Biogenerics take center stage on Capitol Hill

Biogenerics, otherwise known as biosimilars or follow-on biologics, have taken center stage during the healthcare reform debate. There is a number of ‘factions’ arguing their position as to how these generic variations of biologic therapies should be protected by patent exclusivity.

BIO, National Venture Capital Association, American Enterprise Institute and the American Intellectual Property Law Association are all in favor of a longer term. And, patient advocacy groups and generic drug makers are arguing the opposite trying to open up as much competition as possible to lower drug prices. Obviously, the companies themselves are voicing their opinion that their R&D costs are high and that they need exclusive marketing rights in order to recoup their investment.

One Senate Committee has already approved a recommended 12-year exclusive license. The Obama administration is pushing for 7 years. Other (unreasonable) challengers are arguing it should be 5 years or less.

In this video, CEO John Lechleiter of Lilly makes a very strong case for why we cannot allow this decision to stifle innovation across the life sciences industry.

Heal your sunburn, don’t forget about H1N1

While those of us in the U.S. & Europe are all enjoying the traditional summer vices of sunshine, the beach and vacation holidays, an epidemic that gripped our attention this past spring still remains.

The World Health Organization said today that the swine flu is proving unstoppable. Even worse, the virus is intensifying as several extreme cases have emerged in Australia, a southern hemisphere country in the middle of winter. More than 20 Australians have died and several otherwise fit and healthy people have been struck down.

Overall, the swine flu virus has killed about 500 people and infected about 1 million worldwide.

Several vaccine manufacturers, led by Novartis, are working to develop a vaccine as quickly as possible. Just weeks ago, Novartis announced it had successfully produced a first batch of swine flu vaccine ahead of expectations. WHO says drugmakers will likely have vaccines approved and ready for sale after September, hopefully in plenty of time for production & distribution to meet an expected growing need as winter approaches. Also set to respond are GSK & Roche who both manufacture anti-viral drugs used to treat infected patients.

But we have to wonder, could what is ongoing in Australia be a precursor to a rough flu season for us once summer fades?

A tempered victory for Lilly?

Late last week, the FDA announced it had (finally) approved Lilly’s new blood thinning drug, Effient (prasugrel).

Since last summer & fall, many across the industry have been wondering when Lilly’s day would come for this drug. After repeated delays & resetting of expectations, the product can now finally be commercialized, albeit with a ‘black box’ warning about potential side effects.

Sanofi Aventis & Bristol Myers Squibb market the world’s best selling blood thinner, Plavix. Once thought to be a serious competitor to Plavix and Lilly’s next blockbuster, the drug now has more tempered goals in terms of its sales potential.

While a victory for one of the industry’s biggest players, this approval for Lilly only puts a dent in a huge upcoming patent cliff with almost 75% of their existing products, in terms of sales, set to lose patent protection between now & 2016. While Lilly’s CEO has been adamant that they are not seeking a mega-merger the likes of Merck/Schering Plough or Pfizer/Wyeth, should we expect to see them active in bolstering that pipeline in the coming months?

P.S.  What do we think of Mike Huckman’s new glasses?  Hmmm….we’ll let you decide.

Wyeth, J&J and Novartis unknowingly distribute anti-aging drugs?

All the media world was talking about a little known drug from Wyeth this morning called rapamycin.

It seems that a study published in Nature magazine found mice treated with rapamycin had a longer lifespan than those that did not.

The Wall Street Journal and NY Times quickly picked up on the story and the WSJ Health Blog offered the following background on the medication:

The name comes from Rapa Nui, the Polynesian name for Easter Island. Scientists first isolated the compound from bacteria from the island’s soil; the bacteria apparently secrete it to fend off bacterial and fungal rivals.

Wyeth actually markets the drug as Rappamune to prevent organ donors from rejecting their new body parts.  It also happens to be used as a compound in drug eluting stents, including J&J’s breakthrough product of a few years ago:  CYPHER.

As luck would have it, Novartis has a similar compound in its development pipeline.  While cardiovascular & cancer are still rule the roost, could the Fountain of Youth be the next big therapeutic focus for the industry?

Times, they are a changin’ at the FDA

Is it me or is President Obama’s version of the FDA all of a sudden a much, much more active and engaged federal agency in the past few months?

Since Dr. Margaret Hamburg & Joshua Sharfstein took office recently, the FDA has been making headlines on a very regular basis.   Today’s news about Chantix & Zyban follows in the immediate footsteps of strong decisions related to acetaminophen, Percocet & Vicodin, Zicam, the medical device approval process, regulating tobacco, ‘Cheerios are a drug’, and even cookie dough.  The Commissioner even penned a first-person mission statement in the New England Journal of Medicine announcing her next grouping of targets.  And finally, in the vein of a suggestion box brought to life, the agency hosted an open forum town hall forum seeking input on how to make the agency more effective.

That’s quite a bit for less than two months of work!  While there is some humor embedded in the message, let’s be clear that change has come to Rockville…and it’s a welcome (if not unpredictable) sight.

The stem cell industry grows up

The average person doesn’t understand stem cells.  And with all the confusion provided by the mainstream media, it’s no wonder.

But with some recent events, the stem cell industry is beginning to show signs of maturity.  Contrary to popular belief, the short term gains are not to be had in reversing the effects of spinal cord injury or treating neurological diseases.  Instead, the immediate applications for stem cell technology lie in helping companies perform better research for traditional medicines.

For that reason, GE Healthcare has unveiled an exclusive alliance with Geron, a relative grey-haired veteran of the stem cell industry.  Don’t be fooled…GE is not moving into the therapeutic market.  Instead, they are adding Geron’s technology in order to commercialize stem cell-based testing products to help researchers around the world in their development of new drugs.  GE already distributes instruments and consumables to labs all around the world.  Leveraging those relationships provides an immediate channel for this new product line.

There are others chasing this market:  iZumi, Cellular Dynamics, California Stems Cells and others.  And while it’s still considered a niche, this could be the future of how drug developers save time, money and animals in evaluating the potential and safety of new drug candidates.  And with one of the world’s largest companies now wholly committing to new stem cell technologies, the industry has taken yet another step toward maturity.

Roche changing its stripes…at the cost of one of its strongest advocates

Roche is doing its best to distance itself from the ranks of Big Pharma by dropping its membership in the Pharmaceutical Research and Manufacturers Association (PhRMA), the leading trade group for the U.S. pharmaceutical industry. Instead, Roche is shifting its alliance to the Biotechnology Industry Organization (BIO).

Not as dramatic but still noteworthy is that the company is also pulling its sponsorship of a pharmaceutical-related program at Rutgers University.

Less surprising (but equally symbolic) is the fact that South San Francisco will now become the center of Roche’s pharmaceutical & biotechnology operations in the U.S. housing its corporate offices and marketing operations. The move marks a departure from the traditional Big Pharma corridor in New Jersey to a much more bio-centric environment in Bay Area of northern California.

Most significant of all these changes is the decision to essentially abandon PhRMA. “Genentech and Roche believe BIO’s purpose is closely aligned with the direction of the new company and, therefore, can represent the company’s interest in Washington,” quoted a Roche spokesperson.

“It’s a Genentech decision not to join PhRMA,” said Billy Tauzin, Chairman of PhRMA. “They feel they are different.”  Certainly, this is a personal blow to Tauzin.  His affinity for Genentech is widely known as Tauzin’s cancer was treated by Avastin. It’s an experience he speaks of regularly in public forums and part of his powerful messaging as Chairman of PhRMA.

At 3:38 in the video above, discussing the Obama administration’s push for healthcare reform, he refers to his own personal battle with the disease. Ironically, he states (as he often used to): “I am now working for the very company that invented the medicine that saved my life”.

Not anymore…

Boston Scientific gets a new CEO

Jim Tobin has retired as the CEO of Boston Scientific. Mr. Tobin will be succeeded by Ray Elliott, a true medical device veteran. Although his career also spans the food & beverage and communications industries, Elliott’s medical device experience includes Zimmer, Cybex, Centerpulse and American Hospital Supply. He is a very active member of AdvaMed having chaired the orthopedic sector of the medical device industry organization.

In an interview, Mr. Elliott said he will look at diversifying Boston Scientific further outside its core in cardiac devices, citing urology and gynecology as possible expansion areas.

During Mr. Tobin’s tenure as CEO, Boston Scientific reported net losses totaling $3 billion and saw its share price fall 44%. In no uncertain terms, he is being replaced. His biggest win was the 2004 launch of the Taxus drug-eluting stent, which became the industry’s top seller even though J&J’s Cypher was first to market. But the company drew the ire of the FDA over quality control which led to a three-year new products ban that allowed rivals to gain ground. Ironically, Tobin is shown here waxing poetic about the company’s commitment to quality in a video which has seen very little viewership online.

Finally, Boston Scientific has struggled to perform since its fabled acquisition of Guidant in 2006. Riddled with debt after winning a bidding war against J&J, the company’s bonds have fallen to junk status.

Time (and Mr. Elliott’s leadership) will tell whether Boston Scientific can produce consistent financial results and regain its prominence in the industry.

The ‘next big thing’ for Big Pharma?

In response to a report in the New England Journal of Medicine, the mainstream media today was all abuzz with the progress of a new cancer drug called olaparib, which has shown extraordinary promise in a small, early-stage clinical cancer trial for patients who were genetically vulnerable to developing these malignancies.

Olaparib works differently than other cancer drugs in that it blocks Poly(ADP-ribose) polymerase (PARP), a protein involved in DNA repair. In a Phase I trial of only sixty patients with a variety of different cancers, olaparib shrunk their tumors with very minimal side effects. The bigger question is whether the drugs will add benefit beyond those patients genetically disposed to developing cancer in this way, which would determine if this could potentially open up a whole new class of oncology drugs for the industry.

AstraZeneca is developing oliparib & began this journey with its 2006 purchase of KuDOS Pharmaceuticals who discovered the compound. Sanofi Aventis has since acquired BiPar Sciences for $500M to enter the category. Best we can tell, Merck and Abbott are also developing PARP inhibitors.

For an industry where success in the past decade has been predicated on competing within the new emergent drug categories (statins, gliptins, anti angiogenesis inhibitors, etc.), could this be the sign of the next big commercial opportunity? For certain, with this clinical progress and the public’s perception about this as potentially ‘the next big thing’ in cancer treatments, plenty of other CEO’s will be wondering tomorrow morning if they should add a PARP drug candidate to their pipeline.

Zicam CEO hits back at FDA…on Youtube

Maker of Zicam, Matrixx Inititatives’  CEO Bill Hemelt has personally responded to the FDA’s Warning Letter in an internet-based video.  This video, hosted both on the Zicam website and in a Zicam channel on Youtube, has had less than 300 views since Friday when it was released. Meanwhile, late night talk show host Jimmy Kimmel’s entertaining spoof of a new Zicam TV commercial had over 3,000 views over the weekend.

We can learn two things from this approach.  In this web-based world, we can now communicate in new & creative forms to spread our message…but we cannot control what the public will want to hear.