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February FDA NDA/BLA Approvals

2/01 Cosopt PF, Merck Sharp Dohme; 2/03 Giazo, Salix Pharmaceuticals ; 2/07 Mitosol, Mobius Therapeutics;
2/07 Sklice, Sanofi-Topaz; 2/10 Zioptan, Merck Sharp Dohme



THE MRV NEWSLETTER, October 2012


INSIGHTS

Top 15 Potential Blockbusters in Development
There is a feeling in the industry that the day of the multi-billion dollar drug is over. That the market is transitioning to more specialized and targeted therapies. However, according to John Carroll, Editor-in-Chief at Fierce-Biotech, “Despite rumors to the contrary, the blockbuster is far from dead. Here are 15 hopefuls that are alive and kicking.”

  1. The drug: T-DM1
    The disease: Breast cancer
    The developers: Roche/Genentech, ImmunoGen
    Peak sales potential: $5 billion-plus
  2. The drug: BG-12
    The disease: Multiple sclerosis
    The developer: Biogen Idec
    Peak sales potential: $3 billion or so
  3. The drug: Darapladib
    The disease: Atherosclerosis
    The developer: GlaxoSmithKline
    Peak sales potential: Multibillion-dollar market
  4. The drug: Gantenerumab
    The disease: Alzheimer's
    The developers: Roche, MorphoSys AG Peak sales potential: The sky's the limit.
  5. The drug: GS-7977
    The disease: Hepatitis C
    The developer: Gilead
    Peak sales potential: Barclays analyst Tony Butler says $3.8 billion
  6. The drug: REGN727
    The disease: Cardiovascular disease
    The developers: Sanofi/Regeneron
    Peak sales potential: Some estimates start at $2.5 billion, though Deutsche Bank analyst Robyn Karnauskas leads the cheering section with $3 billion to $6 billion in potential.
  7. The drug: Odanacatib
    The disease: Osteoporosis
    The developer: Merck
    Peak sales potential: $2.5 billion (Barclays)
  8. The drug: Anacetrapib
    The disease: Cardiovascular
    The developer: Merck
    Peak sales potential: Estimates range anywhere from $3 billion to $10 billion, but skepticism about its ultimate success seems to be growing.
  9. The drug: Eliquis (apixaban)
    The disease: Atrial fibrillation
    The developer: Bristol-Myers Squibb, Pfizer
    Peak sales potential: Estimates start around $3.8 billion and rise to $5 billion or more.
  10. The drug: Tofacitinib
    The disease: Rheumatoid arthritis
    The developer: Pfizer
    Peak sales potential: $2 billion to $3 billion
  11. The drug: Bardoxolone
    The disease: Chronic kidney disease
    The developers: Reata, Abbott (AbbVie)
    Peak sales potential: Reata believes this drug will earn billions.
  12. The drug: Lu AA21004
    The disease: Major depression
    The developers: Lundbeck, Takeda
    Peak sales potential: Lundbeck estimates $2 billion, and they need it.
  13. The drug: QVA149
    The disease: COPD
    The developers: Novartis, Vectura
    Peak sales potential: Analysts at Credit Suisse have assigned a 50% probability of success with $750 million peak sales for QVA149 ex-U.S. and a 40% shot at $750 million in the U.S.
  14. The drug: Macitentan
    The disease: Pulmonary arterial hypertension
    The developer: Actelion
    Peak sales potential: $1.4 billion to $3 billion
  15. The drug: Alpharadin
    The disease: Cancer
    The developers: Bayer, Algeta
    Peak sales potential: $1 billion-plus Full Story at: FierceBiotech

IN THE NEWS

We have compiled a few links to some sites that we’ve found valuable for our business that we’d like to share:

ABOUT MICHELLE POLONI, CSAM

“My goal is to match qualified and dedicated candidates with stimulating client companies, which will result in a better lifestyle and work environment for all. I look to partner with individuals who have a passion for what they do professionally and personally. Most importantly, I am myself and I expect the same honesty and integrity I provide.”

Before starting in the business of recruiting, I graduated from University of California, San Diego. After which, I worked in cancer research for three years. This knowledge base in science has given me a unique understanding and appreciation for life sciences. I have been with MR Vancouver since 2000 working in the life science industry. I am a Certified Senior Account Manager through MRINetwork, allowing me to continue to sharpen my skills in the recruitment industry and was the Regional CSAM of the Year for 2010.

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