A Medical Device Daily

BD (Becton, Dickinson; Franklin Lakes, New Jersey) said last month that it has entered into an agreement that will form the basis of a public-private collaboration to help prevent the reuse of syringes in India. The program will involve the introduction of auto-disable syringes, education and training of healthcare workers, and the implementation of advocacy programs with the Indian government.

The agreement is between BD and Hindustan Latex (HLL; New Delhi, India), a government of India enterprise.

For the new collaboration, BD will manufacture and sell to HLL auto-disable syringes based on BD SoloShot technology for immunization purposes. HLL will market these syringes under its own brand name, AutoLok. A curative syringe specially designed to prevent reuse, based on BD's SoloMed technology, also will be manufactured by BD and sold to HLL.

BD, which has a manufacturing facility in Bawal, India, also has agreed to provide certain consulting services to HLL relating to the marketing and sale of the auto-disable and reuse prevention syringes. BD and HLL will work together to train and educate healthcare workers about safe injection practices and the new technology.

M. Ayyappan, managing director of Hindustan Latex, said, “HLL is already a leader in HIV/AIDS prevention and this collaboration expands our capabilities. While unsafe sex remains the leading cause of the spread of this disease, medically transmitted HIV/AIDS remains the second-leading cause in India.“

A recent study conducted by the government of India indicated that 60% of all injections given in India were unsafe. World Health Organization (Geneva, Switzerland) figures indicate that worldwide, unsafe injections account for 53.6% of all hepatitis B, 59.5% of hepatitis C and 24.3% of HIV/AIDS infections each year.

The Union Minister for Health and Family Welfare, Dr. Anbumani Ramadoss, recently declared in Parliament that the government of India would introduce legislation to ensure the use of auto-disable syringes in its immunization programs to safeguard children from contracting diseases such as AIDS.

Patent issued for Biocoral biomaterial

Biocoral (Wilmington, Delaware/Cedex, France) reported that the Canadian Intellectual Property Office recently granted to the company a patent called “Bone Prosthesis material Containing Calcium Carbonate Particles Dispersed in a Bioresorbable Polymer Matrix.“

The patent, No. 2093269, was granted to Bio Holdings International, the company's wholly owned subsidiary.

Biocoral, the company's primary product, a bone graft substitute derived from natural coral containing calcium carbonate in crystalline form (aragonite and/or calcite), is used by surgeons and practitioners because of its biocompatibility, resorbability, osteoconduction and safety. The technique covered by the Canadian patent enhances those qualities. As a result of the combination of large amounts of particulate calcium carbonate with a polymer matrix, it is possible to obtain a composite material that has the same advantages as the calcium carbonate-based materials without having their drawbacks, such as the difficulty of producing items of any particular shape.

The polymers can be implanted in humans without causing unacceptable side effects.

Among the polymers that can be used are those derived from hydroxyxarboxylic acids.

Nasser Nassiri, chairman and CEO of Biocoral, said, “[This] will protect the company's technology and its primary product in new applications in Canada, where the company is looking to develop its product.“ He added that an additional 12 titles of patents have been developed for various applications and uses of its products, such as autologous glue, the combination of Biocoral with growth factor and a method of treating a disease associated with demineralization or mineralization bone defects (osteoporosis remediation), among others.

Nassiri said the company now owns more than 185 patent applications around the world, about 140 of which have thus far been granted by the patent offices of various countries.

Hextend, PentaLyte in Japan development

BioTime (Berkeley, California) reported that it has entered into an agreement with Summit Pharmaceuticals International, an affiliate of Sumitomo (Tokyo), to develop Hextend and PentaLyte for the Japanese market.

Hextend and PentaLyte are blood plasma volume expanders designed for the treatment of hypovolemia, a condition caused by low blood volume, often from blood loss during surgery or from injury. Plasma volume expanders maintain circulatory system fluid volume and blood pressure and keep vital organs perfused during surgery.

Hextend and PentaLyte are similar formulations, except that PentaLyte contains a lower molecular weight hydroxyethyl starch than Hextend and is more quickly metabolized. PentaLyte is designed for use when shorter lasting volume expansion is desirable.

In the agreement, Summit will pay BioTime $900,000 in three installments as partial reimbursement of BioTime's development costs of Hextend and PentaLyte. BioTime has already received the first installment of $300,000. In addition, BioTime will pay Summit a one-time fee of $130,000 for its services in preparing a development plan for those products in Japan. Moreover, Summit will apply for regulatory approval to manufacture and market Hextend and PentaLyte in Japan for use at body temperatures above 12 degrees centigrade.

BioTime and Summit said they do not plan to manufacture and market Hextend and PentaLyte themselves but rather will seek to license manufacturing and marketing rights to a third party.

When Hextend and PentaLyte are licensed and sold in Japan, BioTime will receive 40% of the revenues from licensing fees, royalties and net sales, and any other payments made for co-development, manufacturing, or marketing rights, and Summit will be entitled to the remaining 60%. BioTime will pay to Summit 8% of all net royalties actually received by BioTime from the sale of PentaLyte in the U.S. plus 8% of any license fees that BioTime receives in consideration of granting a license to develop, manufacture and market PentaLyte in the U.S.

BioTime's blood plasma volume expanders and blood replacement solutions are used in surgery, emergency trauma treatment and other applications.

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