Indian firm Strides Acrolab gets FDA nod for generic cancer drug

Indian drug firm Strides Arcolab announced it had received approval from the USFDA for the its generic Fluorouracil Injection which will be used to treat various types of cancer. The company’s wholly-owned subsidiary Onco Therapies Ltd has received two approvals from the United States Food and Drug Administration for its abbreviated new drug applications (ANDA) for Fluorouracil Injection USP in two strengths. 
The approvals are for the injection in the strengths of 50 mg / ml, packaged in 10 ml and 20 ml single-dose vials and 2.5 g/ 50 ml and 5 g / 100 ml pharmacy bulk packages, it added. Fluorouracil is among the products in the drug shortage list of USFDA and according to IMS data, the US market for generic Fluorouracil is nearly $14 million.
http://health.india.com/news/indian-firm-strides-acrolab-gets-fda-nod-for-generic-cancer-drug/

Finoso Pharma forms JV with CritiTech

Hyderabad-based Finoso Pharma Private Limited, a formulation development company, on Thursday formed a 50:50 joint venture (JV) with US-based CritiTech Inc, a drug development company.

The joint venture will provide alternative API (active pharmaceutical ingredient) size reduction technology and particle design services to the pharmaceutical industry with associated formulation services to meet the research and development (R&D) and the early-clinical trial supply needs.

The focus will be on generic components and on therapeutic areas including anti-cancer and lung disease areas.

http://www.business-standard.com/india/news/finoso-pharma-forms-jvcrititech/480245/

Adcock buys India drug assets for $86 mn

South African drugmaker Adcock Ingram is to buy a portfolio of about 60 medicines and a distribution network from India’s Cosme Farma for $86 million to bulk up its pres-ence in the country’s $16-billion pharmaceutical market.
Privately held and family-owned, Cosme is a pan-Indian drugs company based in Goa with offices in Mumbai. It has a sales force with about 1,000 staff, making it a smaller player in India’s vast market.
http://www.business-standard.com/india/news/adcock-buys-india-drug-assets-for-86-mn/480068/

Code to bar pharma industry from luring doctors with gifts

The move seeks to end the skewed legal regime in which a mandatory code makes it illegal for doctors to accept "favours" from the pharmaceuticals industry but there is no such deterrent for drug makers from offering inducements to medical practitioners. 
According to sources, the department of pharmaceuticals in the chemicals and fertilizers ministry has called the industry, health ministry and revenue department on July 18 to discuss the marketing practices to be enjoined upon drug-makers. 
The continuing tryst with code of ethics in the health industry is blamed on the mismatch in the "dos and don'ts" for doctors and the industry. 
http://timesofindia.indiatimes.com/india/Code-to-bar-pharma-industry-from-luring-doctors-with-gifts/articleshow/14754579.cms

Indian pharma cos secure approval for 88 ANDAs from US FDA in first half of 2012

The investments in R&D is yielding better results for the Indian pharmaceutical companies and their subsidiaries with higher approvals for ANDAs despite existing stringent approvals norms of US FDA. Indian companies managed to get 88 ANDA approvals from US FDA during the first half ended June 2012 which worked out to 41.1 per cent of the total approvals of 214 ANDAs. During first half of 2011, US FDA approved a total 238 ANDAs, out of which Indian companies received 88 final approvals.
Further, Indian pharma companies obtained 21 tentative approvals during January-June 2012 from US FDA as against 19 in the corresponding period of last year. The total tentative approvals were 49 during the first half of 2012 as compared to 50 in the last period.
Sun Pharma and its subsidiaries, including Taro Pharmaceuticals, received highest final ANDA approvals for 12 products during the first half of 2012. Aurobindo Pharma, Dr Reddy's Laboratories and Strides Arcolab got 9 final approvals each. During 2011, US FDA approved 431 ANDAs, out of which Indian companies grabbed 144 final approvals.
http://pharmabiz.com/NewsDetails.aspx?aid=69955&sid=1

Dr. Reddy's seeks to introduce biosimilars in developed markets

Dr. Reddy's Laboratories is planning to introduce its biosimilar drugs in developed markets, according to chairman K Anji Reddy. "The company's biosimilars business grew by 45 percent over last year and recorded sales of $26 million" in fiscal 2012, the executive stated in Dr. Reddy's annual report, adding that the treatments are available "at prices that are significantly more affordable than the corresponding innovator drugs."

Dr. Reddy's current portfolio of biosimilars is comprised of filgrastim, peg-filgrastim, rituximab and darbepoetin alfa, which are sold in 13 emerging markets. According to Reddy, the company is awaiting approvals for biosimilar filings in 20 other countries and is also making progress in regulated markets

• Last month, the company entered into a partnership with Merck KGaA's Serono division to co-develop a portfolio of biosimilar compounds in oncology, notably monoclonal antibodies. The deal includes development, manufacturing and commercialisation of the drugs globally, barring certain country exceptions. Reddy noted that "with 177 biosimilar and copy biologics, oncology is currently the largest target therapeutic area for development and marketing of biosimilars."
• Reddy also indicated in the annual report that Dr. Reddy's will enter the Japanese generic market through its joint venture with Fujifilm, "with a plan to launch the first products in the next three to four years." The drugmaker expects that the limited competition experienced by generic launches in Japan could help it achieve sustainable growth.

http://www.firstwordpharma.com/node/998803

Govt considering Rs 2,000 cr VC fund for pharma

Government  is considering forming a venture capital fund of Rs 2,000 crore to promote research and development (R&D) in the pharmaceutical sector.
Government today said it is considering forming a venture capital fund of Rs 2,000 crore to promote research and development (R&D) in the pharmaceutical sector.
http://www.moneycontrol.com/smementor/news/government-policy/govt-considering-rs-2000-cr-vc-fund-for-pharma-725707.html

Shasun Pharma setting up intermediates facility in AP

Shasun Pharmaceuticals Limited is planning for backward integration by entering into manufacture of intermediates, initially with starting material for some of its key active pharmaceutical ingredients (APIs).
The company will be setting up a manufacturing facility for some of its petroleum products (for its APIs, which are used as ingredients in drugs) at Naidupeta in Andhra Pradesh with an investment of Rs 50 crore
http://www.business-standard.com/india/news/shasun-pharma-settingintermediates-facility-in-ap/477622/

Boehringer-Lilly alliance to launch first new diabetes drug in India

The diabetes products alliance between multinationals drug-makers Eli Lilly and Boehringer Ingelheim is set to roll out its first new product under the alliance.

Next week, Boehringer Ingelheim’s oral product Linagliptin will be available at chemists.
The product would be priced at Rs 42.70 per dose, per day.
http://www.thehindubusinessline.com/companies/article3527539.ece?homepage=true

Venus Remedies gets US patent for its new antibiotic product

Venus Remedies Limited, a research based global pharmaceutical company, has received patent from the US Patent Office for a breakthrough antibiotic product.

• The new drug product CSE1034 which is an antibiotic adjuvant entity (AAE), has been found to be effective against a wide range of drug resistant infections including the `superbugs’ like carbapenemase resistant Metallobetalactamses (MBL) strains, the company announced.
• Venus’ drug has a unique profile of action which gives it an edge over all the existing therapies. “This unique antibiotics adjuvant entity creates a synergistic effect due to its activity on AMRINGER (Acquired Multiple Resistance in Gram Negative Enterococci and Rods) which stops development and spread of bacterial resistance. Experience with clinical studies on more than 1000 patients have indicated approximately 20-30 per cent reduction in cost of therapy compared to conventional therapies being used

Venus Remedies is planning to launch this drug in India under the brand name ELORES and is planning to have a pre IND meeting with US FDA for fast track approval of this product.
http://pharmabiz.com/NewsDetails.aspx?aid=69513&sid=2

Dr Reddy's launches Parkinson's drug in US

Dr. Reddy's has obtained the approval of the United States Food and Drug Administration ( USFDA) for its abbreviated new drug application for Ropinirole Hydrochloride XR tablets to launch generic product.Ropinirole Hydrochloride XR tablets are bioequivalent generic version of Requip XL tablets, a registered trademark of pharma giant SmithKline Beecham.
Requip XL had reported sales of around $58 million for the 12 months period ended March 2012 in the US market according to IMS Health.
Dr Reddy's said its Ropinirole Hydrochloride XR tablets in 2 mg, 4 mg and 6 mg will be available in 30 and 90 count bottle sizes, 8 mg and 12 mg in 30 count bottle sizes.
http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/dr-reddys-launches-parkinsons-drug-in-us/articleshow/13894089.cms

Lupin Receives FDA Approval for SUPRAX (Cefixime) Capsules, 400 mg

Lupin Pharmaceuticals Inc. (collectively, Lupin) has received approval for SUPRAX^® (Cefixime) Capsules 400 mg from the United States Food and Drugs Administration (FDA). Lupin expects to commence shipping the product in the near future
SUPRAX^® is currently available as 100 mg/5ml and 200 mg/5ml suspensions as well as 400 mg tablets
http://www.firstwordpharma.com/node/989626

Indian pharma market to grow at 15.3% CAGR by FY14

The growth rate for the domestic Indian pharmaceutical market is set to rise over medium-term, according to  Barclays Capital Equity Research report - India Healthcare & Pharmaceuticals.

• The revenue CAGR (compund annual growth rate) over the past three years had been 12.4 percent, but it is expected to be up at 15.3 percent from FY12 to FY14
• The growth is expected due to factors like new product launches, focus on improving effectiveness of field force additions and favourable pricing environment
• Most of the pharma companies are expecting to continue with product launches in India over the next 2-3 years.
• While the net revenue CAGR from Indian coverage group has been 20% over FY2005-12, the US revenue CAGR for the group has been 24.5%, accounting for a large portion of the growth.
• While previously there were no Indian companies in the top-20 generics firms in the US, currently 4-5 of Indian firms are present in this list, according to 2011 prescription trends (IMS data).

http://www.business-standard.com/india/news/indian-pharma-market-to-grow-at-15-cagr-by-fy14/166615/on

Centre promoting pharma cluster in AP with Rs 66-cr outlay

The Centre is promoting a pharma cluster with an investment of Rs 66.16 crore at the PCPIR in coastal Andhra Pradesh
The State is third in formulations in the country. It accounts for 40 per cent of the total Indian bulk drug production and 50 per cent of the bulk drug exports
http://www.thehindubusinessline.com/industry-and-economy/economy/article3462673.ece

Sun Pharma gets USFDA nod for nasal spray

Sun Pharma has received approval from the US Food and Drug Administration (USFDA) for its generic Azelastine HCL nasal spray, which is therapeutically equivalent to Medpointe Pharm HLC's Astelin nasal spray, Sun Pharma said in a statement
The drug is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing and nasal pruritus.
It is also used for treating symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults.
According to the company estimates, Azelastine HCL nasal spray has annual sales of around $144 million in the US
http://www.business-standard.com/india/news/sun-pharma-gets-usfda-nod-for-nasal-spray/165790/on

Aurobindo Pharma gets US nod for generic anti-HIV drug

The company has received final approval from the United States Food and Drug Administration (USFDA) for its Nevirapine tablets in the strength of 200 mg and Nevirapine oral suspension in the strength of 50 mg/5ml, Aurobindo Pharma said in a statement
According to IMS health data the products have a market size of approximately $125 million for the twelve months ending December 2011
http://www.business-standard.com/india/news/aurobindo-pharma-gets-us-nod-for-generic-anti-hiv-drug/165700/on

Piramal completes Phase-I trials of new cancer molecule

The data of the Phase-I trials will be presented at the annual meeting of American Society for Clinical Oncology to be held in Chicago from June 1-5,2012
P1446A-05 exhibits high oral bio-availability, shows potent anti-proliferative activity in several human cancer cells and is efficacious in xenograft tumour models, Piramal Healthcare claimed.

The company further said: "P1446A-05 will be the second molecule in Piramal's oncology pipeline to enter Phase-II trials (conducted on a larger human sample)."
The first molecule P276 in in Phase II/III trials for multiple indications of cancer.
http://www.business-standard.com/india/news/piramal-completes-phase-i-trialsnew-cancer-molecule-/165633/on

Aventis Pharma renamed as Sanofi India

Sanofi Group's listed entity in India, today announced that the Registrar of Companies had approved the company's change of name from Aventis Pharma Ltd to 'Sanofi India Ltd', with effect from May 11,2012. The decision to change the name of the Group's listed entity in India comes a year after the name of the parent company was changed globally from Sanofi-Aventis to Sanofi in May 2011.
http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/aventis-pharma-renamed-as-sanofi-india/articleshow/13165685.cms

India's Piramal Healthcare to buy U.S. firm to boost R&D

The company aims to close the acquisition of Decision Resources Group (DRG), based in Burlington, Massachusetts, by the end of June 30. The unit, with a team of about 300 analysts, is expected to bring in revenues of $160 million in 2012
http://in.reuters.com/article/2012/05/16/us-india-piramal-acquisiton-idINBRE84F06A20120516

Massive gelatine shortage hits capsule makers, may affect formulation production

Indian pharma industry is facing an acute shortage of gelatine, used for the manufacture of hard capsules, soft gels, coated tablets, mini, micro capsules. The shortfall is because gelatine makers have either faced closure of units due to labour unrest, effluent issues and cyclone in December which damaged the plant and material.
http://pharmabiz.com/NewsDetails.aspx?aid=68991&sid=1