Replies to post #11707 on Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Mylan says generic Copaxone approval could be delayed

Shares of generic drug maker Mylan (MYL) are falling and Teva's (TEVA) stock is rising after Mylan said that FDA approval of its generic version of Teva's MS treatment, Copaxone, could be delayed. After receiving permission from a federal appeals court to sell a generic version of the drug last year, Mylan had said that it planned to begin selling the product this month. WHAT'S NEW: "Continued processes" at the FDA could delay the approval of the generic version of Copaxone beyond May 24, when Teva's patent on the drug expires, said Mylan CEO Heather Bresch on the company's earnings conference call earlier today. However, there are no further legal hurdles blocking the launch of the generic drug, Mylan noted, characterizing the FDA delay as "totally regulatory and administrative." The company reiterated its fiscal 2014 earnings per share guidance of $3.25-$3.60, adding that the guidance does not depend on approval of any one drug. However, Mylan explicitly stated that it would not factor in any sales of Copaxone into its second quarter EPS guidance. The company provided second quarter EPS guidance of 67c-70c, versus the consensus outlook of 86c. Mylan also reported first quarter earnings this morning that beat consensus by 3c per share, but its revenue fell a bit short of expectations. For its part, Teva also reported first quarter earnings this morning that narrowly beat consensus on revenue that also trailed that consensus forecast. Teva also reiterated two different sets of guidance for fiscal 2014. If a generic version of Copaxone is not approved, the company expects its EPS for the year to come in at $4.80-$5.10. If a generic version of the drug is approved, Teva estimated that its EPS would be $4.20-$4.50. The Israeli company noted that the U.S. Supreme Court is slated next fall to hear Teva's appeal of the federal appeals court's decision on Copaxone. WHAT'S NOTABLE: Momenta Pharmaceuticals (MNTA) has also developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. PRICE ACTION: In early afternoon trading, Mylan lost 1% to $50.25, while Teva climbed 4.4% to $51. Shares of Momenta were down fractionally to $11.37.

http://www.theflyonthewall.com/permalinks/entry.php/MYL;TEVA;MNTA;NVSid2003304/MYL;TEVA;MNTA;NVS-Mylan-says-generic-Copaxone-approval-could-be-delayed

[indigokid]

Seems like that should be a positive for MNTA.

Also, raises more questions about MYL given how they just said it would be delayed due to "regulatory and administrative" reasons. Aren't all communications with FDA subject to Complete Response Letters? Lacking transparency again?