• Acambis plc, of Cambridge, UK, said it completed the formulation work on its Clostridium difficile vaccine, improving its stability and paving the way for a proof-of-concept trial in 2008. C. difficile infection is the most common cause of hospital-acquired diarrhea in the developed world, resulting in at least 360,000 cases per annum in the U.S. with estimated annual costs to the U.S. and European health care systems of $5 billion. The company said it expected to start the trial around the end of 2008, providing data within 12-18 months of commencement. Acambis claimed it is the only C. difficile vaccine in development. Phase I trials of the previous formulation achieved seroconversion rates of up to 100 percent.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, filed its new drug submission for oral alitretinoin with Health Canada, seeking to get the drug approved in severe refractory chronic hand eczema. Marketing applications have been filed also in Switzerland and in several European Union member states.

• GW Pharmaceuticals plc, of Salisbury, UK, said more than 1,400 patients in the UK have been prescribed Sativex, its cannabis-based treatment for the symptoms of multiple sclerosis on a named patient basis, despite the fact that the product does not have regulatory approval. New patients are being added each day, and now the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has taken the unprecedented step of publishing a public information report on the product. The MHRA said it did so because it is in the public interest for prescribers to have further information on Sativex. Geoffrey Guy, chairman of GW Pharma said, "We continue to receive inquiries from UK physicians and patients on a daily basis and this report will serve to provide them with more information about the medicine and its use." The MHRA refused to approve the drug in July, and in December, the company began a further Phase III trial to address its reasons for doing so.

• Jerini AG, of Berlin, said the FDA accepted the new drug application for Icatibant in hereditary angioedema for priority review and issued a PDUFA date of April 26, 2008. The agency also scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting for Feb. 20. Icatibant is a synthetic peptidomimetic designed to work by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin. The drug previously was granted orphan status in HAE.

• Medivir AB, of Stockholm, Sweden, said Presidio Pharmaceuticals Inc., of San Francisco, elected to return rights to MIV-310, an HIV nucleoside reverse transcriptase inhibitor, which allows Medivir to transfer the full license to the compound and intellectual property to Beijing Mefuvir Medicinal Technology Co. Ltd., of China. Mefuvir will develop MIV-310 for therapeutic use. Medivir licensed MIV-310 and MIV-410 to Presidio in a December 2006 deal valued at $75.3 million. Due to the transfer of MIV-310, financial terms were adjusted, leaving $52.3 million in milestones for continued development of MIV-410, which was not affected by the transfer. MIV-310 is the second drug from Medivir's polymerase program to be licensed to Mefuvir. In August, Mefuvir gained rights to MIV-160 for HIV prophylactic and therapeutic use.

• PepTcell Ltd., of High Wycombe, UK, has entered into a research collaboration with Gador SA, of Buenos Aires, Argentina, to develop a T-cell vaccine for Chagas disease, a neglected tropical disease with no adequate treatment or vaccination. PepTcell will use its proprietary technology to identify parasitic proteins capable of inducing a T-cell immune response. When the vaccine is ready to enter Phase III, Gador will assume responsibility for its development, commercialization in Argentina and manufacturing. PepTcell will receive undisclosed royalties based on net sales. Chagas affects approximately 18 million people in Latin America, where it is one of the leading causes of heart failure. The World Health Organization recently set up an initiative to increase awareness and eradicate the disease by 2010. Gador has been researching the disease for the past 20 years and has developed the first commercially available diagnostic.

• Plethora Solutions Holdings plc, of London, said it received regulatory approval to start a Phase III study of PSD502 for the treatment of premature ejaculation in Europe. That follows the initiation of the U.S. Phase III program. The product is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol. There currently are no approved treatments for premature ejaculation. The European study is expected to recruit 270 patients across 36 centers.

• SkyePharma plc, of London, reached an agreement with its licensee, Abbott Inc., of Abbott Park, Ill., in which Abbott will pick up the tab for additional clinical work on its combination asthma drug, Flutiform, requested by the FDA. In addition, Abbott will be responsible for submitting the NDA. That means SkyePharma will no longer incur expenditure of $20 million on the additional Phase III studies. In return, it has agreed to reduced milestone payments due on the acceptance of filing and approval. Taking that into account, together with the effects on milestones of the delay in filing announced Aug. 6, 2007, the UK drug delivery specialist is in line for up to $124.5 million in total milestones instead of the $165 million stated previously. Sales-related milestones and royalty rates remain unchanged. All Phase III trials are due to be completed in April.

• Solagran Ltd., of Melbourne, Australia, said the firm is on track to start commercial production of its liver protectant Ropren in January 2008. Ropren was registered as a new and low-side-effect pharmaceutical to treat chronic liver disease (hepatitis and cirrhosis) by the Russian Ministry of Health in July. Since then, Solagran has been working with its Russian associate SibEX to build a production facility capable of meeting the first wave of demand.

• Tibotec Pharmaceuticals Ltd., a Cork, Ireland-based unit of New Brunswick, N.J.-based Johnson & Johnson, submitted a supplemental new drug application to the FDA for full approval of the protease inhibitor Prezista (darunavir) as well as an expanded label for use in HIV-1 infected, treatment naïve adults. Prezista received accelerated approval for use in treatment-resistant HIV patients last year based on Phase IIB trials; the sNDA contains data from two Phase III trials.

• Vernalis plc, of London, applied to list 14.7 million shares in order to raise the $5.8 million milestone payment it owes to former holders of Cita NeuroPharmaceuticals Inc., which Vernalis acquired in 2005. The milestone is associated with the successful completion of a Phase II trial with V3381 in neuropathic pain.

• Verona Pharma plc, of London, said it is raising £2.32 million (US$4.6 million) in a placement for the further development of its respiratory portfolio. The company, which is listed on the Alternative Investment Market in London, is working on products including a nonsteroidal asthma treatment and a treatment for unresolved coughing. The asthma product was discovered by David Jack, a former research director at GlaxoWellcome plc, who was involved in the development of a number of marketed respiratory drugs.