PharmaBioBuzz September 2007
Poussot named as new Wyeth chief
Pharmatimes – 28 September 2007
Bernard Poussot has been named President and Chief Executive Officer of US drug major Wyeth, with effect from January 1, 2008, when he takes over the reigns from Robert Essner. “The election of Mr Poussot is a result of the company’s ongoing succession management process that has been an important focus of the Wyeth Board of Directors and management,” Essner commented, adding: “Bernard is exceptionally well-qualified for this role, and we have built a world-class management team to support him and the company.” Although the choice of replacement comes as no great surprise, the timing of the announcement was a little unexpected, and could be a reflection of investor disappointment following a stream of disappointments during the year.
Other source: www.wyeth.com
www.fda.gov
AZ appoints industry outsider as CFO
Pharmatimes – 28 September 2007
AstraZeneca this morning said it has appointed a new chief financial officer from outside the pharmaceutical industry as it looks to bring in experience from other sectors to deal with the new challenges facing pharma. The appointment of Simon Lowth – who joins from energy firm Scottish Power - follows the sudden departure in July of former CFO Jon Symonds to investment bank Goldman Sachs. AZ was caught on the hop by the move and has spent the last months searching both internally and externally for a suitable replacement for Symonds, who was a well-respected figure within the financial community. Symonds lost out to David Brennan for the post of chief executive at AstraZeneca when Sir Tom McKillop stepped down two years ago.
Other source: www.astrazeneca.com
Positive data for Amgen’s Aranesp
Pharmatimes – 27 September 2007
US biotechnology giant has presented clinical data showing that its anaemia drug Aranesp appears to be safe and effective when the dosing is extended. Results of a Phase II trial, presented at the 14th European Cancer Conference in Barcelona, Spain, indicate that extending the dosing of Aranesp (darbepoetin alfa) paired with chemotherapy treatment (every two or three weeks depending on chemotherapy regimen) appeared to be effective in maintaining levels of haemoglobin and, importantly, no unexpected adverse events were observed compared to weekly dosing. This study is the first prospective trial that demonstrates how different dosing regimens can be paired with chemotherapy administered across a range of dosing schedules, the group said. "Flexibility in dosing is important for physicians to optimise anemia management and meet patient needs," explained Timothy Rearden, a haematology oncology consultant. "In this study, Aranesp was consistently effective regardless of dosing frequency, providing healthcare professionals with the ability to adapt Aranesp treatment as required," he added.
Other source: www.amgen.com
Pfizer’s Sutent shows benefit in gastric cancer
Pharmatimes – 27 September 2007
Pfizer’s promising multikinase inhibitor agent Sutent (sunitinib) has been shown to be effective as a second-line treatment in patients with advanced gastric cancer. The data, presented at the European Cancer Conference, also showed that the drug's side effects were "manageable.” Of 72 patients who received Sutent in the open-label trial, partial responses were seen in two and stable disease achieved in 17 patients. Median progression-free survival was 11.1 weeks, with overall survival of 47.7 weeks. Pfizer last month reportedly revealed that a substantial 20% of its R&D budget is directed towards cancer treatments. A large proportion of this will be dedicated to Sutent, which is in a number of late-stage clinical trials for advanced colorectal, breast and non-small cell lung cancer both as a single agent and in combination with other therapies.
Other source: www.pfizer.com
Shock for Novartis as Prexige ‘not approvable’
Pharmatimes – 27 September 2007
Delivering a blow to Swiss giant Novartis, the US Food and Drug Administration yesterday issued a not approvable letter for its new-generation COX-2 inhibitor Prexige (lumiracoxib) as a once-daily treatment for patients suffering pain from osteoarthritis. Earlier this month, Novartis’ Chief Executive Daniel Vasella said he feared the firm would not garner US approval for the drug and now these concerns have been confirmed, though in a statement issued today the firm seemed surprised by the non-approvable status, saying it was delivered “despite a clinical trial database…that comprises approximately 40,000 patients and is one of the largest bodies of evidence for any of the drugs in this class.”
Other source: www.novartis.com
www.fda.gov
Influenza vaccine benefits exaggerated in elderly
Pharmatimes – 26 September 2007
The benefits of vaccinating the elderly against influenza have been greatly exaggerated, according to a major review of the literature published in the latest issue of The Lancet Infectious Diseases. Health policy in most Western countries aims to cuts flu deaths by targeting people aged at least 65 years for vaccination. However, the authors from George Washington University, Washington DC, point out that although placebo-controlled randomised trials show the influenza vaccine is effective in younger adults, few trials have included elderly people, and especially those aged at least 70 years. This age group is supposed to account for three-quarters of all influenza-related deaths. They add that recent excess mortality studies have been unable to confirm a decline in influenza-related mortality since 1980, even though vaccination coverage increased from 15% to 65% during this period.
Other source: www.thelancet.com/..
AZ to move prostate drug into late-stage trials
Pharmatimes – 26 September 2007
AstraZeneca is to begin Phase III testing of its novel prostate cancer treatment ZD4054 later this year after data released this week suggested the drug boosts survival in patients with hormone resistant disease. The oral drug extended patients' lives by seven months, bringing their survival time to about 2 years, compared with just under 1.5 years for those on placebo, according to the results of the Phase II EPOC study released at the European Cancer Conference in Barcelona. The study involved 312 men whose cancer no longer responded to hormone therapy but who had yet to start chemotherapy. The researchers noted that ZD4054 did not stop the disease progressing. However, they said the differences in survival times were encouraging given the limited treatment options in such patients.
Other source: www.astrazeneca.com
Xeloda as effective as standard colorectal cancer therapy, says Roche
Pharmatimes – 26 September 2007
Fresh clinical data on Roche’s cancer drug Xeloda indicate that it is at least as effective as the current gold standard treatment for colorectal cancer, and is associated with fewer side effects. The group presented five-year follow-up survival data from the X-ACT (Xeloda in Adjuvant Colon Cancer Trial) study at the 14th European Cancer Conference in Barcelona, Spain, which showed survival rates of 71.4% in patients with D colon cancer taking the adjuvant oral chemotherapy Xeloda (capecitabine) compared to 68.4% for those given the standard intravenous bolus 5-FU/LV (5 fluorouracil/leucovorin). Furthermore, additional data unveiled at the meeting from a previous analysis demonstrate that Xeloda is also comparable to 5-FU/LV with respect to disease-free survival and relapse-free survival, the group added.
Other source: www.roche.com
Herceptin profile boosted by new data
Pharmatimes – 26 September 2007
Pre-surgical use of Herceptin (trastuzumab) in inflammatory HER2-positive breast cancer eradicates tumours in three times as many patients compared to chemotherapy alone, according to new research. This form of breast cancer is very rare but extremely aggressive; the tumours spread quickly, often leading to the need for full mastectomies, and it has a worse outlook than other breast cancers. Experts said the latest results, presented at the European Cancer Conference in Barcelona suggest treatment with Herceptin in this setting may actually lead to more breast conserving surgery and most importantly, to improved survival. "This Herceptin data is very important for women with inflammatory HER2-positive breast cancer, an extremely aggressive cancer," said Professor Wolfgang Eiermann, the medical director of Munich's Red Cross Womens' Hospital. "Women could have their tumours eradicated by treating with Herceptin and chemotherapy prior to surgery which could lead to fewer mastectomies, and more importantly, fewer deaths from this type of breast cancer."
Other source: www.roche.com
BMS snaps up Adnexus for $430m
Pharmatimes – 25 September 2007
Bristol-Myers Squibb has announced the purchase of Adnexus Therapeutics, a developer of biological drugs, for $430 million. BMS executives say the acquisition will help advance its portfolio in biological drugs across a number of key therapeutic areas, including oncology. Central to the purchase was Adnexus' discovery of adnectins, a novel class of biologic. Most prominent among them is Angiocept, an anti-angiogenic drug that is currently in Phase I development. BMS also gets its hands on PROfusion, Adnexus' proprietary protein
design engine, with which trillions of protein variations can be engineered
at one time. "Adnectins and the PROfusion technology are among the most exciting next generation biologics platforms currently in development," said Dr Elliott Sigal, executive vice president and chief scientific officer of BMS.
Other source: www.bms.com
Exelon patch for Alzheimer’s receives EU approval
Pharmatimes – 24 September 2007
Patients suffering from mild to moderately severe Alzheimer’s disease can now receive their medication transdermally following the European Commission’s approval of Novartis’ Exelon (rivastigmine) patch. The skin patch, which measures 5cm2 and delivers 9.5mg of the drug, is applied once daily to the patient’s back, chest or upper arm, and has similar efficacy to the highest dose Exelon capsules. It has also “been shown to increase compliance, reduce side effects and allow medication to be delivered through the skin into the bloodstream smoothly and continuously over 24 hours, helping to achieve optimal dosing”, said Dr James Shannon, Global Head of Development at Novartis Pharma.
Other source: www.novartis.com
Avastin patients score high success rate with colorectal surgery
Pharmatimes – 24 September 2007
Nearly 80% of advanced colorectal cancer patients who progressed to surgery while taking Roche’s Avastin (bevacizumab) and standard chemotherapy were able to have their metastatic lesions completely removed, a Phase IV clinical trial has shown. Results from First BEAT, a post-marketing, community-based trial that has so far enrolled 1,965 patients in 41 countries with primarily inoperable metastatic colon cancer, were presented at the European Cancer Conference (ECCO) in Barcelona, Spain this week. Of the 215 patients in the data analysis – 11.5% of a 1,914-patient dataset – who became eligible for, and underwent, surgery with curative intent while on Avastin plus commonly used fluoropyrimidine-based chemotherapy regimens, successful, complete removal of the metastatic lesions was achieved in 170 or 79%. As expected, Roche reported, the best outcomes were seen in a subgroup of patients with metastatic disease confined to the liver. Of these 704 patients, 102 (14.5%) had surgery with curative intent and complete resection of liver metastases was achieved in 81. The data analysis found no increase in wound-healing complications or bleeding incidents compared with historical controls.
Other source: www.roche.com
GlaxoSmithKline's Cervarix vaccine gets European green light
Pharmatimes – 24 September 2007
GlaxoSmithKline says that the European Commission has approved its cervical cancer vaccine Cervarix, which means that the jab can now compete with Merck & Co’s Gardasil. Cervarix is indicated for the prevention of precancerous cervical lesions and cervical cancer causally related to human papillomavirus types 16 and 18 in girls and women aged between 10 and 25. The approval is based on data from clinical trials in almost 30,000 females, including data from the largest Phase III cervical cancer vaccine efficacy trial to date, involving more than 18,600 women. The results showed that Cervarix was almost 100% effective in preventing precancerous lesions caused by HPV 16 and 18.
Other source: www.gsk.com
Pfizer's new HIV drug Celsentri gets European approval
Pharmatimes – 24 September 2007
Pfizer’s week has started brightly with the news that European regulators have given the green light to the firm’s new HIV treatment Celsentri. The European Commission has approved Celsentri (maraviroc) as a combination treatment in adults who have CCR5-tropic detectable virus and who have become resistant to other available therapies. The drug, which was approved by the Food and Drug Administration last month in the USA (where it is being marketed as Selzentry) is the first new HIV medicine in more than a decade, says Pfizer, and works by blocking entry of the virus through the CCR5 co-receptor into white blood cells.
Other source: www.pfizer.com
Huge disappointment over failure of Merck & Co's HIV vaccine
Pharmatimes – 24 September 2007
The global fight against AIDS has been dealt a blow with the news that Merck & Co has halted clinical trials on its HIV vaccine V520, generally considered one of the most promising in development. Merck officials announced that the adenoviral vaccine conspicuously failed to protect volunteers in high-risk groups, including sex workers and gay men. The company had expressed high hopes for the jab, which it spent 10 years developing and experts in academia and at organisations such as the International AIDS Vaccine Initiative, had also been optimistic. Merck's international trial, called Step, began in 2004 and involved 3,000 HIV-negative volunteers from diverse backgrounds, between the ages of 18 and 45 in North and South America, the Caribbean and Australia. 24 of 741 volunteers who got the vaccine became infected with HIV, while out of a group of 762 volunteers who were given a dummy version of the jab, 21 became infected. In addition, the vaccine did not reduce the amount of virus in the bloodstream of those who became infected, indicating that it would not slow the onset of AIDS, as Merck had hoped. An independent monitoring panel recommended discontinuing the vaccination of volunteers, saying the trial was headed for failure.
Other source: www.merck.com
Europe recommends return to market for Roche's Viracept
Pharmatimes – 21 September 2007
Roche has received some good news about Viracept at last after European regulators recommended the lifting of a suspension that had stopped the firm from selling the HIV drug. The European Medicines Agency’s Committee for Human Medicinal Products has recommended that the marketing authorisation on Viracept (nelfinavir) is re-instated following its suspension in August. Then, a temporary ban was placed on the drug following the discovery that some of the drug batches contained ethyl mesylate, a substance used in the production of Viracept which could cause cancer. Now the CHMP says that it has assessed “the corrective and preventive measures” put in place by Roche, and these have also been verified by an inspection of the manufacturing site. As a result, the committee “has been reassured that the cause of the contamination has been eliminated” and that future production of Viracept would meet the required quality standards.
Other source: www.roche.com
www.emea.eu.int
Teva's edratide for lupus falls away in Phase II trials
Pharmatimes – 20 September 2007
The world’s leading generics company Teva Pharmaceuticals Industries has suffered a setback in terms of its innovative R&D efforts after a mid-stage trial of its experimental compound for lupus failed to meet its goals. The Israeli drugmaker said that its synthetic peptide, TV-4710 (edratide), did not meet its primary endpoint in the PRELUDE trial, a Phase II study in patients with systemic lupus erythematosus, though the drug, administered as a subcutaneous weekly injection, was shown to be safe and well-tolerated. PRELUDE enrolled 340 patients from 12 countries but data have shown that edratide failed to reduce lupus disease activity over a 26-week treatment period.
Other source: www.tevapharm.com
AstraZeneca's FluMist can be used to vaccinate two-year-olds
Pharmatimes – 20 September 2007
AstraZeneca has been boosted by the news that US regulators have given the go-ahead for FluMist, which comes from its MedImmune subsidiary, to be used as an influenza vaccine for children from two to five years of age. FluMist, an intransal spray, is now approved for active immunisation for the prevention of disease caused by influenza A and B viruses in people from two to 49 years, and AstraZeneca noted that previously only one manufacturer had been licensed in the USA to produce a flu jab for children under four, and that is Sanofi-Aventis’ Fluzone.
Other source: www.astrazeneca.com
Zeltia's cancer Yondelis is approved by Euro Commission
Pharmatimes – 20 September 2007
Spain's Zeltia and its PharmaMar unit are in celebratory mood this morning having just received European approval for its cancer agent Yondelis for soft tissue sarcoma. The European Commission has acted on the European Medicines Agency’s Committee for Medicinal Products for Human Use’s positive opinion given two months ago and approved commercialisation in the 27 countries of the European Union of Yondelis (trabectedin) as a second-line treatment for advanced soft tissue sarcoma. The drug “is the first of marine origin and resulting from Spanish research”, Zeltia noted.
Other source: www.zeltia.com
Allergan buys Esprit Pharma in $370 million cash deal
Pharmatimes – 20 September 2007
The USA’s Allergan has announced plans to acquire privately-held Esprit Pharma in a $370 million all-cash deal that gives the former access to
the overactive bladder therapy Sanctura. In addition to Sanctura (trospium), a twice-a-day anticholinergic which Esprit licenses from Indevus Pharmaceuticals, Allergan is also getting hold of the extended-release, once-daily version of the drug. The US Food and Drug Administration recently granted approval for Sanctura XR and it is this version of the drug that could be a big earner for Allergan.
Other source: www.allergan.com
www.espritpharma.com
More data on Actos puts diabetes drug ahead of Avandia
Pharmatimes – 20 September 2007
Takeda has recorded another victory in the thiazolidinedione wars after yet more new data has emerged which suggests that the firm’s diabetes drug Actos is associated with a much lower risk of heart attack than GlaxoSmithKline’s rival product Avandia. The Japanese drugmaker said that new research, including two studies presented at European Association for the Study of Diabetes meeting in Amsterdam further support the cardiovascular safety of Actos (pioglitazone) and its benefits regarding improved blood glucose and lipid levels for patients with type 2 diabetes. They also “reinforce the consistency of Actos data” and the different effects it has from GSK’s thiazolidinedione Avandia (rosiglitazone) due to differences in molecular structure.
Other source: www.takeda.co.jp
Jobs to go at plants in Belgium as J&J starts to make changes
Pharmatimes – 19 September 2007
Johnson & Johnson has kicked off its restructuring programme in Europe by announcing that almost 700 jobs are to go at the Belgian facilities of its Janssen Pharmaceutica unit. Janssen is cutting 521 full-time jobs and 167 temporary posts from its plants in Beerse and Geel in a move that should reduce costs by 15%. Over 4,700 people presently work for the company in Belgium and the move is part of a bid by J&J to reduce its global work force by up to 4%, or around 4,800 jobs. The cuts have been brought about by J&J’s need to deal with the loss of patent protection that some of its drugs will be facing, notably its biggest-seller, the schizophrenia drug Risperdal (risperidone) and the antiepileptic and migraine agent Topamax (topiramate). Further details of the restructuring programme are expected to be disclosed when J&J releases its third-quarter 2007 results on October 16.
Other source: www.jnj.com
Pfizer presents positive data on Exubera and Selzentry
Pharmatimes – 19 September 2007
Pfizer will be hoping that new data from two studies which show the long-term safety of Exubera will provide a lift to the somewhat disappointing sales that the diabetes drug has generated thus far. The company says that data from an eight-year extension study presented at the European Association for the Study of Diabetes meeting in Amsterdam found that the average yearly reductions in lung function in patients using Exubera (inhaled insulin) were similar to people with diabetes that were not treated with the compound. Lung capacity fell 49 millilitres per year among Exubera users and 71 millilitres among those in the comparator group, and the study also showed that the Pfizer drug provided sustained blood sugar control throughout the eight-year period.
Other source: www.pfizer.com
Evotec acquires the USA's Renovis in $151.8 million deal
Pharmatimes – 19 September 2007
Germany's Evotec has announced plans to acquire the US firm Renovis in a stock deal valued at just under $152 million. The Hamburg-based firm said that the merger would create an emerging global pharmaceutical company with three candidates in the clinic, “a strong late-stage preclinical pipeline focusing on areas of neurological and inflammatory diseases, and pro-forma cash of approximately $175 million”. Joern Aldag, Evotec’s chief executive, said that the link-up “will provide us with discovery talent in the US biotechnology industry and will clearly sharpen” the focus of Evotec’s existing activities. The enlarged company will seek a listing on the Nasdaq stock market once the deal closes, which is expected by the first quarter of 2008, subject to shareholder and antitrust clearance. Under the financial terms of the agreement, Evotec will issue American Depository Shares representing 1.0542 ordinary shares for each Renovis share, giving the German firm’s stockholders a 68.8% stake of the combined group.
Other source: www.evotec.com
www.renovis.com
Fewer broken bones and a reduced risk of death with Reclast
Pharmatimes – 19 September 2007
Novartis has been boosted by a study which claims that a once-yearly infusion of the firm’s osteoporosis drug Reclast after a hip fracture helps prevent future broken bones and prolongs life. The 2,100-patient study, published by the New England Journal of Medicine and presented at the American Society of Bone and Mineral Research's annual meeting in Hawaii, showed that an annual infusion of Reclast (zoledronic acid), which is also sold as Aclasta, reduced the risk of subsequent fractures by 35% compared to osteoporosis patients treated with placebo. It also found that the risk of death was significantly reduced, by 28%, in the Reclast group compared to placebo, which is especially important, says Novartis, since almost a quarter of people over 50 who suffer a hip fracture die within one year. The company acknowledged that the reduction in the risk of death “was probably due to a range of factors”, including fewer cases of new fractures, and said that “further investigation is needed to understand this finding more clearly”. Data from the new study, which is called the Recurrent Fracture Trial, will be submitted to regulatory authorities by the end of 2007 to broaden the treatment indication for Reclast, the Swiss firm added.
Other source: www.novartis.com
Lipoxen raises £2.6m
Biotext – 18 September 2007
Fresh off its recent Bioentrepreneur of the Year Award win, London biopharmaceutical company Lipoxen Plc announced it has raised £2.6m in new funding. The vaccine and oncology drug developer secured its investment from the Serum Institute of India Limited (SIIL) through a subscription agreement and associated warrant agreement. Under terms of the agreement, Lipoxen has agreed to issue to SIIL 10,000,000 ordinary shares in the company at a subscription price of 26p per share, which is conditional upon the admission of the subscription shares to trading on AIM.
Other source: http://www.biotext.co.uk/YXWsHEI.html
Fake Viagra that netted millions
Society Guardian – 18 September 2007
A man described as the UK linchpin of a global conspiracy to sell fake medicines over the internet was yesterday sentenced to four and a half years in prison following what police described as the biggest counterfeit drugs bust in British history. Ashish Halai, 33, masterminded the multimillion-pound movement of fake Viagra and other lucrative drugs from factories in China, India and Pakistan into the UK and then on to the Bahamas and the US. Three other men were also convicted of conspiracy charges; Gary Haywood, 58, Halai's brother-in-law Ashwin Patel, 24, and Pakistan-based Zahid Mirza, 45, are yet to be sentenced. Four others face a retrial after the jury failed to agree verdicts.
Other source: http://society.guardian.co.uk/health/news/0,,2171658,00.html
Sanofi's eagerly-anticipated R&D day fails to fire up investors
Pharmatimes – 18 September 2007
At its eagerly-anticipated R&D meeting in Paris, Sanofi-Aventis’ head of research has told PharmaTimes World News that biotechnology is an area that the firm is still a little weak in but “small molecules will remain the cornerstone of our growth”. Marc Clouzel, senior vice president of science and medical affairs, was speaking at the meeting which saw the French drugmaker highlight some of the 48 projects the firm has in Phase IIb/III which it hopes could led to 31 submissions by the end of 2010, 10 of which might be potential blockbusters. He noted that the company’s portfolio is maturing and the compounds coming through are in the four areas where Sanofi is a market leader – cardiometabolism, central nervous system, vaccines and oncology – and where its expertise should reduce risk. Prominent among these new compounds are a successor to the firm’s antithrombotic blockbuster Lovenox (enoxaparin) and a replacement for its Stilnox/Ambien (zolpidem) sleeping pill franchise, eplivanserin.
Other source: www.sanofi-aventis.com
Novartis completes $200M MS deal with Bayer
Pharmatimes – 16 September 2007
Swiss giant Novartis has completed a $200 million deal with Bayer Schering which will see the manufacturing rights to the big selling multiple sclerosis treatment Betaseron (interferon beta 1b) move over to the German firm. While Betaseron is already marketed by Bayer Schering, it was manufactured first by Chiron after a 1993 deal signed by predecessor Schering and subsequently by Novartis which snapped up Chiron in 2006. The agreement was inked in March and Novartis will now receive the $200 million as a one-off boost to its coffers in return for the Betaseron manufacturing rights, as well as production equipment, stock and buildings leases at a site in California.
Other source: www.novartis.com
www.bayerschering.com
NICE opens doors to cholesterol-lowerer Ezetrol
Pharmatimes – 16 September 2007
Patients having trouble keeping their cholesterol in check will now get easier access to Merck & Co and Schering Plough’s Ezetrol, after the UK’s cost-effectiveness body issued final guidance recommending the drug as a treatment option on the National Health Service. Specifically, the National Institute for Health and Clinical Excellence’s Final Appraisal Document recommends Ezetrol (ezetimibe) for patients with hypercholesterolemia who are already on statin therapy, when their levels of cholesterol or low-density lipoprotein cholesterol are not controlled and doctors are considering switching statins. Importantly, NICE’s Appraisal Committee has also concluded that the option of adding Ezetrol to initial statin therapy is “a cost effective use of NHS resources when compared with switching to an alternative statin.”
Other source: www.nice.org.uk
www.merck.com
www.schering-plough.com
Lilly’s Evista given all clear for breast cancer
Pharmatimes – 16 September 2007
The US Food and Drug Administration Friday cleared the use of Eli Lilly’s osteoporosis drug Evista (raloxifene) for cutting the risk of breast cancer in postmenopausal women. Evista is only the second drug approved to reduce the risk of breast cancer after tamoxifen and follows a thumbs-up from the drug regulator’s scientific advisory committee towards the end of July. Specifically, the so-called selective estrogen receptor modulator can now be used in two groups of postmenopausal women, those with osteoporosis and those at high risk of developing invasive breast cancer. But the agency has also issued a strong warning that "because Evista can cause serious side effects, the benefits and risks should be carefully evaluated for each individual woman." The compound has been linked to blood clots and stroke, and women with a history of blood clots are precluded from treatment. The product's label was updated earlier this year after a trial showed an increase in death due to stroke in patients receiving Evista.
Other source: www.fda.gov
www.lilly.com
J&J unit gets rights to two of Isis' diabetes compounds
Pharmatimes – 14 September 2007
Isis Pharmaceuticals is celebrating after linking up with Johnson & Johnson to develop antisense drugs to treat metabolic diseases, including type 2 diabetes. Under the terms of the deal, J&J’s Ortho-McNeil unit has been granted worldwide rights to develop and commercialise two of its new partner’s diabetes compounds, ISIS 325568 and ISIS 377131, which selectively inhibit the production of glucagon receptor (GCGR) and glucocorticoid receptor (GCCR), respectively.
Other source: www.jnj.com
www.isispharm.com
Warning issued on Cephalon's Fentora after deaths reported
Pharmatimes – 14 September 2007
Shares in the US firm Cephalon have fallen 5.2% after US regulators issued a warning about the firm’s analgesic Fentora, which is approved for the treatment of breakthrough pain in cancer patients. The US Food Drug Administration has issued a product safety alert to healthcare professionals after it received information of serious adverse events, including deaths, that have occurred in patients treated with Fentora (fentanyl). Cephalon, which collaborated with the FDA on the letter, said that the events were a result of improper selection, namely use in opioid non-tolerant patients, incorrect dosing, and/or improper product substitution of Fentora for other fentanyl-based medications. The Pennsylvania-based company noted that Fentora should not be substituted for its own Actiq or other fentanyl-containing products, or be prescribed for people who have acute or postoperative pain, headaches or migraine or sports injuries.
Other source: www.cephalon.com
www.fda.gov
FDA needs more time to review GSK/Adolor's Entereg
Pharmatimes – 14 September 2007
GlaxoSmithKline and Adolor Corp have suffered a fresh setback in their bid to get approval for the investigational bowel drug Entereg after the US regulator said it needs more time to study the compound. This is especially disappointing news for the two firms given that just over a fortnight ago, the US Food and Drug Administration accepted as complete a response from Adolor to an approvable letter issued on the treatment. Now, however, the agency has informed the companies that it needs additional time to complete its review of the submissions for the release of the clinical hold on Enterg (alvimopan). The companies suspended trials of Entereg in April due to cardiovascular risk and two months later, the FDA placed the alvimopan Investigational New Drug applications on clinical hold, including a programme looking at the drug as a treatment for opioid induced bowel dysfunction. As a result of this latest decision, the hold for all alvimopan studies remains in effect and the FDA did not indicate a timeframe within which its review would be completed.
Other source: www.gsk.com
www.adolor.com
www.fda.gov
UK study finds net cancer benefit in oral contraceptive use – 13/09/2007
Pharmatimes – 13 September 2007
Women who take oral contraceptives (OCs) for eight years and under may significantly reduce their risk of developing cancer, a cohort study conducted in the UK suggests. In a smaller dataset, however, the relative risk of cancer was not significantly lower, the researchers reported in the British Medical Journal. Moreover, the study found that women who used OCs for more than eight years had a significantly higher cancer risk. On balance, the authors concluded, oral contraception was “not associated with a significantly increased risk of any cancer; indeed it may even produce a net public health gain”. The estimated absolute risk reduction for any cancer was 12% (45 fewer cases per 100,000 women years) or 3% (10 fewer cases per 100,000 women years), depending on which of two datasets was analysed. “These results suggest that, at least in this relatively healthy UK cohort, the cancer benefits associated with oral contraception outweigh the risks,” they commented.
Other source: www.bmj.com
Novartis confident of return to double-digit growth in H2 2008 – 13/09/2007
Pharmatimes – 13 September 2007
Withdrawn products and generic competition to big earners is going to hurt Novartis for the next year or so but a return to double-digit sales growth should be seen by the second half of 2008 through to 2011. This was the main message coming out of the Swiss company’s Pharma Brand and Business Review in East Hanover, New Jersey, USA, a meeting which saw chief executive Daniel Vasella reiterate the firm’s fears that earnings are going to take a hit from generics of some big sellers. These include the blood pressure drug Lotrel (almodipine/benazepril) and the antifungal Lamisal (terbinafine), and it is also going to take some time to recover from the withdrawal of the irritable bowel syndrome drug Zelnorm (tegaserod) after it was linked to possible heart attacks and strokes.
Other source: www.novartis.com
Antisoma revenues soar thanks to Novartis pact – 13/09/2007
Pharmatimes – 13 September 2007
Antisoma has posted a significant reduction in its losses for the year ended June 30 and says it has more cash available than at any time in its history, boosted by payments from its new partner Novartis. Net loss narrowed 42% to £9.6 million, while turnover rose to £8.0 million from £1.6 million last year, boosted by revenues from Novartis which signed a deal potentially worth up to $890 million with Antisoma for the oncology drug ASA404. The UK firm ended the year with cash and equivalents of £61.4 million.
Other source: www.novartis.com
www.antisoma.com
Sepracor signs up GSK to sell insomnia drug Lunivia – 12/09/2007
Pharmatimes – 12 September 2007
GlaxoSmithKline and Sepracor have linked up for an alliance which will see the UK drugs giant sell the latter’s insomnia drug Lunesta on international markets, under the brand name Lunivia. GSK says it will market Lunivia (eszopiclone) worldwide, excluding the USA, Canada, Mexico and Japan, and under the terms of the agreement, Sepracor will receive an initial payment of $20 million and milestones which could take that figure up to $155 million. In addition, the US firm will get compensation for the supply of the drug, as well as double-digit royalties on product sales.
Other source: www.sepracor.com
Evotec sells off chemical development business in UK to Aptuit – 12/09/2007
Pharmatimes – 12 September 2007
Germany's Evotec has sold off its UK-based chemical development business to Aptuit for around 46.4 million euros as part of its bid to become “an emerging pharmaceutical company”. Aptuit, a US firm which provides drug development services, will be the new owner of the business which employs 210 people based at sites in Oxford and Glasgow, and generated 26.8 million euros of third-party revenues (or 40% of total Evotec revenues) in 2006. The Connecticut-based group said that it intends to retain all the employees.
Other source: www.evotec.com
420 jobs to go as Pfizer stops manufacturing at Sandwich – 12/09/2007
Pharmatimes – 12 September 2007
The south-east of the UK is the latest place to feel the effects of Pfizer’s restructuring plans as the drugs giant has announced that is to close all of its remaining manufacturing operations in Sandwich, Kent. The move is expected to result in the loss of approximately 420 jobs, phased over the next two years, and Pfizer said that its priority will be “to support colleagues affected by this decision, including redeployment where possible”, as well as re-training. The firm added that “every effort will be made to mitigate the impact” on employees and the local community. The end of manufacturing at Sandwich, where around 3,500 people are currently employed “is no reflection on the performance of our talented and skilled workforce”, said Colin Seller, manufacturing site leader. He added that “we recognise that this may be a difficult time for colleagues and our priority now, and over the coming weeks and months, is to support our people through this process”.
Other source: www.pfizer.com
New meta-analyses say Takeda’s Actos safer than GSK’s Avan – 12/09/2007
Pharmatimes – 12 September 2007
GlaxoSmithKline’s type-2 diabetes treatment Avandia is the subject of another unfavourable meta-analysis but a similar study of Takeda’s Actos presents a rosy picture of the latter’s safety profile. Two new meta-analyses have been published in the September 12 issue of the Journal of the American Medical Association and the one dealing with Avandia (rosiglitazone) makes fairly unpleasant reading for GSK. The Avandia meta-analysis, which included findings from just four randomised trials involved 6421 diabetics who received the GSK drug and 7,870 on control therapy, with a follow-up of one to four years. The data demonstrated that rosiglitazone significantly increased the risk, by 42%, of myocardial infarction and more than doubled the possibility of heart failure, compared with control therapy. The findings largely mirrored the controversial meta-analysis published in May in the New England Journal of Medicine and authored by Steven Nissen, which claimed that Avandia increased cardiovascular risks, but the results of the latest report also showed that the drug did not significantly increase the risk of cardiovascular mortality.
Other source: jama.ama-assn.org
www.gsk.com
www.takeda.com
Ranbaxy weighs up options to fund development of NCEs – 11/09/2007
Pharmatimes – 11 September 2007
India's Ranbaxy Laboratories, very much known for its generics, is looking for partners to help finance its innovative R&D efforts and could even spin off its research activities into a separate company. The Economic Times newspaper quotes an unnamed Ranbaxy official as saying that a number of new compounds are going to be entering Phase II and III trials soon so “we are looking at alliances and partners anticipating the heavy cost in the next few years”. The company’s New Drug Discovery Research unit is working on 8-10 programmes headed by the anti-malarial arterolane, which has just completed Phase II trials and could be launched by 2011, making it the first ever New Chemical Entity from India to be launched globally.
Other source: www.ranbaxy.com
Pfizer warns doctors about potential dangers of Viracept – 11/09/2007
Pharmatimes – 11 September 2007
In the wake of a recall in Europe of Roche’s Viracept last month, after certain batches were found to have been contaminated with excess levels of a potential human carcinogen, Pfizer, which sells the antiretroviral in the USA, has issued a warning about the HIV drug. Pfizer has issued a letter to inform healthcare professionals of the presence of ethyl methanesulfonate, “a process-related impurity” in Viracept (nefinavir) and to provide guidance on the use of the drug in pregnant women and children. Data from animal studies indicate EMS is teratogenic, mutagenic and carcinogenic and although no data from humans exist, the US Food and Drug Administration has asked the New York-based firm to “implement new specifications to limit the presence of EMS in Pfizer-manufactured Viracept”.
Other source: www.pfizer.com
Merck KGaA says Erbitux improves survival in lung cancer – 11/09/2007
Pharmatimes – 11 September 2007
Shares in Merck KGaA have risen sharply this morning after the firm posted late-stage data which shows that Erbitux improves overall survival in lung cancer patients. The Darmstadt, Germany-based firm’s Phase III study, called FLEX, using Erbitux (cetuximab) in combination with platinum-based chemotherapy (vinorelbine plus cisplatin) met its primary endpoint of increasing overall survival compared with chemotherapy alone in patients with advanced (stages IIIb or IV) non-small cell lung cancer. Detailed results are expected to be presented at an upcoming medical conference, but this snippet of news alone is causing much excitement.
Other source: www.merck.de
The Netherlands' Crucell signs deal with Merck & Co – 10/09/2007
Pharmatimes – 10 September 2007
Crucell has been boosted by the news that drugs giant Merck & Co has exercised an option for the exclusive use of the Dutch firm’s PER.C6 technology. The agreement also gives Merck an option for access to Crucell's AdVac vaccine technology in two unspecified infectious disease areas, while the Leiden-based firm acquires rights to certain cell-line technology developed by Merck for the manufacturing of recombinant proteins. Financial terms of the pact were not disclosed.
Other source: www.crucell.com
AstraZeneca to start Phase III trail of pain combo – 10/09/2007
Pharmatimes – 10 September 2007
AstraZeneca has unveiled plans to start a Phase III clinical trial programme for PN400, a pain drug in development under a partnership with US group Pozen. The UK drug giant said it will launch the programme in the third quarter of this year, and that a submission to US regulatory authorities is planned for the first half of 2009. PN 400 combines naproxen and esomeprazole in a single pill using Pozen’s proprietary formulation technology, and is targeted for patients with arthritic pain who need chronic non-steroidal anti-inflammation drug treatment but are at risk from developing gastric ulcers associated with this class of analgesics.
Other source: www.astrazeneca.com
www.pozen.com
www.medimmune.com
Boehringer Ingelheim signs nanobody deal with Ablynx – 10/09/2007
Pharmatimes – 10 September 2007
Germany's Boehringer Ingelheim has signed a deal with its old partner Ablynx which will look to develop nanobody therapeutics and could be worth up to 1.3 billion euros to the Belgian biotechnology firm. The agreement involves the discovery, development and commercialisation of up to 10 different nanobodies, a novel class of antibody-derived therapeutic proteins, in areas such as immunology, oncology and respiratory disease. The two firms already have a deal in place potentially worth around $265 million to develop new drugs for Alzheimer's disease.
Other source: www.ablynx.com
www.boehringer-ingelheim.com
Teva stopped from selling generic Famvir by US court – 10/09/2007
Pharmatimes – 10 September 2007
Hours after Teva Pharmaceuticals Industries announced that it had started shipments of its generic version of Novartis’ Famvir, a US court slapped a temporary injunction on the Israeli firm preventing it from selling the genital herpes drug. The day had started well for Teva after it noted that it was starting to ship generic Famvir (famciclovir) after the US District Court for New Jersey denied a motion filed by Novartis for a preliminary injunction. However this was swiftly followed by the US Court of Appeals for the Federal Circuit issuing an order temporarily enjoining Teva from further sales.
Other source: www.tevapharm.com
www.novartis.com
www.wyeth.com
Boehringer Ingelheim to put lung cancer drug into Phase III – 07/09/2007
Pharmatimes – 7 September 2007
Boehringer Ingelheim’s bid to become a major player in oncology is moving closer to reality after the firm revealed that it will soon start late-stage trials of experimental lung cancer compound. The German firm declared at the International Association for the Study of Lung Cancer congress in Seoul, South Korea, that it plans to commence Phase III trials in the disease with BIBW 2992, a novel kinase inhibitor that blocks the activity of both EGFR and HER2. Details of the trials are currently being finalised with the US Food and Drug Administration and the European Medicines Agency.
Other source: www.boehringer-ingelheim.com
Pfizer combines Sutent with Roche's Tarceva in Phase III trial – 07/09/2007
Pharmatimes – 7 September 2007
Pfizer says that it has begun a late-stage trial of Sutent, already approved for advanced kidney cancer, to see how effective the drug is, when combined with Roche’s Tarceva, as a treatment for lung cancer. The New York-based behemoth made the announcement after presenting data from a Phase II trial at the International Association for the Study of Lung Cancer congress in Seoul, South Korea, on the safety and tolerability of Sutent (sunitinib) in combination with Roche’s Tarceva (erlotinib), which is already approved to treat non-small cell lung cancer.
Other source: www.pfizer.com
Latest Vioxx ruling ends class action fears for Merck & Co – 07/09/2007
Pharmatimes – 7 September 2007
Merck & Co is celebrating a hugely significant victory after a court sided with the firm in dismissing a class action lawsuit over its withdrawn COX-2 inhibitor Vioxx.
The New Jersey Supreme Court reversed an earlier ruling that granted nationwide class-action status to insurance companies and healthcare maintenance organisations in the USA seeking reimbursement for Vioxx (rofecoxib) expenditures to the tune of $9.6 billion. The case had been brought by the International Union of Operating Engineers Local 68 Welfare Fund, which claimed that Merck had concealed information about the safety risks associated with Vioxx, so therefore insurers felt they had been overcharged.
Other source: www.merck.com
Lundbeck teams up with Takeda in anxiety disorder pact – 06/09/2007
Pharmatimes – 6 September 2007
After a fairly miserable few months, there is at last some good news for Lundbeck, which comes in the shape of a deal with Japan’s Takeda Pharmaceutical Co that could be worth $345 million. The Danish drugmaker says it has formed a strategic alliance with Takeda to exclusively develop and co-commercialise, both in the USA and Japan, several compounds in Lundbeck's pipeline for the treatment of mood and anxiety disorders.
Other source: www.lundbeck.com
www.takeda.co.jp
www.frx.com
Merck & Co's AIDS drug Isentress is backed by FDA panel – 06/09/2007
Pharmatimes – 6 September 2007
As expected, Merck & Co's Isentress, the firm’s new first-in-class AIDS drug, has received a recommendation for approval from a US regulatory advisory panel. The Antiviral Drugs Advisory Committee of the US Food and Drug Administration has voted unanimously to recommend accelerated approval of Isentress (raltegravir) in combination with other antiretroviral therapy for the treatment of HIV infection in treatment-experienced patients who have developed resistance to other AIDS drugs. If approved by the agency, and a decision is expected as early as the middle of October, Isentress would be the first in a new class of antiretroviral agents, called integrase inhibitors, to hit the market.
Other source: www.merck.com
www.fda.gov
Pfizer study shows risk of switch from Lipitor to simvastatin – 05/09/2007
Pharmatimes – 5 September 2007
Switching patients from Pfizer’s cholesterol blockbuster Lipitor to a generic version of Merck & Co's Zocor has been linked to a major increase in the risk of serious heart problems, according to a new study sponsored by the former firm. Pfizer says that the observational study of a large UK primary care database showed that switching patients from Lipitor (atorvastatin) to simvastatin was associated with a 30% increase in the relative risk of major cardiovascular events, including heart attacks and strokes. The analysis was presented at the European Society of Cardiology meeting in Vienna, Austria, and will be published in The British Journal of Cardiology.
Other source: www.pfizer.com
Patch problems see Shire withdraw ADHD treatment Daytrana – 05/09/2007
Pharmatimes – 5 September 2007
Shire has voluntarily withdrawn what it says are “a limited amount” of packages containing Daytrana, its attention deficit hyperactivity disorder patch, in the USA. The UK drugmaker says that it is taking the step not due to safety and efficacy issues, but because of feedback from patients and caregivers who have experienced difficulty removing the release liner from some patches of Daytrana (methylphenidate transdermal system). The packages that have not been pulled were put on the market in the first quarter of 2007 by Shire and partner Noven using an enhanced process to improve ease of use of the patch, and the companies said current supply levels are sufficient to ensure that patients will have their Daytrana prescriptions at their local pharmacy with the new patch.
Other source: www.shire.com
devalpatrick.com
Actelion's orexin drug shows promise for insomnia sufferers – 04/09/2007
Pharmatimes – 4 September 2007
Swiss biotechnology firm Actelion has unveiled interesting data from a proof-of-concept/dose-ranging study of almorexant, the first of a new class of drugs developed to aid insomniacs. In data presented at the World Sleep Congress in Cairns, Australia, almorexant, an orexin receptor antagonist, was tested on 147 patients (39 at 400mg, 38 at 200mg, 38 at 100mg and 32 at 50mg) at 24 centres in Europe and Israel. The study achieved its primary endpoint demonstrating that almorexant significantly increased sleep efficiency in adults in the first three doses, but the results at 50 mg did not reach statistical significance.
Other source: www.actelion.com
Merck KGaA seeks wider use of Erbitux in Europe – 03/09/2007
Pharmatimes – 3 September 2007
Merck KGaA has submitted an application to the European Medicines Agency to broaden the use of the cancer therapy, Erbitux to include first-line therapy for the treatment of metastatic colorectal cancer. The submission is supported in part by data from the CRYSTAL study presented at ASCO in June that demonstrates the efficacy of Erbitux (cetuximab) as a first-line treatment in mCRC patients which showed that, when added to current standard irinotecan based chemotherapy in first-line, the compound significantly increased progression-free survival, response and resection rates.
Other source: www.merck.de
Novartis unit first to get EU approval for generic epoetin alfa – 03/09/2007
Pharmatimes – 3 September 2007
Novartis’ generics unit Sandoz has pulled off a coup by becoming the first company to get the go-ahead in Europe to develop a generic version of the anaemia drug epoetin alfa. The Swiss firm confirmed that Sandoz has received European Commission approval for its biosimilar epoetin alfa, a copy of Johnson & Johnson’s Eprex, having received a positive opinion in June from the European Medicines Agency's Committee on Medicinal Products for Human Use. The approval means the drug can be used to treat patients with renal anaemia as well as those receiving chemotherapy.
Other source: www.novartis.com
Lilly study highlights a third generation of antipsychotics – 03/09/2007
Pharmatimes – 3 September 2007
Eli Lilly researchers believe they have discovered a new class of schizophrenia medication that avoids key adverse effects seen in current treatments, not least the firm’s own blockbuster Zyprexa. A clinical trial in the September issue of Nature Medicine describes a drug, LY2140023, that works effectively in people with schizophrenia by targeting glutamate-mediated neurotransmission. All current drugs target dopamine receptors, and it is this mode of action that is thought to be responsible for unpleasant extrapyramidal side effects such as involuntary movement – effects that cause some psychotic patients to shun their medication.
Other source: www.lilly.com
www.nature.com/..
Acambis smallvox vaccine ACAM2000 gets FDA approval – 03/09/2007
Pharmatimes – 3 September 2007
Acambis is celebrating the news that the US Food and Drug Administration has approved a smallpox vaccine made by the UK firm which will form part of a government stockpile to be used in case of a biological attack. ACAM2000 is a second-generation smallpox vaccine which is derived from a clone of Dryvax, licensed by the FDA from Wyeth as far back as 1931 and grown on the skin of calves and freeze-dried for storage. It is no longer manufactured and remaining supplies are limited. Now, “the licensure of ACAM2000 supplements our current supply of smallpox vaccine, meaning we are more prepared to protect the population should the virus ever be used as a weapon," said Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research.
Other source: www.acambis.com