Replies to post #160394 on Biotech Values

[oc631]

GILD’s GT3 issue, which the whole world seems willing to overlook, surfaces in this Bloomberg piece on the phase-2 study of Sofosbuvir + Daclatasvir in treatment-experienced patients:

Nice find Dew. The story with Daclatasvir should take a backseat to the more heinous issue of GILD delaying advancement of the interferon-based option for GT3 patients.

Has anyone seen preliminary results from the 2+ year old Sofo/PegRiba study in GT3 treatment-naive patients? Does anyone understand the reasons for the delay? Please post if I'm missing something.

Using Sofo/PegRiba as a comparator, as opposed to the 30-year old GT3 SOC (PegRiba), would put the weak Sofo/Riba combo further into jeopardy. GILD has such a commanding lead in GT3 oral treatment that it's shameful the company doesn't take the time to put together a more viable GT3 oral treatment option. This is about money, not patients.

[oc631]

GILD’s GT3 issue, which the whole world seems willing to overlook, surfaces in this Bloomberg piece on the phase-2 study of Sofosbuvir + Daclatasvir in treatment-experienced patients:

Question Dew: Could failure to achieve GT3 labeling for Sofo/Riba, within the pooled data filing, delay approval for GT2 patients? Is it possible GILD would be required to refile the Sofo/Riba NDA for GT2?

[biocqr]

Shunned Gilead/Bristol-Myers hep C combo may be too good for docs to ignore
April 28, 2013 | By John Carroll


What if you had a great combination of rival drugs that worked in 100% of patients, but one of the companies involved refused to participate in the trials needed for an approval? If you're Gilead ($GILD), the answer is to continue to ignore compelling data, shun the competitor drug and stay focused on an in-house combo that could deliver a big segment of the market. But some patients and doctors appear willing to consider taking matters into their own hands.

Over the weekend investigators went over the numbers for sofosbuvir and daclatasvir, which demonstrated that after 12 weeks the combo cleared 100% of the virus among 40 patients who had already failed the two leading therapies, Incivek and Victrelis. That's the toughest group of patients to target. And there was solid proof that the combination worked among patients in the genotype 3 group, a sizable minority of the market in key regions of the world.

Gilead's sofosbuvir is the $11 billion jewel the biotech acquired with the Pharmasset buyout. But after finding that it worked to perfection in combination with competitor Bristol-Myers' ($BMY) great hep C hope, daclatasvir, Gilead determined that its best market opportunity lay with its own in-house combination with ledipasvir (GS-5885). Investigators like Graham Cooke at Imperial College London say that sofosbuvir/ledipasvir looks like a clear winner in the large genotype 1 population, but G3 patients may be missing out on sofosbuvir/daclatasvir.

"We probably have a better option for G3 that we could be using if the companies were cooperating," Cooke told Bloomberg. "Daclatasvir and sofosbuvir looks much better but Gilead very clearly wants to develop in-house."

Both daclatasvir, now combined in a number of clinical studies with outside drugs, and sofosbuvir appear headed for approvals. That opens the door to an off-label combo. Provided patients could afford it, payers would cover it and doctors can be satisfied that it's safe without a pivotal Phase III study.

"Lots of investigators around Europe and the U.S. are itching for the opportunity to put together what they believe to be the optimum combination for our patients," Mark Thursz, the secretary-general of the European Liver Society, told Bloomberg. "The only barrier to that is what is the combination cost going to be because I suspect there will be package deals to be had."

Gilead officials did not respond to a query from FierceBiotech Sunday. The big biotech has been diversifying in recent years, adding a big new focus on cancer drugs and hep C. But it made its fortune on HIV and developed a rhino-thick hide in the process after enduring years of complaints about the high cost of keeping patients alive. It's unlikely to change its mind just because a few experts in the field believe that patients are coming in second, behind Gilead's primary business plan.

http://www.fiercebiotech.com/story/docs-may-find-stellar-gileadbristol-myers-hep-c-combo-too-good-ignore/2013-04-28#ixzz2RxwtG8uU

[oc631]

From the Bloomberg article mentioning off-label Sofosbuvir/Daclatasvir use in GT3 patients

"Prescribing the two drugs as an off-label combination [GT3] may be too expensive because they’ll probably have high prices as individual therapies whereas Gilead’s cocktail may be cheaper, he said."

What needs to be taken into consideration is the cost of GT3 retreatment. In the real world setting up to 40% of GT3 patients will fail Sofo/Riba therapy. There is no competition for follow-up oral GT3 therapy at this point in time. Just GILD.


In a system based on rewarding individual accomplishments. GILD stands to profit twice from every GT3 patient that fails first-line therapy.