Pharma/fine chemicals roundup—16 September 2014
6:25 AM MDT | September 16, 2014 | By DEEPTI RAMESH
Seattle Genetics and Genmab enter into antibody-drug conjugate collaboration
Biotechnology companies Seattle Genetics (Bothell, WA) and Genmab (Copenhagen) say that they have entered into an additional antibody-drug conjugate (ADC) collaboration. Genmab, under the new agreement, will pay an upfront fee of $11 million for exclusive rights to utilize Seattle Genetics’ auristatin-based ADC technology with Genmab’s HuMax-AXL, an antibody targeting AXL which is expressed on multiple types of solid cancers. Seattle Genetics is also entitled to receive more than $200 million in potential milestone payments and mid-to-high single digit royalties on worldwide net sales of any resulting products. Genmab remains in full control of development and commercialization. ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity. Seattle Genetics has developed proprietary technology employing synthetic cytotoxic agents, and stable linker systems that attach these cytotoxic agents to the antibody. Of the roughly 40 ADCs in clinical development, more than 60% utilize Seattle Genetics’ ADC technology, the company says. Seattle Genetics and Genmab entered into an ADC collaboration for HuMax-TF-ADC in 2010. HuMax-TF-ADC, targeting the tissue factor antigen, is in Phase I trial for solid tumors.
Siegfried expands spray-drying capacity at Pennsville site
Siegfried (Zofingen, Switzerland) says it has expanded spray-drying capacity at its Pennsville, NJ site. Spray drying of an active pharmaceutical ingredient (API) together with excipients, such as polymers, enhances the bioavailability of a drug product, Siegfried says. With this new technology, Siegfried has joined the small circle of cGMP suppliers offering the entire range of pharmaceutical spray drying from pilot to commercial production, the company says. “We are convinced that through our investment in additional spray drying capacities we have made an important strategic step toward strengthening our market position,” says Rudolf Hanko, CEO of Siegfried. The expansion opens up opportunities for the acquisition of additional projects, and it allows Siegfried to expand its integrated offer of drug substance production and the development of finished dosage forms, the company says.
Alchem commits to tropane alkaloid APIs and extends production to resolve supply gap
Alchem International (New Delhi) says that, following the decision by the principal European manufacturers to exit or end market development and regulatory support for the niche range of tropane alkaloid active pharmaceutical ingredients (APIs) — including atropine, atropine sulfate, tropine, nortropine, homatropine methylbromide, homatropine hydrobromide, digoxin and cimetropium bromide — Alchem has confirmed commitment to maintain production and regulatory support from its production units. “Whilst the tropane alkaloid family of APIs is a specialist business and difficult to manage within larger scale production facilities, Alchem has invested in a suite of bespoke manufacturing and regulatory capabilities to support smaller scale, as well as, large scale API production and dossier support,” says Raman Mehta, CEO and president of Alchem. “Alchem's R&D and regulatory teams have worked to provide a solution to our partner customers to resolve the supply gap and consequentially a potential withdrawal of these medicines from the market,” Mehta says.
Indian pharma companies increase investments, exports
The India Brand Equity Foundation (IBEF; Gurgaon, India) says that India's top 20 pharmaceutical companies are expected to increase capital expenditure by 40% to over $8.3 billion by 2018. The investment is expected to be directed towards greater attention to regulated markets, to take advantage of substantial patent expiries expected in the medium term and an ever increasing demand for generics. The top 20 Indian pharma companies contribute close to two-third of the country's total pharma exports. With total global exports of close to $15 billion in the fiscal year ended March 2014, about 220 countries are sourcing pharma products from India, IBEF says. India has also put in place a mechanism for filing complaints about pharma products from India, IBEF says. The Department of Commerce within the Indian government has appointed a nodal officer who will be responsible for handling such complaints. An international cell has been set up in the Central Drugs Standard Control Organization (New Delhi) with 10 dedicated inspectors to handle the cases reported from export markets.
Beyond IHS Chemical Week:
Apotex recalls Paxil tainted at GSK plant
Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline ($GSK) and are part of a larger recall for which the FDA spanked GSK. According to this week's FDA Enforcement Report, Apotex is recalling 25 lots of paroxetine HCL in a variety of doses and formulations because the active pharmaceutical ingredient (API) used in them was contaminated with residual materials and solvents from a waste tank. Apotex did not list the totals for each lot, but one lot of oral suspension contained more than 13,400 bottles.
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