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Anti-cancer moves of biotech companies
Biotech companies are bullish about the prospects in the oncology segment
and are making announcements more frequently now. A list of some of the major
developments is presented here.
Actis Biologics
Mumbai-headquartered Actis Biologics (ABPL), founded in
December 2005, is an emerging biopharmaceutical company developing new therapies
for life-threatening diseases. It has a strong focus in the areas of cancer and
cardiovascular disease. The company is building a strong pipeline of clinical
stage products (some of which are already in human trials) through in-licensing
and internal research. ABPL has in-licensed technology platforms in the areas of
ribozymes, gene therapy, vaccines and recombinant protein technologies. All of
them have shown promise in either human (Phase I and Phase II molecules) or in
animal models (preclinical molecules).
The company submitted a project titled "Delivery of
MSP36 with Lenti Viral Vector" to the DBT in December 2005. This was
approved for funding in 2006 and the loan was sanctioned in April 2007 and funds
dispersed in May 2007. ABPL's major product is Anjizoyme, which will target
mainly lung and breast cancer. "This will target a $16 million market
opportunity, the first application being lung and breast cancer. Angiozyme was
found to be very effective in Phase II trials and we have now applied to DCGI
for Phase III trials," said PN Venugopalan, president, Actis Biologics. The
company was also in news recently for the acquisition of its technology platform
for effective treatment of hepatic cancer, from CellPoint Diagnostics, USA. This
technology, which was given the orphan drug status by the FDA also, helps in
drastically reducing toxicity.
Biocon
Biocon in 2006 launched its lead molecule in oncology--BioMAb
EGFR, the monoclonal antibody for head and neck cancer treatment. The pivotal
trial for BioMAb-EGFR along with standard of care chemo-radiotherapy in advanced
Squamous cell of the head and neck (SCCHN) indicated a significant survival
benefit as compared to chemo-radiotherapy alone. Clinical trials are on going in
glioma and NSCLC. A novel monoclonal antibody targeting CD20 for NHL, B-CLL is
in preclinical development.
Kiran Mazumdar Shaw, chairperson and managing director,
Biocon shared, "It was interesting to bring the first true proprietary
immunotherapeutics to the Indian market. BioMAb-EGFR is competitively priced,
making cancer treatment more affordable. It has the potential to be a billion
dollar product and we expect it to be worth Rs 100 crore in the next three
years."
The company has made an investment of approximately Rs 150
crore in developing BioMAb EGFR, including the clinical development programs and
the manufacturing facility. The investment in the clinical development program
is still in progress for other cancers and each clinical trial is costing around
Rs 15-20 crore. Biocon's other products for use in the oncology segment
includes EPO and G-CSF.
MNCs
GlaxoSmithKline
With in-licensing being a major part of its
strategy, which also accounts for a major part of its growth, the
Indian market saw the launch of Tykerb in the first quarter of 2008.
With around eight in-licensing deals already signed and with sales of
Rs 80 crore in biologicals in the previous fiscal, GSK has a good
number of anti-cancer products in the pipeline. One of its major
offerings in the pipeline for the Indian market is its anti-cancer
vaccine for cervical cancer. The product is to be launched in India by
2009, despite industry experts claiming that the product can face
hurdles of pricing issues. Launched in the US and the EU in 2007, the
product did face some hiccups with the FDA. The authority was seeking
clarification on the clinical data details related to this vaccine
thus delaying the launch. However, the feather in the cap for GSK
proved to be when in June 2008, Cervarix was confirmed as the UK
Department of Health's vaccine of choice for its national human
papilloma virus (HPV) immunization program.
Novartis India
Novartis India's approach to the Indian oncology
market is slightly different from its global business model. It has
taken into account two factors. First, the Indian market has a small
segment of patients who are covered by total medical care and second,
while direct-to-patient promotion is allowed in the US, in India the
promotion of healthcare products is only through physicians. The
Indian business model focuses on generating the prescriptions by
sending representatives. "Global pricing in developing markets
restricts the access of innovative therapies to the reimbursed
masses," said Ranjit Shahani, vice chairman and MD, Novartis
India. Hence, on these lines the company supplied its oncology drug,
Glivec, free to around 9,700 patients. Same is the case with Asunara
which is available globally as Exjade. Exjade is available at a cost
of Rs 60,000 per month's therapy, while Novartis has slashed the
rate down to Rs 4,000 per month!
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Dabur
The oncology major, Dabur Pharma has almost 40 anticancer
drugs in its portfolio. This consists of both cytotoxic agents as well as
hormonal drugs that cover various types of cancer. Dabur came out with a
formulation, Nanoxel (a nanoparticle-based formulation) which is free from
chremophore and the toxicity (hypersensitivity reactions). "Nanoxel is
India's first nanotech-based drug delivery system that was released in January
2007. In a conventional Paclitaxel-based formulation, one has to give a
premedication, whereas this is not required in Nanoxel. There is no nuetropenia
in Nanoxel and its efficacy is higher than conventional Paclitaxel," said
Dr Shivakant Mishra, vice president, clinical research and medical services,
Dabur.
Nanoxel was first approved for metatstatic breast cancer and
later, based on a few studies, was found suitable for other indications such as
ovarian cancer and small-cell lung cancer. "We are working on a NDDS
formulation that is in clinical trials. We would like the anti-cancer drugs
available to the patient in a very cost-effective manner. We are making both
APIs and formulations and we have the interest and ability to see that drugs are
available to a maximum number of patients," Dr Shivakant added.
Intas Biopharmaceuticals
Currently Intas Biopharmaceuticals has an oncology portfolio
of 26 products comprising of 22 oncology drugs and four biotechnology products.
"The introduction of GEFFY, for treatment of lung cancer, especially
non-small cell lung cancer (NSCLC), has strengthened our domestic market share
in the lung-cancer market. Expanding current portfolio of lung cancer drugs,
which comprises CYTAX, GEMIBINE, CARBOPA, and TAXOCARE, the company is poised to
grab a major market share in India," said Simon Daniel, chief executive
(marketing), Intas Biopharmaceuticals Ltd. As part of its expansion strategy,
Intas Biopharmaceuticals Ltd will be launching four oncology products in the
coming months. "Two drugs in solid tumor segment, namely Pemetrexed (brand
name: PEMMET) and Oxaliplatin (brand name: OXITOZ) and two drugs in
hematological malignancies segment, namely Lenalidomide (brand name: LENOME) and
Amphotericin B (brand name: AMFY), are coming up," added Daniel.
With target revenues of Rs 100 crore, currently the company
has a couple of biotech products in the pipeline, which will be launched in the
near future. With these targets, the company believes that growth is fuelled by
deeper penetration into the less regulated markets of Asia, Africa, Latin
America and the Middle East.
Panacea Biotec
The third largest biotech company in India, Panacea Biotec,
forayed into the oncology segment last year. It launched seven ant-cancer
products--for treatment of breast cancer, brain tumor, ovarian cancer,
pancreatic cancer, prostrate cancer and colorectal cancer-in India. The drugs
were manufactured by a Mumbai-based company and sold under the brand name of
Panacea Biotec. A new strategic business unit SBU, Oncotrust, with a strength of
50 sales specialists was set up to market the drugs with an aim to register
sales volumes of Rs 15-20 crore in the oncology chemotherapy segment over the
next three years. The company, which generated total sales of Rs 830.44 crore in
2007-08, hopes to achieve Rs 12 crore in revenues from this segment by the
financial end. "Market for oncology products is highly competitive, yet we
have been able to garner sales of around Rs 50 lakh every month," said
Rajesh Jain, joint managing director, Panacea Biotec.
RPG Life Sciences
RPG Life Sciences, the life sciences division of the Kolkata-based
RPG Group, is revamping its business strategies to enter the biotech industry.
"We will be launching one product every year. We will gradually move from
being an API player to a formulation player. The investments will be on three
fronts-capacity expansion, capacity creation and facility upgradation for
regulated markets," said Arvind Vasudeva, managing director, RPG Life
Sciences.
According to him, RPG Life Sciences' biotech division will
predominantly focus on prime segments such as oncology, immunosuppressant and
other high value biotech products. "We have expanded our R&D team so as
to bring one-two new molecules in the market every year. We have also doubled
our oncology capacity and are working on enhancing our immunosuppressant
capacity. This will help us to commercialize our pipeline products," said
Vasudeva. He also added that the company would spend about Rs 30-35 crore over
the next three years on these initiatives.
Shantha Biotech
Hyderabad-based Shantha had launched the Cytocrest
initiative, in an effort to prolong the life of cancer patients through
cost-effective therapies. Under this initiative, it's introducing several new
generation oncocare products which are either developed in-house or through
alliances with major pharmaceutical companies. Shantha's whole gamut of
therapies in cancer care has therefore been planned under the flagship of
Cytocrest, which includes chemotherapeutics, biological therapy and supportive
therapy. These are for marketing in India only.
Nayantara Som with inputs from Jahanara Parveen (Bangalore) and
Shalini Gupta (New Delhi)
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