News in brief, July 13, 2007

Company news

Genaera discontinues cystic fibrosis and prostate cancer treatments
US pharmaceutical company Genaera and the Cystic Fibrosis Foundation Therapeutics (CFFT), have agreed to discontinue the phase II study of Lomucin (talniflumate) for the treatment of cystic fibrosis (CF). Genaera also announced that the phase II study of squalamine for prostate cancer, which is an investigator-initiated study funded by the Department of Defense, will also be discontinued. As a result of the joint decision to terminate the Lomucin study, the CFFT has agreed to final financial details of the award agreement to support the evaluation of Lomucin in subjects with CF. Genaera will receive a final milestone payment in the amount of USD 100,000 and will not be required to refund any portion of the award previously received from the CFFT. As a result of termination, the company received USD 2.1m of which USD 2m was previously recorded as a long-term liability. Termination of the Lomucin study was a result of a recommendation by the company to the study's Data Monitoring Committee (DMC) to close the ongoing study for futility. The DMC identified no safety concerns in their review. The phase II study of squalamine in prostate cancer had had no recent enrollment, while delays in restarting the study at a new investigative site also contributed to the discontinuation of the trial.

Nigerian court postpones Pfizer drug deaths case
A Nigerian court has adjourned a criminal case between Pfizer and the state of Kano in Nigeria until 3 October 2007. The state is seeking USD 2bn over allegations that a Pfizer drug study conducted in the 1990s led to deaths and disabilities in children. Judge Shehu Atiku said the delay would allow the prosecution to serve a summons requiring Pfizer executives to appear in court when the trial resumes. The Kano state has also launched a separate civil case, which will be heard on 30 July. The Nigerian federal government has also filed a third suit in the capital of Abuja, seeking damages of USD 7bn. Pfizer has denied the charges. The contested study used a group of 200 children to test an experimental meningitis treatment, but took place during a 1996 meningitis epidemic in Kano state's main city, also called Kano.

Evotec and RSIL form jv for compound libraries
Germany-based Evotec and Research Support International Limited (RSIL), a subsidiary of DIL, have formed a joint venture (jv) in India, Evotec-RSIL, to design, synthesise and manage compound libraries as a service. The jv will combine Evotec's expertise in library design, synthesis, analysis, purification and project management with RSIL's scientists alongside a low cost structure in India to provide a cost efficient solution for the provision and management of compound libraries to the pharmaceutical industry. Evotec has collaborated with companies, such as Bayer, Merck & Co, Almirall Prodesfarma, Roche and Solvay. RSIL is a well established contract research organisation (CRO) located on a scientific campus in Thane, a suburb of Mumbai, India. It has provided chemistry services for over 20 years to pharmaceutical and biotech companies worldwide. The jv will be located in Thane and will use newly constructed laboratories. Evotec will contribute its proprietary technologies, years of experience and expertise in library synthesis in addition to providing a range of parallel synthesis equipment, high throughput analytical apparatus and expert training in the design, synthesis and management of compound libraries.

Servier builds EUR 40m plant in Russia
According to Russian newspaper Kommersant, France-headquartered Servier has revealed it will launch a business in Russia by opening a EUR 40m (USD 54.5m) plant. The plant, which is cited near Moscow, will produce prescription drugs, according to Servier. Production will commence in Q4 2007 and will reach an annual capacity of 4.5bn tablets by 2011. The plant should help Servier increase its share in the Russia state-run drug programme, according to David Melik-Guseinov, marketing research director at Pharmexport. The drug programme, which provides pensioners and low-income families with free medicines, received RUB 29bn in 2006. The budget for 2007 is approximately RUB 35bn. Servier currently controls four per cent of this market. Foreign investors are also attracted by growth in the Russian pharmaceutical market, which, according to industry analysts rose 40 per cent to reach USD 2bn in the quarter ending in March 2007.

GSK recalls Hedex Extra in Kenya
GSK is investigating possible manufacturing errors which may have resulted in an error in its Hedex Extra pain formulation under the watch of Kenya's Pharmacy and Poisons Board. GSK said that the product had been incorrectly stored in excessive temperatures above 30 degrees, causing the breakdown of the ingredient aspirin to form crystals of salicylic acid. Hedex Extra was launched as a product extension to Hedex, a companion and fighter brand to increase its share of Kenya's KES 2bn (USD 30m) analgesic drug market. Kenya's Poisons and Pharmacy Board, which regulates the manufacture and marketing of drugs, confirmed that GSK started recalling the product in March. Until yesterday, GSK had not issued a public announcement over the product recall as industry standards requires in global medical marketing.

Clinical news

Lancet reviews HIV entry inhibitors
UK medical journal, the Lancet, has given its opinion on the success of HIV entry inhibitors, a new drug class which prevents HIV entry into CD4 cells. The New Drug Class review mentions a study conducted by Dr Jose Este, Fundacio irsiCaixa, Hosptial Univeristari Germans, Badalona, Spain, and colleagues, which concluded there was a need for new classes of anti-retroviral drugs due to increasing concern about the long-term toxic effects of existing drugs, the need to combat HIV-1 variants resistant to treatment and the frequency of treatment change in drug-experienced patients. HIV entry inhibitors are either fusion inhibitors or co-receptor antagonists. Many of the treatments are in phase III or two clinical trials. Roche's Fuzeon (enfuvirtide) has already been approved after it substantially lowered HIV viral load counts in a proportion of patients. The authors concluded: "The development of a new antiretroviral drug class is a major success. The possibility of blocking HIV entry by fusion inhibitors and co-receptor antagonists proves the value of basic research on the viral life cycle."

Brain cancer vaccine wins commercialisation go-ahead
Northwest Biotherapeutics, a US-based biotech company, has won approval for commercial use of the world's first vaccine against brain cancer in Switzerland. Toshiyuki Sakai said his team had found that alopestatin reduced hair loss by 70 per cent when used on rats also given etoposide to treat lung and other cancers. Sakai, who is a professor at Kyoto Prefectural University of Medicine presented preclinical results at an academic meeting in Japan, but the likelihood of commercialisation was low at the moment. No clinical programmes have been proposed, but one possible use for humans would be to apply it to the head in the period when hair loss is most likely to occur during chemotherapy. In women, brain tumours are the 10th most common cause of cancer death, although they do not affect men to the same extent. Brain tumours generally comprise about one per cent of all newly diagnosed adult cancers.

Generic news

FDA approve generic versions of Lamisil tablets
The FDA has approved the first generic versions of prescription Lamisil (terbinafine) tablets, used to treat nail fungus infection (onychomycosis). The FDA approved applications from multiple generic drug manufacturers for terbinafine tablets in 250mg formulations. Manufacturers included: Amneal Pharmaceuticals, Apotex, Aurobindo Pharma USA, Dr Reddyís, Gedeon Richter, Genpharm, Glenmark Pharmaceuticals, InvaGen Pharmaceuticals, Mylan Pharmaceuticals, Orgenus Pharma, Roxane Laboratories, Teva Pharmaceuticals USA, Watson Laboratories and Wockhardt USA. The remaining patent or exclusivity for Lamisil expired on 30 June 2007. According to the online trade magazine, Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the US. The FDA also approved an application for a generic version of over-the-counter Lamisil cream to treat athlete's foot, The cream is manufactured by Taro Pharmaceuticals.

Financial news

Angel Biotechnology up 44 per cent
The market capitalisation of AIM-listed Angel Biotechnology Holdings rose 44 pct after it revealed it had signed a contract worth about GBP 450,000 with Russian-headquartered Materia Medica Holdings for process development and GMP manufacture of polyclonal antibodies. The biopharmaceutical contract manufacturer said discussions for a second contract with Materia Medica, which makes homeopathic drugs in the Russian Federation and CIS countries, are at an advanced stage.

Noven acquires JDS Pharmaceuticals
US-based Noven Pharmaceuticals has agreed to acquire privately-held specialty pharmaceutical company JDS Pharmaceuticals for approximately USD 125m in cash at closing, plus assumption of nearly USD 10m in net liabilities. The transaction is expected to close by early August 2007. Noven said that JDS Pharma markets two branded prescription psychiatry products and is advancing a pipeline of products in psychiatry and women's health. Noven added that it expected the acquisition to provide an annual sales of over USD 500m beginning in 2012. Following closing, Phillip Satow, CEO and co-founder of JDS, may join Noven's board of directors.

Brandes to oppose Sun's Taro buy
Brandes Investment Partners, the second-largest shareholder in Taro Pharmaceutical Industries, has said it will vote against the USD 230m acquisition by India's Sun Pharmaceutical. Sun's USD 7.75 per share offer was deemed too low by San Diego-based Brandes said in a statement on PR Newswire. Brandes has a stake of about 11 per cent in Taro, which agreed to Sun's acquisition back in May 2007. Shares in Taro, which have traded in the US since 1961, have lost 85 per cent of their value in the past three years. Brandes said in the statement that the proposal was not in the best interest of its shareholders. Taro's shares rose USD 0.15, or 2.4 per cent, to reach USD 6.45 in over-the-counter trading before the Brand statement was released.

Dishman acquires Solvay's fine chemicals arm
Dishman Pharmaceuticals & Chemicals will acquire the fine chemicals, vitamin D and vitamin D analogues business of Solvay Pharmaceuticals for an undisclosed amount. As part of the deal, all facilities, people and activities at Solvay's Veenendaal site in the Netherlands and technology, patent and intellectual property rights for fine chemicals, vitamin D and vitamin D analogues business will be transferred to the company. The transfer of ownership will be completed during 2007. The sale comes as a result of Solvay's strategy to focus on the main therapeutic areas of cardio-metabolic and neurological treatments, while divesting non-core assets. Dishman has a pre-existing relationship with Solvay for contract manufacturing of a patented API and intermediates. In 2001, the company and Solvay entered into toll manufacturing agreement to convert a raw material supplied by Solvay into an intermediate of vitamin D3. Dishman will retain production of cholesterol and vitamin D analogues at Veenendaal and transfer the vitamin D3 production to its manufacturing plants and research facilities which are spread across two locations in Gujarat, India. The company has an approved US FDA facility and cGMP-compliant manufacturing facilities. In 2006, the company acquired Carbogen Amcis, a fully integrated Swiss contract research and manufacturing facility.

Licensing news

Novavax licenses Wyeth's Virus-like particle technology
Novavax has signed a non-exclusive, worldwide license agreement with Wyeth to obtain rights to a patent application covering virus-like particle (VLP) technology for use in human vaccines in certain fields of use. The agreement provides for an upfront payment, annual license fees, milestone payments and royalties on any product sales. Payments under the agreement to Wyeth may net the firm USD 5m to Q4 2008. Novavax develops pandemic and seasonal influenza vaccines based upon VLP technology, which mimics the three-dimensional structure of a virus but does not contain genetic material.  Thus such particles cannot replicate and should be incapable of causing infection or disease. The licensed patent application supplements Novavax's portfolio in the VLP field.

DSM Biologics and Crucell sign licensing deal with Masterclone
Royal DSM and fellow Dutch biotechnology company Crucell have signed a non-exclusive PER.C6 research licensing agreement with Russian-headquartered Masterclone. Masterclone will use Crucell's technology to develop an undisclosed antibody. No financial details have been disclosed. Crucell and DSM's PER.C6 technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as vaccines and proteins. Compared with conventional production technologies, the PER.C6 platform has a better safety profile and is scalable under serum-free culture conditions.

Regulatory news

NICE approves pemetrexed
The National Institute of Clinical Excellence (NICE) has recommended the use of Alimta (pemetrexed) for the treatment of the asbestos cancer mesothelioma. NICE's decision comes after years of campaigning from trades unions and patient groups. NICE originally decided against approving the drug for use in the NHS over cost. TUC General Secretary Brendan Barber said: "This is a victory for all the victim support groups, parliamentarians and trade unions who have campaigned for a change of heart from NICE - but more importantly it is a victory for the patients themselves, who will now have national access to the one drug that has been shown to both extend their lives and also relieve their pain."

Technology news

First Alzheimer's disease transdermal patch approved in US
Swiss drug company Novartis's transdermal Exelon Patch for Alzheimer's disease has been approved by the FDA and is the first such product for patients with the mild to moderate form of the disease. The agnecy also approved the product for the treatment of patients with mild to moderate Parkinson's disease dementia. According to Novartis, the Exelon Patch maintains steady bloodstream levels of cholinesterase inhibitor rivastigmine for 24 hours through a patch applied to the back, chest or upper arm of the patient. The drug delivery method extends tolerability and effectiveness over a wider range of patients, some of which are unable to accept the oral capsule version because of the increased prevalence of gastrointestinal side effects caused by cholinesterase inhibitors. The new therapy was tested in placebo-controlled clinical trials (IDEAL - Investigation of Transdermal Exelon in ALzheimer's disease) and improved patients' memory and overall functioning. Also, compared with the oral capsule, the patch version resulted in three times fewer reported incidents of nausea and vomiting. The efficacy of the patch version of Exelon was similar the highest doses of the capsule version, being well tolerated by patients in the target dose of 9.5mg per 24 hours. Novartis said the product should be available in US pharmacies soon. It was submitted for EU approval in Q4 FY06.

Medical education news

HealthEd to lead patient education marketing
HealthEd, a US-based patient education marketing company, has been appointed by US biopharmaceutical firm Amylin Pharmaceuticals to be its patient education agency for one of its diabetes products. HealthEd will lead the patient education strategy and development, including the launch of a comprehensive adherence program and creation of point-of-care patient support and counselling materials for a major unnamed Amylin brand. HealthEd will direct the messaging and branding for all patient-focused communications related to Amylin's product. The programme is designed to help professionals and patients understand the key points of difference that Amylin's product provides, and the importance of adhering to treatment. The campaign will include a patient call centre featuring both inbound and outbound calls, print pieces and interactive materials. It also includes healthcare professional counselling materials which will assist HCPs with educating patient on diabetes and the drug.

NHS news

NHS overseas recruitment process to be reviewed
UK Prime Minister Gordon Brown has called for a review of NHS jobs recruitment practices. The government is to carry out an urgent review of how overseas staff is recruited to the NHS in light of the doctors involved in the Glasgow attack. Brown said that he had asked Lord West, the new terrorism minister, to conduct an immediate review of the arrangements that the government must make for recruitment to the NHS.

Contracts news

InterMune signs new Actimmune supply agreement
US-based InterMune has entered into a new supply agreement with Boehringer Ingelheim Austria (BI Austria) for immuno-modulator Actimmune (interferon gamma-1b). InterMune has consequently eliminated around USD 91.6m in future purchase commitments for Actimmune that existed under the previous supply agreement. In consideration for terminating the existing supply agreement and for entry into the new supply agreement, InterMune will pay BI Austria the net amount of approximately USD 5.5m. InterMune is now not required to make any minimum annual purchase commitments and BI Austria is not required to commit to reserving any minimum annual capacity for the manufacture of Actimmune. InterMune will purchase supplies of Actimmune from BI Austria based upon a rolling forecast. The cost per vial of Actimmune is the same as existed in the previous supply agreement and will be annually adjusted with inflation. The new supply agreement is effective 29 June 2007 and will expire on 31 December 2012, unless both parties agree to extend it.

Industry news

Prescription costs for retired men more than for women in Italy
Independent research, involving over three million Italians, conducted by Henley Management College and the University of Milan has concluded that the prescription costs for men over the age of 65 is significantly higher than it is for women. The study was published in the 4 July issue of the online, open-access journal PLoS ONE. The primary objective of the study was to make the first step in modelling pharmaceutical demand in Italy to improve the governance of prescribing funds. The research found that the mean annual prescription cost per individual was similar for men (EUR 196.13) and women (EUR 195.12). However after 65 years of age, the mean prescribing costs for males were significantly higher than females. On average, costs for a 75-year-old man would be 12 times the costs for a 25-34 year-old subject if male, eight times as much if female. Subjects over 65 years of age (22 per cent of total population) accounted for 56 per cent of total prescribing costs. The research was able to pinpoint the future resources required by the Italian Regional Health Authorities, according to the demographics of specific regional populations.

Biotech news

Indian biotech revenues worth USD 2bn in 2006-07
According to information disclosed at the Bio 2007 event held in Bangalore, India on 7 June, revenues from the Indian biotechnology industry reached the USD 2bn mark in 2006-07, up from USD 1bn in 2004-05. Red Herring reported that Biocon India's CMD, Kiran Mazumdar Shaw, said in a speech at Bio 2007 that the industry was on target to meet its goal of USD 5bn by the year 2010. State and federal science and technology ministers, however, are targeting sales of around USD 40bn by 2015. Shaw warned that India needed a strong focus on discovery research and had to replace its generics and services mindset with innovation.