The Big Red Biotech Blog

Jennerex Goes i.v. With Cancer Fighting Virus

Jennerex Biotherapeutics is reporting a breakthrough that will allow it to deliver its anti-cancer oncolytic viruses via an intravenous route of injection -- as contrasted with the need to directly inject the viruses into a tumor. In a Nature article this week, Jennerex reports it oncolytic viruses injected i.v. were able to migrate from the bloodstream to the tumor site. Eureka!

"The idea has been around for decades, but nobody has been able to show you could deliver [an oncolytic virus] through an IV. If you can achieve IV delivery, it opens up the possibility of treating 10-fold mor tumors," says David Kim, Jennerex CEO.  See Xconomy.

There are no approved products using oncolytic viruses or this iv delivery concept but let's give them hand for the latest success. Hopefully, this will work and provide another possible way to go after tumors.

Posted by Bruce Lehr Aug 30th 2011.

"Benleasta" Leaves Door Open for Lupus Players

Analyst Yaron Werber says Human Genome Sciences new lupus drug Benlysta is being used right now but the door is open for better drugs to enter.  Benlysta is the first lupus drug in 50 years so specialists are prescribing it, but according to Yaron are not bowled over with its clinical benefits.  He says docs will be open to switch as soon as the next drug comes along with a better clinical profile.

Duh! That's true of most drugs.  It would be better to know more about what is specifically lacking in clinical performance with Benlysta.  In any event, Werber has downgraded sales estimates and the consequent HGS expected stock price.  Investors seem to be paying no attention though. See Fierce Biotech story.

Posted by Bruce Lehr Aug 30th 2011.

India Biotech Grows 25%

Ernst & Young published its 25th annual report - Beyond borders: Global biotechnology report - 2011.  in it, E&Y cited India's biotech as hitting $4 B in 2010 compared to about $3 B in 2009.  Vaccines, diagnostics and devices and personalized medicine were seen as the innovative growth areas. But, while the overall industry grew, most of that growth came from large firms while small firms fell back and continued to struggle to get investor funding.

"The domestic biotech firms wil need to adapt creatively to this environment by doing more with the funding that is available [ed. Pull on those bootstraps!] and by working from the earliest stages of development to demonstrate the potential value of their products to investors, payers and regulators, " said Ajit Mahadevan E&Y partner.  See Fierce Biotech.

Sounds like some small guys will fail or be snapped up by the larger guys for a pittance as the industry goes through a shakeout of the weaker players.

Posted by Bruce Lehr Aug 30th 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.

Zymeworks and Merck Partner on Bi-specific Antibodies

Zymeworks and Merck announced a deal whereby the former's platform technology for the development of bi-specific antibodies will be applied to cancers and autoimmune diseases.  Zymeworks will receive an upfront payment (undisclosed) and have a shot at milestones and royalties that could reach $187 million.

Bi-specific antibodies have binding sites that can recognize two different targets.  The Zymeworks platform provides the means to engineer unique antibodies against multiple targets on a single cell. The proteins can also be engineered to circulate longer in the bloodstream or to induce a stronger immune response.

Merck made a good partner for Zymeworks as it provided some proof of principal data, upfront cash and credibility to draw more investors. It also can complement Zymeworks protein engineerign knowledge with its own drug development expertise and understanding of biology.  Now they both have to make it work as a producers of therapeutics. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Aug 30th 2011.

 

Pfizer & Bristol Report Apixiban Results

Pfizer and Bristol Myers Squibb reported phase II results on their new bloodthinner apixiban as compared to the standard therapy - warfarin.  Apixiban reduced the risk of stroke or embolism by 21%, major bleeding by 31% and mortality by 11% in atrial fibrillation patients.

Pfizer & Bristol Bloodthinner: And The Wags Say… // Pharmalot.

"You now have a drug that is not only more effective but more safe," said Jack Ansell, chairman of the department of medicine at Lennox Hill Hospital. See Fierce Biotech.

Apixiban (marketed as Eliquis) will now take steady aim at the $9 billion market for bloodthinners.  Analysts say the drug could grab up to 50% share.  It will compete with Boehringer Ingelheim's newly approved Pradaxa and with Bayer - J&J's expected to be approved Xarelto.  A large portion of the $9 billion market would go a long way toward helping Pfizer forget about any of its Lipitor troubles as that drug comes off patent and faces heavy generic competition.

Posted by Bruce Lehr Aug 30th 2011.

All Dendreon All The Time

I'm just going to group a series of Dendreon tidbits on several topics into a single post.  It's All Dendreon All the Time around here.

First, Dendreon reports that its last facility in the US, in Atlanta, has now received FDA approval for the manufacture of Provenge.  This completes Dendreon's network of three US facilities -- the other two beng in New Jersey and Los Angeles. The scale up into all three facilities had been touted as being critical to the company's growth plan with Provenge.  However, recent events have shown that issues surrounding physician acceptance and reimbursement are equally important to establishing the product's sales trajectory.  In its last earnings announcment, Dendreon retracted its sales forecast of $350 - $400 million in 2011. See Xconomy.

Picking up on the physician reluctance to prescribe issue further, the Pharmalot blog continues with a report detailing physician anxiety with the product.  Several factors were cited as inhibiting use of Provenge:

• 68% of oncologists and urologists (N=101) the survival benefit was too low at 4.1 months and needed to be at least 7 months.  30% wanted at least 1 year.
• 68% also reported that they thought they would have problems with reimbursement - at $93,000 a pop even 1 patient not receiving reimbursement was viewed as trouble
• Provider education gaps and the novel nature of the treatment itself were also a barrier and was cited by 41% of the docs
• 68% also cited the co-pay for their patients as a major concern

The triple whammy going here is that docs don't know how to use yet, would like to see better survival benefit and worry about being reimbursed for an expensive treatment.

Finally, firmly in Dendreon's court, we have a report from Seeking Alpha decrying the misinformation out there surrounding Provenge.  The report, written by Saul Kerpelman,  says Provenge produced the "largest median survival advantage EVER" in hormone unresponsive prostate cancer patients.  The post further explains median survival benefit and its meaning. 

Provenge's 4.1 months median survival benefit means that 50% of the men in the clinical trial who received Provenge lived 4.1 months longer than 50% of the men in the non-treatment group.  So half the men in the non-treatment group died 4 months earlier than half the men in the Provenge group.  But, Provenge also reduced risk of death by 22.5% and increased 3 year survival by almost 40%.  So many men went on to survive much longer on Provenge. Provenge had 38% more men make it to three years.  So the statement that Provenge "extends life on average 4 months" is wrong.  And it is equally wrong to say that $93,000 buys you only 4 months. Provenge may give you many more years of life and with fewside effects compared to standard treatments.

Kerpelman says Dendreon needs to hire new PR to challenge erroneous and misleading media reports AND do a lot more on the physician and patient education side. Medicare already fully reimburses for Provenge and just issued a Q code (to speed reimbursement) in July. Better education as to benefit will fix the slow adoption rate.

Posted by Bruce Lehr Aug 30th 2011.

 

 

 

 

'GSK to Buy HGS' Rumor Persists

Fierce Biotech reports that rumors are heating up (again!) that GSK will make as move to buy Human Genome Sciences (HGS) as the latter's stock price is down.  GSK, of course, partners with HGS on its recently approved Benlysta for the treatment of lupus.  With HGS stock down, analysts project that GSK coudl actually acquire the company for less than Benlysta's market value -- which would be a good deal indeed.

HGS is still chugging away at launching Benlysta -- building a commercial team to drive revenue and transform the company into a full fledged biotech -- not just a development group without a commercial product.  But as a one hit wonder, without substantial revenue flowing in at the moment, HGS is vunerable to takeover and GSK is the most likely suitor. Even rumors of the takeover haven't been sufficient to bump up HGS' stock value.  It may be only a matter of time.

 

 

Posted by Bruce Lehr Aug 25th 2011.

More Insurer Trouble for Provenge in Near Term

A new survey of insurers conducted by Reimbursement Intelligence indicates that Dendreon's Provenge is likely to face flat uptake over at least the next 6 months.  Cited reasons for this stem frm both physician and insurer perceptions about the new higher priced cancer drug.

Most Insurers Say Provenge Use Will Remain Flat // Pharmalot.

Physicians responding to the survey indicated low prescribing rates due to:

• Limited clinical value 
• The drug's high cost
• Lack of qualifying patients
• Smaller number of centers willing to administer Provenge
• Stricter utilization policies
• Complicated treatment regimen

Insurers for the most part indicated a willingness to reimburse for the drug provided it was being utilized on label. Although, some industry observers indicate that 3rd party payers may be using more stringent criteria to determine reimbursement than Medicare requires.     

This survey would seem to validate that Provenge is going to have a tougher time breaking into the market than perhaps first expected -- until it can establish a clinical record.  Of course, slower uptake will increase the time to establish a record. Based on this, it seems rationale that Dendreon backed off its bullish forecast but of curse raises the question as to why it was so bullish in the first place.  Regardless, it's clear Dendreon management has its work cut out for it.

 

Posted by Bruce Lehr Aug 25th 2011.

 

Biobetters Going to be Better Route in West?

Fierce Biotech reports that surveyed physicians in the US say that they are/will be wary of prescribing biosimilars without clinical data to support similarlity to the reference drug.  In particular, they will be very cautious in prescribing for another indication than the one for which the biosimilar data was developed, i.e. they will resist "indication extrapolation".  Love that moniker -- kind of reminds me of "conjunction junction" as a child.  But I digress.  The Fierce data comes from an analysis done by Decision Resources.

This all implies that there will be a need for more clinical trials to generate data -- both for regulators and to convince physicians -- that will drive costs up and delay time to market. Again, this argues that only BIG companies with deep pockets will really be able to play in biosimilars while these conditions exist and persist.

This again makes me wonder if the strategy in the US ought to be aimed at developing biobetters as the regulatory and user community hurdles appear high.  You may as well get paid for your efforts if you are going to have to do extensive trials anyway, right? On the other hand, Spain (and others) may just order physicians to prescribe the cheaper version.

Posted by Bruce Lehr Aug 25th 2011.

 

 

 

 

India Pharma Companies Stay In Play

According to The Economic Times via the Pharmalot blog, Takeda Pharmaceuticals is seekign to purchase an Indian pharma company and is considering both Cipla and Lupin.  Either company would give Takeda a beach head in the generics market in India, with Cipla as No. 2 in market and Lupin at No. 5.  According to McKinsey, the India pharma market will grow from today's $12 billion to more than $55 billion by 2020 making it one of the world's fastest growers.

Rumor has it that Lupin is asking $1.5 billion for its assets or 17 times sales.  Wow!  Good selling price if you can get extract it from the buyer. A Lupin spokesman however termed the rumor a "baseless market speculation."  Sounds like they are ready to sell any minute doesn't it?

This no doubt gives India regulators heartburn as they have already expressed concern that both Western and Japanese Big Pharma are buying up the domestic Indian companies.  The fear is that the acquirers will drive up prices on medicines for India's copious poor populations -- making many medicines unaffordable.  This is one reason that applications for compulsory licenses to Western drugs still under patent have also been rising.  This is one market dynamic to watch.

Posted by Bruce Lehr Aug 24th 2011.

Takeda and Baxter Cell Culture Based Flu Vaccine Advances

Takeda and Baxter formed a collaboration in August 2010 to commercialize cell culture based flu vaccines in Baxter's Vero cell system.  Today, Takeda announced it has received a $313 million grant from the Japanese government to build a new flu plant in Hikari that is slated to be operational in 2013.

Takeda gets 24bn yen Govt grant for cell culture vacc plant.

Takeda is looking to supply the flu vaccine to the Japanese public as soon as possible thereafter.  In the medium to long term, the Company says it continue to develop vaccines for unmet medical need with a high social demand. These will include combinaton vaccines, high value vaccines using new technology and supply to other Asian and emerging markets outside of Japan.

This is another example of the rebirth of the vaccine industry after decades of slow decline as more and more governments put emphasis back on creating new vaccines to prevent widespread disease.

Posted by Bruce Lehr Aug 23rd 2011.

In AMP v. USPTO - Looks Like What We Got Here Is A Failure to Adjudicate

The Patent Doc blog related that Wake Forest Law Professor Simone Rose charges [in The Huffington Post]  that the Federal Circuit court failed in its duty as "keeper of the Constitution" in rendering its decision in AMP v. USPTO. Specifically, Professor Rose takes issue with the Court allowing the BRCA gene sequences (or any gene sequences) to be patentable subject matter instead of "patent-ineligible products of nature". 

Dr. Rose argues the court erred in its analysis by allowing chemical differences between native genes and isolated DNA sequences to be the primary criterion versus looking at the more important biological identity function of the gene sequences.

Going further, Professor Rose also argues that the Court erred in failing to balance the effects of exclusive rights granted under a patent with providing broader rights of accesss to basic knowledge as required under the Patent Clause in the Constitution.  She claims that granting patent rights to genes prevents access to these basic research tools during the term of the patent and blocks progress in direct violation of the clause.

Finally, Professor Rose believes that had the Court properly invalidated the BRCA patents then the Congress would have been highly motivated to look at the proper legislative framework to govern the matter of gene patenting or not. And hopes that then, the environment would be set for "an appropriate legislative dialogue" to balance access and innovation. 

 

 

Posted by Bruce Lehr Aug 23rd 2011.

Contract Manufacturing Will Explode for Pharma

In a new report, Visiongain says contract manufacturing in the pharma industry will hit $64 billion by 2016 and more than double in the next 10 years. The manufacturing of final dosage forms is expected to grow fastest (CAGR 8.7%) - though making APIs still constitutes more than 71% of the total market.

US companies currently enjoy a 42% masrket share of contract manufacturing business, but this is expected to change as India and China are increasingly, successfully competing in this segment. The Asia and Pacific region is expected to grow by 9.6% annually over the next 5 years compared to an overall market rate of 6.7%. 

While these emerging regions are expected to grow more rapidly in the next 5-10 years, analysts also expect that costs of labor and raw materials will rise over time dampening the rate of future growth.  Markets can be expected to level out to a greater degree as the industry establishes its global footprint. See Pharmalot.

Posted by Bruce Lehr Aug 23rd 2011.

 

Brazil & USP Ink Deals to Raise Quality Standards

In another example that recognizes the increasingly global nature of the pharmaceutical business, USP made several new agreements with entitites in Brazil to promote higher quality and increase the degree of regulatory harmonization.

Brazil & USP ink deals to up quality, harmonise standards.

The USP signed agreements with ANVISA, a Brazilian regulatory group, and with Sindusfarma, an industry group representing drug manufacturers that account for 85% of the country's sales.  Under their agreement, ANVISA and USP will develop joint education programs for drug formulators.

"In helping to ensure a high-quality supply of pharmaceutical products and ingredients in Brazil and throughout the world, Sindusfarma looks forward to a continued and strengthened working relatonship with USP," said Sindusfarma's executive vie president, Lauro Moretto.

And pharmaceutical industry globalization continues to march on.

 

 

 

 

Posted by Bruce Lehr Aug 23rd 2011.

Roche CEO Whips Up Excitement for Company Pipeline

Roche Ceo, Severin Schwan is out beating the drum for Roche's next series of pipeline candidates that the company is counting on to drive revenue growth even as it is losing some drug sales to generic competition.

Schwan says analysts and other commentators are being premature in saying that all the low hanging fruit has been picked (and eaten).  He says, "I believe there are enormous opportunities in this industry as we are only now beginning to understand how diseases are working."  Schwan stays true to his mantra that continued investment in R&D will pay off for Roche's future pipeline.

Next out of the shoot are several drugs that Roche management and the investment community are counting on as the next Roche blockbusters and revenue drivers.  These include:

• Metmab for the treatment of lung cancer
• Lebrikizumab for the treatment of asthma
• Pertuzumab for the treatment of breast cancer (to be filed in the US and EU in 2011)
• Dalcetrapib (a CETP inhibitor) to boost "good cholesterol"

Roche also has its recently approved melanoma drug, Zelboraf to drive sales.  Dalcetrapib is being picked by some analysts as the next mega-blockbuster with peak annual sales estimates ranging up to as high as $6.8 billion.  However, others view it as a potential cautionary tale as Merck is also targeting this indication with its drug, anacetrapib.  Pfizer's entrant into this category, torcetrapib, has already gone down in flames and may not bode well for the other similar drugs.

Nevertheless, Roche has a big bet on its next pipeline candidates and odds appear to be in its favor that some will prove their worth as big revenue drivers.  See the WSJ, Fierce Biotech 1, and Fierce Biotech 2. 

 

Posted by Bruce Lehr Aug 22nd 2011.

Hodgkin’s Lymphoma, Cancers And Drug Pricing

There is a lot of commentary out there in the blogosphere today on Seattle Genetics' just days-ago, FDA- approved, new drug Adcetris and its pricing.  Adcetris (brentuximab vedotin) is approved to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL).  The drug targets CD30 in those patients cells that exhibit this marker. The overexpression of the marker can be determined readily by a simple diagnostic test to indicate whether the patient is a good candidate or not for the treatment.

In clinicals, 73% of patients of these selected Hodgkin's patients had significant tumor shrinkage and 86% of the similar selected ALCL patients showed tumor shrinkage. And, about 1/3 of the Hodgkin's patients and 1/2 of the ALCL patients went into remission.

Hodgin’s Lymphoma And A High-Priced Drug // Pharmalot.

Given that, and given this is the first new treatment for Hodgkin's since 1977, and the first treatment ever for ALCL, will the price of $13,500 per dose or on average $108,000 per course hold up?  Most commentators seemed to think this drug actually justifies its price given the serious disease it is treating, and the patient benefit that it is providing -- especially for patients in the prime of life (30-45 age range). But the volume of commentary underlines the scrutiny new cancer treatments and their pricing receive now.  It also underscores the need to show a good cost vs patient benefit profile to separate the Dendreon Provenge from the Seattle Genetics Adcetris. 

Seattle Genetics' CEO said it best, "We want to make sure we price this drug so that we can maximize the impact on patients, and maximize the effect for the company as well. What we are excited about doing is making sure we can treat as many patients as possible, and also do well for our shareholders."

That's the balance that needs to be struck in modern biotech.  And the challenge that all future medicine developers will face. See Xconomy 1, Xconomy 2, and The Pharma Strategy blog.

Posted by Bruce Lehr Aug 22nd 2011.

 

 

China Ex-Pats Go Home to "Achieve Something" in Biotech

 
The Chinese government has made it well known by now that it wants to be a bigger player in biotech by announcing it will invest more than $300 billion in the next 5 years.  That kind of bait is drawing ex-Pats back to China from US biotechs to start up new biotechs or join other start ups. 

Says Xe Xin, a relocating researcher, "Though we were well paid at American companies, we wanted  to be more than just employees.  We are in our mid-30's and wanted to return home and make things happen."

We can expect this trend to continue as many well educated and well trained Chinese return to their homeland to exercise their entrepreneurial spirit in a land of heightened opportunity fueled by generous government investment and tax policies. 

The US government should take note and work with the groups like BIO to ensure we maintain policies and investment levels in US biotech to keep it at its current front-runner position in the World.  But don't look back as China may be gaining on us.  See Fierce Biotech.

 
Posted by Bruce Lehr Aug 19th 2011.

Beware "The Dendreon Effect"

Dendreon has its own Effect named after it, now that it told the Street it would miss all its revenue targets in 2011.  And not unlike meteorologist Edward Lorenz's Butterflies, its admission has had far reaching ramifications on biotech stocks according to MarketWatch's Val Kennedy. 

Kennedy claims Dendreon's effect has been to scare investors in biotech generally and more particularly scare the beejeeus out of investors in biotechs who are in the process of launching new therapies -- including those backing (more like back-tracking) Human Genome Sciences, Intermune, and Savient.  Even Vertex's seemingly successful launch of Incivek for hepatitis C has not been immune from the dreaded Dendreon Effect.

"Pretty much every company that had just launched a product or was about to launch a product got crushed," said Leerink analyst Howard Liang.  See Fierce Biotech.

 

Posted by Bruce Lehr Aug 19th 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.

FDA Clears Seattle Genetics' Adcetris for Sale in US

Cue the Trumpets!  Seattle Genetics gained FDA approval to market its antibody drug conjugate (ADC) brentuximab vedotin for the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL).  Yeah!

This is the first ADC to gain approval on the US market and it will be sold under the name Adcetris.  The approval came about two weeks ahead of the official review date of August 30th.  This is great news for Seattle Genetics as it is the Company's first approved drug after being in business for 14 years and spending nearly $546 M in R&D to reach this point.

The industry has been watching the progress of so-called "empowered antibodies" -- antibodies linked to powerful toxins to target specific cancers -- and a big success here for Seattle Genetics will only embolden other companies in the field. Seattle Genetics also has several more candidates of its own in various stages of the clinical pipeline. 

The company didn’t discuss one of the key facts investors will want to know immediately about the new product—its price. Most analysts expect that the drug will end up costing more than $100,000 per patient, as it is given to patients in a series of intravenous infusions once every three weeks. Seattle Genetics said it plans to discuss more of its commercial plans on a conference call with investors at 8:30 am ET/5:30 am PT on Aug. 22.  See Xconomy. 

 

Posted by Bruce Lehr Aug 19th 2011.

eHarmony for Drugs at Stanford?

According to piece in Fierce Biotech today, researchers at Stanford University have come up with a new way to try to match drugs coming off patent with new diseases and indications.  They likened their matching algorithms to online dating services, i.e. matching a drug's mode of action with disease symptoms it would be likely to affect.

Preliminary studies identified two old drugs that had positive attributes in animals, including an ulcer drug that might have effects against lung cancer.  These type of studies would fit into the NIH's new translational medicine intiative to get new drugs to market faster.

Drug-discovery investigators generally responded warmly to the research.  Certainly, finding a new use for an old drug has the potential to save money and get to market much quicker - especially if the Feds will support the program's funding.  It could be the perfect date.

Posted by Bruce Lehr Aug 18th 2011.

 

 

Icahn Exits Biotech?

I saw this short piece in In the Pipeline this morning, Derek Lowe noted that Carl Icahn apparently has liquidated his positions in Biogen (shed 8 million shares since June), has no holdings in Amgen and nothing in Regeneron. He appears to have left the building. Derek comments, he must be "finding no positions worth taking" and that probably isn't a good thing either.

To paraphrase, "Old Biotech investors never die they just fade away." And if you read Fierce Biotech this morning too let's hope the industry isn't fading towards China in the future.

Posted by Bruce Lehr Aug 16th 2011.

Never Woulda' Thunk It - 100,000th Page View Today!

 

 
We're celebrating (in a small way) at the Big Red Biotech Blog today.  After being around for 20 months, we hit the 100,000th page view sometime this morning.  I never would have thought that was possible -- either lasting 20 months or having 100,000 page views.  We'll take whatever we can get.  Thanks to anyone -- anywhere -- who has ever visited the site.  If you liked it, please come back.

 

Posted by Bruce Lehr Aug 16th 2011

Generic Producers and FDA Reach Conceptual Agreement on User Fees

The WSJ reports that the FDA and generic-drug producers have reached a general agreement to set up a user fee program to speed the review of drug applications and also to pay for more inspections of foreign (ex-US) manufacturing plants.  The initial year's funding from the drug industry is expected to reach up to $299 million.

The drug manufacturers are happy to have a possible mechanism to speed reviews and approvals as they say it can take up to 2 1/2 years now.  The initial funding to kick off the program will come largely from the companies that have drug in the approval queue at present. New fees will be donated as new applications for approval are submitted.  With regard to inspections, the fee system hopefully will allow the FDA to up its inspection rate of foreign facilities - currently at a low 36% of all 3700 drug facilities overseas.  

It's great that the two sides can agree on a path forward that appears to serve both groups needs.  Now, we only need to get Congress to endorse the program as a solution.

Posted by Bruce Lehr Aug 15th 2011.