Navigating the Global Manufacturing Supply Chain - Pharmaceutical Technology

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Navigating the Global Manufacturing Supply Chain
As the strategic value of emerging markets increase, pharmaceutical companies increase their R&D and manufacturing investments.


Pharmaceutical Technology
Volume 37, Issue 3, pp. 56-59

Russia. Unlike other BRIC countries, such as India and China, which have a domestic manufacturing base, Russia is largely dependent on pharmaceutical imports. Its domestic biomedical industry accounts for only 0.2% of the global market, but the country is committed to change that level through an ambitious program, Pharma 2020. Pharma 2020, a state-initiated plan, seeks to boost output of local medicines from 25% of gross sales in 2010 to 50% by 2020, upgrade domestic pharmaceutical manufacturing operations to GMP standards, and increase the level of innovator pharmaceuticals in the Russian market (3). Several pharmaceutical majors are increasing their presence in Russia with manufacturing and R&D investment (1-2).

In September 2012, Takeda Pharmaceutical completed construction of a EUR 75 million ($99 million), 24,000-m2 pharmaceutical manufacturing facility in Yaroslavl, Russia. The plant, which is approximately 280 kilometers from Moscow, is one of the first by a major multinational company in Yaroslavl's pharmaceutical cluster. The facility is expected to be fully operational by 2014.

The Yaroslavl facility will enable Takeda to meet demand in Russia initially for several products: Cardiomagnyl (acetylsalicylic acid and magnesium hydroxide), Actovegin (derived from calf blood), and calcium tablets. The plant will have the initial capacity to manufacture 90 million sterile ampuls and more than two billion tablets per year. Liquid-sterile production includes solution preparation, washing of ampuls, sterilization, filling, inspection, and packaging. Solid production will encompass all stages, from weighing, mixing, and granulation through compression, coating, and packaging. Takeda estimates that it is the seventh largest pharmaceutical company in Russia and expects company annual growth rate of 15% in Russia through 2016.

In April 2012, Novo Nordisk broke ground on a new $100-million plant in Russia that will formulate and fill insulin into Novo Nordisk's Penfill cartridges and pack the FlexPen prefilled insulin delivery device for the Russian market. Located in Grabtsevo Technopark in the Kaluga region, the plant is expected to start manufacturing in 2014. The company's intention to establish insulin production in Russia was first announced in 2010. At that time, an agreement of cooperation between the government of the Kaluga Region and Novo Nordisk was signed. Sanofi also recently increased insulin capacity at its facility in Orel, Russia. Sanofi obtained the facility following its acquisition of a controlling stake in the pharmaceutical company Bioton Vostok in 2010.

Novartis is proceeding with a new $140-million manufacturing plant for pharmaceuticals and generic drugs in St. Petersburg, Russia. The plant is expected to produce approximately 1.5 billion units per year (oral solid dosage forms). The greenfield facility is in the Novoorlovskaya Special Economic Zone located to the north of the St. Petersburg city center. Novartis began construction of the facility in 2011. The facility is expected to be completed and approved for commercial production in 2014.

The facility is part of a five-year, $500-million investment into Russian healthcare infrastructure announced by Novartis in December 2010. This plan addresses three core areas: local manufacturing, R&D collaborations, and public health development in Russia. These activities include collaborations with academia and emerging Russian private businesses in different areas of medical science. The scope of these collaborations may include efforts, such as out-licensing of Novartis compounds to Russian companies with proven scientific capabilities, in-licensing and scouting for promising drug candidates from Russian scientists and universities, and modeling and simulation activities for clinical trials. Novartis is working in all of these areas to identify high potential projects to be jointly developed. Additionally, Novartis also has made a commitment to double its investments in drug development in clinical trials in Russia and expects to enroll approximately 4000 individuals by 2013, said the company in announcing its plans in December 2010.

In 2011, AstraZeneca announced plans to establish a Predictive Science Center in St. Petersburg, the company's first such center in Russia. The center will focus on developing bioinformatices, data-analysis methods, software, and systems to evaluate safety and efficacy of new drugs. Approximately 30 people will be employed at the center through local collaborations and organizations. Also in 2011, AstraZeneca began construction of a new $150-million manufacturing facility in the Kaluga region in Russia to supply locally produced medicines. The company also has partnerships with several R&D institutes in Russia, including the Skolkovo Innovation Center and Russia Venture Company, for research and clinical trials.

In July 2012, Pfizer granted exclusive development and marketing rights to the Russian firm SatRx for its dipeptidyl peptidase-4 (DPP-4) inhibitor PF-00734200 for Type 2 diabetes.SatRx, which is part of the ChemRar Hi-Tech Center, received worldwide rights (excluding China) to the drug as a monotherapy or in combination with other diabetes drugs. Pfizer will receive royalties and milestone payments based on commercialization activities. The agreement was developed as partial fulfillment of a memorandum of understanding reached in March 2011, under which Pfizer and ChemRar agreed to explore collaborations focused on research, development, and commercialization of compounds and vaccines to treat cardiometabolic, infectious and oncologic diseases in Russia and other countries.

In 2010, GlaxoSmithKline formed an alliance with JSC Binnopharm for the local secondary manufacture of several GSK vaccines. Under this alliance, which was announced in November 2010, GSK is supplying bulk vaccine and providing technology and expertise to enable Binnopharm to undertake the secondary manufacture, including filling and packaging of GSK vaccines. Binnopharm will be responsible for gaining approval of their facilities to allow supply of GSK cervical cancer, rotavirus, and pneumococcal vaccines under Binnopharm's trademark for the Russian public market.

Reference

1. P. Van. Arnum, Pharm. Technol. 36 (8), 38-42 (2012).

2. P. Van Arnum, Pharm. Technol. Sourcing and Management, 8 (10), 2012.

3. G. Peach, "Russia Pledges $4 billion for Pharma-2020 Plan," Nature Medicine online, doi:10.1038/nm0511-517 (2011).


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