Friday, October 04, 2019 3:57:09 PM
MRK's anti-cancer drug Keytruda will become the best selling drug in the
world with expected revenues of $22.2 billion in 2025. Guess how many
clinical trials around the world are using Keytruda? A. Over 1,000!
MRK has a market cap greater than that of PFE. Vascepa should be a
medication that should have 100's of trials around the world. That
is what BP is good at when they have a winning drug. They have the
expertise to run 100's of trials in order to get their drug to the
next level. I sure would love to see Vascepa tested along with most
any cancer drug...I would bet most cancer patients would fare better
having Vascepa as part of their cancer therapy than they would without
it. Imagine if a company like MRK were to test Vascepa alongside
with Keytruda.[courtesy couldbebetter]
Recall MRK's statin, Zocor
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Another view: PFE is the acquirer:
Executive Summary of AMRN CEO Interview
"We're planning for success," John Thero told Scrip in an interview, where he talked about the upcoming US advisory committee[11/14/2019] meeting for Vascepa, commercial expansion plans and deflected questions about a big pharma buyout.
As a single-product company with a potential cardiovascular blockbuster on its hands, Amarin has been considered a potential takeout target by a big pharma. But a huge $460m financing raise in July, which will be used to build out a big commercial structure, has raised some questions about whether a buyout will materialize.
The company's current cash balance stands at more than $600m, a dramatic change from previous years.
"I can't speak for big pharma. What we can focus in on is creating value, and we think we are doing that with our execution," Thero said of a potential acquisition. "Any company that grows, and grows considerably, is often in the spotlight."
He also pointed to the commercial opportunity for Vascepa outside the US and opportunities to build out the company's portfolio through a commercialization agreement. Amarin is frequently approached for co-promotion opportunities he said.
"There is no greater opportunity that I'm aware of right now that we could be working on than being successful with Vascepa, and we've got to get that right," he added.
To that end, the company is building out its sales force from 135 reps to 800, which it hopes to be fully operational in time for the launch at the end of December.
With 135 reps, Amarin was calling on about 20,000 physicians, but with 800 reps the target physician group will jump to 70,000 to 80,000. Those physicians write about half of all statin prescriptions, the company said.
There will also be a big direct-to-consumer marketing initiative, including advertising which will be phased in after the approval.
But for now, there's a lot riding on a successful showing before the review panel in November.
On The Issue Of Mineral Oil As Placebo
Amarin is anticipating the FDA ad comm topics for discussion will be broad, ranging from the unmet medical need to the REDUCE-IT trial design, and the efficacy and safety of Vascepa. As for one potential issue some investors have flagged – the use of mineral oil as placebo and corresponding increases in LDL-C in some of those patients – Thero downplayed the issue as a red flag.
"FDA helped us pick the placebo for this," he said. "I think anytime you have a result that is first of a kind, people end up asking questions about it and they for how do we explain this result, and I think most people that have looked have realized that the multi-factorial effect of Vascepa that goes well beyond a triglyceride reduction is the explanation."
The one worry in the back of his mind, he said, is the unknown. "I get paid to worry," he said. "I'm going into it thinking about this as an opportunity."
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If there is to be a TO/BO, PFE seems a logical choice:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151495163
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151493052
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