Quantcast
Last updated on May 20, 2013 at 16:49 EDT

Pharmalink Enters Manufacturing Agreement for Busulipo(TM)

November 12, 2012

STOCKHOLM, Sweden, November 12, 2012 /PRNewswire/ –

Pharmalink AB, a Swedish specialty pharma company, today announces it has entered into
a service contract with GP Pharm for the manufacturing of Pharmalink’s Busulipo(TM), which
is under development to provide a best-in-class conditioning agent for use prior to
hematopoietic stem cell transplantation (HSCT), often known as bone marrow
transplantation. GP Pharm is a Spanish biopharmaceutical company that focuses on
injectable oncology products. Besides its proprietary products it also offers services in
contract development and contract manufacturing.

The agreement covers the manufacturing of Busulipo from clinical to commercial
quantities and is an important step in progressing the product towards the market. No
commercial terms were disclosed.

Johan Haggblad, Managing Director of Pharmalink, said: “Busulipo is an immediate
release liposome formulation that improves the safety and stability of the chemotherapy
agent busulfan that is currently the gold standard for use in conditioning prior to HSCT.
Busulipo allows the elimination of the toxic solvent DMA and has been designed to have a
two year shelf life and increased stability after reconstitution. GP Pharm has an
excellent track record in the manufacturing of complex injectables and specifically with
liposomes. We look forward to working with GP Pharm as Busulipo enters the next phase of
clinical development.”

HSCT has become a treatment of choice for many diseases in adults and children and
myeloablation as a conditioning regimen is an important part of a successful outcome.
There are more than 50,000 HSCTs carried out per year. The concept behind Busulipo was
originally developed at Karolinska Institute (Sweden) and was acquired by Pharmalink in
2006.

Busulipo has successfully undergone clinical trials with more than 90 patients
treated. Extensive data on efficacy, safety and pharmacokinetics have been collected and
these compare positively with historical controls. Pharmalink is currently preparing the
late stage clinical trials needed for registration and introduction of Busulipo into key
global markets in discussion with regulatory authorities.

About Pharmalink

Pharmalink is a Swedish specialty pharma company developing high value products for
niche indications. Pharmalink draws on its extensive experience of pharmaceutical
development and marketing and the excellence of medical science in Sweden to identify and
progress products that address significant unmet medical needs. With a successful history
in pharmaceutical sales and marketing, and highly experienced, dynamic management team,
Pharmalink is currently focused on the development of valuable, de-risked projects using a
repurposing and reformulation strategy. It has two late-stage clinical phase products
under development, Nefecon(R) and Busulipo(TM), having successfully divested its Xepol(R)
product in 2010. Pharmalink is actively seeking opportunities to acquire or in-licence
product opportunities in niche and hospital care indications. Visit
http://www.pharmalink.se for further information.

About GP Pharm

GP Pharm, is a Spanish biopharmaceutical company located in Barcelona. Its activities
are focused on research, development, production and marketing of injectable products
within the urology and oncology fields, some of them based on proprietary drug delivery
systems. These technological platforms include microspheres and liposomes. The company
works on the complete development of these drugs, from the preclinical studies until the
launch to the markets. These specialties are marketed either under own brands or through
licenses. The last successful submitted product is Lutrate(R) 1 month (a DEPOT formulation
of leuprolide acetate for prostate cancer treatment) that has been approved in 23
countries of the European Union, including UK, Spain, Germany and Italy. Visit
http://www.gp-pharm.com for further information.

        For further information, please contact:

        Pharmalink AB:
        Johan Haggblad, Managing Director, +46(0)70-668-0644
        Email: johan.haggblad@pharmalink.se

http://www.pharmalink.se

        Citigate Dewe Rogerson:
        Chris Gardner/Nina Enegren, +44-207-638-9571

SOURCE Pharmalink


Source: PR Newswire