UK drugmaker Skyepharma has enjoyed a great start to the week after gaining a positive opinion for the approval of Flutiform in Europe and receiving a $10-million milestone payment on the launch of Exparel in the US, sending its share price skywards.
The company's stock price more than doubled yesterday to close at 85.50 pence as investors breathed a sigh of relief that the European Medicine's Agency's Committee for Medicinal Products for Human Use has given the thumbs up for Flutiform's (fluticasone and formoterol) approval in the region as a treatment for asthma.
The drug's road to market has been less than smooth; its marketing application was passed to the EMA last year after member states failed to reach a unanimous decision through the decentralised procedure, with one country disagreeing with the positive benefit/risk assessment made by reference state the United Kingdom.
The US Food and Drug Administration also rejected the New Drug Application for Flutiform as a treatment for asthma in January 2010, and a subsequent 74-page complete response letter the following June meant additional clinical work for extra data on dosing, substantially delaying its approval there and costing the firm its marketing agreement with Abbott.
The recommendation by the CHMP means that, if all goes well, Flutiform could be on pharmacy shelves in some countries in Europe in as little as three months depending on individual pricing and reimbursement negotiations, where it will compete for market share with GlaxoSmithKline’s Advair (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide and formoterol).
Skyepharma has long said that the approval and launch of Flutiform in Europe, where it will be marketed by Mundipharma, is pivotal to the value and longer-term cash-generative potential of the group.
According to IMS data, the preventative asthma/COPD European market size in 2010 was around to be £5.5 billion, with a four-year compound annual growth rate of 6.6%. With preventative asthma treatments comprising well over half this market, the potential for Flutiform is certainly substantial.
Exparel launch triggers $10 million
Further bolstering the firm's stock was the news that it has received a £6.2 million milestone payment from Pacira Pharmaceuticals (SkyePharma's former Injectables Business) triggered by the launch of Exparel (bupivacaine liposome injectable suspension) in the US.
The drug combines bupivacaine with DepoFoam, a product delivery technology that delivers medication over a desired timeframe, and has received US approval for administration into the surgical site to analgesia after surgery.
According to SkyePharma, the DepoFoam platform allows a single dose of Exparel to deliver the painkiller bupivacaine over time, providing analgesia with reduced need for opioid drugs for up to 72 hours.
The company could earn "substantial additional milestone payments" on the product and is entitled to 3% of its net sales in the US.