Pharmabrag: 2016

Sunday 28 August 2016

Trastuzumab marketing approval may come in 12-18 months: Biocon

Shares of Biocon hit a fresh record high of Rs 910, up 5% on the BSE in early morning trade, after the company announced Mylan’s application to market biosimilar Trastuzumab has been accepted by the European Medicines Agency (EMA) for review. The biosimilar Trastuzumab is used to treat certain breast and gastric cancers.

“Mylan and Biocon, which have co-developed this popular biosimilar, anticipate that this may be the first Marketing Authorization Application (MAA) for a biosimilar Trastuzumab accepted by the EMA for review,” Mylan andBiocon said in a joint press release.

“This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe,” it added.

The filing includes analytical, functional and pre-clinical data and results from the pharmacokinetics and confirmatory safety global clinical trials for Trastuzumab, the company said.

At 09:29 am, the stock was up 4.7% at Rs 906 on the BSE, as compared to 0.29% rise in the S&P BSE Sensex. The counter has seen huge trading volumes with a combined 1.26 million equity shares changing hands in first 15 minutes of trade on the NSE and BSE.

Friday 15 July 2016

Biocon's partner firm launches diabetes product in Japan

NEW DELHI: Biocon today said its partner Fujifilm Pharma Co has launched its biosimilar product Insulin Glargine in Japan after receiving approval from the Japanese health authority earlier this year.

"Close on the heels of receiving approval for its Insulin Glargine from the Japanese regulator last year, its partner Fujifilm Pharma Co has launched the product in Japan today," Biocon said in a BSE filing.

In March this year, Biocon received approval from the Japanese he ..

Tuesday 12 July 2016

Syngene International gains after kicking off new development center in Bangalore

Syngene International rose 2.70% to Rs 485.10 at 9:31Iston Bseafter the company announced the establishment of an integrated, multi-disciplinary drug discovery and development center for Amgen, Inc in Bangalore, India.

The announcement was made after market hours yesterday, 6 September 2016.

Meanwhile, the BseSensex was down 24.83 points, or 0.09%, to 28,953.19.

On BSE, so far 8,396 shares were traded in the counter, compared with average daily volume of 26,251 shares in the past one quarter. The stock hit a high of Rs 494.05 and a low of Rs 477.90 so far during the day. The stock hit a record high of Rs 486 on 31 August 2016. The stock hit a 52-week low of Rs 315 on 23 September 2015. The stock had outperformed the market over the past 30 days till 6 September 2016, rising 12.76% compared with 2.82% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 23.25% as against Sensex's 7.24% rise.

The mid-cap company has equity capital of Rs 200 crore. Face value per share is Rs 10.

This center, named Syngene Amgen Research and Development Center (SARC), will be Syngene's fourth such exclusive R&D center. Syngene already operates dedicated R&D centers for Bristol-Myers Squibb, Abbott Nutrition and Baxter Inc. The state-of-the-art dedicated center will be staffed by a team of more than 100 highly qualified Syngene scientists, working in close association with Amgen researchers around the world on the discovery and development of innovative medicines.

In addition to being customized to meet Amgen's functional requirements, the facility complies with the highest regulatory standards. Its design includes a range of environmentally-friendly features and flexible layouts, and is configured to minimize solvent and effluent waste with a strong emphasis on laboratory safety and green chemistry. Syngene has partnered with Amgen in a variety of discovery and development projects. With the establishment of SARC, this association now extends into a multi-discipline collaboration spanning capabilities in medicinal and process chemistry, biologics, bioprocess, drug metabolism, pharmacokinetics, bioanalytical research, and pharmaceutical development.

Net profit of Syngene International rose 28.33% to Rs 59.80 crore on 17.92% rise in net sales to Rs 269.20 crore in Q1 June 2016 over Q1 June 2015.

Promoted by Biocon, Syngene International is a leading India-based contract research organization (CRO) offering a suite of integrated and end-to-end discovery and development services for novel molecular entities (NMEs) across industrial sectors. Biocon holds 74.55% stake in Syngene, as per the shareholding pattern as on 30 June 2016.

Monday 6 June 2016

Biocon, Quark get DCGI nod for trials of new eye disease drug

Biopharmaceutical firm Biocon today said the Drug Controller General of India (DCGI) has given nod to it and partner Quark Pharmaceuticals to proceed with clinical trials on human subjects for a new drug candidate, 'QPI-1007' aimed for ocular neuroprotection.

Biocon and Quark Pharmaceuticals also announced the randomisation of the first patient in India in the global Phase II/III study of the new drug candidate, the company said in a statement.

Randomisation is the allo ..

Biocon cancer drug trial data positive from 3 clinical trials

MUMBAI: Indian biotech frontrunner Biocon and its global partner for biosimilars, Mylan, have announced positive data from phase 3 clinical trials of a proposed copy of trastuzumab, a complex injection used widely to treat a type of breast cancer.

The trial results, being presented this week at the American Society of Clinical Oncology - a prestigious conference held annually in the US —gives the drugmakers an edge over rivals and will enable regulatory submissions for commercial la ..