Pharma/fine chemicals roundup—19 February

Feature
Pharma ingredients: Western manufacturers prepare for further expansion

The active pharmaceutical ingredient industry will see further growth in the near term, and Western manufacturers are making additional investments as they prepare to take advantage of the upturn. Meanwhile, recent regulatory changes in the United States are likely to alter the industry over the next few years, experts say.

API business of Dr. Reddy’s reports rise in sales

The pharmaceutical services and active ingredients (PSAI) business of Dr. Reddy’s Laboratories (Hyderabad, India) reported a 28.1% rise in sales in the company’s fiscal third quarter, ended 31 December 2012, compared with the year-ago period, to 7.12 billion Indian rupees ($131 million). Earnings figures for the PSAI business were not disclosed. Dr. Reddy’s has the second-largest active pharmaceutical ingredient business in the world in terms of sales, after Teva Pharmaceutical Industries (Petaḥ Tiqwa, Israel). During the third quarter of the fiscal year, 13 drug master files (DMF) were filed globally, including 3 in the United States and 1 in Europe, Dr. Reddy’s says. The cumulative DMF filings as of 31 December 2012 were 566, the company says.

Dow and Cambrex collaborate to manufacture drug-solubility solution

Cambrex (East Rutherford, NJ) and Dow Chemical have executed an agreement for Cambrex to contract manufacture Dow hydroxypropyl methylcellulose acetate succinate for drug solubility enhancement, the companies say. This is the final step in building on a solubilization partnership that Dow and drug-formulation development and manufacturing company Bend Research (Bend, OR) established last October, and it will help Dow to commercially supply solubility-enabling excipients. Construction has already begun on the new operational facility at Cambrex Karlskoga (Karlskoga, Sweden) with commercial product availability set for year-end 2013.

AMRI and Codexis enter into technology collaboration

Albany Molecular Research Inc. (AMRI; Albany, NY) and Codexis (Redwood City, CA) say that they have entered into a Smartsourcing partnership. AMRI launched Smartsourcing in April 2012 for contract manufacturing and research services, and it is a series of strategic sourcing options for customers. Under the nonexclusive, two-year agreement, the companies will align their respective strengths to identify and implement new and improved manufacturing routes for selected active pharmaceutical ingredients. Combining Codexis’s directed evolution technology that enables rapid enzyme discovery and optimization with AMRI’s process development and manufacturing capabilities, including utilizing AMRI’s proprietary microbial strains, creates synergies that will broaden both companies’ ability to offer customers cost-effective, efficient, and sustainable manufacturing processes, the companies say.

Almac, DSM biocatalysis collaboration moves ahead

Almac (Craigavon, UK) says that, through a collaboration agreement in the field of biocatalysis with DSM Pharmaceutical Products (Parsippany, NJ), the custom manufacturing and technology business of DSM, the two companies have transferred enzymes for enzyme screening, process development, and scale-up manufacture, and have initiated and completed multiple projects together in the fields of ketoreductase, transaminase, biooixdation, and hydrolase. In October 2012, Almac and DSM Pharmaceutical Products signed an agreement that grants both companies access to their enzyme platform technologies, services, and expertise for the manufacturing of active pharmaceutical ingredients. Almac’s expertise in rapid enzyme identification, scale-up, and implementation into early-phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multiton scale, Almac says. This gives customers of both companies access to enzyme expertise and assets resulting in cost-effective, green processing at all phases of development from preclinical to commercial manufacturing scale. The collaboration also enables Almac to offer its customers a preferred partner for large-scale production.

“The success of the projects undertaken between Almac and DSM already demonstrates there is a market for scalable green technologies to access difficult-to-make chiral chemicals,” says Tom Moody, head of Almac Biocatalysis. “Cost remains a prevalent issue within the industry, and the introduction of enzymes into processes earlier in the drug discovery pipeline helps to drive cost down as projects move forward. Our collaboration is delivering real rewards to clients from both a technical and financial perspective,” Moody says.