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Minor could be major
what [Teva is] trying to make you think they are saying
TEVA has no more significant entry barriers (if one is to believe them)
Their [Teva's] statements over time are perfectly consistent with the FDA having at one point told them...
I don't recall ever having a company announce a date when they will respond to the FDA
Teva's statements have changed simply because of what they have heard from the FDA.
An old example of a Minor Deficiency letter
I found an example of Minor Deficiency letter received by SangStat in 1998. [Note; SangStat was bought by Genzyme in 2003] With this example being so old, it may not be particularly relevant. A few observations and comments:
1. Much of the text in the SangStat PR is identical to that of Teva's PR yesterday.
2. SangStat, however, went much further and included language to provide some details, timeline (2 - 3 weeks vs. "near future") and convey their optimism that CYCLOSPORINE would be ultimately approved.
3. I suspect that Teva used this PR as boilerplate for their own release. Whatever the case, why did Teva not also include some language provide details and to convey optimism of approval, particularly in light of their numerous comments saying that they expected approval?
4. CYCLOSPORINE was approved 9 months after receipt of the Minor Deficiency letter but their path may have been much more clear cut.
SangStat Receives Positive FDA Action Letter for CYCLOSPORINE; Bioequivalence Review Completed
Business Wire, Feb 12, 1998
MENLO PARK, Calif.—(BW HealthWire)—Feb. 12, 1998—SangStat, The Transplant Company(R) (NASDAQ:SANG), announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) indicating that the Agency has completed its review of the Company’s CYCLOSPORINE marketing application. An application for marketing Sang-35, SangStat’s proprietary CYCLOSPORINE product candidate, was submitted to the FDA in November, 1996 as a bioequivalent formulation to Neoral(R) for the prevention of rejection in organ transplant recipients.
The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has completed its review of the CYCLOSPORINE abbreviated antibiotic drug application (AADA) including the Company’s responses to key questions during the review process. Prior to potential final product approval, the Office of Generic Drugs (OGD) requires responses to a short list of questions which SangStat intends to respond to within the next 2-3 weeks. Importantly, the remaining issues raised in this letter are not related to the bioequivalence trials.
The bulk cyclosporine drug substance used in SangStat’s application, supplied by Gensia Sicor, received FDA approval in July, 1997. A pre-approval inspection of the finished product manufacturing facility was deemed not necessary by the FDA.
Philippe Pouletty, M.D., SangStat’s Chairman and CEO said, “We are very pleased that the FDA has completed its review of the application and issued this key action letter for CYCLOSPORINE. Achieving this milestone is another significant accomplishment for SangStat.” He continued, “Subject to providing satisfactory responses to all questions the FDA may have, we look forward to receiving US market clearance for CYCLOSPORINE as a bioequivalent product to Neoral and launch.”
Cyclosporine is the leading immunosuppressive drug used in transplantation to prevent graft rejection. Cyclosporine is marketed by Novartis Ltd. in different formulations as Sandimmune(R) and Neoral with estimated worldwide sales of $1.3 billion in 1997. In the U.S. and Europe there are more than 200,000 transplant recipients requiring daily immunosuppressive therapy for the rest of their lives, the majority of whom take cyclosporine.
In December 1997, Amgen signed an agreement with SangStat for the exclusive commercial rights to SangStat’s CYCLOSPORINE for market approval and distribution in select countries in the Asia Pacific rim (Australia, New Zealand, China and Taiwan). SangStat intends to market directly its products, subject to regulatory approvals, in North America and Europe and seek well-established companies, like Amgen, as partners for marketing CYCLOSPORINE in other territories around the world.SangStat Receives Positive FDA Action Letter for CYCLOSPORINE; Bioequivalence Review Completed
SangStat Gets US Approval For Generic Cyclosporine
3 November 1998
SangStat has been granted marketing approval in the USA for SangCya(cyclosporine 100mg/mL oral solution) for the prevention of rejection in solid organ transplant recipients. This is the first approval for the product, which is also the first alternative version of Novartis’ leading immunosuppressant Neoral. Novartis’ composition-of-matter patent expired in the USA in September 1995.
i think the likelihood of teva approval is higher
Curiously absent from Teva’s PR today is an assertion that Teva expects FDA approval.
they (TEVA)are super smart in their PRs.
If a Minor Deficiency letter indicates that the FDA views T-Enox as approvable in its current form, this raises the stakes of MNTA's patent infringement claim against TEVA. If TEVA's application is based on a drug that infringes on Momenta's patents, TEVA is hardly in the driver's seat.
MNTA’s position on funding development and financial management.
During Craig Wheeler's presentation at Oppenheimer on 11/3/10, at about the 20 minute mark he pretty clearly articulated MNTA’s position on what the company is funding and their financial strategy:
"We are advancing FOBs, we are looking for a partner for M118 and we are pushing M402 forward"
"The way we are managing this company now is...fiscally conservative...we don't know when Teva is coming, we know our economics will change."
"We have basically set a financial plan on the company which says, 'What would it take financially if we had a multiple generics [of Lovenox] today and we couldn't get Copaxone until the patents expired?'"
You’re effectively asking whether the Court would grant a temporary restraining order to be followed by a preliminary injunction.
MNTA’s cash flow occurs only if a competing generic Lovenox is commercially launched.
Even if it is ultimately proven that TEVA infringed on MNTA's patents, if the FDA approves tEnox, MNTA's cash flow will be dramatically impacted until there is a ruling. Thus, even if MNTA is confident of its position, raising cash now is the prudent thing. In the long term, with the potential of treble damages, a patent infringing approval could be the best case scenario for the company and its shareholders.
However, in no scenario being considered is MNTA remotely close to being rendered "dead meat."
And Yanai's motive is...
An eye for an eye.