Sparsha Pharma to launch 3 transdermal products soon, got DCGI nod for marketing one

Sparsha Pharma International, the lone manufacturer of transdermal patches, a medicated adhesive patch that is placed on the skin to deliver a specific amount of drug through skin and into the bloodstream, is planning to launch three products in a couple of months.

The Hyderabad-based company already has a product, fentanyl transdermal patch, in the market. Fentanyl is a potent synthetic narcotic analgesic with a rapid onset and short duration of action. It was given to Dr Reddy’s Laboratories with exclusive rights for one year to sell in the domestic market in 2009 and Dr Reddy’s is marketing the product under the brand name, Finrid. Later, after the expiry of the exclusivity period Sparsha launched the product in the domestic market last year under the brand name, Fen-Touch.

“We are planning to launch two more products in a couple of months and we have already received approval from the Drugs Controller General of India (DCGI) for one of the products. Both the products are for pain management. Another product, which is for the treatment of asthma, is in clinical trial stage and will launch in a few months”, Dange Veerapaneni, managing director, Sparsha Pharma International, told Pharmabiz.

The company has a technology collaboration agreement with Japan-based leading transdermal patches manufacturer. Sparsha, with a manufacturing capacity of 1.5 crore transdermal patches per annum, is planning to invest Rs.60 crore in two phases as a part of expansion of its existing facility near Hyderabad. Sparsha is also mulling options to engage in contract manufacturing services

Commenting on the advantages of transdermal delivery, Dange Veerapaneni said that it avoids stomach upset common to orally administered drugs, side effects are less as the drug does not travel to all parts of the body and the drug is not subject to degradation during the first-pass effect as compared many oral drugs.

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CEL-SCI Gets Approval To Begin Phase III Clinical Trial Of Multikine In India for Head & Neck Cancer

CEL-SCI Corporation announced that it has received approval to begin enrolment of patients in its phase III clinical trial of Multikine in India from the Directorate General of Health Services Office of Drug Controller General of India (DCGI) - the Indian equivalent of the FDA. India is an important country for this nine country clinical trial because about 15 of the 48 clinical centres for this global trial will be located in India and because India has the greatest number of head and neck cancer cases in the world. 

It is expected that patient enrolment in India will be about 4-6 times faster than would be possible in US clinical centres. The global phase III trial for Multikine was started in the United States in late December 2010. CEL-SCI expects to commence the trial in other countries around the world within the next 30-60 days. Multikine is the company's flagship immunotherapy developed as a first-line standard of care in the treatment of head and neck cancer.

CEL-SCI's phase III clinical trial is an open-label, randomized, controlled, multi-centre study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival, versus the subjects treated with standard of care only.

CEL-SCI's 880 patient phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the benefits of immunotherapy.

Phase II clinical trials of Multikine demonstrated that the product was safe and well-tolerated and eliminated tumours in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumours before the start of standard therapy. Follow-up studies of subjects enrolled in phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The US Food and Drug Administration granted orphan drug status to Multikine in the neo-adjuvant therapy of patients with squamous cell carcinoma of the head and neck.

CEL-SCI Corporation is developing products that empower immune defenses. The lead product, Multikine is currently being tested in a global phase III clinical trial that started in December 2010. In phase II clinical trials Multikine was shown to be safe and well-tolerated and to improve the patients overall survival by 33 per cent at a median of three and half years following surgery.

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Stempeutics Research gets DCGI clearance for Stempeucel

Stempeutics Research, a group company of Manipal Education & Medical Group announced today that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel allogeneic product is developed from mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by its share holders - Manipal Group and Cipla.

Being the first of its kind stem cell product developed in India, it took almost 15 months to get DCGI clearance. DCGI referred Stempeutics proposal to Indian Council for Medical Research for review and recommendation. ICMR constituted an expert stem cell committee to examine the proposal and the committee accepted the study as Phase II clinical trials. The DCGI’s clearance of Stempeucel product for the four debilitating diseases is one of Stempeutics’s significant accomplishments towards its goal of bringing safe, effective and affordable stem cell based product in India in the near future. India becomes one of the leading countries after USA to enter this phase of Stem Cell research.

Commenting on the DCGI’s approval, Mr BN Manohar, CEO, Stempeutics Research said “We are the only company in India which has achieved this significant mile stones. Our team is working towards hitting the first stem cell “off-the-shelf” product in the Indian market by the end of 2013. Stempeucel product has been developed using international standards with stringent quality control. We have pioneered large scale upscaling of mesenchymal stem cells and we expect that it will be the most cost effective product globally”.

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