Lupin acquired; FDA grants approval; NATCO gets approval; Wockhardt Ltd. gets import alert; Patent fight

Branded product portfolio of Shionogi acquired by Lupin
Pharma giant Lupin entered into a strategic agreement when its Japanese subsidiary Kyowa Pharmaceutical Industry Co. purchased the product portfolio of Japan’s Shionogi & Co., Ltd. The agreement results in acquisition of 21 products long-listed, and the deal is said to become effective from December 1, 2016.

FDA grants approval to Sanofi’s Adlyxin
FDA reviewed results of GetGoal clinical program as well as the outcome of the ELIXA trial of French Company, Sanofi, and granted approval for Adlyxin drug. It is a one-time meal injection as an adjunct therapy to diet and exercise of T2D patients. The GetGoal program included 13 clinical trials involving over 5000 patients with T2D, for evaluating the safety and efficacy of lixisenatide (Adlyxin). The marketed drug will be available in pre-filled pen (disposable) with a single dose of 20 µg.

NATCO gets approval for developing generic TAMIFLU by FDA
NATCO and Alvogen became the first players to receive and approval for TAMIFLU through Para IV ANDA.  TAMIFLU is the trade name for Roche’s Oseltamivir Phosphate, and the companies have received approval for marketing generic of TAMIFLU oral capsules. This came after the companies settled a patent infringement with Gilead Lifesciences, Hoffmann-La Roche and Genentech Inc. The settlement agreement includes the right for NATCO’s partner Alvogen to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period on February 23, 2017.

FDA approves generic Glumetza from Sun Pharma
Sun Pharma (and its subsidiaries or associate companies) announced that one of Sun Pharma’s subsidiary received a final approval from USFDA for ANDA for generic version of Glumetza that is Metformin Hydrochloride extended release tablets (500 mg and 1000 mg). These extended release tablets are the therapeutic equivalents of Santarus Inc.’s Glumetza tablets.

Ankleshwar unit of Wockhardt Ltd. gets an import alert from USFDA
An FDA inspection carried out in November, 2015 uncovered serious violations of GMP, leading to Wockhardt receiving an import alert for its Ankleshwar. This is the third plant of the company that has received an import alert. This has negatively impacted the company’s plans to revive its business in the US market. The company saw US sales decline to 22% from the 24% of last year, mainly due to import restrictions. The Ankleshwar plant contributes 10-15 percent of the US sales (Rs 964 crore in FY16).

 Patent fight of CRISPR: The bills hare soaring high
Fight over key patents on CRISPR genome editing has sent the legal bills soaring high, with the amount spent on the latest 10-Q filing from Editas Medicine to the Security and Exchange Commission touching the 10 million mark. The company reportedly paid $10.9 million as legal fees this past year to defend patents that have been awarded for CRISPR inventions by Broad’s Feng Zhang. This cost is an addition to the $4.7 million already spent in 2015 for the same dispute. The most surprising fact is that the legal battle is far from being over, with the tussle set for many more years to come. This has certainly raised eyebrows everywhere.