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Pharma/fine chemicals roundup—2 September 2014
4:26 AM MDT | September 2, 2014 | By DEEPTI RAMESH
Amerigen Pharmaceuticals, Ningbo Menovo sign generics deal; Menovo to manufacture APIs
Amerigen Pharmaceuticals (Lyndhurst, NJ) and Ningbo Menovo Pharmaceutical (Ningbo, China) have entered into a collaboration agreement for the development of generic pharmaceuticals, primarily targeting the US market. Amerigen and Menovo, under the terms of the agreement, will jointly develop products for Amerigen to commercialize in the United States. Menovo will be responsible for manufacturing the active pharmaceutical ingredient (API) and finished product whereas Amerigen will be responsible for clinical, regulatory and commercial activities in the United States. Amerigen will also provide support and assistance to Menovo in obtaining US Food and Drug Administration (FDA) approval for their finished dose manufacturing site at Daxie, China.
Catalent and Australian firm collaborate to develop ADC for cancer therapy
Catalent (Somerset, NJ), a provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, is collaborating with privately held Australian biomarker research company, Minomic International (Macquarie Park, Australia), to develop MIL-38, an antibody drug conjugate (ADC) for prostate cancer therapy. Catalent, under the agreement, will initially produce the antibody for a clinical study with a view to larger scale production subject to a successful outcome. Should the initial clinical study prove successful, the antibody will be produced at Catalent’s biomanufacturing facility at Madison, WI.
Brenntag acquires distribution business in India
Brenntag says it has signed an agreement to acquire the specialties chemicals distribution business of Pioma Chemicals (Mumbai), a leading distributor of specialty excipients and functional ingredients to the pharmaceutical, personal care and food industries across India. Financial details of the deal were not disclosed. The acquired business is expected to generate total sales of about €17.2 million ($22.5 million) in 2014. Closing of the transaction is expected later this month. The transaction will be structured as an asset deal and the acquired business will become part of Brenntag India (Mumbai).
Merck KGaA breaks ground on pharmaceutical facility in China
Merck KGaA (Darmstadt, Germany) says that its biopharmaceutical division, Merck Serono (Darmstadt), has broken ground on its previously announced pharmaceutical manufacturing facility at Nantong, China. The plant is located in the Nantong Economical Technological Development Area, in Greater Shanghai. The plant represents an investment of €80 million ($105 million) and will be Merck’s largest manufacturing facility outside of Europe. The construction of the site is scheduled to be completed in 2016, with commercial production starting in 2017. The new facility will focus on the bulk production and packaging of Glucophage, Concor, and Euthyrox, Merck Serono’s leading brands for treating diabetes, cardiovascular diseases, and thyroid disorders, respectively. These medicines are referenced in China’s essential drug list, Merck says.
First woman president for International Pharmaceutical Federation
Spanish pharmacist Carmen Peña was elected on 30 August as president of the International Pharmaceutical Federation (FIP; The Hague, Netherlands). FIP is the global federation representing three million pharmaceutical scientists and pharmacists worldwide. Peña has served FIP for over 20 years including as a vice-president since 2008. She is currently president of the General Pharmaceutical Council of Spain. Peña will take office on 5 September. She is the first woman and the first pharmacist from Spain to be elected as president in the federation's 102-year history. The FIP presidency is a four-year term.
Beyond IHS Chemical Week:
Indian pharmaceutical excipients companies form IPEC India
Giving a much needed boost to the pharmaceutical excipients industry in India, the leading names in the industry have joined hands to set up its first ever excipients council in India, International Pharmaceutical Excipients Council (IPEC) India. The founding members of IPEC India are Ajit Singh of ACG Worldwide and Subodh Priolkar of Colorcon Asia. Indchem International, Micro Labs, Dow Chemicals, Lubrizol India, BASF India, SPI Pharma, and Merck Group are the other founder-member companies. The council will work actively to promote excipients safety and harmonization of regulatory standards and pharmacopoeial monographs. It will give advice and expertise on excipients and excipients-related regulations. The council will focus its attention on the law, regulations, science and business landscape of the Indian pharmaceutical industry for excipient manufacturers and suppliers. It aims to be a proactive colleague of the Indian pharmaceutical industry associations and federations.
Compounding the problem: US warns two more pharmacies
The US FDA has criticized the Compounding Shop and Zion Rx Formulations Services for making unapproved and contaminated drugs. The Agency warned the compounding pharmacies last week, accusing Zion of deficiencies in its manufacture of sterile products and alleging that Compounding Shop made drugs using the unapproved active pharmaceutical ingredient (API) domperidone.