Industry News

(2nd September, 2014); Wockhardt Ltd’s New Drug Discovery program in Anti - Infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from the US FDA. This is the first instance of an Indian Pharmaceutical company receiving a QIDP status.

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(22nd August, 2014; Business Wire India); Celgene Corporation (NASDAQ:CELG) announced that results of a study evaluating the combination of REVLIMID® (lenalidomide) with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) in untreated diffuse large b-cell lymphoma (DLBCL) were published online ahead of print in the Journal of Clinical Oncology.

(6th August, 2014); Sanofi in India announced today that it has entered into a marketing and distribution agreement with Emcure Pharmaceuticals (Emcure) for its oncology portfolio in India. As per the agreement, while Sanofi will continue to own its oncology range - comprising 4 brands namely Taxotere®, Jevtana®, Fludara® and Fasturtec®, Emcure will market and distribute these brands through its Specialty Unit.

(6th August, 2014); Roche announced on last Monday that it has agreed to acquire Santaris Pharma, a privately held biopharmaceutical company based near Copenhagen, Denmark. Santaris Pharma has pioneered its proprietary Locked Nucleic Acid (LNA) platform that has contributed to an emerging era of RNA-targeting therapeutics. This new class of medicines has the potential to address difficult to treat diseases in a range of therapeutic areas.

(31st July, 2014); Indian Patent Act does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy which is major concern for US pharma companies. This indigenous rules agitated US multinational companies for doing fruitful business in India.

(31st July, 2014); U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.

(21st July, 2014); Novartis & Google join together to develop smart contact lens which will be useful in monitoring blood sugar level for diabetic patients and restore focusing capacity of eyes in patients with presbyopia. Alcon, eye care division of Novartis, has entered into an agreement with a division of Google Inc. to in-license its “smart lens” technology for all ocular medical uses.

(10th July, 2014); On 9th July 2014, the European Commission (the EU’s top competition regulator) decided to impose a wholly unjustified fine on Niche /Unichem (jointly and severally) contending that it had acted in breach of EU Antitrust Rules. The European Commission reached this conclusion because its subsidiary, Niche Generics Ltd (Niche), agreed to settle financially crippling patent litigation with Laboratories Servier (Servier) at the beginning of 2005.

(Business Wire India; 10th July, 2014); Celgene Corporation (NASDAQ:CELG) announced results of its phase III POSTURE study evaluating OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with active ankylosing spondylitis. The OTEZLA arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing.

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(Business Wire India; 20th June, 2014); Boehringer Ingelheim today announces a new study of Pradaxa® (dabigatran etexilate) in patients with atrial fibrillation (AF). The RE-CIRCUIT™ study will investigate the safety and efficacy of uninterrupted anticoagulant treatment with Pradaxa® in patients with AF who undergo ablation. Results of the study are expected in 2016.

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