Pharma Marketletter back issues from January 2009:
FDA toughens guidelines on diabetes drug approval with closer scrutiny of CV risk.
Jan 12, 2009 ... The US Food and Drug Administration has raised the bar to the approval of drugs for type 2 diabetes, recommending that drugmakers provide evidence that their product will not increase the risk of cardiovascular events such as a heart attack. Drugs for this lucrative disease ...
Bayer updates press on current pipeline.
Jan 12, 2009 ... Germany-based Bayer Healthcare's head of pharmaceuticals, Wolfgang Plischke, updated journalists from 22 countries on the firm's pipeline at its Perspective on Innovation 2008 conference held at the BayKomm exhibition center in Leverkusen (Marketletter Decemeber 22). Noting ...
NICE recommends Ipsen drug for gout treatment.
Jan 12, 2009 ... The National Institute for Health and Clinical Excellence (NICE), which decides on the drugs that are provided on the UK's National Health Service (apart from in Scotland), has published guidance as part of its rapid single technology appraisal work program on the use of French firm ...
Hawaii Bio completes West Nile study dosing.
Jan 12, 2009 ... Honolulu, USA-based Hawaii Biotech has completed the Phase I dosing of 24 healthy individuals with its HBV-002 West Nile virus vaccine. Chief executive Elliot Parks said that preliminary safety results and immunologic data from the 24 subjects treated with three doses of the ...
Avigen sells hemophilia candidate to Baxter.
Jan 12, 2009 ... US biopharmaceutical company Avigen has sold the rights to its early-stage blood coagulation compound AV513 to health care firm Baxter for $7.0 million. "The sale of AV513 is an example of building value in a product that is differentiated from current therapies, and bringing it ...
Generex signs vaccine deal with Pevion.
Jan 12, 2009 ... USA-based Generex and privately-owned Swiss biopharmaceutical company Pevion Biotech have signed an agreement to develop a range of next-generation vaccines and immunotherapeutic products. The initial goal of the collaboration will be to investigate synergies in the cancer ...
La Jolla Pharma expands Ph III lupus study.(Clinical report)
Jan 12, 2009 ... The USA's La Jolla Pharmaceutical has updated on the continued progress of an ongoing Phase III study of Riquent (abetimus sodium), its drug candidate for systemic lupus erythematosus. The double-blind, placebo-controlled, randomized Phase III study is designed to assess the ...
Merck KGaA buys more rights to Stimuvax.
Jan 12, 2009 ... Germany-based Merck KGaA has licensed the rights to Stimuvax, a vaccine in Phase III development for non-small cell lung cancer, from US firm Oncothyreon for $13.0 million. In conjunction with the transaction, Merck, through its affiliate EMD Serono Canada, has assumed control ...
Drug info and prescribing guidance becomes key part of UK's NHS evidence.
Jan 12, 2009 ... Drug reference information in the British National Formulary will become a key element of the new UK National Health Service Evidence portal due to be launched in April 2009. As a result, responsibility for provision of this information for the NHS will transfer from the Department of ...
US CMS launches 4th Medicare provider satisfaction survey.
Jan 12, 2009 ... The US Centers for Medicare and Medicaid Services (CMS) has launched its fourth annual health care provider satisfaction survey of Medicare fee-for-service contractors who process and pay more than $280.0 billion in Medicare claims each year. "I urge all 30,000 Medicare ...
STTR grants for MabVax Thera.
Jan 12, 2009 ... MabVax Therapeutics, a privately-held, US company focused on the development and commercialization of novel immunotherapies for the treatment of cancer, has received two grant awards from the National Cancer Institute under the Small Business Technology Transfer Program (STTR) totaling ...
S*BIO links with Tan Tock to evaluate SB1518.
Jan 12, 2009 ... Privately-held Singaporean biotechnology firm S*BIO Pte says that it has signed a collaboration agreement with Tan Tock Seng Hospital in Singapore, to evaluate the effects of its JAK2 inhibitor, SB1518, on biological samples from patients with myeloproliferative neoplasms. S*BIO ...
King Pharma files CorVue NDA with FDA.
Jan 12, 2009 ... US specialty drugmaker King Pharmaceuticals has submitted a New Drug Application for CorVue (binodenoson) for injection to the Food and Drug Administration. The product is a cardiac pharmacologic stress single-photon-emission computed tomographic imaging agent intended for use in patients ...
Ardea Bio makes $30.6M placing.(Ardea Biosciences)(Brief article)
Jan 12, 2009 ... San Diego, USA-based Ardea Biosciences says that it has entered into a securities purchase agreement with certain institutional investors to raise around $30.6 million from the private placement of 2,737,336 newly-issued shares of its common stock and warrants to buy 684,332 shares at a ...
Celtic Pharma' s first close of second fund.(Celtic Pharma Holdings Advisors)(Brief article)
Jan 12, 2009 ... Private equity fund management partnership Celtic Pharma Holdings Advisors has announces the first close of the second Celtic Pharma fund, Celtic Pharma Holdings II LP (CP2). CPHA is a subsidiary of Beehive Capital, the Financial Services Agency-regulated fund manager. CP2 will remain open ...
Effects of failure to enroll Part D beneficiaries.
Jan 12, 2009 ... The US Medicare Part D prescription drug benefit has failed to enroll millions of eligible US residents, despite their lack of alternative coverage. The program has cost more than 30% less than originally forecast, largely thanks to competition between private providers, ...
China has double global rate of DR-TB.
Jan 12, 2009 ... China has over twice the global level of drug-resistant tuberculosis, according to a study by Chinese and Dutch scientists for the World Health Organization. Data published in the journal BMC Infectious Diseases indicates that 9.3% of TB cases in China are drug-resistant versus 4.8% ...
Tibotec recruiting for two Ph III trials of NNRTI.(Clinical report)
Jan 12, 2009 ... Tibotec Pharmaceuticals, an Ireland-based unit of US health care major Johnson & Johnson, says it is currently recruiting HIV-positive, treatment-naive adults in Europe for two major Phase III efficacy trials examining, its investigational non-nucleoside reverse transcriptase inhibitor ....
Lectus adds neuropathic pain candidate to pipeline.
Jan 12, 2009 ... Lectus Therapeutics, a UK drug discovery and development firm focused on ion channel modulators, has advanced a novel orally-active modulator of N-type ion channels from research into development for neuropathic pain. The move follows Lectus' series A financing round completed in 2006 and ...
GSK licenses PER.C6 to research a protein.
Jan 12, 2009 ... DSM Biologics and fellow Dutch biopharmaceutical company Crucell NV have signed a license agreement allowing UK drug major GlaxoSmithKline to research an unnamed recombinant protein on the PER.C6 platform. Financial terms of the agreement were not disclosed. The PER.C6 platform ...
Santarus licenses two Cosmo MMX drugs for USA.(Cosmo Pharmaceuticals SpA)(Brief article)
Jan 12, 2009 ... USA-based Santarus has licensed Cosmo Pharmaceuticals SpA's two drugs Budesonide MMX and Rifamycin SV MMX for its domestic market. Under the terms of the deal, Santarus will pay the Italian firm an upfront cash fee of $2.5 million and will issue to Cosmo six million shares of its common ...
Vivus initiates Ph III trial of ED drug.
Jan 12, 2009 ... US drugmaker Vivus has initiated the first of several pivotal Phase III studies of avanafil, an investigational erectile dysfunction drug. The REVIVE trial is a randomized, double-blind, placebo-controlled, efficacy and safety study of avanafil in men with a history of ED. ...
Rituxan slows joint damage in early RA.
Jan 12, 2009 ... US biotechnology firms Genentech and Biogen Idec say that Phase III study data on Rituxan (rituximab) show that it slows the progression of joint damage in patients with early rheumatoid arthritis who have not previously been treated with methotrexate. In this study, known as ...
Antisoma's CLL tablet approved by US FDA.
Jan 12, 2009 ... UK drugmaker Antisoma says that the US Food and Drug Administration has approved its tablet formulation of fludarabine phosphate as a second-line treatment for chronic lymphocytic leukemia. According to the London-headquartered firm, the agent provides an alternative means to ...
Supernus begins Ph III Epliga epilepsy trial.(Clinical report)
Jan 12, 2009 ... Supernus Pharmaceuticals, a US firm focused on developing specialty central nervous system products to improve patient compliance, reduce side effects and address unmet medical needs, has initiated a pivotal Phase III trial for its lead product Epliga (oxcarbazepine). The ...
Memory enrolls first patient in asthma trial.(Clinical report)
Jan 12, 2009 ... The USA's Memory Pharmaceuticals has enrolled its first patient in a Phase IIa trial of its PDE4 inhibitor MEM 1414 in the treament of asthma. In the double-blind, randomized, placebo-controlled study, the efficacy of multiple doses of 600mg of MEM 1414 on the allergen-induced ...
Servier drug improves bone structure vs alendronate.(Clinical report)
Jan 12, 2009 ... French drugmaker Laboratoires Servier has published the results of a head-to-head study showing that its osteoporosis treatment Protelos (strontium ranelate) significantly improves bone structure in postmenopausal women when compared to the bisphosphonate, alendronate, in Osteoporosis ...
MannKind reports rapid insulin trial success.
Jan 12, 2009 ... US drugmaker MannKind has reported preliminary top-line results from two pivotal Phase III studies of Afresa, the company's ultra-rapid acting insulin product, showing both trials achieved their primary endpoints. Study 102 compared the efficacy of meal-time Afresa in ...
GSK buys B-MS' Pakistan unit for $36.5M.
Jan 12, 2009 ... GlaxoSmithKline has continued its expansion into emerging markets, agreeing to buy the Pakistani operations of US drug major Bristol-Myers Squibb for $36.5 million. A few months ago (Marketletter October 27, 2008), the UK drug major acquired the Egyptian mature products business ...
GSK to stop making political donations.
Jan 12, 2009 ... UK drug major GlaxoSmithKline has vowed to stop using corporate funds for US political contributions in a bid to increase transparency, the firm declared in a statement. Company chief executive Andrew Witty also told the UK's Financial Times: "I don't want people to have any ...
GSK enters aptamer development deal with Archemix worth up to $1.4B.
Jan 12, 2009 ... US firm Archemix has entered a deal to develop anti-inflammatory drugs with UK drug major GlaxoSmithKline that could be worth up to $1.4 billion. Using Archemix' portfolio of aptamers - synthesized oligonucleotides - the companies aim to treat diseases such as rheumatoid ...
FDA further delays J&J's psoriasis drug Stelara, requests more information.
Jan 12, 2009 ... The US Food and Drug Administration has announced further delays for US health care major Johnson & Johnson subsidiary Centocor's Stelara (ustekinumab), a subcutaneous biologic therapy for the treatment of adult patients with chronic moderate-to-severe plaque psoriasis, in a "complete ...
Roche's Tamiflu ineffective against primary flu strain for this season; GSK's Relenza set to take over.
Jan 12, 2009 ... Swiss drug major Roche's gold-standard flu medicine Tamiflu (oseltamivir) is ineffective against the main type of influenza set to affect the USA this season, says Centers for Disease Control and Prevention (CDC). From October 1 to December 13, 2008, the CDC tested 50 H1N1 ...
World generic Rx drug sales grew 3.6% in year to Sept 2008, down from 11% in 2007.
Jan 12, 2009 ... Global prescription sales growth of generics drugs slowed to 3.6% in the year ending September 2008, down from 11.4% in 2007, according to a new report by IMS Health, the world's leading provider of market intelligence to the pharmaceutical and health care industries. Global generic ...
NAFDAC blames India and China for fake drug.
Jan 12, 2009 ... Nigeria's National Agency for Food and Drug Administration and Control has blamed counterfeit drug manufacturers in India and China for the contamination of 3,000 bottles of a teething formula which allegedly contained 90% diethylene glycol. The additive is a poisonous ingredient ...
Pierre Fabre teams with Forest for CNS drug.(central nervous system)(Forest Laboratories Inc.)(Brief article)
Jan 12, 2009 ... French independent drugmaker Pierre Fabre and the USA's Forest Laboratories have signed an agreement to develop and the market F2695, a mixed inhibitor of serotonin and noradrenaline recapture for the treatment of depression and other central nervous system disorders, in the USA and ...
Epix stock triples on Vasovist approval.
Jan 12, 2009 ... Shares in US development-stage firm Epix Pharmaceuticals more than tripled on the news that the firm had received US Food and Drug Administration approval for its blood-pool magnetic resonance angiography contrast agent, Vasovist (gadofosveset trisodium), to evaluate aortoiliac occlusive ...
Sanofi and Novozymes sign antibiotic deal.
Jan 12, 2009 ... French drug major Sanofi-Aventis has signed a global licensing and collaboration agreement with UK-based Novozymes for the development and marketing of the novel antibiotic Plectasin NZ2114. Under the terms of the agreement, Sanofi has been granted an exclusive worldwide license ...
Pfizer licenses ZFN tech from Sangamo.
Jan 12, 2009 ... Global drug giant Pfizer has acquired a non-exclusive license from USA-based Sangamo BioSciences for certain zinc finger DNA-binding protein nuclease (ZFN) reagents for the elimination of the glutamine synthetase gene from Chinese hamster ovary cell lines in clinical and commercial ...
Dynavax drops 18.8% as Merck & Co ends accord.
Jan 12, 2009 ... Shares in USA-based Dynavax Technologies Corp dropped 18.8% after Merck & Co decided to end a collaboration centered on the development of a hepatitis B vaccine. Earlier this year, the US Food and Drug Administration placed Heplisav on clinical hold (Marketletter March 31) and ...
Amgen submits BLA for denosumab to US FDA.
Jan 12, 2009 ... US biotechnology firm Amgen has submitted a Biologics License Application to the Food and Drug Administration for denosumab for the treatment and prevention of postmenopausal osteoporosis, as well as bone loss in patients undergoing hormone ablation for prostate or breast cancer. ...
FDA asks UCB to solve Neupro formulation.(Brief article)
Jan 12, 2009 ... Due to formulation problems, the US Food and Drug Administration has rejected Belgian drugmaker UCB's Neupro (rotigotine transdermal system), a skin patch for the signs and symptoms of advanced Parkinson's disease and moderate-to-severe primary restless legs syndrome. In its ...
Alfuzosin fails to improve prostatitis.
Jan 12, 2009 ... French drug major Sanofi-Aventis' Uroxatral (alfuzosin) failed to significantly reduce symptoms in recently-diagnosed men with chronic prostatitis who had not been previously treated with this drug, according to a clinical trial sponsored by the US National Institutes of Health. ...
ProGenTech partners with China CDC.(China Centers for Disease Control and Prevention)(Brief article)
Jan 12, 2009 ... ProGenTech, a life science and molecular diagnostics company based in Shanghai, China, and the San Francisco Bay area, USA, has signed a collaboration agreement with the China Centers for Disease Control and Preention (CDC) to create a joint laboratory that will focus on developing ...
Orphan designation for TransMolecular melanoma drug.
Jan 12, 2009 ... TransMolecular, a US biotechnology firm focused on targeted therapies for cancer, says that the Food and Drug Administration has granted Orphan Drug Designation for its anticancer compound 131I-TM601 for the treatment of Stage IIb-IV melanoma. The drug candidate is currently in a Phase ...
Warner Chilcott and Barr settle Femcon dispute.
Jan 12, 2009 ... Warner Chilcott and Barr Laboratories have entered into a settlement and license agreement to resolve the pending patent litigation involving the former's oral contraceptive product, Femcon Fe (norethindrone and ethinyl estradiol ), chewable and ferrous fumarate tablets). Under ...
Drais and Diatos collaborate on DTS-108.
Jan 12, 2009 ... New Jersey, USA-based Drais Pharmaceuticals and French firm Diatos have entered into a global agreement to develop and commercialize DTS-108 for the treatment of solid tumors. DTS-108 is currently ready to begin Phase I clinical trials in Europe for the treatment of patients with advanced ...
Preclinical safety shown for PharmaMar's Zalypsis.(Brief article)
Jan 12, 2009 ... PharmaMar, a unit of Spain's Zeltia Group, presented promising safety data on Zalypsis (PM00104) in cell lines and animal models of multiple myeloma. Zalypsis is a novel chemical entity related to the marine natural compounds Jorumycin and the family of Renieramycins, obtained ...
Diagnoplex raises $8.3M in series A financing.
Jan 12, 2009 ... Diagnoplex, a US developer of molecular cancer diagnostics has closed a series A financing raising 10.0 million Swiss francs ($8.6 million). The round was led by the Novartis Venture Fund and NeoMed, with Initiative Capital Romandie acting as co-investor. The Novartis Venture ...
Arena expects to abandon Ph IIb-stage insomnia drug.
Jan 12, 2009 ... The USA's Arena Pharmaceuticals says that its insomnia drug candidate APD125 missed the primary and secondary endpoints in a Phase IIb trial. Treatment with APD125 was well tolerated, and there were no reports of serious adverse events and no emerging safety findings compared to ...
M&A continues in pharma/biotech, but are mega acqusitions thing of the past?
Jan 12, 2009 ... While mergers and acquisitions in the pharmaceutical and biotechnology industries continued apace in 2008, the size of the deals compared to a few years back has decreased significantly. Of the 113 M&A deals reported for last year (according to Marketletter records; see pages 4-5 for full ...
Pharma/biotech mergers and acquisitions in 2008.
Jan 12, 2009 ... Company Partner Deal value ($) Completed Abbott Laboratories Ibis Biosciences $210.0 million Jan 2009 (e) Abraxis BioScience Shimoda $15.0 million Apr 2008 Access Pharmaceuticals MacroChem Undisclosed 3Q 2008 (e) AVI BioPharma Ercole Biotech $9.0 million Mar 2008 Aida Pharma ...
AZ eyeing up a move into biosimilars.
Jan 12, 2009 ... AstraZeneca says that it is thinking about selling generic versions of biotechnology drugs. The Anglo-Swedish drug major is the latest R&D-based pharmaceutical firm that could diversify into this area, following on from US companies Merck & Co and Eli Lilly. In an interview with ...
CEO says Pfizer is open to "mega-merger".
Jan 12, 2009 ... The chief executive of Pfizer, Jeffrey Kindler, says that he is open to the possibility of acquiring a pharmaceutical major, despite a prevailing trend among large drug companies that are increasingly taking over small firms rather than their large-cap rivals. In an interview ...
Lord Black: Big Pharma is "too cautious".
Jan 12, 2009 ... Nobel Prize laureate James Black has told the UK's Sunday Times newspaper that the drug industry's "safety-first approach" is hindering innovation. Lord Black helped discover two major classes of drugs, beta blockers and anti-ulcer histamine receptor blockers. He said that, in ...
Novartis speeds R&D ahead of Diovan loss.
Jan 12, 2009 ... Swiss drug major Novartis says it is taking a multi-faceted approach to help cushion it from the effects of blockbuster patent expirations. 2012 will see the loss of exclusivity on two of the companies' top drugs, the $5.0 billion-a-year blood pressure treatment Diovan (valsartan), as well ...
Immutep drug doubles breast cancer response.
Jan 12, 2009 ... French drug developer Immutep has reported that its ImmuFact IMP321 plus paclitaxel showed a statistically-significant response rate of 50% compared to 25% with paclitaxel alone (p=0.03) in the interim results of an ongoing Phase I/II chemo-immunotherapy trial in metastatic breast ...
DOR gets FDA go ahead for pivotal orBec trial.
Jan 12, 2009 ... USA-based DOR BioPharma has reached an agreement with the Food and Drug Administration on the design of a confirmatory, pivotal Phase III trial evaluating its lead product orBec (oral beclomethasone dipropionate) for the treatment of acute gastrointestinal ...
Scientists find cancer relapse mechanism.
Jan 12, 2009 ... Cancer Research UK, a charity funded by private donations, says Chinese researchers have found that cancerous cells can regenerate long after normal ones have been irrevocably damaged by apoptosis. Research published in the British Journal of Cancer by scientists at the ...
Erbitux has almost double KRAS response in trial.
Jan 12, 2009 ... Merck Serono, the pharmaceutical arm of Germany's Merck KGaA, has published the results of a study, demonstrating that the addition of its Erbitux (cetuximab) to standard oxaliplatin-based chemotherapy (FOLFOX-4) in previously-untreated metastatic colorectal cancer patients with KRAS ...
FDA calls in experts for prasugrel review.
Jan 12, 2009 ... The US Food and Drug Administration has called on its Cardiovascular and Renal Drugs Advisory Committee to aid in the review of US drug major Eli Lilly and Japan's Daiichi Sankyo's potential blockbuster blood-thinner prasugrel. The CRDAC will review the drug during an advisory ...
Germany raises health insurance premiums.(Brief article)
Jan 12, 2009 ... Germany's Health Minister, Ulla Schmidt (Social Democrat - SPD), has warned that a rise in the number of older people and improved treatments, including new drugs, have led to greater pressure on the public sector's provision of health care. The coalition government member said that health ...
Germany's VFA warns against wholesale fix.
Jan 12, 2009 ... Germany's research-based pharmaceutical industry association, the VFA, has responded to a draft proposal by the Federal Department of Health to force drugmakers to supply pharmacies at least partly via wholesalers. The move is seen as an effort to prevent the recent trend towards ...
NICE caves to public pressure, allowing terminal patients costly life-extending drugs.
Jan 12, 2009 ... The UK's National Institute for Health and Clinical Excellence (NICE), which advises on what medical care should be provided under the National Health Service, except in Scotland, has made a further concession to patients demanding a greater focus on their quality of life than on cost. ...
French drug recycling scheme discontinued.
Jan 12, 2009 ... A scheme that redistributed unused drugs to charitable causes in France has been discontinued after widespread abuse rendered it unworkable. The Cyclamed operation, which was established in 1993 to meet legal requirements for waste packaging disposal, was wound up at the end of ...