Abbott Japan and Eisai have launched Humira (adalimumab) prefilled syringe 20mg/0.4mL, a fully human anti-TNF-α monoclonal antibody for the treatment of polyarticular juvenile idiopathic arthritis patients with low body weight, on Sept. 29, 2011. The product received manufacturing and marketing approval from Japan’s Ministry of Health, Labor, and Welfare on July 1, 2011, and was subsequently listed on the National Health Insurance price list on Sept. 12.
The CDMO Aesica has announced plans for further growth and expansion following an investment from Silverfleet Capital, a European private-equity firm. Subject to regulatory approval from the German authorities, which is expected to occur within the next four weeks, Silverfleet Capital has agreed to make a majority investment in Aesica, and members of the Aesica executive team have reinvested in a large minority stake in the company. Financial support will be provided by Lloyds Bank Corporate Markets Acquisition Finance, HSBC, and Yorkshire Bank. Additional corporate support will continue to be supplied by PricewaterhouseCoopers, Ernst & Young, and Ward Hadaway.
AstraZeneca has settled its patent-infringement litigation against Handa Pharmaceuticals regarding Handa’s proposed generic version of AstraZeneca’s Seroquel XR (quetiapine fumarate) extended-release tablets. The agreement ends the patent-infringement litigation that followed Handa’s submission of an abbreviated new drug application for a generic version of Seroquel XR. Under the settlement, Handa does not dispute that both patents asserted by AstraZeneca in the litigation are valid and enforceable. As part of the agreement, AstraZeneca has granted Handa a license to enter the US market with generic Seroquel XR on Nov. 1, 2016, or earlier, depending upon certain circumstances. Seroquel XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017. AstraZeneca and Handa will file a proposed consent judgment with the US District Court for the District of New Jersey requesting that the court dismiss the pending legal action between AstraZeneca and Handa. The remaining Seroquel XR patent-infringement litigation remains ongoing.
Braun Medical, a healthcare supply company, has installed Werum Software & Systems’ PAS-X operational system at its production facility in Sempach, Switzerland. PAS-X will be used to optimize the manufacturing of liquids.
The CDMO Catalent Pharma Solutions and Toyobo Biologics, a supplier of bioreactors, have agreed to copromote Catalent’s proprietary GPEx technology in the Japanese market. GPEx technology is used for mammalian cell-line development.
The Johnson & Johnson (J&J) subsidiary McNeil-PPC and its affiliate McNeil MMP have acquired of full ownership of the J&J–Merck Consumer Pharmaceuticals joint venture in the United States from Merck Sharp & Dohme. The joint venture will be renamed McNeil Consumer Pharmaceuticals and will continue to market products under the Pepcid, Mylanta, and Mylicon brands. In addition, J&J, through its McNeil Consumer Healthcare Division (McNeil Canada), has acquired from Merck Canada its partnership interest in the Canadian joint venture. McNeil Canada will continue to market and sell Pepcid, 222, and Fleet Enema in Canada. Ownership of the manufacturing facility in Lancaster, Pennsylvania, will transfer to McNeil-PPC.
The CMO Lonza Group’s acquisitions subsidiary LG Acquisition has extended the expiration date for its tender offer for 100% of the outstanding shares of common stock of the biocides company Arch Chemicals to Oct. 14, 2011. The tender offer is at a price of $47.20 per share in cash, without interest and less any required withholding taxes pursuant to a merger agreement between Arch Chemicals, Lonza, and LG Acquisition, dated July 10, 2011. The tender offer has been extended because the conditions are not expected to be satisfied as of the previously scheduled expiration date.
Lundbeck, a pharmaceutical company, and the pharmaceutical company Proximagen Group have formalized a partnership in which Lundbeck and Proximagen will jointly develop treatments for central-nervous-system disorders. Under the agreement, a steering committee of experts from both companies will focus on developing three of Proximagen’s programs with the aim of identifying therapies for epilepsy, pain, and inflammatory disorders. Lundbeck will also receive certain negotiation rights in relation to these programs and take a 9% stake in Proximagen for £10.3 million ($16.1 million).
Merck Serono, a division of Merck KGaA, signed two separate agreements with Ono Pharmaceutical, an R&D-oriented pharmaceutical company, for the treatment of multiple sclerosis (MS) and cancer. The first agreement grants Merck worldwide exclusive license rights for the development and commercialization of ONO-4641 [sphingosine-1-phosphate (S1P) receptor agonist] outside of Japan, Korea, and Taiwan, for the treatment of relapsing-remitting multiple sclerosis. The second license agreement provides Ono with codevelopment and comarketing rights to Stimuvax (BLP25 liposome) in Japan for the treatment of nonsmall-cell lung cancer. Under the terms of the agreement for ONO-4641, Merck Serono will acquire worldwide exclusive rights, excluding Japan, Korea, and Taiwan, to develop and commercialize ONO-4641. Ono will receive JPY 1.5 billion ($19.5 million) as an up-front payment and could receive additional payments based on the achievement of certain development, regulatory, and commercial milestones. Under the terms of the separate agreement, Ono will receive a codevelopment and comarketing license for Stimuvax in Japan, and Merck Serono will receive an upfront payment of EUR 5 million ($6.6 million).
Roche has opened a new 17,000-ft2 clinical-supply manufacturing facility on its campus in Nutley, New Jersey. The Roche Center of Excellence produces dosage forms of highly potent compounds for preclinical safety studies and Phase I and II clinical studies. The clinical dosage forms produced at the facility include tablets, capsules, powders, suspensions, and solutions.
Roche has named Rainer Metternich as head of small-molecule research. He takes over from Klaus Strein, who will retire from Roche.