1) FDA Approves BMS and Astrazeneca’s combination of saxagliptin and metformin XR (Kombiglyze XR)
2) J&J and Watson enters agreement on generic version of Concerta(R) (methylphenidate hydrochloride extended-release tablets) (Watson Link) (J&J Link). Watson to become authorized generic for Concerta. Under this agreement, Watson will launch the authorized generic beginning May 1, 2011 and J&J will manufacture and exclusively supply Watson with the authorized generic product, which will be available in 18mg, 27mg, 36mg, and 54mg formulations. Watson will market and distribute the product in the United States until the end of 2014.
Note: Watson/Andrx has challenged the Orange book listed patents 6930129 and 6919373. A decision on Watson’s Declaratory Judgment claim on the ‘129 Patent is subject to further proceedings by the parties. US patent ‘373 was held invalid by district court and which was again affrimed by Appeals court. (pdf)
3) Indian Patent has released New Manual on Patent office practice and procedures (Link). This manual includes new guidelines on many recent developments like Grant of patent, Pre-grant opposition, Appropriate office for filing divisional applications etc.
4) Basilea Pharmaceutica Ltd announces that it has received a milestone payment of EUR 5.5 million under its distribution agreement for Toctino® (alitretinoin) with Almirall, S.A. (Link).
5) Lorcaserin Phase 3 Clinical Trial in Patients with Type 2 Diabetes Shows Statistically Significant Weight Loss (link)
6) Astellas has sued Nycomed again in New York on 02/11/2010. Note: Astellas had already sued Nycomed on New jersey.
7) Triax Pharmaceuticals sued Glenmark Generics Inc for filing ANDA for Hydrocortisone butyrate 0.1% topical cream filed on 04/11/2010 (priorsmart.com)
8) Biovista signs development deal with Pfizer. This collaboration will focus on identifying new indications for a number of undisclosed Pfizer development candidates, using Biovista’s technology.
9) Glenmark completes phase-III trial for Crofelemer. Crofelemer, a first-in-class (first of its kind) anti-diarrhoeal drug for HIV-associated diarrhoea, had successfully completed the third and final phase of clinical trials. Glenmark in-licensed this molecule from US-based Napo Pharmaceuticals about five years ago for co-development. Another co-developer of the drug, Salix Pharmaceuticals has the right to sell Crofelemer in the US, Europe and Japan. Glenmark would supply the entire active pharmaceutical ingredient (API) of Crofelemer and set up an API manufacturing facility in India.