Flamel feels fallout from lost partners
removal by rebel shareholders of its former CEO Gerard Soula last
June have taken drug delivery company Flamel from a net profit of
$12.5m (€10.3m) in 2004 to a net loss of $27.4m in 2005, as it
tries to find new partners for its polymer-based drug delivery
technologies.
The French firm's two main platforms - Micropump, for the delivery of small molecule drugs, and Medusa, for the delivery of native protein drugs - have not been clinching any new licences for Flamel recently, leaving it with only $20.8m in licence and research revenue coming primarily from GlaxoSmithKline and TAP Pharmaceutical Products.
GlaxoSmithKline exited a pact with Flamel in 2003 to develop a Micropump version of its blockbuster antibiotic Augmentin but still retains its licence agreement for the Micropump formulation of its beta-blocker Coreg.
In December, GlaxoSmithKline submitted a new drug application (NDA) in the US for the Micropump-delivered formulation of Coreg, resulting in the payment of a $2m milestone to Flamel as well as raising hopes that it may be the company's first FDA-approved implementation of its Micropump technology, with the potential of tens of millions of dollars annually in revenues.
TAP, on the other hand, abandoned ship in September, when it pulled out of deal to develop a formulation of its big-selling gastrointestinal drug lansoprazole, based again on Micropump technology, in order to focus on a single-enantiomer version of the drug with Anglo-Swedish firm AstraZeneca.
Biovail also left the party early when in March it had its agreement to develop a Micropump formulation of the antiviral drug acyclovir called Genvir cancelled by Flamel, after failing to meet its own schedule for starting pivotal trials of the herpes treatment.
Exacerbating the problem of lost revenue was the termination last year of a $165m licensing agreement with Bristol-Myers Squibb for Basulin, a long-acting form of insulin delivered with Medusa technology; Flamel got $12.6m in 2004 in amortisation for an upfront payment from Bristol-Myers Squibb, making the difference with the poorer 2005 results starker.
Despite all these unfinished projects, Flamel spokesman Charles Marlio stressed to In-PharmaTechnologist.com he believes the company can find partners to pick up Basulin and Genvir, as well as other of its advanced products, like its second-generation interleukin-2 and a long-acting native interferon alpha-2b.
"I think the scientific results speak for themselves and the quality of the board we now have serves as a datapoint for potential partners to consider," he said.
"For a company like GlaxoSmithKline, the second largest in the world, to choose Flamel to be a supplier of a $1.1bn drug, growing at 30 per cent a year, is very telling."
Flamel says it has in its pipeline an undisclosed Micropump drug for Merck and a number of internally developed products.
Although R&D costs jumped by a third in 2005 to £47.3m and selling, general and administrative expenses almost doubled to $14.5m, the company's balance sheet remains healthy with $83.7m in cash and hardly any debt.
Moreover, some of these costs - the company will not say how much - are associated with the departure of the previous CEO and the ushering in of a new board that promises to keep spending under control and make securing new partners the top priority.
Flamel did not issue any guidance for 2006 but obviously a lot now is at stake on Coreg's approval, as its commercialisation would not only be very profitable for the drug delivery firm but would also inspire confidence in its potential partners.
