|Analyst Offers Insight on Favorable FDA Ruling for Teva; Shares of MannKind Plummet Prior to Drug Advisory Meeting|
|By Staff and Wire Reports|
|Monday, 31 March 2014 22:04|
Shares of Teva Pharmaceutical (NYSE: TEVA) are up 6.66 percent to $52.74 on news that the company has received a U.S. Supreme Court hearing on generic Copaxone delay.
The news will “bolster investor confidence that a generic will not be on the market in May 2014,” BMO Capital analyst David Maris said.
There is also the possibility that generic drug makers may not risk a debut in May, which would be positive for Teva. Each week the company is able to keep “generics away is good news, as Teva continues to rapidly move patients to the new 3x/week formulation,” according to Maris.
Conversion rate to new 3x per week formulation is trending up from 22 percent last week to 27 percent for existing patients.
Shares of MannKind Corp. (NASDAQ: MNKD) fall as much as 27.105% prior to Tuesday's Endocrinologic and Metabolic Drugs Advisory Committee Meeting.
Piper Jaffray analyst Joshua Schimmer noted that MannKind faces a "number of obstacles" in the U.S. Food and Drug Administration's (FDA) review of the Afrezza Dreamboat insulin inhaler. Schimmer reported that it is "doubtful" for the company to gain positive recommendation from the advisory panel. The analyst commented that a closer read of the FDA staff briefing documents suggest that the agency "has enough concerns that only a cleanly positive vote will enable approval without additional requirements."
Schimmer downgraded MannKind from Underweight to Neutral and drastically lowered the price target from $5.00 to $1.50. Piper sees a 20% chance of clear positive vote, 60% chance of negative vote, 20% of split vote with “wide range of possible stock implications." The analyst added that the timeline with a two-year delay to the partner/ drug introduction "may still be presumptuous."
On Thursday, Summer Street analyst Bart Classen reported on potential problems regarding the Affinity 1 studies. On Monday, Classen continued to voice his concern, noting that the FDA panel will likely recommend against approval.
In addition to the poor glucose control potentially leading to increased complications, the Summer Street analyst highlighted the elevated cost of goods for Afrezza. Classen commented that 2.5 units of injected insulin are the same as 10 units of Afrezza, making the costs unnecessarily high. The analyst concluded that the Afrezza insulin inhaler "offers no real advantage to injectable insulin and is inferior in the control of blood sugar."
Shares of MannKind were down 9.7% in pre-market trading and fell as much as 27.105% to $3.80 Monday morning. The stock is currently down 19.259% at $4.05.
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