Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for Risperdal Consta  to the FDA seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD).

FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor's care. The condition may affect 10-20% of the 27 million people with bipolar disorder worldwide, according to a statement from J&JPRD's manufacturing partner, Alkermes, Inc.

The sNDA is based on results from a recent study comparing patients who received Risperdal Consta and standard treatment to those who received standard treatment combined with placebo. The study found that patients with FRBD had a significant delay in the time to an initial relapse when Risperdal Consta was combined with standard treatment. The study was presented at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland on February 3, 2008.

Risperdal Consta was approved for the treatment of schizophrenia in the U.S. in 2003. Risperdal Consta is marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S.

SynCo Bio Partners has signed a master services agreement with OncoMed Pharmaceuticals, under which SynCo will fill and finish batches of OncoMed's lead product, antibody OMP-21M18, for use in Phase I clinical trials.

Pierre Warffemius, SynCo's chief executive officer, said, "We are delighted that a company at the forefront of cancer therapies has recognized our expertise in biopharmaceutical processing by choosing us to fill their lead antibody for early clinical trails."

Paul J. Hastings, president and chief executive officer of OncoMed, added, "We selected SynCo Bio Partners because we needed a GMP-accredited contract manufacturing organisation that had a proven track record in filling biologics. With SynCo's expertise in all aspects of biopharmaceutical manufacture, they were an ideal partner for us at this crucial stage in our development."

OncoMed recently announced a worldwide strategic alliance with GlaxoSmithKline to develop cancer stem cell antibody therapeutics. One of the key projects in this alliance will be the development of OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.

SynCo will fill and finish antibody OMP-21M18 at its Amsterdam-based facility. This facility is able to fill a wide range of biopharmaceuticals into vials, including protein, polysaccharide, and live-microbial-based products using the latest filling and finishing equipment, according to a SynCo statement.

Alcon plans to build a facility in Singapore that will manufacture pharmaceuticals to be distributed throughout most of Asia. The company plans to break ground in 2009, with the plant becoming fully functional in 2012. Alcon will employ more than 150 employees within three years after production begins.

The company reports that sales of therapeutics for eye diseases and conditions have risen at a CAGR of 20% in Asian markets. "This growth has been driven by many of Alcon’s major brands such as Travatan, Patanol and Vigamox ophthalmic solutions, Tobradex ophthalmic ointment, and Systane eye drops," according to a company statement. The new facility will enable Alcon to distribute products in this region more efficiently and cost effectively.

Alcon will lease a 20-acre plot of land on which the company will build a 250,000-sq.-ft. facility in the Tuas Biomedical Park. The company expects to manufacture at a rate of more than 53 million units per year at this facility by the end of the third year of operation.


"Given the rapid growth in this region, this plant is integral to our ability to meet future market demands," said Ed McGough, Alcon's senior vice president, global manufacturing and technical operations. "After a lengthy and careful analysis of potential plant locations and through close collaboration with the Singapore Economic Development Board, we selected Singapore due to its highly skilled and reliable workforce and well-established government infrastructure."

Novartis recently announced plans to acquire Alcon in the next several years, at a total cost of $39 billion.