The niche generic pharmaceutical company Akorn has agreed to acquire certain assets of the CMO Kilitch Drugs in India as well as certain assets of NBZ Pharma, for approximately $52 million in cash and future contingent payments totaling up to approximately $6 million based on the achievement of certain milestones and financial targets. Under the agreement, Akorn will acquire five cGMP manufacturing sites with approximately 230,000-ft2 of manufacturing space.
The CMO Aesica has formed two manufacturing agreements. The company has partnered with Normaco, a manufacturer and supplier of opiate-derived APIs, for the manufacture of codeine phosphate from a patented poppy supplied by Noramco’s sister company, Tasmanian Alkaloids, allowing for the conversion of the extracted alkaloid to a finished API in a one-step process for codeine phosphate.
Aesica has also formed a long-term partnership with Mitovie Pharma, specifying that Aesica will deliver clinical-trial and commercial batch supply and formulation-development services. Under the agreement, Aesica will provide Mitovie with a service provision that encompasses API and finished-dosage manufacturing services, as well as formulation-development expertise, and Mitovie will condense services by working with a single supplier.
The CRO Alphora Research has completed a cytotoxics R&D laboratory as part of an ongoing $4-million capital program for 2011. The laboratory is designed to handle high-potency APIs and Class IV compounds. It is equipped with three hard enclosure isolator units, pressure lock entryways, and dedicated class HEPA-filtered air-handling systems.
AstraZeneca has entered into a settlement agreement in its US Seroquel XR patent-infringement litigation against the CDMO Intas Pharmaceuticals and its subsidiary Accord Healthcare regarding Accord’s proposed generic version of AstraZeneca’s Seroquel XR (quetiapine fumarate) extended-release tablets. The agreement settles the patent-infringement litigation filed by AstraZeneca following Accord’s submission to FDA of an abbreviated new drug application (ANDA) for a generic version of Seroquel XR. Under the settlement agreement, Accord does not dispute that the patent asserted by AstraZeneca in the US patent litigation is valid and enforceable. As part of the agreement, AstraZeneca has granted Accord a license to enter the US market with generic Seroquel XR on Nov. 1, 2016, or earlier upon certain circumstances. Seroquel XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017. AstraZeneca and Accord will file a proposed consent judgment with the US District Court for the District of New Jersey requesting the court dismiss the pending legal action between AstraZeneca and Accord. The remaining Seroquel XR patent infringement litigations remain ongoing.
In other news, AstraZeneca has announced the reduction of approximately 400 positions at the company’s Wilmington, Delaware, headquarters and some field-based, nonsales roles. About 70 of the estimated 400 positions will come from existing vacancies. In addition, employees will have the option to self-identify to potentially leave the company. All decisions will be finalized by early December 2011.
Avacta Group, a provider of analytical and diagnostic technologies and services, has agreed with Pall Corporation, a provider of filtration, separation, and purification services, to sell and distribute Avacta’s protein drug-development tool Optim in Southeast Asia. This agreement extends Avacta’s commercial partnership with Pall, with whom the company is already partnering on sales and marketing of Optim in North America. Under the agreement, Pall will gain exclusive marketing and distribution rights to Optim, in a number of territories throughout the Pacific Rim, including South Korea, Australia, New Zealand, and Singapore.
Boehringer Ingelheim and Gilead Sciences have entered into a licensing agreement, under which Boehringer Ingelheim has granted Gilead exclusive worldwide rights for the research, development, and commercialization of its noncatalytic site integrase inhibitors for HIV. This includes the lead compound BI 224436, which has been evaluated in a Phase I-a dose-escalation study to assess bioavailability and pharmacokinetics in healthy volunteers. Under the agreement, Gilead will pay Boehringer Ingelheim an upfront payment. Boehringer Ingelheim could receive additional payments based upon the achievement of certain development, regulatory, and commercial milestones, as well as royalties on future net sales.
The CDMO Catalent Pharma Solutions has expanded the geographic reach of its analytical-development services business with the opening of a European development and clinical-services laboratory in Swindon, United Kingdom. This expansion follows a recent expansion of its clinical-supply service capabilities at the company’s facility in Schorndorf, Germany.
The CDMO Hikma Pharmaceuticals has acquired 63.9% of Société de Promotion Pharmaceutique du Maghreb from shareholders comprising existing management, institutions, and related parties, for an aggregate cash consideration of $111.2 million, and will launch a mandatory tender offer for the remaining 36.1% of the company.
MedImmune, the biologics arm of AstraZeneca, reported an execution of an in-licensing agreement with Pfizer for tremelimumab (CP-675,206), a CTLA-4 monoclonal antibody. Under the agreement, MedImmune will assume global development rights to tremelimumab, and Pfizer will retain the rights to use tremelimumab with specified types of combination therapies. MedImmune plans to explore tremelimumab in a number of potential cancer indications. Terms of the agreement were not disclosed.
Merck & Co. has announced that FDA has approved Juvisync (sitagliptin and simvastatin), for the treatment of Type II diabetes.
Pfizer has agreed with Puma Biotechnology for the development and commercialization of neratinib, an investigational oral, multitargeted inhibitor of the ErbB1 (EGFR), ErbB2 (HER2), and ErbB4 (HER4) kinases, being studied for the treatment of cancer. Under the terms of the agreement, Puma will assume sole responsibility for global development and commercialization of neratinib. Pfizer will be entitled to receive payments upon Puma’s achievement of certain development milestones for neratinib as well as royalty payments for any sales of neratinib. Specific terms of the agreement were not disclosed.
Scios, a subsidiary of Johnson & Johnson, has announced an agreement with the US Department of Justice to resolve allegations of misbranding of Natrecor (nesiritide), a prescription medication for the treatment of heart failure. Under the agreement, Scios entered a guilty plea to a single misdemeanor violation of the Food, Drug, and Cosmetic Act and agreed to pay an $85-million fine. Scios acknowledges that Natrecor was misbranded and used in a way not approved by FDA because its labeling lacked adequate directions for that use but denies any wrongful intent in connection with this plea.
Teva Pharmaceutical Industries and the biopharmaceutical company Cephalon report that the US Federal Trade Commission has accepted the proposed consent order in connection with the pending acquisition of Cephalon by Teva and granted early termination of the Hart Scott Rodino waiting period. Under the consent order that has been executed by the parties and accepted for public comment by the FTC, Teva is required to divest two ANDAs for fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix. Teva will also grant nonexclusive US rights to an undisclosed company to market modafinil tablets, the generic version of Provigil. The parties expect to close the transaction by Oct. 14, 2011, subject to approval by the European Commission.
Vetter, a CDMO, has announced that its first US facility is now fully operational. Located at the Illinois Science and Technology Park in suburban Chicago, the 24,000-ft2 site includes microbiology and chemical analysis laboratories, material preparation and compounding functions, three cleanrooms for aseptic filling, and visual inspection. Vetter’s new facility is the first to use Bosch’s new MHI 2020 B fully automated vial filler and offers technology and processes to support preclinical through Phase II compounds.
Xoma, a CDMO, has been awarded a new contract for up to $28 million over five years to develop broad-spectrum antitoxins for the treatment of human botulism poisoning. The botulinum toxin, which causes botulism poisoning, is classified as a Class A bioterror threat by the US government. To date, XOMA has entered into four contracts totaling up to approximately $120 million with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to advance biodefense-related product development.
Aptuit has appointed Jan-Olav Henck as chief scientific officer, effective Oct. 1, 2011. Henck was most recently site director for Aptuit’s SSCI division.
CytomX Therapeutics, a biotechnology company, has announced the promotion of Henry Lowman to chief scientific officer. In this position, Lowman will lead research and development activities to advance the company’s Probody candidates through optimization, preclinical, and early-clinical development.
The pharmaceutical company Lundbeck has appointed three vice-presidents in supply operations and engineering. Kristian Sibilitz was appointed as vice-president of logistics, Christian Houborg as vice-president of supply operations and engineering, and Lene Anderson as vice-president of quality-supply operations.
Merck & Co. has announced that Richard T. Clark, chairman, will retire from the company and the Merck board of directors, effective Dec. 1, 2011. Clark led the company for five years as president and CEO from 2005 through 2010. He has served as a Merck director since May 2005 and chairman of its board of directors since 2007. The board has chosen Kenneth C. Frazier to become Clark’s replacement.
The CDMO Patheon has announced that Peter T. Bigelow, Patheon’s president of North American operations, will leave the company, effective Nov. 1, 2011, to pursue new opportunities.
Syntagon has announced changes to its management team. Andis Slaitas will replace Michael Lofthagen as CEO, effective immediately. Andis has been with Syntagon since 2005. Prior to his promotion, Andis was vice-president of operations at Syntagon. In additon Ulrika Burén has been promoted from quality assurance (QA) associate to QA officer.