Deriving the maximum benefit from SBIRI funding, Bharat
Serum & Vaccines has successfully managed to develop an indigenous
product to treat fertility disorders in women
Fertility disorders, for centuries, have been the cause of grave
concern for women across the globe. Working in this direction, the
Mumbai-based Bharat Serums & Vaccines (BSVL) has produced the
country's first indigenously developed recombinant follicle
stimulating hormone (FSH). This product is used extensively to treat
fertility disorders in women. The timely availability of the Small
Business Innovation Research Initiative (SBIRI) funding provided the
much needed support to the company's in-house efforts and funds for
developing and commercializing the product. It also encouraged the
company to expand its R&D capabilities and capacity.
The trademark name of the product is “FOLIGRAF” (r-hFSH), and it is a
sterile freeze dried preparation of follicle stimulating hormone in
genetically engineered Chinese hamster ovary (CHO) cells. The r-hFSH is
a heteroadimeric glycoprotein consisting of two non-covalently linked
alpha and beta subunits. It is presented in lyophilized form of
75 and 150 IU/vial, intended for subcutaneous injection.
Following intravenous administration, r-hFSH is distributed to the
extra cellular fluid space with an initial half-life of around two
hours and eliminated from the body with a terminal half-life of about
one day. The steady state volume of distribution and total clearance
are 10 l and 0.6 l/h, respectively. One-eighth of the r-hFSH dose is
excreted in the urine. Following subcutaneous administration, the
absolute bioavailability is about 70 percent. The study reports by the
company concluded that r-hFSH is more effective than urinary FSH in
terms of a lower total dose and a shorter treatment period needed to
achieve pre-ovulatory conditions.
Before the BSVL product was introduced in the market, all the
recombinant products used to be imported in the finished form. The
FOLIGRAF vial comes in a packing of 75IU *1's and 150IU*1's with
a cost of $41 (
1800) and $79 (
3500) respectively. Also the
Recombinant FSH provides much better safety than the alternatives. It
has an inherent advantage over the urinary derived FSH with no threat
of transmission of viruses like HIV, HCV, HBsAg with r-FSH. Besides
that the product has batch to batch consistency due to well
controlled manufacturing process.
The Way Forward
BSVL's vaccine would help to make the country self sufficient in terms
of meeting the domestic requirements. Launched in September 2008, the
product is currently available throughout India with an expected
170 million in 2010-11.
BSVL has developed its competency in the areas of novel drug delivery
systems (NDDS) and in development and purification of equine-based
therapeutic products. With a focus on biopharmaceuticals, novel drug
delivery systems and equine products, the company has made significant
progress in R&D activities. To reduce the toxicity of the existing
drugs significantly, the company is developing core competency into new
drug delivery system. The different products that are in pipeline are
liposomal doxorubicin (non pegylated), cisplatin emulsion, amphotericin
B emulsion, amphotericin B lipid complex and propofol lipid free.
For future growth, BSVL is targeting the regulated markets for its
products through technology licensing.
in New Delhi