J&J open to partnering with Vertex in HCV drug development...

Posted on 4/20/12 on Bloomberg.com. The growing body of evidence in HCV drug development suggests that alliances are important (unless you happen to be Gilead) especially with partners that are owned by deep-pocketed, well diversified organizations like Johnson and Johnson.  Hopefully J&J can put back some luster on Vertex's non-nuc VX-222. Actually, despite it's inherent relative lower barrier of resistance, it's a good drug - QD dosing, pretty powerful, clean and low potential for drug interactions. Just needs the right partners in a regimen. TMC435 may be one of 'em - QD dosing, powerful, no need for ritonavir and thus no ritonavir baggage - sounds good on paper, anyway. 


J&J Open to Expanding Hepatitis C Cooperation With Vertex
By Makiko Kitamura - Apr 20, 2012 8:09 AM PT

Johnson & Johnson (JNJ)’s Janssen unit said it may explore widening cooperation on hepatitis C with Vertex Pharmaceuticals Inc. (VRTX) that may develop in tandem with a separate partnership with Medivir AB (MVIRB) on the disease.

“We remain open to see if we can expand our collaboration,” Gaston Picchio, vice president of Janssen’s global clinical virology and hepatitic disease area, said in an interview today in Barcelona, where he’s attending the European Association for the Study of the Liver annual meeting. “Vertex has announced plans for developing interferon-free therapies. We are partners, so that puts us in a better position to be a part of that,” should studies prove to be promising.

Vertex said on April 18 that it will start enrolling patients in a mid-stage study combining three medicines, excluding interferon, a core component of the current standard of care. Vertex and competitors including Gilead Sciences Inc. (GILD), Bristol-Myers Squibb Co. (BMY) and Abbott Laboratories (ABT) are racing to develop next-generation treatments for hepatitis C that exclude interferon because of flu-like side effects.

Vertex and J&J collaborated to develop telaprevir, marketed as Incivek by Vertex in North America and as Incivo by Janssen in other regions including Europe. The drug was approved by regulators last year as a treatment for hepatitis C in combination with interferon and ribavirin.
Medivir Project

J&J, which has its headquarters in New Brunswick, New Jersey, is also developing the protease inhibitor TMC435 with Huddinge, Sweden-based Medivir, which has said mid-stage trials of the drug in interferon-free combinations with Gilead’s 7977 and with Bristol-Myers’s daclatasvir experimental drugs are starting in the second quarter.

While J&J and Medivir are also developing the TMC647 polymerase inhibitor, Vertex’s VX-222 compound in the same class of drugs is further along in development. VX-222 is one of the three drugs included in Cambridge, Massachusetts-based Vertex’s mid-stage interferon-free treatment study.

Meanwhile, J&J is also “committed” to improving the labeling of Incivo by conducting further trials that examine less frequent dosage as well as efficacy in patients also infected by the HIV virus and those who have had liver transplants, Picchio said.

To contact the reporter on this story: Makiko Kitamura in Barcelona via mkitamura1@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Bristol-Myers Squibb and Medivir/J&J expand on Direct Acting Antiviral agreement...

Posted on 4/18/12 on Bloomberg.com - A good day for Medivir/J&J's late stage HCV protease inhibitor TMC435 as both companies inked a deal with BMS looking at mixing and matching Direct Acting Antivirals with TMC435 in interferon-free regimens for treating chronic Hepatitis C. Expect to see more data on both TMC435 and BMS's arsenal of DAA's this week from EASL. 

Bristol-Myers Expands Hepatitis C Accord With J&J, Medivir
By Makiko Kitamura - Apr 18, 2012 5:27 AM PT

Bristol-Myers Squibb Co. (BMY) agreed to conduct two trials of experimental hepatitis C treatments in collaboration with Medivir AB (MVIRB) and Johnson & Johnson. (JNJ) Medivir shares rose as much as 5.7 percent in Stockholm.

The companies will conduct a late-stage trial of Bristol- Myers’ daclatasvir and J&J and Medivir’s TMC435, depending on the outcome of a mid-stage study, Stockholm-based Medivir said today in a statement. A drug interaction study of TMC435 with Bristol-Myers’ BMS-986094 will also be conducted, they said. That expands a collaboration between J&J and Bristol-Myers announced Dec. 2, Medivir said.

The Bristol-Myers drug in the second study entered the company’s pipeline with the acquisition of Inhibitex Inc. for $2.5 billion in February. TMC435 is a protease inhibitor, which blocks the action of the protease enzyme the hepatitis virus needs to replicate, directly stopping it from spreading. BMS-986094 is a nucleotide polymerase inhibitor, which works differently to block the virus’ ability to replicate in the body.

“We see the expanded clinical collaboration as a strong validation of TMC435, especially as we know of no other competing protease inhibitors running interferon-free combination trials with other direct-acting antivirals externally,” which include polymerase inhibitors, said Hans Jeppsson, an analyst at Danske Bank, in a note to investors today.

Medivir shares rose 4.6 percent to 73.25 kronor at 2:17 p.m. in Stockholm, giving the company a market value of 2.29 billion kronor ($339 million).

Drug Combinations
Other nucleotide polymerase inhibitors include Gilead Sciences Inc.’s 7977 compound, which was gained through the company’s acquisition of experimental hepatitis C-treatment maker Pharmasset Inc. for $10.8 billion in November. Bristol- Myers, based in New York, and Medivir are also testing their experimental treatments in combination with Gilead’s 7977.

Drugmakers are exploring cocktails of hepatitis C treatments that exclude interferon, a component of the current standard of care, because of the injectable therapy’s side effects.

Hepatitis C affects as many as 170 million people globally, putting them at risk of developing liver cancer, according to the World Health Organization. The disease is most commonly transmitted through contaminated blood transfusions, organ transplants, contaminated syringes and needle-injected drug use, according to the WHO.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Seeking Alpha - Achillion Will Soar Higher On New Hepatitis C Drug In 2013

Posted on 4/16/2012 on Seeking Alpha.com. I'm trying to figure this guy out. He makes some valid points on Achillion's PI ACH-1625, but says nothing about their NS5A inhibitors. Then he mentions GSK's Promacta (Eltrombobag) as a 'competitor' and a 'Hepatitis C drug', which doesn't do much for this particular person's street cred. Anyway, I like to root for Achillion and I like it when people say nice things about the company, so I'm including it here for your reading pleasure. 

Achillion Will Soar Higher On New Hepatitis C Drug In 2013

By Vatalyst - Seeking Alpha.com

April 12, 2012

Achillion Pharmaceuticals (ACHN) has risen 51% since last year, which is a surprising number for a development stage pharmaceutical industry with no FDA approved drugs on the market. The news has been hyping up Achillion's hepatitis C drug ACH-1625, which is only just now ending Phase 2 clinical trials. Along with ACH-1625, are four other hepatitis C drugs and one bacterial infection antibiotic, ACH-702. The hepatitis C drug pipeline is composed of some very unique drugs and mechanisms for treating hepatitis C.

Should these drugs gain FDA approval, there would be a major upside for the company to sell ACH-1625 state side and worldwide to nearly corner the market. However, ACH-1625 is only just finishing Phase 2 and releasing results. I always highly advise against investing in any company with promising drugs that have not been FDA approved.

The first reason is that Achillion is getting great news hype about ACH-1625, which is causing the stock price to increase very well. But, Achillion is now starting Phase 3 clinical trials and will not have any more news reports that would cause a stock rise in the next year. The second reason is that more often than not, drugs fail to gain FDA approval for hundreds of different reasons, including toxicity, efficacy, and potency. It is never safe to bet on a drug before it is FDA approved so do not invest until there are conclusive and positive phase 3 trial results released.

Finally, due to the fact that ACH-1625 is starting phase 3 trials in the beginning of 2012, we cannot expect to see the drug on the market until at least late 2013 or early 2014.

Phase 3 trials can take a year or longer, plus new drug application for the FDA takes a substantial amount of time. Therefore, I do not expect stock price to do much of anything until late 2013 at the earliest. If you are a long-term investor and already own stock with Achillion, sit tight until late 2013 when share price will see a major upside if the clinical results are positive. If you are short term, keep a close eye on the company until late 2013 and if the phase 3 results are positive then it is time to invest.

Achillion has a market cap of $773 million and a 52 week range of $4-$13. Achillion has a competitor in the hepatitis C drug Promacta by GlaxoSmithKline (GSK), which has a market capitalization of $223 billion, a 52-week range of $39-$47 and a price to earnings ratio of 27.45. Achillion's next competitor is a hepatitis C drug, TMC435, by Johnson & Johnson (JNJ) with a 52 week range of $59-$68, a price to earnings ratio of 18.74 and a market cap of $179 billion. The last competitor of Achillion are three hepatitis C drugs by Roche Holding AG (RHHBY.PK) with a price to earnings ratio of 14.3, a market cap of $145 billion and a 52-week range of $42-$43. For a company that has no FDA approved products on the market, Achillion seems to be in pretty good standing with its competitors.

Johnson & Johnson is set to be Achillion's biggest competitor. It currently has a hepatitis C drug, TMC435, entering Phase 3 trials. The results of the Phase 2 trials showed that the drug was effective, safe, and 83% of patients were able to discontinue treatment with TMC435 after 24 weeks. With the release of this positive clinical trial news, Johnson & Johnson is receiving equal amounts of positive hype over this hepatitis C drug as Achillion. It is possibly receiving even more hype when considering the other drugs currently in Phase 3 of the Johnson & Johnson pipeline. Share has stayed relatively the same over the past year with a nearly 10% increase. I feel that right now Achillion and Johnson & Johnson are going to mirror one another until the Phase 3 data is released. I recommend keeping an eye on both companies until then; once the data is released we will know which company has the better drug and which is worth investing in.

Roche Holding AG is currently developing three hepatitis C drugs in its pipeline. These drugs are all in Phase 2 testing and will not be ready for the market until late 2014 at the very earliest, most likely by 2016. This is assuming that the drugs even pass FDA regulation in the coming years. I see no real competition from Roche Holding AG in the next few years to hurt share price of Achillion, but Roche Holding AG would be a good company to keep an eye on and possibly invest in if ACH-1625 ends up failing FDA approval.

GlaxoSmithKline has developed an FDA approved drug, Promacta, used for the treatment of hepatitis C in compound with other treatments. I feel that this drug wont provide much competition for ACH-1625 should it become FDA approved. Promacta's main function is to increase blood platelet count in patients with hepatitis C while other drugs attack the hepatitis virus, whereas ACH-1625 directly treats hepatitis C with no need for compounding with other drugs. I feel that ACH-1625 would out-compete Promacta relatively easily and no reason to be wary of GlaxoSmithKline.

To sum up Achillion's stance on the market, it is too soon to be investing in ACH-1625. There is no current upside to raise share price substantially for at least the next year while the trials carry on. Considering Johnson & Johnson's position currently mirrors that of Achillion, it would be smart to let the research data of both company's respective drugs decide which is going to be the best bet in 2013. Lastly, I believe ACH-1625 will beat out GlaxoSmithKline's Promacta if it becomes FDA approved, so expect little competition on the market from GlaxoSmithKline.

Hepatitis C: Drugmakers jockey to create cocktail...

Bloomberg News article published in the San Francisco Chronicle on 2/15/2012 on the recent M&As and speculation on the M&As to come. Very nice overview if you're new to the HCV drug development space and have a hankerin' to learn who the big players are.


Hepatitis C: Drugmakers jockey to create cocktail


Bloomberg News
Wednesday, February 15, 2012

A developing medical theory that hepatitis C can be overcome with the same type of drug cocktails that tamed HIV is shaking up the pharmaceutical industry.

Companies are trying to anticipate which medicines might work best together and planning their acquisition strategies accordingly. Because only a few hepatitis C drugs are approved, and others in testing may not pan out, "we don't know what the winning formula will be," said Ben Weintraub, an analyst at Wolters Kluwer InThought. To raise the odds, "companies are doing M&A (mergers and aquisitions) and starting new trials on almost a daily basis."

With more than two dozen drugs in development, doctors predict a new age of therapy for a blood-borne virus carried by 170 million people that now has few treatment options. The promise of a potential $20 billion market has already spurred three deals in the past year - the latest being Bristol-Myers Squibb's $2.5 billion purchase this month of Inhibitex.
Next in line may be Idenix Pharmaceuticals and Achillion Pharmaceuticals, said Raghuram Selvaraju, an analyst with Morgan Joseph TriArtisan.

"I don't think either of these companies will remain independent very long," Selvaraju said. "I think we'll see both of them out of there by the end of the year."

Increased urgency
Achillion is testing a so-called protease inhibitor, while Idenix is developing a nucleotide polymerase inhibitor. The two medicines, which work differently to block the virus' ability to replicate in the body, are in the second of three stages of testing normally required for U.S. approval.

By combining several classes of these new hepatitis C drugs, doctors may be able to limit the virus' ability to infect, mimicking the strategy that a decade earlier helped turn HIV from a killer disease to a controlled one, said Charles Chiu, an infectious disease doctor at UCSF.

With the success of treatments that "work on the virus itself, there's an increased urgency now to explore drugs in many different stages of the viral life cycle," Chui said.

Until last year's introduction of Victrelis from Merck and Incivek by Vertex Pharmaceuticals - two protease inhibitors - the standard treatment combined the antiviral drug ribavirin with interferon, an immune-boosting protein sold by Merck as PegIntron and by Roche as Pegasys.

That treatment relied on interferon shots given weekly for a year, and it cured only about half of patients with the most common U.S. strain, called genotype 1. The drugs also caused side effects that include fatigue and flu-like symptoms.

Across different types
The new protease inhibitors stop an enzyme that splits proteins and allows them to replicate. While they've been shown to cure more patients in less time than previous therapies, with fewer side effects, they still need to be combined with interferon shots.

Scientists see promise in the other class being developed, the nucleotide polymerase inhibitors, which bind to a different part of the virus than the protease inhibitors. These drugs are pan-genotypic - meaning they are effective across the different types of hepatitis C. They could become the backbone for an interferon-free combination.

Mixing the classes together may be even more effective in beating the disease, which is blamed for more than 350,000 deaths a year worldwide.

"We waited 15 years for protease inhibitors, and a year later we could have a new class of drugs, nucleotides, that surpass them," said Steve Worland, former CEO of Anadys Pharmaceuticals, an experimental hepatitis C drugmaker acquired by Roche in November for about $230 million. "That kind of dramatic change I have never seen before."

Drugmakers want to own a piece of the eventual cocktail that will work best among patients worldwide. They've been working in the lab to create their own drugs, as well as scouting other companies with an eye toward buying promising candidates.

Takeover targets
Foster City's Gilead Sciences paid $10.8 billion for Pharmasset last month to use its experimental nucleotide drug, PSI-7977, as a cornerstone to a new hepatitis C combination - one that it expects other drugmakers will want to use - opening the door to added licensing revenue.

Selvaraju said: "7977 is going to be the driver of an all-oral regimen, and all of these other drugs are going to be layered on top of it."

Rivals have the same idea as they hunt for potential targets. That's why Achillion and Idenix are being closely watched as potential takeover targets, Selvaraju said. Abbott Laboratories and Roche are potential bidders, he said. Merck, Bristol-Myers and Johnson & Johnson are also in pursuit of the new regimens.

The potential market size for these therapies is at least $20 billion, according to Michael Kishbauch, CEO of Achillion.

Competition grows
Gilead increased its offer to acquire Pharmasset four times last year to $137 per share from $100 per share, after a clinical trial showed PSI-7977 cured all patients in a study.

"The opportunity to be able to cure people with three months of therapy is one of the most amazing breakthroughs we can bring to health care - and there's a lot of competition," Gilead CEO John Martin said last month.

Idenix is in talks to find a partner to create a combination hepatitis C treatment, said Ron Renaud, the company's CEO. While declining to comment on whether the company may be acquired, he said interest in hepatitis C drugs picked up last year during a liver disease conference.

"There is a tremendous market opportunity here that people want to take advantage of, and there's an intense race that's under way to get to that point," Renaud said.

http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/02/15/BUDC1N7L0U.DTL
his article appeared on page D - 1 of the San Francisco Chronicle