Companies Under The Radar of a Talking Head

Two of my previous blog posts mentioned the FDA’s decision on diabetes drugs’ fate, curiously and inevitably I also looked at the stock prices of the companies hammered or bolstered by FDA’s announcement.  Recently, a famous/infamous self-proclaimed financial guru talking head did a week-long report on several biotech/pharma companies facing upcoming FDA decisions or having new development reports in the conferences.  I thought for educational purpose, it is no harm to learn the characteristics of some diseases and drugs available on the markets.  No stock recommendation implied, buyers beware!

Multiple Sclerosis is a chronic multifactorial disease diagnosed in ~350,000 Americans in 2009 whose central and peripheral nervous systems, eyes, and bladder are affected.  Drug sales reach $10 billion and estimated number will reach $15 billion in the next 10 years.

  • Biogen Idec’s Avonex is an interferon beta-1a drug to slow down the progression of disability in MS patients.  Side effect of liver injury has been reported.
  • Merck Serono’s Rebif is also an interferon beta-1a drug.
  • Bayer’s Betaseron is an in interferon beta-1b drug for the treatment of relapsing remitting MS.
  • Teva Pharmaceutical’s Copaxone is a class of medications called immunomodulators.
  • Novartis’ Gilenya is a sphingosine 1-phosphate receptor modulator and has fewer side effects than Biogen Idec’s Avonex.

Type I and II Diabetes: In the US alone, 23.6 millions adults and children have diabetes, which accounts for 7.8% of population; by 2020, estimated 38 millions adults and children will be diabetic.

  • Sanofi-Aventis’s Lantus is once-daily injected insulin.
  • Amylin Pharmaceuticals/Alkermes/Eli Lilly’s Bydureon (once-weely injectable version of Byetta) was rejected by FDA on 10/19/2010 due to increased heart attack risk.  According to Bloomberg:

Lilly markets Byetta outside the U.S. and co-markets it with Amylin in the U.S. The drug was developed by Amylin, and the technology enabling it to be used in a longer-acting form was developed by Alkermes. Alkermes will receive royalties of about 8 percent on Bydureon sales.

Colorectal Cancer is the second leading cause of cancer death in the US.  It is estimated one-thirds of deaths could be avoided with early regular screening.  About 5 millions colonoscopies performed in the US this year, 30% of market shares could capture $1.2 billion.

Hepatitis C virus infection is transmitted by blood that affects about 3% (~170 million) people worldwide.  HCV infection is the most common cause of liver failure in the US.  No treatment is available and existing treatments made patients feel worse.

  • BMS/ZymoGenetics’s PEGylated-interferon lambda
  • Vertex Pharmaceutical’s Telaprevir
  • Pharmasset’s PSI-7977 is an oral uridine nucleotide analog polymerase inhibitor of HCV.
  • Merck’s Boceprivir is a protease inhibitor.

Orphan Diseases, also known as rare diseases, affect fewer than 200,000 people in the US.  There are estimated 5000-7000 orphan diseases existing worldwide.

  • Genzyme’s Cerezyme to treat Gaucher’s disease and Fabrazyme to treat Fabry’s disease.
  • BioMarin Pharmaceuticals’ Aldurazyme and Naglazyme are used for enzyme replacement for mucopolysaccharidosis.
  • Alexion Pharmaceuticals’ Soliris to treat rare, progressive, and life-threatening blood disease paroxysmal nocturnal hemoglobinuria.

Until next post, keep on reading and writing!!

A Different Kind of Direct Sale: Direct-to-Consumer Genetic Test

What is Direct-to-Consumer Genetic Test?

According to the National Institutes of Health’s (NIH) Genetics Home Reference website, direct-to-consumer (DTC) genetic test involves a direct to consumer marketing and sales tactics that bypass the engagement of the health care professionals such as medical doctors, nurse practitioners, or genetic counselors.  In general, consumers order test kits online or through mail, and send in requested samples back to companies; then the test results are sent directly to consumers with minimal consultation and interpretation from health care professionals.

Personalized Medicine Fuels The Development of The DTC Genetic Tests

When the alliance between the NIH-sponsored laboratories and Celera Genomics jointly announced the completion of sequencing the draft of the human genome in 2000, many have predicted the coming era of “personalized medicine”.  The idea is to develop and prescribe a treatment plan or drug based on the information encoding in each individual’s genome.  As a result, personalized medicine tailors individual’s intrinsic differences to improve diagnostics and treatment of diseases.  With the advancement of faster and less expensive DNA sequencing platforms, getting DNA information is easier than ever.  In a sense, the growing numbers of the DTC genetic test products are likely inspired by personalized medicine, a Holy Grail of future medicine.

Who Jumps on The Bandwagon of The DTC Genetic Test

It is a fast-growing market place for at home DTC genetic test that comes with garden varieties of selection. Tests include risk evaluation of diseases like Parkinson, Alzheimer’s, asthma, breast cancer, diabetes, gluten sensitivity, ancestry tracing, drug responsivity, and whole genome scan, etc.  So far, there are 20 companies receiving the FDA’s letters concerning their genetic test kits as medical “devices” that require data-driven regulatory review and postmarket monitor.

Can FDA Come Out a Win-Win Regulatory Policy?

Currently there are already many do-it-yourself at home tests on the markets, such as blood-sugar meter, home pregnancy test, or home colon-cancer-screening test kit, just to name a few.  So what is it so concerned about DTC genetic test?  It is crucial to understand that in all scientific measurements, there are intrinsic errors in sample selection/representation, technology platforms, or statistics inference.  One has to understand the perils of being misled or misinterpreted by the genetic test results, due to test errors (false positive or false negative), excessive claims (based on unproven study), or unrealistic risks/benefits.  It is time for the FDA to come out a clear regulatory policy to protect consumers from getting incorrect information and potential losing privacy, and at the same time to validate safety and effectiveness of company’s test device/kit as well as to monitor proper disclosure of risks and benefits of test results.

Until next post, keep on reading and writing!!

Fat Chance for Weight Loss Drugs

The Country in Desperate Need of Biggest Losers

Obesity has become a national image of the US population given that one in every three US residents (>72 millions) are overweight or obese. Compared with ~400 millions of overweight/obese human beings worldwide, 18% of them are in the US despite the fact that the US population only accounts for 4.52% of the entire population on earth.

Although it is fairly easy to tell if a person is overweight/obese, there is a scientific definition.  According to the Centers for Disease Control and Prevention, overweight is defined as the body mass index (BMI) is over 25 in an adult, whereas BMI greater than 30 is doomed obesity. Want to know your BMI? Click here to find out.  In addition to the severe distortion of body appearance by excess body fats, obesity can cause many notorious chronic diseases, such as diabetes, hypertension, heart attack, stroke, just to name a few (check this article to learn more diseases caused by obesity).

Losing is Simple But Not Easy

Obesity has created a huge market for biotech/pharmaceutical companies, from weight loss to lowering blood sugar, surgical fat removal to gastric bypass surgery.  Since obese patients are expected to rely on weight loss drug for a long period of time, it is conceivable that a FDA-approved magic pill can potentially become a cash cow for a pharmaceutical company.  Unfortunately, that magic pill is proved hard to find.  For instance, a fen-phen weight loss cocktail was recalled in 1997 due to serious heart and lung side effects.  On 8 October 2010, the FDA announced that Abbott Laboratories withdrew its 1997-approved weight loss drug Meridia off the market due to increased risk of heart attack and stroke.

During past few months, the FDA advisory committee had suggested “NO” to two companies developing weight loss drugs with unwanted side effects: Vivus’s Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’s Lorqess (lorcaserin).  The next drug facing the FDA advisory committee, Orexigen and Takeda’s Contrave, is looking gloom given the recent FDA advisory committee’s tone on weight loss drugs.

Several companies with weight loss products still on the market are facing mixed sales records and potential side effects during aftermarket analysis.

  • GlaxoSmithKline: Alli
  • Roche: Xenical
  • Allergan: Lap-Band
  • Novo Nordisk: Victoza
  • Sanofi-Aventis: Lantus
  • Merck: Januvia
  • Eli Lilly/Amylin: Byetta

Go Back to The Basics

Although I am in the sickness industry (medical research to find the cause and cure for diseases), I really think the simplest way to reduce obesity incidence is to implement healthy diet and regular exercise promoted by the wellness industry.  Forget about that magic pill, eat right and sweat more!

Until next post, keep on reading and writing!!