Author: bpc

Aspen Pharmacare Holdings Limited (Aspen) has signed definitive joint venture (JV) agreements with Indian-based Matrix Laboratories Limited (Matrix). The deals strengthen Aspen’s vertical integration into the manufacture of Active Pharmaceutical Ingredients (APIs), the key raw materials required in the manufacture of finished dosage form pharmaceuticals including anti-retrovirals (ARVs), and they unlock additional global supply and manufacturing opportunities.   The basis of the two JVs is: The sale of 50% of Aspen’s 100% ownership of Cape Town based Fine Chemicals Corporation Pty Ltd (FCC) to Matrix for a purchase consideration of US$ 20million. FCC is South Africa’s leading API manufacturer and a major exporter of product to the USA and other territories; Aspen to acquire a 50% stake of a newly incorporated Indian company, Astrix Laboratories (“Astrix”), into which Matrix will transfer an API manufacturing facility, technology and intellectual property (IP) for a consideration of US$36,5 million   Stephen Saad, Aspen’s Group Chief Executive said “the JVs strengthen Aspen’s supply source for APIs to meet the increasing demand for pharmaceutical products, most notably ARVs. The deals also provide for additional global trading opportunities for Aspen. Matrix’s technological expertise complements Aspen’s successful strategy of manufacturing quality, internationally approved medicines, including ARVs. The finished dosage form products for which the APIs are required will be manufactured at Aspen’s US Food and Drug Administration (FDA) and World Health Organisation (WHO) accredited Oral Solid Dose (OSD) facility in Port Elizabeth”.   Saad added that he expected Astrix to record revenue in the order of $40 million in its first full year of operation and that Aspen would be a material customer.   N Prasad, Executive Chairman of Matrix said “the long-term strategic relationship between Matrix and Aspen is a great leap forward. It will result in combining the strengths of both the companies to achieve global leadership positions by meeting the large unfulfilled needs in the treatment of HIV/AIDS. This alliance also gives Matrix a strategic presence in South Africa. Technological expertise provided by Matrix will assist in unlocking additional value in the FCC business.”   The Astrix facility, situated near Hyderabad, will be Aspen’s lead supplier of ARV APIs. Astrix will also continue supplying its existing customer base with ARV APIs. The site offers scope for modular expansion and in terms of the agreement Astrix may also source additional API volumes from other Matrix production facilities on a toll-manufacture basis.   Approvals for the JVs are subject to approvals by, inter alia, the South African Reserve Bank, the Reserve Bank of India and South Africa’s Competition authorities.   JSE listed Aspen is the southern hemisphere’s largest generic pharmaceutical manufacturer and a global leader in generic ARVs. Matrix is a leading international API manufacturer listed on the National and Bombay Stock Exchanges.   The US FDA’s 2004 accreditation of Aspen’s world class OSD facility and registration of its co-pack triple combination generic ARV treatment qualified Aspen as the first generic supplier under President Bush’s Emergency Plan for AIDS relief (PEPFAR) programme to which funding of US$15 billion has been committed.   Aspen has actively pursued a meaningful solution to the provision of high quality, affordable generic ARVs in the fight against HIV/AIDS. Aspen pioneered the conclusion of voluntary licence agreements with leading multinationals for the manufacture of generic ARVs which were developed in Aspen’s own laboratories. This underscores Aspen’s scientific and technical capabilities, its manufacturing and quality standards, and GMP compliances. Aspen was also recently awarded the lion’s share of the South African government’s ARV tender.

East London – Bevan Gogwana, MEC for health in the Eastern Cape officially opened Aspen Pharmacare’s Oral Contraceptive manufacturing facility earlier today. Stephen Saad, Group Chief Executive of Aspen Pharmacare, Southern Africa’s largest JSE-listed pharmaceutical company, said “the world-class oral contraceptive facility has been designed, built and validated to European standards, and has the capacity to produce between 24 and 30 million oral contraceptive packs per year”. Aspen Pharmacare supplies the majority of the state’s requirements for oral contraceptives.  The newly opened facility forms part of the company’s East London operation, which it is estimated would cost over R160 million to replace. Saad said “a number of international pharmaceutical manufacturers have strongly endorsed Aspen Pharmacare’s standards and manufacturing processes. This was demonstrated through Wyeth International licensing Aspen Pharmacare to manufacture, market and distribute their oral contraceptives, among other products, from the East London facility”. “It is also strategic that local businesses assist government in addressing the needs prevalent in the health sector. As such, Aspen Pharmacare introduced training and skills development enrichment programmes, and in association with the Department of Health and the South African Health Services, has trained and improved the skills of more than 120 nurses.” In addition, Aspen Pharmacare has made a contribution to primary health care in this region. Engcobo Clinic, which was officially opened by Nelson Mandela earlier this month, provides the community with a fully functional delivery room for pregnant women, doctors’ consulting rooms, nurses’ training facilities and a medicine dispensary.  The trainee nurses receive on-the-job training and Aspen Pharmacare has provided all computer equipment and infrastructure to support the training. Due to limited facilities in the area, Engcobo Clinic also assists with the overflow of patients who cannot be attended to at the All Saints Hospital. Commenting on the outcome of the recent court case between government and the Pharmaceutical Manufacturers Association, Saad said that Aspen Pharmacare was extremely positive about the result. “We are able to manufacture much needed generic anti-retroviral drugs for HIV/Aids patients, and are presently awaiting government’s decision regarding the process that will be followed in this regard.” Saad confirmed that an announcement was imminent concerning a joint venture agreement with an Indian based company to supply raw materials for the local manufacture of generic antiretroviral drugs, which would enable further cost savings for their products throughout Africa. “The impact of legalised generic substitution of medicines is however the main coup for the broader community as well as for Aspen Pharmacare. Medicines account for approximately 33 percent of medical aid expenditure, and through legislated generic substitution medicines, medical aid allocations could be managed more efficiently through the reduction of the cost of medicines. Currently the market split between generic and ethical medicines is 20 : 80, with changes expected to these statistics as a consequence of the above legislative promulgations. Aspen Pharmacare, although actively involved in the manufacture of ethical, as well as over the counter (OTC) and personal care products, is South Africa’s largest generic producer.