Agreements and pacts

August 1, 2007
Pharmaceutical Technology Editors
PTSM: Pharmaceutical Technology Sourcing and Management
Volume 3, Issue 8

The latest pacts from the pharmaceutical supply chain.

Whitehouse Station (July 12) and Ariad Pharmaceuticals, Inc. (Cambridge, MA) formed a global collaboration to jointly develop and commercialize AP23573, Ariad's mTOR inhibitor, which is expected to enter Phase III trials this year.

The agreement provides for an initial payment of $75 million to Ariad and as much as $452 million more in milestone payments, based on the successful development of AP23573 in multiple cancer indications. Both companies will share overall responsibility for global commercialization and development of AP23573. Each party will fund 50% of the cost of global development of AP23573, except that Merck will fund 100% of the cost of development outside the United States.

On a global basis, Ariad will be responsible for manufacturing the active pharmaceutical ingredient used in the product, and Merck will be responsible for the formulation of the finished product (tablets).

Marlboro, MA (July 17) received two Phase I contracts totaling $13 million from the (Arlington, VA) for the Accelerated Manufacture of Pharmaceuticals (AMP) program. The AMP program is a three-phase program in which the US military is focused on technologies for producing emergency therapeutics and vaccines. Phase I of the AMP program optimizes host strains that will express a model vaccine and antibody and demonstrate small-scale production. Subsequent phases will be aimed at rapid process optimization, scale-up, and cost-effective production.

Xcellerex will serve as the prime contractor on the first grant, in which the company is collaborating with (Midland, MI), a business unit of (Midland, MI), (Marlboro, MA), and (London). On the second contract, Xcellerex is collaborating with (Burlingame, CA) as the prime contractor, (Menlo Park, CA), and BioPharm Services.

Armonk, NY (July 16, 2007) (Armonk, NY) signed a $1.4-billion global outsourcing deal with (London). The seven-year agreement, which renews and expands on a current contract, covers the provision of information technology (IT) infrastructure services to 60 countries and additional functions within AstraZeneca.

The original agreement was signed in 2001 for a reported $1.7 billion, covering 45 countries. In the renewed contract, IBM will provide a single global technical infrastructure, managing IT services for AstraZeneca such as email and computer operations, storage hosting, and communication services. AstraZeneca, in turn, will manage its overall IT strategy, as it has been doing under the existing contract, as well as the development and support of its application systems.

Birmingham, AL (July 16), a privately held developer and marketer of prescription and nonprescription pharmaceutical products, signed a manufacturing and supply agreement with Cedar Pharmaceuticals (Shreveport, LA) for "Northyx" (methimazole) oral tablets. Under the agreement, Centrix will sell and distribute four strengths, two of which (15 mg and 20 mg) have not been previously available. Cedar Pharmaceuticals manufactures and supplies Northyx.

Bridgewater, NJ (July 11)— completed its agreement with (Taizhou, China) to double its capacity to manufacture vancomycin, one of Hisun's major active ingredients, subject to US and European regulatory approvals. Vancomycin treats severe gram-positive hospital infections. Alpharma currently manufactures vancomycin at its sites in Copenhagen, Denmark, and Budapest, Hungary.

Brisbane, CA (July 10)entered into an agreement with (South San Francisco, CA) for the development, manufacture, and worldwide commercialization of two products containing Genentech's recombinant human-growth hormone "Nutropin AQ" (somatropin (rDNA origin)) and Tercica's recombinant insulin-like growth factor-1 "Increlex" (mecasermin (rDNA origin) injection) for the treatment of short stature, adult growth-hormone deficiency, and potentially other metabolic disorders. The Nutropin AQ and Increlex hormones were originally designed and formulated to be combined and administered as a single, daily injection.

Brisbane, CA (July 9)— entered into a supply agreement with (Vienna) for "Actimmune" (interferon gamma-1b). InterMune thus eliminates roughly $91.6 million in future purchase commitments for Actimmune that existed under the previous supply agreement. InterMune will pay Boehringer Ingelheim Austria approximately $5.5 million to terminate the existing supply agreement and to enter into the new supply agreement.

Cramlington, UK (July 6), a biopharmaceutical contract manufacturer, signed a contract with (Moscow) for the process development and manufacture of polyclonal antibodies. The contract is valued at approximately $914,000.

Pasadena, CA (July 3)will provide engineering, procurement, and construction-management services for 's (Basel, Switzerland) new manufacturing facility to be located in Holly Springs, North Carolina. The new facility will produce trivalent pandemic and interpandemic influenza vaccines using a cell-culture-based process for American and overseas markets. Officials did not disclose the contract value.

Victoria, Australia (July 3) joined forces with international life-sciences supply company (Zurich, Switzerland) to develop a new state-of-the-art monoclonal-antibody production system at the university's Clayton campus.