The Big Red Biotech Blog

Top 10 Companies for New Drug Approvals Over Past 10 Years

Fierce Biotech via Mathew Herper's column in Forbes, reports that J&J had the most drug approvals in the 10 year period ending in 2012. This is one measure of R&D pipeline success (personally I'd like to see the amount of revenue generated from these drugs as the lead measure). Regardless, here's the score:

• Johnson & Johnson 13 approvals
• Pfizer + Wyeth  13
• Merck + Schering Plough 12
• Roche + Genentech 12
• GlaxoSmithkline 11
• Sanofi + Genzyme 11
• Novartis 10
• Bristol-Myers Squibb 9
• Amgen 5
• Bayer 5

I'm representing the ranking slightly differently than either the Forbes or Fierce Biotech article as I've combined the production of companies that have themselves combined through M&A activity.  This makes a large difference for companies like Pfizer, Sanofi and Roche.

Posted by Bruce Lehr Apr 16th 2013.

 

Roche's T-DM1 Crosses Finish Line as Kadcyla

The second ADC in the past year has crossed the finish line to be approved by the FDA.  This time it is Roche's (Genentech) Kadcyla to be used in the treatment of HER2 positive breast cancers.  The drug has performed in clinicals -- despite missing out on accelerated approval -- as it was widely expeced to be approved this time around.

"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, Roche's chief medical officer and head of global product development

Unfortunately, it is priced at $9800 per month per patient and is expected to cost about $94,000 for a single course of treatment -- about double its predeccessor (non-ADC) Herceptin alone.  While I am excited to see ADCs make it to market --- and to be successful clinically.  I do worry about pricing models that have most new biological drugs -- particularly in oncology areas --- costing a minimum of 6 figures per patient course. 

It is the type of thing that does not seem sustainable in the current world fiscal and economic crisis.  See reports from Fierce Biotech and Xconomy for more on the medicine and FDA approval.

On a happier economic note, Genetech (no doubt boosted by successes like Kadcyla) announced that it will be adding 600 new staff in the US.  Just to put that into perspective, 600 staffers would easily handle the work of more than 30 average biotechs in pursuit of their first drug approval.  Genentech says it prefers to promote from within, making a number of these new hires replacements for upward bound employees. And they pay well, with many of these positions tied to starting salaries that range from $70,000 to $80,000 a year.  At least this company is hiring for more success as it experiences new successes. Huzzah!  See Fierce Biotech.

Posted by Bruce Lehr Feb 23rd 2013

 

PS - There is no truth to the rumor that Kadcyla battled Xalkori to a draw over Tokyo for control of that fine metropolis.    

New Drug Approvals in 2012

Here's a quick piece from CEN-Online that overviews and discusses the 39 new drug approvals by FDA in 2012.  The good news is that we have seen a 2 year trend now where more drugs have been approved than in the recent past.  This may say that changes being made to R&D departments throughout the industry are starting to have an effect but more than likely it is too early to make such a statement -- however at least the trend is "good". 

It does appear that the relationships between FDA and the drug companies have improved and there is better information sharing and collaboration.  A troubling trend has been developing though with pricing and this may be the next hurdle that needs to be addressed in the industry and among goverments and payers -- not to mention patients and physicians.

Posted by Bruce Lehr February 13th 2013

 

FDA's Sprinter Pathway to Possible Approval

The FDA's new "breakthrough" designation may allow drug makers to get their products through to commercialization after only performing enhanced Phase I trials -- of course they have to meet the criterion and actually show their product works.  No small task.  However, this could be a game changer in terms of shortening the path to market and gaining return on investment --- not to mention giving patients a shot at a new treatment much earlier.

Vertex has already expoited this pathway twice in gaining approval for its cystic fibrosis medication Kalydeco and in testing its cobination therapy VX-809.  A third drug also has breaktrhough status and 18 more applications are pending with FDA.  It seems the race is on -- and its a sprint.

This will no doubt have many backers with drug makers, patients, payers and investors.  It offers many potential benefits for novel treatments of diseases with unmet needs in particular.  We'll just have to see if the program lives up to its advertisements.  See Fierce Biotech.

Posted by Bruce Lehr Feb 13th 2013.

Actual Companion Diagnostics Sighting!

Xconomy published today on Qiagen's recent application to the FDA for the approval of a diagnostic test that looks at a mutation in the EGF receptor.  The test is useful in the diagnosis of the speed of disease spread in non-small cell lung cancers (NSCLC) -- 10 to 15 percent of Caucasions and 40 percent of Asians carry the mutation.  The test was developed in conjunction with Boehringer Ingelheim's cancer therapy, afatinib that targets the mutation -- and they've asked the FDA to approve both products simultaneously.

This type of "companion diagnostic" has long been talked about, particularly with cancers, as being advantageous to define the target patient population that will respond to the drug. This helps recruitment for clinical trials and to better ensure the drug will actually be effective in the trial. The proto-type for this concept is Roche's combination Herceptin and the HER2 positive breast cancer from the late 90's. But not much else has really reached the market since then.

With Qiagen's/BI's application, we expect to see a new surge in companion diagnostics-therapeutic combination being developed and brought forth. In fact, co-development of the therapy and the diagnostic is the major difference in these programs now compared to what may have been done in the past where a test was typically developed sometime well after the therapy was available.  The result is that the tests didn't work particularly well and only 1% of drugs in the US actually have a companion diagnostic -- most in cancer area.

That's changing as the FDA has encouraged this approach.  Qiagen says it now has 15 programs in progress -- including with not only BI -- but with big companies like Pfizer and AZ. Last year, Roche had a companion diagnostic it developed with its Zelboraf treatment for melanoma. Pfizer's Xalkori has a companion diagnostic developed by Abbott. Other drug-companion diagnostic programs in progress include the following companies:

• Synadex Pharmaceuticals and Ventana Medical with entinostat & NSCLC's 
• Seattle Genetics/Takeda and Ventana Medical with Adcetris & hopefully various cancers
• Qiagen and Bayer with tests therapies and tests for solid tumors
• Qiagen also has a similar deal with Pfizer
• Astellas Pharma and Roche with Tarceva and lung cancers

The industry and FDA are looking for more of these to be successful -- and would expect clinical trials to flow more smoothly and result in more approved drug applications. It remains to be seen if this will translate into reality -- though the promise is clearly there.

Posted by Bruce Lehr Jan 31st 2013.

 

Antisense Drug Gains FDA Approval

Isis Pharmaceuticals antisense drug, mipomersen (Kynamro), recieved FDA approval for the treatment of a rare familal hypercholesterolemia (say fast 3x).  The drug was developed in partnership with Genzyme (now part of Sanofi) and triggers a $25 M milestone payment to Isis.

This is the first time a drug of this type has been approved and Isis says that this validates its strategy and platform. Isis CEO, Stanley Crooke, said that the drug is "the culmination of two decades of work to create a new, more efficient drug technology platform."  Isis says its pipeline shows the validity of the antisense approach which can be applied to a variety of diseases -- including rare or orphan ones. See Xconomy.

Posted by Bruce Lehr Jan 30th 2013.

List of Last Year's New Drug Approvals

Here's the list of drugs approved last year by FDA courtesy of the Patent Docs blog.  It is always good to have a list someplace easy where you can find it.

Posted by Bruce Lehr Jan 23rd 2013

Breakthrough Therapy Designation

In the fifth renewal of PDUFA, section 902 authorized a 'Breakthrough Therapy Designation' to speed regulatory review and (potential) approval of drugs that offer "substantial improvement over existing therapies on 1 or more clinically significant endpoints such as substantial treatment effects observed early in clinical development". 

When a application is submitted, the agency has 60 days to grant 'breakthrough' status or not. If 'breakthrough status' is designated, then the applicant can collaborate closely with the FDA on trial design for the intended patient populations reflecting the most up to date thinking on design.  A quick approval provides potential huge benefits to not only target patient populations but to the company sponsor itself - it could have a tremendous impact on economic state of smaller companies. This could give shot to investors as well with a more predictable pathway and shorter timelines to commercialization.

Thus the door is opened to the FDA for another accelerated approval pathway. The agency is encouraging applications. Said Janet Woodcock, "...We're excited about it.  In fact, although the law is only a few months old, we're already putting it to use. Recently, we identified the first therapy (Vertex's Kalydeco for some CF patients) to this special designation. And it likely won't be long before we have more..."  See Xconomy.

Posted by Bruce Lehr Jan 15th 2013.

T-DM1: Four More Months! Four More Months!

Roche reported today that the FDA has granted it (and partner ImmunoGen) a priority review for its breast cancer drug T-DM1.  The decision is due by Feb 26th.  When approved, T-DM1 will be the second approved ADC on the market. The EMA also accepted Roche's marketing application for the key European market.  Phase III results for T-DM1 have been strong and the drug is considered to be a potential blockbuster by many analysts.  Peak sales volumes of $5B or greater have been projected upon its approval. See Fierce Biotech.

We only have 4 months (maximum) to wait.

Posted by Bruce Lehr Nov 7th 2012.

ADCs Clear Another Hurdle as Adcetris Gains EU Approval

Backers of ADCs have more good news coming from Europe today as the EU approves Adcetris for use in the treatment of relapsesed Hodgkin's and ALCL.  Millennium (Takeda) licensed rights to sell the product outside the US from its inventor Seattle Genetics and will now pay the latter a $25 M milestone.  SeaGen will also receive tiered double digit royalties on the sales of the product.

Thus ADCs continue their role as one of the hottest new technologies in the treatment of cancers. SeaGen has already generated nearly $150 M in sales in the US since the drug's approval earlier this year.  Many companies now have ADC programs in their pipelines and there are 10's of drugs in clinical trials. This is only expected to expand with Adcetris' success so far and the expected approval soon of Roche's T-DM1 for breast cancer. See Xconomy.

How Many New Drug Approvals by FDA in 2012?

Here is an analysis by Fitch Ratings projecting how many new drugs the FDA will approve in 2012.  Fitch creates its estimate by following the activities of Abbott, Amgen, AstraZeneca, Bayer, BMS, Eli Lilly, GSK, J&J, Merck, Pfizer, Roche, and Sanofi. 

The FDA Will Approve How Many New Drugs? // Pharmalot.

Their prediction for 2012 is that it won't match the 30 approvals seen in 2011.  Year to date, there have been 14 new approvals in 2012 versus 18 for the same period in 2011.  And, filings are down for the second half of 2012. So expect a down year compared to last says Fitch. 

So much for a reinvogorated pharma R&D model and pipeline -- at least using these numbers as "the evidence" as many commentators did in 2011.  On the other hand, Fitch's analysis also depends on the above companies being the representative market basket of filers -- if that mix starts to change radically then using it as the sole indicator will result in flawed projections. One could argue other firms could be included in the mix.

Posted by Bruce Lehr Jul 26th 2012.

 

FDA Approvals: ‘We Are Back On Track’

The FDA patted itself on the back for meeting its PDUFA review cycle targets (>90%) on New Drug Applications (NDAs) and Biologics License Applications (BLAs) for the past two years.

FDA Approvals: ‘We Are Back On Track’ // Pharmalot.

With PDUFA V just waiting to be signed by the President, the agency is supremely confident in its ability to keep the ball rolling.  Through June 18th this year, CDER has approved a higher percentage of NME applications (12/15) - one third of these for rare diseases continuing a strong trend.

The median approval time for NMEs and NBEs reached 9.9 months in 2011 slightly bettering 10 months in 2010 and beating the 13 months seen in 2009 and 2008.  Faster is better.

Posted by Bruce Lehr Jun 28th 2012

Quick Senate Passage Puts House Under Pressure to Act on FDA User Fee Legislation

The Senate passed the FDA Safety and Innovation Act (FDASIA) authorizing the collection of some $6.4 billion in user fees to fund FDA.  The pay day was enough to halt partisan bickering and bring Senate Democrats and Republicans together quickly. The legislation, approved just before Memorial Day, reauthorizes hefty user fees from drug and medical device companies, along with a host of new requirements that will govern FDA operations over the next five years.

PharmTech Talk » House Under Pressure to Act on FDA User Fee Legislation Following Speedy Senate Approval..

The House is now under pressure to pass their version of the Bill.  And, lo and behold, they did so today in overwhelming fashion. The bill includes a section to "fast-track" review of new drugs that potentially treat serious or life-threatening diseases that have no good alternatives.  The FDA will also be empowered to pull drugs from the market that have been fast-tracked but don't live up to after market review requirements. See Fierce Biotech.

The House and Senate versions now need to be reconciled, but the biopharma industry should be happy that their lobbying effort has paid off. The reconciled bill should be ready for a vote by October 1st. Then it will be up to the FDA to act.

Posted by Bruce Lehr May 31st 2012.

First mAb Submitted to EMA for Biosimilar Approval

A biosimilar version of Remicade (anti-TNF drug) is the first mAb to be submitted to the EMA for review.  Celltrion is believed to be the company making the submission, although this has not been formally revealed.  Celltrion has conducted clinical trials with its version of the drug in 19 countries over the past 2 years. There are 16 -- yes 16 -- approved indications for Remicade.  It is not known if Celltrion is seeking approval for only the RA indication (matching trials) or going for additional indications as well.  Extrapolation of safety and efficacy data from one indication to others is allowed potentially so it is a pertinent question.

First Monoclonal Antibody Submitted to EMA for Biosimilar Approval.

 The anti-TNF market is estimated to be worth $21 B. Analysts are torn as to whether a biosimilar version is a bigger threat to J&J's Remicade or whether a (humanized) biobetter version of the antibody will more likely prevail.  J&J has its own humanized replacment called Simponi. Celltrion is betting on gettig share however and is submitting its application well ahead of Remicade's 2014 patent expiration date. Celltrion will also go to Korea and other emerging markets in Asia and Central/South America where Remicade is not under patent.

Now, we all wait to see how Celltrion's application does at EMA.  More mAb biosimilar applications are expected to be submitted to EMA this year.  Whether these have a huge impact on the market, depends upon how easily they are approved and whether companies like Celltrion (or Samsung) can make good on their promise to drop prices by 40-50% over the reference product. The race has begun in earnest now.

Posted by Bruce Lehr May 2nd 2012.

Big News for Vertex and CF Patients

 

The FDA approved Vertex's second drug today when it ratified Kalydeco (ivacaftor) for sale to cystic fibrosis patients with the G551D mutation.  These patients represent about 4% of the US CF population or about 1200 patients.  There are another 1000 such patients in Europe.  Vertex is seeking approval in the EU by Qtr 3 in 2012.

FDA OKs Vertex Drug For Cystic Fibrosis; $294K/Yr // Pharmalot.

Kalydeco represents the first drug that actually corrects for the dysfunctional CF protein CFTR that results in disease for these patients.  Genetic tests will reveal which patients have the G551D mutation and therefore will be good candidates for the drug. In clincal trials, Kalydeco resulted in significant improvement to lung function, reduced side effects and improved quality of life. The drug will cost $294,000 per year per patient.  Analysts predict peak sales of Kalydeco of around $550 M annually. The drug also carries orphan status.

There is real excitement that this targeted therapy made it thorugh the FDA in 3 months -- a record.  This is also the 2nd personalized medicine drug in approved by the FDA over the past few days.  It shows the high-level agency interest in programs of this sort and their favorable disposition.

"Kalydeco is an excellent example of the promise of personalized medicine --- targeted drugs that treat patients with a specific genetic makeup," said FDA Commissioner Margaret Hamburg.

The drug was part of a 13 year development program with the CF Foundation, which spent almost $70 M towards development.  The CFF will now also benefit with this approval by collecting royalties that start in "high single digits" and could reach as high as 12 percent. A first and a win for this type of collaboration.  See Xconomy, Fierce Biotech, and PharmTech Talk.

 

Posted by Bruce Lehr Jan 31st 2012.

Genentech and Curis Gain FDA Approval for Drug to Treat Skin Cancer

Another biological oncology drug received approval from the FDA today.  This time it was Genentech and Curis' drug vismodegib (marketed as Erivedge) for the treatment of basal cell carcinoma, a common skin cancer.  They won the approval well ahead of the agency's decision deadline. And top regulators signaled that they would look kindly on other developers who take the same approach to targeted therapeutics.

The drug will be used to treat BCC patients who's cancers have spread after surgeries or other treatments. The median progression-free survival rate was 9.5 months. Erivedge is the first drug that targets the hedgehog signaling pathway that has been approved.  More are on the way. See Xconomy.

This is Curis' first approved drug. The company is now due a $10 M milestonepayment from Genentech upon the approval. Curis also stands to earn royalties on sales.  Curis investors spared no time in starting to cash in by selling their shares in brisk trading today.

Posted by Bruce Lehr Jan 30th 2012. 

FINALLY! Bydureon Gets Through FDA

The FDA posted its approval of Bydureon to its website today. It's official.  Amylin (and Alkermes) will be able to market its once-weekly injectable GLP-1 diabetes medication.  It will now move into a closely watched competition with Novo's Victoza (also a GLP-1 drug). 

Since the last delay at the FDA in October 2010, Amylin has broken up with its co-marketing partner Eli Lilly and will be on its own in marketing the drug.  Lilly received $250 M to dissolve the partnership and will get $150 M with the FDA approval. It will also receive a 15% royalty on sales until a $1.2 billion note has been satisfied. Analysts say that Amylin sales of Bydureon could reach a peak value of $1.8 billion annually by 2018. See Xconomy, Seeking Alpha and Pharmalot.

If at first you don't succeed, try try again.

Posted by Bruce Lehr Jan 27th 2012.

Do FDA Approvals Even Guarantee Success?

Much has been made about the welcomed increase in the number of FDA approved new drugs in 2011 -- up to 30 this year.  Time for a hip-hip-hurrah no doubt. See Fierce Biotech.

I'm not so sure though if you worked for Dendreon (Provenge) or Human Genome Sciences (Benlysta).  Both companies -- when the afterglow of approval waned -- experienced slower than forecasted sales.  The result was that Dendreon's stock price plummeted more than 60% overnight when its Q3 earnings were released. The Company was forced to layoff more than 500 (mostly manufacturing) employees shortly thereafter. See Pharmalot and Seeking Alpha.

Much the same story has occured with HGS.  It's sales have lagged -- only $25 million in Q4.  It's stock price has suffered.  It is now going to layoff more than 150 of its staff.  So much for the first lupus drug in 50 years showing a quick sales takeoff. See Fierce Biotech.

Analysts and investors still remain cautiously optimistic that both treatments will catch on -- but the jury is out -- and it shows that the FDA is NOT the only obstacle to filling the coffers with geld when it comes to new drug approvals. You still have to pass muster with the subscribers and reimbursement community too.

Posted by Bruce Lehr Jan 10th 2012.

2011 Final FDA Drug Approval Statistics

The FDA approvals for full year 2011 can now be formally tallied.  The agency did approve more drugs this year than it has for any of the past seven.  Some points include 30 new drugs approved, including many novel applications that were approved in the US first.  Both J&J and GSK each achieved 3 new approvals.

Analysts attribute the higher approval numbers to such things as pharma's improved data packages being submitted with drug applications, specifically with more safety data.  Pharma companies also appear to be picking better candidates that represent more novel treatments as drug they preferential push toward approval.

The agency for its part says it is trying to streamline the approval process -- a process that heretofore has been under heavy criticism by pharma company's, industry analysts and investment groups. It remains to be seen if 2012 will be as rosy -- but we can start 2012 optimistically can't we?  See Fierce Biotech.

Posted by Bruce Lehr Jan 6th 2012.

Jury Still Out on FDA Approval Rate

The jury is still out on whether the FDA increased drug approval rate in 2011 represents the start of a more positive trend or is just a one year hiccup. By November the FDA had 35 approvals to claim--with 24 coming ahead of OKs in other countries. The agency publicly noted that 2011's approval rate will go down as one of the best years in the past decade after years of anemic approval rates. 

True, but will it be sustained?

Most industry execs aren't ready to cheer just yet. The industry is still struggling with a poor productivity rate over the past decade, and is undergoing an unfinished revolution on the development front.  Next year, we could see a drop in approvals.  And if that happens, the FDA will be under even more pressure to work more closely with developers to better turn the odds in their favor.  See Fierce Biotech.

Posted by Bruce Lehr Dec 26th 2011.

EMA Stats Point To Improved Pipelines

According to PharmTech Talk approvals in EMA in 2011 look much rosier than the picture seen at the end of 2010 -- and this may give us hope that this will continue in 2012 and beyond. Let's look at the numbers.

PharmTech Talk » EMA Stats Point To Improved Pipelines.

2010 Jan - Dec

• positive opinions 51
• finalized marketing authorization applications 54
• finalized new drug applications 21
• finalized new orphan drug applications 6

2011 Jan - Sep

• positive opinions 74
• finalized marketing authorization applications 79
• finalized new drug applications 32
• finalized new orphan drug applications 11

There seems to be a pretty substantial increase in authorizations even when comparing a partial year 2011 to a full [dismal] year in 2010 - which coudl be interpreted as a sign of hope for the industry in 2012.

Posted by Bruce Lehr Nov 11th 2011.

 

 

 

 

 

 

 

FDA Approves 35 Drugs in 2011 YTD

The FDA released a statement touting that it has approved 35 drugs YTD which is only 2 less than its best year in the past 10 years (37 in 2009).  What's more?  The approval times are faster than elsewhere - 24 of the 35 newly approved drugs occurred in the US before any other country in the world and also before the European Union.

The FDA Approved How Many New Drugs? // Pharmalot.

According to the agency, of the 35 approvals, two are “breakthroughs” in personalized medicine that were approved with a diagnostic test; seven provide major advances in cancer treatment; 10 are for orphan diseases; 16 were approved under priority review; two-thirds were completed in a single review cycle; three were approved under accelerated approval, and 34 were approved on or before the agreed-upon review time targets, including three cancer drugs approved in less than six months (you can read the complete report here).

Beat your drum loudly while you can.

 

 

 

 

Posted by Bruce Lehr Nov 3rd 2011.

FDA Panel Recommends Xarelto

There had been speculation earlier this week the J&J and Bayer's new blood thinner Xarelto might run into problems with an FDA advisory panel, when some alleged gaps in its safety data with certain heart patients was raised in a memo by FDA reviewers. 

FDA Panel Recommends The Xarelto Bloodthinner // Pharmalot.

Nevertheless, the FDA advisory panel voted 9-2 to recommend the agency approve the drug.  Xarelto, if/when approved, will be another drug that replaces the old standard warfarin.  It will have competition though from the recently approved Pradaxa from BI and a forthcoming drug from Pfizer and BMS called Eliquis.  Eliquis is supposed to have the best clinical data of the three.

 

 

Posted by Bruce Lehr Sep 8th 2011.

Niche Cancer Drugs Making Inroads

Fierce Biotech reminds us today that new cancer drugs aimed at defined patient niches and paired with a companion diagnostic are starting to see regulatory success in the market.  Yesterday, Pfizer's crizotinib received approval for the treatment of non-small cell lung cancer in ALK+ patients.  It will be marketed under the trade name Xalkori (former consort of Xena Warrior Princess).  It's priced at $115,000 per year and analysts are pegging it to hit $540 million in annual revenues by 2015. 

Similarly, Roche's Zelboraf (vemurafenib) and its companion diagnostic (and $56,000 6-months price tag) were approved earlier this month for the treatment of certain melanoma patients.  It in fact received accelerated approval as the agency appears to be motivated to get these type of targeted therapies on the market. The FDA has now approved 25 drugs so far this year (as compared to 21 all of 2010) and is rolling toward a big year.

With this type of encouragement, Big Pharma can be expected to deliver more targeted therapies (with high prices) to help replace its cadre of expiring broad population blockbusters (e.g. Lipitor) as the drug strategy begins to shift.  I personally hope to see more of these targeted drugs make it to market sooner rather than later.  See Fierce Biotech 1 and Fierce Biotech 2.

Posted by Bruce Lehr Aug 30th 2011.

Roche Gets Early Approval Too for Zelboraf

Earlier this week, Roche also got early approval for its cancer drug Zelboraf (vemurafenib) for the treatment of BRAF V600E melanoma -- a full two months ahead of its PDUFA date. The approval marked a key milestone in personalizing treatment of metastatic melanoma.  This is good news for melanoma patients.  In fact, it is the second major new drug approved against melanomas this year -- the other being BMS' Yervoy (ipilumumab). 

Zelboraf is a small molecule tyrosine kinase inhibitor that targets BRAF --  specifically the V600E mutation.  This mutation is seen in approximately half of patients with metastatic melanoma.  The companion diagnostic (also from Roche) will enable oncologists to test patients upfront and determine who should receive the therapy since the clinical results have only been demonstrated in those with the mutation.  That's cool.  We can identify a clear population in which the drug will work.

As mentioned in the previous post on Adcetris, pricing is a hot topic of interest.  Roche plans to sell the drug for $56,400 per treatment course. Yervoy (mentioned above) sells for approximately $120,000 per course.  Wow these are expensive but do result in progression free survival in range of 5-6 months.  All in all it is an advance in the treatment of melanoma patients.  And it also represents a continuation of the increase in the number of approvals that we are seeing from the FDA. See the Pharma Strategy blog for more.

 

 

Posted by Bruce Lehr Aug 19th 2011.