• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the European Commission approved the use of Soliris (eculizumab) for the treatment of patients with paroxysmal nocturnal hemoglobinuria. Soliris is the first therapy approved in Europe for treating PNH, a rare, disabling and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Alexion said it is prepared to begin reimbursement discussions with healthcare systems in major European countries, and expects to introduce Soliris in one or more of them by the end of 2007, with additional countries to follow in 2008. The product was approved by the FDA in March.
• Celgene International Sarl, of Boundry, Switzerland, a wholly owned subsidiary of Celgene Corp., said Revlimid (lenalidomide) has been granted full marketing authorization by the European Commission for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. The drug has orphan drug status in the U.S., EU and Australia for treatment of multiple myeloma.
• CeNeS Pharmaceuticals plc, of Cambridge, UK, announced new preclinical data on its short-acting sedative CNS 7056, showing it induces deep sedation, has a rapid onset of action and rapid offset of action with predictable effects over a wide range of doses. The compound will now be developed for the indications of induction and maintenance of anesthesia in addition to sedation for day-case procedures.
• F. Hoffmann-La Roche Ltd., of Basel, Switzerland, signed a definitive agreement to acquire NimbleGen Systems Inc., of Madison, Wis., for $272.5 million. NimbleGen has a high-density DNA microarray business and technologies focused on targeted DNA sequencing. Roche said the move would strengthen its position in the genomics research market. NimbleGen will become part of Roche Applied Science, a business area of the Diagnostic Division of Roche, which intends to maintain current NimbleGen facilities in Wisconsin, Iceland and Germany, as well as its 140 employees. NimbleGen expects to expand its product portfolio in the near term to include higher-density arrays, integrated instrument systems and related reagents and consumables for advanced genome analysis. The deal is expected to close in the third quarter.
• Haptogen Ltd., of Aberdeen, UK announced a license with Aberdeen University for a library of shark antibodies discovered at the university. Shark antibodies are the smallest found in the animal kingdom, a property that is expected to enable them to reach targets that are not accessible with larger counterparts. The university's technology platform makes it possible to construct large libraries from a few blood samples taken from live sharks.
• Inspire Pharmaceuticals Inc., of Durham, N.C., and FAES Farma SA, of Madrid, Spain, have amended their licensing agreement for the U.S. and Canadian development and commercialization of oral bilastine for the treatment of allergic rhinitis after talks with the FDA. FAES has agreed to conduct additional clinical work and an expanded QT/QTc comparative trial, which likely will include an FDA-approved antihistamine. Inspire will have no financial obligations for the oral program while FAES is conducting the additional clinical work. As a result, Inspire said it expects to decrease estimated cash expenditures by approximately $14 million in 2007, including an $8 million milestone payment that had been anticipated this year. Inspire will continue to hold the new drug application for oral bilastine and will work with FAES over the next year to evaluate the additional clinical data with an eye on a new drug application filing. Beginning in December 2007, FAES has the option to discontinue the additional clinical work, and Inspire has the option to terminate the agreement, in whole or in part, with no further expense.
• Intercytex Group plc, of Manchester, UK, claimed a breakthrough in regenerative medicine following a clinical trial in which its off-the-shelf living skin product was shown to be fully and consistently integrated. The company said ICX-SKN contrasts with all other living skin alternatives, which biodegrade too quickly to act as stable grafts. In the trial a full-thickness skin sample was excised and replaced with ICX-SKN. After 28 days both visual and histological analysis showed that the grafts were rapidly vascularized and overgrown with the volunteers' own cells, resulting in a fully integrated skin graft that had closed and healed the wound site. ICX-SKN comprises a combination of living human fibroblasts in a human fibroblast-produced matrix.
• Invitrogen Corp., of Carlsbad, Calif., and Greiner Bio-One, of Frickenhausen, Germany, finalized a licensing agreement to help improve the reliability of Greiner Bio-One's HPV-DNA test PapilloCheck and DNA-array CytoCheck products. The deal covers rights for the use of dUTP (deoxyuridine trophosphate) in PCR-based methods to prevent sample contamination by amplification products in aerosols. Greiner Bio-One is incorporating into two of its DNA arrays a procedure patented by Invitrogen to prevent PCR carryover contamination and, therefore, avoid false positives. Financial terms of the deal were not disclosed.
• Life Therapeutics Inc., of Atlanta, entered a deal with the specialty pharma firm Kedrion SpA, of Lucca, Italy, under which Life Therapeutics will take up a 5.5 percent equity stake in Kedrion and will divest assets from its Life Sera business into a new joint venture company with Kedrion. The existing Life Diagnostics business will continue to be wholly owned by Life Therapeutics. The deal gives Life Therapeutics, focused on niche therapeutic hyperimmune products, exposure to blood fractionation operations. Kedrion is Italy's largest blood fractionator.
• Noven Pharmaceuticals Inc., of Miami, said Shire plc, of Basingstoke, UK, has exercised its option under agreements with Noven to acquire exclusive development rights to a new transdermal patch for ADHD to be formulated by Noven. In connection with that, Noven received a $5.9 million milestone payment from Shire. Noven successfully completed a Phase I study of an amphetamine transdermal system (ATS) for the treatment of ADHD. Shire has requested modifications to the original patch formulation to align ATS with its future direction in ADHD. In addition to the milestone payment, Noven will receive an unspecified amount from Shire for continuing development efforts.
• Phosphagenics Ltd., of Melbourne, Australia, disclosed positive results from preclinical studies with TPM-02 dermal drug delivery technology formulated with retinoic acid, a topical treatment for severe acne and an active ingredient used in anti-aging cosmetics. The proof-of-concept studies showed a threefold increase in the amount of retinoic acid delivered into the skin when formulated with TPM-02, compared to a control formulation, with no retinoic acid detected in the bloodstream.
• Phytopharm plc, of Godmanchester, UK, entered a collaboration with the Beijing Institute, Academy of Military Medical Sciences for the development of drugs and functional foods based on traditional Chinese medicine. The two will progress the institute's lead product for memory and concentration selected from its compound library. The agreement covers other patented compounds that may have utility in diseases including vascular disorders and stroke. Phytopharm has the rights to develop and commercialize resulting products globally in return for royalty and milestone payments. Financial terms of the agreement were not disclosed. The Beijing Institute focuses on quality control for traditional Chinese medicine products and in the identification and development of active compounds.
• PolyTherics Ltd., of London raised £2.3 million in a funding round led by Longbow Capital LLP, for the further development of the company's pegylation technology for extending the half-life of protein drugs. PolyTherics claims its technology, called Therapeg, produces an improvement in biological activity and a higher yield than existing pegylation technologies. The company, which was spun out of Imperial College London in 2002, has three revenue-generating development contracts in place and is in discussions with other potential partners.
• Proteros Biostructures GmbH, of Martinsried, Germany, said it is due a milestone payment following progress in its collaboration with Bayer HealthCare AG, of Berlin, in the field of fragment-based protein crystallography. Under the deal from June 2006, Proteros is applying technologies to deliver protein-ligand structures of active fragments from Bayer's discovery programs. Proteros also gets a copy of the jointly selected fragment library for its own use. Specifics on the milestone were not disclosed.
• ReNeuron Group plc, of Guilford, UK, said it presented data on its ReN002 diabetes program. ReNeuron said it used its c-mycER stem cell expansion technology to generate stable human pancreatic cell lines that form islet-like cell clusters. The clusters were shown to secrete insulin in response to glucose concentrations, demonstrating their potential as a cell therapy candidate for Type I diabetes. The ReN002 cells are being taken forward into preclinical models of diabetes.
• Speedel Holding AG, of Basel, Switzerland, said partner Novartis AG, also of Basel, received a positive opinion recommending European Union approval of SPP100 (Rasilez) as the first-in-class, once-daily direct renin inhibitor for the treatment of hypertension. The Committee for Medicinal Products for Human Use issued the positive opinion for Rasilez based on data from more than 7,800 patients in 44 clinical studies. The European Commission generally follows the CHMP's recommendations and is expected to issue a decision within three months. SPP100 was approved by the FDA and launched by Novartis in the U.S. in March 2007 under the trade name Tekturna.
• Stem Cell Sciences plc, of Edinburgh, UK, licensed rights to a technology that it said was expected to accelerate the application of human embryonic stem cells in both research and cell-based therapies. The technology uses Rho-associated kinase, or ROCK, inhibitors to block the onset of stem cell death when the clusters of growing cells are dissociated for transfer and scale-up. SCS has exclusive, worldwide rights to the discovery, except in Japan, where it holds nonexclusive rights. Financial terms were not disclosed. The license was granted by the RIKEN Centre for Developmental Biology in Kobe, Japan.
• Syngenta AG, of Basel, Switzerland, and the Institute of Genetics and Developmental Biology in Beijing signed a five-year research deal focused on agronomic traits, including drought tolerance for key crops, including corn, soybean, wheat, sugar beet and sugar cane. IGDB forms part of the Chinese Academy of Sciences in Beijing and is one of China's leading biotechnology research institutes. Syngenta has rights to commercialize previously and newly developed traits in the agreed range of field crops. Under the agreement, traits not only will be developed for the Chinese seeds market, but also for global agriculture markets. Financial details were not disclosed.
• Toyama Chemical Co. Ltd., of Tokyo, and Hoffmann-La Roche Inc., of Nutley, N.J., entered a licensing agreement for the worldwide research, development and commercialization of Toyama's oral rheumatoid arthritis agent T-5224. By inhibiting a specific inflammatory process, T-5224 has the potential to block signs and symptoms of rheumatoid arthritis as well as the progressive destruction of joint and bone, the companies said. T-5224 is in Phase I trials. Toyama Chemical is entitled to up-front and milestone payments of up to $370 million. It also would get royalties on resulting sales.
• VASTox plc, of Oxford, UK, has been awarded a grant of £400,000 (US$797,000) by the Welsh Development Agency under the SMARTCymru program. The 12-month grant will support the research and development work undertaken at VASTox's Aberystwyth facility, which works to identify naturally occurring biologically-active carbohydrate compounds.