A Medical Device Daily

Major hospital products supply company Hospira (Lake Forest, Illinois) plans to bolster its presence in the provision of specialty injectable pharmaceuticals with its proposal to acquire Australia-based Mayne Pharma (Melbourne, Australia/London).

Under the terms of the agreement, Mayne shareholders will receive AUD $4.10 cash per outstanding ordinary share of Mayne, or a total equity consideration of about $2.6 billion ($2.0 billion), including options. The transaction represents a 32% premium over Mayne's Sept. 18 closing price.

Christopher Begley, CEO of Hospira, said that the merger “will create the leading generic injectable pharmaceuticals company in the world . . . The Mayne acquisition more than doubles Hospira's international presence and significantly accelerates the expansion of our generic injectables business.”

Hospira said it already holds the No. 1 generic injectables market position in the U.S. while eMayne has leadership positions “in Europe and Australia, and significant presence in Canada.”

It said that the acquisition will double its international sales to nearly 30% of total sales and expand sales and distribution internationally. It said the merger expands its oncology presence since oncolytics represents half of Mayne's portfolio.

The combination of the two companies is estimated to generate a minimum of $50 million of annual synergies in 2008 through infrastructure optimization as well as improved supply chain, administrative and other operational efficiencies.

To finance the acquisition, Hospira will use available cash and incur about $1.9 billion of debt under committed financing facilities provided by Morgan Stanley.

Mayne sells its products in more than 65 countries and generated sales of AUD$800 million in last fiscal year.

Calypte products approved in Russia

Calypte Biomedical (Lake Oswego, Oregon), a developer of tests used to detect antibodies to the human immunodeficiency virus (HIV) for the point of care (PRO) and over the counter (OTC) segments, reported receiving approval for its Aware Oral Fluid (OMT) HIV-1/2 rapid test for both PRO and OTC markets in the Russian Federation.

The company said that the Russian Federation is now the second market, following the United Arab Emirates, to approve the use of an HIV-1/2 test in OTC settings, permitting greater access to HIV testing in these countries.

The approval, valid through August 2011, was granted by the Minister of the Federal Service of Health Care and Social Development Control of the Ministry of Health of the Russian Federation.

Roger Gale, CEO and chairman of Calypte, said: “[g]iven the potential size of the Russian market, we expect that it will be one of our most significant markets for sales. . . We believe strongly that the privacy and non-invasive ease of use provided by our OTC test are attributes that squarely address the needs of the Russian Federation in its plans to contain the HIV/AIDS epidemic.”

The Russian Federation is home to 143 million people. According to the 2005 AIDS Epidemic Update, jointly published by the Joint United Nations Programme on HIV/AIDS and the World Health Organization (Geneva), there are 860,000 adults living with AIDS in the Russian Federation (as of the end of 2003). The Bill and Melinda Gates Foundation considers Russia one of the “Next Wave” countries facing the largest increase in HIV/AIDS this decade.

Condom FC-2 registered in India

The Female Health Company (Chicago) reported that its second generation Female Condom FC-2 has received registration by the Indian governmental authorities, permitting and its Indian partner Hindustan Latex Limited (HLL;) to initiate sales of FC-2 in India.

It said that India is now reported to have the highest number of HIV positive people in the world. Although such cases are less than 1% of its 1 billion population, the Indian government, through its National Aids Control Organization, is implementing prevention programs. Nearly 1 million FC-1 female condoms have been shipped to India in the last year for use in such programs.

In May, the company reported signing a Memorandum of Understanding with HLL to jointly manufacture FC-2 in India. HLL is an Indian Government company with an annual male condom manufacturing capacity of 1 billion units. HLL is launching the FC-1 female condom to consumers, under the trade name Confidom, on a city-by-city basis. It is now available in Bangalore, Chennai, and Kolcutta, as well as on-line, with a series of additional city launches planned.

The Female Health Company owns certain worldwide rights to FC Female Condom, including patents which have been issued in the U.S., UK, Japan, France, Italy, Germany, Spain, The People's Republic of China, Canada, New Zealand, South Korea and Australia. The company says that the FC Female Condom is the only product approved by the FDA “under a woman's control that provides dual protection against unintended pregnancy and sexually transmitted diseases including HIV/AIDS.”

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