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pharmafile | July 9, 2007 | News story | Research and Development, Sales and Marketing |Â Â Â
Genzyme says osteoarthritis treatment misses trial goals
Genzyme has reported that its trial of hylastan in treating pain in patients with osteoarthritis of the knee did not meet its primary endpoints.
The pivotal hylastan trial involved nearly 400 patients with osteoarthritis of the knee enrolled at 27 sites in North America and Europe.
Patients were randomised to receive two intra-articular injections of hylastan delivered two weeks apart, a single injection of hylastan, or an injection of a corticosteroid. Patients were evaluated for 26 weeks following treatment. Results showed a statistically significant and clinically meaningful reduction in knee pain compared to baseline for each of the three treatment arms.
However, the difference in pain reduction between patients treated with hylastan and patients treated with a steroid was not significant, and the trial did not meet its primary endpoint of demonstrating that hylastan provides superior pain relief to steroids.
Hylastan is being developed within Genzyme's programme to introduce a viscosupplementation product that can be delivered through a single knee injection.
Genzyme says its goal is to simplify OA pain management, reduce the overall cost of therapy and advance a treatment option that may expand the benefits of viscosupplementation to a broader number of patients.
Genzyme's development programme also includes Synvisc-One, an investigational combined-dose regimen of Synvisc (hylan G-F 20) provided in a single injection, which the company is currently seeking to market in the US and Europe.
Genzyme has submitted an application to the FDA for Synvisc-One, and later this month will apply for a CE Mark to introduce Synvisc-One in Europe. Regulatory action on both applications is expected this year.
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AstraZeneca distribution scheme on hold
AstraZeneca is to delay the implementation of its new distribution system for its medicines in the UK until 2008.
The company had planned to have the system up and running by late summer. UniChem and AAH Pharmaceuticals were appointed as distribution partners in April.
The system replaces the traditional method of supplying drugs indirectly through wholesalers. Pfizer adopted a similar approach, but is now being investigated by the Office of Fair Trading after angering wholesalers and chemists with its exclusive Unichem deal.
Wholesalers and pharmacists argue that the new distribution deals are stifling competition in the UK. The OFT is due to report its findings in late 2007.
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Biomira seeks FDA clearance for cancer drug trials
Biomira has submitted an investigational new drug application to the FDA for PX-478, a novel inhibitor of a protein that controls genes whose products are important for tumour growth and survival.
In preclinical studies, PX-478 produced significant tumour regression and growth delay in multiple models of human cancers, including cancers of the lung, breast, prostate, colon, kidney, pancreas and ovary.
"HIF-1 alpha is a drug target that provides a multi-pronged approach for cancer therapy. We believe that PX-478 will be the first small molecule to enter clinical development that acts directly to lower HIF-1 alpha protein levels," said Dr Lynn Kirkpatrick, chief scientific officer of Biomira.
Upon clearance of the IND, Biomira intends to initiate a phase I trial for this compound in the third quarter of 2007.
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Genaera drops cystic fibrosis and prostate cancer trials
Genaera Corporation is discontinuing its phase II study of Lomucin for the treatment of cystic fibrosis, and its phase II trial of squalamine in prostate cancer.
The company said that the decision to end the Lomucin trial was made when it determined that there would be no additional benefit to further enrollment. Genaera plans to evaluate the impact of the drug, which it was developing with Cystic Fibrosis Foundation Therapeutics (CFFT), then move forward to focus on its core programmes for asthma and obesity.
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, Genara said. The company will receive a final milestone payment in the amount of $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 will recognise revenue of $2.1 million of which $2 million was previously recorded as a long-term liability.
The phase II study of squalamine in prostate cancer, another of Genaera's non-core assets, was also discontinued. There had been no recent enrolment in this trial, and delays in restarting the study at a new investigative site made the decision to end the study appropriate, the company said.
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Lexicon develops antibodies for potential heart disease treatment
Lexicon Pharmaceuticals is developing antibodies that lower triglycerides and cholesterol as a potential new therapy for heart disease.
The company reported results from preclinical research demonstrating that antibodies directed to a potential new target, angiopoietin-like protein 4 (ANGPTL4), rapidly lower triglycerides and cholesterol. Research suggests that a monoclonal antibody targeting ANGPTL4 may have therapeutic application in the treatment of cardiovascular disease.
Lexicon scientists first identified ANGPTL4 as a potential target for cardiovascular disease using the company's gene knockout technology.
Lexicon scientists created animal models that had alterations in specific genes in order to discover the physiological and behavioral effects that result from the loss of the protein encoded by the gene. Researchers found that animal models in which the ANGPTL4 gene was knocked out had lower triglyceride and cholesterol levels than normal animals.
Lexicon's biotherapeutics group developed a monoclonal antibody as an injectable agent targeting the ANGPTL4 protein to reproduce the triglyceride and cholesterol- lowering effects identified in the animal models. "Notably, this appears to be the first successful production of a monoclonal antibody to this target," the company said in a press release.
Lexicon is collaborating with Genentech to develop and commercialise new biologic drugs based on the companies' research. Under the collaboration, Lexicon has the right to develop and commercialise biotherapeutic drugs for up to six targets. ANGPTL4, referred to internally as LG842, is one of two targets already chosen by Lexicon.
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