Almirall introduces state-of-the art inhaler for COPD patients
BARCELONA, Spain Almirall has introduced a new, state-of-the-art dry-powder inhaler, which the company will market with its leading pipeline compound aclidinium bromide. The drug is designed for treating chronic obstructive pulmonary disease, which include diseases like chronic bronchitis and emphysema.
The drug is currently in Phase III trials with 1,600 COPD patients from 23 countries worldwide. The results of the trials will be announced at the 2008 American Thoracic Society meeting.
Almirall is pursuing a three-line strategy for aclidinium bromide. It is being developed initially as a once-daily monotherapy for first-line maintenance therapy in COPD and will be filed with regulators for this indication in 2009. It is also in phase II trials in a fixed-dose combination with the long-acting beta agonist formoterol. This is expected to be filed in 2011. Additionally, it is at a preclinical development stage as a fixed-dose combination with an inhaled corticosteroid, which could be ready to file in 2012.
Almirall’s director of pharmaceutical development, Carsten Niederlaender, said the inhalation device will appeal to patients and healthcare professionals because “it is small, compact, portable, preloaded and extremely easy to use—unlike some of the currently available inhalers for COPD medications. Patients merely have to remove the cap, press the dose-release button and inhale. It should therefore improve patient adherence. The device, which comes preloaded with 30 doses, has a window that changes from red to green when a dose has been effectively delivered and which registers an audible click, providing patients with feedback and reassurance. A dose indicator flags up a red signal to warn patients when the inhaler is close to empty and the device locks out when its 30-day supply is exhausted to prevent patients inhaling inert dry-powder residue. The new inhaler is one of very few that ticks all the boxes for complying with international regulatory requirements,” said Niederlaender.
Wyeth and GSK may see competition in pediatric vaccines
LONDON There may be a clash of the titans underway.
Pharma giants Wyeth and GlaxoSmithKline are set to go head to head with their competing childhood vaccines, but Wyeth dismissed any worries about the newcomer to the vaccine playground.
Wyeth’s Prevnar will remain a key sales driver for the company but would not be hindered by Glaxo’s Synflorix, said Emilio Emini, the U.S. group’s head of vaccine research and development, on Tuesday.
Prevnar, a vaccine for infants and children to prevent certain invasive pneumococcal diseases, is active against seven types of streptococcus pneumonia, which together account for some 80 percent of illnesses, Reuters reported Tuesday.
Glaxo’s Synflorix, which a company spokeswoman said remained on track for submission to European regulators by the end of 2007, targets 10 types, and even prevents inflammation of the middle ear.
But Emini said Synflorix was incomparable to the new version of Prevnar.
“Essentially, it is a direct equivalent of the original Prevnar,” he said in an interview with Reuters on the sidelines of the FT Global Pharmaceutical and Biotechnology Conference. “If you look at the residual 20 percent of disease (not addressed by Prevnar) and ask how much is covered by the GSK 10-valent vaccine, it’s actually a small percentage. How much is covered by Prevnar-13? It’s over 60 percent,” Emini said.
Wyeth intends to submit a new version of Prevnar, active against 13 strains, to both European and U.S. regulators by the beginning of 2009.
The original version of the vaccine was introduced in 2000. Third-quarter sales of Prevnar were up 24 percent from a year earlier at $634 million.
Biomira to make move to U.S. under new name
EDMONTON, Canada Biomira shareholders have approved a plan to move the company to the U.S. and to change its name to Oncothyreon Incorporated. Oncothyreon will be the parent corporation of a successor company of Biomira and its subsidiaries, according to Canada.com.
The biotech company, which focuses on cancer treatment, currently has a few drugs in its pipeline including Stimuvax, which it is developing with Merck to treat non-small cell lung cancer. That drug is currently in a Phase III clinical trial. The next drug that is furthest along in development is a small molecule called PX-12, which is a drug used to treat pancreatic cancer and is currently in a Phase II trial.
“We are very pleased to have received the strong support of our shareholders for our relocation and the revision of our capital structure,” chief executive officer Robert Kirkland said. The shareholders will receive one-sixth of a share of common stock of Oncothyreon in exchange for each Biomira share. The new company will be based in Seattle.