Paul Pockros, a hematologist at the Scripps Clinic in La Jolla, also emphasized that HCV drugs need to demonstrate continued efficacy with lower treatment times in harder-to-treat patients in order to qualify for regulatory approval. He said: “The FDA really doesn’t want to accept any relapse at all.”
Achillion understands this issue. It now plans to conduct a study of its HCV treatment in harder-to-treat patient groups, including those affected by advanced fibrosis, according to company spokesman Glenn Schulman. He said: “Next-generation regimens, including ours, will have to simplify and shorten treatment duration across broad patient populations.”
SPARTA Phase 2 program which evaluated 6 weeks durations with once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients. Meaning sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 is already evaluated for 4 weeks regimen, and data shall be anytime soon.
Johnson & Johnson obviously has a global sales force that could get ramped up and could drive sales for this drug, and actually make a go of it against Gilead. There's a lot that needs to happen between here and there.
Specifically you've got a situation where Johnson & Johnson has now licensed global rights to Achillion HCV, Hep-C pipeline. That pipeline includes ACH3102, and ACH3102 is a next generation, S5A inhibitor. Basically it targets the same target that Ledipasvir does in Gilead's top selling Harvoni -- which is a mashup of that Ledipasvir and Sovaldi.
So, the idea is "Can we come up with a better combination that would deliver similar efficacy, but do it in a shorter treatment duration?" In very small trials, they've been able to effectively cure patients in both six weeks and eight weeks by combining ACH3102 and Sovaldi. That has gotten people's attention.
It's like, if J&J license 3102 -- which it has -- and then it can take that and combine it with -- it acquired some drugs that worked similarly to the way Sovaldi does, last fall when it bought Alios and got their nuke pipeline -- So, they can combine it with that, then possibly they can come up with a pan genotype drug that would outperform, or equally perform with Harvoni, but require patients to take it for less time.
FDA rescinds 'breakthrough' status for Merck's hepatitis C drug meaning something seriously wrong and that was a the rare move by the FDA follows the market debut of two new hepatitis C treatments in the last year.
HCV is a global epidemic associated with burdensome complications. Research suggests that the treatment paradigm for HCV will evolve from the current interferon-based therapies to interferon-free combination treatments that deliver high cure rates for a majority of HCV patients, minimal side effects, shortened treatment durations of 12 weeks or less, and a competitive cost. Due to the widespread infection of HCV and demand for these improved therapies, multiple estimates forecast the global market for HCV treatment will reach $20 billion annually by the end of the decade. The market is projected to persist through 2030 due to the low rates of HCV diagnosis globally, which will require intensive screening and linkage to care efforts during the initial introduction of interferon-free treatments, and the large number of patients requiring care from a limited number of specialty physicians.
Mackenzie Financial starts a new position in Newmont Mining
In the first quarter of 2015, around 65 hedge funds created new positions in Newmont Mining (NEM) and over 160 hedge funds added to their positions in NEM, including Vanguard Group. Gold price fluctuation affects gold mining stocks like Newmont Mining (NEM), Kinross Gold (KGC), Barrick Gold (ABX), and Primero Mining (PPP). These stocks account for 20.4% of the Market Vectors Gold Miners ETF (GDX).
Listen Basher ! How much Short R U? Get your pants up as SEC filling underway. More details of the deal is in the filling. From face value of this collaboration even $20 is not enough as GILD enjoying $12.5Billions in this Market which JNJ+ACHN can dominate with Triplet nuke short term treatment.
JNJ ...Zytiga is the example when DNDN was ruling the Prostate Cancer Market like GILD today. By the way you know probably that DNDN was darling of WallStreet which now bankrupted.
ACHN - JNJ collaborations ...Analyst downgrade ! All nonsense.
If JNJ invest $225Millions in ACHN for further research, Approval process, Manufacturing and Marketing is it not a good thing? ...Can ACHN do it alone? Even if ACHN does that how much it cost?
Yes granting equity for long term.... Nothing wrong in it for present share holders!
At the end of the day what ACHN want is get the product into Mkt with help of Strong Pharma and earn royalties. That definately pinch GILD and ABBV.
Wrong! as somebody said, $12 quite possible as the agreement and Factor-D Inhibitors is another huge potential in Billions and coming very soon to compete with ALXN monopoly. Alexion Pharma planning to Pay $8.4 Billion for Synageva BioPharma ...but who knows ACHN is better option!
Janssen & Achillion Enter Into A Definitive Agreement
Johnson & Johnson
It seems as though the reason for the missed engagement for an entirely different reason. Janssen Pharmaceuticals, Inc. one of the subsidiary companies of Johnson & Johnson (NYSE:JNJ) made a big announcement today. Janssen Pharmaceuticals and Achillion Pharmaceuticals have entered into an exclusive worldwide license and collaboration agreement. Janssen will be in charge of the development and commercialization of Achillion’s lead hepatitis C virus assets including ACH-3102, ACH 3422 and sovaprevir. So essentially, Janssen Pharmaceuticals and Achillion Pharmaceuticals will be working together to develop and commercialize HCV treatments.
As a result of the agreement, Johnson & Johnson Innovation will invest $225 million into ACHN; receiving 18.4 million newly issued and unregistered shares of Ahillion at a price per share of $12.25.
How The Market Reacted To The News
The news was released yesterday after hours, and it seems as though ACHN investors aren’t too happy with what they’re seeing. So far today, the stock has given up all of the gains we’ve seen since Monday. The simple fact is that it seems as though investors were looking for an Acquisition, not a collaboration. Currently (12:01), ACHN is trading at $9.18 per share after a loss of 14.04% so far today.
What We Can Expect To See Moving Forward
Moving forward, I’m expecting to see overwhelmingly positive news from Achillion Pharmaceuticals stock. Now, there’s no doubt that investors didn’t seem to get what they wanted. However, Johnson & Johnson is a huge company; the type of company that several experts have been saying that Achillion will need to pair with in order to be successful in the HCV market. The reality is…that pairing is now a reality. I can see why investors could be a bit upset about the 18.4 million new shares that will be issued; however, in the long run, I expect this to be an overwhelmingly positive thing. It is important however, to keep in mind that when it comes to biotech in general, we tend to see quite a bit of volatility. Considering that ACHN is a small cap, volatility is all, but guaranteed. Nonetheless, if you’re not concerned with short-term price volatility, ACHN may be presenting quite the buying opportunity at the moment.
As always additional issues shares are issued according to present Mkt value and JNJ agrees to Buy equity investment with18Million additional shares at $12.25, however the real value exceeds $18 per shares today also. Now with given fact that JNJ will rule the HCV market and ACHN the shares are going well above $30 moment the results will be announced buying today ACHN would be the Rockbottom.