With its inhaled levodopa product for Parkinson's disease (PD) gearing up for a phase III trial and $55 million just gained in a series C financing, Civitas Therapeutics Inc. filed to raise up to $86.2 million in an initial public offering (IPO).
CVT-301, designed to provide quick relief from debilitating motor fluctuations, known as "off" episodes, associated with Parkinson's disease, got a boost for its phase IIb trial last fall with the $38 million series B round, and Chelsea, Mass.-based Civitas, spun out from Alkermes plc, hit the ground running with $20 million in its series A at the start of 2011.
The treatment would be self-administered and adjunctive as needed, giving extra levodopa to the brain as a booster when necessary to the oral levodopa regimen. Delivery takes place by way of Civitas' Arcus technology, a reusable pocket-sized inhaler that is actuated by the breath. Studies with CVT-301 so far have been funded partly by grants from the Michael J. Fox Foundation for Parkinson's Research.
Civitas' device consists of seven plastic parts, two springs and a staple. When the patient inhales, the capsule in the device spins and medicine is automatically drawn into the lung. The delivery method emerged from Alkermes' pulmonary delivery technology, which was the focus of a deal with Indianapolis-based Eli Lilly and Co. that ended in 2008. (See BioWorld Today, March 10, 2008.)
Coincidentally, also going under at the end of April 2013 was the PD deal between Impax Pharmaceuticals, of Hayward, Calif., a division of Impax Laboratories Inc., and London-based Glaxosmithkline plc (GSK) for the development and commercialization of Rytary (IPX066), an extended-release oral form of carbidopa-levodopa, outside the U.S. and Taiwan. The decision was made due to delays in regulatory approval, which hasn't gone especially well in the U.S., either, because of manufacturing issues. (See BioWorld Today, Jan. 23, 2013.)
Oral levodopa is the standard of care for PD – more than 70 percent of patients take the dopamine precursor daily – but does not reliably maintain blood levels, hence the off episodes, which can cause freezing, or the sudden inability to move. It's a large neutral amino acid that may compete in the stomach with food, causing suboptimal absorption. Only a small drop in serum level of the drug can cause major motor difficulty for patients, and fast.
The most common adverse events to date in trials with of CVT-301 have been dizziness and headache, showing up with similar frequency in CVT-301 and placebo-treated patients, along with cough, observed less often.
CVT-301 would compete against on-demand therapies that aim to specifically address off episodes, the only approved such drug being injectable Apokyn (apomorphine, Vernalis plc), cleared in the U.S. in 2004 and in Europe in 2003, Civitas noted in SEC paperwork related to the IPO. Cynapsus Therapeutics Inc., of Toronto, has a sublingual form in development. Last month, Cynapsus said phase II trials had begun with APL-130277, following guidance from the FDA. The study will enroll 16 patients with PD who are naïve to the use of apomorphine and who experience at least one daily off episode. (See BioWorld Today, Nov. 7, 2005.)
Pricing details of the Civitas IPO were not disclosed. J.P. Morgan Securities LLC and BofA Merrill Lynch will act as joint book-running managers for the deal, with Cowen and Co. LLC and Oppenheimer & Co. Inc. serving as co-managers.
Upon pricing, the stock would trade on Nasdaq under the ticker CVTS.
In other financing news:
Immunovaccine Inc., of Halifax, Nova Scotia, carried out an overnight marketed offering to sell about 9.1 million units for 95 cents each, representing gross proceeds of about $8.6 million. Each unit will consist of one common share in the share capital of Immunovaccine and one-half of one common share purchase warrant. Each whole warrant entitles the holder thereof to purchase one additional common share upon payment of the exercise price of $1.24 per warrant during a period of 18 months after the date of closing of the offering.