I cant wait for what next week brings.
ACHN - Achillion Pharmaceuticals Inc. - Page 5
Poster presentation PR's from EASL
Additional cohort data 1625( Once daily dose & down dosing BID arms)
ACH-702 partnership( 1st term sheet is in)
ACH-1625 partnership( this is the big one)
3 month tox on 1625 due in May (not sure if they will PR this)
Will have to see how this behaves tomorrow morning.
4 days 11 hours 6 minutes ago - PMZ via Comtex
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), 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 months ended March 31, 2011. For the first quarter of 2011, the Company reported a net loss of $10.1 million or $0.17 per share, compared with a net loss of $5.6 million or $0.16 per share for the first quarter of 2010. Cash, cash equivalents and marketable securities as of March 31, 2011 were $46.4 million.
"Achillion achieved a number of significant pipeline milestones during the early part of 2011, including the release of robust RVR results for ACH-1625 and the recent submission of two IND applications that pave the way for the start of clinical trials with ACH-2684, our pan-genotypic protease inhibitor, and for ACH-2928, the most advanced candidate from our NS5A development program," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion.
"Over the next several months, Achillion plans to achieve a number of significant milestones in the development of our HCV pipeline, including 12-week cEVR results with ACH-1625 and proof-of-concept results from the upcoming Phase 1 trials evaluating ACH-2684 and ACH-2928," commented Dr. Elizabeth Olek, Vice President of Clinical Development and Chief Medical Officer. "Furthermore, we are tailoring our HCV program to leverage the unique strengths of our protease inhibitors by targeting underserved HCV populations, highlighted by the planned Phase 1b investigation of ACH-2684 against genotype 3, as well as genotype 1, HCV-infected patients."
First Quarter Results
For the first quarter of 2011, the Company reported a net loss of $10.1 million, or $0.17 per share, compared with a net loss of $5.6 million, or $0.16 per share for the first quarter of 2010. Cash, cash equivalents and marketable securities as of March 31, 2010 were $46.4 million.
Revenue for the three months ended March 31, 2011 was $65,000, compared with revenue of $74,000 for the three months ended March 31, 2010. Revenue in both periods consisted primarily of reimbursed costs under the Company's collaboration with Gilead Sciences, Inc.
Research and development expenses were $8.0 million in the first quarter of 2011, compared with $4.0 million for the same period of 2010. Research and development expenses were primarily related to costs incurred from the ongoing Phase 2 clinical trial with ACH-1625 and preparations to advance the Company's two additional HCV compounds, ACH-2684 and ACH-2928, into clinical trials during the first half of 2011. As the Company continues to advance its three HCV compounds in the clinic, it expects that research and development expenses will remain consistent with first quarter levels during the remaining quarters of 2011.
For the three months ended March 31, 2010, general and administrative expenses totaled $2.2 million, increased slightly from $1.7 million for the same period in 2010.
Achillion announces positive results from Phase IIa HCV trial
38 days 8 hours 29 minutes ago - DTM via Comtex
Achillion Pharmaceuticals, Inc., a pharmaceutical company, has announced top-line results from its on-going Phase IIa clinical trial of ACH-1625 dosed once daily, or QD, in combination with Pegasys, or peginterferon alfa-2a, and Copegus, or ribavirin, a current standard of care, or SOC in patients with chronic hepatitis C, or 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.
In this first of a two segment Phase IIa trial, a total of 64 patients were enrolled and randomized across three doses of ACH-1625 given once daily (200mg, 400mg or 800mg) or placebo with peginterferon alfa-2a and ribavirin, and were dosed for 4 weeks of therapy. Patients then continue on SOC for up to an additional 44 weeks. Subjects were randomized and stratified by HCV genotype and IL28B genotype.
The majority of the 64 patients enrolled were HCV genotype 1a (73%), with a smaller percentage of HCV genotype 1b patients (25%). A total of 75% of the patients enrolled were genotype CT/TT, a marker of the patient's diminished response to interferon, and 25% were genotype CC.
All patients receiving 4 weeks of treatment with ACH-1625 demonstrated continuous and substantial declines in HCV RNA with no viral breakthrough during therapy at any of the doses.
Safety results from a planned safety analysis included 56 patients from this segment of the trial and indicated that adverse events (AEs) were similar to those observed in the previously reported Phase Ia and 1b trials of ACH-1625. Over 4 weeks of co-administration of ACH-1625 with SOC, there were no discontinuations due to adverse events and there were no serious adverse events (SAEs) reported.
Most reported AEs in patients receiving ACH-1625 were classified as mild to moderate and were transient. The most common AEs were consistent with peginterferon alfa-2a and ribavirin.
"We are quite pleased with the continued robust efficacy results and good safety profile with once-daily doses of ACH-1625," said Michael D. Kishbauch, Achillion's President and CEO. "ACH-1625 continues to demonstrate best-in-class features, including once-daily dosing, robust antiviral activity, coupled with safety and tolerability for patients. These attributes distinguish our drug and suggest it could offer improvements over other next-generation protease inhibitors that will reach the market mid-decade."
4 days 23 hours 43 minutes ago - Standard & Poor's
Analyst Matthew Harrison tells salesforce ACHN downgrade follows news that combo of BMY'S NS5a, GILD'S GS-7977 hepatitis C (HCV) drugs demonstrated 100% Sustained Virologic Response without ribavirin in a 24-week study. Notes this is first combo to remove ribavirin, offer a once-daily well-tolerated all-oral pill with cures in HCV. Says lack of ribavirin in regimen should allow GILD and/or BMY to potentially gain majority market share. Given competitive concerns, lack of strategic value for ACHN's pipeline compounds, sees ACHN stock trending lower in coming mos. B.Egli
3 days 10 hours 11 minutes ago - GlobeNewswire via Comtex
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 in the second segment of its Phase 2a trial of ACH-1625, 94 to 100 percent of patients with treatment naïve genotype 1 chronic hepatitis C virus (HCV) achieved a complete early virologic response (cEVR) after 12 weeks of treatment with ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin (P/R). ACH-1625 in combination with P/R for up to 12 weeks was safe and well tolerated and produced high viral response rates regardless of dose level or IL28B genotype status.
Results from this trial were presented during the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) International Liver Congress 2012 in Barcelona, Spain from April 18 -- 22, 2012. Additional posters detailing Achillion's NS5A inhibitor program, including ACH-2928 and ACH-3102, were also presented during EASL
Michael D. Kishbauch, President and Chief Executive Officer of Achillion commented, "We are extremely pleased with the safety and efficacy that ACH-1625 has achieved in this Phase 2 clinical trial as well as the impressive resistance profile this compound has shown to date. As we finalize this Phase 2 trial and report on SVR later this year, we are now focused on initiating our all-oral program for the treatment of HCV. With the recent submission of an IND for ACH-3102, our second-generation NS5A inhibitor, we look forward to initiating its Phase 1 program this quarter and rapidly advancing toward a therapeutic, interferon-free combination trial evaluating ACH-1625 plus ACH-3102 during the fourth quarter of this year."
ACH-1625: Phase 2 protease inhibitor for the treatment of HCV
In Segment 2 of this Phase 2a trial, a total of 58 subjects with HCV were enrolled, randomized and stratified by IL28B genotype, including CT and TT, which is a marker of a patient's responsiveness to interferon, to receive one of three doses of once-daily ACH-1625 (200 mg, 400 mg or 800 mg) in combination with P/R for 12 weeks of therapy.
Of the patients enrolled, the majority had HCV genotype 1a (n=35 (60%)), with remaining patients having HCV genotype 1b (n=20) or genotype 1 (n=3). Approximately 71% of the patients were IL28B genotype CT/TT, the more difficult to treat mutation, 64% were male and 17% were African American. No viral breakthroughs were observed during treatment.
1 days 3 hours 31 minutes ago - Dow Jones News
DOW JONES NEWSWIRES
Achillion Pharmaceuticals Inc.'s (ACHN) shares declined Monday as Phase II study data for its lead hepatitis C treatment was deemed disappointing in light of the recent success of peers.
Bristol-Myers Squibb Co. (BMY), Gilead Sciences Inc. (GILD) and others, including Abbott Laboratories (ABT), are racing to bring an all-oral hepatitis C regimen to market, hoping to tap what is expected to be a multibillion-dollar market for such a therapy. Gilead shares surged last week as it appeared to be leading the race: it hopes to bring a GS-7977-based therapy to market late next year or in 2014.
Achillion shares were down 12% at $7.25 in recent trading, pushing their decline for the past three months to 21%.
Over the weekend, Achillion presented final results of a 12-week study of its ACH-1625 treatment in combination with standard-of-care treatment at a European Association for the Study of the Liver conference in Barcelona, along with plans to combine a study of the oral drug candidate with another treatment later this year.
The company on Saturday had reported that in the second segment of its Phase 2a trial of ACH-1625, 94% to 100% of patients achieved a complete early virologic response after 12 weeks of the experimental treatment in combination with pegylated interferon alfa-2a and ribavirin. The company also reported the combined treatments were safe and well tolerated and produced high viral response rates.
J.P. Morgan Chase & Co. (JPM) said in a research note the data Achillion presented on Saturday "raises eyebrows" as it downgraded the stock to market perform from market outperform.
"Overall, the data were confusing and raised questions regarding the interim safety and efficacy analysis, particularly regarding the compounds ability to clear the virus relative to other competitive agents, liver elevations, and gastrointestinal symptoms," the analysts said. "As such, we are waiting on the sidelines until we get a better handle on the breadth of the therapeutic window."
Achillion on Monday aimed to clarify data regarding end-of-treatment data included in the data presented over the weekend.
The company in a statement said that 58 patients were given a once-daily dose of 200 milligrams, 400 milligrams or 800 milligrams of ACH-1625 pegylated interferon and ribavirin for 12 weeks. At the time of the presentation, 22 of the patients had completed 12 weeks of ACH-1625 plus the other two drugs followed by 12 weeks of pegylated interferon and ribavirin. At the end of 24 weeks all 22 patients had undetectable levels of the virus.
"We are providing these results as we recognized that some of the data was not clear" during its presentation at the conference, Achillion President and Chief Executive Michael Kishbauch said.
Oppenheimer analysts said earlier Monday that based on the results, "we believe '1625 has meaningful strategic value and could play a role in an all-oral combination regimen."
However, the analysts also said that despite their favorable view of 1625 and Achillion's earlier hepatitis C pipeline they believe the stock currently "reflects appropriate value for these programs."
The study data was released a few days after another study found a regimen combining experimental drugs from Gilead and Bristol-Myers suppressed the hepatitis C virus in most patients four weeks after completing treatment. In a separate study, Gilead also said a combination of its drug, GS-7977, with an older drug, ribavirin, suppressed the liver-disease-causing virus in most patients four weeks after treatment.
The results bolster the prospects for an all-oral regimen for hepatitis C that eliminates an injectable drug used in the current standard treatment, interferon, which can be difficult for patients to tolerate.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com
UPDATE 1- Achillion's hepatitis C drug gets FDA fast track
May 15 (Reuters) - The U.S. Food and Drug Administration granted a fast track designation to Achillion Pharmaceuticals Inc's experimental hepatitis C drug ACH-3102, currently in an early-stage trial.
The fast-track status is designed to expedite the regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs.
The New Haven, Connecticut-based company got a fast track designation in January for another of its experimental hepatitis C (HCV) drug ACH-1625, which was in a mid-stage trial.
The hepatitis C virus infects the liver and is the most common cause of viral hepatitis, an inflammation of the liver.
The market for hepatitis C treatments is expected to be worth around $15 billion by 2019, garnering significant investor interest, and most firms trying to develop a drug for the infection have seen stock prices skyrocketing over the past one year.
Shares of Achillion closed at $6.89 on Monday on the Nasdaq.
The recent correction in the stock market has created new buying opportunities for investors. With all the concerns about the global economy, it makes sense to consider investing in companies that are not deeply impacted by recessions. Biotech and healthcare companies are generally insulated from the economy much better than most. The lower stock prices brought about by the correction and the recession-resistant nature of these companies, could allow biotech and healthcare investments to outperform. To be sure, investing in this sector has major risks, but the rewards can be equally large. The names below might be particularly compelling because all are pursuing treatments for hepatitis, which is has blockbuster potential. Some investors might remember that earlier this year, Bristol-Myers (BMY) acquired Inhibitex, Inc. (INHX), a biotech focused on hepatitis treatments, for $26 per share. Many healthcare and major biotech companies are actively pursuing merger and acquisition deals, and more buyouts could occur in this sector. Some corporate balance sheets are loaded with cash, financing costs are low and major pharmaceutical companies need to find growth through acquisitions. Here are some stocks to consider now:
Achillion Pharmaceuticals, Inc. (ACHN) is a biopharmaceutical company focusing on developing treatments for hepatitis C infections. It also has antiviral and antibacterial candidates in the pipeline. ACH-1625 is the most advanced candidate, and it is currently in phase 2 clinical trials. It is a promising hepatitis C inhibitor with the potential for once-daily dosing. Investor interest in hepatitis is strong because it has block-buster market potential and companies (like Inhibitex) pursuing this segment have been the subject of takeovers. This company could be particularly attractive to a suitor because it is so highly focused on hepatitis. Achillion has a strong balance sheet with about $65 million in cash and less than $1 million in debt. At least one insider is taking advantage of the currently low stock price: On June 11, 2012, Dennis Liotta, a director, bought 10,000 shares in a transaction valued at about $61,600. On June 10, he also bought 10,000 shares for a two day total of 20,000 shares.
Here are some key points for ACHN:
- Current share price: $6.38
- The 52 week range is $3.81 to $12.95
- Earnings estimates for 2012: a loss of 64 cents per share
- Earnings estimates for 2013: a loss of 69 cents per share
- Annual dividend: none
Opko Health Inc., (OPK) shares have been in a trading range of around $4.50 to $5 for the past couple of months. With the shares now at the low end of that range, it could be an ideal time to buy. This company is developing specialized drugs and vaccines. It recently announced acquiring a 45% stake in a private Israeli company that is developing a hepatitis B vaccine which has shown promise in clinical studies. The CEO of Opko, Phillip Frost, is a billionaire who has been very successful in past biotech and healthcare-related endeavors. He has also been involved in merger and acquisition deals and he serves as chairman of the board at Teva Pharmaceutical Industries (TEVA). That is another reason why it is particularly interesting to follow and perhaps invest in Opko. On June 14, 2012, Phillip Frost, bought 200,000 shares in a transaction valued at about $922,000. On June 13, he also bought 85,000 shares for a two day total of 285,000 shares. The CEO has been steadily buying over the past few months.
Here are some key points for OPK:
- Current share price: $4.59
- The 52 week range is $3.30 to $5.85
- Earnings estimates for 2012: a loss of 12 cents per share
- Earnings estimates for 2013: a loss of 13 cents per share
- Annual dividend: none
Bristol-Myers Squibb shares have been a great investment for the past several months. Thanks to a stable revenue source and a generous dividend yielding about 4%, this company makes sense for income investors. This company acquired Inhibitex for about $2.5 billion or $26 per share earlier this year. Inhibitex was acquired due to a candidate it developed to treat hepatitis, and the stock went from about $3, to $26 in just months. Bristol-Myers also owns blockbuster drugs such as Plavix and Abilify. The deal for Inhibitex could add growth potential in the future, and more deals are possible thanks to the strong balance sheet.
Here are some key points for BMY:
- Current share price: $34.13
- The 52 week range is $25.69 to $35.44
- Earnings estimates for 2012: $1.96 per share
- Earnings estimates for 2013: $1.92 per share
- Annual dividend: $1.36 per share which yields 4%
Disclaimer: Data is sourced from Yahoo Finance. No guarantees or representations are made. Hawkinvest is not a registered investment advisor and does not provide specific investment advice. The information is for informational purposes only. You should always consult a financial advisor.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Achillion: Down But Not Out And Progress Being Made ///// Still "IN PLAY."
Disclosure: I am long ACHN.
Achillion Pharmaceuticals' (ACHN) share price has been driven down recently from when I first suggested considering this stock to buy. I even doubled down on the initial purchase in The Young And Restless Retirement Portfolio.
I followed up with this report which detailed some of the successful results in phase II trials, as noted by Milind Deshpande, Chief Scientific Officer and President of Research and Development:
"We are very pleased to see that the profile of ACH-3102 continues to exceed our expectations for providing a truly improved barrier to resistance. As the first-ever clinical trial to evaluate a NS5A inhibitor as a single direct-acting antiviral in combination with ribavirin, we are extremely encouraged by these initial results that demonstrate rapid suppression of the HCV GT1b virus and a well-tolerated safety profile through 12 weeks of therapy," commented Milind Deshpande, Ph.D., President of Research and Development and Chief Scientific Officer of Achillion. "As this data set continues to mature, we look forward to reporting initial SVR results at a medical meeting in the second quarter, and are planning to expand enrollment in the study to include non-CC GT 1b treatment-naïve patients later this quarter pending regulatory discussions."
At the time of that report, it was also stated that the company will report further clinical results more frequently:
ACHN has 3 drugs in its pipeline at various stages of clinical trials that could be considered potential hepatitis C oral, once per day, treatments.
Sovaprevir (ACH-1625) and ACH-3102 are nearing phase III trials, which will be the most significant, and ACH-2684 is nearing phase II trials. As of today, the company has stated that throughout the balance of 2013, more updates on success or the lack thereof will be given on each.
Achillion Has Made Progress And More Announcements Are Soon To Come
A few weeks ago the company released this report which detailed the positive progress on the efficacy and safety of ACH-3102, as well as the differentiation of the drug from other drugs being tested:
Dr. Andrew Muir, Principal Investigator and Assistant Professor of Medicine and Director of Gastroenterology/Hepatology Research at Duke Clinical Research Institute commented, "The preliminary results from this novel study of a single DAA, an NS5A inhibitor, plus ribavirin demonstrates the safety, high barrier to resistance, and preliminary efficacy of ACH-3102. The profound activity of ACH-3102 as a single DAA, along with its safety profile and lack of virologic breakthrough to date makes this a very promising compound to study further in combination with other oral agents, including sovaprevir, for the treatment of HCV."
Having the progress measured by Duke Clinical Research, and have the principal investigator impressed, is very encouraging to say the least.
In addition to that report, ACHN presented at the ILC conference with an even more focused progress report, aimed directly at the promising results of both ACH-3102 and sovaprevir in treating hepatitis types 1a and 1b:
"The high barrier to resistance observed with ACH-3102 to date continues to confirm our view that ACH-3102 is unique from other NS5As and has the promise to be a cornerstone therapy in the treatment of Hepatitis C," said Milind Deshpande, Ph.D., President of Research and Development and Chief Scientific Officer of Achillion. "The unique characteristics of ACH-3102, combined with the unique profile of our 2nd generation PI, sovaprevir, which also has a higher barrier to resistance than typical PIs, make for what we believe is a high potential combo, competitive against both current and emerging combinations."
Supportive of these findings, other sources have honed in on the potential of ACHN in this huge market. As reported in this article, the effectiveness of the drug regimen is duly noted:
Achillion Pharmaceuticals Inc. said an experimental drug against hepatitis C suppressed the virus in 63 percent patients in a study. Four weeks after completing a 12-week course of treatment with the medicine, ACH-3102, the liver-damaging virus, was undetectable in the blood of five out of eight patients, New Haven, Connecticut-based Achillion said in a statement today. Two didn't respond to the drug while on treatment, and in another the virus returned three weeks after therapy ended.
Achillion said last week its started a trial of ACH-3102 in combination with its lead drug, sovaprevir, in as many as 50 patients, and expects to report interim results in the third quarter. Other drugmakers, including Bristol-Myers Squibb Co. (BMY), are also trying to develop treatments that are faster and safer than the current standard, and which don't involve injections. Achillion "will continue to explore and execute opportunities to combine our agents with other compounds that could further shorten the treatment duration or provide additional flexibility for treatment regimens to broadly cure HCV," Chief Executive Officer Michael Kishbauch said in the statement.
There are also indications that the investment community is beginning to see the potential for the stock as well as the drugs. This article offers some insight from a key analyst in this sector, Brian Skorney, Senior Analyst at Robert W. Baird & Co.:
Achillion Pharmaceuticals remains undervalued as investors continue focusing almost exclusively on Gilead Sciences (GILD) for hepatitis C treatment, a market so large that ACHN has the opportunity to find and penetrate segments Big Pharma is not expected to reach for years......."I think Gilead is a great powerhouse on hepatitis C, but the market opportunity is so large from a volume perspective that I just can't see one company really dominating the market; to that extent, there will be pockets where pricing is going to have an opportunity to create a market where Gilead may not even want the price to penetrate for a number of years," Skorney said........"I think Achillion has a great opportunity with a regimen for hepatitis C that I think will come very close to matching Gilead's profile."
As far as I am concerned, this is a wonderful endorsement of the recent progress that Achillion has delivered.
Further progress reports will be forthcoming this week, as the company will be a key presenter at three upcoming conferences:
- Bank of America Merrill Lynch 2013 Health Care Conference on Wednesday, May 15, 2013 at 3:00 p.m. PT at the Encore at the Wynn in Las Vegas, NV;
- UBS Global Healthcare Conference on Tuesday, May 21, 2013 at 3:30 p.m. ET at the Sheraton New York Hotel in New York, NY;
- Deutsche Bank 38th Annual dbAccess Health Care Conference on Thursday, May 30, 2013 at 2:10 p.m. ET at The Westin Boston Waterfront Hotel in Boston, MA.
Investors will surely be looking for more positive news at these events.
Other Reports On The Advancements In Hepatitis C Drug Treatments
There have been updates on a variety of progress reports covered by Medpage Today in various articles, and you can visit that link for all of the latest advancements in the treatment of hepatitis C, and see that some drugs are progressing, and some have not lived up to expectations.
In this particular report, it was duly noted that an all oral, triple combination of drugs appeared to be effective in the most difficult form of hep C to treat; viral genotype 1a, which is the primary focus of the ACHN drug regimen:
Hitting hepatitis C virus (HCV) from three directions was a winner in a phase II trial involving patients with the particularly hard-to-treat viral genotype 1a, researchers said here.
Excellent sustained 12-week viral response were seen in a phase II study of patients infected with HCV genotype-1 receiving various regimens that were interferon free and combined the investigational agents daclatasvir, asunaprevir, and BMS-791325.
The study was done by Bristol-Myers (BMY), and now that ACHN has released company earnings the other day, investors have been further emboldened by Achillions' progress, with this statement by Michael Kishbauch, President and CEO:
"Our goal to advance our potentially best-in-class HCV compounds continued to pick up significant momentum during 2013. We believe that the 12-week safety and efficacy results recently announced on ACH-3102, our second-generation pan-genotypic NS5A inhibitor, continue to support its differentiated profile with a high barrier to resistance and no viral breakthrough," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "We recently initiated an all-oral Phase 2 program evaluating sovaprevir and ACH-3102 for the treatment of genotype 1 HCV, and we expect to achieve a number of significant catalysts over the next few months including interim RVR results from the -007 trial in the third quarter, followed by SVR results during the fourth quarter. Furthermore, we remain focused on evaluating additional assets with complementary mechanisms of action that could potentially expand our treatment regimens to treat subsets of patient populations not adequately addressed by current regimens."
ACHN is focused on developing a strong pipeline of drugs, and while I believe ACHN could still be a takeover target, the company does have over $200 million in cash to see these trials right through phase III, on its own. By going after the type 1 viral strain, ACHN seems to be making a clear statement that their drugs work better than the myriad of competitors.
The risks of course, is the failure of any of the drugs during clinical trial phases, and the risk of losing an entire investment. That being said, I believe at the current price, the shares offer a risk/reward in this market that cannot be overlooked.
I remain bullish on the potential of ACHN and believe that the company will be a vital part of a $20-$30 billion market. Whether on its own, or gobbled up by a larger company, investors could profit from the success of ACHN.
The recent pullback in price makes for yet another compelling entry point.
Disclaimer: The opinions of the author is not a recommendation to either buy or sell any security and is strictly his opinions. Please do your own research prior to making any investment decisions.
NEW HAVEN, Conn., May 15, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (ACHN) today announced the appointment of David Apelian, M.D., Ph.D., MBA, to the position of Executive Vice President and Chief Medical Officer, effective May 28, 2013. Dr. Apelian wll assume responsibility for the clinical development of Achillion's portfolio of compounds to treat HCV.
In addition, Achillion also announced today the expansion of its clinical operations group with the recent addition of Kevin Kucharski, formerly head of clinical operations at Pharmasset, who will serve as Senior Vice President of Clinical Operations.
"We are delighted that David is bringing his wealth of hepatitis and drug development expertise to Achillion. His operational and regulatory experience, highlighted by the regulatory approval of antivirals such as interferon alpha-2b/ribavirin and entecavir, will greatly benefit Achillion as we accelerate our development plans and seek to initiate registrational studies with sovaprevir and ACH-3102 during the latter part of next year," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion.
Dr. Apelian commented, "It is a very exciting time for me to be joining Achillion as Chief Medical Officer, and I look forward to further accelerating the development of the all-oral, interferon-free regimens containing sovaprevir and ACH-3102 for the treatment of chronic HCV."
Mr. Kishbauch also stated, "As Achillion continues its maturation into a late-stage biopharmaceutical company, the addition of both Kevin and David will expand our bandwidth, providing critical expertise and the support necessary for our HCV clinical development programs and our planned Phase 3 development."
David Apelian, M.D., Ph.D., MBA
Dr. Apelian brings to Achillion more than 13 years of industry experience from Bristol-Myers Squibb, Schering Plough and GlobeImmune where he focused on hepatology and infectious disease clinical development. Dr. Apelian was Clinical Director in the Infectious Diseases Group at Bristol-Myers Squibb (BMS), serving as medical co-lead for the clinical development and NDA submission of entecavir for chronic hepatitis B viral infection (HBV). Prior to BMS, Dr. Apelian served as Clinical Director in the Department of Hepatology/Gastroenterology at Schering Plough, coordinating a supplemental NDA filing for interferon alpha-2b and ribavirin for the treatment of pediatric patients with chronic hepatitis C viral infection (HCV). Most recently, Dr. Apelian served as Senior Vice President of Research and Development and Chief Medical Officer at GlobeImmune, where he was responsible for clinical development, regulatory affairs, clinical immunology, development of companion diagnostics, as well as target discovery and preclinical research.
Dr. Apelian completed his residency training in Pediatrics at New York Hospital, Cornell Medical Center. He received his M.D. from the University of Medicine and Dentistry of New Jersey, and his Ph.D. in Biochemistry and B.A. from Rutgers University. He also holds an M.B.A. from Quinnipiac University
Mr. Kucharski comes to Achillion with more than two decades of clinical operations expertise, with a focus on conducting U.S. and global clinical trials, ranging from Phase 1 through Phase 4. Prior to joining Achillion, Mr. Kucharski was Vice President of Clinical Operations at Pharmasset since 2007, and then at Gilead Sciences following their acquisition of Pharmasset. While at Pharmasset, Mr. Kucharski provided effective oversight and execution of various global clinical development projects including PSI-7977 and PSI-938. Prior to Pharmasset, Mr. Kucharski was Senior Director of Clinical Operations at Altana Pharma US, a Nycomed Company, where he established the Clinical Operations group. Prior to that, Mr. Kucharski held positions of increasing responsibility in Clinical Operations at Schering-Plough Research Institute. Mr. Kucharski was awarded his B.S. in Biology Research from the University of Scranton.
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 including more than 5 million people in the United States, more than twice as widespread as HIV. Three-fourths 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. 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 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 HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
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, including statements with respect to: the potency, safety, tolerability, effectiveness and other characteristics of sovaprevir and ACH-3102; Achillion's expectations regarding timing for the commencement, completion and reporting of results of its -007 clinical trial of sovaprevir and ACH-3102 in combination with ribavirin, as well as with respect to the advancement into later stages of its clinical studies; and the expected contributions of Dr. Apelian and Mr. Kucharski and the planned expansion of the clinical operations group. Among the 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: replicate in later clinical trials positive results found in earlier stage clinical trials of sovaprevir, ACH-3102 and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain 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 successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; successfully execute on its business plans and strategies; and raise the substantial additional capital needed to achieve its business objectives. 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 fiscal year ended December 31, 2012 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 obligation to update any forward-looking statement, except as required by applicable law.