MNTA: I’m going to go out on a limb and propose that the FDA’s response to Teva’s Copaxone Citizen Petition is neutral or even slightly bearish for MNTA. The overall tenor of Janet Woodcock’s letter to Teva (excerpted in #msg-50149604) is that the FDA is setting a relatively low bar for the definition of sameness. A relatively low bar for sameness increases the likelihood of multiple FDA-approved generics for Lovenox, which decreases the probability of the best-case scenario for MNTA (a sole FDA-approved generic Lovenox).
The FDA’s response to Teva’s CP does, of course, make eventual FDA approval of MNTA’s generic Copaxone more likely.* However, from a valuation standpoint, this is offset or even outweighed (IMO) by the slightly reduced likelihood of MNTA’s having a sole FDA-approved generic Lovenox.
*I especially like Dr. Woodcock’s rebuttal of Teva’s chutzpah in comparing Copaxone (a synthetically produced polypeptide) to Premarin (a biologic).
›2nd UPDATE: FDA Rejects Teva Petition Against Generic Copaxone
By Thomas Gryta MAY 13, 2010, 4:47 P.M. ET
NEW YORK (Dow Jones)--The Food and Drug Administration has again denied Teva Pharmaceutical Industries Ltd.'s (TEVA) citizen's petition asking the agency to block approval of a generic version of its Copaxone multiple sclerosis treatment.
The Israeli drug giant filed the letter in November after its initial attempt failed earlier in 2009. The FDA rejected the second petition for the same reason as the first, because it would be "premature and inappropriate" to grant Teva's requests, but gave a detailed response that rejects many of the company's arguments against the generic approval.
Momenta Pharmaceuticals Inc. (MNTA) and Mylan Inc. (MYL) have both filed to produce generic versions of Copaxone, a process that is likely to span years. The drug, one of the world's best-selling MS treatments and a key component of Teva's business, was approved in 1996. In 2009, it racked up sales of $2.8 billion.[Annualized Copaxone sales in the US, specifically, are about $2B: #msg-49741817.]
Teva has sued both companies. That triggered an automatic 30-month stay on FDA approval, which is required by a generics-related law, meaning no generic version of Copaxone can enter the U.S. market until early 2011.[However, the 30-month stay on FDA approval lasting until Feb 2011 becomes void if the Court issues a summary judgment in favor of NVS/MNTA.]
The rejection letter is dated Tuesday, but was posted on a government website Wednesday.
Shares of Teva closed Thursday down 1.5% to $57.82, Mylan was down 2.1% at $21.14, and Momenta dropped 6 cents to $13.76.
The Copaxone battle is notable because it pits the world's largest generics company, which has benefited from challenging the patents of other pharmaceutical companies, against generic competitors to protect the exclusivity of its own brand.
Drug makers can ask the FDA to use special criteria when considering approval of generic copies of branded drugs, citing health or safety reasons. The petitions can slow the approval process and prolong market exclusivity for branded drugs, but recent rules require the FDA to respond to such requests within six months.
A spokeswoman for Momenta, which has a worldwide partnership with Novartis AG (NVS) unit Sandoz for generic Copaxone, declined to comment.
Officials from Mylan weren't immediately available for comment.
In a statement, a Teva spokeswoman reiterated that the petition lays out the company's position toward a generic Copaxone and said the company is continuing its "dialogue with the agency."
In its original letter, Teva claims generic drug makers can't show their drug is a precise copy of Copaxone--a fact that should preclude market approval. It claimed that current analytical methods aren't capable of characterizing Copaxone's make-up and reverse engineering won't create an identical product.[This is a disingenuous argument by Teva insofar as reverse engineering the production process can allow MNTA to manufacture generic Copaxone within the same lot-to-lot tolerances as Teva’s branded Copaxone: #msg-45378265, #msg-48127583, #msg-30647865.]
In the latest FDA response, which is eight pages longer than the previous four-page rejection, the agency repeatedly asserts its "broad discretion" in determining whether the submitted information is enough to conclude that the generic product is the same as the original.[Setting a relatively low a bar on sameness is not necessarily bullish for MNTA, however—see #msg-50151784.]
The agency said it will continue to take the specific drug into account when making its determination, and may require a generic company to prove sameness "although we cannot state with any certainty what these criteria may be."
"A finding of sameness does not, however, necessitate a finding of 'complete chemical identity.' Thus, the Agency may consider other criteria to determine sameness, taking into account the complexity of the active ingredient," it said.
Teva had also asserted that tests of a generic version sold in India and Ukraine produced by Natco Pharma Ltd. "differed greatly" from branded Copaxone. Mylan signed a worldwide marketing and distribution license with Natco for its generic version of Copaxone in 2008[#msg-41441618, #msg-41481687]. [No one I respect thinks the Natco/Mylan application has a realistic chance of FDA approval insofar as the product sold in India differs markedly from branded Copaxone.]The agency called Teva's contentions "unpersuasive" because those products weren't approved by the FDA and their existence doesn't preclude the possibility that a generic could meet "rigorous standards for demonstrating sameness" to Copaxone.
Despite the rejection, the FDA said the information in Teva's letter will help the agency's assessment of the types of information needed to support generic Copaxone.‹
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