Week of June 18, 2012: US District Court for NJ Rules Against Merck & Co. in Nasonex Patent Infringement Case; FDA Issues Complete Response Letter to Pfizer for Tafamidis Meglumine NDA; and More

Jun 21, 2012
By PharmTech Editors

Fujifilm Diosynth Biotechnologies is increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell-line development and process development, and the addition of a new multiproduct cGMP facility at its Billingham, United Kingdom, site. The first phase has included development of the company’s cell line and process/analytical development facilities, including the addition of high-throughput technologies. The company has begun construction on a cGMP cell bank and a 1000-L biologics manufacturing facility on the Billingham site. This facility will be based upon single-use technology for both upstream and downstream operations. The cell-bank manufacturing facility will be available in the second quarter of 2013, and the mammalian cell culture facility is expected to be operational in the second half. Read More

GlaxoSmithKline (GSK) is continuing to tender its offer to acquire all outstanding shares of Human Genome Sciences (HGS). GSK also notes the newly announced date of July 16, 2012, for submission of definitive acquisition proposals. GSK continues to believe that participation in the process is unnecessary given the company’s offer is not conditioned on due diligence or financing and can be completed expeditiously. GSK has therefore today sent a letter on June 15, 2012, to HGS declining again to participate in this process. GSK’s offer to acquire all of the outstanding shares of HGS for $13.00 per share in cash represents a premium of 81% to HGS’s closing share price of $7.17 on Apr. 18, 2012, the last trading day before HGS publicly disclosed GSK’s private offer. Read More

The US District Court for the District of New Jersey has ruled against Merck & Co. in a patent infringement suit against Apotex involving Nasonex (mometasone furoate monohydrate). The patent at issue in this case is US Patent No. 6,127,353 that covers mometasone furoate monohydrate, the active ingredient in NASONEX and which provides exclusivity for this form of mometasone until Apr. 3, 2018. Apotex is seeking FDA approval to sell a generic version of Nasonex. Read More

Pfizer has received a Complete Response Letter from FDA in regards to its new drug application (NDA) for tafamidis meglumine. FDA is requesting the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. The agency has also asked for additional information on the data within the current tafamidis NDA. Pfizer plans to work with the FDA to address the content of the letter. Tafamidis is an investigational medication for treating transthyretin familial amyloid polyneuropathy in adult patients with symptomatic polyneuropathy to delay neurologic impairment. Read More

The CDMO Vetter Pharma International is building a new filling line for syringes at its Ravensburg Vetter South (Germany) location. The line can handle batches of up to 1 million units per day and is especially designed for the aseptic filling of high-volume products, such as vaccines. The company is also expanding its services for the early clinical phases of new drugs at its Vetter Development Service locations in Chicago, Illinois, and Ravensburg (Germany). Read More

Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More