Wockhardt gets nod to enter Lamisil market

Pharmaceutical and biotechnology major Wockhardt received USFDA tentative approval to market Terbinafine tablets (Lamisil) in the US. Terbinafine is used to treat fungal infections such as onychomycosis (condition that affects the toenails or the fingernails). With the US product patent for this drug expiring on June 29, 2007, Wockhardt will launch Terbinafine, the generic version of brand Lamisil sold by Novartis, in early July.

"Our Wockhardt USA team is ready to embark on the 'Day-one' launch of Terbinafine," said Wockhardt chairman, Habil Khorakiwala. "The US market for Terbinafine tablets is about $680 million. Tapping this market, in addition to our speedily increasing product portfolio is a manifestation of our rapidly expanding capabilities in the US."

The Terbinafine tablets are manufactured at Wockhardt's US FDA certified formulation plant at Waluj, Maharashtra. Market shares of all Wockhardt USA products are exhibiting a good growth. Wockhardt currently markets 20 products in the US.

"We now also have on the management board of Wockhardt USA, president, Kurt Orlofski, who will spearhead the US generics business. We are confident that Wockhardt's generic business will scale greater heights and establish an important position in the generic industry," said Khorakiwala.

Q4 performance boosts Zenotech's profit

For the 4th quarter ended March 31, 2007, Zenotech Laboratories' total income from sales and operations and license fees aggregated to Rs 1,178.67 lakh (Rs 326.36 lakh) and net profit for the quarter stood at Rs 481.76 lakh (loss of Rs.11.26 lakh).

For the year ended March 31, 2007, total Income from sales and operations and license fees aggregated to Rs 2,264.64 lakh (Rs 1,319.62 lakh) and Profit After Tax (PAT) for the year stood at Rs 362.47 lakh (loss of Rs 73.80 lakh). The company's results were boosted by license fees of Rs 900 lakh earned during the fourth quarter of the year.

GEAC approves multi locational research trials of Bt cotton

The 78th meeting of the Genetic Engineering Approval Committee (GEAC) approved Multi Location Research Trials (MLRT) of several Bt cotton, although the food crops rice, okra, corn, brinjal and potato could not get approval.

Permission to conduct MLRT of Bt cotton expressing approved gene/events have been approved. This includes BG I cotton hybrids, BG II cotton hybrid, cry1Ac gene, 3 intra – hirsutum hybrids, 2 inter-specific hybrids, 3 inter-specific hybrids, 5 Bt cotton hybrids, Bollgard cotton hybrids has been given. The MLRT will be taken in central and south zones at various locations.

The committee also approved the proposal for strip trials of Bt cotton expressing approved gene/events. This will cover 35 Bt cotton hybrids, 115 transgenic Bt cotton hybrids, 29 intra-specific Bt cotton hybrids and others will be included. Experimental seed production of Bt cotton expressing approved gene/events has also been given approval.

MLRT of GM food crops were not given approval. Companies require to submit validated protocol for detection of 0.01 per cent level contamination. Subject to this submission they will get approval later on. This include six transgenic Bt rice hybrids, 3 transgenic Bt Okra hybrids, YieldGuard corn parental lines, Roundup Ready Corn hybrid, Bt brinjal, 8 cotton hybrids, flex cotton hybrids etc.

The Large Scale Field Trials (LSFT) of Bt cotton expressing new gene/events did not get approval today because they did not complete full bio-safety studies. This include cotton hybrids expressing Cry1C gene and seed production of cotton hybrids. The committee has approved the import of Soybean oil obtained from round-up ready soybean by Solvent Extractors' Association of India.

Indoco sets up Rs 22.5-crore R&D facility

Indoco Remedies has set up a new R&D center at Navi Mumbai at a cost of
Rs 22.5 crore, in order to fully integrate into CRAMS space. The research activities at the facility include synthesis of APIs, process improvement and development of non-infringing processes for APIs and intermediates, formulations development, analytical studies and regulatory affairs.

Aditi Kare Panandikar, director, business development, Indoco, said, "Indoco aims to transform itself into a completely integrated player in CRAMS space."

India has emerged as a secure territory for research and manufacturing of patented products and the company would leverage this opportunity. The facility would be aimed to work for firms from European countries and the US market.

"The unique feature of the R&D center is the Kilolab, which is versatile to perform a wide variety of reactions and complete multistage intermediate and API processes for preclinical phase to Phase III clinical studies, and will in turn amplify Indoco's contract development and manufacturing services to the rest of the world," explained Aditi.

Indoco views its R&D capabilities as a vital component of its business strategy that will provide the company long-term competitive advantage. The company intends to take up NDDS research and expects to commercialize the first NDDS product in calendar 2008, It is in the process of setting up a separate R&D team for the same.

With the commissioning of its new R&D center in April 2006, Indoco now has in place a total of five facilities for formulation, Goa Plant I {oral solids, creams and liquid dosage plant: Approved by MHRA-UK and Darmstadt Germany} Goa Plant II {sterile facility for ophthalmic and injectables: Approved by USFDA} Baddi {WHO: GMP}, Aurangabad and Tarapur facilities for non regulated market. For APIs, scale up facility- Kilolab is backed by two commercial manufacturing facilities at Patalganga as per USFDA standards and at Rabale as per WHO: GMP standards.

Intas Biopharma receives EU-GMP certification

Intas Biopharmaceuticals Ltd (IBPL) has achieved the unique distinction of becoming India's first dedicated biopharmaceutical company to receive certification of European Agency for the Evaluation of Medicinal Products (EMEA) or an EU-GMP certification for its manufacturing facility at Ahmedabad. The certification is a significant step towards fulfilment of IBPL's plans to tap Europe market. Moreover the certification give strong advantage to IBPL as the company can strengthen existing alliances and look forward to possible agreements with other pharma/biotech companies in new geographical regions of Europe .

Addressing mediapersons, Mani Iyer, director, IBPL, said, "On the R&D front, the certification will allow IBPL to get an entry into regulated markets of Europe to conduct clinical trials for many of our products which are in the pipeline. The process of clinical trials is mandatory and a pre-requisite for the company to develop the products and market them in Europe. Additionally, this certification has opened new avenues for the company to explore existing/new technologies and processes.

For IBPL, EU-GMP certification will also simplify the procedure for product registration in different countries of the world by significantly reducing the time required by the company to get the product registration. Also, many companies across the globe would be keen to associate with us for our products and services."

The company has successfully launched therapeutic recombinant proteins Neukine (rHu G-CSF), Erykine & Epofit (rHu EPO) and Intalfa (rHu IFN Alfa-2b) in the domestic markets and couple of international markets. It is the only company in Gujarat with an impressive track record of launching three indigenously developed biotech products in as many years.

Strides Arcolab completes acquisition of Grandix Pharmaceuticals

Strides Arcolab has announced that it has signed a definitive agreement to acquire 100 percent of Grandix Pharmaceuticals and its subsidiary Grandix Laboratories on a cash and debt free basis valuing 100 percent of the company at Rs 100 crore.

The transaction is accretive to Strides EPS and offers a platform to grow a domestic strategy by infusing a robust Strides pipeline. Pricewaterhouse Coopers acted as an independent valuer of the transaction. For the FY 2006, Grandix posted sales of Rs 48.50 crores ($11.80 million) and EBITDA of Rs 10.89 crore ($2.60 million)- 22 percent. Sales in 2007 is expected to grow at over 30 percent.

Strides Arcolab has no domestic presence and Grandix will be the springboard to launch a national presence by leveraging existing Grandix products with the company's strong R&D pipeline.

New antibiotic launched to battle drug-resistant infections

Wyeth Ltd, the subsidiary of the $20-billion global pharmaceutical and healthcare company Wyeth, recently announced the launch in India of Tygacil (tigecycline), its novel intravenous (IV) antibiotic with a broad spectrum of antimicrobial activity against drug-resistant bacteria.

Tygacil is the first antibiotic in a new class called glycylcyclines. It is indicated for use in complicated infections of the skin and soft tissue and complicated intra-abdominal infections. Tygacil has in-vitro activity against many gram-positive and gram-negative bacteria, including multi-drug resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE).

The new drug provides doctors with a treatment alternative for complicated skin and intra-abdominal infections. Tygacil will be immediately available to hospitals and surgical professionals across the country for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) in adults.

Speaking at the launch in New Delhi, Prof. John T Sinnott, director of the Division of Infectious Disease and International Medicine, Florida, USA said, "Drug-resistant organisms are a growing problem worldwide. Inadequate infection control and shortfall in hygiene and public health are driving resistance in developing countries. The unique structure of tigecycline not only provides expanded broad spectrum of in-vitro activity, it avoids the tetracycline-resistance mechanism."

"It is the most appropriate time to introduce a new class of antibacterial agent in India," said Dr Chand Wattal, senior consultant and chairman, Department of Clinical Microbiology, Sir Ganga Ram Hospital, New Delhi. "The availability of Tygacil is a boon at a time when life-threatening hospital acquired infections are present universally."

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