BioMed News Bytes: IntelGenx, Pressure BioSciences Print E-mail
Wednesday, 14 October 2009 10:50

On 10/14/09, Pressure BioSciences (NASDAQ: PBIO) announced that they have entered into a strategic co-marketing / sales, R&D agreement with Protein Forest, Inc. The companies intend to co-market their product lines through industry publications, at scientific meetings, on their respective websites, through common collaborator studies, and at key industry trade shows.

Click here for my mid-September overview article on PBIO, which is developing products and services that represent a new paradigm in the long-neglected niche of sample processing as the initial step across the entire spectrum of the life sciences research process - with much of the attention and innovations focused on latter stages such as analyzing the samples and processing this information to generate results and a conclusion from the raw data.

The deal announced today with Protein Forest is a win / win situation for both companies and represents a cost-effective means of achieving increased market share / sales, new product development, and co-marketing synergies due to the common end market targeting research labs that use mass spectrometry and are involved in biomarker analysis. Specifically, Protein Forest offers software applications for the rapid analysis of sample data in addition to products for processing and enriching complex protein mixtures.

The research download section has been updated today to reflect the most recent corporate presentation for IntelGenx (IGXT.OB) (IGX.V), including the following update below on its pending FDA decision for a novel, once-daily 450 mg formulation of the widely used anti-depressant Wellbutrin (bupropion). On 8/21/09, IntelGenx announced that as required in connection with the filing of the CPI-300 NDA, its development partner and NDA applicant, Cary Pharma, provided notice of the filing to Biovail on 6/29/09, which holds the patent for Wellbutrin XL since CPI-300 is a novel, 450 mg high-strength formulation of the active ingredient of Wellbutrin (bupropion).

On 8/18/09, IntelGenx learned that Cary Pharma was named in a lawsuit filed by Biovail for patent infringement. Pursuant to the Hatch-Waxman Act, the filing of the patent infringement lawsuit against Cary Pharma by Biovail instituted an automatic stay of any FDA approval of the NDA until the earlier of a judgment or 1/3/12. However, Cary Pharma and IntelGenx believe that CPI-300 does not infringe Biovail's patent and will vigorously assert their rights in order to achieve a favorable judgment ahead of the 1/3/12 patent expiration.

On 4/3/09, IGXT.OB and privately-held Cary Pharma filed a NDA with the FDA under the 505(b)(2) pathway for their CPI-300 antidepressant, which represents a new strength and formulation of bupropion (450 mg) to provide a more convenient dosing option to patients with major depressive disorder. The NDA has been formally accepted by the FDA for a standard, 10-month review with a previous PDUFA action date of 2/6/10. IntelGenx reported in its most recent presentation that the P-IV (Paragraph IV) complaint by Biovail was filed August 13 but not served and the request for data will be used to prove non-infringement with a strong case history against Biovail, which has lost three previous cases.

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