As 2012 Begins, NASDAQ Reports That New HCV Drugs Are At The Forefront Of Another Year Of Sky High Pharmaceutical Profits

A Booming Biotech High With HCV Market Overflowing:

There is a Question of Love, a Question of Our Humanity —

Can People Come Before Profits?

A Common Goal With The Occupy Movement - People Before Profits

Another Year, Another High… The biotechnology sector, though a risky investment arena, offers a tremendous potential for huge gains. Binary events like clinical trial results and FDA decisions are typical in biotechnology companies, and can cause significant swings in share price. The following are some of our bio stock picks of 2011 that have been setting new highs.

Pharmaceuticals Inc. (IDIX) is a biopharmaceutical company building a pipeline of drug candidates for hepatitis C, a market with high levels of unmet need. IDIX was trading around $5.06 when we alerted readers to the stock on September 6, 2011, and it set a new 52 week high of $15.25 in intraday trading on Jan.19, 2012, representing a gain of 201 percent. The stock closed Friday's trading at $11.68.

The acquisition of Inhibitex Inc. (INHX), a hepatitis C drug developer, by Bristol-Myers Squibb Company Co (BMY) on Jan.9, for $26 a share, or about $2.5 billion, which was a 163% premium, sparked an interest in other hepatitis C drugmakers.

Achillion Pharmaceuticals Inc. (ACHN) is a biopharmaceutical company focused on the development of antivirals for the treatment of chronic hepatitis C. ACHN was trading around $4.37 when we alerted readers to the stock on October 7, 2011, and it set a new 52 week high of $12.95 in intraday trading on Jan.13, 2012, which implies a gain of 196 percent. The acquisition of Inhibitex Inc. (INHX), a hepatitis C drug developer, by Bristol-Myers Squibb Company Co (BMY) on Jan.9, for $26 a share, or about $2.5 billion, which was a 163% premium, sparked an interest in other hepatitis C drugmakers.

Based upon recent results of clinical trials, Achillion is planning further exploration of ACH-1625 in combination with other oral antiviral agents for the treatment of all HCV genotypes and continues to evaluate ACH-2684 in a phase 1 clinical trial. Achillion plans to submit an investigational new drug application and initiate a phase 1 clinical trial with ACH-3102 during the second quarter of 2012. During the second half of 2012, Achillion plans to initiate an interferon-free, all-oral combination clinical study evaluating a protease inhibitor and a NS5A inhibitor, with or without ribavirin, for the treatment of HCV.

Can Profits Before People Shift To People Before Profits In Health Industry

Without question, the development of an interferon free, all oral protease inhibitor will revolutionize worldwide the HCV market. The question is can the people come before the profits. If the treatments costs too much and is too expensive for people to access without bucket loads of assets or the perfect insurance plan, then this is not what the world needs. The focus has to be that everyone should be taken care of and given access to a treatment that potentially can and will save lives.

The Shift Must Be Made - 

People Before Profits, Not Profits Before People 

When It Comes Down To The Health Industry

The So-Called Biotechnology Sector
?Beyond Our Understanding?
No More Excuses or Rationalizations

Accessible Medical Treatment For All!

Money Talks - If The Hepatitis C Market Is The Next Mecca For The Pharmaceutical Fat Cats, Who Will Win The Rat Race?

Is the Hepatitis C market the next Mecca for the pharmaceutical sector? If so, who will win the rat race: the millions of HCV patient with little or no resources or the pharmaceutical fat cats. It seems like the fat cats are salivating right now if we go by the flurry of activity and heightened interest in the HCV market. The Hepatitis C virus (HCV) market seems to have caught the eye of several pharma/biotech companies – as evident by the deals being signed for the development of drugs for the treatment of HCV.


Biotech rivalries are like bare knuckles boxing matches: two lone fighters battle until they are beaten and bloodied for the prize. But the hepatitis C market is turning into a battle royal that’s more wide open and unpredictable. The medical advances in hepatitis C have been dizzying this year, especially in what it means in terms of multi-billion dollar business implications. The safest thing to say is that there’s plenty of good news for patients this year, but that shareholders in the major hepatitis C drug developers had better hold on tight as a new standard of care gets established.

Pharmaceutical Companies Battling For Big HCV Profits

The Allure of the HCV Market
HCV is a hot development area which has come into the limelight with the launch of two new treatments – Vertex Pharmaceuticals’ (NASDAQ:VRTX) Incivek and Merck’s (NYSE:MRK) Victrelis. Both drugs gained approval in the US earlier this year. Incivek, which was launched in May 2011, posted a whopping $419.6 million in sales in the first full quarter of its launch.


With two new recently launched products in the market, why is the HCV market considered so attractive? Firstly, it is estimated that about 170 million people suffer from HCV infection across the world. However, the treated population is much lower. In major markets like the US, EU, Japan, Australia, Turkey, Canada, only 200,000 HCV patients out of a total of more than 12 million are estimated to receive treatment each year. This means a huge number of HCV patients go untreated, leaving the field open for new treatments. 


A 48-week course of both peg-interferon and ribavirin are the standard treatment for genotype 1 HCV infection. However, this treatment regimen is associated with significant side-effects like fatigue, flu-like symptoms, rash, depression and anemia. As we have seen with me, it is tough to say the least. However, let's not forget that my extreme side effects, the endless itching and pain of the rash, was caused by the new Protease Inhibitor and not the other drugs. Hell, in retrospect, the other drugs that I still take every week are a walk in the park in comparison. Yes, it sucks, but it is so very far from hell on earth.


With a large number of HCV patients failing to achieve a sustained viral response (SVR) on the current standard of care, there are several patients who would be open to treatment with new and potentially more effective therapies. These factors have made the HCV market an attractive commercial opportunity for pharma and biotech companies. It also has made it attractive to the millions of patients like myself with the American genotype. Suddenly we have a chance to live that has risen from about 45% to almost 80% treatment success rate.


Cocktail Therapy – The Next Big Thing in HCV
The goal is to change the treatment paradigm for HCV patients by providing them with all-oral treatment regimens. The aim is to develop a treatment which does not require the administration of interferon, thereby doing away with a whole range of side effects. The treatment duration will also be shorter. In retrospect, I wish I had waited until such treatments were available, but regrets are silly. I am powerless over the past and I cannot change it. All I can do is embrace health and happiness in the future.

The Financial Fat Cats Love The HCV Marketplace As It Opens Up

Who Will Win the Rat Race?
With several companies pursuing cocktail therapies for HCV, it will be interesting to see which of these companies will be the first to hit the market with a new treatment option. Hopefully, the rat race will help the millions of infected Americans and not just line of the pockets of the pharmaceutical fat cats.

Why The Silence? A Certain Malaise Sets In As The Hell Of The Side Effects Ends And Purgatory Is Restored But A Hero Is Reborn

I would apologize for the recent silence, but I honestly don't believe that such an apology is necessary. After going through the utter hell of six straight weeks of endless itching and intense pain, I find myself giving in to a certain malaise and ennui. Yes, purgatory is an utter pleasure when compared to the fires down below, but it is not quite a celebration and not quite an inspiration. I am tired and burned out to the bone as I struggle to retain a certain equilibrium within. It is strange because the rewards of such an experience are so much greater than the scars, but the scars and the damage of the wounds remain.

The thing about a hero, is even when it doesn't look like there's a light at the end of the tunnel, he's going to keep digging, he's going to keep trying to do right and make up for what's gone before, just because that's who he is.                                                                — Joss Whedon

I am beginning a new journey as I approach the end of treatment that I believe is successful and the Hepatitis C virus will have been eradicated from my body. But I still have another month and a half of Interferon and Ribavirin so I spend several days each week with flu-like symptoms and exhaustion. It remains difficult to eat at times and the indigestion is constant and the toilet is not my friend. But I have survived and I have learned lessons that not only cannot be taken from me, but will be maintained through practice and a loving focus. It is nice not only to see the light at the end of the tunnel, but to walk into the sunshine with the knowledge that another always awaits.

Faith Is The Realization That The Light Is The Gift Of A New Dawn

Do you recognize the hero within? Not only are you the main character of your story, but you alos have the power to define the genre of the story. It does not have to be a tragedy or a farce, it does not have to be epic or absurd. Your story is your own and you are the hero of its creation. Welcome to the freedom to define the journey of your name and your life.

Here is a new poem that I rediscovred and recently recreated... gotta love such a reenvisioning and a reawakening and a simple return because even if re is a prefix, occurring originally in  Latin, used with the meaning “again” or “again and again” to indicate repetition,or with the meaning “back” or “backward” to indicate withdrawal or backward motion, it still provides the ability to express the eternal recurrence of being a-okay. Here is that poem I mentioned above...

between

between the first step taken

and lying down on a leather couch,

between the opening of a door

and the turning of the bedroom lock,

between putting pen to paper

and checking out what’s in the fridge

fall the sunken eyes of ennui.

between the biting of a nail

and the opening of a fist,

between the twitching of a palm

and the raising of a thumb,

between the flapping of tongues

and the calmness of silence

stands the bright shadow of courage.

Night 145 - Innovations In Hepatitis C Treatment Definitely One Of The Major Medical And Financial Breakthroughs Of 011

Several other Protease Inhibitors are being developed as well, including the nightmare experience I had with the Protease Inhibitor by BI. Still, I believe I will be cured so it does work, and my side effects were more extreme than anyone else in the clinical trials. Lucky boy!

Drug Research Is Big Business: 4-6 Million HCV Infected Adults In The US

Overall, the innovation in the Hepatitis C treatment arena and thus the overall marketplace are nothing less than stunning. Within a few years, it looks like Interferon and Ribavirin will be removed from the treatment regimen, replaced by a Protease Inhibitor that covers all the bases. How great is that!

But let me be clear about my response to these incredible innovations. Despite the severity of my side effects, I am not bitter about my decision to enter the clinical trial and get treatment now. It was the right decision to make at the time, and my bad luck in regards to the side effects was just that - simple bad luck with no dark magic or evil curses. Hey, sometimes we roll the bones and we come up aces and sometimes we just crap out.

Such is life, and I choose to free myself from the burden of bitterness and regret. What's the point?! It's not like I was playing with loaded dice and got screwed. Sometimes the universe works for you and sometimes you work hard for the universe.
             I wish we had more control, but, as the French say, C'est La Vie!

If you choose to hold tight and carry the bitter weight of your regrets, do not ask why their no fluidity or rhythm to your life. What the hell do you expect when you are so overwhelmed by the horrors of the past that you sacrifice the freedom to live in the present.

Here is the article below about some of the new Hep C innovations:

2011 has brought patients with hepatitis C not one but two new groundbreaking medicines to treat the condition. Merck’s Victrelis (boceprevir) and Johnson & Johnson/Vertex’s Incivek (telaprevir) were both launched in the US in May. 

The drugs are both oral protease inhibitors, and promise to significantly improve treatment when added to the current standard treatments for the disease. An estimated 270-300 million people throughout the world have the disease.

Analysts predict Incivek will prevail because it has shown a higher cure rate, and a simpler and faster simpler dosing regimen. But Vertex, which has never launched a drug before, will have to overcome the might of Merck and its new US marketing partner Roche. 

Vertex’s belief in the superiority of its product is reflected in its price, which is $49,200 for a 12-week course. This cost is much higher than Victrelis, and is equivalent to the price of a whole 48-week treatment with Merck’s drug. 

Incivek has had the best start, earning $420 million between May to October, while the same period saw Victrelis earn a more modest $31 million.

Night 136 - Long Silence As Ennui Sets In + The Side Effects Added To Warning Label Of Peg Interferon - Depression and Suicidal Ideation

I know I have been silent for almost ten days which is the longest gap since I started treatment. It is strange because you would think I would have been silent during he nightmare and living hell of the constant itch and pain of the rash and staph infection. But the blog was my life preserver during that six weeks of hell, and it provided me with a sense of value and faith. Now things have shifted as I slowly recover from the trauma while remaining on the Interferon and the Ribavirin. 

Although I See The Way Out, I Remain In The Dark Tunnel At Essence

Although I see the light at the end of the tunnel I am still in the tunnel, still nursing my wounds, and, in the stillness of the cold night, facing the weight of the consequences. I have shifted into the doldrums of ennui as my burned-out body sags to the floor, and I fall on the couch and surrender to the banality of just being uncomfortable. Mind you, being consistently uncomfortable 24-7 is so much better than being in the thick of hell on earth. I am grateful, but being out of the flames and the fire, you begin to register the price and the traumatic effects of the wounds and damage. It is a bit overwhelming as I give in to being a couchaholic once again and find refuge in the arms of my old brown leather couch.

At the same time, I am writing beautiful poetry, and I shall publish a few newly rewritten and completely revised poems in the next blog. Right now, I am healing from the most extreme trauma of my life, and I must be gentle with myself. It is hard and brutal at times, and I must realize the toll taken in terms of the extremity of my survival. Yes, I survived and even did well in the face of a such a living nightmare, but there was damage and there was a lasting price. Although the long-term consequences have turned out to be both negative and positive, I must recognize that the negative cannot be ignored and must be treated with the respect of the price and the necessity of healing and recovering slowly.

Finally, I am still on the Ribavirin and Peg Interferon for another 2.5 months. The traditional side effects of these two drugs is what you always heard about when people mentioned how awful and difficult the process of going through Hepatitis C treatment. The worst side effects I experienced was due to the new Protease Inhibitor, but I am in a clinical trial, the drug is completely new, and my side effects won the gold medal for the worst in the entire country, if not, the entire world of clinical trials. Nevertheless, the side effects of the other two drugs continues to be a challenge.

The Ribavirin and Peg Inteferon Side Effects Continue To Be A Challenge

Here is a recent article about side effects officially added to the Interferon warning label:

FDA Hepatitis Update - Important Updates to PegIntron Warning Labeling

On December 22, 2011, the Food and Drug Administration approved revisions to the product labeling for PegIntron to include the use of PegIntron with hepatitis C virus (HCV) NS3/4A protease inhibitors for the treatment of genotype 1, chronic hepatitis C (CHC) infection. Additionally, the product labeling was update to include revisions to the text regarding the use of PegIntron in patients with neuropsychiatric disorders. Changes were made to the Medication Guide for consistency. The following changes were made to the warning and precaution sections of the product labeling.

Warning and Precaution section was revised as follows:

Neuropsychiatric Events

Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.

PegIntron should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.

Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate. In severe cases, PegIntron should be stopped immediately and psychiatric intervention instituted. Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of PegIntron.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Boehringer Ingelheim Has A Better Non-Interferon Treatment That I Know Nothing About? Now I Truly Feel Like A Guinea Pig Suffering Through These Side Effects!

Hepatitis C: Interferon-free combination of BI 201335 plus BI 207127 and ribavirin shows up to 76% of patients achieve a virological response at week 12, and 59% achieve SVR12 with 16 weeks treatment

Data from pre-specified interim analysis of Phase IIb SOUND-C21 trial with Boehringer Ingelheim’s two investigational HCV direct-acting antivirals presented at AASLD

For media outside of the U.S.A. only  (Why?)

San Francisco, USA and Ingelheim, Germany [7 November 2011] – Boehringer Ingelheim today announced results from a pre-specified interim analysis of a Phase IIb study, named SOUND-C2. These data showed the combination of two oral direct acting anti hepatitis C virus (HCV) compounds (the protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, with and without ribavirin (RBV), was successful in providing virological response rates at week 12 in treatment-naïve patients infected with the most difficult to treat genotype-1 (GT1) HCV. ¹ The shortest treatment duration tested in the study (16 weeks) achieved SVR12 in 59% of patients. None of the five study arms included treatment with interferon. ^1,2 These data were presented today at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA. ¹

“Results from the interim analysis of SOUND-C2 look promising,” said Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany and lead investigator of the study. “They highlight the potential of BI 201335 plus BI 207127 to lessen the burden of existing treatments for a large portion of patients by offering a potential treatment option without the inclusion of interferon.”

The use of interferon in HCV treatment is challenging for a number of patients due to suboptimal response rates, contraindications or severe side effects and treatment durations. ³

“We very much look forward to the final results from the SOUND-C2 study. The development of an oral interferon-free direct-acting antiviral regimen underlines Boehringer Ingelheim’s goal of eliminating interferon from HCV treatment and a commitment to deliver innovative novel treatments in virology,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “At AASLD we will also present further data from anti-HCV portfolio that demonstrates our dedication to meet the real-world challenges of HCV patients globally, ^1,4–7 including patient populations with traditionally difficult to treat virus types.” ^8–10

All five treatment arms of the interferon-free oral combination therapy of BI 201335/BI 207127/RBV showed high virologic response rates through week 12, defined by measuring the level of HCV RNA in patient blood:

• 70–76% of patients who received BI 201335 once daily (QD) + BI 207127 three times daily (TID) or twice daily (BID) with RBV achieved undetectable HCV RNA at week 12, with 13–21% of patients developing a viral load breakthrough during treatment
• 57% of patients who received BI 201335 QD + BI 207127 TID without RBV achieved viral response at week 12
• SVR12, which is considered highly predictive of SVR and cure of the infection, was achieved after 16 weeks of treatment in 59% of patients.

The safety and tolerability profile was comparable to other direct acting antiviral regimens.

Other BI data being presented at the meeting include:

• SILEN C3: Treatment for 12 or 24 weeks with BI201335 combined with peginterferon alfa-2a and ribavirin (P/R) in treatment-naïve patients with chronic genotype-1 HCV infection 
  (Abstract 39. D. Dieterich, et al., November 6, 4:15 p.m. - 4:30 p.m. PT) ⁴
• Characterization of HCV NS3 variants that emerged during virologic breakthrough and relapse from BI 201335 phase 2 SILEN-C1 study 
  (Poster 1339. G. Kukolj, et al., November 7, 8:00 a.m. - 5:00 p.m. PT) ⁵
• Treatment with the 2nd generation HCV protease inhibitor BI201335 results in high and consistent SVR rates – results from SILEN-C1 in treatment-naïve patients across different baseline factors 
  (Abstract 226. M.S. Sulkowski, et al., November 8, 8:45 a.m. - 9:00 a.m. PT) ⁶
• High sustained virologic response following interferon-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI201335, polymerase inhibitor BI207127 and ribavirin, followed by BI201335 and PegIFN/ribavirin –the SOUND-C1 study 
  (Abstract 249. S. Zeuzem, et al., November 8, 11:15 a.m. - 11:30 a.m. PT) ⁷

NOTES TO EDITORS 
Results of this open-label, randomised, Phase IIb study were presented as a late breaking poster titled, “Virologic response to an interferon-free regimen of BI201335 and BI207127, with and without ribavirin, in treatment-naive patients with chronic genotype-1 HCV infection: Week 12 interim results of the SOUND-C2 study,” by Professor Stefan Zeuzem. In the study, 362 treatment-naïve GT1 HCV patients were randomised into five interferon-free treatment groups, each with 120mg BI 201335 once daily but with different dosing of BI 207127 and treatment durations as follows:

• BI 201335 120mg QD + BI 207127 600mg TID + RBV for 16 weeks;
• BI 201335 120mg QD + BI 207127 600mg TID + RBV for 28 weeks;
• BI 201335 120mg QD + BI 207127 600mg TID + RBV for 40 weeks;
• BI 201335 120mg QD + BI 207127 600mg BID + RBV for 28 weeks; or
• BI 201335 120mg QD + BI 207127 600mg TID without RBV for 28 weeks.

About Hepatitis C Virus (HCV) HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. The number of individuals chronically infected with HCV globally has been estimated at 175 million, with 3–4 million new infections occurring each year. Only about 20–45% of patients clear the virus in the acute phase. Of the remaining chronically infected patients, 20% will develop cirrhosis within a mean of 20 years. The mortality rate after cirrhosis has developed is 2-5% per year. End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world. 

Boehringer Ingelheim in Hepatitis C Virus (HCV) 

Boehringer Ingelheim has a dedicated HCV treatment development programme, called HCVersoTM, which at its core, aims to reverse the existing HCV paradigm. The ultimate aim of this programme is to deliver improved HCV treatment outcomes for patients whilst breaking down the barriers of current treatment regimens.

BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim’s own research and development, which has completed clinical trials through Phase IIb (SILEN-C studies). This Phase II programme supports the investigation of BI 201335 in Phase III trials currently ongoing. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase I clinical trials. Phase II trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.

Boehringer Ingelheim The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development. 

SVR = sustained viral response, referred to as HCV cure. SVR12 = sustained viral response at week 12 after treatment is completed. RVR = Rapid virologic response, undetectable viral RNA at week 4 of treatment (indicator of how patient will respond). eRVR = extended rapid virologic response, undetectable viral RNA enduring through week 12 of treatment.