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Actelion could announce a licensing deal on almorexant as early as next week, industry sources told Pharmawire. One source said that the company had begun with a list of eight of the top ten pharmaceutical companies, although another source claiming knowledge of the situation said that this list has since been whittled down to two – GlaxoSmithKline and Novartis.
A senior source at GSK refused to comment. A spokesperson for Novartis also would not comment. Actelion could not be reached due to the May holiday.
The source with knowledge claimed that front runner Merck & Co had dropped out as it could not agree on the terms. “It is a very competitive process that will go down to the wire,” the source said.
A Merck source was unavailable to comment.
Eli Lilly had also joined the process as a late entrant at one stage but later dropped out, the same source claimed. A report from this news service in January noted that Lilly had a 5-HT2a drug in development that could have a synergistic effect with almorexant in prolonging sleep in the elderly.
As for the two companies allegedly left in the process, a clinician familiar with the development of almorexant noted earlier that GSK has had teething problems developing its own orexin antagonist, while the company itself made no mention of this drug in its neuroscience update in December.
An insomnia drug would be the start of a new therapeutic area for Novartis but could potentially prove a lead in for further CNS buys in the future, an industry source agreed. “There are quite a lot of early stage CNS drugs out there,” the source said.
The source claiming knowledge intimated that interest from Novartis and GSK could also be more strategic, since anyone who strikes a deal with almorexant, will almost certainly be a future buyer for Actelion.
Meanwhile, the industry source recently met with Actelion management and had been told that the Swiss company was working on a major licensing deal that could be struck in the next seven days, although the source was not aware of whether it was almorexant or another deal entirely. However, a company source at the Allschwil, Switzerland-based small molecule developer had told this service in December that Actelion had hoped to strike a deal before H1 2008.
The deal has been trumpeted as the biggest deal in Actelion’s history but investment sources are unclear as to whether almorexant could represent the type of paradigm shift for the hypnotics market that has been suggested.
Almorexant is a novel, first-in-class hypocretin orexin antagonist. Orexins, which reside in the lateral hypothalamus, are neurotransmitter peptides that have been linked to sleep-awake behaviour in both humans and animals, although research has suggested that this peptide family also influences cardiovascular function, food intake, body temperature, blood pressure and other parts of the neuroendocrine system. This prompted one neurophysiologist, who has led research into the functional purpose of hypocretin orexins, to note that the long term effects of treating insomniacs with almorexant may not necessarily be captured in the pivotal trial. A second doctor said there could be a possibility that some patients may experience higher blood pressure when taking an orexin antagonist.
An industry investor said Actelion needs a partner as it only has a specialty sales force for pulmonologists and cardiologists directed towards the company’s pulmonary arterial hypertension (PAH) drug, so it obviously needs support from big pharma for almorexant.
Still, the investor added its is difficult to find a corporate who would logically do this deal for a huge upfront in multiples of hundreds of millions, with a 50/50 cost and sales split.
Meanwhile, a second industry investor said he had heard that the company was nervous about being taken out at CHF 55 (USD 52.14) and the board has been discussing that very intently.
The market for hypnotics is an extremely competitive space with the current gold standard Ambien, zolpidem tartrate, now generic. The experience Sepracor has had in establishing its novel hypnotic, Lunesta, the first to obtain a chronic usage label, may well factor into the final price negotiations on almorexant. DTC Perspectives last year published data that showed the Massachusetts, US based pharmaceutical spent USD 182.7m dollars in DTC advertising for Lunesta in the first half of 2007, which when pro rated and compared to the USD 565.4m Sepracor booked in sales for the entire year(minus 6% COGS) leaves a margin of just under 40% and a negative ROI.
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