1. Genzyme / Sanofi : $75-80 per share, The Big Win-Win
$69 per share on Genzyme is obviously a lowball bid, comments analyst Mark Schoenebaum. Is Sanofi posturing, hoping for a higher bid? Most believe so and the controversy is on how high it will go. Genzyme is valued by some shareholders at $80-90 per share, but Mark believes most investors would be happy with an exit in the $75-80 range. Will Sanofi be willing to pay that much for an orphan drug company? What are the chances of another Pharma making a bid on Genzyme? Have shareholder activists (such as Carl Icahn) been helpful or harmful in the process?
2. Biosimilars, the Abbreviated BLA, and TEVA’s Response Letter
When the new healthcare reform was passed, an accelerated legal pathway for generic versions of biotech drugs was created. TEVA’s generic version of Amgen’s NEUPOGEN, for which approval was recently delayed by the FDA, was filed with a regular BLA and not the abbreviated one. This abbreviated pathway still remains to be tested. Will the standards for approval change?
3. Hepatitis C News to be Expected in November (AASLD) – VRTX, MRK, BMY, GILD, JNJ
Hepatitis C and liver infections offer a lot of room for improvement, and as such have become a large area of development for Biotech and Pharma. The market is fairly developed but currently the standard of care is insufficient and therapies are hard to take. While Vertex and Merck are in the lead, Mark Schoenebaum is mostly in the 3rd, 4th, and 5th place sprinters that are 1-3 years behind and for whom the story hasn’t necessarily been told.
4. Novartis’ Multiple Sclerosis Pill (Gilenya) Joepardizing the Biogen Idec Franchise?
While the approval of Gilenya is important because it is oral (in contrast with the injections in current therapies), its safety profile has yet to be fully understood. The relatively benign FDA label may encourage broader use and give Gilenya a larger than expected Multiple Sclerosis market share of up to 20%. Biogen Idec’s answer to this competitive threat will be found in their pipeline, with 2-3 products in Phase 3.
5. State of the Markets: “Healthiest Time for Mid-Caps in 10 years.”
Mark Schoenebaum talks about investor sentiment in the past year, and how that has affected pricing. He is very optimistic for the years to come, particularly in the mid-cap space (e.g. HGSI, DNDN, ALXN). Mid-cap biotech will transform to large cap in the next 5 years and bring more capital into biotech.
This interview was conducted at the NASDAQ Marketsite, on October 1st, 2010, in New York City.
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