I'm here to decipher stock quote/clinical trial data to the layman. I don't know everything but I work in the field of biotech, so if I can't answer or post your question about some data, I have the resources to find the answer.
Upcoming, data from Sequinom. Just like my blood pressure, up and down.
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I'm trying to evaluate the impact on CBST as a result of TEVA's ANDA filing regarding Cubicin. Can you help? (I am long CBST). For some reason, TEVA waited for more than a year to file from when they were legally allowed to file. Since there are benefits to being the first filer (a generic exclusivity period) TEVA's delay (which permitted others to file first even though that did not happen) may be indicative of TEVA's weak position. CBST has said all along their patent position is very strong, etc., but I am not an expert.
Any help will be greatly appreciated.
Here is Cubists press release from this morning:
Press Release Source: Cubist Pharmaceuticals, Inc.
Cubist Plans to Commence Patent Infringement Litigation against Teva Parenteral Medicines, Inc. In Response To ANDA filing
Tuesday February 10, 2009, 7:00 am EST
LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST - News) today announced that it has received a Paragraph IV Certification Notice Letter from Teva Parenteral Medicines, Inc. (TPM) notifying Cubist that TPM had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval to market a generic version of CUBICIN® (daptomycin for injection). TPM’s notice letter advised that it is seeking FDA approval to market daptomycin for injection prior to the expiration of US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016. The notice letter further stated that TPM is asserting that claims in the referenced patents are not infringed and/or invalid.
By statute, if Cubist initiates a patent infringement lawsuit against TPM within 45 days of receiving the notice letter, then the FDA would be automatically precluded from approving TPM’s ANDA for 30 months, or until a district court decision finding the patents invalid or not infringed, whichever occurs earlier. Once the lawsuit is filed, the 30 month stay period will begin as of the date Cubist was notified of the filing.
“We have confidence in our patents and intend to assert our rights vigorously,” said Michael W. Bonney, Cubist’s president and CEO. “TPM’s filing in no way affects the priorities we have as a business. Our business goals and guidance for 2009 remain unchanged.”
Cubist also announced that it plans to file a patent infringement lawsuit against TPM in response to the ANDA filing. Cubist continues to be confident in its intellectual property portfolio protecting CUBICIN, including the patents listed in the FDA Orange Book.
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