion.com or http://ir.achillion.com. 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 for 30 days on www.achillion.com. Alternatively, a replay of the conference call will be available starting at 8:00 p.m. Eastern time on May 19, 2015, through 11:59 p.m. Eastern time on May 25, 2015 by dialing (855) 859-2056 or (404) 537-3406. The replay passcode is 51773113.

Read the rest of this press release here: http://ir.achillion.com/releasedetail.cfm?releaseid=913980

Janssen Highlights Hepatitis C Virus Development Programme at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL)

Presentations include late-breaking final results from the Phase 3 OPTIMIST trials and interim results from the Phase 2 IMPACT trial of simeprevir

CORK, Ireland--(BUSINESS WIRE)--Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) taking place in Vienna from April 22-26. Early-stage data on the investigational nucleotide analog polymerase inhibitors AL-335 and AL-516, which were recently obtained through Janssen’s acquisition of Alios BioPharma, will also be presented.

“Janssen has an extensive and ongoing clinical trial programme for hepatitis C, including confirmatory and new exploratory studies, and we look forward to sharing these results. We remain focused on investigating alternative and more immediate treatment options for patients with a high unmet need.”

Several key presentations will report on the efficacy and tolerability of simeprevir in interferon-free combination regimens in Phase 2, Phase 3 and real-world clinical settings.

“Hepatitis C remains a serious health problem. The breadth of data we are presenting at The International Liver Congress™ reinforces our commitment to reducing the significant burden of this infectious disease around the world,” said Gaston Picchio, hepatitis disease area leader, Janssen. “Janssen has an extensive and ongoing clinical trial programme for hepatitis C, including confirmatory and new exploratory studies, and we look forward to sharing these results. We remain focused on investigating alternative and more immediate treatment options for patients with a high unmet need.”

A total of 14 company-sponsored abstracts supporting Janssen’s marketed and investigational therapies for HCV will be presented, including three abstracts on simeprevir accepted as late-breaking presentations. The scope and rigor of these data underscore Janssen’s commitment to being a positive catalyst in the fight against this serious public health threat.

“These data highlight the strength of our commitment to advancing research in the area of viral hepatitis,” said Lawrence M. Blatt, Ph.D., global head therapeutics, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma. “We are delighted to present additional data for simeprevir in combination with other currently available therapeutic options alongside early-stage data for our nucleotide portfolio.”

Studies on Janssen’s HCV portfolio to be presented at The International Liver Congress™ 2015 include:

 
Late-Breaking Poster Presentations
All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.

• A Phase 3, randomised, open-label study to evaluate the efficacy and safety of 12 and 8 weeks of simeprevir (SMV) plus sofosbuvir (SOF)▼ in treatment-naïve and -experienced patients with chronic HCV genotype 1 infection without cirrhosis: The OPTIMIST-1 study¹
  • Abstract LP14
  • Lead Author: P. Kwo; Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, IN, USA

• A Phase 3, open-label, single-arm study to evaluate the efficacy and safety of 12 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve or -experienced patients with chronic HCV genotype 1 infection and cirrhosis: The OPTIMIST-2 study²
  • Abstract LP04
  • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA

• Simeprevir (SMV) plus daclatasvir (DCV)▼ and sofosbuvir (SOF) in treatment-naïve and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease: Interim results from the Phase 2 IMPACT study¹
  • Abstract LP07
  • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA

Oral Presentation

• On-treatment virologic response and tolerability of simeprevir, daclatasvir and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation (OLT): Interim data from the Phase 2 SATURN Study¹
  • Abstract 0004: Thursday 23 April, 16:45 – 17:00, Hall D
  • Lead Author: X. Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations
All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.

• Significant drug-drug interaction between simeprevir and cyclosporine A but not tacrolimus in patients with recurrent chronic HCV infection after orthotopic liver transplantation: The SATURN study¹
  • Abstract P0834
  • Lead Author: S. Ouwerkerk-Mahadevan; Janssen Research & Development, Beerse, Belgium
• Deep sequencing analyses in HCV genotype 1-infected patients treated with simeprevir plus sofosbuvir with/without ribavirin in the COSMOS study⁶
  • Abstract P0780
  • Lead Author: B. Fevery; Janssen Infectious Diseases BVBA, Beerse, Belgium
• Effectiveness of simeprevir (SMV)-containing regimens among patients with chronic hepatitis C virus (HCV) in various U.S. practice settings: Interim analysis of the SONET study⁷
  • Abstract P0826
  • Lead Author: I. Alam; Austin Hepatitis Center, Austin, TX, USA
• Study protocol for a partly randomised, open-label Phase 2a trial of once-daily simeprevir combined with sofosbuvir for the treatment of HCV genotype 4-infected patients with or without cirrhosis (OSIRIS)⁸
  • Abstract P1346
  • Lead Author: M. El Raziky, Departments of Pediatrics, Cairo University, Cairo, Egypt
• Baseline factors associated with increased SVR rates in 123 treatment-naïve chronic HCV genotype 1 patients treated with a shortened 12-week simeprevir plus pegylated interferon and ribavirin regimen: A multivariate analysis⁹
  • Abstract P0792
  • Lead Author: T. Asselah, Beaujon Hospital, University of Paris, France
• Clinical characteristics and outcomes of chronic hepatitis C (CHC) patients treated with newer direct-acting antiviral (DAA)-based regimens from a large U.S. payer perspective¹⁰
  • Abstract P0852
  • Lead Author: N. Tandon; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
• A descriptive analysis of a real-world population with chronic hepatitis C (CHC) treated with simeprevir (SMV)-and/or sofosbuvir (SOF)-based regimens: Findings from a U.S. payer database¹¹
  • Abstract P0827
  • Lead Author: J.B. Forlenza; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
• Real world effectiveness and cost of simeprevir- and/or sofosbuvir-based HCV treatments: $175,000 per SVR12¹²
  • Abstract P0881
  • Lead Author: K. Bichoupan; Division of Liver Diseases, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY, USA

Alios BioPharma Poster Presentations

• Derisking the potential for mitochondrial toxicity of nucleoside analogs¹³
  • Abstract P0679
  • Lead author: Z. Jin; Alios BioPharma, San Francisco, CA, USA
• Preclinical characterization of AL-335, a potent uridine based nucleoside polymerase inhibitor for the treatment of chronic hepatitis C¹⁴
  • Abstract P0682
  • Lead Author: H. Tan; Alios BioPharma, San Francisco, CA, USA

Full session details and data presentation listings for The International Liver Congress™ 2015 can be found at http://www.ilc-congress.eu.

Press Release Source: 

UK: Janssen will cover cost of unsuccessful hepatitis C treatment

NHS England will only have to pay for Olysio if patient clears virus 

The innovative 'pay if you clear' scheme marks a new way of dealing with the struggle for market access in the UK for pharma companies, with Janssen offsetting the cost of the drug if a patient remains infected after 12 weeks of treatment.

Olysio (simeprevir) is one of several new oral drugs that mark a major step forward in hepatitis C treatment, alongside Gilead Science's Sovaldi (sofosbuvir) and AbbVie's regimen combining Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir).

Both Olysio and Sovaldi were this week recommended for NHS reimbursement in draft guidance published by the National Institute for Health and Care Excellence (NICE).

Read more...