Six months of uncertainty have come to an end for Cardiome Pharma Corp., as Merck & Co. Inc. announced it would hand global marketing and development rights for I.V. and oral formulations of heart drug vernakalant back to the Vancouver, British Columbia-based company.

Merck abruptly discontinued development of oral vernakalant in March, annihilating Cardiome's stock price, but the pharma firm had maintained possession of the asset. (See BioWorld Today, March 20, 2012.)

Cardiome's stock (NASDAQ:CRME) was unaffected Wednesday, actually gaining 3 cents, to close at 40 cents, following the handover and news that Cardiome would continue advancing vernakalant oral worldwide and vernakalant I.V. in North America.

"We are respectful of the fact that we've been dealt with fairly and quickly," said Cardiome's interim CEO Bill Hunter in a press conference Wednesday morning.

Hunter said Whitehouse Station, N.J.-based Merck was handing vernakalant back for business reasons. "It doesn't meet their specific strategic needs at this time."

He pointed out, however, that the needs of a global pharmaceutical company and a small biotech are very different.

"The market has been waiting for clarity as to where the franchise is going. The company needed that clarity; the shareholders needed that clarity. We can move forward, take the next steps as an organization and make this a successful drug as we know it has the potential to be," Hunter said.

Merck acquired North American rights to vernakalant in 2011 . At that time, Merck's involvement was viewed as a vote of confidence in a drug that had suffered a major setback in 2010, when clinical testing of the I.V. version was suspended due to a case of cardiogenic shock at a South American clinical site. (See BioWorld Today, Oct. 22, 2010, and July 27, 2011.)

That trial was to have been a confirmatory Phase III trial of I.V. vernakalant (marketed in Europe under the trade name Brinavess) for rapid conversion of atrial fibrillation to sinus rhythm.

The trial, carried out in partnership with Astellas Pharma Inc., would have enrolled up to 450 patients with atrial fibrillation of more than three hours duration, but less than seven days, excluding patients with congestive heart failure.

The FDA put the trial on hold, requesting full data from the site before it would give permission to continue. But the clinical hold was not expected to last so long.

Merck was expected to resolve the clinical hold on I.V. vernakalant and advance oral vernakalant.

The firm previously had acquired ex-North American rights to vernakalant in a deal worth up to $800 million. (See BioWorld Today, April 10, 2009.)

Although Cardiome is optimistic about regaining full ownership of vernakalant once more, some analysts are concerned that the fledgling company may not have the resources to advance it, or that Merck's withdrawal signals reduced expectations.

"Commercial, clinical and regulatory uncertainty still exist, and Cardiome's resources alone are unlikely to kickstart Brinavess sales or to gain U.S. approval," wrote Douglas Miehm, of RBC Capital Markets.

Miehm pointed out that Brinavess uptake in Europe has been poor since its approval in 2010, and that Cardiome's cash of about $60 million won't be sufficient to fund trials to completion and also support Brinavess European sales.

Cardiome will require a partner or some source of additional funding in order to fully take over responsibility for vernakalant.

"The oral program is a completely different proposal, which would require significant capital to resurrect if a partner were to invest in that high-risk program," Miehm added.

Merck has not disclosed Brinavess sales figures. "While they continue to sell it, we'll respect that wish," Hunter said, indicating that once the transition period was over, Cardiome would provide more detail on sales.

Cardiome's credit line with Merck also has been terminated. The biotech had borrowed $50 million and is required to repay it by 2017.

There have been changes to the agreement, but Cardiome did not disclose the details.

Hunter acknowledged that as a small company that now has an approved drug on the market, Cardiome may be of interest for acquisition by other companies.

"The next five to six months could open a lot of avenues," he said. "It could be a very interesting time for us."