The Big Red Biotech Blog

Pfizer’s Falling Share Price Couldn’t Be Cured & Kindler is Out

PharmaGossip, WSJ and Forbes all offer tidbits about why Jeff Kindler chose to leave Pfizer - but mainly it appears to be a case where the stock price was suffering and the road to recovery is still projected to be a long one.  Couple that with the pressures of the executive suite -- particularly as lead executive and a decision to leave is probably quite rational.

PharmaGossip: Pfizer’s Falling Share Price Couldn’t Be Cured.

Keep in mind, Pfizer's stock price has declined by more than 20% sinceKindler began his tenure.  Lipitor and its $11 B in 2009 revenue will soon lose a large part of its value after its patent expiration.  The Wyeth acquisition has yet to pay dividends - albeit - the jury is still out on the final grade for that deal.  Forbes also points out that Pfizer's PE ratio (7.3) is lower than 91 percent of pharmaceutical companies and 97 percent of the S&P 500 index.  Ouch!  Is there really an doubt to the decision when pondering "Should I stay or should I go?"  Afterall, if I stay it could be double.

 

Posted by Bruce Lehr December 7th 2010.

 

Sanofi's Viehbacher Replaces Pfizer's Kindler at PhRMA

PhRMA published a press release announcing that Sanofi's CEO Chris Viehbacher will take over as the new Board Chairman for the outgoing Jeff Kindler of Pfizer.  Viehbacher took the opportunity of his appointment to outline the pharma industy's priorities:

• Putting patients first by delivering innovative medicines that address unmet medical needs
• Prevention and better management of chronic diseases

Chronic diseases give rise to 75% of the national healthcare spend so addressing these is an important measure of controlling overall costs - albeit through better health for patients.  PhRMA will continue to stress medical innovation to patients, policies that reward investment in R&D, economic growth and jobs.

 

 

Posted by Bruce Lehr December 6th 2010.

 

AZ Survey Says: US Will Drop From #1 World Innovator by 2020

AstraZeneca conducted a survey of 6000 respondents from the United States, Britain, Sweden, Japan, India and China to seek their opinion's on who currently leads the world in innovation and how that might change in the next 10 years.  The Survey Says:

Current Innovation Ranking

• United States picked as number 1 by 30%
• Japan ranked number 1 by 25%
• China ranked number 1 by 14%

Now, fast forward by 10 years.  The Survey Says:

10 yr Future Innovation Ranking

• China selected as number 1 by 27%
• India selected as number 1 by 17%
• United States selected as number 1 by only 14%
• Japan selcted as number one by 12%

Survey respondents indicated that China's fast growing economy (currently no. 2 in the world), and its emerging technological know-how influenced the voting.  A recent Thomas Reuters study showed China is now the number two producer of scientific papers behind the US.  But R&D spending is also up across Asia as it begins to compete more vigorously with the US.  R&D spending estimates for 2008 were:

• Asia $387 B
• US $384 B
• EU $280 B

The survey also found that respondents in China and India had a strong sense of optimism as compared to a greater sense of relative pessimism in the developed Western economies. Maybe you are what you think?

 
Posted by Bruce Lehr December 6th 2010.

Seattle Genetics Reports Groundbreaking Results With SGN-35 for Hodgkin's

Seattle Genetics will report results today at ASH Meetings of its clinical trials with SGN-35 (brentuximab vedotin) on relapsing Hodgkin's disease patients.  In the latest clinical trial, 94 percent of the patents had at least some observable tumor shrinkage - 75% saw at least 50% shrinkage and 34% went into complete remission. Side effects were mostly mild compared to conventional chemotherapy.

Seattle Genetics Report Groundbreaking Results With Drug for Hodgkin's.

The results are being hailed as groundbreaking by company officials and some clinicians involved in the clinical trials. This is the first success of a so-called empowered antibody (antibody drug conjugate) and is being closely watched in the industry. Seattle Genetics plans to file an application with the FDA by the end of March seeking approval.  About 1/3 of the 8500 patients diagnosed with Hodgkin's will relapse at some point during their treatment. Seattle Genentics is aready talking about testing the hypothesis that the drug has the potential to be the standard of care with chemotherapy for 100% of newly diagnosed Hodgkin's patients.

Seattle Genetics controls 100% of the commercial rights in the US.If approved, Seattle Genetics will have its first product on the market and will begin to transform itself from and R&D organization to a more fully integrated commercial one. By the end of 2011, the company expects to add a commercial team numbering 110 and overall staffing could grow to 475-500 employees in the next 12 months.

"We want to be the next Celgene, the next Genzyme, the next really important biotech company," said Clay Siegall, Seattle Genetics CEO.

 

Posted by Bruce Lehr December 6th 2010.

Lilly claims UK "Value-pricing" will Increase Costs and Bureaucracy

According to InPharm, Lilly's UK director of corporate affairs, Rick Ascroft, says that the government's planned 'value-pricing' model will increase costs and add bureaucracy thus delaying availability of new drugs to patients.  The UK government plans to replace the current PPRS pricing scheme with a value-based pricing (VBP) scheme – under which drug prices will be set according to the value medicines provide – in 2014.

In speaking to the Department of Health, Ascroft said, "While the goal of the system is to improve access, at least up front it may actually do the opposite."  Likewise, speaking at the Wellards health conference in November, Association of British Pharmaceutical Industry director general Richard Barker said: “Value-based pricing is thoroughly logical, but not a magic bullet,” and warned that this system would not necessarily bring drug prices down. 

Not a big surprise that Big Pharma would express concerns about a new policy that could help control pricing and upset the status quo.  Like everything else, I suppose, the devil's in the details of implementation for which we all have some sympathy.

 

 

Posted by Bruce Lehr December 6th 2010.

Big Red Hits 35 - 35,000 Page Views

Another month and another milestone -- of course I pick what is a milestone so it's not that hard to achieve.  As always I'm appreciative of anyone who ever checks out the site and am particularly grateful to any of you who may choose to visit regularly.  We'll see if we can make 40 K before the end of the month.

 

Posted by Bruce Lehr December 5th 2010.
 

Recipe of the Month - November

These two come to me via the NY Times.

Maple Roasted Brussels Sprouts with Toasted Hazelnuts

• 1 1/2 pounds of brussel sprouts
• 1/4 cup olive oil
• 3/4 teaspoon sea salt
• 1/4 teaspoon (or 10 grinds) black pepper
• 2 tablespoons maple syrup
• 1/2 cup toasted hazelnuts coarsely chopped

Preheat the oven to 375 degrees. Cut brussel sprouts in half and remove yellow or brown outer leaves.  In large bowl, toss brussel sprouts with olive oil, salt and pepper.  After sprouts are coated, spread evenly in 9 x 13 inch or larger baking dish or sheet tray.  If you choose a tray, you may want to cover with foil for easier clean up.

Place in oven.  After 15 minutes, stir sprouts with spatula or large spoon to even out browning. After 30 minutes, stir in maple syrup.  (You can store here overnight if you wish).  Bake 15 more minutes or until sprouts are fork tender (about 45 minutes total roasting time).  Toss sprouts in toasted hazel nuts and serve.

Raw Butternut Squash Salad with Cranberry Dressing

•  1/2 cup fresh or frozen cranberries, picked over and rinsed
• 3/4 cup orange juice
• 1 tablespoon minced ginger
• 3 tablespoons olive oil
• 1 tablespoon honey
• Salt
• Black pepper
• 1 butternut squash (about 1 1/2 pounds) peeled and seeded

Combine the cranberries, orange juice and ginger in a small saucepan over medium-low heat. Cover and cook (about 10 min) until berries have begun to break. Remove from heat and add olive oil, honey and salt and pepper. Stir well to combine.

Grate the butternut squash by hand or in a food processor. Add squash to a large bowl, add the warm cranberry dressing and toss to combine.  Serve warm or at room temperature. 

Posted by Bruce Lehr December 5th 2010.

 

 

 

More on Biosimilar Approval Pathways

Chemical & Engineering News just published its take on the FDA's progress towards establishment of a biosimilars approval process. The publication writes, "Fights over testing requirements, data exclusivity, and even how to name these so-called biosimilars, or follow-on biologics, are delaying the agency from putting an approval process in place."

FDA now has to decide how much testing is necessary to show that a biosimilar is as safe and effective as the original product.  But there is much disagreement over exactly how much clinical testing FDA should require.  Because of the complexity of protein-based drugs, FDA is finding it difficult to strike the right balance between the desire for low-cost biologics and the need for careful evaluation of safety and efficacy.

On one side of the debate are the biotech companies and patient groups, which insist that the complexity of biological products makes animal toxicology studies and human clinical trials essential for establishing safety and efficacy.  They argue that, “A biosimilar product will invariably be made up of a different mixture of related molecules than the product it is attempting to copy. The challenge with biosimilars is knowing which structural variations matter clinically and which do not.”  Makes sense, huh?

On the other side of the debate are the generic drug manufacturers that claim that clinical testing for biosimilars is redundant and unethical because it has already been performed on the original products.  They argue that if biosimilars producers have confirmed that their product is “highly similar” to a reference biologic with state-of-the-art analytical tools, then that biosimilar “should be subject to clinical study requirements only to the same degree as is expected for originator products making manufacturing changes.” Such requirements typically do not involve clinical testing.  Makes sense, huh? 

FDA has begun the process of establishing a biosimilars approval pathway, but observers say it will likely be several years before the agency sorts through all the challenges related to implementing the new law.

So stay tuned, and read the whole article, entiled "Untangling Biosimilars".

 

Download Untangling Biosimilars

  

 

 

 

 

Posted by Bruce Lehr December 4th 2010.

 

Complex supply chain driving shift in analytical methods

As the pharmaceutical industry becomes increasingly global, so has its supply chain.  The complexity of the chain is such that more and more stringency and oversight is needed to ensure product safety and integrity.  Recent examples, including contaminated heparin, have pointed out this problem emphatically.

Complex supply chain driving shift in analytical methods.

As a result, companies and regulators are increasingly looking at more and better analytical methods for characterizing key raw materials used in the manufacture of pharmaceuticals.  This is one means (by no means the full solution) that can be used to better assure the safety of supply. This article describes how the heparin monograph and analytical methods have been upgraded in response to this issue by the FDA and USP working together.

Along this same light, I've written here often about SAFC's internal program to better characterize raw materials that it is supplying in its cell culture products for use by the biopharmaceutical industry in manufacturing of recombinant protein drugs. This is a program that has strongly resonated with the industry due to the issues described.  See here, here, here and here for more on this topic from this blog.

Posted by Bruce Lehr December 4th 2010.

Seattle Genetics Nears Finish Line with SGN-35

As reported by Bloomberg, Seattle Genetics and its partner Takeda are expecting to apply for approval of their antibody drug conjugate, SGN-35, for the treatment of lymphoma when the latest clinical data is reported next week.  SGN-35 will then be able to beat Roche's own ADC, known asT-DM1, to market (albeit for a different clinical application) and become the only ADC approved by the FDA at that point.  A previous ADC, Mylotarg, was withdrawn from the market earlier this year by Pfizer. SGN-35 is expected to generate as much as $420 M annually by 2015 if approved.

Seattle Genetics, which has no marketed products, plans to apply to the U.S. Food and Drug Administration for conditional approval of SGN-35 in the first half of 2011, said Chairman and Chief Executive Officer Clay Siegall. That process would allow the drug to be used while the company conducts confirmatory studies. If the agency agrees, SGN-35 may be in doctors’ hands by the end of 2011, Siegall said in an interview.

The industry has been anxiously watching both SGN-35 and Roche's T-DM1 as these new class of drugs promise to make a large impact on the treatment of various cancers by allowing the targetted delivery of high-potent toxins to cancer cells.  When these drugs are approved and prove themselves in the clinic, analysts expect a new wave of further therapies to follow using this strategy. 

Seattle Genetics and other partners are also testing different antibody-drug combinations for treating cancers of the kidney, prostate, pancreas and other organs. The allies include Roche’s Genentech unit; Bayer AG of Leverkusen, Germany; Celldex Therapeutics Inc. of Needham, Massachusetts; Daiichi Sankyo Co. of Tokyo; GlaxoSmithKline Plc of London; AstraZeneca Plc of London, and Astellas Pharma Inc. of Tokyo.

 

Posted by Bruce Lehr December 4th 2010.

Everything You Wanted to Know About EMA Guidelines for BioSimilar Antibodies but Were Afraid to Ask......

Today the Patent Doc blog provides some nice coverage on the EMA published guidelines for biosimilar monoclonal antibodies.  The guidelines will now be subjected to public comment until May 31, 2011.  The FDA will undoubtedly be watching with interest as it is currently tasked to come up with similar guidelines for the US following the healthcare reform legislation this past Spring.

The first installment of the guidelines is entitled, "Guidelines on similar biological medicinal products containing monoclonal antibodies" and covers non-clinical and clinical studies. 

The second set of guidelines addresses the problems with detection and risk related to the development of the mAb response - i.e. immunogenicity.

 

 

 

 

Posted by Bruce Lehr December 3rd 2011.

GE Aims to Bring Alzheimer Biomarkers to Life

Fierce Biotech reports that GE will team up with J&J to find new-presymptomatic biomarkers for Alzheimer's disease. The markers will be used to accelerate diagnosis and treatment. The two will try to use GE's Flutemetamol imaging agent to identify Alzheimer's very very early in disease progression.  The tool may help J&J and its partner Pfizer select patients for treatment with new Alzheimer drug candidates, like their bapineuzumab. 

"The collaboration we are announcing today is part of this effort to understand Alzheimer's," Pascale Witz, president and chief executive of medical diagnostics at GE Healthcare. "We think defining this biosignature could allow a major step forward in managing Alzheimer's disease in patients,"

 

 

 

Posted by Bruce Lehr December 3rd 2010.

Is it Pay for Delay? Or a Patent Settlement?

Diane Bieri, PhRMA Vice President and General Counsel, writes (in Xconomy) that so called "pay for delay" legislation outlawing the practice would be bad policy.  She argues that "patent settlements" of this type by Big Pharma and its generic drug challengers actually free up court time, and get generic drugs to market sooner - before the innovator patent  actually expires.  She writes that "pay for delay" is a mischaracterization and that some federal legislators are falling for it.

According to Biere, rather than change the law, we should all rely on the FTC and courts to oversee that any so-called "pay for delay" deals are not anti-competitive and int he best interests of patients.  Misguided attempts to outlaw "pay fo delay" will only raise court costs and hinder patient access to lower-cost generics -- that account for 74% of all prescriptions written in the US today.

That's certainly one point of view -- that of PhRMA. This point of view was backed by four US Senators seeking to block any legislation to ban "pay for delay" deals back in September.  Also in September, a Federal Appeals court declined to change its previous ruling that "pay for delay" deals were legal.

The CBO, FTC and US DOJ have all at one time or another come out against "pay for delay" deals.  One top regulator, Jon Lebowitz of the FTC, terms the practice the "most corrupt" in the healthcare industry and "blatantly anti-competitve".  That's the other point of view. See here and here for more.

 

 

 

Posted by Bruce Lehr December 3rd 2010.

 

 

J&J Proceeds with Caution on Closing Crucell Deal

According to the WSJ, J&J will proceed with its $2.27 B acquisition of Crucell, but reserves the right to modify the deal should Crucell experience more difficulty with its manufacturing in South Korea. Crucell was forced to stop shipments of two vaccines due to sterility issues in late October.

The Dutch market regulator Autoriteit Financiele Markten (AFM) said that once it has approved the merger, the rules to amend an offer are very strict, making it difficult to adjust the bid. J&J expects to get final approval before the Crucell general shareholder meeting on December 10th.

 

 

Posted by Bruce Lehr December 3rd 2010.

Genzyme and Sanofi still Play for High Stakes

Fierce Biotech reports that Sanofi is still sticking to its $69 per share offer that Genzyme has steadfastly rejected.  As previously reported, a CVR based on future Campath success may be a possible mechanism to get a deal to progress.  However, today Sanofi made a CVR based deal sound more unlikley and an unknown spokesman was quoted as saying that a CVR at even $5 or $10 per share would be unlikley to pass muster (Genzyme thinks $20 per share may be right price).  Time is running out on the Sanofi tender though which will expire on December 10th. 

Thus far, Genzyme's price has not dipped below the Sanofi offer price of $69 per share -- we'll see if that holds up after December 10th deadline passes and there is no competing offer waiting in the wings.

Posted by Bruce Lehr December 3, 2010.