The Big Red Biotech Blog

Info Clearinghouse May Clear Way in Fight Against Adulteration

Here's an interesting idea from the GAO.  They are advocating for the creation of an information clearinghouse to combat intentional product adulteration -- based on FDA comments that getting information from industry about potential instances of economic adulteration is crucial to addressing the problem. Up to now, companies have been reluctant to share this information. 

The clearinghouse would allow companies to share information anonymously on adulterated ingredients with FDA and other companies. It could help FDA disseminate information about adulterated products quickly and enable the agency and industry to respond to adulteration rapidly. The creation of a clearinghouse managed by a third party could further ensure that the information did not identify specific companies.

PharmTech Talk » Let’s Fight Adulteration with Information.

This strategy could help allay industry’s concerns about sharing information when an adulterated ingredient has not entered into commerce. Companies are afraid that they may be sued if they reported that a supplier intentionally adulterated a product and the accusation is later found to be baseless.

Because potential adulterants often are unknown or unidentified, it can be hard for FDA to detect them, as was the case in the recent heparin adulteration. Industry may be the best source of tests to detect adulteration because companies develop such tests to monitor the products they receive from their suppliers; however, industry officials indicated that they are often reluctant to share such information because it is proprietary. The clearinghouse might solve the fears surrounding sharing proprietary information -- which in turn could help the FDA do its job better and better protect the consumer.

It seems like an idea worth exploring.

Postd by Bruce Lehr Nov 29th 2011.

 

 

 

Those Returns On R&D Are Falling Fast

Here's one post (of many) reporting on the results of a new Deloitte study on the R&D productivity of the world's 12 largest BIG pharma companies.  As would be expected if you have been paying attention to talk of patent cliffs and dry pipelines, the results are not too pretty. 

Those Returns On R&D Are Falling Fast // Pharmalot.

Let me hit you with the Reader's Digest version of Deloitte's findings from last year:

• The average cost of bringing a drug to market rose by 25% to more than $1 B up from $830 M (note these figures are hotly disputed by others as "grossly inflated" and several posts on this site discuss the controversy)
• The number of late stage drugs in development dropped from 23 to 18 (22% decrease) per company on average
• Ten of twelve firms saw R&D ROI decline resulting in a group drop from 11.8% return to only 8.4%
• Two-thirds of the top 12 did realize "more value" from product commercialization than they lost in late stage failures (Thank God for minor blessings)
• Non-R&D costs declined across the top 12 to free up cash to go back into R&D

This analysis should be viewed as a snapshot and may or may not reflect a trend. Deloitee stated that more improvments need to be made, and suggested that "more collaboration" occur between companies to "pool" disease knowledge. In particular, sharing knowledge on failed molecules and approaches could be very helpful to industry learning. Drugmakers may also share "non-competitive" areas of R&D to reduce costs for all.  See more in PharmaGossip and Fierce Biotech.

Finally, In the Pipeline had an interesting post the same day talking about "what if" the principles espoused in Moneyball could be applied to the Big Pharma pipelines?  It's an interesting thought and one I'd like to see undertaken (at least do the math and assess predictive value as theoretical exercise).  Anyone got Bill James' phone number?

Posted by Bruce Lehr Nov 29th 2011

 

 

A Proposal To Expand Accelerated Approval

Looks like BIO has been reading my previous post.

From Pharmalot, a post describing BIO's lobbying efforts with the Senate and FDA to expand the use of accelerated review in the FDA for drugs to diseases that do not have any approved cures. This would be applied not only to drugs for Orphan conditions but likely to cancers or AIDs drugs as well.

Under accelerated approval, a drugmaker can conduct shorter trials based on the measured effect of the drug rather than on an actual clinical outcome.  Sen. Kay Hagan (NC-Dem) would also ask that Phase II data could be used for drugs where data can't be "ethically, feasibly or practicably generated."

A Proposal To Expand Accelerated Approval // Pharmalot.

Presumably, this lobbying effort is being done in part as a consequence of criticism that the FDA's approval process has become too unpredictable in these type of clinical areas.  The FDA responded that the agency has approved 85 rare-disease treatments since 2006, and that 75 percent were based on limited clinical trials.

That observation would tend to undermine industry's claims and make them sound as if they are sounding a "false alarm".  Notwithstanding, I would still tend to favor expedited approval on drugs meeting the criteria above if there is also strong post-approval surveilance.  Based on analysis of that data, all parties involved should be willing and prepared to pull drugs from the market that do not live up to their pre-approval performance predictions when exposed to larger patient groups.

 

 

 

 Posted by Bruce Lehr Nov 16th 2011.

 

 

Innovating Fast and Motivatng More Speed

Sometimes two concepts just come together for me.

First from the Innovate on Purpose blog, a post dealing with why firms have trouble innovating quickly.  They don't have models that allow them to prototype quickly.  This retards their learning and slows progress toward an innovative result. Short, rapid experiments with imperfect prototypes is the key.  Plus the ability to plow learning back into more protyping quickly.

Then by happenstance, a piece from In the Pipeline blog dealing with management's motivation of speed. You'll find the answer is surprisingly simple.  Simple enough that it might work.

Posted by Bruce Lehr Nov. 15th 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.

 

 

 

 

 

 

 

Irreconcilable Differences: Lilly & Amylin Divorce

Breaking up is hard to do.

Irreconcilable Differences: Lilly & Amylin Divorce // Pharmalot.

In this case, apparently not as Lilly and Amylin part ways in their diabetes efforts with the drugs Bydureon and Byetta -- which Amylin will take control of after giving Lilly some cash. Amlylin will pay Lilly $250 million now and a 15 percent royalty on global sales until a $1.2 billion note has been repaid to Lilly.

The split ends a long partnership that unravelled after Lilly signed a deal with Boehringer Ingelheim to jointly develop and sell several diabetes compounds that are in mid- and late-stage development -- and compete with Amylin's drugs. 

What do they say about fury and a partner scorned?

Posted by Bruce Lehr Nov 11, 2011.  

FDA Probes Compounded Versions Of Makena

I (along with everyone else) picked on KV Pharmaceuticals earlier this year for the pricing decisions they made in introducing their premie drug Makena.  Now it appears that there are some quality/cosnistency issues with at least some compounders of the drug.  The FDA is looking into it.

FDA Probes Compounded Versions Of Makena // Pharmalot.

I present this in my effort to be "fair and balanced" hehehe.

Posted by Bruce Lehr Nov 11 2011

Novo Nordisk Stays True to China R&D Aims

Novo Nordisk senior execs state that their strategy to build a presence in China is centered on developing innovative new therapeutics. Staying true to that aim, they'll continue to steer clear of any big acquisitions in the growing Asian market.

Ronald Frank Christie, president of Novo Nordisk (China) Pharmaceuticals, says "We are not interested in bringing in generic (products). We are only interested in bringing new drugs to the market, to make a difference."

Its $100 million plan to grow a sizeable R&D program in Beijing and to boost the ranks of its Chinese scientists to 200 is its biggest research effort outside of Europe.  Recent market research indicates that the fast-growing number of diabetics in the country will help feed Novo's growth plans. The International Market Analysis Research and Consulting Group has estimated that the market for diabetes therapeutics will grow from $642 million to $2.8 billion in 2015.  Novartis also has plans to grow its manufacturing base in China. See Fierce Biotech.

As an aside, this is just another example of Western Big Pharma investment in China -- development and manufacturing.  It continually makes me question the wisdom of any pharma companies looking to eliminate China from their raw material supply chains.  It seems evident to me that China will become a major manufacturing center and a quality local supply chain will be needed to support this.  Efforts would be better placed to bring up local quality standards in manufacturing and quality assurance to support this obvious consequence (to me at least).

Posted by Bruce Lehr Nov 3rd 2011.

 

Sanford-Burnham Joins Pfizer's Translational Medicine Partners

Sanford-Burnham Medical Research Institute in La Jolla, CA has joined a growing list of scientific groups to team with Pfizer on its effort to spur translational medicine programs for early-stage research.  Pfizer will now open up its compound libraries, screening techniques and antibody development technologies to Sanford-Burnham investigators.

"The 'open innovation' model of the CTI is a perfect fit for Sanford-Burnham," said Sanford-Burnham CEO John Reed, M.D., Ph.D. "The Institute's culture of collaboration is enhanced by the opportunity to work side by side with Pfizer researchers to accelerate our ability to translate our research more quickly into the development of biopharmaceutical products."

Sanford-Burnham has expanded significantly in recent years. The National Institutes of Health awarded Sanford-Burnham a $97.9 million grant in 2008 to establish a high-throughput screening center. It was renamed as the Conrad Prebys Center for Chemical Genomics in 2009 when San Diego philanthropist Conrad Prebys agreed to donate $10 million to the institute. Philanthropist T. Denny Sanford prompted a similar name change for the institute itself when he pledged $50 million and the research center became the Sanford-Burnham Medical Research Institute.

Pfizer isn't the only big pharma to explore models working more closely with academic groups and research institutes. GSK, Sanofi  and others have been fostering their own initiatives after growing increasingly disenchanted by the poor productivity of their in-house groups.  In general, investors and analysts have further encouraged (without seeing if they actually work) such efforts.  Its the trend du jour in R&D for now. See Fierce Biotech and Xconomy.

Posted by Bruce Lehr Nov 3rd 2011.

ViiV teams with Russian manufacturer

ViiV, GSK and Pfizer’s HIV joint venture, has partnered with Russia’s JSC Binnopharm to boost manufacturing capacity in the country.  The deal extends GSK and Binnopharm's manufacturing pact for GSK range of cervical cancer, pneumoncoccal and rotavirus vaccines.

ViiV teams with Russian manufacturer.

The deal is another example of the recent trend of Western pharma manufacturers partnering with Russian firms to manufacture products in Russia in accordance with the government's Pharma 20-20 plan.  The plan calls for increased investment in Russian manufacturing capability and creation of more highly skilled jobs to support the growth of a local Russian pharma industry to more international standards. The ViiV partners plan full manufacturing transfer of core antiretroviral products from overseas to the Russian Federation.

Independently, Pfizer has further bolstered its Russian manufacturing presence through a deal with Petrovax Pharm.  Petrovax will make Pfizer's pneumococcal vaccine.  One can expect more of these deals in alignment with Russian goverment priorities -- especially if one plans to grow sales in this pharmerging market.

Posted by Bruce Lehr Nov 3rd 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.

New Leader - Sanofi overtakes Pfizer

Sanofi will overtake Pfizer as the world's biggest drug company, largely on the strength of its acquisiton of Genzyme and Pfizer's loss of sales through patent expirations.  Can anyone say Lipitor....

Sanofi overtakes Pfizer as world’s biggest drug company .

We soon will have a new sales leader in the clubhouse $51.6 B to $49.8 B. And believe it or not, Novartis is expected to slip into second at $49.9 B.

Posted by Bruce Lehr Nov 1st 2011.

 

GSK Hooks Up with Alnylam on siRNA Enabled Vaccines

GSK and the RNAi-company Alnylam announced a new licensing deal where by GSK will use siRNAs from the latter to apply to its vaccine program.  The Alnylam technology involved is termed VaxiRNA.  The deal is initially focused on influenza vaccine production. Under terms of the agreement, GSK will provide research funding and certain milestone payments to Alnylam. 

Alnylam’s VaxiRNA platform applies siRNAs for the silencing of specific genes that limit or prevent efficient growth of viruses in vaccine manufacturing systems, including those in cell culture.  Alnylam says this new platform addresses the significant unmet commercial need for innovative technologies that can improve the manufacture of vaccine products, especially where vaccine production is a limiting factor for the scale and speed of global immunization needs.

The deal comes at a good time for Alnylam, which lost partnerships with Novartis and Roche earlier in the year, and is expected to report a loss of 35 cents per share for Qtr 3 in a late day earnings call. They could use the shot in the arm so to speak. See GEN and Xconomy.

 

 

Posted by Bruce Lehr Nov 1st 2011.