The Big Red Biotech Blog

Sanofi Explains Growth Plan and Next Round R&D Cuts

Sanofi's CEO, Chris Viehbacher was quoted in a release that Sanofi was banking on its next round of pipeline candidates, up to 19 of which may be introduced between 2012 and 2015, to fuel its top line growth by 5% CAGR. Top candidates include: Kynamro (mipomersen) for familial hypercholesterolemia, Visamerin/Mulsevo (semuloparin) for venous thrombosis, Aubagio (teruflunomide) for CVS disease, Zaltrap (aflibercept) for colon cancer, Lyxumia (lixisenatide) for type II diabetes and Lemtrada (alemtuzumab) for muscular sclerosis. 

That's the plus side of the balance sheet so to speak.  On the minus side, Sanofi will cut $2.9 billion more out of its costs (exclusive of Genzyme).  Costs will be reduced in R&D by 12% from the spend in 2008 and headcount will be reduced by 22% from that same time period (about 3000 jobs).

Fiscal austerity becomes necessary as Sanofi faces its personal patent cliff with the patent expiration of its top sellers Plavix (blood thinner) and Avapro (high blood pressure).  The top line (hopefully) will be bolstered by Viehbach's decision to spend $23 billion in acquistions over the past 2 plus years. Analyst reviews were mixed (what else is new) on the prospects of Sanofi hitting its 5% growth goals. See Fierce Biotech and Pharmalot.

 

 

Posted by Bruce Lehr Sep 7th 2011.

Novartis, A Gleevec Patent & India

In follow up to the previous post, the Pharmalot blog published an interview with Brook Baker, a professor in the Program on Human Rights and the Global Economy at Northwestern University School of Law, and a member of Health Gap, Global Access Project. Dr. Baker explains sequence of events in the case and why advocates on both sides have latched onto it.

Novartis, A Gleevec Patent & India: Baker Explains // Pharmalot.

The Indian Supreme Court postponed its hearing this week. The case will establish patentability for changes to existing drugs, define "enhanced efficacy", set rules for evergreening and will likely have important implications to generic manufacturers and drug availability and pricing in India.

That's all.

Posted by Bruce Lehr Sep 7th 2011.

 

Novartis Patent Dispute In India Heats Up

Pharmagossip and Pharmalot below both provide coverage of an avidly watched patent case playing out before India's Supreme Court. Novartis is challenging an Indian patent office ruling that its new crystalline salt form of the cancer drug Gleevec is not patent eligible as it provides "little enhanced efficacy". 

Novartis Patent Dispute In India Heats Up // Pharmalot.

The case is important to the innovator Pharma industry, Generic producers, patient advocates and Indian health policy makers as it is effectively establishing the rules for "evergreening" by setting the standard for "enhanced efficacy". 

Novartis argues that by not granting a patent for this improvment, it (and other innovators) lose any incentive to create "new" drugs.  Patient advocates fear that allowing small changes to result in increased patent protection "up to 20 years", i.e. evergreening, will drive up medicines to unaffordable rates for the poor and gut the generics industry. Novartis' drug is a cancer drug but this same concept might be applied to AIDs medicines for example.

Thus, the case is heavily in the spotlight.  For the moment, we'll have to wait on the ruling as one of the Justices recused himself and the hearing schedule for this week was postponed.

 

 

 

 

 

Posted by Bruce Lehr Sep 7th 2011.

Is Reproducibility on New Drug Targets 50% or 20%?

This post from In the Pipeline talks about how venture capitalists with long careers investing in drug development have estimated in the past that only 50% of new drug target findings can be reproduced in an independent lab setting.  Now we have more data on that from Bayer Pharmaceuticals.

In the Bayer study that looked at its own in-house validation program aimed at showing which new targets in the literature could be confirmed -- and therefore developed into a potentially profitable drug -- uncovered that only 1/4 to 1/5 of all putative targets were reproducible in their labs. That's right, in looking at 67 projects (47 in cancer), the analysis showed only a 20% to 25% confirmation rate.

The conclusion is obvious.  You can't take the literature at face value.  You need to do the work to confirm which targets in the literature will actually be reproducible and it appears that rate will be well under 50%.  Keep that in mind when investing in new targets!

 

Posted by Bruce Lehr Sep 2nd 2011.

Merck Serono Opens Its R&D Site in China

Merck Serono (MS) opened the doors on its new $225 m R&D center in Beijing, China this week.  The center will focus on drugs for cancer, neurodegenerative disorders, autoimmune and inflammatory diseases.  MS says these programs will be tailored to specific target populations using biomarkers and companion diagnostics to identify likely responders. (See previous blog post on Roche for more on this trend).

The new R&D center complements other Merck Serono hubs in the US, Germany and Switzerland.  MS management also notes that it is keeping a very close watch on the developing domestic China drug market.  China is expected to become the number 2 pharma market (behind the US) within the next 6 years.  So this R&D move also gets Merck Serono closer to a patient population that it hopes to serve more in the very near future. See Fierce Biotech.

 

 

Posted by Bruce Lehr Sep 2nd 2011.

 

Roche Will Lead With Companion Diagnostics' Drugs

According to CEO Severin Schwan, Roche will continue to produce new drugs that have companion diagnostics.  He says he expects these products to become a much bigger percentage of the Roche pipeline -- more than 50% of the portfolio by next 10 years -- and account for higher percentages of revenue too.  Schwan says Roche has a good head start in this field as it has a strong diagnostics group that it began leveraging earlier than competitors.

"We believe that by having it integrated at a very, very early stage, we have a competitive edge," Schwan said.  He also said that everyone has to follow the science to be successful in pharma and that the revolution in molecular biology has provided new understanding that will enable Roche to keep coming up with innovative products. Schwan says cancer treatments, like Herceptin and newly approved Zelboraf, have benefited from these targeted drug approaches in defined populations and asthma patients may be next to realize these benefits with Roche's coming lebrikizumab. 

Schwan finishes by saying these more niche drugs can still be blockbusters (> $1 billion  in sales) as they deliver great benefits to the patients they treat.  Targeted drugs will also eliminate unneccessary testing and treatment of patients who won't be responsive which will save money and protect these patients from unnecessary side effects. He believes that healthcare policy makers will recognize this and be willing to pay a premium for drugs that deliver the goods in terms of real patient benefit.  See Fierce Biotech and Reuters. 

 

 

Posted by Bruce Lehr Sep 1st 2011.