OSG Norwich Pharmaceuticals, a CMO based in Norwich, NY, has been acquired by AFI Partners, a NYC-based private equity group. The company, which was owned by Outsourcing Services Group, will now be known as Norwich Pharmaceuticals, Inc., and operations at the Norwich facility will continue uninterrupted, according to a company statement. In addition, the current leadership team will remain in place, and continue to manage the business. OSG Norwich launched in 2001 and its workforce has grown from 250 people to 425; all current employees will also remain with the new company.

"We are excited to begin the next chapter of our company's history with AFI Partners," remarked Christopher R. Calhoun, president of OSG Norwich. "Our focus will remain on providing best-in-class services to our valued customers in the pharmaceutical business. We have demonstrated that we have highly competent people who can provide the quality and service demanded by the industry, with a high level of regulatory expertise, at a value level that our customers expect. With the support of AFI, we will be able to continue to make the necessary investments in the operation to remain at the forefront of our industry."

E. J. Antonio, managing partner at AFI, stated, "AFI brings considerable manufacturing expertise to Norwich, in addition to a shared vision for long-term growth. We are fully prepared to make the necessary investments that will expand Norwich's capacity and capabilities. We look forward to working with the Norwich team, as we build a strategy that will maximize the company's potential."

ImClone Systems and Bristol-Myers Squibb have amended the terms of their Erbitux agreement regarding the development and promotion in North America. Under this amendment, the companies have expanded the investment in the ongoing clinical development program for Erbitux by as much as several hundred million dollars. BMS will be responsible for development costs up to a threshold value. The companies will share costs beyond this threshold.

The companies added Phase II and Phase III trials to further explore the activity of Erbitux in a variety of therapeutic settings. The results of these studies will be used to support new registrational opportunities for the drug. The clinical program will supplement the existing data for Erbitux in colorectal and head and neck cancers and explore the use of Erbitux in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate.

"By broadening the Erbitux development program with ImClone Systems and utilizing pharmacogenomic markers and other screening technologies, we intend to enhance cancer patient outcomes which may further differentiate Erbitux from other commercially available antibodies," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, R&D, BMS. "This plan further demonstrates BMS's focus on the development of innovative compounds, like Erbitux, and highlights our company's dedication to partnerships that can maximize the potential of products in our portfolio."

"This new commitment to Erbitux represents one of the largest and broadest cancer-focused development programs for any antibody. The agreement aligns the development and commercialization of Erbitux at ImClone Systems and BMS to benefit both companies' shareholders, and most importantly, cancer patients," stated Alexander J. Denner, Ph.D., chairman, executive committee of ImClone Systems. "We are very pleased by this agreement and look forward to the two companies working in harmony."

Akorn, Inc. and Hyaluron Contract Manufacturing (HCM) have signed a development and supply agreement for two ANDA injectable suspension products.

One of the products is an injectable sustained release pharmaceutical, which will be available in both prefilled syringe and vial configurations. The second ANDA product is an anti-inflammatory and will be available in multiple packaging configurations. Hyaluron will manufacture both drug products for Akorn, which will be responsible for marketing and distributing them within the U.S. Akorn will own both ANDAs, coordinate the bioequivalency clinical trials and prepare the ANDA regulatory filings. Financial terms of the agreement were not disclosed. The products are expected to launch in 2010.

Arthur S. Przybyl, Akorn's president and chief executive officer stated "We are excited to be working with Hyaluron on these two opportunities. Both products will be key growth drivers for our company, similar to our upcoming Vancomycin capsule, Tetanus Diphtheria Vaccine and Akten product launches. The addition of injectable suspensions to Akorn's portfolio complements our line of injectable drug products that includes both proprietary and generic drugs."

Shawn Kinney, Hyaluron's president stated, "Our decision to partner with Akorn is reflective of our commitment to provide our clients with innovative solutions to all their formulation and filling needs. We look forward to working with Akorn, and to the opportunities this collaboration presents to make a lasting contribution to the market for sterile injectable products."

Crucell N.V. has entered into a co-exclusive PER.C6 and Advac technology license agreement with Wyeth. Under the terms of the agreement, Crucell will receive an upfront payment, milestone payments, annual maintenance fees, and royalties on product sales. Financial details were not disclosed.

AdVac technology is a recombinant vector technology used to develop adenoviral-based products. PER.C6 technology is based on a human cell line developed for the large-scale manufacture of biological products including vaccines.

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