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Collaboration helps cut drug development costs

4th March 2013


Page 1 of 8

As the cost and complexity of drug development continues to grow, collaboration between manufacturers is becoming an ever more important aspect of the business.

Pfizer, the world's largest research-based pharmaceutical company, and Zhejiang Hisun Pharmaceuticals have launched Hisun-Pfizer, a joint venture to develop, manufacture and commercialise off-patent pharmaceutical products in China and global markets.

The creation of the joint venture marks an important milestone in strengthening the ability of both companies to reach more patients with high-quality and low-cost medicines in the branded generics arena.

Off-patent medicines, including branded generics, represent one of the fastest-growing segments in the global pharmaceutical market. This is especially true in emerging markets, where cost and access are primary drivers of off-patent medicine growth. In China, branded generics account for 70 per cent of the domestic pharmaceutical market.

Hisun-Pfizer will take advantage of Hisun's strong product portfolio, broad market outreach and experience with the production and commercialisation of branded generic medicines. The joint venture will also benefit from Pfizer's world class R&D, manufacturing quality management, international market promotion and operational capabilities. It will focus on R&D and the production and commercialisation of high-quality branded generic medicines, and the broader commercialisation of existing medicines through a local and global sales and marketing infrastructure.

It is one of the first joint ventures between a multinational pharmaceutical company and a local leading pharmaceutical company in branded generic medicines in China, and is also one of the largest pharmaceutical joint venture projects in Zhejiang province.

Bai Hua, chairman and president of Hisun, said that establishing this joint venture with a leading global pharmaceutical company is an important step towards achieving Hisun's long-term vision of becoming a widely respected international pharmaceutical company "persisting in pharmaceutical innovation for the benefit of human beings."

The partnership also paves the way for Hisun to transition from being an active pharmaceutical ingredients (API) manufacturer to an established branded generics company. "The joint venture will provide our patients with high-quality and low-cost branded generic medicines through our internationally compatible management systems and R&D and production technology. This will help us better contribute to the development of the Chinese pharmaceutical industry, advance the drug innovation and manufacturing capabilities of Zhejiang province and China, and lay a solid foundation for Chinese pharmaceutical companies to enter the international market," he said.

"Providing high-quality, accessible and affordable health care to people over a vast area and from broad socioeconomic levels has become a primary objective of Chinese healthcare reforms, which is aligned with Pfizer's mission to provide high-quality and affordable medicines to our patients," said Xiaobing Wu, country manager of Pfizer China. "The joint venture demonstrates Pfizer's commitment to China's ongoing healthcare reforms and is an important milestone for Pfizer's efforts to broaden the reach of its world-class healthcare solutions in China. We are glad to be partnering with Hisun in this venture to address the needs of our patients."

The production plants of the joint venture will be located in Fuyang, Zhejiang province, while the management centre and R&D centre will be located in Shanghai and Hangzhou, respectively. The parties will contribute select existing products to the joint venture, which will have a broad portfolio covering cardiovascular disease, infectious disease, oncology, mental health, and other therapeutic areas.

"We are confident that our joint venture will allow both companies to build upon existing core capabilities and our respective areas of expertise to address the needs of more patients than ever before," adds Olivier Brandicourt, president and general manager of Pfizer's emerging markets and established products business units. "This partnership further supports the government of China's goals for improved access to medicines and treatments for the patients of China."

Dermo-cosmetics

Quintiles and Sinclair IS Pharma have signed a 10-year collaboration and licensing agreement for Quintiles Rowfarma Mexico to commercialise Sinclair's portfolio of dermo-cosmetic products and medical devices in Mexico.

Under the agreement, Quintiles will handle the entire process including: regulatory submissions; product importation, warehousing and distribution to wholesalers; sales force promotion to dermatologists and plastic surgeons; and marketing, advertising and promotion.

"This collaboration, a further step in Latin America, supports our company's growth strategy, to move our product portfolio into fast-growing, emerging markets through strategic, regional partnerships," said Chris Spooner, ceo Sinclair IS Pharma. "Quintiles' extensive commercialisation experience and proven track record in Mexico and other emerging markets made it the clear choice to help us execute our strategy."

The Sinclair portfolio consists of the following products: Atopiclair for the treatment of mild to moderate atopic dermatitis; Kelo-cote silicone-gel scar reduction range for the prevention and management of abnormal scars; Sebclair for the treatment of seborrhoeic dermatitis; Bio-Taches for hyperpigmentation disorders; XClair for the treatment of radiation dermatitis; and Papulex for the management and maintenance of mild to moderate acne.

"Our customers are thinking carefully about their strategy in emerging markets, and are looking for a trusted partner who can help navigate the complexities these markets present. With this agreement, Quintiles' will work on a wide range of services - from registration through to launch, to help Sinclair expand its geographic footprint in a more predictable manner," said company senior vice president of commercial strategy James Featherstone.

Cristobal Thompson, country manager for Quintiles Commercial Solutions in Mexico, added: "We look forward to working with Sinclair to commercialise these promising products in Mexico, a market that offers significant business opportunities. With our 16-year heritage in Mexico, our local market experience will complement Quintiles global systems and standards, to help accelerate outcomes for Sinclair."

Meanwhile EMD Millipore, the life science division of Merck KGaA, has opened its advanced GMP bioproduction facility in Martillac, France, offering a full, single-use process train to speed a molecule's journey to the clinic (Fig.1).

The site will serve users of EMD Millipore's Provantage biodevelopment and clinical supply solutions, an innovative, 'open source' manufacturing option that incorporates the latest technologies for upstream and downstream processes.

The open source approach provides customers with greater control over production. With a traditional outsourcing model, the customer's process must fit the facility and the contract manufacturer controls the process. With ProVantage solutions, EMD Millipore develops the process for further use by the customer.

At the new facility, EMD Millipore provides access to proven technologies, process development expertise and validation services, offering a robust template that makes it possible to go from clone selection to GMP product in only 12 months. The facility offers GMP production of mammalian proteins for pre-clinical to phase II production at the 50-1250 litre scale. For phase III and commercial production, customers can transfer manufacturing to any location, at any scale. This freedom brings enhances development and manufacturing.

"EMD Millipore leverages more than 25 years of biomanufacturing experience with 150 molecules in our new facility in France," said Christophe Couturier, vice president of services and solutions, EMD Millipore. "As the basis for Provantage solutions, our experts complement customers' internal capabilities in a way that combines the best of in-house production and conventional outsourcing. The end result is increased productivity and an accelerated time to market."

Non-profit tie-up to speed up drug development

Ten major global drug firms have teamed up to establish and fund a non-profit organisation focused on ultimately speeding drug development by addressing a range of existing challenges. Slated as the largest ever initiative of its kind, TransCelerate Biopharma will initially target issues in clinical study execution.

The organisation's founding partners are: Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche's Genentech, and Sanofi. Each will combine financial and other resources, including personnel, and have agreed specific outcome-orientated objectives and guidelines for sharing data and expertise.

Five clinical trials-related projects have been for initial funding and development. These include: development of a shared-user interface for investigator site portals; mutual recognition of study-site qualification and training; development of risk-based site monitoring approach and standards; development of clinical data standards; and establishment of a comparator drug supply model.

The firms say that as solutions in clinical research and other areas are developed it will draw in other relevant industry alliances and regulatory bodies, including the Clinical Data Interchange Standards Consortium (CDISC), Critical-Path Institute (C-Path), the Clinical Trials Transformation Initiative (CTT), Inovative Medicines Initiative (IMI), FDA, and the European Medicines Agency (EMA), as well as contract research organisations.

TransCelerate is headed by ceo Garry Neil, a partner at Apple Tree Partners and formerly corporate vp for science and technology at Johnson & Johnson. "There is widespread alignment among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs," he said


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