Prasugrel receives positive opinion from CHMP

Daiichi Sankyo and Eli Lilly and Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation. Upon approval, this new oral antiplatelet agent is expected to be marketed throughout the European Union under the proposed brand name Efient.

Freepatents online creates another landmark by introducing citepatents

FreePatentsOnline.com (FPO), one of the widely used free online search engines for patents has launched an informational site, http://www.citepatents.com/, particularly to help bloggers, journalists and others to easily reference to patent information, and to provide a free patent search box for adding to websites with a single mouse click.

One has to log in by creating a free account first. Another useful free patent search site launched by the FPO is SumoBrain with a powerful new feature of bulk PDF downloading from a database of tens of millions of records including US patents and published applications, European patents and published applications, and WO publications at a single go. SumoBrain also features basic and advanced search capabilities including field search, word stemming, proximity search and search term weighting. SumoBrain saves lot of time and capital investment. Ipblogger would suggest its esteemed readers to login to this website and benefit from its advantages.

RANBAXY reconstitutes Board of Directors

Ranbaxy and Daiichi Sankyo Company Limited have announced the reconstitution of Ranbaxy’s Board of Directors. The composition of the new Board reflects the new ownership structure at Ranbaxy following Daiichi Sankyo’s strategic investment completed in November 2008. Daiichi Sankyo now holds 63.92% of the equity share capital of Ranbaxy.

The detailed news can be viewed by our privileged readers from linking into this site

Pfizer sues Apotex for infringement of '995 patent

Innovator Pfizer sued Canadian pharma giant Apotex (as per complaint filed on December, 17, 2008 in federal court in Wilmington, Delaware) for filing ANDA with Para IV certification to United States Food and Drug Administration (USFDA) to import and sell 10, 20, 40 and 80 mg/tablet dosage strengths of the Atorvastatin Hemicalcium, in violation of a enantiomer patent listed in Orange Book.

For a detailed action filed by Pfizer, click here

NovaDel Pharma receives FDA Approval of Zolpimist

NovaDel Pharma's Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray has been approved by the USFDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpimist is NovaDel's second product approved by the FDA that uses NovaDel's proprietary NovaMist oral spray technology. Zolpimist contains zolpidem tartrate, the same active ingredient as Ambien®, the world's leading sedative hypnotic for the treatment of insomnia.

Aurobindo receives USFDA tentative nod for Abacavir Sulfate/Lamivudine tablets FDC

Hyderabad based Aurobindo Pharma Limited has received tentative US FDA approval to manufacture and market fixed dosed combination Abacavir Sulfate/Lamivudine tablets 60/30mg for the treatment of HIV infections.

The company had earlier received tentative approvals to co-packaged Lamivudine/Zidovudine tablets + Abacavir Sulfate tables 150/300mg + 300mg and Abacavir Sulfate/Lamivudine tablets 600/300 mg. This is Aurobindo 87th ANDA approval from US FDA, a company release said.

Santarus, Cosmo sign pact for US rights to Budesonide & Rifamycin

Santarus, Inc has entered into a strategic collaboration with Cosmo Technologies Limited (Cosmo), which grants Santarus exclusive rights to develop and commercialize Budesonide MMX and Rifamycin SV MMX for the US market.

Terms of the agreements include an upfront payment to Cosmo of cash and Santarus common stock, shared development costs, clinical/regulatory and commercial milestones and a royalty on net sales.

Budesonide MMX is an oral corticosteroid currently being investigated in two multi-centre phase-III clinical trials involving more than 800 patients in North America and Europe for the induction of remission of mild-to-moderate ulcerative colitis. Budesonide MMX is designed to retain the effectiveness of classical corticosteroids, but with reduced side effects due to its targeted controlled release in the colon with minimal systemic absorption. Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic that also has targeted release characteristics when taken orally. The application of MMX technology to Rifamycin SV allows the antibiotic to be delivered directly to the colon, with the goal of minimizing unwanted effects on the bacterial flora in the small intestine. Cosmo has completed a phase-II clinical programme in traveler's diarrhoea. These two compounds are formulated using Cosmo's patented MMX Multi Matrix System technology.

MMX is a proprietary technology platform designed to produce a controlled release, homogeneous local application of the active pharmaceutical ingredient (API) throughout the colon, thereby limiting systemic absorption and offering an opportunity for reduced side effects. The MMX technology is covered by two issued US patents that expire in mid-2020, and additional patent applications are pending at the USPTO.

Centocor receives Complete Response Letter for Ustekinumab BLA from USFDA

The USFDA has issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab. The application, filed by Centocor in late 2007, seeks approval to market ustekinumab as a subcutaneous biologic therapy for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

The Complete Response letter requests additional information, including a proposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS). FDA requires REMS to ensure that benefits of an investigational or marketed treatment outweigh the risks. The ustekinumab REMS must contain a Medication Guide and communication plan. It does not require restricted distribution. The FDA has not requested any new non-clinical or clinical studies evaluating the efficacy or safety of ustekinumab prior to approval.

Unique website for claim mapping

Ipblogger has come across a very useful website (Patent Matrix) link which aids in instantly providing claims mappings for all patents in an IP Portfolio. The said site requires one time free online registration.

The power of Patent Matrix Diagrams lie in their ability to Reduce Costs, Optimize IP Communication, and Identify Competitive Advantages through a competitive landscape analysis.Matrix saves money on legal costs. The speed and ease of Patent Matrix Diagrams allow organizations to focus their time and resources on competitive endeavors rather than legal issues.

Patent Matrix effectively and lucidly communicates IP Portfolio by focusing on the heart of each Patent -- the Claims. This ensures a total and uniform understanding of the Patent Scope. Identify CompetitionPatent Matrix empowers an organization to analyze competitive IP and identify a breadth of competitive advantages ranging from infringement issues to licensing capabilities. Ipblogger has checked and found it to be a useful handytool in order to cut expenses.

Recent updates for US patent law 2007-2008

IP blogger has come across Recent updates regarding US patent law for the year 2007-2008. The said article is contributed by one of our co-authors Mr. Deeptymaya Sahu. Ipblogger would suggest to read the article. The said article can be downloaded from the link here