On 22 May, European Patent court at the Hague overturned Benitec’s cardinal DNA-directed RNA patent for the European Union. Benitec will hereafter have to pay to use Mick Graham’s work in the EU, and there will not get exclusive rights to it.
It would be difficult to convey concisely how disappointing and bad this is for Benitec shareholders, especially in view of other events taking place. This event is very counter to guidance previously given by Benitec management, who have stated that Benitec’s global patent estate was secure. Since the full legal background for this challenge is not known (the company never even admitted it existed), the full impact cannot be known. It may augur other challenges.
Benitec snubbed, thumbed its nose, at all its ample American shareholders yesterday. This event happened during American business hours, and was known to Benitec management on hand in the Netherlands, but no American announcement was made. It seems that Peter French was quite content to let American investors dangle on this one. No empathy, no concern.
Despite Peter French’s claims in a recent set of radio-aired comments about Benitec in Australia, the perennial and absurdist delay in dosing for the TT-034 trial at Duke University Medical Center (which French keeps ignominiously referring to as “Duke Medical”….groan) is NOT because of the FDA. Management in fact has been positively flimflammy about this. Carl Stubbings has claimed to many in telephone comments that “It’s not us, it’s Duke Medical!” Stubbings cannot keep his stories straight. And he has stopped replying to emails. Poor Carl. Must be hard remembering what to tell whom, what line of hooey works for which kind of shareholder. The trial opened on 14 January. It is now 23 May. HCV is a pressing disease. Yet Benitec cannot be troubled to allow anyone to get its drug.
In fact it is neither the FDA nor is it Duke. It is Benitec, pure and simple. The protocol has in it one obscene and asinine exclusion criterion: patients with body mass index of 30 or above are not “eligible.” And so three dozen perfectly good candidates at Duke have been turned down…by Benitec. With the stroke of a pen, with a 2-line memo, Benitec could waive this. It does not because somehow it does not want this trial to proceed. It wants to obfuscate, blame others. It is trying to get the San Diego site up and going because Duke has in all probability told Benitec it is being coquettishly ridiculous. Duke is not paid for screen failures, but only for enrolled patients.And no one has been enrolled. The TT-034 trial, which Benitec would have you believe is of a magic bullet for HCV, has been open for more than 4 months and Benitec’s great wonderful drug is so ruthlessly exclusionary that NO ONE is suited to receive it! No fertile females…oh no! And no one with BMI 30 or over. There is no firm theoretical reason a person with BMI 30 cannot get this drug. Insulin resistance and fatty liver disease do not begin suddenly at BMI 30. This is a line in the sand Benitec drew, and one it will not waver on, even if the whole world is kept waiting and the investments of all go to nil. It is artificial. It is a ruse for something else. Benitec for some reason does not want to see this trial happen, perhaps because as long as it doesn’t happen, they can sell investors on hope and hype. Once it happens, there will be data. The data could show this effective. Or the data could show TT-034 is worthless.
Even if Benitec dosed tomorrow, at this pace, ocean height will have risen 20 feet by the time the company gets this trial done.
Benitec is consummately failing to launch, failing to keep promises, failing to deliver, and making excuses, increasingly not credible, for why. It has cardinally misled investors about its patent position. It is spraying squid ink for why TT-034 is not dosing.
Do not buy Benitec here. Consider selling. No reason to reward those trying to lead you right over a cliff.
Time for a new CEO ?? Where is the fiduciary responsibility ??
Nice article …..
Let’s not throw the baby out with the bath water……..I hope?
PF needs to get his shit together now and get a patient dosed.
Doc, you have guided us all in no uncertain terms about your baby, your darling precious Benitec. Let’s try to save them first. I beg of you.
Otherwise, was Dirk right all along in that he said to paraphrase – they have a lab, they have a tech, but they have no patient dosed?
Even if management does not provide any further update one thing is for sure, that is we can no longer claim to be a one-stop-shop for ddRNAi IP unless we lodge an appeal and win.
Nice work Dr… continued systemic failures of Benitec’s Leadership has been re-occurring theme for some time now! Will they ever learn from their mistakes and behave like professionals rather than amateurs?
Is this really the same Dr KSS who posted just a few short weeks ago extolling the virtues of Benitec? If you want a more up to date version of ‘the truth’ suggest you read Hoyland et al on Australia’s Hot Copper
http://hotcopper.com.au/post_threadview.asp?fid=309&tid=2257870&msgno=46064#46064
Dr KSS. For once I have to say you are out of line mate. Annoyed, frustrated, angry…I understand…but please don’t bend the facts.
-RS
I find it interesting that blue chip investors still invested in Benitec despite your delay in dosing rant.
I like how Hoyland on Hotcopper reveals that BMI restrictions are in place due to dosing amounts being limited by BMI, coupled with limited supply for the trial.
I doubt your rant and delay is reLly going to matter when they dose and it DOES work.
Angry, yes. Irrationally impetuous, most truly.
I am long bnikf.
Dr KSS,
You are right. Management must have answers of your questions.
Many of us have invested our hard earned money in Benitec, dreaming that one day I will be rich or retirement will be easy!
Some of them wanted to be witness and a part of revolution which is coming. We all are happy but ..
Is has been so long around 4 months when FDA allowed them to start Dosing. Till now they did not get any patient … ?
That is a big question we all wanted to know answer, because it is frustrating and show picture of management which is either not responsible or lying.
Here is how things work.
Company have to setup guidelines and FDA have to approved and then FDA monitor company’s guidelines and rules.
Now those Inclusion Criteria and Exclusion Criteria which have been setup by Benitec are so hard to match. It has become super hard to get bunch of people and dose them.
Peter French is saying its FDA and Duke we have no control and DUKE is saying its company….
FDA will not change those steps so easily until CEO and his management approach and request them. Where are they ???
Bneitec already knows ddRNAi works in human, Calimmune have already validated it. It works! It works!
http://clinicaltrials.gov/ says –
This is a first-time use of a method of therapy designed to transfer anti-HCV genetic sequences into the hepatocytes of subjects infected with HCV. The anti-HCV sequences will be comprised of three different short hairpin RNAs (shRNA) that have the ability to directly cleave the RNA genome of HCV by a process known as RNA interference. The transfer of the anti-HCV sequences will be accomplished using a “vector” that was made from an adenovirus-associated virus (AAV) by removing the viral genes and replacing them with a non-replicating genetic sequence that produces three different shRNA that target three different regions within the HCV genes.
This type of vector has been used in other clinical trials in order to transduce the hepatocytes of subjects who suffer from hemophilia.
Here is Inclusion Criteria and Exclusion Criteria –
Inclusion Criteria:
Subjects must a history of chronic HCV infection defined as documented HCV genotype 1 infection for at least 6 months.
Subjects must have:
Documented failure to respond to prior treatment or relapse with a combination of peg-interferon (peg-IFN), ribavirin (RBV), and either boceprevir or telaprevir, OR a combination of peg-IFN and ribavirin or
Subject is ineligible or unwilling to receive a combination of peg-IFN, RBV, and either boceprevir or telaprevir.
Female subjects have to be of non-childbearing potential, defined as meeting any of the following criteria:
Female subjects over the age 60.
Female subjects aged 45-60 years old must be amenorrhoeic for at least 2 years and must have serum follicle stimulating hormone (FSH) levels > 30 IU/L.
Female subjects with hysterectomy or bilateral oophorectomy. All female subjects must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
Male subjects and their partners must be willing to comply with the following requirements to use 2 methods of effective contraception: Male subjects with a vasectomy must use a condom. Without a vasectomy, male subjects must use a condom. The female must be sterile or willing to use an additional form of contraception.
Baseline HCV RNA level of > 100,000 IU/mL and:
No evidence of cirrhosis at Screening
At least 3 months since prior therapy for HCV
A willingness to enroll in a 5 year follow-up safety study
Exclusion Criteria:
Body mass index 30
Female subjects of childbearing potential (including females with tubal ligation) or women who are pregnant or nursing
Male subjects who are unwilling to provide the required semen samples
Presence of nAb levels to AAV8 that abrogate AAV8 transduction
Severe Liver disease
Hepatocellular carcinoma (HCC) or suspicion of HCC
Coronary artery disease
Platelet count of 465 ms at Screening
Chronic hepatic diseases
Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurologic, or allergic diseases.
Evidence of autoimmune disease or pre-existing autoimmune or antibody-mediated diseases
Use of immunosuppressive medications within 6 months before the entry into this study, except for inhaled or topical corticosteroids
Now if they are not dosing it means what ??? Is it going to take extra 6 month to find few patient ?
Do you want to see Benitec as QRXPY which vaporized investors money in a few hrs.
Now CEO is looking for Job!!
We all don’t want like that and want to see some real progress in reasonable time period.
We all believe in science and RNAi henceforth invested our hard earned money, didn’t you ?
Now if Dr, KSS asking question from management what is wrong in that ?