Alkermes, Inc. is restructuring its operations after partner Eli Lilly and Co. terminated the AIR Insulin program. Alkermes is reducing its staff by approximately 18% (150 employees) and closing its AIR commercial manufacturing facility in Chelsea, MA. The restructuring is an effort to combat the financial impact of Lilly's termination of the program.
   
"We are implementing a new operational cost structure to align our expenses with near-term revenues, which we anticipate will be lower than expected due to Lilly's termination of the inhaled insulin program," stated David Broecker, president and chief executive officer of Alkermes. "The flexibility of our business model allows us to adapt our cost structure while maintaining our ability to develop innovative products of our own."
   
Mr. Broecker added, "Lilly's termination of the program forced us to make difficult choices about the optimal size of the organization. We acknowledge the outstanding contributions that these employees have made, and I wish to express my sincere thanks for their hard work."
   
Employees affected by the restructuring will be eligible for a severance package that includes severance pay, continuation of benefits and outplacement services. The company does not anticipate any expense savings as a result of the restructuring in fiscal 2008, ending March 31, 2008. The company expects to take a restructuring charge in 4Q08 in the range of $5 million to $10 million and an impairment charge of as much as $15 million related to fixed assets at the Chelsea facility. Alkermes expects cost savings from the restructuring in the range of $15 million to $20 million in fiscal 2009.  

NicOx S.A. has signed an agreement with Archimica for the commercial manufacturing and supply of naproxcinod API. Naproxcinod is NicOx's lead candidate in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents. NicOx expects to file a NDA for naproxcinod with the FDA mid-2009.
   
Michele Garufi, chairman and chief executive officer of NicOx, said, "We are very happy to have signed this agreement with Archimica, which is an essential step as we advance naproxcinod towards the market. With Archimica's extensive manufacturing experience and history of producing APIs for the U.S. and other major markets, NicOx is in a strong position to prepare the regulatory submissions and subsequent market launch of naproxcinod. We now have a large capacity producer that is capable of supporting the high commercial potential of naproxcinod that has been suggested by our market research."
   
Under the agreement, Archimica will supply naproxcinod API from Archimica's FDA inspected site in Springfield, MO, making Archimica a significant component of NicOx's supply chain for the drug. NicOx anticipates the first deliveries of significant quantities of commercial material being made from 4Q09 onwards, following the installation of equipment required for its manufacture. As part of the strategy to maximize the commercial potential of naproxcinod, the company may sign agreements with two additional suppliers. Going forward, NicOx will be looking for co-commercialization partnerships for naproxcinod, while retaining certain commercialization rights in the U.S. and selected EU markets.
   
James Harrison, chief executive officer of Archimica, said, "We are very pleased to have this opportunity to apply our expertise to the manufacturing of naproxcinod and are excited by the clear potential of this innovative product. We look forward to continuing our work with the NicOx team, and leveraging our manufacturing experience to support their timely and successful launch of naproxcinod."
   
Naproxcinod is in Phase III studies designed to demonstrate safety and efficacy for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to existing therapies.

Britton Jimenez has been named business development executive, Penn Pharmaceutical Services U.S., Inc. He is responsible for building sales for the west coast U.S. territory.
   
Mr. Jimenez joins the company from Cardinal Health where spent five years working up from national account manager to director of sales and marketing within the Global Manufacturer Services business unit. While at Cardinal, he was responsible for the creation of next-generation services for the pharmaceutical and biotech market. Prior to that, he worked at Surgipath Medical Industries for two years and also spent four years at Bristol-Myers Squibb.
   
Mr. Jimenez said, “I am very excited to have joined such a fast-growing company at a pivotal point in their expansion. The pharma industry in the U.S. is growing rapidly and with Penn having a thriving U.S. base, we are ideally located to help U.S. companies with their European trade.”
   
Paul Wituschek, business development director in the U.S., remarked, “Penn will benefit from the knowledge and experience Britton has in the outsourcing market and the insights he will bring into his new role. We expect him to make an immediate impact at Penn and will be a key asset to our U.S. growth strategy.”

News from our sister sites