Shire launches Vpriv to capitalise on Genzyme woes
pharmafile | March 2, 2010 | News story | Sales and Marketing | Cerezyme, Gaucher's, Shire
Shire has gained US approval to launch Vpriv, its new treatment for Gaucher’s disease, which it hopes will steal market share from rival Genzyme.
Shire has been swift to capitalise on Genzyme’s problems manufacturing Cerezyme for patients with Gaucher’s disease – a rare condition which represents one of the industry’s most lucrative markets.
There are only approximately 5,000 patients worldwide who receive treatment for Gaucher’s disease, but annual treatment costs more than $200,000 a year per person.
This makes it one of the highest cost per-patient medicines ever, and has helped it reach blockbuster status.
Cerezyme earned $1.23 billlion in revenue in 2008, but sales dropped by more than a third last year because of the supply problems.
Faced with acute shortages, the FDA asked Shire to make Vpriv (velaglucerase alfa) available on compassionate-use grounds midway through 2009, even though it had not yet gained approval.
Since then, Shire and the FDA have worked together to fast-track its full approval, which has arrived several months earlier than initially planned.
Shire says it has already manufactured enough Vpriv to treat around 400 Gaucher disease patients and is set to increase production as the year progresses.
The company expects to start production at its new large-scale facility for the product in Lexington, US, in the middle of 2010. Shire has accelerated its investment at the Lexington site to permit large-scale manufacturing of Shire’s human genetic therapies (HGT) business, including Vpriv.
The plant will initially concentrate on Vpriv production in order to meet demand, but can also be used to make other products in the Shire HGT portfolio. Vpriv is currently being made at the company’s plant in Cambridge, Massachusetts.
Under-cutting in a high cost market Genzyme and Shire are the pre-eminent orphan diseases companies, successfully developing specialist medicines for rare diseases and charging very high prices for their treatments.
Shire is aiming to under-cut the price of Cerezyme with Vpriv by marketing it at a 15% discount to its rival.
This is clearly aimed at helping it to hold on to market share once Cerezyme supplies return to normal. The launch of the new treatment was welcomed by the US patient group.
“The last six months have been very challenging for the entire Gaucher community, and the approval of VPRIV brings an important new treatment option to patients suffering from Type 1 Gaucher disease,” said Rhonda Buyers, chief executive/executive director, National Gaucher Foundation.
“We at the NGF are excited about this approval, and by the steps that Shire has taken to improve access to treatments for patients with life-altering conditions. This co-pay programme will greatly assist the Gaucher patient population, and we appreciate the fact that Shire has taken the time to listen to us and to act on the needs of patients.”
Shire’s nimble positioning has helped raise its share price to a nine-year high.
Analysts Jefferies predict the company could make $70 million from the market this year, rising to a peak of $220 million, which would represent approximately a 20% share of the market.
The profitablity of the disease area has not escaped the industry’s biggest player – in December Pfizer acquired rights to Protalix BioTherapeutics Gaucher’s treatment Uplyso (taliglucerase alfa).
Protalix is awaiting approval for its marketing approval, which has been delayed slightly because of the FDA’s request for further validation of its manufacturing process.
The FDA stepped in to help secure supplies of an alternative treatment, because without medication Gaucher’s patients can experience an irreversible deterioration in their condition.
The FDA has also clearly endorsed Vpriv as a direct substitute which will become invaluable for Shire breaking into the market, as otherwise this would have proven to be far more difficult without.
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