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Industry analyst says carfilzomib (Kyprolis) will be approved by FDA

Home/News, Research/Industry analyst says carfilzomib (Kyprolis) will be approved by FDA

Industry analyst says carfilzomib (Kyprolis) will be approved by FDA

Shortly after I was diagnosed and started covering multiple myeloma news, I also started blogging about it.

Early-on, I included a lot of myeloma business related news.  My reasoning was this:  The pharmaceutical industry plays an inescapable role in our lives as patients when we are dependent on taking one or more anti-myeloma agents practically non-stop from diagnosis to grave.

However, one of the PR consultants for the IMF pulled-me-aside early-on and cautioned me about reporting or blogging about business related news.  Since the things people write about companies can affect stock prices, he felt the responsibility was too big–and it was best to avoid the topic altogether.

In the four years since, I haven’t always followed his advice.  But I have toned things down a bit, keeping my reporting about stock related issues to a minimum.

I do include a lot of drug company features on my MyelomaNews.com site.  But I don’t editorialize much there.  I’m merely passing-along links to press releases and articles I think might interest fellow patients and caregivers that are really interested in the hows and whys of myeloma research and drug development.

Anyway, one thing that I’ve learned is that rules and guidelines are meant to be broken.   Let me explain.

Whenever I attend an oncology meeting or conference, I try and strike-up conversations with as many fellow attendees and journalists as possible.  You can learn a lot that way!

I have found that Pharmaceutical stock analists are among the most knowledgeable of anyone who knows the industry.  And that makes sense.  It’s their job to help keep clients and newsletter readers informed.  After all, there can be a lot of money on the line.

I have met PhD s, physicians and nurses who do this type of work, and they always seem very bright.

Let’s jump ahead.  I haven’t written about it, but I have heard rumors that Onyx, the company developing carfilzomib (trade name Kyprolis), may be running out of money as they wait impatiently for the FDA to approve their number one drug.

SEE!  This is exactly the kind of thing I was advised not to write!  I have also heard rumors that there have been glitches with carfilzomib’s safety data–and that’s why the drug’s first attempt at FDA approval stalled last winter.

None of this is verified.  Neither is the fact several oncologists I have spoken with feel that carfilzomib is going to be a game changer.  Just as the negative rumors I shared previously are probably overblown, calling carfilzomib a “game changer” may be overly optimistic.  A promising drug and another useful tool in a myeloma specialist’s toolbox?  YES!  A game changer?  Probably not.  These are all just opinions from people in and around the industry.

But, that isn’t the story.  This is:

Onyx rises on analyst view of blood cancer drug

AP/Bloomberg Businessweek

Onyx Pharmaceuticals Inc. shares rose Thursday after a Bernstein Research analyst started covering the stock with an “Outperform” rating, saying he thinks the company’s blood cancer drug candidate will reach $1 billion in annual sales by 2016.

THE SPARK: Analyst Geoffrey Porges said he thinks that the drug, Kyprolis, will win broad marketing approval from regulators in 2014. He said sales could reach $2 billion annually by 2020.

THE BIG PICTURE: The South San Francisco, Calif., company’s annual revenue in 2011 was $477.2 million, so that would be a big increase. Onyx sells a liver and kidney cancer drug, Nexavar, through a partnership with German drugmaker Bayer AG.

Kyprolis, or carfilzomib, is an experimental treatment for multiple myeloma, a type of cancer that affects plasma cells in bone marrow. In November, Onyx asked the Food and Drug Administration to approve the drug for multiple myeloma patients who have gone through several other treatments. The FDA is scheduled to make a decision on that application in July. Onyx is conducting additional trials to win further approvals of the drug…

Here is the LINK back to the article if you would like to read more.

But this is what interests me.  I don’t know Mr. Porges.  But I did a little research and learned that he is a former Vice President of Marketing at Merck, and is currently a Senior Analyst, Global Biotechnology, so the guy should know his stuff.  And I hope that he knows what he’s doing, because his opinion just lifted the Onyx stock price up!

And he has also lifted my hopes as a myeloma patient.  Because like I wrote previously, the medical money guys who follow this stuff tend to be bright and know what they’re looking for.

Geoffrey Porges  may have merely examined things superficially and noticed that whether the FDA approves carfilzomib this summer or sometime later down the line, carfilzomib will likely make Onyx a lot of money.  But more likely, the guy has talked with a lot of industry contacts and determined that carfilzomib trial data is looking good and can be expected to help push the FDA to approve Kyprolis.

I’m betting on the latter.  This could be one of the more interesting story-lines at ASCO in Chicago next week, as analysts and medical reporters speculate about carfilzomib’s future–and whether the FDA will approve it’s use for relapsed/refractory multiple myeloma patients in July.

Sounds like a great topic for a new post!  Maybe I should come-up with a list of other intriguing story-lines before I leave for Chicago on Thursday.  Stay tuned!

Feel good and keep smiling!  Pat