Global Insight Perspective | |
Significance | Pulzium's poor reception by the FDA panel is Solvay's second major U.S. setback in less than six months. |
Implications | With major delays expected before a potential resubmission for Pulzium with the FDA, Solvay's options for boosting a lacklustre pipeline are shrinking fast. An approval for Abbott Laboratories' drug Simcor—which Solvay will co-market in the U.S.—is now the only near-term event that could improve the company's U.S. fortunes. |
Outlook | This will still not be sufficient to plug the hole left by the expiry of marketing rights to gastrointestinal drug Pantoloc (pantoprazole) earlier this year, and Solvay should be on the lookout for more such deals where possible. |
Belgian pharmaceutical company Solvay has seen its atrial fibrillation treatment Pulzium (tedisamil) fall at the first hurdle in its attempts to obtain U.S. marketing approval. Following a review of the clinical data contained in Solvay's regulatory application, the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted unanimously not to recommend the drug's approval for sale. The main reason behind CRDAC's decision was a perceived potential for dosing errors when administering the drug, with panel members citing Pulzium's gender-specific, height- and weight-based dosing guidance as a key factor that could lead to accidental overdosing. Receiving a higher-dose infusion of Pulzium than necessary could, CRDAC suggested, increase the risk of patients developing torsades de pointes; a form of polymorphic ventricular tachycardia.
Another factor that prompted CRDAC's unwillingness to back Pulzium for approval was the make-up of the patient population used in the pivotal trials that formed the basis of Solvay's regulatory submission to the FDA. With a large proportion of patients assessed in the studies coming from Eastern Europe, CRDAC panellists were concerned that the resulting safety data would not necessarily be applicable to the U.S. population that would gain access to Pulzium through am FDA approval. However, it was made clear that Pulzium did show enough potential to warrant an eventual FDA approval on the condition that Solvay provided data on new safety studies focusing specifically on U.S. patients.
The setback for Pulzium came just days after a rival atrial fibrillation product made by Japan's Astellas and Canada's Cardiome, Kynapid (vernakalant), was recommended by the very same panel, paving the way for a full FDA approval in a month's time (see Japan: 10 December 2007: Astellas, Cardiome's Vernakalant Recommended by FDA Reviewer). Both drugs were given 19 January 2008 as a date by which the FDA would make its final approval decision, and Kynapid's favourable recommendation from CRDAC would suggest that the FDA's ruling will likely follow suit.
Investment in CNS Research
In other company news, Solvay has embarked on a collaboration with DNage, a subsidiary of Dutch biotech Pharming, that will see the two firms work alongside eight academic research groups in a four-year project. The aim of the project, which has been given a total budget of just 6.8 million euro (US$9.8 million), is to identify target molecules with potential use in developing novel treatments for Parkinson's disease and Alzheimer's disease. Netherlands-based TI Pharma will provide the majority of the financial backing for the scheme at 3.4 million euro, with the other 10 member splitting the remainder of the costs among them.
Outlook and Implications
Pulzium's rejection by the FDA panel is a bitter blow to Solvay, which had grown increasingly reliant on a positive U.S. reception of the drug in the wake of several other regulatory setbacks (see Belgium: 13 August 2007: FDA Action Letter Dashes U.S. Approval Hopes for Solvay and Wyeth's Bifeprunox and Belgium:11 December 2006: Solvay Withdraws Marketing Application for Synordia over EMEA's Request for More Data). Solvay has said that it will work in conjunction with the FDA to determine the best steps for ensuring a regulatory approval for Pulzium, but with entirely new clinical trials now certain to be required, any approval is likely to be at least two years behind schedule. This leaves Solvay with few pipeline-based options for boosting short-to-medium-term growth at a time when it is cutting back on other areas in order to maximise its available resources (see Belgium: 26 October 2007: Temporary Reprieve for Solvay as Q3 Pharma Sales are Boosted by 'Flu Vaccines). The group's full-year forecast includes an expected stabilisation of drug sales and operating profit at levels roughly similar to last year. Following the signing of a U.S. co-marketing agreement over Abbott Laboratories' (U.S.) cardiovascular drug Simcor (niacin and simvastatin; see Belgium:22 October 2007: Solvay to Co-Market Abbott's Simcor in U.S.), an FDA approval for the treatment is being anxiously awaited. With in-house pipeline projects having brought a string of disappointments in recent months, Solvay would do well to seek out more of such marketing deals, although potentially in markets outside the United States, in order to avoid to avoid the uncertainty of a still-fluctuating U.S. dollar.