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pharmafile | June 19, 2007 | News story | Sales and Marketing |Â Â Â
Lilly launches research effort to fight TB
Eli Lilly has announced the creation of a public-private partnership to conduct early-phase discovery research of new medicines urgently needed to treat tuberculosis, including emerging resistant strains.
The partnership will be a not-for-profit, drug-research organisation based in Seattle, which will draw upon resources from some of the nation's leading tuberculosis (TB) and infectious diseases drug researchers and organisations, said Eli Lilly.
Lilly is committing $15 million to catalyze the partnership over the next five years and will fund the leasing of laboratory space to host the partnership's drug researchers. Lilly also will equip the facility with high-tech machinery and biological tools used for drug screening and testing. Further, the company will open its library of more than 500,000 Lilly medicinal compounds to researchers, who will test and screen them for possible TB treatments.
Gino Santini, senior vice president of corporate strategy and business development at Lilly, said: "We recognise that new drug research is needed to help save the millions of lives that today are being lost to TB. By merging the resources of the public and private sectors – both scientific and financial – this partnership will serve as a catalyst to advance the early discovery of new medicines for this ancient killer."
The target growth for the new drug research organisation will be to staff up to 25 full-time, highly-skilled drug researchers. This will include a board of directors and steering committee comprised of representatives from Lilly and partnering organisations. It will seek grants and contracts for additional funding with the ultimate goal of becoming self-sustaining.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Foundation for the NIH will partner with Lilly on the project. NIAID's current domestic and international investment in TB research is $120 million.
Related links
Eli Lily & Co: LSA company profile
Tropical Infections: A Status Update
Tuberculosis: Extracting Value From a Stagnant Market
Warner pays $5.5 million to settle contraceptive lawsuit
Warner Chilcott has agreed to pay $5.5 million to settle a case in which the company was accused of conspiring with Barr Pharmaceuticals to prevent generic versions of the oral contraceptive Ovcon from reaching the market.
The lawsuit was filed in 2005 in the US District Court for the District of Columbia, and will continue to move forward for Barr. According to the complaint, Ovcon has been sold in the US since 1976 and Warner Chilcott became the exclusive US distributor of Ovcon in early 2000.
During 2003, Barr Pharmaceuticals publicly announced that it planned to have a generic version of Ovcon on the market by the end of that year. The lawsuit alleges that Warner Chilcott paid Barr Pharmaceuticals $1 million in September 2003 for an agreement designed to prevent Barr's generic product from coming to market.
Under the terms of the alleged agreement, once Barr received FDA approval to market generic Ovcon, Warner Chilcott had 90 days to pay Barr $19 million, after which Barr would refuse to bring the cheaper generic version to the market. The lawsuit alleged that as a result of the agreement, Warner Chilcott paid Barr a total of $20 million to keep it from marketing its generic version of Ovcon.
"Warner Chilcott and Barr Pharmaceuticals allegedly conspired to keep generic alternatives to Ovcon off the market, to keep the price of Ovcon as high as possible, and to share in the allegedly illegal profits," Attorney General Martha Coakley said. "This lawsuit and settlement holds Warner Chilcott accountable for its actions, and helps ensure more choice and lower drug prices for consumers."
As part of the ten-year term of the settlement, Warner Chilcott is prohibited from entering into any agreement that would have the effect of limiting the research, development, manufacture, or sale of a generic alternative to one of its drugs. Furthermore, Warner Chilcott must provide the states notice of certain agreements it has entered into with generic manufacturers, and must continue to make its records available to the states for inspection to determine whether the company is complying with the terms of the agreement.
Related links
Barr Pharmaceuticals Inc: LSA company profile
Stakeholder Opinions: Hormonal Contraceptives – New directions in a competitive market
Endometriosis Pipeline Forecast
Wex cleared to begin late-stage pain drug trial
Wex Pharmaceuticals has been given the go-ahead by Canadian regulators to start a phase III trial in cancer pain for its lead product, Tectin.
The placebo-controlled trial will include approximately 120 patients with moderate to severe cancer-related pain. A primary composite endpoint that evaluates pain reduction with an improvement in quality of life will be used to define true responder to treatment, Vancouver-based Wex said.
The company believes that the trial has a high probability of meeting its endpoint. The last study for the drug was terminated early when it became apparent that the trial would not meet its objective when based solely on pain reduction.
However, a reanalysis showed that an endpoint that combines pain reduction with an improvement in quality of life would have produced a statistically significant and clinically meaningful result, Wex said. The company added that a primary composite endpoint is commonly used in chronic pain trial, as pain assessment is subjective.
Wex said that a successful trial, along with data from previous studies, should be enough to receive new drug submission approval from Canadian regulators.
Related links
Wex Pharmaceuticals Inc: LSA company profile
Regulator Perceptions in Cancer – Evolving opinions about the oncology drug approval process
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
Geron presents promising data in ongoing leukaemia trial
Geron's telomerase inhibitor cancer drug has demonstrated good pharmacokinetics and tolerability in its ongoing phase I/II trial involving patients with chronic lymphocytic leukaemia, according to the biopharmaceutical company.
A pharmacokinetic analysis of three patients in the highest dose cohort of 160mg/m2 has shown transient peak plasma concentrations of approximately 10ug/ml. This and other data indicate that the drug, GRN163L, continues to exhibit favorable pharmacokinetic properties that are linear with respect to the doses tested so far, Geron said.
Up to the current dose levels, no significant changes in telomerase activity or telomere length in the bulk circulating chronic lymphocytic leukaemia (CLL) cells of treated patients have been observed. These pharmacodynamic results are consistent with expectations because of the relatively short exposure of CLL cells in patients' blood to concentrations of drug capable of inhibiting telomerase.
With dosing and accrual to cohort 4 continuing, patients treated at the current dose levels have tolerated the drug well, and the maximum tolerated dose has not yet been identified. "We are encouraged by the results," said Dr Alan Colowick, the company's president.
"Based on preclinical data demonstrating the effects of GRN163L on both mature and cancer stem cells in multiple myeloma, Geron will initiate a clinical trial involving multiple myeloma patients. In addition, the company will begin a fourth trial of GRN163L in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer. The basis for this trial is the result of promising preclinical animal data demonstrating the drug's activity in this tumor type as well. Geron expects to initiate both trials in the coming months."
Related links
Geron Corporation: LSA company profile
Stakeholder Opinions: Chronic Leukaemias – Curative Intent Raises the Bar
Acute Leukaemias – Persistent unmet needs confer significant commercial opportunity
