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 biosimilarTrastuzumab has been accepted by the European Medicines Agency (EMA) for review. The biosimilarTrastuzumab 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 biosimilarTrastuzumab 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.
 

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 .. 

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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.

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 .. 

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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 .. 

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Pharma tycoons climb as stocks zoom

 

Over a dozen people from pharmaceuticals and healthcare industry made it to the Forbes list of India's 100 Richest People.

Apart from the second richest Indian Dilip Shanghvi of Sun Pharmaceutical Industries (net worth $18 billion), the list includes vaccine king Cyrus Poonawala (net worth $7.9 billion) who owns Serum Institute of India, who made it to the top ten, Desh Bandhu Gupta (net worth of $5.9 billion) of Lupin, Pankaj Patel ($4.1 billion) of Cadila Healthcare, Yusuf Hamied ($3 billion) of Cipla, PV Ramprasad Reddy ($2.8 billion) of Aurobindo Pharma, Reddy Family ($2.6 billion) of Dr Reddy's Laboratories, Samprada Singh ($2 billion of Alkem Laboratories) and Glenn Saldanha ($2 billion) of Glenmark.

 

Forbes in its list said Dilip Shanghvi's wealth flatlined as Sun Pharma reported a 46% drop in net profit due to merger costs linked to acquisition of rival Ranbaxy Industries.

The list of 100 people also saw Leena Tiwari of USV Pharma, Mannalal Agarwal of Ajanta Pharma and Chirayu Amin of Alembic Pharmaceuticals making an entry with net worths of $1.9 billion, $1.4 billion and $1.2 billion, respectively.

Both Mannalal Agrawal and Chirayu Amin debut on list after shares of Ajanta Pharma more than doubled in the past year, while that of Alembic Pharmaceuticals rose 66% in the past 12 months on the back of higher revenues and profits.

The list includes Rajendra Agarwal of Macleod's Pharmaceuticals, Habil Khorakiwala of Wockhardt, Ajay Piramal of Piramal Enterprises, Malvinder and Shivinder Singh of Fortis, all with net worths of $1.8 billion. It also lists B R Shetty ($1.7 billion) of UAE-based NMC Healthcare, Dilip and Anand Surana ($1.6 billion) of Micro Labs, Ramesh Juneja ($1.5 billion) of Mankind Pharma and Azad Moopen ($1.5 billion) of Aster DM Healthcare.

Sun Pharma arm suffers US jolt

 

In a setback to Sun Pharma Advanced Research Company (SPARC), the US Food and Drug Administration (USFDA) has revoked an approval for its anti-epileptic drug because of manufacturing quality concerns at the Halol plant of Sun Pharmaceutical Industries.

SPARC is the research & development arm of Sun Pharma and it has plans to manufacture the drug at the Halol facility. It may be recalled that the US drug regulator had earlier observed certain current good manufacturing practices (cGMP) deviations at the unit.

SPARC had received a final approval from the USFDA in March this year for the product and it was evaluating several marketing partners for the product.

However, in a communication to the bourses today, the company said that the US drug regulator has issued a complete response letter to its new drug application for the anti-epileptic drug, indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.

"SPARC has now received a letter from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval,'' it said.

Under the USFDA website, complete response letters are issued when communicating a decision to a drug company that its new drug application or abbreviated new drug application to market a new or generic drug will not be approved in its present form.

SPARC said Sun Pharma is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.

In a presentation this June, SPARC had said that the market for the drug in the US is at 720 million units and is growing at 5 year compounded annual growth rate (CAGR) of 9 per cent. It had forecast that opportunity exists to market Elepsia XR at significant premium to generics. Commercialisation of the drug in the US market was slated in the second half of this fiscal.

Under new regulations, USFDA's Center for Drug Evaluation and Research (CDER) no longer issues "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER issues a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.