Week of July 18, 2011: Amgen Resolves Patent Dispute with Teva; PharmaNet Development Group Names George Scott Vice-President of Bioanalytical Services; and More. - Pharmaceutical Technology

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Week of July 18, 2011: Amgen Resolves Patent Dispute with Teva; PharmaNet Development Group Names George Scott Vice-President of Bioanalytical Services; and More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Company Notes

Abbott reports that it plans to develop two new formulations of its HIV medicines, Kaletra (lopinavir/ritonavir) and Norvir (ritonavir). The company is currently investigating a new powder formulation of Norvir as well as a co-formulation of three HIV medicines: lopinavir, ritonavir and 3TC (lamivudine). The Norvir powder formulation is intended to make it easier to store the medicine. The investigational fixed-dose combination of lopinavir, ritonavir, and 3TC could reduce the daily number of tablets a patient takes of the fixed-dose combination. If developed and approved, the fixed-dose combination would be designed to be taken with one additional anti-HIV medicine. Abbott is developing the new formulations with the goal to make a contribution to the World Health Organization’s Treatment 2.0 strategy. This strategy includes providing treatment options to make the most of the resources available in those developing countries that carry the heaviest HIV burden.

Amgen reported that the US District Court in Pennsylvania has entered final judgment and a permanent injunction against Teva Pharmaceutical Industries and Teva Pharmaceuticals USA prohibiting them from infringing Amgen’s patents relating to human G-CSF (granulocyte colony-stimulating factor) and methods for its use. The judgment was accompanied by Teva’s admission that its Neutroval product infringes the two Amgen patents at issue in the litigation and that those patents are valid and enforceable. The court's injunction extends until Nov. 10, 2013, after which date, Teva may sell Neutroval in the US. Regarding Neugranin, another Teva G-CSF product, Teva agreed not to sell Neugranin until Nov. 10, 2013, unless it first obtains a final court decision that Amgen’s patents are not infringed by Neugranin. The launch date for either product could be sooner if certain unexpected events occur: a third party launches a similar G-CSF product and Amgen fails to sue that third party or the patents are held invalid or unenforceable in a final court decision in an action brought by a third party. The settlement terms do not include any financial payments between the parties. The two patents at issue in the litigation, US Patent Nos. 5,580,755 and 5,582,823, expire in early December 2013.

Catalent, a drug-delivery technology and contract services provider, and Sanwa Kagaku Kenkyusho, a Japanese pharmaceutical and healthcare company, have formed an exclusive agreement to bring Sanwa’s drug-delivery tableting technology to global markets. The technology will be marketed by Catalent in all markets outside of Japan, Korea, China (Hong Kong), and Taiwan. OSDrC is a fully developed optimized dose-delivery technology to enable the design of single or multicore tablets. The technology can produce pulsatile tablets, bilayer tablets, multicore tablets, dividable tablets, delayed-release tablets, and direct compression orally dissolving tablets. The technology has already been commercially proven by Sanwa in Japan, and Catalent will use its global footprint, modified-release delivery expertise, and integrated manufacturing expertise to bring OSDrC to the global market. Catalent expects to commence customer product-development trials at its Winchester, Kentucky, facility in January 2012.

Cephalon’s stockholders have approved Teva Pharmaceutical Industries’ proposal to acquire Cephalon for $81.50 per share in cash, or a total enterprise value of approximately $6.8 billion. The transaction remains under review by the US Federal Trade Commission and the European Commission. Cephalon and Teva continue to operate as two independent companies pending those clearances.

Granules India, a pharmaceutical manufacturer, and Ajinomoto OmniChem, a producer of fine chemicals for the pharmaceutical industry, announced a joint-venture to offer active pharmaceutical ingredients (APIs) and intermediates to pharmaceutical companies. The new company, Granules-OmniChem, will be a joint-venture and be equally owned by both companies. Ganules OmniChem will operate its facility in Vishakhapatnam (Vizag), Andhra Pradesh, India. The construction of the facility will begin by November 2011, is expected to be completed by late 2012, and begin production by January 2013. The company will initially focus on high-value, low-volume APIs and intermediates for existing customers and will custom manufacture new chemical entities in the future.

INC Research, a contract research organization (CRO) privately held by Avista Capital Partners and Ontario Teachers’ Pension Plan, has completed the acquisition of Kendle International, also a CRO, in an all-cash transaction with a total equity value of approximately $232 million or $15.25 per share.

Janssen Pharmaceuticals, part of Johnson & Johnson, has agreed to divest the assets of its Ortho Dermatologics division in the US to subsidiaries of Valeant Pharmaceuticals International for approximately $345 million in cash. The divestiture of Ortho Dermatologics’ assets includes prescription brands, Retin-A-Micro, Ertaczo, Renova, sold in the US. The transaction is expected to close by the end of 2011, subject to customary closing conditions.

The contract manufacturing organization Lonza has acquired all of the outstanding shares of common stock of the biocides company Arch Chemicals at a price of $47.20 per share, net to the seller in cash, without interest and less any required withholding of taxes. The board of directors of Arch Chemicals has unanimously approved the terms of the merger agreement and recommended that Arch Chemicals shareholders tender their shares pursuant to the tender offer. The deal is subject to customary closing conditions and regulatory approval.

Merck & Co. has announced that company researchers will participate in two new collaborative efforts led by the University of North Carolina Chapel Hill (UNC) and the University of California San Francisco (UCSF) to develop new approaches towards eradicating HIV. As announced by UNC, researchers from nine US universities as well as Merck scientists will begin to study HIV latency and identify ways to purge persistent infection of the virus from the body. Separately, researchers at UCSF announced that an international team of academic, governmental, and Merck scientists will begin work on a five-year research effort to define HIV's reservoirs, better understand the reservoirs, and test potential treatments. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is the primary funding organization for both of these research efforts. Merck will not receive any funding for its participation in either effort.

Novartis has reported that it has started shipping its seasonal influenza vaccine to its US customers for the 2011–2012 influenza season. Novartis plans to ship over 30 million doses of its Fluvirin influenza virus vaccine, which has been approved by FDA for adults and children 4 years of age and older.

Roche has agreed to acquire 100% of mtm laboratories AG (mtm), a privately held company based in Heidelberg, Germany. mtm is a provider of in vitro diagnostics with a focus on early detection and diagnosis of cervical cancer. mtm will become part of Roche’s Tissue Diagnostics (Ventana Medical Systems) business unit. Under the agreement, Roche will pay mtm shareholders an upfront payment of approximately EUR 130 million ($184.1 million) as well as up to approximately EUR 60 million ($84.6 million) upon reaching performance-related milestones. The transaction is subject to customary closing conditions and is expected to close in the coming weeks.

People Notes

George Scott, PhD, has been named vice-president of bioanalytical services for PharmaNet Development Group. Prior to joining PharmaNet, Scott served as director of pharmacokinetics and drug metabolism at Amgen.

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