Thetransaction is expected to Tier 1 common equity by approximately $1.2 billion.FITB will retain 49% ownership in the joint venture, and is providing $1.25billion in bank loans to fund the new company. Although Fitch acknowledges thefavorable impact on capital from the sale, revenue diversity is somewhatlessened as a result of the transaction. Nimotuzumab’s differentiated mechanistic attributes resultin it selectively targeting tissues over-expressing EGFR while avoiding normaltissue. The debilitating and dangerous side effects observed with the marketedEGFR-targeted drugs result from their indiscriminant targeting of normalhealthy tissues in addition to their binding to tumor.”YM and its licensee Kuhnil Pharmaceutical Co. in Korea recentlycollaborated on a Phase I trial treating patients with palliative radiotherapyfor NSCLC. The data from the Canadian arm of the trial were presented at ASCO2008 and indicated that the combination of nimotuzumab with radiation wasfeasible and safe and has the potential to provide an important quality oflife and survival advantage to patients over radiation alone in the palliativesetting.
Continued treatment for prolonged periods was very well tolerated andthere was no evidence of Grade III or IV rash at any of the three dose levelsnor did nimotuzumab increase the toxicity of radiotherapy. Based on theseresults, YM is currently conducting an international 128-patient Phase IIrandomized, double-blind, placebo-controlled study that will examine theeffect of nimotuzumab when added to palliative radiotherapy to treat NSCLC.The incidence of NSCLC exceeds 367,000 new cases each year in the seven majorpharmaceutical markets.YM licensees Daiichi and Kuhnil are currently collaborating on a Phase IIrandomized, open-label trial they are conducting evaluating nimotuzumab plusirinotecan compared to irinotecan alone in patients with advanced or recurrentgastric cancer who are refractory to 5-FU-containing regimens. The licenseesreport enrollment continues to progress and remains on track to be completedin calendar 2009.Results were reported recently at the 2009 ASCO Annual Meeting from arandomized Phase IIb, four-arm, open-label trial of nimotuzumab in combinationwith radiation therapy (RT) or chemoradiation therapy (CRT) in patients withinoperable, locoregionally advanced Stage III/IVa head and neck cancerconducted in India by Reddy BK et al. The addition of nimotuzumab to both theRT and CRT regimens improved the overall response rate, survival rate at 30months, median progression-free survival and median overall survival Acombined group analysis of the nimotuzumab arms vs. the non-nimotuzumab armsdemonstrated a significant difference in overall survival (p (equal sign)0.0018) favoring nimotuzumab. The addition of nimotuzumab did not add to thetoxicities of either regimen, with no Grade III/IV skin toxicities observed.The trial demonstrates that the efficacy of nimotuzumab compares favorably toresults reported for cetuximab, an EGFR-targeting antibody marketed asErbitux(R), but that this efficacy was not accompanied by the severetoxicities reported in patients treated with cetuximab.YM BioSciences today posted a series of documents on its website, that address frequently asked questions made by theinvestment community and pharmaceutical industry relating to YM’s products andbusiness strategy. A comprehensive description of the completed and ongoingtrials being conducted by YM and the other licensees of nimotuzumab is alsoavailable at YM’s website.About YM BioSciencesYM BioSciences Inc.
is a life sciences product development company thatidentifies and advances a diverse portfolio of promising cancer-relatedproducts at various stages of development. The Company is currently developingtwo late-stage products: nimotuzumab, an EGFR-targeting Affinity-OptimizedAntibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition offree and liposome-encapsulated fentanyl. YM has proven regulatory and clinicaltrial expertise and a diversified business model designed to reduce risk whileadvancing clinical products toward international approval, marketing andcommercialization.Nimotuzumab is a humanized monoclonal antibody in development worldwide,targeting multiple tumor types primarily in combination with radiation andchemoradiation. It is significantly differentiated from all other currentlymarketed EGFR-targeting agents due to its remarkably benign side-effectprofile. Nimotuzumab’s anti-tumor activity has led to its approval formarketing in more than 12 countries. In more than 3,500 patients reported ashaving been treated with nimotuzumab worldwide to date, no Grade IV incidentsof radiation dermatitis have been described, severe rash has not been observedand reports of the other severe side-effects that are typical ofEGFR-targeting molecules have been rare.
Nimotuzumab is licensed to YM’smajority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and wasdeveloped at the Center of Molecular Immunology. YM is developing AeroLEF forthe treatment of moderate to severe acute pain. The product is differentiatedfrom other approaches using fentanyl because patients can individually controlthe analgesia required for their differing intensities of pain. AeroLEF metall endpoints in a randomized Phase II trial and is currently being preparedfor late-stage development internationally.This press release may contain forward-looking statements, which reflectthe Company’s current expectation regarding future events. Theseforward-looking statements involve risks and uncertainties that may causeactual results, events or developments to be materially different from anyfuture results, events or developments expressed or implied by suchforward-looking statements. Such factors include, but are not limited to,changing market conditions, the successful and timely completion of clinicalstudies, the establishment of corporate alliances, the impact of competitiveproducts and pricing, new product development, uncertainties related to theregulatory approval process and other risks detailed from time to time in theCompany’s ongoing quarterly and annual reporting.
