Edwards Tiptoes into the Market

Edwards Lifesciences, a medical device manufacturer of trans-catheter heart valves, has traditionally been known for its innovative thinking and aggressive marketing. Edwards is set to receive FDA approval for Sapien, a trans-catheter aortic valve for patients with aortic valve disease. Sapien is the first aortic valve in the US market with Medtronic and several other medical device companies at least 1-2 years behind.

However, as these articles points out (1, 2), Edwards has decided not to aggressively enter the US market, the largest market for this product. Rather, Edwards is slowly onboarding key centers like Robert Wood Johnson. Conventional wisdom suggests that first-to-market players should capitalize on their early entry to the market but trying to capture as many customers as possible and trying to build loyalty early. So why then has Edwards chosen a conservative launch strategy for the US market?

Here are some potential reasons:

• The FDA has mandated a more careful roll out of Sapien.
• Assure early success of the device to convince skeptical physicians.
• Inadequate reimbursement
• Carefully select patients to reduce the risk of stroke, an adverse event associated with trans-catheter aortic valve implantations

The slower roll out will make patient access to TAVI more difficult in the US. However, the strategy may pay off in the long run as failed or improper implantations could lead to death and recalls. This would open the door for competitors like Medtronic to gain share.

All industries, but especially the medical device industry, have numerous examples of first-to-market players. Cordis, a J&J company, was first-to-market with stents but was forced to exit the market several years later due to heated competition.

Having worked on Medtronic’s trans-catheter pulmonary valve last summer, I will be eagerly watching the battle for the TAVI market.

Geron's Gambit

Three years ago, I decided to switch careers and enter the health care industry. It was around this time that I blogged about Geron receiving approval to begin a clinical trial to test its stem cell therapy for patients with spinal chord injuries. It was an exciting time for the Biotech industry and people like me who were entering it – stem cells, once pure science fiction, were about to become reality.

Then, in November 2011, Geron announced that it was jettisoning its stem cell business. Citing difficulty in recruiting patients into its trial and the general cost of its stem cell program, Geron decided to focus on its two cancer drugs: Imetelstat (telomerase inhibitor) and GRN1005 (LRP peptide-drug conjugate). This decision was certainly difficult for all Geron stakeholders: patients, employees, management, and investors. Geron was founded as a stem-cell company and emerged as the standard-bearer of this industry.

However, with limited cash and reluctant to frequently go to the equity markets to raise money, Geron (and its new CEO) decided to cut its losses and focus on its cancer drugs. When Geron made this announcement, its stock fell from $2.5 to $1.5 per share.

Clearly, the decision to abandon stem cell research was a difficult one. Geron gave up a potential blockbuster drug and monopoly in the spinal chord injury market. In addition, Geron laid off almost all its workforce related to the stem cell program. In fact, it may have even lost its CEO and CFO in this decision.

However, in recent months, the stock has crept back up to pre-announcement levels. I believe that Geron made the right decision. If running the stem cell program was bankrupting the company and preventing it from funding its promising cancer drugs, then the stem cell program needed to go. It is unfortunate that Geron lost a lot of great researchers in the process. I only hope that another company can pick up Geron’s trial where it left off; even if not, Geron has paved the way for other companies to enter the stem cell business. Geron was one of the first companies to work with the FDA on establishing protocols for stem cell trials.

And who knows, if Geron’s cancer drugs become blockbusters, Geron could get back into the stem cell game. It’s important to remember that Geron exited the stem cell business for financial reasons, not because of the ineffectiveness of its stem cell therapy.

The Future of Medicine

Welcome to Pivotal Trial, a blog that discusses various health care topics. Having written a few blogs on my own experiences (Rickety Rickshaw and Letter of Marque), I've decided to shed some light and express my opinion on current health care topics. I invite you to follow this blog and share your opinions in the comments section.

A few months ago, Steve Jobs passed away after a long and undesirably public battle with pancreatic cancer. Shortly after his death, a biography on Jobs written by Walter Isaacson was released. I read this amazing biography in a week. One of the most fascinating sections was a discussion of Jobs' life with pancreatic cancer. Although pancreatic cancer is one of the deadliest cancers, Jobs managed to live for 7 years with the disease before it ultimately killed him (2004 - 2011). Yet, the life expectancy of someone who is recently diagnosed with pancreatic cancer is only 5-8 months.

So how did Jobs manage to live so long with this fearsome cancer?

I believe the answer is the experimental approach that doctors used to treat his disease. In fact, Jobs may have beaten the disease completely had he not refused surgery during the first 9 months after its diagnosis. Jobs initially employed natural remedies to combat this cancer. While I am somewhat of a believer in the benefits of natural products, something as complicated as cancer needs the best that modern medicine has to offer. Eventually, after Jobs was convinced by his doctors and family to undergo surgery and mainstream treatment, his health improved dramatically.

Jobs was one of the few people to have his entire genome sequenced. Thus, doctors were able to select the right medicines to address his particular brand of cancer. Chemotherapeutics (drugs that kill cancer cells) are notorious for initially working against a cancer only to have the cancer 'adapt' to the drug and eventually build a tolerance to it. When this happens, doctors frantically (and randomly) try a cocktail of new chemotherapy drugs in the hopes that one or more of this drugs will hit. In the case of Jobs, doctors were able to hand pick the right drugs to address his cancer thanks to a complete understanding of his genome.

This form of treatment, a direct application of the widely touted 'personalized medicine' philosophy, is experimental and not available to the masses. A patient needs to be wealthy and have access to the best doctors who know what to do with this genetic information after it is discovered.

Personalized medicine comes in many forms: stem cells, gene therapy, etc. Seattle-based Dendreon (DNDN) applies personalized medicine by training the body's immune system to identify and kill prostate cancer cells. However, the company has fallen on hard times due to a key mistake in its business strategy - namely marketing their therapy for all prostate cancers instead of particular prostate cancers in which it is most effective. This mistake, combined with the outrageous price for the treatment, makes the data on therapy effectiveness vs. price look worse than it actually is. Thus, many oncologists have abandoned this otherwise excellent treatment.

Nevertheless, personalized medicine will live up to the hype and allow people to live longer and fuller lives. Start thinking about what you want to do in your 90s and 100s because with personalized medicine you just might get there.