CSL soars on news of blood-clotting advance

INVESTORS pushed CSL shares higher after it revealed plans to launch a new haemophilia drug in early 2016.

CSL plans to launch a mew haemophilia drug in 2016.

INVESTORS pushed CSL shares higher yesterday after the blood products and vaccine maker revealed it was planning to launch a new drug to treat the genetic blood-clotting disorder haemophilia B in early 2016.

At an annual research and development briefing, chief scientific officer Andrew Cuthbertson said CSL would lodge the required documents with drug regulators in the US and Europe to approve the company’s recombinant coagulation factor IX.

Dr Cuthbertson said that instead of being infused two or three times a week, patients would only require treatment once a week or fortnightly to prevent bleeding into joints or the brain.

“We have done all the clinical trials and we’ve got large dossiers to file with the regulatory agencies,” he said. “This is a very important announcement for patients and for CSL.”

The estimated size of the market for CSL, he said, was $500 million, although it could be as large as $1 billion. The product had an “excellent” safety profile, with no adverse events reported during trials. It was also effective in seven-day, 10-day and 14-day treatments, and boasted a 5.3-fold longer half-life than existing products.

CSL spends almost $500m a year on research and development, employing a network of about 1000 scientists around the world.

Leading healthcare analyst Andrew Goodsall of UBS said it had been some time since CSL had announced a breakthrough product like its haemophilia B treatment.

“The highlight of the R&D briefing was that CSL is only a stone’s throw away from launching into the long-acting haemophilia market,” Mr Goodsall said. “It wasn’t lost on the share price.”

Against a firmer overall market, up 0.8 per cent, shares in CSL jumped $1.73, or 2 per cent, to $86.35 — a level not seen since before the global financial crisis.

The company also revealed progress in its CSL 112 drug to prevent secondary heart attacks and strokes in people who have already experienced cardiac arrest. The drug is made from plasma that CSL currently discards.

A phase 2b trial involving 1200 patients around the world, including Australia, is expected to start next year and take more than two years to complete. If the drug is successful, the potential market is in the billions of dollars.

“There’s a very big unmet need,” said Dr Cuthbertson, who has been a strong supporter of the Abbott government’s proposed medical research future fund.

Overall, he said the R&D portfolio was in good shape compared with a few years ago.

“Back then, there were a lot of things in the early stage of research,” he said. “Now we have new medicines at a late stage that are poised for registration.”

CSL stock has been supported over the years by a continuing buyback program. Last August, with a $950m buyback unveiled in October 2013 almost complete, CSL said the board would consider a further buyback of a similar magnitude.

The new buyback is in its infancy, with the $41bn company having approval to buy a further $903.2m of CSL shares.